Simvastatin PensA: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

SIMVASTATIN PENSA 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may 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:

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

1. WHAT SIMVASTATIN PENSA IS AND WHAT IT IS USED FOR

Simvastatin is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances in the blood called triglycerides. In addition, simvastatin increases levels of "good" cholesterol (HDL cholesterol). You must follow a low-fat diet while taking this medicine. Simvastatin belongs to a class of medicines known as statins.
Simvastatin is used together with diet if you have:

elevated blood cholesterol levels (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia).
an inherited disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You may also receive other treatments.
coronary heart disease (CHD) or are at high risk of CHD (if you have diabetes, have had a stroke, or have other blood vessel diseases). Simvastatin may prolong your life by reducing the risk of problems due to heart disease, regardless of the amount of cholesterol in your blood.

In most people, high cholesterol does not cause immediate symptoms.
Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol levels, and discuss your goals with your doctor.

2. WHAT YOU SHOULD KNOW BEFORE TAKING SIMVASTATIN PENSA

DO NOT take SIMVASTATIN PENSA:

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 one or more of the following medicines simultaneously:
- itraconazole, ketoconazole, or posaconazole (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 infection)
- nefazodone (a medicine for depression)
- gemfibrozil (a medicine to lower cholesterol)
- cyclosporine (a medicine often used in organ transplant patients)
- danazol (a synthetic hormone used to treat endometriosis)
- fusidic acid; if you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and simvastatin may lead to serious muscle problems (rhabdomyolysis).

Ask your doctor if you are unsure whether the medicine you are taking is among those listed above.
Warnings and precautions

Inform your doctor about all your medical conditions (diseases), including allergies.
Inform your doctor if you drink large amounts of alcohol.
Inform your doctor if you have ever had liver disease. SIMVASTATIN PENSA may not be suitable for you. Inform your doctor if you are due to undergo surgery. You may need to temporarily stop taking SIMVASTATIN PENSA tablets.
Your doctor will perform a blood test before you start taking SIMVASTATIN PENSA. This is to check how well your liver is functioning.
Your doctor may also order blood tests to monitor liver function after you have started taking SIMVASTATIN PENSA.
Inform your doctor if you have a serious lung disease.
Consult your doctor or pharmacist before taking SIMVASTATIN PENSA if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases may include the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or cause its onset (see section 4).

Contact your doctor immediately if you experience muscle pain, tenderness, or
muscle weakness. This is because, in rare cases, muscle problems can be
serious and may include muscle tissue damage leading to kidney damage; very
rarely, cases of death have occurred.
The risk of muscle breakdown is higher at higher doses of Simvastatin, particularly at the 80 mg dose. The risk of muscle breakdown is also increased in certain patients. Consult 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 had muscle problems during treatment with cholesterol-lowering medicines called "statins" or "fibrates"
you or a close family member have a hereditary muscle disease

Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatment may be needed to diagnose and manage this condition.
While being treated with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at increased risk of developing diabetes if you have high levels of sugar and fats in your blood, if you are overweight, and if you have high blood pressure.
Children
Safety and efficacy have been studied in adolescents aged 10 to 17 years and in girls whose menstrual cycle started at least one year earlier (see section 3 “How to take SIMVASTATIN PENSA”). SIMVASTATIN PENSA has not been studied in children under 10 years of age. For further information, consult your doctor.
Other medicines and SIMVASTATIN PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is very important that you inform your doctor if you are taking any of the medicines listed below. Taking Simvastatin with any of these medicines may increase the risk of muscle problems (some of which have already been listed in the previous section “DO NOT take SIMVASTATIN PENSA”):

cyclosporine (a medicine often used in organ transplant patients)
danazol (a synthetic hormone used to treat endometriosis)
medicines such as itraconazole, ketoconazole, fluconazole, or posaconazole (medicines for fungal infections)
fibrates such as gemfibrozil and benzafibrate (medicines to lower cholesterol)
erythromycin, clarithromycin, telithromycin, or fusidic acid (medicines for bacterial infections)
HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines for AIDS)
nefazodone (a medicine for depression)
amiodarone (a medicine used to treat irregular heartbeat)
verapamil, diltiazem, or amlodipine (medicines used for high blood pressure, chest pain associated with heart disease, or other heart problems)
colchicine (a medicine used to treat gout)
fusidic acid, a medicine used to treat bacterial infections. 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, tenderness, or pain (rhabdomyolysis). See section 4 for more information about rhabdomyolysis.

In addition to the medicines listed above, tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. In particular, inform your doctor if you are taking any of the following:

medicines to prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants)
fenofibrate (another medicine to lower cholesterol)
niacin (another medicine to lower cholesterol)
rifampicin (a medicine 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 ethnicity.
You should also inform any doctor who prescribes you a new medicine that you are taking Simvastatin.
SIMVASTATIN PENSA and beverages
Grapefruit juice contains one or more components that may alter how your body processes certain medicines, including Simvastatin. Consumption of grapefruit juice should be avoided.
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.
Do not take SIMVASTATIN PENSA if you are pregnant or suspect you are pregnant. If you become pregnant while taking SIMVASTATIN PENSA, stop taking the tablets immediately and contact your doctor.
Do not take SIMVASTATIN PENSA if you are breastfeeding, as it is not known whether the medicine passes into breast milk.
Consult your doctor or pharmacist before taking this medicine.
Driving and using machines
SIMVASTATIN PENSA should not affect your ability to drive or use machines.
However, be aware that some people may experience dizziness after taking SIMVASTATIN PENSA.
SIMVASTATIN PENSA contains lactose:
SIMVASTATIN PENSA tablets contain 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 PENSA

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
While taking SIMVASTATIN PENSA, you must follow a low-cholesterol diet.
The recommended dose is 1 tablet of SIMVASTATIN PENSA 5 mg, 10 mg, 20 mg, 40 mg, or 80 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 problems who have not achieved their cholesterol-lowering goals with lower doses.
Your doctor will determine the appropriate tablet dosage for you, based on your condition, current treatment, and risk profile.
Take SIMVASTATIN PENSA in the evening. You may take it with or without food. The usual starting dose is 10 mg, 20 mg, or, in some cases, 40 mg daily. Your doctor may adjust your 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 a lower dose, especially if you are taking certain medicinal products listed above or have certain kidney conditions. Continue taking SIMVASTATIN PENSA unless your doctor tells you otherwise.
If your doctor has prescribed SIMVASTATIN PENSA together with any bile acid sequestrant (medicines to lower cholesterol), you should take SIMVASTATIN PENSA at least 2 hours before or 4 hours after taking the bile acid sequestrant.

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

If you take more SIMVASTATIN PENSA than you should:
Contact your doctor or pharmacist immediately.

If you forget to take SIMVASTATIN PENSA:
Do not take a double dose to make up for the missed tablet. Do not take an extra dose; simply take your next normal dose of SIMVASTATIN PENSA at the usual time the following day.

If you stop taking SIMVASTATIN PENSA:
Your cholesterol levels may rise again.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following terms are used to describe the frequency of adverse effects:

Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Frequency not known (frequency cannot be estimated from the available data).

The following rare serious adverse effects have been reported (may affect up to 1 in 1,000 people).
If you experience any of these serious adverse effects, stop taking the medicine immediately and contact your doctor or go to the nearest hospital emergency department.

Muscle pain, tenderness, weakness, or cramps. In rare cases, these muscle problems can be severe, including muscle breakdown leading to kidney damage; death has occurred very rarely.
Hypersensitivity (allergic) reactions, including:
- Swelling of the face, tongue, and throat that may cause breathing difficulties (angioedema)
- Severe muscle pain, usually in the shoulders and hips
- Skin rash associated with weakness in the limbs 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 illness (including rash, joint disorders, and effects on blood cells)
- Liver inflammation, with yellowing of the skin and eyes, itching, dark urine or pale stools, liver failure (very rare)
- Pancreas inflammation, often with severe abdominal pain.

The following very rare adverse effect has been reported:

A severe allergic reaction causing breathing difficulties or dizziness (anaphylaxis).

The following rare adverse effects (may affect up to 1 in 1,000 people) have also been reported:

Low red blood cell count (anaemia)
Numbness or weakness in the arms and legs
Headache, tingling sensation, dizziness
Gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)
Skin rash, itching, hair loss
Weakness
Sleep disorders (very rare)
Memory impairment (very rare).

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

Erectile dysfunction
Depression
Lung inflammation causing breathing problems, including persistent cough and/or shortness of breath or fever
Tendon problems, sometimes complicated by tendon rupture
Persistent muscle weakness
Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing)
Ocular myasthenia (a disease causing weakness of the eye muscles). Contact your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.

Other adverse effects reported with some statins:

Sleep disorders, including nightmares
Memory loss
Sexual difficulties

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

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

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

5. HOW TO STORE SIMVASTATIN PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store the medicine in its original packaging. Do not store above 30°C.
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. PACK CONTENT AND OTHER INFORMATION

What SIMVASTATINA PENSA contains
The active substance is: simvastatin. Each tablet contains 10 mg / 20 mg / 40 mg of simvastatin.
The other components are:
Tablet Core:
Lactose, microcrystalline cellulose (E 460), pregelatinized corn starch, butylated hydroxyanisole (E 320), ascorbic acid (E 300), citric acid (E 330), colloidal anhydrous silica (E 551), talc (E 553b), magnesium stearate (E 470b)
Tablet Coating:
Hypromellose (E 464), red iron oxide (E 172), yellow iron oxide (E 172), triethyl citrate (E 1505), titanium dioxide (E 171), talc (E 553b), povidone K-30.

Description of the appearance of SIMVASTATINA PENSA and package contents
Simvastatina Pensa 10 mg is a film-coated peach-colored, oval, biconvex tablet with a break line on one side. The break line is intended only to facilitate breaking the tablet for ease of swallowing and not for dividing it into equal doses.
Simvastatina Pensa 20 mg is a film-coated light brown-colored, oval, biconvex tablet.
Simvastatina Pensa 40 mg is a film-coated brick-red-colored, oval, biconvex tablet.
The tablets are packaged in blisters within a cardboard box containing 10, 20, or 28 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan - Italy

Manufacturers:
Farmaprojects S.A.
Santa Eulàlia 240-242
08902 L’Hospitalet de Llobregat (Barcelona)
Spain
Polpharma S.A. Pharmaceutical Works
Pelplińska 19, 83-200 Starogard Gdański
Poland

This medicinal product is authorized in the European Economic Area under the following names:
Italy: SIMVASTATINA PENSA 10 / 20 / 40 mg film-coated tablets.