Furosemide 20mg Tablets
|
Artw#rl< • • Creative Designs |
Artwork No. |
250415/1 |
Colours Used | |||
|
Customer |
Relon Chem |
■ |
Balck | |||
|
Description |
Furosemide 20/40 mg Pil | |||||
|
Market |
UK | |||||
|
Language |
English |
■ |
Keyline (not to print) | |||
|
Size |
148 x 370 mm (Finished) | |||||
|
Min. Font Size |
9 pt | |||||
|
Page No. |
1 of 1 | |||||
|
e-mail : prasad.pdp@gmail.com Ph : +91-9845156610 |
Version No. |
6 | ||||
|
Date |
06-01-16 | |||||
|
Software |
Illustrator 10 | |||||
|
Packaging Development |
Quality Assurance (QA) |
Quality Control (QC) |
Production | |||
PACKAGE LEAFLET: INFORMATION FOR THE USER
Furosemide 20mg Tablets Furosemide 40mg Tablets
Furosemide (the new name for Frusemide)
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 or nurse.
• 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 Tablets are and what they are used for
2. What you need to know before you take Furosemide Tablets
3. How to take Furosemide Tablets
4. Possible side effects
5. How to store Furosemide Tablets
6. Contents of the pack and other information
1. What Furosemide Tablets are and what they are used for
Furosemide is a member of a group of medicines called diuretics (also called water tablets). It works by altering the function of the kidneys. They help remove excess water from the body by increasing the amount lost as urine.
Furosemide is used to treat oedema (fluid retention) caused by heart failure, and certain liver and kidney disorders. It is also used to manage a condition called oliguria, where the body produces an abnormally small amount of urine due to kidney disease.
2. What you need to know before you take Furosemide Tablets
Do not take Furosemide Tablets:
• If you are allergic (hypersensitive) to furosemide, sulphonomides or any other ingredients in these tablets
• If you are unable to pass urine
• If you have a rare condition called porphyria
• If you have been told that you have an electrolyte deficiency (low salt levels in the blood or low potassium levels in the blood)
• If you have suffered from precoma associated with liver disease
• have digitalis poisoning (feeling or being sick, high levels of potassium in the blood, slow fast or irregular heart beats)
• are breast-feeding
• If you suffer from chronic kidney trouble then your doctor may increase your dose
• If you have problems with your adrenal glands.
Warnings and precautions
Talk to your doctor or pharmacist before taking Furosemisde Tablets:
• If you are elderly, if you are on other medications which can cause the drop the blood pressure and if you have other medical conditions that are risks for the drop of blood pressure.
• If you have liver congestion (slowed blood flow through the vessels) or other liver problems
• If you have diabetes mellitus
• If you have an enlarged prostate or have difficulty passing urine
• If you are taking ACE inhibitors (e.g. captopril or enalapril) used for high blood pressure and heart failure
• If you have a history of gout
• If you have low blood volume (hypovolaemia) or at risk of developing low blood pressure
• If you have kidney problems
• If you are about to undergo any blood or urine tests
• If you have an abnormal blood condition
• If you have low levels of protein in the blood (hypoproteinaemia)
• If you are pregnant or breast-feeding. Refer to Pregnancy and Breast-feeding section below.
Your doctor will want to monitor you, and may take blood for testing while you are taking this medicine.
Furosemide Tablets should be discontinued if bone marrow suppression occurs.
Other medicines and Furosemide Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
Relon 3 an
medicines:
• Medicines for high blood pressure e.g. methyldopa, atenolol, nifedipine.
• Antibiotics for infections that affect your kidneys or ears (e.g. cefaclor, colistin, gentamicin, vancomycin)
• Antifungals e.g itraconazole.
• Non-steroidal anti-inflammatory drugs e.g. ibuprofen.
• Analgesics e.g. indometacin used with high dose aspirin, aspirin
• Lithium used to treat depression.
• Medicines for heart conditions e.g. digoxin, lidocaine, mexiletine and tocainide.
• Medicines used in diabetes e.g. insulin.
• Antihistamines
• Glucocorticoids e.g. hydrocortisone or prednisolone.
• Antiepileptics e.g phenytoin
• Antipsychotics e.g pimozide
• Medicines for arrhythmias e.g. sotalol, amiodarone, flecanide
• Other water tablets (diuretics) such as bendroflumethiazide. Your doctor may need to change the dose of your medicine
• Medicines used to treat cancer
• Medicine used to stop the rejection of organs after a transplant such as tacrolimus, ciclosporin, aldesleukin
• Moxisylte for Raynaud's syndrome
• Nitrates for angina
• Antidepressants e.g. monoamine oxidase inhibitors (MAOIs)
• Medicines for ADHD
• Oral contraceptives
• Levodopa for Parkinson's disease
• Colestyramine or colestipol for high cholesterol
• Chloral hydrate to treat insomnia
• Alprostadil for erectile dysfunction
• Certain treatments for asthma such as theophylline or salbutamol
• Probenecid to treat gout
• Laxatives used over a long period of time
• Medicines or foods containing liquorice
• If you are about to undergo a procedure where curariform muscle relaxants (e.g. vercuronium) or anaesthetics may be used, tell your anaesthetist/dentist or healthcare professional
• Renin inhibitors used to treat high blood pressure
• Chelating agents used to treat metal poisoning.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medications including medicines obtained without a prescription.
Pregnancy and Breast-feeding:
Tell your doctor if you are, think you might be pregnant or planning to become pregnant or if you are breast-feeding. Furosemide can be used for short-term treatment on advice of your doctor. This medicine should not be used for high blood pressure in pregnancy. Furosemide can interfere with breast milk production. Ask your doctor or pharmacist for advice before taking any medicine.
Furosemide Tablets with food, drink and alcohol:
You should avoid drinking alcohol while taking Furosemide Tablets as this may lower your blood pressure further.
Driving and using machines:
This medicine may reduce mental alertness and cause dizziness. Make sure you are not affected before you drive or operate machinery.
Furosemide Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Furosemide Tablets
Always take Furosemide Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults
The usual dose is 20-40mg daily, to be taken orally with water.
If you suffer from chronic kidney trouble, your doctor may prescribe you a starting dose of 250mg furosemide per day. If necessary, you doctor may increase this to 250mg every 4 to 6 hours up to a maximum of 1500mg a day.
Children under 12 years old
If Furosemide Tablets are prescribed for a child make sure that the tablets are taken as instructed by the doctor.
The dosage is worked out depending on the child's weight. The doctor will work out a dose based on 1-3mg for each kilogram of the child's body weight. The dose should not exceed 40mg per day.
If you take more Furosemide Tablets than you should:
If you take too many of these tablets, or someone else accidently swallows these tablets, contact your doctor, pharmacist or nearest hospital immediately.
If you forget to take Furosemide Tablets:
If you forget to take a dose then take it as soon as you remember. But never take two doses together. Then continue to take your next dose at the usual time and carry on as before.
If you stop taking Furosemide Tablets:
Do not stop taking Furosemide Tablets without first discussing it with your doctor.
If you have any further questions on the use of Furosemide Tablets ask your doctor or pharmacist.
4. Possible side effects:
Like all medicines, this medicine can cause side effects, although not everyone gets them.
If any of the below mentioned side effects are observed please inform your doctor immediately.
• Sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.
• Inflammation of blood vessels (vasculitis, which may cause rash, fever and joint or muscle pains) or kidney inflammation, this may change the number of times you pass urine or you may see blood in your urine. You may have had a fever, feel drowsy, or notice swelling e.g. of the ankles
• Blood clot (causing pain, swelling or tenderness in the legs)
Tell your doctor or pharmacist if you notice any of the following side effects:
Very common: may affect more than 1 in 10 people
• Dehydration
• Altered balance of fluid or chemicals in the body (e.g. sodium, potassium, chlorine, calcium and magnesium) causing a dry mouth
• Decreased blood pressure (which may cause signs and symptoms such as impairment of concentration and reactions, light-headedness, sensations of pressure in the head, headache, dizziness when standing, drowsiness, weakness, disorders of vision, dry mouth.
Common: may affect up to 1 in 10 people
• Low blood volume (hypovolaemia)
• Increased creatinine and blood urea (seen in blood tests).
Uncommon: may affect up to 1 in 100 people
• Anaemia causing breathlessness, unusual bleeding or bruising
• Gout
• Changes in the body seen in tests such as levels of cholesterol, glucose, uric acid
• Changes in vision including blurred or yellow vision
• Irregular heartbeat
• Tiredness
• Dry mouth, thirst
• Feeling or being sick
• Changes in bowel movements including diarrhoea and constipation
• Muscle cramps or weakness
• Changes in amount or need to urinate. If you have a urinary tract obstruction, increased urine production may occur or worsen.
• Liver dysfunction
• deafness (sometimes irreversible)
Rare: may affect up to 1 in 1000 people
• A reduction of the blood cells in the bone marrow causing tiredness, unexplained bruising and paleness. Treatment should be withdrawn if this occurs
• Psychiatric disorders causing delusions, hallucinations, disorganized speech
• Pins and needles or tingling sensation
• Confusion
• Headache, dizziness
• Ringing in the ears and loss of hearing
• Symptoms of shock such as changes in heart rate, breathlessness, cool clammy skin
• Inflammation of the pancreas causing pains in your abdomen or back and nausea
• Changes in the liver causing yellowing of the skin or whites of the eyes
• Skin rashes, peeling or blistering of the skin
• Increase in the sensitivity of skin to sunlight
• Tiredness, generally feeling unwell
• Fever
• Increase in certain liver enzymes.
Very rare: may affect up to 1 in 10,000 people
• Blood abnormalities
• Involuntary movements of the muscle
Not known: Frequency can not be estimated from the available data:
• Worsening of conditions where there is already imbalances of fluid or chemicals in the body
• acute generalised exanthematous pustulosis (AGEP)" (acute febrile drug eruption)
• dizziness, fainting and loss of consciousness (caused by symptomatic hypotension)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine
5. How to store Furosemide Tablets:
Keep out of the sight and reach of children.
Keep in the original packaging.
Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month.
Do not store above 25° C.
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 protect the environment.
6. Contents of the pack and other information
What Furosemide Tablets contain:
The active substance in this medicine is called furosemide. The 20mg tablets contain 20mg furosemide and the 40mg tablets contain 40mg furosemide.
The other ingredients are lactose monohydrate, magnesium stearate, sodium starch glycollate and maize starch.
What Furosemide Tablets look like and contents of the pack:
Furosemide 20mg and 40mg tablets are white, circular tablets with a break line on one side. Furosemide 20mg tablets come as 28 tablets in strips or tubes, or 250 tablets in tubes. Furosemide 40mg tablets come as 28 tablets in strips or tubes, or 1000 tablets in tubes.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder and manufacturer is:
RelonChem Limited
27 Old Gloucester Street
London
WC1 3XX
England
PL 20395/0030 I POM
PL 20395/0031
This leaflet was last revised in January 2016