Gemfibrozil STADA 900 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Gemfibrozil STADA 900 mg Film-coated Tablets EFG

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

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

• If you have any questions, consult 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 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 side effects

5. How to store Gemfibrozil STADA

6. Contents of the pack and other 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 reduce the level of fats (lipids) in the blood, such as those 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 reduce blood cholesterol levels in people who cannot be prescribed other lipid-lowering medicines.

2. What you need to know before taking Gemfibrozilo STADA

Do not take Gemfibrozilo 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 insufficiency
• if you have a history of gallstones or gallbladder disease (biliary tract disease)
• if you previously experienced photosensitivity or phototoxic reactions (an allergic reaction triggered by exposure to sunlight) 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 reduce cholesterol levels), 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 you start taking gemfibrozil.

Inform your doctor if you have any of the following conditions to help determine whether gemfibrozil is suitable for you:

• high risk of muscle breakdown (rhabdomyolysis): risk factors include renal impairment; underactive thyroid; being over 70 years of age; excessive alcohol use; 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 reduce bad cholesterol and triglycerides and increase good cholesterol, such as rosuvastatin and simvastatin (for simvastatin and rosuvastatin 40 mg, see “Do not take Gemfibrozilo STADA” and “Other medicines and Gemfibrozilo STADA”)
• mild or moderate kidney disease
• underactive thyroid
• diabetes

Other medicines and Gemfibrozilo 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 reduce blood sugar levels) (for repaglinide, see “Do not take Gemfibrozilo STADA”)
• dasabuvir, a medicine used to treat hepatitis C infection (see “Do not take Gemfibrozilo STADA” above)
• selexipag, a treatment for pulmonary hypertension (see “Do not take Gemfibrozilo STADA” above)
• statins used to reduce 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 Gemfibrozilo 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 or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Breastfeeding

Gemfibrozil is not recommended during breastfeeding.

Driving and using machines

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

Gemfibrozilo STADA contains sodium

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

3. How to take Gemfibrozil STADA

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

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

Gemfibrozil is 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 this leaflet.

If you are instructed to take a 1200 mg dose, you must take 600 mg half an hour before breakfast and another 600 mg half an hour before dinner.

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

Adults with mild to moderate renal impairment

Your doctor will assess 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 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. Telephone: 91 562 04 20. Always bring the container with you, 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 a missed dose.

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 cause 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)

• reduction 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 sensation (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 skin that peels or sloughs off
• 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 type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Gemfibrozil STADA after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gemfibrozilo STADA

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

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

Appearance of the medicinal product and contents of the pack

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

Each pack contains 30 tablets.

Other presentations

Gemfibrozilo 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 the most recent 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/.