VASTGEN 10 mg Film-Coated Tablets

Зміст інструкції

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

VASTGEN 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 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. Do not pass it on to others even if they have the same symptoms as you, as it may 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 VASTGENis and what it is used for
• 2.What you need to know before you take VASTGEN
• 3.How to take VASTGEN
• 4.Possible side effects
• 5.How to store VASTGEN
• 6.Contents of the pack and other information

1. What is VASTGEN and what is it used for

VASTGENis a medicine used to reduce levels of cholesterol and fatty substances
called triglycerides in the blood. In addition, VASTGEN increases levels of “good” cholesterol (HDL cholesterol). While taking this medicine, you must follow a diet to lower cholesterol. VASTGEN belongs to a group of medicines
called statins.
VASTGEN 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);
• a hereditary disease (homozygous familial hypercholesterolemia) that increases your cholesterol levels in the blood. It is possible that you are also being treated with other therapies;
• 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). VASTGEN 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. See your doctor regularly and keep track of your cholesterol levels and define goals to achieve with your doctor.

2. What you need to know before taking VASTGEN

Do not take VASTGEN:

• if you are allergic (hypersensitive) to simvastatin or 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 VASTGEN:

• if you are allergic;
• if you consume significant amounts of alcohol;
• if you have ever had a liver disease. In this case VASTGEN may not be suitable for you;
• if you are going to have surgery. You may need to stop taking VASTGEN for a short period;
• if you have a severe 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 VASTGEN.
This test is done to see if your liver is working properly.
The doctor may also prescribe you blood tests to check your liver function after starting therapy with VASTGEN.
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 fats in your blood, if you are overweight and have high blood pressure.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because, rarely, muscle problems can be serious and can include muscle tissue injury leading to kidney damage; very rarely, cases of death have occurred.
The risk of muscle injury is greater at higher doses of VASTGEN 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 a hereditary muscle disease.

Children and adolescents
Safety and efficacy have been studied in boys aged between 10 and 17 years and in girls who have started to have their menstrual period for at least one year (see section “How to take VASTGEN”).
VASTGEN has not been studied in children under 10 years of age. For more information ask your doctor.

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

• 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).

In addition, 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.

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

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

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

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

Driving and using machines
It is not expected that VASTGENwill interfere with your ability to drive or use machines. However, it should be kept in mind that dizziness has been reported after taking VASTGEN.

VASTGEN contains lactose
The tablets of VASTGEN contain a sugar called lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact your doctor before taking the medicine.

3. How to take VASTGEN

Always take VASTGEN exactly as your doctor has instructed. If you have any doubts
consult your doctor or pharmacist.
During treatment with VASTGEN, you should follow a diet to lower your cholesterol levels.
The usual starting dose is one VASTGEN 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 have not reached their ideal cholesterol level with lower doses.
The doctor will determine the correct tablet dose for you, based on your condition,
your current treatment and your risk profile.
Take VASTGEN 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 above-mentioned medications
or have certain kidney problems. Continue to take VASTGEN unless your doctor
tells you to stop treatment.
If your doctor has prescribed VASTGEN with a bile acid sequestrant (medicines
to lower cholesterol), you must take VASTGEN 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 years), 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 VASTGEN than you should
In case of accidental ingestion/intake of an excessive dose of VASTGEN, immediately inform
your doctor or go to the nearest hospital.

If you forget to take VASTGEN
Do not take a double dose to make up for a missed dose.
Just take your usual dose of VASTGEN the next day at the usual time.

If you stop taking VASTGEN
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 (frequency cannot be estimated from 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 damage 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, flushing;
• shortness of breath and feeling unwell;
• a collection of symptoms like lupus (which includes skin rash, joint disorders, and effects on blood cells);
• inflammation of the liver with yellowing of the skin and eyes, itching, dark urine, or pale stools, liver failure (very rare);
• 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 regarding 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):

• memory impairment.

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

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

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/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 VASTGEN

Keep this medicine out of the sight and reach of children.
Do not use VASTGEN after the expiry date which is stated on the pack after “Scad.” The
expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 VASTGEN 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 VASTGEN and contents of the pack
Vastgen 10 mg Pack in blister made of a three-layer film composed of polyvinyl
chloride (PVC)/polyethylene (PE)/ polyvinylidene chloride (PVDC) with an Aluminium
foil as a cover in packs of 20 tablets .
Vastgen 20 mg
Pack in blister made of a three-layer film composed of polyvinyl chloride
(PVC)/polyethylene (PE)/ polyvinylidene chloride (PVDC) with an Aluminium foil as
cover in packs of 28 tablets .
Vastgen 40 mg
Pack in blister made of a three-layer film composed of polyvinyl chloride
(PVC)/polyethylene (PE)/ polyvinylidene chloride (PVDC) with an Aluminium foil as
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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