Simvastatin Krka

Package leaflet: Information for the patient

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

1. What Simvastatin KRKA is and what it is used for

Simvastatin KRKA contains the active substance "simvastatin".
Simvastatin KRKA is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fats called triglycerides in the blood. In addition, Simvastatin KRKA increases levels of "good" cholesterol (HDL).
Simvastatin KRKA belongs to a class of medicines called statins.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol is mainly composed of LDL and HDL cholesterol.
LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of arteries, forming plaque. 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. Such blockage of blood flow may cause a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the buildup of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another form of fat in the blood that may increase the risk of heart disease.
You should remain on a low-fat, low-cholesterol diet while taking this medicine.
Simvastatin KRKA is used, in addition to a cholesterol-lowering diet, if you have:

• elevated cholesterol levels in the blood (primary hypercholesterolemia) or elevated levels of fats in the blood (mixed hyperlipidemia);
• an inherited condition (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You may also be treated with other therapies;
• coronary heart disease (CHD), or you are at high risk of CHD (because you have diabetes, a history of stroke, or other blood vessel diseases). Simvastatin KRKA can prolong your life by reducing the risk of heart problems, 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, monitor your cholesterol levels, and discuss your target goals with your doctor.

2. What you should know before taking Simvastatin KRKA

Do not take Simvastatin KRKA

• 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 one or more of the following active substances:
  • itraconazole, ketoconazole, posaconazole or voriconazole (used for fungal infections);
  • erythromycin, clarithromycin or telithromycin (used for infections);
  • HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used for HIV infections);
  • boceprevir and telaprevir (used to treat hepatitis C virus infection);
  • nefazodone (used to treat 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).

Do not take more than 40 mg of Simvastatin KRKA if you are taking lomitapide (used for the treatment of a severe and rare genetic cholesterol disorder).
Ask your doctor if you are unsure whether your medicine is listed above.
Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatin KRKA.
Inform your doctor:

• about all your medical conditions, including allergies;
• if you drink large amounts of alcohol;
• if you have ever had liver disease. Simvastatin KRKA may not be suitable for you;
• if you are due to undergo surgery. You may need to stop taking Simvastatin KRKA tablets temporarily;
• if you are of Asian origin, as a different dose may be recommended for you;
• if you are taking or have taken within the last seven days an oral or injectable medicine called fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Simvastatin KRKA can lead to serious muscle problems (rhabdomyolysis).

Your doctor must perform a blood test before you start taking Simvastatin KRKA and if you develop symptoms of liver problems while taking Simvastatin KRKA. This is necessary to monitor your liver function.
Your doctor may also want you to have blood tests to check liver function after starting Simvastatin KRKA.
While taking this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. Your risk of developing diabetes is higher if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure.
Inform your doctor if you have a serious lung disease.
Contact your doctor immediately if you experience muscle pain, tenderness or weakness.
This is because, in rare cases, muscle problems can be serious, including muscle breakdown, which can cause kidney damage; in very rare cases, death has occurred.
The risk of muscle breakdown is higher at higher doses of Simvastatin KRKA, particularly the 80 mg dose. Other patients may also be at increased risk of muscle damage. Inform your doctor if any of the following apply to you:

• you consume large amounts of alcohol;
• you have kidney problems;
• you have thyroid problems;
• you are aged 65 years or older;
• you are female;
• you have previously experienced muscle problems during treatment with cholesterol-lowering medicines called "statins" or fibrates;
• you or your family members have hereditary muscle disorders.

Also inform your doctor or pharmacist if you experience persistent muscle weakness.
Further tests and treatments may be needed to diagnose and treat you.
Children and adolescents
The safety and efficacy of simvastatin have been studied in boys and girls aged 10–17 years, and in girls who have had menstrual periods for at least one year (see section 3). Simvastatin has not been studied in children under 10 years of age. For further information, consult your doctor.
Other medicines and Simvastatin KRKA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Taking Simvastatin KRKA with any of the following medicines may increase the risk of muscle problems (some of these have already been listed above in the section "Do not take Simvastatin KRKA"):

• cyclosporine (often used in patients who have had an organ transplant);
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus);
• medicines with an active substance such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections);
• fibrates with an active substance such as gemfibrozil and bezafibrate (used to reduce cholesterol);
• erythromycin, clarithromycin, telithromycin or fusidic acid (used to treat bacterial infections). Do not take fusidic acid while using this medicine. See also section 4 of this leaflet;
• 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 grazoprevir (used to treat hepatitis C virus infection);
• medicines containing cobicistat as the active ingredient;
• nefazodone (used to treat depression);
• 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 for the treatment of a severe and rare genetic cholesterol disorder);
• colchicine (used to treat gout);
• if you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart treatment with Simvastatin KRKA. Rarely, taking Simvastatin KRKA with fusidic acid may cause muscle weakness, soreness or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

In addition to the medicines listed above, inform your doctor or pharmacist if you are taking or have recently taken any other medicines, 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 an active substance that prevents 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).

You should also tell any doctor who prescribes you a new medicine that you are taking Simvastatin KRKA.
Simvastatin KRKA with food and drink
Grapefruit juice contains one or more components that interfere with how your body processes certain medicines, including Simvastatin KRKA. Consumption of grapefruit juice should be avoided.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you become pregnant while taking Simvastatin KRKA, stop taking it immediately and contact your doctor.
Do not take this medicine if you are 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 KRKA should not affect your ability to drive or operate machinery. However, bear in mind that some people have experienced dizziness after taking Simvastatin KRKA.
Simvastatin KRKA contains 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 KRKA

Your doctor will determine the appropriate dose for you, depending on your condition, current treatment, and personal risk factors.
Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
While taking Simvastatin KRKA, you should follow a cholesterol-lowering diet.

Dosage
The recommended dose is 1 tablet of Simvastatin KRKA 10 mg, 20 mg or 40 mg taken orally once daily.

Adults
The initial 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 of the medicines listed above or due to certain kidney conditions.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and at high risk of heart disease who have not achieved the desired cholesterol levels with lower doses.

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

Method and duration of administration
Take Simvastatin KRKA in the evening. It can be taken with or without food. Continue taking Simvastatin KRKA unless your doctor tells you to stop.
If your doctor has prescribed Simvastatin KRKA together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must take Simvastatin KRKA at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Simvastatin KRKA than you should
Contact your doctor or pharmacist.

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

If you stop taking Simvastatin KRKA
Talk to 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, this medicine can cause side effects, although not everyone experiences them.
The following terms have been used to describe the frequency of side effects:
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 rare, serious side effects have been reported.
If you experience any of these serious side effects, stop taking this medicine immediately,
contact your doctor or go to the nearest hospital emergency department without delay.

• Muscle pain, tenderness, weakness, or cramps. In rare cases, these muscle problems can be severe, including muscle breakdown that may lead to kidney damage, and in very rare cases, death has occurred.
• Allergic (hypersensitivity) reactions including:
• swelling of the face, tongue, and throat that may cause difficulty breathing (angioedema);
• severe muscle pain, usually in the shoulders and hips;
• skin rash with weakness in the limbs and neck muscles;
• joint pain or inflammation (polymyalgia rheumatica);
• 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 illness (including skin rash, joint problems, and effects on blood cells);
• Liver inflammation with the following symptoms: yellowing of the skin and eyes (jaundice), itching, dark-coloured urine or pale-coloured stools, feeling tired or weak, loss of appetite, liver failure (very rare).
• Inflammation of the pancreas, often with severe abdominal pain.

The following side effects have also been reported, but rarely:

• low red blood cell count (anaemia);
• numbness or weakness in arms and legs;
• headache, tingling sensation, dizziness;
• digestive problems (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting);
• skin rash, itching, hair loss;
• weakness;
• sleep problems (very rare);
• poor memory (very rare), memory loss, confusion.

The following side effects have very rarely been reported:

• a serious allergic reaction causing difficulty breathing or dizziness (anaphylaxis).

The following side 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.

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 fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine;
• muscle pain, soreness, or weakness that is persistent and may not resolve after stopping Simvastatin KRKA (frequency not known).

Laboratory tests
In laboratory tests, increases in certain values related to liver function and in 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:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Simvastatin KRKA

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging. 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Simvastatina KRKA contains

• The active substance is simvastatin. Each film-coated tablet contains 20 mg or 40 mg of simvastatin.
• The other ingredients are: pregelatinized starch, lactose monohydrate, microcrystalline cellulose (E460), butylated hydroxyanisole (E320), ascorbic acid (E300), corn starch, anhydrous citric acid, magnesium stearate (E572) in the tablet core. Coating: hypromellose (E464), talc (E553b), propylene glycol, titanium dioxide (E171) (see section 2).

Description of the appearance of Simvastatina KRKA and pack sizes
Simvastatina KRKA 20 mg film-coated tablets are oval, white, marked with 20 on one side and a break line on the other side.
Simvastatina KRKA 40 mg film-coated tablets are round, white, smooth on one side and have a break line on the other side.
Simvastatina KRKA film-coated tablets are available in packs of 10, 20, 28, 30, 40, 50, 56, 60, 84, 98, 100 and 100x1 film-coated tablets contained in blisters made of (PVC/PE/PVDC/Al).
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative for Italy
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorized in the European Economic Area countries with the following names: