FRUSOL Oral solution (2020)

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Περιεχόμενα

1. Name of the medicinal product

Frusol 20mg/5ml Oral Solution.

2. Qualitative and quantitative composition

Each 5ml contains 20 milligrams Furosemide. Excipient(s) with known effect: Ethanol 397.28mg/5ml Quinoline Yellow (E104) 0.075mg/5ml Liquid Maltitol (E965) 2.5g/5ml Propylene Glycol (E1520) 0.35mg/5ml ...

3. Pharmaceutical form

A clear yellow liquid (Oral Solution).

4.1. 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 ...

4.2. Posology and method of administration

Posology Adults The usual initial daily dose is 40mg. This may be adjusted until an effective dose is achieved. Paediatric population 1 to 3mg/Kg body weight daily up to a maximum total dose of 40mg/day. ...

4.3. Contraindications

Contra-indicated conditions See also Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or sulphonamides, sulphonamide derivatives. - Hypovolaemia and dehydration ...

4.4. Special warnings and precautions for use

Conditions requiring correction before furosemide is started (see also section 4.3): Hypotension Hypovolaemia Severe electrolyte disturbances – particularly hypokalaemia, hyponatraemia and acid-base ...

4.5. Interaction with other medicinal products and other forms of interaction

Antihypertensives: enhanced hypotensive effect possible with all types. Concurrent use with ACE inhibitors or Angiotensin II receptor antagonists can result in marked falls in blood pressure, furosemide ...

4.6. Pregnancy and lactation

Pregnancy Frusol must not be given during pregnancy unless there are compelling medical reasons. Breast-feeding Furosemide may inhibit lactation and may pass into breast milk. Women must not breastfeed ...

4.7. Effects on ability to drive and use machines

Mental alertness may be reduced and the ability to drive or operate machinery may be impaired.

4.8. Undesirable effects

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); Frequency not known (cannot be estimated from the available data). Blood ...

4.9. Overdose

Symptoms Overdosing may lead to dehydration and electrolyte depletion through excessive diuresis. Severe potassium loss may lead to serious cardiac arrhythmias. Management Treatment of overdose consists ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: High-Ceiling Diuretic Sulfonamide ATC code: CO3CA01 Furosemide is a potent loop diuretic which inhibits sodium and chloride reabsorption at the Loop of Henlé. The ...

5.2. Pharmacokinetic properties

When oral doses of Furosemide are given to normal subjects the mean bioavailability of the drug is approximately 52% but the range is wide. In plasma, Furosemide is extensively bound to proteins mainly ...

5.3. Preclinical safety data

Furosemide is a widely used diuretic which has been available for over thirty years and its safety profile in man is well established.

6.1. List of excipients

Ethanol Sodium hydroxide Quinoline yellow (E104) Cherry flavour (containing ethanol and propylene glycol (E1520)) Liquid maltitol (E965) Disodium hydrogen phosphate (E339) Citric acid monohydrate (E330) ...

6.2. Incompatibilities

None known.

6.3. Shelf life

24 months. 3 months after first opening.

6.4. Special precautions for storage

Store at or below 25°C.

6.5. Nature and contents of container

Bottles: Amber (Type III) glass. Closures: HDPE, EPE wadded, tamper evident, child resistant. Capacity: 150ml.

6.6. Special precautions for disposal and other handling

Keep out of the sight and reach of children. Instruction for administration via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes: Ensure that the enteral feeding tube is free from obstruction ...

7. Marketing authorization holder

Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

8. Marketing authorization number(s)

PL 00427/0109

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 06 April 1998 Date of latest renewal: 31 March 2003

10. Date of revision of the text

01/10/2020

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