Lopid 600 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

LOPID 600 mg film-coated tablets

Gemfibrozil

Read the entire 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 and must not be given to other people, even if they have the same symptoms, as it may harm them
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Lopid is and what it is used for
2. What you need to know before taking Lopid
3. How to take Lopid
4. Possible adverse effects
   1. Storage of Lopid
   2. Contents of the pack and other information

1. What Lopid is and what it is used for

Lopid contains the active substance gemfibrozil, which 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.

Lopid is used, together with a low-fat diet and other non-medical treatments such as exercise and weight loss, to reduce levels of fats in the blood. Lopid 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.

Lopid 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 Lopid

Do not take Lopid

• if you are allergic to gemfibrozil or to 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 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 Lopid.

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

• high risk of muscle breakdown (rhabdomyolysis): risk factors include kidney impairment; underactive thyroid; being 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, 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 Lopid” and “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 need to 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 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 Lopid” 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
• bexarotene medication 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

Lopid is not recommended during breastfeeding.

Driving and use of machines

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

Low-sodium diet

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

3. How to take Lopid

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

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

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

Taking Lopid with food and drink

Lopid 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 dose of 1200 mg, you will need to take 600 mg half an hour before breakfast and another 600 mg half an hour before dinner.

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

Adults with mild to moderate renal impairment

Your doctor will evaluate your condition before and during treatment with Lopid. Your treatment will start at 900 mg daily and may be increased up to 1200 mg depending on response. Lopid must not be used in patients with severe renal impairment.

Use in children

Lopid is not recommended for use in children.

If you take more Lopid than you should

If you accidentally take too much Lopid, contact your doctor immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service. Telephone: 91 562 04 20. Always take the container with you, even if no Lopid remains. 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 forgotten doses.

If you stop treatment with Lopid

Do not stop taking Lopid unless your doctor tells you to. Follow all your doctor's instructions while taking Lopid in order 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, this medicine can 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 Lopid:

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
• gas
• fatigue

Uncommon adverse effects (may affect up to 1 in 100 people)

• irregular heartbeat

Rare (may affect up to 1 in 1,000 people)

• decrease or increase in white blood cells (leucopenia, eosinophilia), bone marrow disorder (bone marrow failure)
• reduction in the number of platelets (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 sheds
• muscle inflammation (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, raised, itchy skin areas
• itching

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 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 refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers 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 components are pregelatinized corn starch, microcrystalline cellulose, colloidal anhydrous silica (E-551), sodium carboxymethyl starch (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 supplied in transparent PVC blisters with an aluminum backing, in packs containing 14, 20, 28, 30, 50, 56, 60, 98, 100, 196, 500, and 600 tablets.

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

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

Gevilon: Austria, Germany

Lipur: France

Date of the most recent review of this summary: March 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS) http://www.aemps.gob.es/