patient information leaflet frusol 20mg

PATIENT INFORMATION LEAFLET

What You Need To Know About FRUSOL® 20mg/5ml

Furosemide

This leaflet should be read carefully before taking this medicine and kept in a handy place for reference. It can only provide a brief summary about your medicine and if you have any further questions, ask your doctor or pharmacist.

Remember: This medicine can only be obtained with a prescription from a doctor. This medicine is for your use only and you should not give it to other people.

What is Frusol 20mg/5ml?

Frusol is an oral solution which contains 20mg Furosemide Ph.Eur per 5ml spoonful.

The medicine also contains ethanol (10% v/v), sodium hydroxide, colouring E104, cherry flavour (containing ethanol and propylene glycol), liquid maltitol, disodium hydrogen phosphate, citric acid monohydrate and purified water.

The medicine is available in packs of 150ml.

Furosemide belongs to a group of medicines called Diuretics which are used to reduce excess amounts of water in the body.

Why have you been prescribed Frusol 20mg/5ml?

You may have certain conditions which affect the heart, lungs, kidney, liver or blood vessels which lead to a build up of water in the body. Furosemide helps to reduce these levels of excess water.

What you should know before taking this medicine

You must tell your doctor if:

you have ever had an unusual reaction to Furosemide, sulphonamides or any of the ingredients listed;
you are pregnant or breast-feeding;
you have the following medical conditions:-
- difficulty in passing urine;
- liver or kidney problems;
- enlargement of the prostate gland;
- low blood pressure (symptoms include dizziness, reduced alertness, fainting, general weakness), severe changes in blood salts (e.g. low sodium and high potassium levels. Symptoms include muscle cramps, weakness or fatigue) or low blood volume (symptoms include weakness, difficulty breathing, light-headedness);
- diabetes or gout;
- porphyria (a metabolic disorder that can cause skin blisters, abdominal pain and brain/ nervous system disorders)
- dehydration
- low levels of protein in the blood. Symptoms may include swelling, feeling or being sick, diarrhoea and stomach pain.
Speak to the doctor before this medicine is given to a premature infant
you are taking any of the following medicines:
- ACE inhibitors or angiotensin-II receptor antagonists (drugs used in high blood pressure or heart failure, e.g. captopril, losartan), alpha-blockers (used in high blood pressure or prostatic hyperplasia e.g. prazosin), non-steroidal anti-inflammatory drugs (pain killers e.g. indometacin), drugs to control the rate the heart beats (e.g. amiodarone, disopyramide, flecainide), drugs to treat bacterial infections (e.g. lymecycline, vancomycin, gentamicin, colistin), antidepressants (e.g. reboxetine, amitriptyline, phenelzine), drugs used to treat psychosis (e.g. amisulpiride, sertindole, pimozide, chlorpromazine), drugs used to treat epilepsy (e.g. carbamazepine, phenytoin), drugs used to treat fungal infections (e.g.amphotericin), drugs used to treat viral infections (e.g.nelfinavir, ritonavir, saquinavir), atomoxetine (used to treat attention deficit/hyperactivity disorder, ADHD), phenobarbital (used to treat severe insomnia), beta blockers (e.g. propranolol, atenolol, carvedilol and used to treat for example, high blood pressure, angina, heart failure, problems in the rhythm of the heart), digoxin (used to treat heart failure and problems in the rhythm of the heart), drugs used in transplant patients (tacrolimus, ciclosporin), corticosteroids (e.g. prednisolone, dexamethasone and used to treat different types of inflammation), other diuretics (e.g. acetazolamide, metolazone and used in hypertension and water retention), lithium (used to treat mood disorders), potassium salts (used to treat low potassium in the blood), drugs used to treat asthma (e.g. salmeterol, salbutamol), drugs used to treat nasal congestion (e.g. ephedrine, xylometazoline), theophylline (used to treat asthma and chronic obstructive pulmonary disease), carbenoloxone (used to treat mouth ulcers and upper gastrointestinal disorders), laxatives, anything containing large amounts of liquorice.

If you are driving or operating machinery, care should be taken as furosemide may decrease your mental alertness.

This product contains 10% of ethanol by volume. Each dose contains up to 0.4g of alcohol. It is harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children. It may modify or increase the effect of other medicines.

This product also contains liquid maltitol. You should not take this medicine if you have a rare hereditary problem of fructose intolerance.

This product also contains quinoline yellow (E104) which may cause allergic - type reactions including asthma. The allergy is more common in people who are allergic to aspirin.

How should you take your Frusol liquid?

This medicine is only to be taken via the mouth.

It is best to take your dose in the morning. However, it is best to plan your dose or doses according to a schedule that will least affect your personal activities and sleep. Ask your doctor or pharmacist to help you plan the best time to take this medicine.

The usual dose is 40mg (two 5ml spoonfuls) daily but you must take exactly what has been prescribed by your doctor. Children’s doses may be lower but they must not take more than 40mg a day.

If you are elderly, you may find the doctor starts your treatment on a low dose and gradually increases it until the response needed is met.

Keep taking your medicine until your doctor tells you to stop.

If you forget to take your medicine, take a dose as soon as you remember then continue as normal the following morning.

If you take too much of the medicine, you should contact a doctor or hospital immediately.

Does Frusol 20mg/5ml have any side effects?

Along with its desired effect, a medicine may have unwanted effects. Not everyone will experience these but some, if they occur, may require medical attention.

The following side-effects are usually minor – nausea, vomiting, diarrhoea and mild physical discomfort.

However there can be more serious effects and if you develop any of these speak to your doctor immediately

Disturbances of body water and salts/minerals indicated by thirst, headache, dizziness (particularly when standing up), confusion, muscle twitching and disordered heart rate or rhythm. These may occur rapidly but can also develop gradually. Patients with liver problems may be at particular risk
Obstruction to the outflow of urine/difficulty in passing water
Severe reduction in blood cells that can result in weakness, unexplained bruising or bleeding, increased risk of infections and sores/ulceration of the mouth
Difficulty in controlling blood sugar levels in patients with diabetes: development of the symptoms of diabetes (e.g. thirst, increased urination, weight loss)
Hearing loss and/or ringing in the ears (tinnitus) – especially in patients with kidney problems
Severe allergic reactions which can cause immediate difficulty in breathing, collapse, fever and/or rash. More long-term allergic reactions include inflammation of kidneys and blood vessels and particular sensitivity of the skin to the sun and other sources of light (e.g. sun-beds) continued overleaf
Other skin disorders including rash, itching and a serious illness with blistering of skin, mouth, eyes and genitals
Inflammation of the pancreas (indicated by severe abdominal and/or back pain) and jaundice (yellowing of the skin and whites of the eyes caused by liver or blood problems)
Tingling or numbness in the hands and feet
Gout (sudden severe joint pains associated with increased uric acid in the blood)
Thrombosis (formation of blood clots) when you are severely dehydrated
Low blood pressure. This may show as unable to concentrate, feeling light-headed, feeling of pressure in the head, headache, dizziness, drowsiness, weakness, changes in vision, dry mouth and feeling dizzy when standing up.

Furosemide may increase certain elements in the blood including cholesterol and lipids.

If used in premature infants, furosemide can result in

Persistence of a blood channel that normally closes at or around birth (possibly resulting in heart failure, failure to thrive, shortness of breath and rapid pulse)
Kidney stones and/or calcium deposits in the kidney

If you are not sure about something or have a symptom that is not listed here, you should talk to your doctor.

How to store your medicine

Frusol 20mg/5ml should be stored at or below 25°C.

Once the bottle has been opened for more than 3 months, the product should not be used.

The label on the bottle shows an expiry date (month, year). Do not use this product after this date.

Do not keep outdated medicine or medicine that is no longer wanted. Take it to your pharmacist for safe disposal.

Always keep the medicine in the bottle in which it was originally given to you.

Medicine: frusol 20mg