LOPID 600 mg Коированная Таблетка

Содержание инструкции

1. LOPID 600 mg film-coated tablets, 900 mg film-coated tablets
   1. What is Lopid and what is it 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. Package contents and other information

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

Gemfibrozil

Read this leaflet carefully before you start taking this medicine, as 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. Do not pass it on to others. It may be harmful to people even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Lopid and what is it used for

Lopid contains the active ingredient 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 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 blood fat levels.
Lopid may be used when other medicines (statins) are inadequate to reduce
the incidence of heart problems in males with high “bad cholesterol” and high
cardiovascular risk.
Lopid may also be prescribed to people who cannot be prescribed 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 any of the other ingredients of this medicine (listed in section 6);
• if you suffer from liver disease;
• if you suffer from severe kidney disease;
• if you suffer from gallstones, gallbladder disease or bile disease (biliary tract disease);

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• if you have had photoallergy or phototoxic reactions (allergic reactions following exposure to sunlight) in the past during treatment with fibrates;
• if you are currently taking a medicine called repaglinide (a drug used to reduce blood sugar levels in case of diabetes), simvastatin or rosuvastatin 40 mg (drugs to lower cholesterol) or dasabuvir (a drug 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
your case:

• high risk of muscle breakdown (rhabdomyolysis): risk factors include kidney impairment; low thyroid activity; age over 70 years; excessive alcohol use; previous history of muscle pain or weakness (muscle toxicity) with other fibrates or statins; history of hereditary muscle disorders; use of Lopid in combination with statins, 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 see “Other medicines and Lopid”);
• mild-moderate kidney disease;
• low thyroid activity;
• 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 in particular rosiglitazone or repaglinide (used to reduce blood sugar levels) (for repaglinide see the paragraph “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 reduce bad cholesterol and triglycerides and increase good cholesterol (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 diarrhoea;
• montelukast, a treatment for asthma;
• pioglitazone, a treatment used for diabetes;
• warfarin, acenocoumarol and phenprocoumon (anticoagulants used to make the blood more fluid);
• 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 treatment for cancer
• enzalutamide, a treatment for prostate cancer

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor for advice before taking this medicine.
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Breastfeeding
It is recommended not to take Lopid during breastfeeding.

Driving and using machines
In rare cases Lopid may cause dizziness and affect vision, if this happens, avoid driving or
using machines. You can drive or use machines until you feel well.

Sodium content
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 your doctor or pharmacist has told you. If you have doubts, ask your doctor or pharmacist.
Before and during treatment with Lopid, your blood lipid levels will be carefully monitored and evaluated regularly. If you are diabetic or have thyroid problems, your doctor will try to treat these conditions before starting treatment. Your doctor will also advise you to follow a correct diet, exercise, stop smoking and drinking alcohol and, if necessary, to lose weight.
Lopid must be taken orally. It is recommended to swallow the capsules or tablets with a glass of water, as the tablets, if crushed, have an unpleasant taste.

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

Adult and elderly patients:
The usual initial dose is between 900 mg and 1200 mg per day. Your doctor will decide which dose is most suitable for you following the instructions contained in the package leaflet.
If you are advised to take a dose of 1200 mg, you will need to take 600 mg half an hour before breakfast and the second dose of 600 mg half an hour before the evening meal.
If you are advised to take a dose of 900 mg, you will need to take this dose half an hour before the evening meal.

Adult patients with mild to moderate kidney disease:
The doctor will assess your condition before and during treatment with Lopid. Treatment will start at a daily dose of 900 mg and may be increased to 1200 mg according to your response. Lopid should not be used in patients with severe kidney disease.

Use in children
Lopid is not recommended 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 room. Always bring the package of the medicine with you, whether or not any medicine remains. Signs of overdose may include abdominal cramps, diarrhea, 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 right time. Do not take a double dose to make up for a missed dose.
If you stop taking Lopid
Do not stop Lopid unless your doctor has told you to. It is recommended to follow the advice received while being treated with Lopid in order to obtain all the benefits of treatment.
If you have any questions about 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 everyone will experience them.

Serious side effects
Although serious reactions may occur, it is advisable to contact your doctor immediately if any of the following symptoms occur after taking Lopid:
Rare (may affect up to 1 in 1,000 people)

• allergic reaction in which the face, tongue or throat may begin to swell, causing difficulty breathing (angioedema)
• skin peeling and blistering of the skin, mouth, eyes and genitals
• rash affecting the whole 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 (may affect more than 1 in 10 people)

• indigestion

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

• sense of spinning or swaying (dizziness)
• eczema, rash (especially itchy or swollen rash)
• headache
• stomach pain
• diarrhoea
• nausea
• vomiting
• constipation
• flatulence
• fatigue

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

• irregular heartbeat

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

• reduction or increase in white blood cells (leukopenia, eosinophilia), bone marrow disease (bone marrow failure)
• decrease in platelets in the blood (thrombocytopenia)
• inflammation of the nerves (peripheral neuropathy)
• unusual bruising or wounds due to a reduction in platelets in the blood (thrombocytopenia)

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• severe anaemia
• loss of sensation and tingling (paraesthesia)
• pancreatitis
• blurred vision
• jaundice (yellowing of the skin), impaired liver function
• inflammation of the liver (hepatitis)
• gallstones (cholelithiasis), inflammation of the gallbladder (cholecystitis)
• appendicitis
• depression
• vertigo
• drowsiness
• joint and limb pain
• inflamed skin or inflamed skin that scales or falls off
• muscle inflammation (myositis)
• inflammation of the synovial membrane (synovitis)
• persistent lack of energy
• impotence
• decreased libido
• hair loss
• photosensitivity (sensitivity to light that can cause skin discoloration or rash)
• raised, red, itchy areas of skin
• itching

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you 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 at a temperature below 25ºC.
Do not dispose of any medicine in 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 ingredient is gemfibrozil. Each film-coated tablet contains 600 mg of gemfibrozil.
• The excipients are: pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide (anhydrous), sodium glycolate starch, polysorbate 80 (E433) and magnesium stearate.

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Lopid 900 mg film-coated tablets

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

The film coating for all tablet strengths contains hydroxypropylmethylcellulose
(E464), titanium dioxide (E171), polydimethylsiloxane, polyethylene glycol 6000 and talc (E553b).

Description of Lopid and package contents
Lopid 600 mg tablets are white, oval and film-coated. The tablets are
packaged 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.
Lopid 900 mg tablets are white, oval and film-coated. The tablets are
packaged in transparent PVC blisters with an aluminum backing in packs containing 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 Member States of the European Economic Area and
in the United Kingdom (Northern Ireland) with the following denominations:
Lopid:Denmark, Finland, Greece, Iceland, Ireland, Italy, Netherlands, Portugal, Spain,
Sweden and United Kingdom (Northern Ireland)

Gevilon:Austria, Germany

Lipur: France
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