Simvastatin Alter

Package leaflet: Information for the patient

SIMVASTATINA ALTER 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SIMVASTATINA ALTER is and what it is used for

SIMVASTATINA ALTER belongs to a group of medicines known as "statins" and is used to lower levels of total cholesterol, "bad" cholesterol (LDL), and fatty substances in the blood called triglycerides. In addition, SIMVASTATINA ALTER increases levels of "good" cholesterol (HDL).

SIMVASTATINA ALTER is used, in combination with a specific diet, if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed dyslipidemia), when the response to diet, exercise, and weight reduction is inadequate;
• an inherited disease that increases cholesterol levels in the blood (called "homozygous familial hypercholesterolemia"), together with diet and other treatments or as an alternative to them if these have not been effective.

This medicine is also indicated to prevent heart and circulatory damage when there is a high risk of coronary heart disease due to diabetes, history of stroke, or other blood vessel diseases, even if cholesterol levels are normal.
SIMVASTATINA ALTER, together with other therapies and correction of risk factors (such as diabetes mellitus or cardiovascular disease), may prolong survival.
In most people, high cholesterol does not cause immediate symptoms. Your doctor can measure cholesterol with a simple blood test. Visit your doctor regularly to monitor your cholesterol levels and to set appropriate treatment goals with him.

2. What you need to know before taking SIMVASTATIN ALTER

Do not take SIMVASTATIN ALTER

• if you are allergic to simvastatin or to any of the other ingredients of this medicine (listed in section 6);
• if you have liver problems;
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”);
• if you are currently taking one or more of the following medicines:
  • itraconazole, ketoconazole, or posaconazole (medicines used for fungal infections);
  • HIV protease inhibitors (used for HIV virus infections) such as: indinavir, nelfinavir, ritonavir, and saquinavir;
  • boceprevir or telaprevir (medicines used for hepatitis C virus infections);
  • erythromycin, clarithromycin, and telithromycin (antibiotics used for infections);
  • nefazodone (a medicine used for depression);
  • gemfibrozil (a medicine used to lower cholesterol);
  • cyclosporine (a medicine often used after organ transplants);
  • danazol (a synthetic hormone used to treat endometriosis) (See “Other medicines and SIMVASTATIN ALTER”);
• if you are unsure whether the medicine you are taking is among those listed above, ask your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking SIMVASTATIN ALTER.

• If you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) taken orally or by injection. The combination of fusidic acid and SIMVASTATIN ALTER may lead to serious muscle problems (rhabdomyolysis). Be particularly careful with this medicine, as it may cause muscle problems such as pain, tenderness, or muscle weakness. Rarely, muscle damage has occurred, leading to kidney problems. Inform your doctor immediately if you experience unexplained muscle disorders, as treatment may need to be stopped. Fatal outcomes have very rarely been reported (See section “Possible side effects”). The risk of muscle damage is higher at higher doses of SIMVASTATIN ALTER, particularly with the 80 mg dose, and in the following cases:
  • if you are 65 years of age or older;
  • if you are female;
  • if you have kidney problems;
  • if you have thyroid problems;
  • if you or a family member has a hereditary muscle disease;
  • if you have previously experienced muscle problems during treatment with cholesterol-lowering medicines called "statins" or fibrates;
  • if you consume large amounts of alcohol;
  • if you are taking certain medicines listed in section “Other medicines and SIMVASTATIN ALTER”;
  • if you suffer from severe respiratory insufficiency.

Additionally, inform your doctor or pharmacist if you have persistent muscle weakness.
Further tests and treatments may be needed to diagnose and manage this condition.
Use particular caution:

• if you are allergic or have other underlying medical conditions, inform your doctor;
• if you have had liver disease, inform your doctor. SIMVASTATIN ALTER may not be suitable for you;
• if you are scheduled for surgery, inform your doctor. It may be necessary to temporarily stop taking simvastatin;
• if you have a severe lung disease;
• inform your doctor if you consume large amounts of alcohol.

Before and during treatment with SIMVASTATIN ALTER, your doctor will perform simple blood tests to check that your liver is functioning properly. Your doctor may also order blood tests to monitor liver function after you start treatment with SIMVASTATIN ALTER, as treatment may need to be stopped if liver problems occur. During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high blood sugar and fat levels, being overweight, and having high blood pressure.
SIMVASTATIN ALTER may cause lung problems (See section “Possible side effects”).

Children and adolescents
Safety and efficacy have been studied in adolescents aged 10 to 17 years and in girls who have had regular menstrual cycles for at least one year. SIMVASTATIN ALTER has not been studied in individuals under 10 years of age. It is recommended to consult your doctor in such cases.

Use in the elderly
Dosage adjustments are not required in the elderly. Age over 70 is a predisposing factor for muscle damage.

Other medicines and SIMVASTATIN ALTER
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart SIMVASTATIN ALTER. Taking SIMVASTATIN ALTER with fusidic acid may rarely lead to muscle weakness, tenderness, or muscle pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

Taking SIMVASTATIN ALTER with any of the following medicines may increase the risk of muscle problems (some of which are already listed in the previous section “Do not take SIMVASTATIN ALTER”):

• cyclosporine, a medicine used to prevent organ transplant rejection;
• danazol, a synthetic hormone used to treat endometriosis (a condition in which tissue normally lining the uterus grows elsewhere in the body) and breast cysts in women;
• antifungal medicines such as itraconazole, fluconazole, ketoconazole, and posaconazole;
• gemfibrozil and bezafibrate, which are medicines called "fibrates" used to lower fat (cholesterol) levels in the blood;
• antibiotics used for bacterial infections such as erythromycin, clarithromycin, telithromycin, or fusidic acid;
• medicines used for AIDS such as indinavir, nelfinavir, ritonavir, and saquinavir;
• boceprevir or telaprevir, medicines used for hepatitis C virus infections;
• nefazodone, a medicine used for depression;
• colchicine, a medicine used to treat gout.

The following medicines may cause muscle problems (myopathy or rhabdomyolysis) but may be taken together with SIMVASTATIN ALTER if the daily dose limit of 20 mg is respected:

• amiodarone, a medicine for irregular heartbeat;
• verapamil, amlodipine, and diltiazem, medicines used for high blood pressure (hypertension), chest pain associated with heart failure, or other heart conditions.

For patients taking SIMVASTATIN ALTER together with fibrates (medicines used to lower cholesterol) other than gemfibrozil (See section “Do not take SIMVASTATIN ALTER”), the dose of SIMVASTATIN ALTER must not exceed 10 mg/day.

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

• medicines to prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants);
• fenofibrate (a medicine used to lower cholesterol);
• niacin or a medicine containing niacin (a medicine for lowering cholesterol);
• rifampicin (a medicine used to treat tuberculosis).

Inform your doctor if you are of Chinese descent.
You should also inform any doctor prescribing a new medicine that you are taking SIMVASTATIN ALTER.

SIMVASTATIN ALTER with food and drink
Grapefruit juice affects the action of SIMVASTATIN ALTER; therefore, do not drink grapefruit juice while taking this medicine.

Fertility, pregnancy, and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine is contraindicated during pregnancy. If you become pregnant while taking SIMVASTATIN ALTER, stop treatment immediately and contact your doctor. Do not take SIMVASTATIN ALTER while breastfeeding (See section “Do not take SIMVASTATIN ALTER”).

Driving and using machines
SIMVASTATIN ALTER does not affect or has a negligible effect on the ability to drive or use machines. However, you should be aware that dizziness has been reported after taking SIMVASTATIN ALTER. If this occurs, do not drive or operate machinery.

SIMVASTATIN ALTER contains lactose
This medicine contains a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take SIMVASTATIN ALTER

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
While taking SIMVASTATIN ALTER, you must follow a diet aimed at lowering cholesterol levels.
Your doctor will decide the appropriate dose for you, based on your condition, current treatment, and risk profile.
Take SIMVASTATIN ALTER with water, either before or after a meal.
The recommended dose ranges from 5 to 80 mg, taken orally once daily.
The 80 mg dose is recommended only for patients with very high cholesterol levels and at high risk of heart disease, who have not reached their target cholesterol level with lower doses.
The usual starting dose is 10, 20, or in some cases, 40 mg per day. Your doctor may adjust your dose after at least 4 weeks, up to a maximum of 80 mg per day. Do not take more than 80 mg per day. Your doctor may prescribe lower doses, especially if you are taking certain medicines listed above or if you have kidney problems. Continue taking SIMVASTATIN ALTER unless your doctor tells you to stop.

If your doctor has prescribed SIMVASTATIN ALTER together with "bile acid sequestrants" (medicines to lower cholesterol), you must take SIMVASTATIN ALTER at least 2 hours before or 4 hours after taking the bile acid sequestrant medicine.

In patients taking "fibrates" (excluding gemfibrozil – see "Do not take SIMVASTATIN ALTER") together with SIMVASTATIN ALTER, the dose of SIMVASTATIN ALTER must not exceed 10 mg per day.

In patients taking amiodarone, amlodipine, verapamil, or diltiazem together with SIMVASTATIN ALTER, the dose of SIMVASTATIN ALTER must not exceed 20 mg per day.

Use in children and adolescents
For children and adolescents aged 10 to 17 years, the recommended starting dose is 10 mg per day, taken in the evening. The maximum recommended dose is 40 mg per day.

If you take more SIMVASTATIN ALTER than you should
If you accidentally take too much SIMVASTATIN ALTER, contact your doctor immediately or go to the nearest hospital.

If you forget to take SIMVASTATIN ALTER
Do not take a double dose to make up for the missed tablet. Take only your usual dose of SIMVASTATIN ALTER at the next scheduled time.

If you stop taking SIMVASTATIN ALTER
Your blood cholesterol levels may rise again.
If you have any doubts about how to use 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.
If you experience any of the following serious side effects, you must stop treatment
and contact your doctor immediately or go to the nearest hospital emergency department.

• Hypersensitivity reactions (allergies) including:
• swelling of the face, tongue and throat which may cause breathing difficulties (angioedema). The following very rare serious adverse reaction has been reported:
• a severe allergic reaction causing breathing difficulties or dizziness (anaphylaxis)

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

• decrease in the number of red blood cells in the blood (anaemia);
• headache, tingling sensation, dizziness, numbness or weakness of the arms and legs (peripheral neuropathy);
• digestive disorders such as constipation, abdominal pain, flatulence, indigestion, diarrhoea, nausea, vomiting, inflammation of the pancreas;
• liver disorders such as hepatitis and accumulation of bilirubin in the blood causing yellowing of the skin (jaundice);
• skin rash, itching, hair loss (alopecia);
• muscle disorders such as myopathy* (including myositis, inflammation of the muscle), muscle injury (rhabdomyolysis) with or without severe kidney problems, muscle pain (myalgia), cramps;
• weakness;
• blurred vision and impaired vision.

Rarely, an apparent hypersensitivity syndrome has been reported, including some of the following features: facial swelling, lupus-like syndrome, severe muscle pain usually in the shoulders, forearms, hips and legs (polymyalgia rheumatica), skin rashes with tenderness of the muscles in the arms and legs which may lead to loss of their function (dermatomyositis), inflammation of blood vessels (vasculitis), thrombocytopenia (reduced number of platelets), eosinophilia (increased number of certain blood cells), increased ESR, arthritis and arthralgia, urticaria, photosensitivity, fever, hot flushes, shortness of breath and malaise.

• alterations in liver function test results with increases in certain values, increases in serum transaminases (known as ALT, AST, GGT), increases in alkaline phosphatase and blood creatine kinase levels;
• increased fasting blood glucose (glycated haemoglobin, HbA1c).

Rare post-marketing reports of cognitive impairment (e.g. memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with the use of statins have been reported.
These reports were generally non-serious and reversible after discontinuation of statin therapy, with variable time to onset of symptoms (from 1 day to years) and resolution of symptoms (approximately 3 weeks).
Other events reported following the use of certain statins include:

• sleep disorders, including nightmares;
• sexual dysfunction;
• type 2 diabetes mellitus: frequency depends on the presence or absence of risk factors. Very rare (may affect up to 1 in 10,000 people):
• insomnia;
• memory disturbances;
• skin rash which may appear on the skin or ulcers in the mouth (drug-induced lichenoid eruptions);
• severe or even fatal liver problems;
• gynaecomastia (enlargement of the breast in men);
• muscle breakdown.

Not known (frequency cannot be estimated from the available data):

• depression;
• inflammation of the lungs causing breathing problems (interstitial lung disease);
• tendon problems, sometimes complicated by tendon rupture;
• erectile dysfunction;
• persistent muscle weakness.

* In a clinical study, myopathy occurred more frequently in patients treated with
simvastatin 80 mg daily compared to patients treated with 20 mg daily (see section “Warnings and Precautions”).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store SIMVASTATIN ALTER

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 “Exp.”.
The expiry date refers to the last day of that month.
Store below 25°C.
Do not dispose of medicines 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 ALTER contains
SIMVASTATINA ALTER 10 mg tablets

• The active substance is simvastatin. Each tablet contains 10 mg of simvastatin.
• The other components are: monohydrate lactose, microcrystalline cellulose, sodium starch glycolate, hydrogenated castor oil, pregelatinized starch, talc, magnesium stearate, hypromellose, anhydrous colloidal silica, macrogol 6000, titanium dioxide, butyl-hydroxyanisole.

SIMVASTATINA ALTER 20 mg tablets

• The active substance is simvastatin. Each tablet contains 20 mg of simvastatin.
• The other components are: monohydrate lactose, microcrystalline cellulose, sodium starch glycolate, hydrogenated castor oil, pregelatinized starch, talc, magnesium stearate, hypromellose, anhydrous colloidal silica, macrogol 6000, titanium dioxide, butyl-hydroxyanisole.

SIMVASTATINA ALTER 40 mg tablets

• The active substance is simvastatin. Each tablet contains 40 mg of simvastatin.
• The other components are: monohydrate lactose, microcrystalline cellulose, sodium starch glycolate, hydrogenated castor oil, pregelatinized starch, talc, magnesium stearate, hypromellose, anhydrous colloidal silica, macrogol 6000, titanium dioxide, butyl-hydroxyanisole.

Description of the appearance of SIMVASTATINA ALTER and contents of the pack
SIMVASTATINA ALTER 10 mg film-coated tablets
Each pack contains 20 film-coated tablets of 10 mg.
SIMVASTATINA ALTER 20 mg film-coated tablets
Each pack contains 10 and 28 film-coated tablets of 20 mg.
SIMVASTATINA ALTER 40 mg film-coated tablets
Each pack contains 10 and 28 film-coated tablets of 40 mg.
Marketing Authorization Holder
Laboratori Alter S.r.l., Via Egadi, 7 – 20144 Milano
Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43 – 24041 Brembate (BG)