Simvastatin Teva Italia: detailed information

Package leaflet: Information for the patient

SIMVASTATIN TEVA ITALY 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Simvastatin Teva Italy is and what it is used for
What you need to know before taking Simvastatin Teva Italy
How to take Simvastatin Teva Italy
Possible side effects
How to store Simvastatin Teva Italy
Contents of the pack and other information

1. What Simvastatina Teva Italia is and what it is used for

Simvastatina Teva Italia contains the active substance simvastatin. Simvastatina Teva Italia is a
medicinal product used to lower blood levels of total cholesterol, "bad" cholesterol
(LDL-cholesterol), and fats known as triglycerides. Simvastatina Teva Italia also
increases levels of "good" cholesterol (HDL-cholesterol). Simvastatina Teva Italia
belongs to a class of medicinal products called statins.

Cholesterol is one of the many types of fats present in the blood. Total cholesterol is mainly
composed of LDL and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of
arteries, forming plaques. Over time, these plaques can lead to narrowing of the arteries.
This narrowing can slow down or block blood flow to vital organs such as the heart and brain.
Such blockage of blood flow may cause heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol
from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat circulating in the blood that may increase the risk of
heart disease.

You must follow a cholesterol-lowering diet while taking this medicinal product.
Simvastatina Teva Italia is used in addition to your cholesterol-lowering diet in the following conditions:

elevated levels of cholesterol in the blood (primary hypercholesterolaemia) or elevated levels of fats in the blood (mixed hyperlipidaemia),
a hereditary disease (homozygous familial hypercholesterolaemia) that increases cholesterol levels in the blood. In this case, other treatments may also be administered,
coronary heart disease or a high risk of developing coronary heart disease (due to diabetes, a previous stroke, or another blood vessel disease). Simvastatina Teva Italia may prolong life by reducing the risk of heart problems, regardless of the cholesterol level in the blood.

In most people, high cholesterol levels do not cause immediate symptoms. Your doctor can measure cholesterol with a simple blood test. You should see your doctor regularly, monitor your cholesterol levels, and set treatment goals together with your doctor.

2. What you need to know before taking Simvastatina Teva Italia

Do not take Simvastatina Teva Italia

if you are allergic to simvastatin 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 a medicine(s) containing any of the following active substances:
o itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections),
o erythromycin, clarithromycin or telithromycin (used to treat infections),
o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used for HIV infections),
o boceprevir or telaprevir (used to treat hepatitis C virus infection),
o nefazodone (used to treat depression),
o cobicistat,
o gemfibrozil (used to lower cholesterol),
o cyclosporine (used in organ transplant patients),
o danazol (a hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).
Do not take more than 40 mg of Simvastatina Teva Italia if you are taking lomitapide (used to treat a rare and serious genetic condition characterized by high cholesterol levels).
Ask your doctor if you are unsure whether the medicine you are taking is included in the list above.

Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatina Teva Italia.
Inform your doctor:

about all medical conditions you have, including allergies,
if you drink large amounts of alcohol, if you have ever had liver disease. In this case, Simvastatina Teva Italia may not be suitable for you, if you are due to undergo surgery. In this case, you may need to temporarily stop taking Simvastatina Teva Italia tablets,
if you have severe respiratory failure,
if you are of Asian origin, as you may require a different dose of the medicine,
if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat a bacterial infection). The combination of fusidic acid and Simvastatina Teva Italia can lead to serious muscle problems (rhabdomyolysis).

Your doctor should perform blood tests before starting your treatment with Simvastatina Teva Italia and if you develop any symptoms of liver problems while taking Simvastatina Teva Italia. This is to monitor your liver function.
Your doctor may also perform blood tests to check your liver function after you have started taking Simvastatina Teva Italia.
While taking this medicine, your doctor will monitor you carefully if you have diabetes or are at risk of developing diabetes. You are more likely to be at risk of developing diabetes if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

If you experience unexplained muscle pain, tenderness or weakness, inform your doctor immediately. This is necessary because, in rare cases, muscle problems can be serious and may lead to muscle breakdown with subsequent kidney damage: very rare cases of death have occurred.
The risk of muscle breakdown is higher with high doses of Simvastatina Teva Italia, particularly the 80 mg dose. The risk of muscle damage is also higher in certain patients.
Consult your doctor in the following cases:

if you drink large amounts of alcohol;
if you have kidney problems;
if you have thyroid problems;
if you are aged 65 years or older;
if you are a woman;
if you have previously experienced muscle problems during treatment with other cholesterol-lowering medicines called "statins" or fibrates;
if you or a close family member has an inherited muscle disorder.

Also, inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medicines may be needed to diagnose and treat this condition.

Children and adolescents
The safety and efficacy of Simvastatina Teva Italia have been studied in boys and girls aged between 10 and 17 years, the latter having had menstrual periods (menstruation) for at least one year (see section 3 “How to take Simvastatina Teva Italia”). Simvastatina Teva Italia has not been studied in children under 10 years of age. For further information, consult your doctor.

Other medicines and Simvastatina Teva Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine containing any of the following active substances. Taking Simvastatina Teva Italia with any of the following medicines may increase the risk of muscle problems (some of these have already been listed in the previous section "Do not take Simvastatina Teva Italia").

If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart simvastatin. Taking simvastatin with fusidic acid may rarely cause muscle weakness, pain or tenderness (rhabdomyolysis). See section 4 for more information about rhabdomyolysis.
cyclosporine (often used in patients who have undergone organ transplantation),
danazol (a human hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections),
fibrates containing active substances such as gemfibrozil and bezafibrate (used to lower cholesterol),
erythromycin, clarithromycin or telithromycin (used to treat bacterial infections),
HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat HIV),
antiviral agents for hepatitis C such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
nefazodone (used to treat depression),
medicines containing the active substance cobicistat,
amiodarone (used to treat irregular heartbeat),
verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart conditions),
lomitapide (used to treat a rare and serious genetic condition of high cholesterol),
daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). The risk of muscle-related side effects may be increased when this medicine is taken during treatment with simvastatin (e.g. Simvastatina Teva Italia film-coated tablets). Your doctor may decide to temporarily stop taking Simvastatina Teva Italia film-coated tablets,
colchicine (used to treat gout).

In addition to the medicines listed above, inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those without a prescription. In particular, inform your doctor if you are taking a medicine(s) containing any of the following active substances:

medicines containing active substances that prevent blood clotting, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants),
fenofibrate (also used to reduce cholesterol),
niacin (also used to reduce cholesterol),
rifampicin (used to treat tuberculosis).

Also, inform any doctor who is prescribing a new medicine for you that you are taking Simvastatina Teva Italia.

Simvastatina Teva Italia with food and drink
Grapefruit juice contains one or more components that alter the way the body processes certain medicines, including Simvastatina Teva Italia. Consumption of grapefruit juice should be avoided.

Pregnancy and breastfeeding
Do not take Simvastatina Teva Italia if you are pregnant, trying to become pregnant, or think you may be pregnant.
If you become pregnant while taking Simvastatina Teva Italia, you must stop taking it immediately and contact your doctor. Do not take Simvastatina Teva Italia if you are breastfeeding, as it is not known whether the medicine is excreted in breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Simvastatina Teva Italia is not expected to impair your ability to drive or use machines. However, bear in mind that some people may experience dizziness after taking simvastatin.

Simvastatina Teva Italia contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Simvastatina Teva Italia

Your doctor will decide the appropriate tablet dose for you, based on your condition, ongoing treatment and personal risk status.
Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
During treatment with Simvastatina Teva Italia, you must follow a low-cholesterol diet.

Dosage
The recommended dose is simvastatin 5 mg, 10 mg, 20 mg, 40 mg or 80 mg taken orally once daily.

Adults
The usual recommended starting dose is 10 mg, 20 mg or, in some cases, 40 mg daily. 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 daily.
Your doctor may prescribe lower doses, especially if you are taking certain medicines listed above or have certain kidney conditions.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and a high risk of developing heart problems, who have not achieved desired cholesterol levels with lower doses.

Use in children and adolescents:
For children (10–17 years), the usual recommended starting dose is 10 mg once daily in the evening. The maximum recommended dose is 40 mg daily.

Method of administration:
Take Simvastatina Teva Italia in the evening. You may take the tablet with or without food. Continue taking Simvastatina Teva Italia for as long as your doctor tells you to.
If your doctor has prescribed Simvastatina Teva Italia together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must take Simvastatina Teva Italia at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Simvastatina Teva Italia than you should

contact your doctor or pharmacist.

If you forget to take Simvastatina Teva Italia
Do not take a double dose to make up for the forgotten tablet. Take only your usual dose of Simvastatina Teva Italia at the usual time the next day.

If you stop taking Simvastatina Teva Italia

inform your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following terms are used to describe how often side effects have been reported:

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 the available data).

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

Muscle pain, tenderness, weakness, or cramps, muscle breakdown (very rare). In rare cases, these muscle problems can be severe and may lead to muscle breakdown (rhabdomyolysis), which can damage the kidneys; very rare cases of death have occurred.
Hypersensitivity (allergic) reactions including:
- Swelling of the face, tongue, and throat that may cause breathing difficulties (angioedema),
- Acute muscle pain, usually in shoulders and hips (polymyalgia rheumatica),
- Skin rash with weakness of limbs and neck muscles,
- Skin rash that may appear on the skin or sores in the mouth (drug-induced lichenoid eruptions) (very rare),
- Joint pain or inflammation,
- Inflammation of blood vessels (vasculitis),
- Unusual bruising, skin rash and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, hot flushes,
- Shortness of breath (dyspnea) and feeling unwell,
- Lupus-like symptoms (including skin rash, joint problems, and effects on blood cells),
- Liver inflammation with the following symptoms: yellowing of the skin and eyes, itching, dark urine or pale stools, feeling tired or weak, loss of appetite; fatal and non-fatal liver failure (very rare),
- Inflammation of the pancreas, often accompanied by severe abdominal pain.

The following very rare serious side effect has been reported:

A severe allergic reaction causing difficulty breathing or dizziness (anaphylaxis),
Gynaecomastia (enlargement of the breast in men).

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 sensation, dizziness,
Blurred vision, altered vision,
Digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
Skin rash, itching, hair loss,
Weakness,
Sleep disorders (very rare),
Poor memory (very rare), memory loss, confusion.

The following side effects have also been reported, but their frequency cannot be estimated from the available data (frequency not known):

Erectile dysfunction,
Depression,
Tendon problems, sometimes complicated by tendon rupture,
Persistent muscle weakness.

Possible side effects reported with some statins:

Sleep disorders including nightmares, sexual problems,
Respiratory problems including persistent cough and/or shortness of breath or fever,

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 tests
Increases in certain blood laboratory tests indicating liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of suspected adverse reactions
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after
EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Simvastatin Teva Italia 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets
HDPE tablet container
The shelf life after first opening of the tablet container is 10 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Simvastatina Teva Italia contains
The active substance is simvastatin. Each tablet contains 5, 10, 20, 40 or 80 mg of simvastatin.
The other components are monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, butylhydroxyanisole (E320), magnesium stearate, ascorbic acid and citric acid monohydrate, hypromellose, titanium dioxide, macrogol 3350, triacetin (E1518), red iron oxide, 5, 10, 20, 80 mg: yellow iron oxide, 5, 80 mg: black iron oxide.
Description of the appearance of Simvastatina Teva Italia and contents of the pack
Film-coated tablets.

Simvastatina Teva Italia 5 mg film-coated tablets are yellow-brown tablets, with the number “7152” imprinted on one side and the number “93” on the other.
Simvastatina Teva Italia 10 mg film-coated tablets are light pink, oval-shaped tablets with a score line on one side.
Simvastatina Teva Italia 20 mg film-coated tablets are light brown, oval-shaped tablets with a score line on one side.
Simvastatina Teva Italia 40 mg film-coated tablets are pink, oval-shaped tablets with a score line on one side.
Simvastatina Teva Italia 80 mg film-coated tablets are brick-red, oval-shaped tablets with a score line on one side.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milano, Italy
Manufacturer
Teva UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
Teva Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Teva Czech Industries s.r.o., Ostravská 29, c.p. 305, 747 70 Opava, Komárov, Czech Republic
Teva Pharma S.L.U., C/ C, n° 4, Poligono Industrial Malpica, 50016 Zaragoza, Spain
Merckle GmbH Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Daxistin 20 mg Filmtabletten
Daxistin 40 mg Filmtabletten
Daxistin 80 mg Filmtabletten
Belgium Simvapharma 5 mg filmomhulde tabletten
Simvapharma 10 mg filmomhulde tabletten
Simvapharma 20 mg filmomhulde tabletten
Simvapharma 40 mg filmomhulde tabletten
Simvapharma 80 mg filmomhulde tabletten
Bulgaria Simvastatin Teva Pharma 5 mg film-coated tablets
Simvastatin Teva Pharma 10 mg film-coated tablets
Simvastatin Teva Pharma 20 mg film-coated tablets
Simvastatin Teva Pharma 40 mg film-coated tablets
Czech Republic Simvastatin Teva 10 mg film-coated tablets
Simvastatin Teva 20 mg film-coated tablets
Simvastatin Teva 40 mg film-coated tablets
Germany Simvastatin-ratiopharm 5 mg Filmtabletten
Simvastatin-ratiopharm 10 mg Filmtabletten
Simvastatin-ratiopharm 20 mg Filmtabletten
Simvastatin-ratiopharm 40 mg Filmtabletten
Simvastatin-ratiopharm 80 mg Filmtabletten
Greece Simvastatin Teva 5 mg Επικαλυµµένα µε λεπτό υµένιο δισκία
Simvastatin Teva 10 mg Επικαλυµµένα µε λεπτό υµένιο δισκία
Simvastatin Teva 20 mg Επικαλυµµένα µε λεπτό υµένιο δισκία
Simvastatin Teva 40 mg Επικαλυµµένα µε λεπτό υµένιο δισκία
Simvastatin Teva 80 mg Επικαλυµµένα µε λεπτό υµένιο δισκία
Spain Simvastatina Tevagroup 5 mg comprimidos recubiertos con película EFG
Simvastatina Tevagroup 10 mg comprimidos recubiertos con película EFG
Simvastatina Tevagroup 20 mg comprimidos recubiertos con película EFG
Simvastatina Tevagroup 40 mg comprimidos recubiertos con película EFG
Simvastatina Tevagroup 80 mg comprimidos recubiertos con película EFG
Finland Daxistin 5 mg kalvopäällysteistä tablettia
Daxistin 10 mg kalvopäällysteistä tablettia
Daxistin 20 mg kalvopäällysteistä tablettia
Daxistin 40 mg kalvopäällysteistä tablettia
Simvastatin ratiopharm 80 mg tabletti, kalvopäällysteinen
France Simvastatine Teva Pharma 5 mg, comprimé pelliculé
Simvastatine Teva Pharma 10 mg, comprimé pelliculé
Simvastatine Teva Pharma 20 mg, comprimé pelliculé
Simvastatine Teva Pharma 40 mg, comprimé pelliculé
Simvastatine Teva Pharma 80 mg, comprimé pelliculé
Hungary Simvastatin-Teva 10, 20, 40, 80 mg filmtabletta
Ireland Simvastatin 5 mg Film-coated tablets
Simvastatin 10 mg Film-coated tablets
Simvastatin 20 mg Film-coated tablets
Simvastatin 40 mg Film-coated tablets
Simvastatin 80 mg Film-coated tablets
Italy Simvastatina Teva Italia 5mg, compresse rivestite con film
Simvastatina Teva Italia 10mg, compresse rivestite con film
Simvastatina Teva Italia 20mg, compresse rivestite con film
Simvastatina Teva Italia 40mg, compresse rivestite con film
Simvastatina Teva Italia 80mg, compresse rivestite con film
Luxembourg Simvastatin-ratiopharm 5 mg Filmtabletten
Simvastatin-ratiopharm 10 mg Filmtabletten
Simvastatin-ratiopharm 20 mg Filmtabletten
Simvastatin-ratiopharm 40 mg Filmtabletten
Simvastatin-ratiopharm 80 mg Filmtabletten
Netherlands Simvastatine 10 mg Teva, filmomhulde tabletten
Simvastatine 20 mg Teva, filmomhulde tabletten
Simvastatine 40 mg Teva, filmomhulde tabletten
Simvastatine 80 mg Teva, filmomhulde tabletten
Norway Simvastatin Teva 5 mg tabletter, filmdrasjerte
Simvastatin Teva 10 mg tabletter, filmdrasjerte
Simvastatin Teva 20 mg tabletter, filmdrasjerte
Simvastatin Teva 40 mg tabletter, filmdrasjerte
Simvastatin Teva 80 mg tabletter, filmdrasjerte
Poland Simvastatin Teva Pharma (5, 10, 20, 40 & 80 mg)
Portugal Sinvastatina ratiopharm (10mg)
Sinvastatina Green Avet (20, 40 & 80 mg)
Romania Simvastatină Teva 5 mg comprimate filmate
Simvastatină Teva 10 mg comprimate filmate
Simvastatină Teva 20 mg comprimate filmate
Simvastatină Teva 40 mg comprimate filmate
Simvastatină Teva 80 mg comprimate filmate
Slovenia Statex 5 mg filmsko obložene tablete
Statex 10 mg filmsko obložene tablete
Statex 20 mg filmsko obložene tablete
Statex 40 mg filmsko obložene tablete
Statex 80 mg filmsko obložene tablete
Slovakia SIMVATEV 10 mg
SIMVATEV 20 mg
SIMVATEV 40 mg