Gemfibrozil 600mg Film-Coated Tablets

• Keep this leaflet. You may need to read it again.
• If you have 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.

1. What this medicine is and what it is used for
2. What you need to know before you take Gemfibrozil
3. How to take Gemfibrozil
4. Possible side effects
5. How to store Gemfibrozil
6. Contents of the pack and other information

• You are allergic to Gemfibrozil or any of the other ingredients of this medicine (listed in section 6)
• 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), simvastatin or rosuvastatin (cholesterol-lowering medicines), dasabuvir (used to treat hepatitis C infection) or selexipag (used to treat pulmonary arterial hypertension) (see “Other medicines and Gemfibrozil” section)

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
• If you develop muscle pain or tenderness as you 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:
  • You suffer from kidney problems
  • You have an underactive thyroid (hypothyroidism)
  • You suffer from alcoholism
  • You are over 70 years of age
  • You or your family have a history of inherited muscular disorders
  • 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 and liver function tests should be performed periodically during treatment. Blood count should be measured every 12 months of treatment with Gemfibrozil. Treatment with Gemfibrozil should be stopped if any abnormalities in the test results persist.

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.

• Anti-diabetic medication, particularly rosiglitazone or repaglinide (used to reduce blood sugar levels) (for repaglinide see “Do not take Gemfibrozil”)
• Dasabuvir, a medicine used to treat hepatitis C infection (see “Do not take Gemfibrozil”)
• Selexipag, a medicine used to treat pulmonary hypertension
• Statins used to lower bad cholesterol and triglycerides, and increase good cholesterol such as atorvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin (for simvastatin see “Do not take Gemfibrozil”)
• Dabrafenib, a treatment for melanoma
• Loperamide, a treatment for diarrhoea
• Montelukast, a treatment for asthma
• Pioglitazone, a treatment used for diabetes
• Warfarin, acenocoumarol, and phenprocoumon (anticoagulants used to thin blood)
• Colestipol resin granules for the treatment of high levels of fat (cholesterol) in your blood
• Bexarotene medication for the treatment of skin cancer
• Colchicine for the treatment of gout
• Paclitaxel, a treatment for cancer
• Enzalutamide, a treatment for prostate cancer

• 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.

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.

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.

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

This medicine contains 36 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult.

• The recommended dose range is 900mg - 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.

• 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…”).

Gemfibrozil Tablets are not recommended for children.

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 a dose, do not worry. Simply miss that dose and take your next dose at the right time. Do not take a double dose to make up for a forgotten dose.

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

• 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:
  • Throat may feel sore, tight, itchy, feel as if there is a “lump” or have difficulty swallowing
  • 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 weakness or weakness accompanied by dark urine, fever, rapid heart rate or palpitations, nausea or vomiting (rhabdomyolysis)
• Severe abdominal pain, which may indicate you have gallstones (cholelithiasis) or swelling (inflammation) of the gallbladder (cholecystitis)
• Peeling of the skin over large areas of the body (exfoliative dermatitis)
• Abnormal liver function or inflammation or the liver, where signs can include yellowing of the skin or eyes, nausea and abdominal pain

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)
• 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)
• 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 lower right hand side of the abdomen (acute appendicitis)
• 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)
• Painful extremities (arms & legs)
• Muscle pain (myalgia)
• Pain or swelling in the joints (arthralgia/synovitis)
• Inflammation of the muscles (myositis)

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

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 dioxide (E171) and macrogol 4000.

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