Gemfibrozil Stada 600 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Gemfibrozil STADA 600 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience any serious adverse reactions or any adverse reactions not listed in this leaflet, consult your doctor or pharmacist, even if they are adverse reactions not mentioned in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Gemfibrozil STADA

3. How to take Gemfibrozil STADA

4. Possible adverse effects

5. How to store Gemfibrozil STADA

6. Contents of the pack and other information

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

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

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

Gemfibrozil may be used when other medicines [statins] are not suitable, to reduce the occurrence of heart problems in men at high risk and whose "bad cholesterol" is elevated.

Gemfibrozil may also be prescribed to lower cholesterol levels in the blood in people who cannot be prescribed other lipid-lowering medicines.

2. What you need to know before taking Gemfibrozil STADA

Do not take Gemfibrozil STADA

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

Warnings and precautions

Talk to your doctor or pharmacist before starting gemfibrozil.

Inform your doctor if you have any of the following conditions so they can determine whether gemfibrozil is suitable for you:

• high risk of muscle breakdown (rhabdomyolysis): risk factors include renal impairment; hypothyroidism; being over 70 years of age; excessive alcohol consumption; history of muscle pain and weakness (muscle toxicity) with another fibrate or statin; history of inherited muscle disorders; use of gemfibrozil in combination with statins, which are 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 “Other medicines and Gemfibrozil STADA”)
• mild or moderate kidney disease
• hypothyroidism
• diabetes

Other medicines and Gemfibrozil STADA

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

• antidiabetic 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 levels of bad cholesterol and triglycerides and increase levels of good cholesterol, such as atorvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin (for simvastatin and rosuvastatin 40 mg, see “Do not take Gemfibrozil STADA” and “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)
• colestipol resin granules for the treatment of high fat (cholesterol) levels in the blood
• medication containing bexarotene for the treatment of skin cancer
• colchicine for the treatment of gout
• paclitaxel, a cancer treatment
• enzalutamide, a treatment for prostate cancer

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Breastfeeding

Taking gemfibrozil is not recommended during breastfeeding.

Driving and using machines

In rare cases, gemfibrozil may cause dizziness and affect your vision. If this occurs, do not drive or operate machinery until you feel well again.

Gemfibrozil STADA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

3. How to take Gemfibrozil STADA

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

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

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

Taking gemfibrozil with food and drink

This medicine should be taken half an hour before meals.

Adults and elderly patients

The usual 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 instructed to take a dose of 1200 mg, you should take 600 mg half an hour before breakfast and another 600 mg half an hour before dinner.

If you are instructed to take a dose of 900 mg, you should take the single dose half an hour before dinner.

Adults with mild to moderate renal impairment

Your doctor will evaluate your condition before and during treatment with this medicine. Your treatment will start at 900 mg per day and may be increased up to 1200 mg, depending on your response. Gemfibrozil must not be used in patients with severe renal impairment.

Use in children

This medicine is not recommended for use in children.

If you take more gemfibrozil than you should

If you accidentally take too much gemfibrozil, contact your doctor immediately or go to the nearest hospital emergency department, or call the Toxicology Information Service at: 91 562 04 20. Always bring the packaging, even if no gemfibrozil remains. 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. Simply take the next dose at the correct time. Do not take a double dose to make up for missed doses.

If you stop taking Gemfibrozil STADA

Do not stop taking this medicine unless instructed by your doctor. Follow all your doctor's instructions while taking gemfibrozil to achieve the maximum benefit from treatment.

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

4. Possible adverse effects

Like all medicines, gemfibrozil may produce adverse effects, although not everyone experiences them.

Serious adverse effects

Although serious reactions may occur, 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 1,000 people)

• allergic reaction in which the face, tongue, or throat may swell, causing difficulty breathing (angioedema)
• skin peeling and blistering, affecting the mouth, eyes, and genitals
• rash affecting the entire body
• muscle weakness or weakness accompanied by dark urine, fever, rapid heartbeat (palpitations), nausea, or vomiting

Other reported adverse effects include

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

• indigestion

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

• sensation of spinning or swaying (dizziness)
• eczema, rash (especially itchy or inflamed rash)
• headache
• abdominal pain
• diarrhoea
• feeling unwell
• malaise
• constipation
• flatulence
• fatigue

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

• irregular heartbeat

Rare (may affect up to 1 in 1,000 people)

• decrease or increase in white blood cells (leucopenia, eosinophilia), bone marrow disorder (bone marrow failure)
• reduction in platelet count (thrombocytopenia)
• nerve inflammation (peripheral neuritis)
• unusual bruising or bleeding due to reduced blood platelets (thrombocytopenia)
• severe anaemia
• loss of sensation and tingling sensations (paraesthesia)
• pancreatitis
• blurred vision
• jaundice (yellowing of the skin), liver function abnormalities
• liver inflammation (hepatitis)
• gallstones (cholelithiasis), inflammation of the gallbladder (cholecystitis)
• appendicitis
• depression
• dizziness
• somnolence
• joint and limb pain
• skin inflammation or inflamed, peeling, or shedding skin
• muscle inflammation (myositis)
• inflammation of the synovial membrane (synovitis)
• persistent lack of energy
• impotence
• reduced libido
• hair loss
• photosensitivity (sensitivity to light which may cause skin discoloration or rash)
• red, raised, itchy skin areas
• itching

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gemfibrozil STADA

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gemfibrozil STADA

The active substance is gemfibrozil. Each tablet contains 600 mg of gemfibrozil.

The other components are: Corn starch, microcrystalline cellulose, anhydrous colloidal silica, polysorbate 80, sodium carboxymethyl starch type A (from potato), pregelatinized starch (from corn), magnesium stearate, Opadry White 03F28756 (containing hypromellose, titanium dioxide and macrogol).

Appearance of the product and contents of the pack

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

Each pack contains 60 tablets.

Other presentations

Gemfibrozil STADA 900 mg film-coated tablets EFG

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 latest review of this leaflet: March 2025

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