Patient Information Leaflet: Information for the Patient

Gemfibrozilo STADA 900 mg Film-Coated Tablets EFG

Read this leaflet carefully before you start taking the 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. Do not give it to others, even if they have the same symptoms, as it may harm them.

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

1. How to take Gemfibrozilo STADA

1. Possible side effects
2. Storage of Gemfibrozilo STADA

1. Contents of the pack and additional information

Gemfibrozilo 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.

Gemfibrozilo is used, along 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.

Gemfibrozilo can be used when other medicines [statins] are not suitable to reduce the risk of heart problems in men who are at high risk and have higher levels of “bad cholesterol”.

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

Do not take Gemfibrozilo STADA

• if you are allergic to gemfibrozilo or any of the other ingredients of this medication (listed in section 6)
• if you have liver insufficiency
• if you have severe kidney insufficiency
• if you have a history of gallstones, biliary tract diseases (biliary tract disease)
• if in the past you had photosensitivity or phototoxic reactions (allergic reaction triggered by exposure to the sun) during treatment with fibrates
• if you are taking a medication called repaglinida (used to reduce blood sugar levels), simvastatina or rosuvastatina 40 mg (used to reduce cholesterol levels), dasabuvir (used to treat hepatitis C infection) or selexipag (used to treat pulmonary hypertension)

Warnings and precautions

Consult your doctor or pharmacist before starting to take gemfibrozilo.

Inform your doctor if you experience any of the following problems to help them decide if gemfibrozilo is suitable for you:

• high risk of muscle destruction (rhabdomyolysis): risk factors include kidney insufficiency; hypothyroidism; over 70 years old; excessive alcohol use; history of muscle pain and weakness (muscle toxicity) with another fibrate or statin; history of hereditary muscle disorders; use of gemfibrozilo in combination with statins, used to reduce bad cholesterol and triglycerides, and increase good cholesterol, such as rosuvastatina and simvastatina (for simvastatins and rosuvastatina 40 mg, see “Do not take Gemfibrozilo STADA” and see “Other medications and Gemfibrozilo STADA”)
• mild or moderate kidney disease
• hypothyroidism
• diabetes

Other medications and Gemfibrozilo STADA

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

• oral antidiabetic medications, especially rosiglitazona or repaglinida (used to reduce blood sugar levels) (for repaglinida, see “Do not take Gemfibrozilo STADA”)
• dasabuvir, a medication 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 bad cholesterol and triglycerides and increase good cholesterol such as atorvastatina, lovastatina, pravastatina, rosuvastatina and simvastatina (for simvastatina and rosuvastatina 40 mg, see “Do not take Gemfibrozilo STADA” and see “Warnings and precautions”)
• dabrafenib, a treatment for melanoma
• loperamida, a treatment for diarrhea
• montelukast, a treatment for asthma
• pioglitazona, a treatment used for diabetes
• warfarina, acenocumarol, and femprocumon (blood thinners used to make blood thinner)
• cholestyramine granules for the treatment of high levels of fat (cholesterol) in the blood
• medication with bexaroteno for the treatment of skin cancer
• colchicina for the treatment of gout
• paclitaxel, a treatment for cancer
• enzalutamida, a treatment for prostate cancer

Pregnancy and breastfeeding

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

Breastfeeding

It is not recommended to take gemfibrozilo during breastfeeding.

Driving and operating machinery

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

Gemfibrozilo STADA contains sodium

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

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

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

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

Gemfibrozilo with food and beverages

This medication should be taken 30 minutes before meals.

Adults and elderly patients

The initial dose is usually between 900 and 1200 mg per day. Your doctor will decide the best dose for you, follow the instructions on the package insert.

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

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

Adults with mild to moderate kidney disease

Your doctor will evaluate 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 your response. Gemfibrozilo should not be used in patients with severe kidney disease.

Use in children

This medication is not recommended for children.

If you take more gemfibrozilo than you should

If you accidentally take too much gemfibrozilo, consult your doctor immediately or go to the nearest hospital emergency department or call the Toxicology Information Service. Phone: 91 562 04 20. Always carry the packaging, even if there is no gemfibrozilo left. Signs of overdose may include abdominal cramps, diarrhea, joint and muscle pain, nausea, and vomiting.

If you forget to take Gemfibrozilo 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 interrupt treatment with Gemfibrozilo STADA

Do not stop taking this medication unless your doctor tells you to. Follow all your doctor's instructions while taking gemfibrozilo to achieve the maximum benefit from treatment.

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

Like all medications, gemfibrozil may cause side effects, although not everyone will experience them.

Severe side effects

Although severe reactions may occur, 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 facial, tongue, or throat inflammation, leading to difficulty breathing (angioedema)
• peeling and blistering of the skin, mouth, eyes, and genitals
• body-wide rash
• muscle weakness or weakness accompanied by dark urine, fever, rapid heart rate (palpitations), nausea, or vomiting

Other reported side effects include

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

• indigestion

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

• feeling of dizziness or balance (vertigo)
• eczema, rash (especially itchy or inflamed rash)
• headache
• abdominal pain
• diarrhea
• feeling unwell
• uncomfortable feeling
• constipation
• gas
• fatigue

Infrequent 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 insufficiency)
• reduction in platelet count (thrombocytopenia)
• inflammation of nerves (peripheral neuritis)
• unusual bleeding or bruising due to reduced platelet count (thrombocytopenia)
• severe anemia
• loss of sensation and tingling (paresthesia)
• pancreatitis
• blurred vision
• jaundice (yellowing of the skin), liver function abnormalities
• inflammation of the liver (hepatitis)
• gallstones (cholelithiasis), inflammation of the gallbladder (cholecystitis)
• appendicitis
• depression
• dizziness
• drowsiness
• joint or limb pain
• inflammation of the skin or skin that peels or falls off
• inflammation of muscles (myositis)
• inflammation of the synovial membrane (synovitis)
• persistent lack of energy
• impotence
• reduced libido
• hair loss
• photosensitivity (sensitivity to light that may cause skin discoloration or rash)
• red, elevated skin areas with itching
• itching

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's a possible side effect not listed in this prospectus. You can also report them directly through the Spanish Medicines Vigilance System:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Gemfibrozilo this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines that you do not need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines that you do not need. In this way, you will help to protect the environment.

Composition of Gemfibrozilo STADA

The active ingredient is gemfibrozilo. Each tablet contains 900 mg of gemfibrozilo.

The other components are: Maize starch, microcrystalline cellulose, colloidal silica, polysorbate 80, sodium carboxymethyl starch, pregelatinized maize starch, magnesium stearate, hypromellose, titanium dioxide, and polyethylene glycol.

Appearance of the product and contents of the packaging

Gemfibrozilo STADA is presented in the form of film-coated, white, oval-shaped tablets.

Each package contains 30 tablets.

Other presentations

Gemfibrozilo STADA 600 mg film-coated tablets EFG

Holder of the marketing authorization and responsible for manufacturing

Holder:

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing

STADA Arzneimittel AG

Stadastraße 2-18,

61118 Bad Vilbel

Germany

Last review date of this leaflet:March 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.