Lopid

Package leaflet: Information for the patient

LOPID 600 mg film-coated tablets, 900 mg film-coated tablets

Gemfibrozil
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. 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. Never give it to others. It could be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 side effects
5. How to store Lopid
6. 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 lower the level of fats (lipids) in the blood, such as triglycerides.
Lopid is used in combination with a low-fat diet and other non-medical treatments, such as physical exercise and weight loss, to reduce fat levels in the blood.
Lopid may be used when other medicines (statins) are insufficient to reduce the incidence of heart problems in men with high "bad cholesterol" and high cardiovascular risk.
Lopid may also be prescribed to individuals who cannot be treated with other medicines intended to lower blood cholesterol levels.

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 gallstones or diseases of the gallbladder or bile (biliary tract disease);

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• if you previously experienced photoallergy or phototoxic reactions (allergic reactions following exposure to sunlight) during treatment with fibrates;
• if you are currently taking a medicine called repaglinide (a drug used to lower blood sugar levels in diabetes), simvastatin or rosuvastatin 40 mg (cholesterol-lowering drugs), or dasabuvir (a medicine used to treat hepatitis C infection) or selexipag (a medicine used to treat pulmonary arterial hypertension).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lopid.
Talk to your doctor before taking Lopid if any of the following conditions apply to you:

• high risk of muscle breakdown (rhabdomyolysis): risk factors include impaired kidney function; low thyroid activity; age over 70 years; excessive alcohol consumption; previous history of muscle pain or weakness (muscle toxicity) with other fibrates or statins; 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 "Other medicines and Lopid");
• mild to moderate kidney disease;
• low thyroid activity;
• diabetes.

Other medicines and Lopid
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:

• antidiabetic medicines, particularly rosiglitazone or repaglinide (used to reduce blood sugar levels) (for repaglinide, see section "Do not take Lopid");
• dasabuvir, a medicine used to treat hepatitis C infection (see "Do not take Lopid");
• selexipag, a treatment for pulmonary hypertension (see "Do not take Lopid");
• statins such as atorvastatin, lovastatin, pravastatin, rosuvastatin, and simvastatin, used to lower bad cholesterol and triglycerides and increase good cholesterol (for simvastatin and rosuvastatin 40 mg, see "Do not take Lopid" and "Warnings and precautions");
• dabrafenib, a treatment for melanoma;
• loperamide, a treatment for diarrhoea;
• montelukast, a treatment for asthma;
• pioglitazone, a treatment used for diabetes;
• warfarin, acenocoumarol, and phenprocoumon (anticoagulants used to thin the blood);
• resin-based medicines such as colestipol for the treatment of high lipid (cholesterol) levels in the blood;
• bexarotene 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, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
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Breastfeeding
It is recommended not to take Lopid during breastfeeding.
Driving and using machines
Lopid may rarely cause dizziness and affect vision; if this occurs, avoid driving or using machinery. You may drive or use machinery as long as you feel well.
Sodium in diet
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Lopid

Always take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your blood lipid levels will be carefully monitored and regularly assessed before and during treatment with Lopid. If you have diabetes or thyroid problems, your doctor will try to manage these conditions before starting treatment. Your doctor will also advise you to follow a proper diet, exercise, stop smoking and drinking alcohol, and, if necessary, to lose weight.
Lopid is taken orally. It is recommended to swallow the capsules or tablets with a glass of water, as crushed tablets have an unpleasant taste.

Lopid with food and drinks
Lopid should be taken half an hour before meals.

Adult and elderly patients:
The usual starting dose is between 900 mg and 1200 mg daily. Your doctor will decide the most appropriate dose for you according to the instructions in this leaflet.
If you are advised to take a 1200 mg dose, you should take 600 mg half an hour before breakfast and the second 600 mg dose half an hour before the evening meal.
If you are advised to take a 900 mg dose, you should take it half an hour before the evening meal.

Adult patients with mild to moderate renal impairment:
Your doctor will evaluate your condition before and during treatment with Lopid. Treatment will start at a daily dose of 900 mg and may be increased up to 1200 mg depending on your response. Lopid must not be used in patients with severe kidney disease.

Use in children
Lopid is not recommended for use in children.

If you take more Lopid than you should:
If you accidentally take more Lopid than you should, contact your doctor immediately or go to the nearest hospital emergency department. Always bring the medicine pack with you, whether or not there is any medicine left. Signs of overdose may include abdominal cramps, diarrhoea, muscle and joint pain, nausea and vomiting.

If you forget to take Lopid
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If you forget to take a dose, do not worry. Simply skip that dose and take the next dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Lopid
Do not stop taking Lopid unless your doctor tells you to. It is recommended that you follow the advice provided during treatment with Lopid in order to obtain the full benefits of the treatment.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Although serious reactions may occur, you should contact your doctor immediately if you experience any of the following symptoms after taking Lopid:
Rare (affects up to 1 in 1,000 people)

• allergic reaction with swelling of the face, tongue or throat, causing difficulty in breathing (angioedema)
• skin peeling and formation of blisters on the skin, 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 side effects include:
Very common side effects (affects more than 1 in 10 people)

• indigestion

Common side effects (affects up to 1 in 10 people)

• sensation of spinning or dizziness (vertigo)
• eczema, rash (particularly itchy rash or rash with swelling)
• headache
• stomach pain
• diarrhoea
• nausea
• vomiting
• constipation
• flatulence
• fatigue

Uncommon side effects (affects up to 1 in 100 people)

• irregular heartbeat

Rare side effects (affects up to 1 in 1,000 people)

• decrease or increase in white blood cells in the blood (leucopenia, eosinophilia), bone marrow disorder (bone marrow failure)
• reduction in platelets in the blood (thrombocytopenia)
• inflammation of the nerves (peripheral neuropathy)
• unusual bruising or bleeding due to reduced platelets in the blood (thrombocytopenia)

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• severe anaemia
• loss of sensation and tingling sensation (paraesthesia)
• pancreatitis
• blurred vision
• jaundice (yellowing of the skin), liver function disorders
• inflammation of the liver (hepatitis)
• gallstones (cholelithiasis), inflammation of the gallbladder (cholecystitis)
• appendicitis
• depression
• dizziness
• somnolence
• joint and extremity pain
• skin inflammation or inflamed skin that peels or sheds
• inflammation of the muscles (myositis)
• inflammation of the synovial membrane (synovitis)
• persistent lack of energy
• impotence
• decreased libido
• hair loss
• photosensitivity (sensitivity to light which may cause skin discolouration or rash)
• raised, red, itchy areas of skin
• itching

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Lopid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and on the
blister after EXP. The expiry date refers to the last day of the month.
Lopid 600 mg film-coated tablets and Lopid 900 mg film-coated tablets:
store below 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lopid contains
Lopid 600 mg film-coated tablets

• The active substance is gemfibrozil. Each film-coated tablet contains 600 mg of gemfibrozil.
• The excipients are: pregelatinized starch, microcrystalline cellulose, colloidal anhydrous silica, sodium glycolate starch, polysorbate 80 (E433), and magnesium stearate.

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Lopid 900 mg film-coated tablets

• The active substance is gemfibrozil. Each film-coated tablet contains 900 mg of gemfibrozil.
• The excipients are: colloidal anhydrous silica, precipitated silica (E551), pregelatinized starch, sodium glycolate starch, polysorbate 80 (E433), and magnesium stearate.

The coating film for all tablet strengths contains hypromellose (E464), titanium dioxide (E171), polydimethylsiloxane, polyethylene glycol 6000, and talc (E553b).
Description of the appearance of Lopid and contents of the pack
Lopid 600 mg tablets are white, oval-shaped, film-coated tablets. The tablets are packaged in transparent PVC blisters with aluminum backing, in pack sizes of 14, 20, 28, 30, 50, 56, 60, 98, 100, 196, 500, and 600 tablets.
Lopid 900 mg tablets are white, oval-shaped, film-coated tablets. The tablets are packaged in transparent PVC blisters with aluminum backing, in pack sizes of 20, 30, and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Pfizer Italia S.r.l., Via Isonzo, 71 – 04100 Latina
Manufacturer
Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1, D-79090 Freiburg, Germany
This medicinal product is authorized in the European Economic Area countries and in the
United Kingdom (Northern Ireland) under the following names:
Lopid: Denmark, Finland, Greece, Iceland, Ireland, Italy, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom (Northern Ireland)
Gevilon: Austria, Germany
Lipur: France
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