GEMFIBROZIL STADA 600 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Gemfibrozil STADA 600 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

• If you have any doubts, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.

• If you experience serious side effects or any side effect not mentioned in this package leaflet, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. How to take Gemfibrozil STADA

1. Possible side effects
2. Storage of Gemfibrozil STADA

1. Package contents and additional information

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

Gemfibrozil belongs to a group of medications commonly known as fibrates. These medications are used to reduce 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 reduce fat levels in the blood.

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

Gemfibrozil may also be prescribed to reduce blood cholesterol levels in people who cannot be prescribed other lipid-lowering medications.

2. What you need to know before taking Gemfibrozil STADA

Do not take Gemfibrozil STADA

• if you are allergic to gemfibrozil or any of the other components of this medication (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 (other cholesterol medications of the same family as gemfibrozil)
• if you are taking a medication called repaglinide (medication used to reduce blood sugar levels), simvastatin, or rosuvastatin 40 mg (medications that reduce cholesterol levels), dasabuvir (medication used to treat hepatitis C infection), or selexipag (medication used to treat pulmonary hypertension)

Warnings and precautions

Consult your doctor or pharmacist before starting to take gemfibrozil.

Inform your doctor if you have any of the following problems to help 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 reduce "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 medications and Gemfibrozil STADA")
• mild or moderate kidney disease
• underactive thyroid
• diabetes

Other medications and Gemfibrozil STADA

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

• antidiabetic medications, especially rosiglitazone or repaglinide (used to reduce blood sugar levels) (for repaglinide, see "Do not take Gemfibrozil STADA")
• dasabuvir, a medication 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 reduce "bad" cholesterol and triglyceride levels and increase "good" cholesterol levels, 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 fenprocoumon (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 breastfeeding

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

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.

Gemfibrozil STADA contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Gemfibrozil STADA

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Before and during treatment with gemfibrozil, your lipid levels in the blood will be closely and regularly monitored. 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 orally. It is recommended to swallow the tablets with a glass of water, as they have an unpleasant taste if broken

Taking gemfibrozil with food and drinks

This medication should be taken 30 minutes 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 package leaflet.

If you are prescribed a dose of 1200 mg, you will need to take 600 mg 30 minutes before breakfast and another 600 mg 30 minutes before dinner.

If you are prescribed a dose of 900 mg, you will need to take the single dose 30 minutes before dinner.

Adults with mild to moderate kidney disease

Your doctor will assess your condition before and during treatment with this medication. 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 disease.

Use in children

This medication is not recommended for children.

If you take more gemfibrozil than you should

If you accidentally take too much gemfibrozil, consult your doctor immediately or go to the emergency department of the nearest hospital or call the Toxicology Information Service. Phone: 91 562 04 20. Always carry the package, even if there is no gemfibrozil left. The signs of overdose may be 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 the missed doses.

If you stop taking Gemfibrozil STADA

Do not stop taking this medication 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, gemfibrozil can cause side effects, although not everyone gets them.

Serious side effects

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

Rare (may affect up to 1 in 1000 people)

• allergic reaction that can cause swelling of the face, tongue, or throat, causing difficulty breathing (angioedema)
• peeling and blisters on the skin, mouth, eyes, and genitals
• rash that affects the whole body
• muscle weakness or weakness accompanied by dark urine, fever, rapid heartbeat (palpitations), nausea, or vomiting

Other reported side effects 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
• discomfort
• 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 (leukopenia, eosinophilia), bone marrow disease (bone marrow failure)
• reduction in platelet count (thrombocytopenia)
• nerve inflammation (peripheral neuritis)
• bruising or unusual bleeding due to reduced 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)
• synovial membrane inflammation (synovitis)
• persistent lack of energy
• impotence
• reduced libido
• hair loss
• photosensitivity (sensitivity to light that can cause skin color change or rash)
• red, raised skin areas with itching
• itching

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Gemfibrozil STADA

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Gemfibrozil STADA composition

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

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

Product appearance and package contents

Gemfibrozil STADA is presented in the form of film-coated tablets, white and oval.

Each package contains 60 tablets.

Other presentations

Gemfibrozil STADA 900 mg film-coated tablets EFG

Marketing authorization holder and manufacturer

Holder:

Laboratory 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 last revision of this package leaflet:March 2025

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