SINVALIP 10 mg Фильм-Coated Таблетки

Содержание инструкции

1. SINVALIP 10 mg FILM-COATED TABLETS, 20 mg FILM-COATED TABLETS, 40 mg FILM-COATED TABLETS
   1. What is SINVALIP and what it is used for
   2. What you need to know before taking SINVALIP
   3. How to take SINVALIP
   4. Possible side effects
   5. How to store SINVALIP
   6. Contents of the pack and other information

SINVALIP 10 mg FILM-COATED TABLETS, 20 mg FILM-COATED TABLETS, 40 mg FILM-COATED TABLETS

Simvastatina
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, even if their symptoms are the same as yours, 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 SINVALIP is and what it is used for
• 2. What you need to know before you take SINVALIP
• 3. How to take SINVALIP
• 4. Possible side effects
• 5. How to store SINVALIP
• 6. Contents of the pack and other information

1. What is SINVALIP and what it is used for

SINVALIPis a medicine used to reduce levels of cholesterol and fatty substances
called triglycerides in the blood. In addition, SINVALIP increases levels of “good” cholesterol
(HDL cholesterol). During the intake of this medicine you must follow a diet
to lower cholesterol. SINVALIP belongs to the group of medicines called
statins.
SINVALIP is used together with diet if you have:

• increased levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• an inherited disease (homozygous familial hypercholesterolemia) that increases your cholesterol levels in the blood. You may also be undergoing other treatments;
• coronary heart disease (CHD) or if you are at high risk of CHD (because you have diabetes, or have had a stroke, or have another disease of the blood vessels). SINVALIP can prolong survival by reducing the risk of problems related to heart disease regardless of cholesterol levels in the blood.

In most people, no immediate symptoms appear due to
high cholesterol. Your doctor is able to check your cholesterol with a simple
blood test. Visit your doctor regularly and keep track of your cholesterol levels and define the goals to be achieved with your doctor.

2. What you need to know before taking SINVALIP

Do not take SINVALIP:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you currently have liver problems;
• if you are pregnant or breastfeeding;
• if you are taking:
• itraconazole or ketoconazole (medicines for fungal infections);
• erythromycin, clarithromycin or telithromycin (antibiotics for infections);
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used for HIV infections);
• nefazodone (a medicine for depression).

Warnings and precautions
Talk to your doctor or pharmacist before taking SINVALIP:

• if you are allergic;
• if you consume significant amounts of alcohol;
• if you have ever had a liver disease. In this case SINVALIP may not be suitable for you;
• if you are going to have surgery. You may need to stop taking SINVALIP for a short period;
• if you have a serious lung disease.
• if you are Asian, because a different dose may be appropriate for you

The doctor will need to have a blood test done before giving you SINVALIP.
This test is done to check if your liver is functioning properly.
The doctor may also prescribe blood tests to check your liver function after starting therapy with SINVALIP.
During treatment with this medicine, your doctor will carefully monitor
that you do not have diabetes or are at risk of developing diabetes. You are at risk of
developing diabetes if you have high levels of sugar and fat in your blood, if you are
overweight and have high blood pressure.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness
or muscle weakness. This is because, rarely, muscle problems can be serious
and can include muscle tissue damage leading to kidney damage; very
rarely, cases of death have occurred.
The risk of muscle injury is greater at higher doses of SINVALIP and is greater
in some patients. Talk to your doctor if any of the following conditions apply to
you:

• consume significant amounts of alcohol;
• have kidney problems;
• have thyroid problems;
• are 65 years of age or older;
• are female;
• have ever had muscle problems while taking cholesterol-lowering medicines called “statins” or fibrates; you or a close family member suffers from an inherited muscle disease.

Children and adolescents
Safety and efficacy have been studied in boys aged 10 to 17 years and
in girls who have started menstruating for at least one year (see the
section “how to take SINVALIP”).
Sinvalip has not been studied in children under 10 years of age. For more
information, ask your doctor for advice.

Other medicines and SINVALIP
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Taking SINVALIP with any of these medicines can increase the risk of
muscle problems (see section “Do not take Sinvalip”):

• Cyclosporine (a medicine often used in patients receiving an organ transplant);
• Danazol (an artificial hormone used to treat endometriosis, a benign disease affecting women);
• Itraconazole or ketoconazole (medicines used for fungal infections);
• Fibrates such as gemfibrozil and bezafibrate (medicines used to reduce cholesterol);
• Erythromycin, clarithromycin, telithromycin, or fusidic acid (medicines used for bacterial infections);
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used against AIDS);
• Nefazodone (a medicine used against depression);
• Amiodarone (a medicine used to treat irregular heartbeat);
• Verapamil or diltiazem or amlodipine (medicines used to treat high blood pressure, chest pain associated with heart disease or other heart conditions).

Furthermore, interactions are possible with the following medicines:

• Medicines to prevent blood clots from forming, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants);
• Fenofibrate and niacin (medicines used to lower cholesterol).

Also tell your doctor if you are taking niacin (nicotinic acid) or a product
containing niacin and if you are Chinese.

SINVALIP with food and drink
Grapefruit juice contains one or more substances that change the way
the body uses some medicines, including SINVALIP. Avoid consuming grapefruit
juice.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before
taking this medicine.

Pregnancy
Do not use SINVALIP if you are pregnant, intend to become pregnant or
suspect you are pregnant. If you become pregnant during treatment with SINVALIP,
stop taking it immediately and contact your doctor.

Breastfeeding
Do not use SINVALIP while breastfeeding as it is not known whether the medicine passes into
breast milk.

Driving and using machines
SINVALIP is not expected to interfere with your ability to drive or operate
machinery. However, it should be noted that dizziness has been reported
after taking SINVALIP.

SINVALIP contains lactose
SINVALIP tablets contain a sugar called lactose. If your doctor has
diagnosed you as having intolerance to some sugars, contact him before taking
the medicine.

3. How to take SINVALIP

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
During treatment with SINVALIP, you must follow a diet to lower your cholesterol levels.
The usual starting dose is one SINVALIP tablet of 5 mg, 10 mg, 20 mg, 40mg or
80 mg by mouth once a day. The 80 mg dose is recommended only if you are
an adult with very high cholesterol levels and at high risk of heart disease who, with
lower doses, have not reached their ideal cholesterol level.
The doctor will establish the right tablet dose for you in relation to your conditions,
your current treatment and your risk profile.
Take SINVALIP in the evening.
You can take it independently of meals. The starting dose is usually 10 mg, 20 mg or,
in some cases, 40 mg per day.
The doctor may adjust the dose after at least 4 weeks up to a maximum
of 80 mg per day. Do not take more than 80 mg per day. The doctor may
prescribe lower doses, especially if you are taking some of the aforementioned medicines
or have certain kidney problems. Continue taking SINVALIP unless
your doctor tells you to stop treatment.
If your doctor has prescribed SINVALIP with a bile acid sequestrant (medicines for
lowering cholesterol), you must take SINVALIP at least 2 hours before or 4 hours after
taking the bile acid sequestrant medicine.

Use in children and adolescents
For children (ages 10-17), the usual recommended starting dose is 10 mg per day
administered in the evening. The maximum recommended dose is 40 mg per day.

If you take more SINVALIP than you should
In case of accidental ingestion/intake of an excessive dose of SINVALIP, immediately inform
your doctor or go to the nearest hospital.

If you forget to take SINVALIP
Do not take a double dose to make up for a missed dose.
Take only the usual dose of SINVALIP the next day at the usual time.

If you stop taking SINVALIP
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
Your cholesterol may increase again.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
To describe the frequency with which side effects occur, the following terms are used:

• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people)
• Not known (the frequency cannot be estimated based on available data)

The following serious rare side effects have been reported.

If any of the following serious side effects occur, you must stop treatment and immediately contact your doctor or go to the nearest hospital emergency room.

• hypersensitivity reactions (allergies) including:
• swelling of the face, tongue and throat which can cause difficulty breathing (angioedema)

The following serious very rare side effect has been reported:

• a severe allergic reaction that causes difficulty breathing or dizziness (anaphylaxis)

Rare (may affect up to 1 in 1000):

• pain, tenderness, weakness or muscle cramps. In rare cases, these muscle problems can be serious and can include muscle tissue injury leading to kidney damage; and very rarely, deaths have occurred;
• hypersensitivity reactions (allergies) including:
• swelling of the face, tongue and throat which can cause difficulty breathing;
• severe muscle pain usually in the shoulders or hips;
• redness with weakness in the legs and neck muscles;
• pain or inflammation in the joints;
• inflammation of blood vessels;
• unusual bruising, skin rashes and swelling, hives, skin sensitivity to the sun, fever, hot flushes;
• shortness of breath and feeling unwell;
• a collection of symptoms like lupus (including skin rash, joint disorders, and effects on blood cells);
• inflammation of the liver with yellowing of the skin and eyes, dark urine, or pale stools;
• decrease in the number of red blood cells (anemia);
• numbness or weakness in the arms and legs;
• headache, tingling, dizziness;
• digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhea, nausea, vomiting);
• skin rash, itching, hair loss;
• weakness;
• Increases in some blood test values related to liver function and a muscle enzyme (creatine kinase) have been observed.
• inflammation of the pancreas often associated with severe abdominal pain

Very Rare (may affect up to 1 in 10,000):

• impaired memory
• liver failure

Not known: persistent muscle weakness.
Possible side effects reported with some statins:

• sleep disturbances, including insomnia and nightmares;
• memory loss
• sexual dysfunction;
• depression;
• breathing problems including persistent cough and/or shortness of breath or fever.
• diabetes

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/it. /content/come-segnalare-una-sospetta-reazione-
avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store SINVALIP

Keep this medicine out of the sight and reach of children.
Do not use SINVALIP after the expiry date which is stated on the pack after “Exp.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in the 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 SINVALIP contains

• The active ingredient is: simvastatin. Each tablet contains 10 mg, 20 mg or 40 mg of simvastatin; The other ingredients are: Butylated Hydroxyanisole (E320), ascorbic acid (E300), citric acid monohydrate (E330), microcrystalline cellulose (E460), pregelatinized starch, magnesium stearate (E572) and lactosemonohydrate. The tablet coating contains hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), talc (E553b) and red iron oxide (E172).

Description of the appearance of SINVALIP and contents of the pack
Sinvalip 10 mg
Packaged in blister packs made of a trilaminate film composed of polyvinyl chloride
(PVC)/polyethylene (PE)/ polyvinylidene chloride (PVDC) with an aluminum foil as
a cover in packs of 20 tablets .
Sinvalip 20 mg
Packaged in blister packs made of a trilaminate film composed of polyvinyl chloride
(PVC)/polyethylene (PE)/ polyvinylidene chloride (PVDC) with an aluminum foil as
a cover in packs of 28 tablets .
Sinvalip 40 mg
Packaged in blister packs made of a trilaminate film composed of polyvinyl chloride
(PVC)/polyethylene (PE)/ polyvinylidene chloride (PVDC) with an aluminum foil as
a cover in packs of 28 tablets .
Marketing Authorisation Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA)

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