Ximve

Leaflet accompanying the packaging: patient information

Ximve, 10 mg, film-coated tablets

Ximve, 20 mg, film-coated tablets

Ximve, 40 mg, film-coated tablets

Simvastatin

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ximve and what is it used for
• 2. Important information before taking Ximve
• 3. How to take Ximve
• 4. Possible side effects
• 5. How to store Ximve
• 6. Contents of the packaging and other information

1. What is Ximve and what is it used for

Ximve contains the active substance simvastatin. Ximve is a medicine used to lower the level of cholesterol in the blood, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides. Additionally, Ximve increases the level of "good" cholesterol (HDL cholesterol). Ximve belongs to a group of medicines called statins.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol mainly consists of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can accumulate on the walls of arteries, forming plaques. Eventually, these plaques can cause narrowing of the arteries, resulting in restricted or blocked blood flow to vital organs, such as the heart and brain. Restricted blood flow can lead to heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the accumulation of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat present in the blood, which can contribute to an increased risk of developing heart disease.
While taking this medicine, you should follow a cholesterol-lowering diet.
Ximve is used as a complementary measure to a cholesterol-lowering diet, in the case of:

• high cholesterol levels in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• a hereditary disorder (homozygous familial hypercholesterolemia) that causes high cholesterol levels in the blood. Other treatment methods may also be used;
• ischemic heart disease (coronary artery disease) or a high risk of developing ischemic heart disease (due to diabetes, a history of stroke or other vascular diseases). Ximve may prolong the patient's life by reducing the risk of developing heart disease, regardless of cholesterol levels in the blood.

In most people, there are no direct symptoms of high cholesterol levels. The doctor may assess cholesterol levels by ordering a simple blood test. You should regularly attend check-ups, monitor your cholesterol levels, and discuss your treatment goals with your doctor.

2. Important information before taking Ximve

When not to take Ximve:

• 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 used to treat HIV infection),
• boceprevir and telaprevir (used to treat hepatitis C virus infection)
• nefazodone (used to treat depression)
• cobicistat
• gemfibrozil (used to lower cholesterol levels)
• cyclosporine (used in patients after organ transplants)
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the lining of the uterus grows outside the uterus)

If in doubt about any of the above medicines, consult your doctor.

Warnings and precautions

Before starting Ximve, discuss it with your doctor or pharmacist.
Tell your doctor:

• about all your conditions, including allergies.
• about consuming large amounts of alcohol.
• about any history of liver disease. Taking Ximve may not be suitable.
• about any planned surgery. It may be necessary to stop taking Ximve for a short time.

gravis (a disease that causes muscle weakness, including eye muscles), as statins may sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4).
Your doctor should perform a blood test before starting Ximve and during treatment if you have any liver disorders. The purpose of the test is to assess liver function.
Your doctor may also perform blood tests to assess liver function after starting Ximve.
During therapy, your doctor will closely monitor your health if you have diabetes or are at risk of developing diabetes. The risk of developing diabetes exists in people with high blood sugar and fat levels, overweight, and high blood pressure.
Tell your doctor about any serious lung diseases.

You should contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems can be serious, including muscle breakdown leading to kidney damage, and in

very rare cases, death.
The risk of muscle damage is higher when taking higher doses of Ximve, particularly the 80 mg dose. The risk of muscle breakdown is also higher in some patients. You should tell your doctor if:

• you consume large amounts of alcohol
• you have kidney problems
• you have thyroid problems
• you are 65 years or older
• you are female
• you have had muscle problems while taking cholesterol-lowering medicines called "statins" or fibrates
• you or a close relative have had hereditary muscle disorders.

Your doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.

Children and adolescents

The safety and efficacy of simvastatin have been studied in boys aged 10-17 years and girls who have started menstruation (menstruation) at least one year earlier (see section 3 "How to take Ximve"). No studies have been conducted in children under the age of 10. For more information, consult your doctor.

Ximve and other medicines

Tell your doctor about all medicines you are currently taking or plan to take, including those that are available without a prescription. If it is necessary to take fusidic acid orally to treat a bacterial infection, it may be necessary to stop taking Ximve temporarily. Your doctor will inform you when it is safe to restart Ximve.

• Taking Ximve with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). Additional information on rhabdomyolysis can be found in section 4.

Concomitant use of Ximve with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis).

• cyclosporine (often used in patients after organ transplants)
• danazol (a synthetic hormone used to treat endometriosis, a disease 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 levels)
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections)
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS)
• antiviral medicines used to treat hepatitis C virus infection, 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 heart rhythm disorders)
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases)
• lomitapide (used to treat a rare genetic cholesterol disorder)
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). It is possible that muscle-related side effects may be greater when this medicine is taken with simvastatin (e.g., Ximve). Your doctor may decide to stop Ximve for a while,
• colchicine (used to treat gout)
• tikagrelor (an antiplatelet medicine).

You should also tell your doctor or pharmacist about all medicines you have taken recently, including those available without a prescription. In particular, you should tell your doctor about medicines containing any of the following active substances:

• medicines that prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulant medicines)
• fenofibrate (also used to lower cholesterol levels)
• niacin (also used to lower cholesterol levels)
• rifampicin (used to treat tuberculosis).

You should also inform any doctor who prescribes a new medicine that you are taking Ximve.

Taking Ximve with food and drink

Grapefruit juice contains one or more compounds that affect the action of some medicines in the body, including Ximve. You should avoid drinking grapefruit juice.

Pregnancy and breastfeeding

Do not take Ximve if you are pregnant, planning to have a baby, or think you may be pregnant. If you become pregnant while taking Ximve, you should stop treatment and consult your doctor immediately. Do not take Ximve while breastfeeding, as it is not known whether the medicine is excreted in breast milk.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Ximve does not affect the ability to drive or use machines. However, you should consider that some people may experience dizziness after taking Ximve.

Ximve contains lactose

Ximve tablets contain a sugar called lactose. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking Ximve.

3. How to take Ximve

Your doctor will determine the dose of Ximve suitable for you, depending on your current treatment and individual risk.
This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.
While taking Ximve, you should follow a cholesterol-lowering diet.
Dosage:
The recommended dose is 10 mg, 20 mg, 40 mg, or 80 mg taken orally once a day.
Adults:
The initial dose is 10 mg, 20 mg, or in some cases 40 mg per day. Your doctor may adjust the dose after at least 4 weeks of treatment to a maximum of 80 mg per day. Do not take more than 80 mg per day.
Your doctor may recommend lower doses, especially if you are taking certain medicines listed above or have certain kidney-related conditions.
A dose of 80 mg is recommended only for adult patients with very high cholesterol levels in the blood and a high risk of developing heart disease, who have not achieved the target cholesterol level with a lower dose.

Use in children and adolescents

For children (aged 10-17 years), the recommended initial dose is 10 mg once daily in the evening.
The maximum recommended dose is 40 mg per day.
Method of administration:
Ximve should be taken in the evening. The medicine can be taken with or without food. Ximve should be taken continuously until your doctor advises you to stop.
If your doctor has prescribed Ximve with another cholesterol-lowering medicine containing a bile acid sequestrant, take Ximve at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Ximve than recommended

Consult your doctor or pharmacist.

Missing a dose of Ximve

Do not take a double dose to make up for a missed dose. Take the next dose of Ximve at the usual time the next day.

Stopping Ximve

Consult your doctor or pharmacist, as your cholesterol levels may rise again.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ximve can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects are reported:

• rare (may affect up to 1 in 100 people)
• very rare (may affect up to 1 in 10,000 people)
• not known (frequency cannot be estimated from the available data).

If you experience any of these serious side effects, stop taking Ximve and immediately consult your doctor or go to the emergency department of your nearest hospital.

The following rare but serious side effects have been reported:

• muscle pain, tenderness, or weakness, or muscle damage, which in rare cases can lead to kidney damage, and in
• allergic reactions (including anaphylaxis) involving:
• swelling of the face, tongue, and throat that can cause breathing difficulties (angioedema)
• severe muscle pain, usually in the shoulder and hip areas
• rash with weakness of the muscles of the arms and neck
• rash that can occur on the skin or ulcers of the mucous membranes of the mouth (drug-induced lupus-like reactions).
• inflammation of the liver with symptoms of yellowing of the skin and eyes, itching, dark urine, or pale stools, fatigue, or weakness, loss of appetite, liver failure (very rare)
• inflammation of the pancreas, often with severe abdominal pain.

The following very rare but serious side effects have been reported:

• a severe allergic reaction that causes breathing difficulties or dizziness (anaphylaxis)
• gynecomastia (breast enlargement in men)
• rash that can occur on the skin or ulcers of the mucous membranes of the mouth (drug-induced lupus-like reactions)
• muscle damage.

Rarely, the following side effects have also been reported:

• decreased red blood cell count (anemia)
• numbness or weakness of the hands and feet
• headache, tingling, dizziness
• gastrointestinal disorders (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting)
• rash, itching, hair loss
• weakness
• sleep disorders (very rare)
• poor memory (very rare), memory loss, confusion
• blurred vision and vision disturbances.

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 difficulties, including persistent cough and/or shortness of breath or fever
• tendon disorders, sometimes complicated by tendon rupture
• myasthenia (a disease that causes general muscle weakness, including muscles used for breathing)
• myasthenia gravis (a disease that causes muscle weakness, including eye muscles). You should consult your doctor if you experience weakness of the arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

The following additional side effects have been reported with the use of some statins:

• sleep disorders, including nightmares
• sexual disorders
• diabetes. The development of diabetes is more likely in people with high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor your health during treatment with Ximve
• pain, tenderness, or persistent weakness of the muscles, which may not resolve after stopping Ximve (frequency not known).

Laboratory test results
Increased muscle enzyme activity (creatine kinase) in the blood and abnormal liver function test results have been observed.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Ximve

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/blisters after "EXP". The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ximve contains

• The active substance of Ximve is simvastatin. Each film-coated tablet contains 10 mg, 20 mg, or 40 mg of simvastatin.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, maize starch, butylhydroxyanisole, magnesium stearate, talc. Coating: hydroxypropylcellulose, hypromellose, talc, titanium dioxide (E 171).

What Ximve looks like and contents of the pack

Ximve is a white, oval, biconvex film-coated tablet with a score line on one side.
Ximve 10 mg - the tablets have "SVT" engraved on the side without the score line and "10" on the other side.
Ximve 20 mg - the tablets have "SVT" engraved on the side without the score line and "20" on the other side.
Ximve 40 mg - the tablets have "SVT" engraved on the side without the score line and "40" on the other side.
The tablets are packaged in blisters contained in a carton. The cartons contain 28 or 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
Tel. +48 22 206 84 50
Manufacturer:
Synthon Hispania S.L.
Castelló 1
08830 Sant Boi de Llobregat
Spain
Rottendorf Pharma GmbH
Ostenfelder Strasse 51-61
59320 Ennigerloh
Germany

Date of last revision of the leaflet: