Gemfibrozil Tablets 600mg
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Pharma code 476
GEMFIBROZIL 600 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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.
IN THIS LEAFLET:
1. What Gemfibrozil is and what it is used for
2. Before you take Gemfibrozil
3. How to take Gemfibrozil
4. Possible side effects
5. How to store Gemfibrozil
6. Further information
OWHAT GEMFIBROZIL IS AND WHAT IT IS USED FOR
Gemfibrozil belongs to a group of medicines called lipid lowering agents.
It is used to reduce high fat levels (cholesterol and triglycerides) in the blood and so help in the prevention of coronary heart disease. These tablets should be used along with dieting, exercise and weight reduction.
r2 BEFORE YOU TAKE GEMFIBROZIL
Do NOT take Gemfibrozil if you:
• are allergic (hypersensitive) to gemfibrozil or any of the other ingredients of this medicine
• have or have had gall bladder disease, biliary tract disease or gall stones
• have liver or severe kidney problems
• have experienced sensitivity to light when previously treated with similar cholesterol lowering drugs
• are taking repaglinide (used to treat diabetes).
Take special care with Gemfibrozil
Tell your doctor before you start to take this
medicine if you:
• are over 70 years of age
• have an under active thyroid gland or diabetes
• have a hereditary muscular disorder or a family history of such problems
• have previously suffered from side effects affecting your muscles when taking another cholesterol lowering medicine such as a statin or a fibrate
• have problems with alcohol abuse (regularly drinking large amounts of alcohol)
• have kidney problems.
Your doctor may carry out liver function and
other blood tests.
Taking other medicines
• Do NOT take repaglinide in combination with Gemfibrozil.
Talk to your doctor if you are taking any of
the following:
• other drugs to lower your cholesterol e.g. simvastatin, lovastatin, pravastatin or rosuvastatin
• drugs to prevent blood clots (e.g. warfarin)
• rosiglitazone, glimepiride or other drugs for diabetes
• paclitaxel (used to treat cancer)
• bexarotene (used to treat skin cancer)
• drugs known as bile acid sequestrants (a class of drugs that prevents bile acids being reabsorbed from the digestive system, so promoting conversion of cholesterol into bile acids) e.g. colestyramine, colestipol (please see in section 3,Taking in combination with a bile acid sequestrant)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Gemfibrozil with food and drink
• Keep alcohol intake to a minimum
• Your doctor will have explained the importance of a low fat diet as well as taking Gemfibrozil.
Pregnancy and Breast-feeding
Gemfibrozil is not recommended if you are pregnant or breast-feeding.
If you are pregnant or planning to become pregnant, ask your doctor for advice before taking this medicine.
Driving and using machines
Gemfibrozil may cause dizziness and blurred vision. If affected, do not drive or operate machinery.
HOW TO TAKE GEMFIBROZIL
Always take Gemfibrozil exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure. The tablets should be swallowed preferably with a glass of water.
The usual dose is:
Adults (including the elderly)
• The normal dosage range is between 900 mg and 1,200 mg (two tablets) each day
• The 1,200 mg dose is taken as one tablet half an hour before breakfast and one tablet half an hour before the evening meal
• The 900 mg dose is taken as a single dose half an hour before the evening meal. Please note that there is a 300 mg product available which is recommended for the 900 mg dosage.
Taking in combination with a bile acid sequestrant
Gemfibrozil may be given in combination with a bile acid sequestrant e.g. colestyramine or cholestipol.
Gemfibrozil should be taken 2 hours before or after taking your bile acid sequestrant, as the absorption of Gemfibrozil can be affected by these medicines if taken too closely together.
Patients with Kidney problems
If you have mild to moderate kidney problems your doctor may reduce the dose given above. Gemfibrozil should not be used if you have severe kidney problems.
Children and adolescents:
Gemfibrozil is not recommended for use in children or adolescents.
If you take more Gemfibrozil than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause stomach pains, diarrhoea, joint and muscle pain, nausea and vomiting.
Top of page cut-off to middle of registration mark: 44 mm.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Gemfibrozil If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for the forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
^ POSSIBLE SIDE EFFECTS
Like all medicines, Gemfibrozil can cause side effects, although not everybody gets them.
If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
• An allergic reaction (swelling of the face or tongue or neck, muscle and joint pain, hives, fever, flushing, shortness of breath).
This is a very serious but rare side effect.
You may need urgent medical attention or hospitalisation.
Contact your doctor as soon as possible and stop taking Gemfibrozil if you develop
• any unexplained or persistent muscle pain, tenderness, weakness or cramps, especially, if at the same time you feel sick or unwell, are sick, have a high temperature, dark urine, facial swelling or a rapid heart beat. In rare cases (affecting fewer than one person in 1,000) this can progress to become a serious and potentially life threatening condition, called rhabdomyolysis.
The following side effects have been reported at the approximate frequencies shown:
Very common (affecting more than one person in 10):
• heartburn, indigestion.
Common (affecting fewer than one person in 10 but more than one person in 100):
• vertigo, headache
• abdominal pain, diarrhoea, wind, constipation, feeling sick or being sick
• eczema, rash
• fatigue
Uncommon (affecting fewer than one person in 100 but more than one person in 1,000):
• irregular heart beat.
Rare (affecting fewer than one person in 1,000 but more than one person in 10,000):
• unusual bleeding or unexplained bruising
• blood disorders that may be characterised by fever or chills, sore throat, ulcers in the mouth or throat
• severe anaemia (a reduction in red blood cells) causing unusual tiredness or weakness
• reduction or increase in white blood cells (leucopenia, eosinophilia), bone marrow disease (bone marrow failure)
• dizziness, sleepiness, pins-and-needles, inflammation or damage of the nerves (peripheral neuropathy), depression, reduced sex drive
• blurred vision
• jaundice (yellowing of the skin and whites of the eyes)
• liver problems including hepatitis (inflammation of the liver)
• inflammation of the gall bladder, gall stones
• pancreatitis (inflammation of the pancreas)
• skin problems including dermatitis, peeling or itching, red, itchy raised areas of skin
• photosensitivity (a sensitivity to light that can cause skin discolouration or a rash)
• hair loss
• joint or muscle pain, cramp, wasting of the muscles, inflammation of the muscles (myositis), painful arms and legs, temporary paralysis or weakness of the muscles. swelling of the joints
• inflammation of the synovial membrane (synovitis)
• problems getting or maintaining an erection
• acute appendicitis (inflammation of the appendix)
• persistent lack of energy
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
HOW TO STORE GEMFIBROZIL
Keep out of the reach and sight of children.
Store at or below 25°C. Do not use Gemfibrozil after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month. 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.
FURTHER INFORMATION
What Gemfibrozil contains:
• The active ingredient is gemfibrozil 600 mg
• The other ingredients are pregelatinised maize starch, colloidal anhydrous silica, hydroxypropylcellulose, polysorbate 80, microcrystalline cellulose, calcium stearate, methylhydroxypropylcellulose, macrogol 4000, titanium dioxide (E171) and polydextrose K.
What Gemfibrozil looks like and contents of the pack:
• Gemfibrozil tablets are white to off white, oval-shaped, film-coated tablets. Scored on one side with engraving "93" and "670" on each side of the score line.The other side is plain.
• The tablets are available in pack sizes* of 56, 60, 500 and 1,000 tablets.
*Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and manufacturer: TEVA UK Limited, Eastbourne, BN22 9AG This leaflet was last revised: March 2015 PL 00289/0788
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