GENLIP 600 mg Таблетки

Содержание инструкции

1. GENLIP 600 mg tablets, 900 mg tablets
   1. What is GENLIP and what is it used for
   2. What you need to know before taking GENLIP
   3. How to take GENLIP
   4. Possible side effects
   5. How to store GENLIP
   6. Contents of the pack and other information

GENLIP 600 mg tablets, 900 mg tablets

Gemfibrozil

Read this leaflet carefully before 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, even if they have the same symptoms as you, as it could be harmful.
• 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 GENLIP is and what it is used for
• 2. What you need to know before you take GENLIP
• 3. How to take GENLIP
• 4. Possible side effects
• 5. How to store GENLIP
• 6. Contents of the pack and other information

1. What is GENLIP and what is it used for

This medicine contains the active substance gemfibrozil, belonging to the class of medicines
that reduce cholesterol and fat levels in the blood.
GENLIP is indicated as an adjunct to a low-fat diet or other
non-pharmacological treatments (physical activity, weight reduction), for the treatment of:

• high levels of fats in the blood (severe hypertriglyceridaemia), both in the absence or presence of low levels of cholesterol (HDL cholesterol);
• high levels of fats in the blood (mixed hyperlipidaemia), when treatments with other medicines called statins are not possible;
• high levels of cholesterol in the blood (primary hypercholesterolaemia), when treatments with other medicines called statins are not possible.

This medicine is also used to prevent the risk of heart and blood vessel
diseases (cardiovascular pathologies), in male patients, with high blood cholesterol levels (non-
HDL) and a high risk of having a first cardiovascular event, when other medicines called statins cannot
be taken.

2. What you need to know before taking GENLIP

Do not take GENLIP

• if you are allergic to gemfibrozil or any of the other ingredients of this medicine (listed in section 6);
• if you have liver problems (hepatic impairment);
• if you have severe kidney problems (severe renal impairment);
• if you suffer from or have suffered from gallbladder or bile duct disorders, including gallstones;
• if you are using repaglinide, a medicine used to treat diabetes (see “Other medicines and GENLIP”);
• if you have previously suffered from allergic or toxic skin disorders exposed to light (photoallergy or phototoxic reactions) during treatments with medicines of the same class as GENLIP (fibrates).

Warnings and precautions
Talk to your doctor or pharmacist before taking GENLIP.
Pay particular attention and talk to your doctor if during treatment with this
medicine you experience muscle pain (diffuse myalgia and tenderness) and if blood tests show particularly high levels of a substance produced by the muscles (CPK, > 5x
ULN). In this case, talk to your doctor because muscle damage (myopathy,
rhabdomyolysis) may occur, especially if you are taking other medicines that reduce fat levels in
the blood (other fibrates or HMG-CoA reductase inhibitors, see section “Other medicines and
GENLIP”).
Treatment with GENLIP in combination with other medicines that reduce fat levels in
the blood (HMG-CoA reductase inhibitors) must be carefully evaluated by your doctor
especially if you have a predisposition to muscle diseases (myopathies and rhabdomyolysis), this
risk increases if:

• you suffer from kidney problems;
• your thyroid gland is underactive (hypothyroidism);
• you regularly consume large amounts of alcohol;
• you are over 70 years of age;
• you or someone in your family has suffered from hereditary muscle disorders;
• you have previously suffered from muscle disorders after taking other medicines that reduce fat levels in the blood (fibrates or HMG-CoA reductase inhibitors). Also, before starting combination therapy with multiple medicines, your doctor will need to check levels of creatine phosphokinase (CPK).

This medicine may increase the elimination of cholesterol in the bile and therefore during
treatment with this medicine, the formation of gallstones (cholelithiasis) may occur,
therefore it is recommended to perform checks and to discontinue treatment if the
presence of gallstones is found.
Your doctor will perform periodic checks:

• of blood fat levels; a temporary increase in cholesterol (total and LDL) may occur. If your condition does not improve after 3 months of treatment, you should stop treatment and your doctor will indicate alternative therapy;
• of liver enzyme levels (ASAT and ALAT transaminases, alkaline phosphatase, LDH, CK and bilirubin);
• of the blood (complete blood count with white blood cell formula) during the first 12 months of treatment.

Children and adolescents
The use of this medicine is not recommended in children and adolescents due to the
lack of data on this population.

Other medicines and GENLIP
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Take this medicine with caution and inform your doctor if you are taking:

• medicines used to treat diabetes (oral agents and insulin) including rosiglitazone;
• other medicines used to reduce fat levels in the blood (bile acid sequestrants such as cholestyramine, HMG-CoA reductase inhibitors, such as simvastatin, lovastatin, pravastatin and rosuvastatin, see the Warnings and precautions section);
• medicines used to treat some circulatory disorders (oral anticoagulants) as it may increase the risk of bleeding; in this case, the dose of these medicines may need to be reduced;
• bexarotene, a medicine used to treat some types of cancer (lymphomas).

The combination of gemfibrozil and repaglinide is contraindicated (see “Do not take GENLIP”)

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no adequate studies on the use of Genlip in pregnant women. The use of this medicine
is not recommended during pregnancy unless absolutely necessary and under direct medical supervision.
Breastfeeding
No data are available on the excretion of gemfibrozil into breast milk. The use of this
medicine is not recommended during breastfeeding.

Driving and using machines
Studies have not been conducted on the ability to drive vehicles and operate machinery. This
medicine can rarely cause dizziness and visual disturbances that may impair the ability
to drive and operate machinery. If you experience these effects, avoid driving vehicles and
operating machinery.

3. How to take GENLIP

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Use in adults and the elderly
The recommended dose is between 900 mg and 1200 mg per day.
If you have been prescribed a dose of 900 mg per day, take it in a single administration
30 minutes before the evening meal.
If you have been prescribed a dose of 1200 mg per day, take it as two separate doses of
600 mg each, one 30 minutes before breakfast and the other 30 minutes before the evening meal.

Use in patients with kidney problems
If you suffer from kidney problems (mild-moderate renal impairment), the recommended initial dose is 900
mg per day. The doctor will increase this dose based on kidney function. If you take more
GENLIP than you should
In case of overdose, nausea and vomiting may occur.
In case of ingestion/taking an excessive dose of this medicine, inform your
doctor immediately or go to the nearest hospital.

If you forget to take GENLIP
Do not take a double dose to make up for the missed tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Very common(may affect more than 1 in 10 people):

• digestive disorders (dyspepsia).

Common(may affect up to 1 in 10 people):

• dizziness, headache (cephalalgia);
• abdominal pain, diarrhoea, flatulence, nausea, vomiting and constipation;
• skin irritation (eczema, rash);
• fatigue.

Uncommon(may affect up to 1 in 100 people):

• heartbeat disorders (atrial fibrillation).

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

• decrease in platelet levels (thrombocytopenia);
• severe decrease in red blood cell levels (severe anaemia);
• decrease in white blood cell levels and bone marrow function (leucopenia, eosinophilia, bone marrow hypoplasia);
• vertigo, drowsiness;
• sensation of tingling (paraesthesia);
• nerve inflammation (peripheral neuritis);
• depression;
• decreased libido;
• blurred vision;
• inflammation of the pancreas (pancreatitis);
• acute appendicitis;
• liver disorders (cholestatic jaundice, altered liver function, hepatitis, cholelithiasis, cholecystitis);
• skin irritation (exfoliative dermatitis, dermatitis, urticaria) and itching;
• hair loss (alopecia);
• joint (arthralgia, synovitis) and muscle (myalgia, myopathy, myasthenia, myositis, rhabdomyolysis) pain, pain in the arms and legs due to increased creatine phosphokinase;
• sexual disorders (impotence);
• skin sensitivity to light (photosensitivity);
• swelling due to fluid retention, around the mouth and eyes (angioedema), swelling of the throat (laryngeal oedema).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store GENLIP

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 after Exp. The
expiry date refers to the last day of that month.
Genlip 900 mg tablets: store at a temperature not exceeding 25° C.
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. Contents of the pack and other information

What GENLIP contains
GENLIP 600 mg tablets

• The active ingredient is gemfibrozil. Each tablet contains 600 mg of gemfibrozil.
• The other ingredients are microcrystalline cellulose, pregelatinized starch, silica, polysorbate 80, magnesium stearate, sodium carboxymethylcellulose, hydroxypropylmethylcellulose, simethicone, polyethylene glycol 6000, titanium dioxide, talc.

GENLIP 900 mg tablets

• The active ingredient is gemfibrozil. Each tablet contains 900 mg of gemfibrozil.
• The other ingredients are pregelatinized starch, silica, polysorbate 80, magnesium stearate, sodium carboxymethylcellulose, hydroxypropylmethylcellulose, simethicone, polyethylene glycol 6000, titanium dioxide, talc.

Description of the appearance of GENLIP and contents of the pack
GENLIP 600 mg tablets
Pack of 30 tablets.

GENLIP 900 mg tablets
Pack of 20 tablets.

Marketing Authorisation Holder
TEOFARMA S.r.l. – Via F.lli Cervi, 8 – 27010 Valle Salimbene (PV)

Manufacturer
TEOFARMA S.r.l. - V.le Certosa 8/A – 27100 Pavia