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The product code for this leaflet is: PL 00427/0111

 

Frusol 50mg/5ml Oral Solution

Company Details

Rosemont Pharmaceuticals Limited


Rosemont HouseYorkdale Industrial ParkBraithwaite StreetLeedsYorkshireLS11 9XE
Telephone:
Fax:
WWW:http://www.rosemontpharma.com
Customer Care direct line:
Out of Hours Telephone:
Out of Hours e-mail:pharmacovigilance@rosemontpharma.com
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Patient Information Leaflet

Frusol® 50mg/5ml Oral Solution

furosemide

Read all of this leaflet carefully before you start taking this medicine

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1. What is Frusol 50mg/5ml Oral Solution and what is it used for
2. Before you take Frusol 50mg/5ml Oral Solution
3. How to take Frusol 50mg/5ml Oral Solution
4. Possible side effects
5. How to store Frusol 50mg/5ml Oral Solution
6. Further information

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1. What is Frusol 50mg/5ml Oral Solution and what is it used for

The name of your medicine is Frusol 50mg/5ml Oral Solution (called Frusol in this leaflet). It contains furosemide. This belongs to a group of medicines called diuretics, or water tablets.

Furosemide can be used to remove the levels of excess water in the body caused by heart, lung, kidney, liver or blood vessel problems.

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2. Before you take Frusol 50mg/5ml Oral Solution

Do not take Frusol and tell your doctor if:

  • you are allergic (hypersensitive) to furosemide, amiloride, sulphonamides or any other ingredients in this liquid (listed in Section 6 below). The signs of an allergic reaction include a rash, itching or shortness of breath
  • you have symptoms of weakness, difficulty in breathing and light-headedness. This could be a sign of having too little water in the body
  • you are dehydrated
  • you are not passing water (urine) at all or only a small amount each day
  • you have kidney failure or liver problems, including cirrhosis
  • you have a severe change in blood salts, such as high potassium or calcium levels or low sodium or magnesium levels. You may notice signs of this such as muscle cramps, weakness and tiredness. You must not take other medicines or supplements that contain potassium
  • you have low blood pressure. The signs of this include dizziness, feeling less alert than usual, fainting and general weakness
  • you have an illness called ‘Addison’s disease’. This is when your adrenal glands are not working properly. It can cause weakness, tiredness, weight loss and low blood pressure
  • you are taking digoxin, used to treat heart problems
  • you are breast-feeding.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Frusol.

Take special care with Frusol

Before you take furosemide tell your doctor if:

  • you have difficulty in passing water (urine), particularly if you have an enlarged prostate gland
  • you have gout
  • you have low levels of protein in the blood. The signs of this may include swelling, feeling sick (nausea) or being sick (vomiting), diarrhoea and stomach pain
  • you have brain disorders affecting your nervous system, or a condition called porphyria. This is a disorder that can cause skin blisters, pain in and around the stomach area (abdomen)
  • you have diabetes
  • you are going to give this medicine to a baby that was born too early
  • you have an abnormal heart rhythm or have a history of heart problems
  • you are elderly (above 65), especially if you are taking risperidone for dementia
  • you are pregnant.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Frusol.

Having operations and tests whilst on Frusol

Tell your doctor, dentist or nurse you are taking this medicine if

  • you are going to have an anaesthetic
  • you are going to have an X-ray examination that involves taking medicines before the procedure

While you are taking this medicine, your doctor may give you regular blood tests. Your doctor will do this to monitor levels of salts, minerals and glucose in your blood and to check that your kidneys are working properly.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because furosemide, the main ingredient of this medicine, can affect the way some other medicines work. Also some medicines can affect the way furosemide works.

Tell your doctor if you are taking any of these medicines:

  • medicines used to treat high blood pressure known as ACE-inhibitors or Angiotensin-II receptor antagonists, such as captopril and losartan or aliskiren or hydralazine
  • medicines used to treat high blood pressure or prostate problems known as alpha-blockers, such as prazosin
  • medicines used to treat high blood pressure and other medicines used to remove water from the body known as diuretics, such as amiloride, spironolactone, acetazolamide and metolazone
  • medicines used to treat unusual heart beats, such as amiodarone, disopyramide, flecainide, lidocaine, sotalol and mexiletine
  • medicines used to treat angina that you spray or dissolve under your tongue such as glyceryl trinitrate or isosorbide dinitrate
  • warfarin, used to prevent atrial fibrillation, unwanted clotting and stroke
  • clofibrate, used to treat high cholesterol
  • moxisylyte used to treat Raynaud's syndrome
  • medicines used to treat pain and inflammation known as NSAIDs, such as indometacin or salicylates such as aspirin
  • medicines used to treat inflammation known as corticosteroids, such as prednisolone and dexamethasone
  • medicines used to treat infections caused by bacteria, such as lymecycline, vancomycin, gentamicin, trimethoprim, cephaloridine, ceftriaxone and colistin
  • medicines used to treat infections caused by fungus, such as amphotericin
  • medicines used to treat infections caused by a virus, such as nelfinavir, ritonavir and saquinavir
  • drugs used after transplants, such as tacrolimus, ciclosporin, aldesleukin
  • medicines used for depression, such as reboxetine, amitriptyline and phenelzine
  • medicines used for mental problems called ‘psychoses’, such as risperidone (see section ‘Do not take Frusol’), amisulpride, sertindole, pimozide and chlorpromazine. Avoid using pimozide at the same time as furosemide
  • lithium, used to treat extreme mood swings
  • medicines used to help you sleep, such as chloral hydrate and triclofos
  • atomoxetine used to treat Attention Deficit Hyperactivity Disorder (ADHD)
  • medicines used to treat epilepsy, such as carbamazepine, phenobarbital and phenytoin
  • medicines used to treat Parkinson’s disease such as levodopa
  • medicines used to treat diabetes
  • medicines to treat asthma, such as salmeterol, salbutamol and theophylline. These medicines also treat chronic obstructive pulmonary disease
  • medicines used to treat blocked noses, such as ephedrine and xylometazoline
  • medicines used to treat cancer such as cisplatin, methotrexate and aminoglutethimide
  • medicines to relax muscles such as baclofen and tizanidine
  • laxatives that help you go to the toilet
  • alprostadil, used to treat male impotence
  • oestrogen and drospirenone, used as contraceptives or in hormone replacement therapy (HRT)
  • probenecid, used to treat gout
  • potassium salts used to treat low potassium in the blood
  • sucralfate, used to treat stomach ulcers. Do not take sucralfate within two hours of taking Frusol. This is because the sucralfate can stop the Frusol from working properly
  • antihistamines, used to treat allergies such as cetirizine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Frusol.

Taking Frusol with food and drink

You should avoid drinking alcohol while taking Frusol as this may lower your blood pressure further.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant or planning to become pregnant.

You should not take this medicine if you are breast-feeding.

Driving and using machines

While taking this medicine you may feel less alert than normal. If this happens, do not drive a car or use any tools or machines.

Important information about what is in Frusol

This medicine contains:

  • liquid maltitol. If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine
  • ethanol (alcohol). Each dose contains up to 0.4g of alcohol. It may change or increase the effects of other medicines. It is harmful to those who suffer from alcoholism. You should be aware the product has alcohol in it if:
    • you are pregnant or breast-feeding
    • you have liver disease
    • you have epilepsy
    • you have had a brain injury or brain disease
    • you are going to give this medicine to a child.
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3. How to take Frusol 50mg/5ml Oral Solution

Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.

Taking this medicine

  • this medicine contains 50mg of furosemide in each 5ml
  • take this medicine by mouth
  • it is best to take your dose in the morning
  • plan your doses so that they do not affect your personal activities and sleep
  • ask your doctor or pharmacist to help you plan the best time to take this medicine.

Adults

The usual dose for adults is:

  • 40mg each day
  • take the dose prescribed by your doctor.

Children

The usual dose for children is:

  • 1mg to 3mg for each kilogram of the child’s body weight
  • the correct dose will be worked out by the doctor
  • children should not take more than 40mg each day.

Older People

If you are an older person, your doctor may start you on a lower dose and gradually raise this dose.

If you take more Frusol than you should

If you take more of the medicine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.

If you forget to take Frusol

  • If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose
  • Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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4. Possible side effects

Like all medicines, Frusol can cause side effects, although not everybody gets them.

If you have an allergic reaction to Frusol, see a doctor straight away.

An allergic reaction may include:

  • any kind of skin rash
  • difficulty in breathing, fever and collapse
  • more long-term allergic reactions including swelling of the kidneys and blood vessels and particular sensitivity of the skin to sunlight and other sources of light such as sun-beds.

If you get any of the following side effects, see your doctor as soon as possible:

  • changes in the amounts of water, salts or minerals in your body. The signs of this you may feel are thirst, headache, feeling dizzy particularly when standing up, feeling confused, muscle twitching and unusual heart beats. These may happen quickly but also over time. If you have liver problems you may be more at risk of these symptoms
  • difficulty in passing water (urine)
  • a change in the amount of blood cells. The signs you may feel are feeling weak, unexplained bruises or bleeding, getting more infections and sores or ulcers in the mouth
  • difficulty in controlling your blood sugar levels if you have diabetes
  • developing diabetes. The signs you may feel are thirst, needing to go to the toilet a lot more and weight loss
  • loss of hearing and/or ringing in the ears. If you have kidney problems you may be more at risk
  • skin problems such as rash, itching and a serious illness with blistering of the skin, mouth, eyes and genitals. A more severe form may occur where layers of the skin may peel off to leave large areas of raw exposed skin all over the body
  • swelling of the pancreas. This may show as severe pain in the back and/or in the area in and around the stomach (the abdomen) and jaundice which shows as yellowing of the skin and the whites of the eyes caused by liver or blood problems. A more severe liver problem called liver encephalopathy may occur. Symptoms include forgetfulness, fits, mood changes and coma
  • tingling or numbness in the hands and feet
  • sudden severe joint pains linked to increased amounts of uric acid in the blood. This is known as gout
  • blood clots forming when you are severely dehydrated
  • low blood pressure. The signs you may feel are being unable to concentrate, feeling light-headed, a feeling of pressure in the head, headache, feeling drowsy, feeling weak, changes in vision, dry mouth and feeling dizzy when standing up.

This medicine may raise cholesterol and lipid (fat) levels in the blood.

If this medicine is used in babies born too soon (prematurely), this medicine can cause:

  • persistence of a blood channel that normally closes at or around birth. This may cause heart failure, failure to grow, shortness of breath and rapid pulse
  • kidney stones and/or calcium deposits in the body.

Tell your doctor if you get any of these side effects:

  • feeling sick (nausea) or being sick (vomiting)
  • generally feeling unwell.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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5. How to store Frusol 50mg/5ml Oral Solution

  • keep out of the reach and sight of children.
  • do not store above 25°C.
  • after you open the bottle, this medicine expires after 3 months. Take this medicine back to the pharmacy three months after you first open it.
  • do not use after the expiry date which is stated on the label and carton (exp: month, year).
  • the expiry date refers to the last day of that month.
  • do not use Frusol if you notice that the appearance or smell of your medicine has changed. Talk to your pharmacist.
  • medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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6. Further information

What Frusol 50mg/5ml Oral Solution contains

  • The active ingredient is furosemide.
  • The other ingredients are ethanol, sodium hydroxide, cherry flavour (containing ethanol and propylene glycol), liquid maltitol (E965), disodium hydrogen phosphate (E339), citric acid monohydrate (E330) and purified water.

What Frusol 50mg/5ml Oral Solution looks like and contents of the pack

A clear, colourless to pale yellow liquid that smells like cherry.

It comes in a brown glass bottle holding 150ml of solution.

Marketing Authorisation Holder and Manufacturer

Rosemont Pharmaceuticals Ltd
Yorkdale Industrial Park
Braithwaite Street
Leeds
LS11 9XE
UK
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This leaflet was last approved in April 2011.

P0546


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