Informations for option: Gemfibrozil 600mg Film-Coated Tablets, show other option

Select option:

1. Gemfibrozil 600mg Film-Coated Tablets
2. Gemfibrozil 600mg Film-Coated Tablets

Document: leaflet MAH GENERIC_PL 11311-0099 change

• leaflet MAH BRAND_PLPI 33532-0444
• leaflet MAH GENERIC_PL 11311-0099

---

PATIENT INFORMATION LEAFLET

Gemfibrozil 600mg Film-Coated Tablets

□ What this medicine is and what it is used for

Gemfibrozil belongs to a group of medicines called lipidlowering medicines or fibrates. These work by helping to reduce cholesterol and triglycerides (fats) in the blood.

Gemfibrozil is used to treat the following:

•    To prevent heart disease in men between 40-55 years of age suffering from hyperlipidaemias (where the concentration of fats in the blood is too high) and diet/other appropriate measures have been insufficient to correct the condition

•    To prevent heart disease in men with increased cholesterol levels and at high risk for first-time heart problems and statin medicines (HMG-CoA reductase inhibitors) are contraindicated or not well tolerated

•    It is also used to treat patients who have high blood cholesterol and triglyceride levels (hyperlipidaemia of types IIa, IIb, III, IV and V), which cannot be controlled by diet or exercise or weight loss or other means alone

What you need to know before you take Gemfibrozil

Do not take Gemfibrozil if:

•    You are allergic (hypersensitive) to Gemfibrozil, lipidlowering medicines or fibrates or any of the other ingredients of this medicine (see section 6 "Contents of the pack and other information")

•    You suffer from alcoholism

•    You suffer from liver disorders

•    You suffer from severe kidney disorders

•    You suffer from or have a history of suffering from gall bladder or biliary tract disease including gallstones. Treatment with Gemfibrozil should be discontinued if gallstones are found

•    You have a history of photoallergy or phototoxicity reactions (allergic reactions caused by exposure to sunlight) during treatment with fibrates

•    You are taking repaglinide, a medicine used to reduce blood sugar levels (antidiabetic) (see "Other medicines and Gemfibrozil" section)

Warnings and precautions

Talk to your doctor before taking Gemfibrozil:

•    If you have an underactive thyroid (hypothyroidism) as this condition must be controlled as much as possible before starting treatment with Gemfibrozil

•    If you are diabetic as your condition must be controlled as much as possible before starting treatment with Gemfibrozil

•    Patients who develop signs of muscle toxicity (muscle pain or tenderness) should be monitored closely

•    If you are at risk of developing a condition in which damaged skeletal muscle tissue breaks down (rhabdomyolysis) due to the following:

o You suffer from kidney problems o You have an underactive thyroid (hypothyroidism) o You suffer from alcoholism o You are over 70 years of age o You or your family have a history of inherited muscular disorders

o You have a previous history of muscular toxicity (muscle pain or tenderness) with another fibrate or statin (see "Other medicines and Gemfibrozil" section)

•    As Gemfibrozil is intended for long-term use, the level of fats in the blood, blood count and liver function tests should be measured before treatment and monitored at regular intervals, especially during the first 12 months of treatment with Gemfibrozil. Treatment with Gemfibrozil should be stopped if there are any abnormalities in the test results

Other medicines and Gemfibrozil

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Medicines not to be taken with Gemfibrozil

•    Repaglinide, a medicine used to reduce blood sugar levels (antidiabetic) (see section 2 "What you need to know before you take Gemfibrozil, Do not take...")

Other medicines which may interact with or be affected by

Gemfibrozil

•    Medicines used to thin the blood e.g. warfarin (anticoagulants), as the dose of the anticoagulant may need to be carefully monitored

•    Medicines used to lower cholesterol, such as colestipol (resin granule medicines). You should take Gemfibrozil at least 2 hours apart from a resin granule medicine

•    Rosiglitazone, glimepiride and insulin, medicines used to reduce blood sugar levels (antidiabetics). Monitoring of blood sugar levels is recommended

•    Paclitaxel, a medicine used to treat cancer (chemotherapy)

•    Simvastatin, lovastatin, pravastatin, rosuvastatin, medicines used to lower cholesterol levels (HMG-CoA reductase inhibitors or statins)

•    Bexarotene, a medicine used to treat cancer (antineoplastic agent)

•    Colchicine, a medicine used to treat gout

Taking Gemfibrozil with food and drink and alcohol

•    Patients should be placed on a diet to help lower their cholesterol levels, which should be continued during treatment with Gemfibrozil.

•    Patients should limit their intake of alcohol whilst being treated with Gemfibrozil.

•    Gemfibrozil should be taken half an hour before breakfast and/or half an hour before the evening meal.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Do not take Gemfibrozil if you are pregnant, trying to become pregnant or think you may be pregnant unless it is absolutely necessary.

Breastfeeding

Do not take Gemfibrozil if you are breast-feeding.

Fertility

Decreases in male fertility have been observed but this is reversible.

Driving and using machines

Although unlikely, you may feel dizzy or experience visual disturbances whilst taking this medicine. If either of these symptoms are experienced, it may be necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.

Gemfibrozil contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Gemfibrozil

Always take Gemfibrozil exactly as your doctor has

told you. Check with your doctor or pharmacist if you

are not sure.

Before starting treatment with Gemfibrozil, attempts should

be made to control fats in the blood:

•    With appropriate diet and exercise and weight loss in obese patients

•    By stopping smoking

•    By limiting intake of alcohol

•    Treatment of the causes of secondary hyperlipidaemias such as underactive thyroid (hypothyroidism) and diabetes (see "Warnings and precautions" section)

•    These tablets are to be taken orally.

•    The score line on the tablet is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses.

•    Gemfibrozil should be withdrawn or additional therapy introduced if the therapeutic response is inadequate after three months.

Adults

•    The recommended dose range is 900 - 1200mg daily.

•    A 900mg dose is taken as a single dose (taken as one and a half tablets) half an hour before the evening meal.

•    A 1200mg dose is taken as 600mg twice daily, half an hour before breakfast and half an hour before the evening meal.

•    Patients with Type V hyperlipidaemia [severe hypertriglyceridaemia] (very high levels of fats in the blood), up to 1500mg daily (taken as two and a half tablets) may be needed.

Older people (over 65 years of age)

•    The recommended doses are the same as those given for adults.

•    Patients aged 60 years or older who are at increased risk of heart disease should be treated with a suitable diet for at least three months. If the diet is not effective, treatment with Gemfibrozil should then be considered.

continued....

Patients with kidney disorders

•    Treatment should be started at 900mg daily and kidney function should be assessed before increasing dose.

•    Gemfibrozil should not be used in patients with severely impaired kidney function (see section 2 "What you need to know before you take Gemfibrozil, Do not take...").

Gemfibrozil must not be used in patients suffering from liver disorders (see section 2 "What you need to know before you take Gemfibrozil, Do not take.").

Use in children

Gemfibrozil Tablets are not recommended for children.

If you take more Gemfibrozil than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

Symptoms of an overdose may include; stomach cramps, abnormal liver function tests, diarrhoea, increased enzymes in the body (signs of this are muscle pain, tenderness, weakness, swelling, urine becomes dark in colour), joint or muscle pain, feeling or being sick.

If you forget to take Gemfibrozil

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose do not take a double dose to make up for a forgotten dose.

If you stop taking Gemfibrozil

It is important that you keep taking Gemfibrozil for as long as your doctor has told you to.

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

Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

Seek medical advice immediately if you develop the

following symptoms:

•    Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness

•    Swelling of the voice box (laryngeal oedema). Symptoms may include the following:

o Throat may feel sore, tight, itchy, feel as if there is a "lump" or have difficulty swallowing o Voice may become high-pitched, hoarse, develop a full-throated 'barky' cough or be unable to speak

•    Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)

•    Muscle pain, weakness or tenderness, especially if you also have dark coloured urine (see "Rare side effects" section)

•    Severe abdominal pain (see "Common side effects" section), which may indicate you have gallstones (cholelithiasis) or swelling (inflammation) of the gallbladder (cholecystitis) (see "Rare side effects" section)

•    Peeling of the skin over large areas of the body (exfoliative dermatitis)

Very common side effects (may affect more than 1 in

10 people)

•    Indigestion (dyspepsia)

Common side effects (may affect up to 1 in 10 people)

•    A sensation of whirling and loss of balance, feeling dizzy or giddy (vertigo)

•    Abdominal pain (see "Seek medical advice immediately." section)

•    Diarrhoea

•    Feeling/being sick (nausea/vomiting)

•    Constipation

•    Feeling bloated/wind (flatulence)

•    Rash

•    Inflammation of the skin (eczema)

•    Headache

•    Tiredness, weakness or lack energy (fatigue)

Uncommon side effects (may affect up to 1 in 100

people)

•    Irregular heartbeat (atrial fibrillation)

Rare side effects (may affect up to 1 in 1000 people)

•    Reduction in blood platelets, which increases the risk of bleeding or bruising (thrombocytopenia)

•    Looking very pale and feeling very tired (severe anaemia)

•    A reduction in white blood cells (leucopenia)

•    Frequent wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough & rashes due to an increase in certain white blood cells (eosinophilia)

•    The bone marrow contains very few blood cells (bone marrow hypoplasia)

•    Insufficient amounts of red blood cells, white blood cells, and platelets (bone marrow failure)

•    Changes in blood test results

•    Inflammation of the pancreas (pancreatitis)

•    Sudden painful swelling (inflammation) of the stomach (acute appendicitis)

•    Yellowing of the skin or whites of the eyes (jaundice)

•    Abnormal liver function

•    Inflammation of liver (hepatitis)

•    Gallstones (cholelithiasis) (see "Seek medical advice immediately." section)

•    Swelling (inflammation) of the gallbladder (cholecystitis) (see "Seek medical advice immediately." section)

•    Severe itching (pruritus)

•    Skin rash or inflammation (dermatitis)

•    Skin rashes with the formation of wheals (urticaria)

•    Abnormal sensitivity of the skin to sunlight (photosensitivity)

•    Hair loss (alopecia)

•    Dizziness

•    Sleepiness or drowsiness (somnolence)

•    Tingling or numbness in the hands or feet (paraesthesia)

•    Disorders of the nervous system e.g. "creeping" sensation and other sensory disorders affecting hands &/or feet (peripheral neuritis/peripheral neuropathy)

•    Depression

•    Loss of sex drive (decreased libido)

•    Inability to have or maintain an erection (erectile dysfunction)

•    Blurred vision

•    Muscle weakness (myaesthenia/myopathy)

•    Condition in which damaged skeletal muscle tissue breaks down (rhabdomyolysis)

•    Painful extremities (arms & legs)

•    Muscle pain (myalgia)

•    Pain or swelling in the joints (arthralgia/synovitis)

•    Inflammation of the muscles (myositis)

Other side effects (frequency not known)

•    Cough

•    Ringing in the ears (tinnitus)

•    Pain around the stomach

•    Dry mouth

•    Fainting (syncope)

•    Difficulty in sleeping (insomnia)

•    Back pain

•    Muscle cramps

•    Swollen joints

•    Generally feeling unwell (malaise)

•    Loss of appetite (anorexia)

•    Abnormally low levels of potassium in blood (hypokalaemia)

•    Viral and bacterial infections

•    Common cold

•    Urinary tract infections

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 internet at www.mhra.gsi.gov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Gemfibrozil

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the carton/bottle after EXP. 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 to protect the environment.

Contents of the pack and other information

What Gemfibrozil contains:

Each tablet contains 600mg of Gemfibrozil.

The other ingredients are: microcrystalline cellulose, maize starch, hydroxypropylcellulose, sodium starch glycollate (type A), polysorbate 80 (tween 80), colloidal anhydrous silica, magnesium stearate, lactose monohydrate, hypromellose, titanium (E171) and macrogol 4000.

What Gemfibrozil looks like and contents of the pack:

Gemfibrozil are white, oblong, film-coated tablets of 9 x 19mm dimension, with three break marks on both sides

Gemfibrozil is available in:

Gemfibrozil Tablets are available in packs of 28, 30, 56 or 100 tablets.

Not all pack sizes may be marketed.

Product Licence Number:

PL 11311/0099

Marketing Authorisation Holder:

Tillomed Laboratories Ltd,

3 Howard Road,

Eaton Socon, St Neots,

Cambridgeshire, PE19 8ET United Kingdom.

Manufacturer:

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany.

This leaflet was last revised in October 2014

Hard to Read? Phone 0800 970 6115 for help

Till-Ver.2.1s