GEMFIBROZIL STADA 900 mg TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Gemfibrozil STADA 900 mg film-coated tablets EFG

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 experience any serious side effects, or any side effect not mentioned in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the pack

1. What Gemfibrozil STADA is and what it is used for
2. What you need to know before you take Gemfibrozil STADA

1. How to take Gemfibrozil STADA

1. Possible side effects
2. Storage of Gemfibrozil STADA

1. Contents of the pack and further information

1. What Gemfibrozil STADA is and what it is used for

Gemfibrozil belongs to a group of medicines commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example, fats called triglycerides.

Gemfibrozil is used, along with a low-fat diet and other non-medical treatments such as exercise and weight loss, to lower the levels of fats in the blood.

Gemfibrozil may be used when other medicines [statins] are not suitable for reducing the risk of heart problems in men at high risk and with high "bad" cholesterol.

Gemfibrozil may also be prescribed to lower the level of cholesterol in the blood in people who cannot take other medicines that lower lipids.

2. What you need to know before you take Gemfibrozil STADA

Do not take Gemfibrozil STADA

• if you are allergic to gemfibrozil or any of the other ingredients of this medicine (listed in section 6)
• if you have liver failure
• if you have severe kidney failure
• if you have a history of gallstones, gallbladder disease (biliary tract disease)
• if you have had photosensitivity or phototoxic reactions (allergic reaction triggered by sun exposure) during treatment with fibrates
• if you are taking a medicine called repaglinide (a medicine used to lower blood sugar levels), simvastatin or rosuvastatin 40 mg (medicines that lower cholesterol levels), dasabuvir (a medicine used to treat hepatitis C infection) or selexipag (a medicine used to treat pulmonary hypertension)

Warnings and precautions

Consult your doctor or pharmacist before starting to take gemfibrozil.

Tell your doctor if you have any of the following problems to help them decide if gemfibrozil is suitable for you:

• high risk of muscle destruction (rhabdomyolysis): risk factors include kidney failure; underactive thyroid; over 70 years; excessive alcohol use; history of muscle pain and weakness (muscle toxicity) with another fibrate or statin; history of hereditary muscle disorders; use of gemfibrozil in combination with statins, used to lower "bad" cholesterol and triglycerides, and increase "good" cholesterol, such as rosuvastatin and simvastatin (for simvastatin and rosuvastatin 40 mg, see "Do not take Gemfibrozil STADA" and see "Other medicines and Gemfibrozil STADA")
• mild or moderate kidney disease
• underactive thyroid
• diabetes

Other medicines and Gemfibrozil STADA

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• anti-diabetic medicines, especially rosiglitazone or repaglinide (used to lower blood sugar levels) (for repaglinide, see "Do not take Gemfibrozil STADA")
• dasabuvir, a medicine used to treat hepatitis C infection (see "Do not take Gemfibrozil STADA" above)
• selexipag, a treatment for pulmonary hypertension (see "Do not take Gemfibrozil STADA" above)
• statins used to lower "bad" cholesterol and triglycerides and increase "good" cholesterol, such as atorvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin (for simvastatin and rosuvastatin 40 mg, see "Do not take Gemfibrozil STADA" and see "Warnings and precautions")
• dabrafenib, a treatment for melanoma
• loperamide, a treatment for diarrhea
• montelukast, a treatment for asthma
• pioglitazone, a treatment used for diabetes
• warfarin, acenocoumarol, and phenprocoumon (anticoagulants used to thin the blood)
• cholestyramine resin granules for the treatment of high blood fat (cholesterol) levels
• 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

Pregnancy and breast-feeding

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.

Breast-feeding

Gemfibrozil is not recommended during breast-feeding.

Driving and using machines

Gemfibrozil can cause dizziness and affect your vision. If this happens, do not drive or use machines until you feel better.

Gemfibrozil STADA contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Gemfibrozil STADA

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Before and during treatment with gemfibrozil, your doctor will closely monitor your blood lipid levels. If you are diabetic or have thyroid problems, your doctor will need to treat these conditions before you start treatment. Your doctor will also advise you on the diet to follow, exercise, quitting smoking, reducing alcohol consumption, and if necessary, weight loss.

Gemfibrozil should be taken by mouth. It is recommended to swallow the tablets with a glass of water, as they have an unpleasant taste if they are broken.

Taking gemfibrozil with food and drinks

This medicine should be taken half an hour before meals.

Adults and elderly patients

Normally, the initial dose is between 900 and 1200 mg per day. Your doctor will decide the best dose for you, follow the instructions in the leaflet.

If you are told to take a dose of 1200 mg, you will need to take 600 mg half an hour before breakfast and another 600 mg half an hour before dinner.

If you are told to take a dose of 900 mg, you will need to take the single dose half an hour before dinner.

Adults with mild to moderate kidney disease

Your doctor will assess your condition before and during treatment with this medicine. Your treatment will start with 900 mg per day and may be increased to 1200 mg, depending on the response. Gemfibrozil should not be used in patients with severe kidney failure.

Use in children

This medicine is not recommended for children.

If you take more Gemfibrozil STADA than you should

If you accidentally take too much gemfibrozil, contact your doctor or go to the nearest hospital emergency department or call the Toxicology Information Service. Telephone: 91 562 04 20. Always take the pack with you, even if it is empty. Signs of overdose may include abdominal cramps, diarrhea, joint and muscle pain, nausea, and vomiting.

If you forget to take Gemfibrozil STADA

Do not worry if you forget to take a dose. Just take the next dose at the right time. Do not take a double dose to make up for forgotten doses.

If you stop taking Gemfibrozil STADA

Do not stop taking this medicine unless your doctor tells you to. Follow all your doctor's instructions while taking gemfibrozil to get the maximum benefit from the treatment.

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

4. Possible side effects

Like all medicines, gemfibrozil can cause side effects, although not everybody gets them.

Serious side effects

You should contact your doctor immediately if you experience any of the following symptoms after taking this medicine:

Rare (may affect up to 1 in 1000 people)

• allergic reaction where the face, tongue, or throat may swell, causing difficulty breathing (angioedema)
• peeling and blistering of the skin, mouth, eyes, and genitals
• rash that affects the whole body
• muscle weakness or weakness with dark urine, fever, rapid heartbeat (palpitations), nausea, or vomiting

Other side effects reported include

Very common side effects (may affect more than 1 in 10 people)

• indigestion

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

• feeling of spinning or swaying (vertigo)
• eczema, rash (especially itchy or inflamed rash)
• headache
• abdominal pain
• diarrhea
• feeling of discomfort
• malaise
• constipation
• gas
• fatigue

Uncommon side effects (may affect up to 1 in 100 people)

• irregular heartbeat

Rare (may affect up to 1 in 1000 people)

• reduction or increase in white blood cells (leucopenia, eosinophilia), bone marrow disease (bone marrow failure)
• reduction in platelet count (thrombocytopenia)
• inflammation of the nerves (peripheral neuritis)
• bruising or unusual bleeding due to low platelet count (thrombocytopenia)
• severe anemia
• loss of sensation and tingling (paresthesia)
• pancreatitis
• blurred vision
• jaundice (yellowing of the skin), liver function changes
• liver inflammation (hepatitis)
• gallstones (cholelithiasis), gallbladder inflammation (cholecystitis)
• appendicitis
• depression
• dizziness
• drowsiness
• joint and limb pain
• skin inflammation or inflamed skin that scales or peels
• muscle inflammation (myositis)
• inflammation of the synovial membrane (synovitis)
• persistent lack of energy
• impotence
• reduced libido
• hair loss
• photosensitivity (sensitivity to light that can cause skin color change or rash)
• red, raised areas of skin with itching
• itching

Reporting of side effects

If you experience 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 Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gemfibrozil STADA

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Gemfibrozil STADA after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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 further information

Composition of Gemfibrozil STADA

The active substance is gemfibrozil. Each tablet contains 900 mg of gemfibrozil.

The other ingredients are: maize starch, microcrystalline cellulose, anhydrous colloidal silica, polysorbate 80, sodium carboxymethylcellulose (type A, potato), pregelatinized maize starch, magnesium stearate, white coating 03F28756 (containing hypromellose, titanium dioxide, and macrogol).

Appearance and packaging

Gemfibrozil STADA is presented as film-coated tablets, white and oval.

Each pack contains 30 tablets.

Other presentations

Gemfibrozil STADA 600 mg film-coated tablets EFG

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer:

STADA Arzneimittel AG

Stadastraße 2-18,

61118 Bad Vilbel

Germany

Date of last revision of this leaflet:March 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.