Simvastatin Tecnigen

Package leaflet: Information for the user

Simvastatina TecniGen 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Simvastatin
Generic medicine
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. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Simvastatina TecniGen is and what it is used for

Simvastatina TecniGen is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatina TecniGen increases levels of "good" cholesterol (HDL cholesterol). While taking this medicine, you must follow a cholesterol-lowering diet. Simvastatina TecniGen belongs to a group of medicines called statins.

Simvastatina TecniGen is used together with diet if you have:

• Elevated 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 blood cholesterol levels. You may also be receiving other treatments.
• Coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, have had a stroke, or have another blood vessel disease). Simvastatina TecniGen can prolong survival by reducing the risk of heart disease-related problems regardless of your blood cholesterol levels. In most people, high cholesterol does not cause immediate symptoms. Your doctor can check your cholesterol levels with a simple blood test. Visit your doctor regularly, keep track of your cholesterol values, and set target goals with your doctor.

2. What you need to know before taking Simvastatin TecniGen

Do not take Simvastatin TecniGen:

• If you are allergic (hypersensitive) to simvastatin or to any of the other ingredients of this medicine (listed in section 6), or if you currently have liver problems or have a persistent increase in liver enzymes (transaminases) without an obvious cause.
• If you are pregnant or breastfeeding.
• If you are taking:
  • itraconazole, ketoconazole, posaconazole, or voriconazole (medicines for fungal infections);
  • erythromycin, clarithromycin, or telithromycin (antibiotics for infections);
  • HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors used for HIV infections); boceprevir, telaprevir (used to treat hepatitis C virus infection);
  • nefazodone (a medicine for depression);
  • cobicistat;
  • gemfibrozil (used to lower cholesterol);
  • cyclosporine (used in organ transplant patients);
  • danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus);
• if you are currently taking, have taken within the last 7 days, or have been administered a medicine called fusidic acid (used to treat bacterial infection);
• Do not take more than 40 mg of Simvastatin TecniGen if you are taking lomitapide (used to treat a rare, severe genetic cholesterol condition).

Ask your doctor for advice if you are unsure whether the medicine you are taking is one of those listed above.

Warnings and precautions

Talk to your doctor or pharmacist before taking Simvastatin TecniGen

• Inform your doctor if you have any medical condition or any allergies.
• Inform your doctor if you consume large amounts of alcohol.
• Inform your doctor if you have ever had liver disease. In this case, Simvastatin TecniGen may not be suitable for you.
• Inform your doctor if you are due to undergo surgery. You may need to stop taking Simvastatin TecniGen temporarily.
• If you are of Asian origin, as you may require a different dose.
• Your doctor will perform a blood test before starting Simvastatin TecniGen to check whether your liver is functioning properly.
• Your doctor may also order periodic blood tests to monitor liver function after starting Simvastatin TecniGen.
• Inform your doctor if you have a severe lung disease.
• If you are taking, or have taken within the last 7 days, or have been administered orally or by injection a medicine called fusidic acid (used to treat bacterial infection). The combination of fusidic acid and simvastatin may lead to serious muscle problems (rhabdomyolysis).
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may occasionally worsen myasthenia or trigger its onset (see section 4).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness.
This is because, although rarely, muscle problems can be serious and may include damage to muscle tissue leading to kidney damage; very rarely, fatal cases have been reported.
The risk of muscle injury is higher at higher doses of Simvastatin TecniGen and is increased in certain patients. Talk to your doctor if any of the following conditions apply to you:

• You consume large amounts of alcohol.
• You have kidney problems.
• You have thyroid problems.
• You are 65 years of age or older.
• You are female.
• You have previously experienced muscle problems during treatment with cholesterol-lowering medicines known as "statins" or fibrates.
• You or a close family member have a hereditary muscle disease.

In addition, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatment may be needed to diagnose and manage this condition.

Children and adolescents

Safety and efficacy have been studied in adolescents aged between 10 and 17 years and in girls who have had regular menstrual periods for at least one year (see HOW TO TAKE SIMVASTATIN TECNIGEN).
Simvastatin TecniGen has not been studied in children under 10 years of age. For further information, consult your doctor.

Other medicines and Simvastatin TecniGen

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Taking Simvastatin TecniGen with any of the following medicines may increase the risk of muscle problems (some of which have already been listed in the section "Do not take Simvastatin TecniGen").

• Cyclosporine (a medicine often used in patients who have received an organ transplant).

• Danazol (an artificial hormone used to treat endometriosis).

• Medicines such as itraconazole, ketoconazole, posaconazole, voriconazole, or fluconazole (medicines for fungal infections).

• Fibrates such as gemfibrozil and benzafibrate (medicines to reduce cholesterol).

• Erythromycin, clarithromycin, telithromycin, or fusidic acid (medicines for bacterial infections).

• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines for AIDS).

• Boceprevir or telaprevir (used to treat hepatitis C virus infection).

• Nefazodone (a medicine for depression).

• Medicines containing cobicistat as the active ingredient.

• Amiodarone (a medicine used to treat irregular heartbeat).

• Verapamil, diltiazem, or amlodipine (medicines used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions).

• Lomitapide (used to treat a rare, severe genetic cholesterol condition).

• Colchicine (used to treat gout).

• If you need to take fusidic acid orally to treat bacterial infections, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Simvastatin TecniGen. Taking Simvastatin TecniGen with fusidic acid may rarely cause muscle weakness, fragility, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

In particular, inform your doctor if you are taking any of the following medicines:

• Medicines to prevent blood clotting, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants).
• Fenofibrate (another medicine to lower cholesterol).
• Niacin (another medicine to lower cholesterol).
• Rifampicin (used to treat tuberculosis).

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

Simvastatin TecniGen with food and drink

Grapefruit juice contains one or more substances that alter how the body processes certain medicines, including Simvastatin TecniGen. Consumption of grapefruit juice should be avoided.

Pregnancy and breastfeeding

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

If you become pregnant while taking Simvastatin TecniGen, stop taking it immediately and contact your doctor.

Breastfeeding

Do not use Simvastatin TecniGen while breastfeeding, as it is not known whether the medicine passes into breast milk.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Simvastatin TecniGen is not expected to affect your ability to drive or operate machinery. However, you should be aware that dizziness has been reported after taking Simvastatin TecniGen.

Simvastatin TecniGen contains lactose

Simvastatin TecniGen tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult your doctor before taking this medicine.

During treatment with this medicine, your doctor will closely monitor whether you 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, are overweight, and have high blood pressure.

3. How to take Simvastatina TecniGen

Always take Simvastatina TecniGen exactly as your doctor has instructed you. If you have any doubts,
consult your doctor or pharmacist.
During treatment with Simvastatina TecniGen, you must follow a diet aimed at reducing cholesterol levels.
The recommended dose is one tablet of Simvastatina TecniGen 10 mg, 20 mg, or 40 mg, taken orally once daily.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and a high risk of heart disease who have not reached their target cholesterol levels with lower doses.

Use in children and adolescents
For children (aged 10–17 years), the usual recommended starting dose is 10 mg once daily in the evening. The maximum recommended dose is 40 mg daily.
Your doctor will determine the appropriate tablet strength for you based on your condition, current treatment, and risk profile.
Take Simvastatina TecniGen in the evening. You may take it regardless of meals. The usual starting dose is 10 mg, 20 mg, or in some cases, 40 mg per day.
Your doctor may adjust the dose after at least 4 weeks, up to a maximum of 80 mg daily. Do not take more than 80 mg per day. Your doctor may prescribe a lower dose, especially if you are taking any of the medicines listed above or have certain kidney problems.
Continue taking Simvastatina TecniGen unless your doctor tells you to stop.
If your doctor has prescribed Simvastatina TecniGen together with a bile acid sequestrant (a medicine used to lower cholesterol), you must take Simvastatina TecniGen at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Simvastatina TecniGen than you should

• Contact your doctor or pharmacist immediately.

If you forget to take Simvastatina TecniGen

• Do not take a double dose to make up for the missed tablet; take only your usual dose at the next scheduled time.

If you stop taking Simvastatina TecniGen

• Your cholesterol levels may rise again.

If you have any questions 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 everyone will experience them. The following terms are used to describe how frequently side effects occur:

• Rare (affects 1 or more in 10,000 treated patients but less than 1 in 1,000).
• Very rare (affects less than 1 in 10,000 treated patients).
• Not known (frequency cannot be estimated from the available data).

The following serious side effects have been reported in rare cases.
If you experience any of the following side effects, you must stop treatment and
contact your doctor immediately or go to the nearest hospital emergency department.

• Muscle pain, tenderness, weakness, or cramps. Muscle rupture (very rare). In rare cases, these muscle problems can be serious and may include muscle tissue damage leading to kidney injury; very rarely, cases of death have occurred.
• Hypersensitivity reactions (allergies) including:
• swelling of the face, tongue, and throat, which may cause difficulty breathing (angioedema);
• severe muscle pain, usually in the shoulders or hips;
• redness with weakness in the legs and neck muscles;
• joint pain or inflammation;
• inflammation of blood vessels;
• unusual bruising, skin rashes and swelling, hives, skin sensitivity to sunlight, fever, hot flushes;
• shortness of breath and feeling unwell;
• lupus-like symptoms (including skin rash, joint problems, and effects on blood cells);
• skin rash which may occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions), very rare;
• liver inflammation with yellowing of the skin and eyes, itching, dark urine, or pale stools, liver failure (very rare);
• inflammation of the pancreas, often associated with severe abdominal pain;
• blurred vision and impaired vision (rare).

The following very rare serious side effect has been reported:

• a severe allergic reaction causing difficulty breathing or dizziness (anaphylaxis). The following side effects have also been reported rarely:
• reduction in red blood cell count (anaemia);
• numbness or weakness in arms and legs;
• headache, tingling, dizziness;
• digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting);
• skin rash, itching, hair loss;
• weakness;
• difficulty sleeping (very rare);
• memory impairment (very rare);
• gynaecomastia (enlargement of breast tissue in men), very rare.

Possible side effects reported with some statins:

• Sleep disorders, including insomnia and nightmares.
• Sexual dysfunction.
• Depression.
• Breathing problems including persistent cough and/or shortness of breath or fever.

Side effects of unknown frequency
Persistent muscle weakness.
Problems with tendons, sometimes complicated by tendon rupture.
Myasthenia gravis (a condition causing generalized muscle weakness, including in some cases the muscles used for breathing).
Ocular myasthenia (a condition causing weakness of the eye muscles).
Contact your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or laboured breathing.

Diabetes
This is more likely if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Laboratory findings
Increases in certain blood test values related to liver function and a muscle enzyme (creatine kinase) have been observed.

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) - Website: 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 Simvastatin TecniGen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the term
“Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Simvastatina TecniGen contains
The active substance is simvastatin (10 mg, 20 mg, 40 mg).
The excipients are: butylated hydroxyanisole (E320), ascorbic acid (E300), citric acid monohydrate (E330), microcrystalline cellulose (E460), pregelatinized starch, magnesium stearate (E572) and lactose monohydrate.
The tablet coating contains hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), talc (E553b) and red iron oxide (E172).

Description of the appearance of Simvastatina TecniGen and contents of the pack
Simvastatina TecniGen 10 mg
Packaged in blisters made of a trilayer film composed of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVDC), covered with an aluminum foil, in packs of 20 tablets.

Simvastatina TecniGen 20 mg
Packaged in blisters made of a trilayer film composed of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVDC), covered with an aluminum foil, in packs of 28 tablets.

Simvastatina TecniGen 40 mg
Packaged in blisters made of a trilayer film composed of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVDC), covered with an aluminum foil, in packs of 28 tablets.

MARKETING AUTHORISATION HOLDER
Tecnigen S.r.l., via Galileo Galilei 40, 20092 - Cinisello Balsamo (MI).

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