Simvastatin Almus

Patient Information Leaflet

Simvastatina Almus 10, 20, 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:

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

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

Simvastatina Almus contains the active substance simvastatin. Simvastatina Almus is a medicine used to
reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fats known as
triglycerides in the blood. In addition, Simvastatina Almus increases levels of "good" cholesterol (HDL cholesterol).
Simvastatina Almus belongs to a group of medicines called statins.
Cholesterol is one of several types of fat found in the bloodstream. Total cholesterol is
mainly composed of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries,
forming plaques. Over time, this plaque buildup 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. This blockage of blood flow can cause a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from
accumulating in the arteries and protects against heart disease.
Triglycerides are another type of fat present in the blood that may increase the risk of heart disease.
You must follow a cholesterol-lowering diet while taking this medicine.
Simvastatina Almus is used in addition to diet to lower cholesterol if you have:
elevated levels of cholesterol in the blood (primary hypercholesterolemia), or elevated levels of fats in the
blood (mixed hyperlipidemia),
an inherited disease (homozygous familial hypercholesterolemia) that increases your cholesterol
levels in the blood. You may also be receiving other treatments,
coronary heart disease (CHD) or if you are at high risk of CHD (because you have diabetes, have had a
stroke, or have another blood vessel disease). Simvastatina Almus may 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 discuss cholesterol targets with your doctor.

2. What you should know before taking Simvastatina Almus

Do not take Simvastatina Almus:
if you are allergic (hypersensitive) to simvastatin or to any of the other ingredients of this
medicine (listed in section 6: Contents of the pack and other information);
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:
itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections),
erythromycin, clarithromycin or telithromycin (used to treat infections),
HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used for HIV infections),
boceprevir or telaprevir (used to treat hepatitis C virus infection),
nefazodone (used to treat depression),
cobicistat,
gemfibrozil (used to lower cholesterol),
ciclosporine (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 taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infection). The combination of fusidic acid and Simvastatina Almus may lead to serious muscle problems (rhabdomyolysis).
Do not take more than 40 mg of Simvastatina Almus 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 included in the list above.

Warnings and precautions
Inform your doctor:

• about all your medical conditions, including allergies,
• if you consume large amounts of alcohol,
• if you have ever had liver disease. In this case, Simvastatina Almus may not be suitable for you,
• if you are scheduled for surgery. You may need to temporarily stop taking Simvastatina Almus,
• if you are of Asian descent, as you may require a different dose,
• 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 sometimes worsen myasthenia or trigger its onset (see section 4). Your doctor should perform a blood test before you start taking Simvastatina Almus and if you develop symptoms of liver problems during treatment. This test is performed to check whether your liver is functioning properly.

Your doctor may also prescribe blood tests to monitor liver function after starting treatment with Simvastatina Almus.
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 levels of sugar and fats in the blood, being overweight, and having high blood pressure.
Inform your doctor if you have a severe lung disease.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness of unknown cause. This is because, rarely, 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 injury is higher at higher doses of Simvastatina Almus, particularly at the 80 mg dose. The risk of muscle injury is also higher 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 while being treated with cholesterol-lowering medicines known as “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 medicines may be needed to diagnose and treat this condition.

Children and adolescents
The safety and efficacy of simvastatin have been studied in adolescents aged between 10 and 17 years and in girls who have had their menstrual period (menstruation) for at least one year (see section 3: “How to take Simvastatina Almus”). Simvastatin has not been studied in children under 10 years of age.
For further information, consult your doctor.

Other medicines and Simvastatina Almus
Inform your doctor if you are currently taking, have recently taken, or might take any other medicine containing any of the following active substances.
Taking Simvastatina Almus together with any of the following medicines may increase the risk of muscle problems (some of these have already been listed in the section “Do not take Simvastatina Almus”):
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 treatment with Simvastatina Almus. Taking Simvastatina Almus with fusidic acid may rarely cause muscle weakness, pain or tenderness (rhabdomyolysis). See further information on rhabdomyolysis in section 4.
ciclosporine (often 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),
medicines with active substances such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections),
fibrates with 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 AIDS),
antiviral agents for hepatitis C such as boceprevir, telaprevir, elbasvir or grazeprevir (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, severe genetic cholesterol condition),
colchicine (used to treat gout).
As with 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 with an active substance to prevent blood clots, such as warfarin,
phenprocoumon or acenocoumarol (anticoagulants),
fenofibrate (also used to lower cholesterol),
niacin (also used to lower cholesterol),
rifampicin (used to treat tuberculosis).
You should also inform any doctor prescribing you a new medicine that you are taking Simvastatina Almus.

Simvastatina Almus with food and drink
Grapefruit juice contains one or more substances that alter how the body processes certain medicines, including Simvastatina Almus. Consumption of grapefruit juice should be avoided.

Pregnancy and breastfeeding
Do not use Simvastatina Almus if you are pregnant, planning to become pregnant, or suspect you may be pregnant. If you become pregnant while taking Simvastatina Almus, stop treatment immediately and contact your doctor.
Do not use Simvastatina Almus while breastfeeding, as it is not known whether the medicine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Simvastatina Almus is not expected to affect your ability to drive or operate machinery.
However, you should be aware that dizziness has been reported after taking Simvastatina Almus.

Simvastatina Almus contains lactose
Simvastatina Almus tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Simvastatina Almus

Your doctor will determine the appropriate tablet dosage for you, based on your condition, current treatment, and risk profile.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
During treatment with Simvastatina Almus, you must follow a diet aimed at reducing cholesterol levels.

Dosage
The recommended dose is Simvastatina Almus 10 mg, 20 mg, or 40 mg taken orally once daily.

Adults
The usual starting dose is typically 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 per day.
Your doctor may prescribe lower doses, especially if you are taking any of the medicines listed above or have certain kidney problems.
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 level with lower doses.

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

Method of administration
Take Simvastatina Almus in the evening. You may take it regardless of meals. Continue taking Simvastatina Almus unless your doctor tells you to stop. If your doctor has prescribed Simvastatina Almus together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must take Simvastatina Almus at least 2 hours before or 4 hours after taking the bile acid sequestrant medicine.

If you take more Simvastatina Almus than you should

• contact your doctor or pharmacist

If you forget to take Simvastatina Almus

• do not take a double dose to make up for the missed tablet. Take only the usual dose of Simvastatina Almus the next day at the usual time.

If you stop taking Simvastatina Almus

• speak with your doctor or pharmacist, as your 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, Simvastatina Almus can cause side effects, although not everybody gets them.
The following terms are used to describe how frequently side effects occur:
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 side effects have been reported in rare cases.
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:
muscle pain, tenderness, weakness, muscle breakdown (may affect up to 1 in 10,000 people), or muscle cramps. In rare instances, these muscle problems can be severe and may include injury to muscle tissue leading to kidney damage; and very rarely, cases of death have occurred;
hypersensitivity reactions (allergies) including:

• swelling of the face, tongue and throat which may cause breathing difficulties (angioedema),
• severe muscle pain, usually in the shoulders or hips,
• skin rash with weakness in the legs and neck muscles, skin rash which may appear on the skin or in the folds of the mouth (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people),
• joint pain or inflammation (polymyalgia rheumatica),
• inflammation of blood vessels (vasculitis),
• unusual bruising, skin rashes and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, hot flushes,
• shortness of breath (dyspnea) and feeling unwell, together with symptoms resembling lupus (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, liver failure (very rare); inflammation of the pancreas, often associated with severe abdominal pain.

The following very rare serious side effect has been reported:
a severe allergic reaction causing breathing difficulties 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 the arms and legs,
headache, tingling sensation, dizziness,
blurred vision, impaired vision,
digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
skin rash, itching, hair loss,
weakness,
difficulty sleeping (very rare),
memory impairment (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,
inflammation of the lungs causing breathing problems, including persistent cough and/or shortness of breath and fever,
problems with tendons, sometimes complicated by tendon rupture,
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 laboured breathing.

Additional possible side effects reported with some statins:
sleep disorders, including nightmares,
sexual difficulties,
diabetes. This is more likely if you have high levels of sugar and fat in your blood, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine,
muscle pain, tenderness or weakness that is persistent and may not resolve after stopping treatment with Simvastatina Almus (frequency not known).

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

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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Simvastatin Almus

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the blister and outer packaging after “Exp.” The first two digits indicate the month and the last four digits the year. The expiry date refers to the last day of the specified month.
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 Almus contains
The active substance is simvastatin.
The excipients are: anhydrous lactose, microcrystalline cellulose, pregelatinized corn starch,
butylhydroxyanisole (E320), magnesium stearate, talc, hydroxypropylcellulose, hypromellose and titanium
dioxide (E171).
Description of the appearance of Simvastatina Almus and contents of the pack
Simvastatina Almus film-coated tablets are white, capsule-shaped tablets. The tablets are marked with "SVT" on the side without the break line and with "10", "20" or "40" on the side with the break line.
Simvastatina Almus is available in packs of 10, 14, 20, 28, 30, 50, 56 or 100 tablets in blisters.
Simvastatina Almus is also available in a pack of 50 tablets (divisible packaging for single doses, for hospital use).
Simvastatina Almus is also available in tablet containers of 100, 250, 300 or 500 tablets, sealed with child-resistant closure.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Almus S.r.l.
Via Cesarea, 11/10
16121 Genoa
Italy
Tel. 0185-315782
Fax. 0185-315738
Manufacturers
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania, S.L.
Castelló 1, Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain