LOPID 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

LOPID 600 mg film-coated tablets

Gemfibrozil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lopid and what is it 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 other information

1. What is Lopid and what is it used for

Lopid contains the active substance gemfibrozil, which belongs to a group of medicines commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example, fats called triglycerides.

Lopid is used, along with a low-fat diet and other non-medical treatments such as exercise and weight loss, to lower the levels of fats in the blood. Lopid can be used when other medicines [statins] are not suitable for reducing the risk of heart problems in men at high risk and whose "bad" cholesterol is higher.

Lopid can also be prescribed to lower the level of cholesterol in the blood in people who cannot be prescribed other medicines that lower lipids.

2. What you need to know before you take Lopid

Do not take Lopid

• if you are allergic to gemfibrozil or any of the other ingredients of 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 reaction triggered by sun exposure) 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 lower cholesterol levels), dasabuvir (a medicine used to treat hepatitis C infection), or selexipag (a medicine used to treat pulmonary hypertension)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lopid.

Tell your doctor if you have 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 failure; underactive thyroid; over 70 years; 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 rosuvastatin and simvastatin (for simvastatin and rosuvastatin 40 mg, see "Do not take Lopid" and see "Other medicines and Lopid")
• mild or moderate kidney disease
• underactive thyroid
• diabetes

Other medicines and Lopid

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

• antidiabetic medicines, especially rosiglitazone 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 atorvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin (for simvastatin and rosuvastatin 40 mg, see "Do not take Lopid" 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 phenprocoumon (anticoagulants used to make the blood more fluid)
• 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 breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Breast-feeding

Lopid is not recommended during breast-feeding.

Driving and using machines

In rare cases, Lopid can cause dizziness and affect your vision. If this happens, do not drive or use machines until you feel better.

Low sodium diet

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

3. How to take Lopid

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. Ask your doctor or pharmacist if you have any doubts.

Before and during treatment with Lopid, your lipid levels in the blood will be closely and regularly monitored. If you are diabetic or have thyroid problems, your doctor will have 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.

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

Taking Lopid with food and drinks

Lopid should be taken half an hour 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 leaflet.

If you are told to take a dose of 1200 mg, you will have to take 600 mg half an hour before breakfast and another 600 mg half an hour before dinner.

If you are told to take a dose of 900 mg, you will have to take the single dose half an hour before dinner.

Adults with mild to moderate kidney disease

Your doctor will assess your condition before and during treatment with Lopid. Your treatment will start with 900 mg per day and may increase to 1200 mg, depending on the response. Lopid should not be used in patients with severe kidney 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 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 Lopid left. The signs of overdose may be 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 forgotten doses. Do not take a double dose to make up for forgotten doses.

If you stop taking Lopid

Do not stop taking Lopid unless your doctor tells you to. Follow all your doctor's instructions while taking Lopid, in order to get the maximum benefit from the treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

You should immediately contact your doctor 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 blistering of 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 side effects reported 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
• malaise
• 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 the number of platelets (thrombocytopenia)
• inflammation of the nerves (peripheral neuritis)
• bruising or unusual bleeding due to a reduction in blood platelets (thrombocytopenia)
• severe anemia
• loss of sensation and tingling (paresthesia)
• pancreatitis
• blurred vision
• jaundice (yellowing of the skin), liver function changes
• 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 inflamed skin that scales or peels
• inflammation of the muscles (myositis)
• inflammation of the synovial membrane (synovitis)
• persistent lack of energy
• impotence
• reduced libido
• hair loss
• photosensitivity (sensitivity to light that can cause skin color change or rash)
• red, raised areas of skin with itching
• itching

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lopid

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

Do not use this medicine after the expiry date (EXP) stated on the packaging and outer carton. The expiry date is the last day of the month stated.

Lopid 600 mg film-coated tablets: Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lopid

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

The other ingredients are pregelatinized maize starch, microcrystalline cellulose, colloidal anhydrous silica (E-551), sodium carboxymethyl cellulose (type A), polysorbate 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 pack

Lopid 600 mg are white, oval, film-coated tablets. They are presented in transparent PVC blister strips with an aluminum foil backing in packs containing 14, 20, 28, 30, 50, 56, 60, 98, 100, 196, 500, and 600 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pfizer, S.L.

Avda. de Europa 20 B,

Parque Empresarial La Moraleja,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

This medicine 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

Date of last revision of this leaflet: March 2023

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