Patient Information Leaflet

LOPID 900 mg Film-Coated Tablets

Gemfibrozil

Read this 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. Do not pass it on to others even if their symptoms are the same. It may harm them
• If you experience any side effects, talk to your doctor, pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Lopid is and what it is used for

2.What you need to know before you take Lopid

3.How to take Lopid

4.Possible side effects

1. Storage of Lopid
2. Contents of the pack and additional information

Lopid contains the active ingredient gemfibrozilo, which 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 known as triglycerides.

Lopid 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. Lopid may be used when other medications [statins] are not suitable to reduce the risk of heart problems in men who are at high risk and have high levels of "bad" cholesterol.

Lopid may also be prescribed to reduce the level of cholesterol in the blood in individuals who cannot be prescribed other medications that lower lipids.

Do not take Lopid

• if you are allergic to gemfibrozil or any of the other ingredients in this medicine (listed in section 6)
• if you have liver disease
• if you have severe kidney disease
• if you have a history of gallstones, gallbladder disease (biliary tract disease)
• if you have had photosensitivity or phototoxic reactions (allergic reactions triggered by sun exposure) during treatment with fibrates in the past
• if you are taking a medicine called repaglinide (used to lower blood sugar levels), simvastatin or rosuvastatina 40 mg (used to lower 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 Lopid.

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

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

Other medicines and Lopid

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

• antidiabetic medicines, especially rosiglitazona or repaglinide (used to lower blood sugar levels) (for repaglinide, see “Do not take Lopid”)
• dasabuvir, a medicine used to treat hepatitis C infection (see “Do not take Lopid” above)
• selexipag, a treatment for pulmonary hypertension (see “Do not take Lopid” above)
• statins used to lower 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 Lopid and rosuvastatina 40 mg”)
• 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 medicine.

Breastfeeding

It is not recommended to take Lopid during breastfeeding.

Driving and operating machinery

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

Low-sodium diet

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

Follow exactly the administration instructions of 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 Lopid. 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 if necessary, weight loss.

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

Lopid with food and beverages

Lopid 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 need 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 need to take the single dose 30 minutes before dinner.

Adults with mild to moderate renal disease

Your doctor will evaluate your condition before and during treatment with Lopid. Your treatment will start with 900 mg per day and may be increased to 1200 mg, depending on your response. Lopid should not be used in patients with severe renal disease.

Use in children

Lopid is not recommended for children.

If you take more Lopid than you should

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

If you forget to take Lopid

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.Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Lopid

Do not stop taking Lopid unless your doctor tells you to.Follow all your doctor's instructions while taking Lopid to achieve the maximum benefit of the treatment.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects

Although severe reactions may occur, you should contact your doctor immediately if you experience any of the following symptoms after taking Lopid:

Rare (may affect up to 1 in 1000 people)

allergic reaction in which the face, tongue, or throat may become inflamed, causing difficulty breathing (angioedema)

• peeling and blisters on the skin, mouth, eyes, and genitals
• eruption affecting the entire body
• weakness or weakness accompanied by dark urine, fever, rapid heart rate (palpitations), nausea, and 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 dizziness or balance (vertigo)
• eczema, rash (especially rash with itching or inflammation)
• headache
• abdominal pain
• diarrhea
• feeling unwell
• uncomfortable feeling
• 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 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 feeling of numbness (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 and limb pain
• inflammation of the skin or skin that peels or falls off
• inflammation of the muscles (myositis)
• inflammation of the synovial membrane (synovitis)
• persistent lack of energy
• impotence
• reduced libido
• hair loss
• sensitivity to light that may cause skin color change or rash
• red, elevated areas of skin with itching
• itching

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date (EXP) that appears on the packaging and outer carton. The expiration date is the last day of the month indicated.

Lopid 900 mg film-coated tablets:Do not store above25°C.

Medicines should not be disposed of through the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need.This will help protect the environment.

Composition of Lopid

The active ingredient is gemfibrozil. Each coated tablet contains 900 mg of gemfibrozil.

The other components are colloidal silica (anhydrous), precipitated silicon dioxide (E-551), cornstarch pregelatinized, sodium carboxymethyl starch (type A), polisorbate 80 (E-433), and magnesium stearate (E-470b).

The coating contains hypromellose (E-464), titanium dioxide (E-171), simethicone, macrogol 6000, and talc (E-553b).

Appearance of Lopid and contents of the packaging

Lopid 900 mg are white, oval-shaped coated tablets. They are presented in transparent PVC blisters with an aluminum backing in packs containing 20, 30, and 100 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Pfizer, S.L.

Avda. de Europa 20 B,

Parque Empresarial La Moraleja,

28108 Alcobendas (Madrid)

Spain

Responsible manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Lopid : Denmark, Greece, Iceland, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, and United Kingdom (Northern Ireland)

Gevilon : Austria, Germany

Lipur : France

Last review date of this leaflet: March 2023

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/