Furosemide 20mg Tablets Bp
Package leaflet: Information for the user
FUROSEMIDE 20 mg TABLETS FUROSEMIDE 40 mg TABLETS
(Furosemide)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section
4._
What is in this leaflet
1. What Furosemide is and what it is used for
2. What you need to know before you take Furosemide
3. How to take Furosemide
4. Possible side effects
5. How to store Furosemide
6. Contents of the pack and other information
_1. What Furosemide is and what it is used for_
Furosemide Tablets can be used to stop the build up of extra water in your body. This extra water can cause swollen ankles, shortness of breath and feeling more tired than usual.
How Furosemide Tablets work
Furosemide Tablets work by helping you to pass more water (urine) than you usually do. If the extra water in your body is not removed, it can put extra strain on the heart, blood vessels, lungs, kidneys or liver.
2. What you need to know before you take Furosemide
Do not take Furosemide if:
• You are allergic to Furosemide and/or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling ofyour lips, face, throat or tongue;
• You are allergic to amiloride, sulfonamides or sulphonamide derivatives, such as sulfadiazine or cotrimoxazole;
• You have been told by a doctor that you have kidney failure. In some types of kidney failure, it is still okay to have this medicine. Your doctor will be able to decide;
• You have severe liver problems (cirrhosis);
• Your doctor has told you that you have a low blood volume or are dehydrated (with or without accompanying low blood pressure);
• You have too little potassium or sodium in your blood (shown in blood test);
• You have an illness called 'Addison's Disease' This can make you feel tired and weak;
• You are breast-feading (see "Pregnancy and breast-feeding" section below);
• You are taking other medicines which change the amount of potassium in your blood (see "Other medicines and Furosemide" section below);
• You are taking digoxin, used to treat heart problems;
• You suffer from acute porphyria symptoms of which may include severe stomach, back or thigh pain. Nausea, vomiting or constipation may also present along with weakness in arms and legs;
• You are children and adolescents under 18 years of age. Furosemide tablets are not suitable for children.
Do not take Furosemide Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Furosemide Tablets.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Furosemide if:
• You have low blood pressure, or feel dizzy when you stand up;
• You have diabetes (high blood sugar);
• You are 65 years of age or older;
• You have difficulty in passing water (urine);
• You have gout;
• You have liver or kidney problems;
• You have low levels of protein in your blood (hypoproteinaemia);
• You are an elderly patient with dementia and are also taking risperidone;
• You have prostate problems;
• You feel dizzy or dehydrated. This can happen if you have lost a lot of water through being sick, having diarrhoea or passing water very often. It can also happen if you are having troubledrinking or eating;
• You are going to give this medicine to a baby that was born too early;
• You are at high risk for kidney problems;
• You are going to have a glucose test;
• You are an elderly and on other medications which can cause the drop in blood pressure and if you have other medical conditions that are risks for the drop in blood pressure;
• You have elevated calcium levels (hypercalcaemia).
• You are taking any other water tablets.
If you are not sure if any of the above apply to you, talk: to your doctor or pharmacist before takingfurosemide tablets.
Other medicines and Furosemide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription, including herbal medicines.
This is because Furosemide tablets can affect the way some other medicines work. Also some medicines can affect the way Furosemide tablets work.
Do not take this medicine, and tell your doctor, if you are taking:
Medicines which change the amount of potassium in your blood. These include potassium supplements such as potassium chloride or certain water tablets (diuretics) such as triamterene.
The following medicines can affect the way Furosemide Tablets work and increase the chance of you getting side effects:
• Medicines used to treat high blood pressure such as ramipril, enalapril, perindopril (called 'ACE inhibitors') or losartan, candesartan, irbesartan (called 'angiotensin II receptor antagonists'). Your doctor may need to change the dose of your tablets or ask you to stop taking them;
• Medicines used to treat high blood pressure or prostate problems known as alpha-blockers, such as prazosin;
• Other 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 to help you sleep and relax such as chloral hydrate;
• Medicines used as a general anaesthetic for relaxing your muscles during surgery. If you are going to have an anaesthetic please ensure that the doctor or nurse knows you are taking furosemide;
• Medicines for diabetes. These may not work as well when you are taking Furosemide Tablets;
• Theophylline used for wheezing or difficulty in breathing;
• Phenytoin - used for epilepsy. This can lower the effect of Furosemide Tablets;
• Renin inhibitors such as Aliskerin;
• Medicines used for mental problems called 'psychoses', such as risperidone, amisulpride, sertindole, pimozide and chlorpromazine. Avoid using pimozide at the same time as furosemide.
The following medicines can increase the chance of side effects when taken with Furosemide Tablets:
• Lithium - used for mental illnesses. To help stop side effects your doctor may need to change the dose of your lithium and check the amount of lithium in your blood;
• Cisplatin - used for some cancers;
• Digoxin - used for heart problems. Your doctor may need to change the dose of your medicine;
• Non-steroidal anti-inflammatory drugs (NSAIDS) used for pain and inflammation such as aspirin, ibuprofen, ketoprofen or indomethacin;
• Carbamazepine - used for epilepsy;
• Aminoglutethimide - used for breast cancer;
• Medicine used to stop the rejection of organs after a transplant such as tacrolimus, ciclosporin, aldesleukin;
• Moxisylyte used to treat Raynaud's syndrome;
• Medicines used to treat angina that you spray or dissolve under your tongue such as glyceryl trinitrate or isosorbide dinitrate;
• Methotrexate - used for cancers of the skin, joint or bowel diseases;
• Carbenoxolone and sucralfate - used for ulcers of the foodpipe (gullet);
• Medicines used for depression, such as reboxetine, amitriptyline and phenelzine;
• Amphotericin - used for fungal infections if used for a long time;
• Corticosteroids - used for inflammation such as prednisolone;
• Atomoxetine used to treat Attention Deficit Hyperactivity Disorder (ADHD);
• Medicines to relax muscles such as baclofen and tizanidine;
• Antihistamines, used to treat allergies such as cetirizine;
• Alprostadil, used to treat male impotence;
• Oestrogen and drospirenone, used as contraceptives or in hormone replacement therapy (HRT);
• Liquorice - often used in cough medicines if taken in large amounts;
• Probenecid (used with another HIV medicine);
• Medicines for infection such as gentamicin, amikacin, neomycin, netilmicin, tobramycin, vancomycin or high doses of cephalosporins;
• Medicines used as injections before X-ray examinations (radiocontrast agent);
• Medicines used for constipation (laxatives) if used for a long time such as bisacodyl or senna;
• Medicines for asthma when given in high doses such as salbutamol, terbutaline sulphate, salmeterol, formoterol or bambuterol;
• Potassium salts used to treat low potassium in the blood;
• Medicines used to treat Parkinson's disease such as levodopa;
• Other water tablets (diuretics) such as bendroflumethiazide. Your doctor may need to change the dose of your medicine Furosemide with food, drink and alcohol
You should avoid drinking alcohol while taking Furosemide tablets as this may lower your blood pressure further.
Pregnancy and breast-feeding
Do not take Furosemide Tablets if you are pregnant. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not breast-feed if you are taking Furosemide
Tablets. This is because small amounts may pass into the mothers milk. Talk to your doctor before taking this medicine if you are
breastfeeding or planning to breast-feed.
Driving and using machines
Same Size Artwork 150 x 480 mm
Front
You may feel dizzy or unwell after taking Furosemide. If this happens, do not drive or use any tools or machines.
Furosemide contains lactose
This medicine contains lactose. If you have been told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor or pharmacist before taking this medicine.
3. How to take Furosemide
Always take these tablets exactly as advised by your doctor. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth;
• Swallow the tablets whole with a drink of water;
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.
The recommended dose is:
Adults and elderly:
The usual starting dose is 40mg in the morning, then 20mg a day or 40mg on alternate days. Up to 80mg a day may be given.
The dose may be reduced in elderly.
Children and adolescents (under 18 years of age):
Not recommended as safety in this age group has not yet been established.
If you are taking sucralfate (a medicine for stomach ulcers): Do not take sucralfate at the same time as Furosemide Tablets. Take your dose at least 2 hours before or after Furosemide Tablets. This is because it can affect the way your medicine works.
If you take more Furosemide than you should:
If you think you may have taken more Furosemide Tablets than you should or if a child has swallowed any of these tablets, contact your doctor or pharmacist or hospital emergency department immediately.
Always take any leftover tablets with you, also the box and leaflet as this will allow easier identification of the tablets. Taking too much Furosemide Tablets may make you feel confused, unable to focus, show a lack emotion or interest in anything. You may also have dizziness, lightheadedness, fainting (due to low blood pressure), uneven heartbeat, muscle weakness or crampsand blood clots (signs include pain and swelling at the part of the body that is affected). You may also have problems with your kidneys or blood.
If you forget to take Furosemide Tablets:
If you forget to take a dose, take it as soon as you remember. Then continue the following morning as normal. Do not take a double dose to make up for a forgotten dose.
If you stop taking Furosemide Tablets:
Keep taking Furosemide tablets until your doctor tells you to stop taking it.
Blood tests
Your doctor may carry out blood tests to check that the levels of some salts in the blood are at the correct levels.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Furosemide Tablets can cause side effects, although not everybody gets them.
If any of the below mentioned side effects are observed please inform your doctor immediately:
• Allergic reactions such as itching, skin rash with severe itching and nettle rash, fever, allergic to light, severe allergic reaction with (high) fever, red patches on the skin, joint pain and/or inflammation of the eyes, severe, acute (allergic) reaction accompanied by fever and blisters onthe skin/peeling skin and tiny spots from bleeding in the skin (Stevens-Johnsons syndrome);
• Sudden inflammation of the pancreas accompanied by severe pain in the upper abdomen,shifting towards the back;
• Shock (severe drop in blood pressure, extreme paleness, restlessness, weak fast pulse, clammy skin, impaired consciousness) as a result of a sudden severe dilatation of the blood vessels due to allergy to certain substances;
• A life-threatening form of unconsciousness.
The other possible side effects are listed under headings of frequency, using the following categories:
- Common (affects 1 to 10 users in 100)
- Uncommon (affects 1 to 10 users in 1,000)
- Rare (affects 1 to 10 users in 10,000)
- Very rare (affects less than 1 user in 10,000)
Common
Furosemide can cause an excessive depletion of bodily fluids (e.g. passing urine more often than normal) and minerals (sodium, potassium, magnesium, calcium). Symptoms that can occur are thirst, headache, confusion, muscle cramps, increased irritability of the muscles, muscular weakness, heart rhythm disturbances and gastrointestinal problems such as sensation of unease and discomfort in stomach with an urge to vomit, or diarrhoea.
If you have a shortage of sodium (sodium deficiency):
• Cramp in the calf muscles;
• Loss of appetite;
• Listlessness;
• Feeling of weakness;
• Dizziness;
• Drowsiness;
• Confusion.
If you have a shortage of potassium (potassium deficiency):
• Muscular weakness and the inability to contract one or more muscles (paralysis);
• Increased excretion of urine;
• Heart problems;
• In the case of severe potassium deficiency: interference with the function of the intestine orconfusion, which can result in coma.
If you have a shortage of magnesium and calcium (magnesium and calcium deficiency):
• Increased irritability of the muscles;
• Heart rhythm disturbances;
• Lowering of blood pressure, resulting in impaired concentration and reactions, light-headedness, a feeling of pressure in the head, headache, dizziness, drowsiness, a feeling of weakness, visual disturbances, dry mouth and an inability to stand upright.
Uncommon
• Abnormal blood count accompanied by bruising and a tendency to bleed;
• Sensitivity to light (photosensitivity);
• Involuntary leakage of urine;
• Deafness (sometimes irreversible);
• Fatigue:
• Visual disturbance:
• Cardiac arrhythmias;
• Dry mouth;
• Thirst;
• Nausea;
• Bowel motility disturbances;
• Vomiting and diahorrea;
• Constipation;
• In the elderly, this can lead to a low blood volume, fluid depletion and thickening of the blood. This can cause clots to form in the blood. Rare
• Abnormal blood count (white blood cell deficiency) accompanied by a increased susceptibility to infection;
• Increase in certain substances (eosinophilic cells) in the blood;
• A crawling sensation on the skin, itching or tingling without any reason;
• Hearing disorders & ringing in the ears. These disorders are usually temporary in nature;
• Inflammation of a blood vessel;
• Acute kidney failure;
• Inflammation of the kidneys associated with blood in the urine, fever and pain in the sides. If you have a urinary tract obstruction, increased urine production may occur or worsen;
• If you have a bladder disorder, enlarged prostate or narrowing of the ureters, urine production can stop suddenly;
• Fever Very rare
• Anaemia (a condition characterised by shortage of red blood cells);
• Very severe blood abnormality (white blood cell deficiency) accompanied by a sudden high fever, severe throat pain and ulcers in the mouth;
• Certain liver function disorders;
• Increase in certain liver enzymes.
Frequency not known:
• Acute generalised exanthematous pustulosis (AGEP) (acute febrile drug eruption), symptoms include the skin becoming red with swollen areas covered in numerous small pustules ;
• Dizziness;
• Fainting and loss of consciousness (caused by symptomatic hypotension).
During treatment with furosemide, the blood levels of some fats (cholesterol and triglyceride) may rise, but usually return to normal within 6 months.
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.
5. How to store Furosemide
Keep this medicine out of the sight and reach of children.
Blisters: Do not store above 25°C. Store in the original package (blister carton).
Tablet Containers: Do not store above 25°C. Keep the container tightly closed.
Do not use the tablets after the expiry date as shown on the blister, label or carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Furosemide contains
- The active substance is furosemide.
- The other ingredients are: lactose monohydrate, maize starch, pregelatinised maize starch, sodium starch glycollate (Type A) and magnesium stearate.
What Furosemide looks like and content of the pack
- Furosemide 20 mg tablets are round, white to off-white tablets marked 'F20' on one side and 'BL'on the other.
- Furosemide 40 mg tablets are round, white to off-white, tablets marked 'F40' separated by a break line on one side and 'BL' on the other.
- The tablets are supplied in blister packs containing 28, 30, 50, 56, 84, 98 and 100 tablets and containers containing 100, 250, 500 & 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and manufacture:
Name and address:
Brill Pharma Limited,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1 EG, United Kingdom
Telephone: 01442 200 922 Fax: 01442873717
Email: info@brillpharma-labs.co.uk
This leaflet was revised in July 2016
PL 40496/0043 -Furosemide 20 mg Tablets PL 40496/0044 - Furosemide 40 mg Tablets
V3 19-07-16 D0