Prescribing Information

Abbreviated Prescribing Information: Amlodipine 1 mg/ml and 2 mg/ml Oral Solution, and 1 mg/ml Oral suspension. Consult Summary of Product Characteristics before prescribing. Presentation: Oral solution, each 1 ml contains 1 mg and 2 mg of amlodipine, respectively, and Oral suspension, each 1 ml contains 1 mg of amlodipine. Therapeutic Indications: Hypertension, Chronic stable angina pectoris and Vasospastic (Prinzmetal’s) angina. Posology and method of administration: Adult: Hypertension and angina: 5 mg – 10 mg once daily in adults and the elderly. Hepatic impairment: Amlodipine should be initiated at the lowest dose and titrated slowly in patients with severe hepatic impairment. Renal impairment: Normal dosage is recommended. Paediatric population: 2.5 mg – 5 mg once daily for hypertension in children aged 6 – 17 years. Oral solution is suitable for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. The product should not be shaken prior to administration or mixed with food or beverages before use. Oral suspension: Shake the suspension in the bottle lightly 5 times and then turn the bottle upside down to ensure that no precipitation is sedimented on the bottom of the bottle. Contra-indications: Hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients. Severe hypotension. Shock (including cardiogenic shock). Obstruction of the outflow tract of the left ventricle. Haemodynamically unstable heart failure after acute myocardial infarction. Special Warnings and Precautions for use: The safety and efficacy of amlodipine in hypertensive crisis has not been established. Patients with heart failure should be treated with caution. Patients with impaired hepatic function should be initiated at the lower end of the dosing range and treated with caution. Dose titration should be done carefully in the elderly. Normal doses may be used in patients with renal failure. Amlodipine is not dialysable. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: POM. The very common and common reactions are presented below and refer the SmPC for other adverse reactions: Very common: Oedema. Common: Somnolence, dizziness, headache (especially at the beginning of the treatment), visual disturbance (including diplopia), palpitations, flushing, dyspnoea, abdominal pain, nausea, dyspepsia, altered bowel habits (including diarrhoea and constipation), ankle swelling, muscle cramps, fatigue, and asthenia. Pack Size and NHS Price: Oral solution: 1 mg/ml 150 ml – £72.00. 2 mg/ml 150 ml – £110.00. Oral suspension: 1 mg/ml 150 ml – £70.00. Marketing Authorisation Number: Oral solution: 1 mg/ml PL 00427/0234 and 2 mg/ml PL 00427/0235. Oral suspension: 1 mg/ml PL 00427/0277. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: December 2022.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400

Abbreviated Prescribing Information: Atenolol 25 mg/5 ml Sugar Free Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: Clear colourless oral solution with an odour of lemon and lime. Each 5 ml contains 25 mg atenolol. Therapeutic Indications: Atenolol Oral Solution is indicated for management of hypertension, angina, cardiac arrhythmias, and myocardial infarction. Early intervention in the acute phase. Posology and Method of Administration: Atenolol oral solution is intended for patients who are unable to swallow atenolol tablets. For adult patients with hypertension 50 mg (two 5 ml spoonfuls) or 100 mg (four 5 ml spoonfuls) in patients. Most patients with angina pectoris will respond to 100 mg (four 5 ml spoonfuls) given orally once a day, or 50 mg (two 5 ml spoonfuls) given twice a day. In patient with cardiac arrhythmias 50 mg (two 5 ml spoonfuls) to 100 mg (four 5 ml spoonfuls) administered daily as a single dose following initial intravenous injection or infusion of atenolol. For patients with Myocardial infarction, 15 minutes after the initial atenolol intravenous injection, 50 mg (two 5 ml spoonfuls) to be administered, provided no untoward effects have occurred from the intravenous dose. This should be followed by a further 50 mg (two 5 ml spoonfuls) orally 12 hours after the intravenous dose and then 12 hours later by 100 mg (four 5 ml spoonfuls) orally, once daily. Atenolol should be used with caution in elderly, especially in patients with impaired renal function and in patients with severe impairment of renal function. Patient’s on haemodialysis should be given 50 mg (two 5 ml spoonfuls) orally after each dialysis and this should be done under hospital supervision as marked falls in blood pressure can occur. Paediatric population: Atenolol oral solution is not recommended for use in children. Contra-indications: Atenolol oral solution is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients; cardiogenic shock, uncontrolled heart failure, sick sinus syndrome, second or third degree heart block, untreated phaeochromocytoma, metabolic acidosis, bradycardia (<45 bpm), hypotension, and severe peripheral arterial circulatory disturbances. Special Warnings and Precautions for use: Atenolol, as with other beta-blockers should not be withdrawn abruptly. The dosage should be withdrawn gradually over a period of 7-14 days, to facilitate a reduction in beta-blocker dosage. Caution should be exercised with the following: when a patient is scheduled for surgery, in patients with poor cardiac reserve, usage of drug in patients with Prinzmetal’s angina, usage of drug in less severe peripheral arterial circulatory disturbances, patients with first degree heart block. May mask the symptoms of hypoglycaemia, in particular tachycardia, usage of drug in elderly patients, in patients with a creatinine clearance of below 35 ml/min/1.73 m², and in in patients with reversible obstructive airways disease. Furthermore, it may mask the signs of thyrotoxicosis and symptoms of hypoglycaemia, in particular, tachycardia, and may cause hypersensitivity reaction including angioedema and urticaria. It may reduce the heart rate, as a result of its pharmacological action and may cause a more severe reaction to a variety of allergens, when given to patients with a history of anaphylactic reaction. In patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: not applicable. Legal Category: Prescription only medicine. Undesirable Effects. A list of common serious adverse reactions are presented here and refer the SmPC for details of other adverse reactions. Bradycardia, Peripheral coldness, Gastrointestinal disorder, and Fatigue. Pack Size and NHS Price: 300 ml – £10.48. Marketing Authorisation Number: PL 00427/0280. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [November-2022].

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400

Abbreviated Prescribing Information: Atorvastatin 4mg /ml Oral Suspension Consult Summary of Product Characteristics before prescribing. Presentation: Oral Suspension. White to brownish white Suspension, each 1 ml contains 4 mg of Atorvastatin (as 4.14 mg atorvastatin calcium trihydrate). Therapeutic Indications: For hypercholesterolaemia Atorvastatin Oral Suspension is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and Iib of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Atorvastatin Oral Suspension is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. Posology and Method of Administration: The patient should be placed on a standard cholesterol-lowering diet before receiving Atorvastatin Oral Suspension and should continue this diet during treatment with Atorvastatin Oral Suspension. The dose should be individualised according to baseline LDL-C levels, the goal of therapy and patient response. The usual starting dose is 10 mg (2.5 ml) once a day. Adjustment of dose should be made at intervals of 4 weeks or more. The maximum dose is 80 mg (20 ml) once a day. For primary hypercholesterolaemia and combined (mixed) hyperlipidaemia the majority of patients are controlled with Atorvastatin Oral Suspension 10 mg (2.5 ml) once a day. A therapeutic response is evident within 2 weeks, and the maximum therapeutic response is usually achieved within 4 weeks. The response is maintained during chronic therapy. For heterozygous familial hypercholesterolaemia patients should be started with Atorvastatin Oral Suspension 10 mg (2.5 ml) daily. Doses should be individualised and adjusted every 4 weeks to 40 mg (10 ml) daily. Thereafter, either the dose may be increased to a maximum of 80 mg (20 ml) daily or a bile acid sequestrant may be combined with 40 mg (10 ml) atorvastatin once daily. For homozygous familial hypercholesterolaemia. Only limited data are available. The dose of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg (2.5 to 20 ml) daily. Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable. Paediatric population: Paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia and patients should be re-evaluated on a regular basis to assess progress. For patients with Heterozygous Familial Hypercholesterolemia aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg (2.5 ml) per day. The dose may be increased to 80 mg (20 ml) daily, according to the response and tolerability. Doses should be individualised according to the recommended goal of therapy. Adjustments should be made at intervals of 4 weeks or more. The dose titration to 80 mg (20 ml) daily is supported by study data in adults and by limited clinical data from studies in children with Heterozygous Familial Hypercholesterolemia. There are limited safety and efficacy data available in children with Heterozygous Familial Hypercholesterolemia between 6 to 10 years of age derived from open-label studies. Atorvastatin is not indicated in the treatment of patients below the age of 10 years. Currently available data are described in the SmPC but no recommendation on posology can be made. Other pharmaceutical forms/strengths may be more appropriate for this population. Contra-indications: Atorvastatin Oral Suspension is contraindicated in patients: with hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC; with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal; during pregnancy, while breastfeeding and in women of child-bearing potential not using appropriate contraceptive measures; treated with the hepatitis C antivirals glecaprevir/pibrentasvir. Special Warnings and Precautions for use: Liver function tests should be performed before the initiation of treatment and periodically thereafter. Patients who develop any signs or symptoms suggestive of liver injury should have liver function tests performed. Atorvastatin Oral Suspension should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. The potential risk of hemorrhagic stroke should be carefully considered before initiating treatment particularly in patients with prior hemorrhagic stroke or lacunar infarct. Atorvastatin, like other HMG-CoA reductase inhibitors, may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis and subsequently to renal failure. Special care should be exercised for immune-mediated necrotizing myopathy during or after treatment as it is reported for some statins. Atorvastatin should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis. Creatine Kinase (CK) level should be measured before starting statin treatment and if CK levels are significantly elevated (> 5 times ULN) at baseline, treatment should not be started. Given the increased risk of rhabdomyolysis, care should be taken when giving atorvastatin in combination with other medications including potent inhibitors of CYP3A4 or transport proteins. The risk of myopathy may also be increased with the concomitant use of gemfibrozil and other fibric acid derivates, antivirals for the treatment of hepatitis C (HCV). Atorvastatin must not be co-administered with systemic formulations of fusidic acid or within 7 days of stopping fusidic acid treatment. In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout the duration of fusidic acid treatment. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. No clinically significant effect on growth and sexual maturation was observed in paediatric population in a 3- year study. Patients at risk of diabetes mellitus (fasting glucose 5.6 to 6.9 mmol/L, BMI>30kg/m², raised triglycerides, hypertension) should be monitored both clinically and biochemically. If myasthenia gravis or ocular myasthenia develops or worsens, atorvastatin oral suspension should be stopped using. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: POM. The common adverse reactions are nasopharyngitis, allergic reactions, hyperglycaemia, headache, pharyngolaryngeal pain, epistaxis, constipation, flatulence, dyspepsia, nausea, diarrhoea, myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain, liver function test abnormal, and blood creatine kinase increased. Refer the SmPC for details of other adverse reactions. Pack Size and NHS Price: 150ml – £216.00. Marketing Authorisation Number: PL 00427/0256 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [August-2023].

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400

Abbreviated Prescribing Information: Bumetanide 0.2 mg/ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: Bumetanide oral solution is a clear, green liquid with the flavour of peppermint. Each ml contains 0.2 mg bumetanide. Therapeutic Indications: Bumetanide oral solution is indicated whenever diuretic therapy is required in the treatment of oedema. Posology and Method of Administration: For oral administration only and the dosage should be adjusted according to the patient’s response. In Adults, adolescents, and children aged 12 years and older, usually 1 mg (5 ml) as a single oral dose given morning or early evening and a dose of 0.5 mg bumetanide per day may be sufficient in some elderly patients. Paediatric population: Bumetanide Liquid should not be used for children under 12 years of age. Contra-indications: Bumetanide oral solution is contraindicated in patients with: hypersensitivity to the active substance or to any of the excipients, hepatic coma, and marked increase in blood urea or the development of oliguria or anuria during treatment of severe progressing renal disease. Special Warnings and Precautions for use: Caution should be exercised in patients with the following: taking a low salt diet, diabetics and patients suspected of latent diabetes, chronic renal failure on high doses of bumetanide, hypotension and porphyria, hepatic impairment, already receiving nephrotoxic or ototoxic drugs, and known hypersensitivity to sulfonamides or thiazides. Bumetanide found in urine by doping test is cause for disqualification of athletes. Excipient warnings: Bumetanide contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, sorbitol, and less than 1 mmol sodium in each 5 ml. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: N/A. Legal Category: Prescription only medicine. Undesirable Effects: Thrombocytopenia, leukopenia, bone marrow failure, agranulocytosis, hypersensitivity, electrolyte imbalance, hypokalaemia, hyponatraemia, dehydration, hypomagnesaemia, gout, hyperuricaemia, alkalosis hypochloraemic, hyperglycaemia, hypocalcaemia, hyperlipidaemia, headache, dizziness, Tinnitus, deafness, orthostatic hypotension, hypotension, gastrointestinal disorder, nausea, vomiting, diarrhoea, abdominal pain, cholestasis, jaundice, rash, urticaria, dermatitis, photosensitivity reaction, pruritus, myalgia, muscle spasm, arthralgia, myalgia, muscle spasm, arthralgia, renal failure acute, gynaecomastia, breast pain, fatigue, and blood creatinine increased. Pack Size and NHS Price: 150 ml – £258.00. Marketing Authorisation Number: PL 00427/0281. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [December-2022].

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400

Abbreviated Prescribing Information: Dipyridamole 50 mg/5 ml Oral Suspension. Consult Summary of Product Characteristics before prescribing. Presentation: A bright yellow suspension with odour of almond, each 5 ml containing 50 mg of Dipyridamole. Therapeutic Indications: An adjunct to oral anticoagulation for prophylaxis of thromboembolism associated with prosthetic heart valves. Posology and Method of Administration: For oral use only. Dipyridamole suspension should usually be taken before meals. Adults: 300 mg to a maximum of 600 mg daily in three or four doses. Paediatric population: Dipyridamole is not recommended for children. Contraindications: Hypersensitivity to any of the ingredients in the product. Special Warnings and Precautions for use: Dipyridamole acts as a vasodilator. It should be used with caution in patients with severe coronary artery disease, including unstable angina and/or recent myocardial infarction, left ventricular outflow obstruction or haemodynamic instability (e.g., decompensated heart failure). Dipyridamole should be used with caution in patients with coagulation disorders. In patients with myasthenia gravis, readjustment of therapy may be necessary after changes in dipyridamole dosage (see Drug Interactions). Patients treated with regular oral doses of dipyridamole should not receive additional intravenous dipyridamole. If pharmacological stress testing with intravenous dipyridamole for coronary artery disease is considered necessary, then oral dipyridamole should be discontinued 24 hours prior to testing. A small number of cases have been reported in which unconjugated dipyridamole was shown to be incorporated into gallstones to a variable extent (up to 70% by dry weight of stone). These patients were all elderly, had evidence of ascending cholangitis and had been treated with oral dipyridamole for several years. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: POM. A list of very common and common adverse reactions (refer the SmPC for other adverse reactions): Headache, Dizziness, Angina pectoris, Diarrhoea, Nausea, Vomiting, Rash, Myalgia. Pack Size and NHS Price: 150 ml – £190.39. Marketing Authorisation Number: PL 00427/0133 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [December-2022].

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400

Abbreviated Prescribing Information: Frusol 20 mg/5 ml, 40 mg/5 ml, and 50 mg/5 ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear yellow liquid (Oral Solution), Each 5 ml contains 20 milligrams Furosemide for 20 mg/5 ml strength, each 5 ml contains 40milligrams Furosemide for 40 mg/5 ml strength and 5 ml containing 50 milligrams Furosemide for 50 mg/ml strength. Therapeutic Indications: Furosemide is indicated in all conditions requiring prompt diuresis, including cardiac, pulmonary, hepatic and renal oedema, peripheral oedema due to mechanical obstruction or venous insufficiency and hypertension. It is also indicated for the maintenance therapy of mild oedema of any origin. Posology and Method of Administration: For adults the usual initial daily dose is 40 mg. This may be adjusted until an effective dose is achieved. In the elderly, Furosemide is generally eliminated more slowly. Dosage should be titrated until the required response is achieved. For oral administration. Suitable for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. The medication should be administered in the morning to avoid nocturnal diuresis. Paediatric population: For paediatric population the dose is 1 to 3 mg/Kg body weight daily up to a maximum total dose of 40 mg/day. Contra-indications: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or sulphonamides, sulphonamide derivatives; Hypovolaemia and dehydration (with or without accompanying hypotension); Severe hypokalaemia: severe hyponatraemia; Comatose or pre-comatose states associated with hepatic cirrhosis or encephalopathy; Anuria or renal failure with anuria not responding to furosemide, renal failure as a result of poisoning by nephrotoxic or hepatotoxic agents; Impaired renal function with a creatinine clearance below 30 ml/min per 1.73 m² body surface area; Addison’s disease; Digitalis intoxication; Concomitant potassium supplements or potassium sparing diuretics and breast-feeding women. Special Warnings and Precautions for use: Hypotension; Hypovolaemia; Furosemide is not recommended in patients at high risk for radiocontrast nephropathy – it should not be used for diuresis as part of the preventative measures against radiocontrast-induced nephropathy and in elderly patients with dementia taking risperidone – Increased mortality. Caution and/or dose reduction required in elderly patients, difficulty with micturition including prostatic hypertrophy (increased risk of urinary retention: consider lower dose). Closely monitor patients with partial occlusion of the urinary tract, in moderate liver congestion dosage adjustment may be needed, diabetes mellitus (latent diabetes may become overt: insulin requirements in established diabetes may increase stop furosemide before a glucose tolerance test), pregnancy, gout (furosemide may raise uric acid levels/precipitate gout) impaired hepatic function, impaired renal function and hepato-renal syndrome, adrenal disease, hypoproteinemia e.g. nephrotic syndrome, acute hypercalcaemia, premature infants, some diuretics have been considered unsafe in acute porphyria, symptomatic hypotension leading to dizziness, fainting or loss of consciousness can occur in patients treated with furosemide, particularly in the elderly, patients on other medications which can cause hypotension and patients with other medical conditions that are risks for hypotension. concurrent NSAIDs should be avoided, ACE-inhibitors & Angiotensin II receptor antagonists – severe hypotension may occur, concurrent risperidone in elderly patients with dementia has resulted in increased mortality. Laboratory and other monitoring requirements: Serum sodium particularly in the elderly or in patients liable to electrolyte deficiency, Serum potassium particular in patients with cirrhosis of the liver, those receiving concomitant treatment with corticosteroids, those with an unbalanced diet and those who abuse laxatives. If used in premature infants there is a risk of nephrocalcinosis /nephrolithiasis so renal function must be monitored and renal ultrasonography performed. Regular monitoring of blood glucose levels is desirable, during long-term therapy (especially at high doses) magnesium, calcium, chloride, bicarbonate and uric acid should be regularly measured. Regular monitoring for blood dyscrasias. If these occur, stop furosemide immediately, liver damage, idiosyncratic reactions. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: POM. A list of common and very common adverse reactions (Refer the SmPC for full details of other adverse reactions): dehydration, hyponatraemia, hypochloremic metabolic alkalosis, hypocalcaemia, hypomagnesemia (incidences of the last three are reduced by triamterene), Hypovolaemia, hypochloraemia, hypotension, (which, if pronounced may cause signs and symptoms such as impairment of concentration and reactions, light-headedness, sensations of pressure in the head, headache, drowsiness, weakness, disorders of vision, dry mouth, orthostatic intolerance), nephrocalcinosis in infants, creatinine increased, blood urea increased. Pack Size and NHS Price: 20 mg/5 ml 150 ml – £12.07, 40 mg/5 ml 150 ml – £15.58, 50 mg/5 ml 150 ml – £16.84. Marketing Authorisation Number: PL 00427/0109, PL 00427/0110, PL 00427/0111. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [January 2023].

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400

Abbreviated Prescribing Information: Lisinopril 1 mg/ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear and colourless oral solution with a sweet taste, each 1 ml contains 1 mg lisinopril (as lisinopril dihydrate). Therapeutic Indications: Treatment of hypertension, symptomatic heart failure, acute myocardial infarction, and renal complications of diabetes mellitus. Posology and Method of Administration: Lisinopril 1 mg/ml oral solution should be administered orally in a single daily dose. Depending on the indication and the patient’s profile and blood pressure response, the recommended starting dose falls between 2.5 mg and 10 mg once daily and the maximum daily dose can be up to 40 mg. Paediatric population: Lisinopril 1 mg/ml oral solution is not recommended in children aged >6 years in other indications than hypertension and not recommended in children below the age of 6, or in children with severe renal impairment (GFR <30 ml/min/1.73m²). Elderly people: the dosage should be adjusted according to the blood pressure response. Use in kidney transplant patients: Lisinopril 1 mg/ml oral solution is not recommended in kidney transplant patients. Contra-indications: Hypersensitivity to Lisinopril or to any of the excipients or to any other angiotensin converting enzyme (ACE) inhibitor; History of angioedema associated with previous ACE inhibitor therapy; Hereditary or idiopathic angioedema; Second and third trimesters of pregnancy; Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²); and concomitant use with sacubitril/valsartan therapy. Lisinopril must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan. Special Warnings and Precautions for use: Caution should be exercised in following conditions: symptomatic hypotension, patients with acute myocardial infarction who are at risk of further serious haemodynamic deterioration after treatment with a vasodilator, mitral valve stenosis and obstruction in the outflow of the left ventricle, renal function impairment, hypersensitivity/angioedema, anaphylactoid reactions in haemodialysis patients, during low-density lipoproteins (LDL) apheresis as life-threatening anaphylactoid reactions have been reported, during desensitisation treatment, hepatic failure, neutropenia/agranulocytosis, concomitant use with aliskiren-containing medicines, patients undergoing major surgery or during anaesthesia with agents that produce hypotension, hyperkalaemia, ACE inhibitor-induced cough, diabetic patients treated with oral antidiabetic agents or insulin. It was identified that angiotensin-converting enzyme inhibitors cause a higher rate of angioedema in black patients than in non-black patients. The combination of lithium and lisinopril is not recommended. In pregnancy, ACE inhibitors should not be initiated and when pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice (if relevant): N/A. Legal Category: POM. The common adverse reactions are presented below and refer the SmPC for full details of other adverse reactions: dizziness, headache, orthostatic effects (including hypotension), cough, diarrhoea, vomiting, and renal dysfunction. Pack Size and NHS Price: 150 ml – £218.00. Marketing Authorisation Number: PL 00427/0284. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [December-2022].

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400

Abbreviated Prescribing Information: Propranolol Rosemont 5 mg/5 ml, 10 mg/5 ml, 40 mg/ml, 50 mg/5 ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: Oral solutions containing 5 mg, 10 mg, 40 mg, and 50 mg of propranolol hydrochloride in each 5 ml respectively. Therapeutic Indications: Propranolol is indicated in the control of hypertension; the management of angina pectoris; the long term prophylaxis against reinfarction after recovery from acute myocardial infarction; control of most forms of cardiac arrhythmia; prophylaxis of migraine; management of essential tremor; relief of situational anxiety and generalised anxiety symptoms, prophylaxis of upper gastro-intestinal bleeding in patients with portal hypertension and oesophageal varices; adjunctive management of thyrotoxicosis and thyrotoxic crisis; management of hypertrophic obstructive cardiomyopathy; and management of phaeochromocytoma perioperatively (with an alpha-adrenoceptor blocking drug). Posology and Method of Administration: For oral administration only. Depending on the indication, the dose of Propranolol for Adults: usually between 30 mg and 320 mg per day. Children: usually between 750–2000 micrograms per kilogram daily as required. Elderly: the optimum dose should be individually determined according to the clinical response. Contra-indications: History of bronchial asthma or bronchospasm, hypersensitivity to propranolol hydrochloride or any of the ingredients; second or third degree heart block; cardiogenic shock; metabolic acidosis; hypoglycaemia; prolonged fasting; bradycardia; hypotension; severe peripheral arterial circulatory disturbances; sick sinus syndrome; untreated phaeochromocytoma; uncontrolled heart failure or Prinzmetal’s angina. Special Warnings and Precautions for use: Caution in patients whose cardiac reserve is poor. Treatment should not be discontinued abruptly in patients with ischaemic heart disease. It may block/modify the signs and symptoms of hypoglycaemia (especially tachycardia), caution must be exercised in the concurrent use of propranolol and hypoglycaemic therapy in diabetic patients. Propranolol may aggravate less severe peripheral arterial circulatory disturbances. Should not be used in untreated phaeochromocytoma. Discontinuation of treatment for surgery should be done at least 24 hours prior to procedure. Dosage should be reduced where symptoms are attributable to a slow heart rate. Caution if it is given to patients with first degree heart block and when starting treatment and selecting the initial dose. In portal hypertension, liver function may deteriorate, and hepatic encephalopathy may develop. Propranolol may cause a more severe reaction to a variety of allergens. Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions. Propranolol may mask the signs of thyrotoxicosis. Caution in decompensated cirrhosis. Propranolol should be used to treat the elderly with caution starting with a lower dose. administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis as it may reach the foetus and was found in milk. Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old.Caution should be exercised in patients with impaired renal or hepatic functions. Propranolol has been reported to interfere with the estimation of serum bilirubin by the diazo method and with the determination of catecholamines by methods using fluorescence. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: POM. Undesirable effects: Common reactions are presented here and refer the SmPC for details of other adverse reactions: Sleep disturbances, nightmares, Bradycardia, Cold extremities, Raynaud’s phenomenon, Fatigue and/or Lassitude (often transient). Pack Size and NHS Price: 5 mg/5 ml 150 ml – £23.50, 10 mg/5 ml 150 ml – £28.45, 40 mg/5 ml 150 ml – £36.50, 50 mg/5 ml 150 ml – £38.50. Marketing Authorisation Number: PL 00427/0123 (10 mg/5 ml), PL 00427/0135 (40 mg/5 ml), PL 00427/0124 (50 mg/5 ml), and PL 00427/0122 (5 mg/5 ml). Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [December-2022].

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400

Abbreviated Prescribing Information: Ramipril 2.5 mg/5 ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear colourless solution, each 5 ml of solution contains 2.5 mg Ramipril. Therapeutic Indications: Ramipril oral solution is indicated for the treatment of hypertension. Cardiovascular prevention in patients with manifest atherothrombotic cardiovascular disease or diabetes with at least one cardiovascular risk factor. Treatment of renal disease: Incipient glomerular diabetic nephropathy, manifest glomerular diabetic nephropathy, manifest glomerular nondiabetic nephropathy. Treatment of symptomatic heart failure. Secondary prevention after acute myocardial infarction. Posology and Method of Administration: Ramiprilshould be taken each day at the same time. Depending on the indication and the patient the dosage ranges from 1.25 mg (2.5 ml) initially up to a maximum daily dosage of 10 mg (20 ml). Paediatric population: The safety and efficacy of ramipril in children has not yet been established. Oral use. Suitable for administration via nasogastric or percutaneous endoscopic gastrostomy tubes. Contraindications: Hypersensitivity to ramipril, to any of the excipients or any other ACE inhibitors, history of angioedema, extracorporeal treatments leading to contact of blood with negatively charged surfaces, bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney, 2nd and 3rd trimester of pregnancy, patients with hypotensive or haemodynamically unstable states,concomitant use with sacubitril/valsartan and or aliskiren containing products in patients with diabetes mellitus or renal impairment. Special warnings and Precautions for use: Ramipril should not be initiated during pregnancy and should be stopped immediately when pregnancy is diagnosed. Caution should be exercised with the following: patients at risk of hypotension, strongly activated reninangiotensin-aldosterone system, severe hypertension, decompensated congestive heart failure, haemodynamically relevant left ventricular inflow or outflow impediment, unilateral renal artery stenosis with a second functional kidney, fluid or salt depletion, liver cirrhosis and/or ascites, surgery or during anaesthesia with agents that produce hypotension, concomitant use of ACE-inhibitors,angiotensin II receptor blockers or aliskiren, transient or persistent heart failure post MI, patients at risk of cardiac or cerebral ischemia in case of acute hypotension, and the elderly. Ramipril should be discontinued one day before surgery. Where there is renal impairment, dosage should be adjusted. In case of angioedema, Ramipril must be discontinued. The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens are increased under ACE inhibition. Hyperkalaemia and hyponatraemia have been observed in some patients. Neutropenia/agranulocytosis, thrombocytopenia, and anaemia have been rarely seen and bone marrow depression has also been reported. ACE inhibitors may be less effective and cause higher rate of angioedema in black patients. Cough has been reported with the use of ACE inhibitors. Excipient warnings: contains ethyl and butyl hydroxybenzoate which may cause allergic reactions. Also contains sodium, propylene glycol which may induce adverse effects in children less than 5 years old and potentially pregnant or breast-feeding patients. Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: not applicable. Legal Category: Prescription only medicine. Undesirable Effects. A list of common and serious adverse reactions are presented here and refer the SmPC for details of other adverse reactions. Angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis, blood potassium increased, headache, dizziness, hypotension, orthostatic blood pressure decreased, syncope, non-productive tickling cough, bronchitis, sinusitis, dyspnoea, gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting, rash in particular maculo-papular, muscle spasms, myalgia, chest pain, and fatigue. Pack Size and NHS Price: 150 ml – £196.00. Marketing Authorisation Number: PL 00427/0162. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE. Date of Preparation: November 2022.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400

Abbreviated Prescribing Information: Simvastatin Rosemont 20 mg/5 ml and 40 mg/5 ml Oral Suspension. Consult Summary of Product Characteristics before prescribing. Presentation: A white to off-white oral suspension containing 20 mg or 40 mg simvastatin per 5 ml. Therapeutic Indications: Hypercholesterolaemia and reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy. Posology and Method of Administration: Adults: The dosage range is 5 – 80 mg/day depending on condition given orally as a single dose in the evening. Adjustments of dosage should be made at intervals of not less than 4 weeks, to a maximum of 80 mg/day. The 80 mg dose is only recommended in patients with severe hypercholesterolaemia and high risk for cardiovascular complications. In patients taking lomitapide concomitantly with simvastatin, the dose of Simvastatin Oral Suspension must not exceed 40 mg/day. In patients with severe renal insufficiency (creatinine clearance <30 ml/min), dosages above 10 mg/day should be carefully considered. Children: 10-17 years of age, boys Tanner Stage II and above and girls who are at least one-year post-menarche with heterozygous familial hypercholesterolaemia, starting dose is 10 mg once a day in the evening. The recommended dosing range is 10–40 mg/day. Adjustments should be made at intervals of 4 weeks or more. The experience of simvastatin in pre-pubertal children is limited. Elderly: No dosage adjustment is necessary. Contra-indications: Hypersensitivity to simvastatin or to any of the excipients. Concomitant administration of gemfibrozil, ciclosporin, danozol or potent CYP3A4 inhibitors. Active liver disease or unexplained persistent elevations of serum transaminases. Pregnancy and lactation. In patients with HoFH, concomitant administration of lomitapide with doses > 40 mg simvastatin. Special Warnings and Precautions for use: Myopathy/Rhabdomyolysis: risk of myopathy is increased by high levels (80 mg and above) and is greater than other statin-based therapies with similar LDL-C-lowering efficacy. Hepatic effects: persistent increases in serum transaminases have occurred. When simvastatin was interrupted or discontinued in these patients, the transaminase levels usually fell slowly to pre-treatment levels. Reduced function of hepatic OATP transport proteins can increase the systemic exposure of simvastatin and increase the risk of myopathy and rhabdomyolysis. Use with caution in patients who consume substantial quantities of alcohol. Interstitial lung disease: exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy. Diabetes Mellitus: some evidence suggests that statins as a class can raise blood glucose. The dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant medication with products containing elbasvir or grazoprevir due to an increased risk of myopathy. Cases of myopathy and/or rhabdomyolysis have been reported with H MG-CoA reductase inhibitors (e.g., simvastatin) co-administered with daptomycin. Paediatric population: Simvastatin has not been studied in patients younger than 10 years of age, nor in pre-pubertal children and pre-menarchal girls. Also, doses greater than 40 mg have not been studied patients 10-17 years of age. Excipient Warnings: contains parahydroxybenzoates which may cause allergic reactions, and propylene glycol. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: not applicable. Legal Category: Prescription only medicine. A list of common and serious adverse reactions (include statement to consult the SmPC for full details of other adverse reactions): Blood and lymphatic system disorders: Rare: anaemia. Psychiatric disorders: Very rare: insomnia. Not known: depression. Nervous system disorders: Rare: headache, paraesthesia, dizziness, peripheral neuropathy. Very rare: memory impairment. Eye disorders: Rare: vision blurred, visual impairment. Respiratory, thoracic and mediastinal disorders: Not known: interstitial lung disease. Gastrointestinal disorders: Rare: constipation, abdominal pain, flatulence, dyspepsia, diarrhoea, nausea, vomiting, pancreatitis. Hepatobiliary disorders: Rare: hepatitis/jaundice. Very rare: hepatic failure. Skin and subcutaneous tissue disorders: Rare: rash, pruritus, alopecia. Very rare: lichenoid drug eruptions. Musculoskeletal, connective tissue and bone disorders: Rare: myopathy, rhabdomyolysis, myalgia, muscle cramps. Very rare: muscle rupture. Not known: tendinopathy, immune-mexdiated necrotizing myopathy. Reproductive system and breast disorders: Very rare: gynecomastia. Not known: erectile dysfunction. General disorders and administration site conditions: Rare: asthenia, apparent hypersensitivity syndrome. Immune system disorders: Very rare: anaphylaxis. Investigations: Rare: increases in serum transaminases, elevated alkaline phosphatase, increase in serum CK levels, increases in HbA 1c and fasting serum glucose levels and rare post-marketing reports of cognitive impairment have been reported. Pack Size and NHS Price: 20 mg/5 ml 150 ml – £203.00, 40 mg/5 ml 150 ml – £285.00. Marketing Authorisation Number: 20 mg/5 ml PL 00427/0230, 40 mg/5 ml PL 00427/0231. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [December-2022].

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400

Abbreviated Prescribing Information: Warfarin Sodium 1 mg/1 ml Oral Suspension. Consult Summary of Product Characteristics before prescribing. Presentation: A white to off white suspension, each 1 ml of suspension contains Warfarin Sodium 1 mg. Therapeutic Indications: Prophylaxis of systemic embolism in patients with rheumatic heart disease and atrial fibrillation. Prophylaxis after insertion of prosthetic heart valves. Prophylaxis of venous thrombosis and pulmonary embolism and for use in the treatment of these conditions to prevent their extension. Posology and Method of Administration: For oral administration only. Adults: Between 3 mg and 10 mg per day. Elderly: dosage may need to be lowered. Paediatric population: Warfarin 1 mg/ml Oral Suspension is not recommended for use in children. Contra-indications: Hypersensitivity to the active substance or to any of the excipients, haemorrhagic stroke and clinically significant bleeding, use within 72 hours of surgery with risk of severe bleeding, use within 48 hours postpartum, pregnancy, fibrinolytic drugs, drugs where interactions lead to a significantly increased risk of bleeding, and any physical condition in which the risk of haemorrhage might be greater than the potential clinical benefits. Special Warnings and Precautions for use: Most adverse events reported with warfarin are a result of over anticoagulation. If this preparation replaces or is replaced by another warfarin product, the patient should be monitored closely in the period immediately following the change.Monitoring: Regular depending on risk. Thrombophilia: Patients with protein C or S deficiency are at risk of developing skin necrosis when starting warfarin treatment. There is a risk of haemorrhage with warfarin treatment. Haemorrhage can indicate an overdose of warfarin has been taken. Warfarin treatment should be re-started 2–14 days following ischaemic stroke, depending on the size of the infarct and blood pressure. Minor surgical procedures with low risk of bleeding can be performed in general with an INR of <2.5. Where there is a risk of severe bleeding, warfarin should be stopped 3-5 days prior to surgery. Where it is necessary to continue anticoagulation the INR should be reduced to <2.5 and heparin therapy should be started. If surgery is required and warfarin cannot be stopped 3 days beforehand, anticoagulation should be reversed with low-dose vitamin K. The timing for re-instating warfarin therapy depends on the risk of post-operative haemorrhage. In most instances warfarin treatment can be re-started as soon as the patient has an oral intake. In most cases warfarin need not be stopped before routine dental surgery. Calciphylaxis has been reported. Patients with history of peptic ulcers should be reviewed regularly. Any change to medication, including self-medication with OTC products, warrants increased monitoring of the INR. The rate of warfarin metabolism depends on thyroid status; patients with hyper- or hypo-thyroidism should be closely monitored on starting warfarin therapy. The following may exaggerate the effect of warfarin, and necessitate a reduction of dosage: loss of weight, acute illness, cessation of smoking. The following may reduce the effect of warfarin, and require the dosage to be increased: weight gain, diarrhoea, vomiting. Acquired or inherited warfarin resistance should be suspected if larger than usual daily doses of warfarin are required to achieve the desired anticoagulant effect. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: POM. The adverse reactions are: Fever, hypersensitivity, cerebral haemorrhage, cerebral subdural haematoma, haemorrhage, haemothorax, epistaxis, gastrointestinal haemorrhage, rectal haemorrhage, haematemesis, pancreatitis, diarrhoea, nausea, vomiting, melaena, rash, alopecia, purpura, erythematous swollen skin patches leading to ecchymosis, infarction and skin necrosis, calciphylaxis, jaundice, hepatic dysfunction, haematuria, anticoagulant-related nephropathy, unexplained drop in haematocrit, haemoglobin decreased, and purple toes. Pack Size and NHS Price: 150 ml – £187.00. Marketing Authorisation Number: PL 00427/0156. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE. Date of Preparation: December 2022.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400