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 that you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 pack 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 found in the blood. Total cholesterol mainly consists of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often referred to as "bad" cholesterol because it can build up 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. Reduced blood flow can lead to heart attack or stroke.
HDL cholesterol is often referred to as "good" cholesterol because it helps prevent the buildup of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat found in the blood, which can contribute to an increased risk of heart disease.
While taking this medicine, you should follow a cholesterol-lowering diet.
Ximve is used as an adjunct 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 treatments may also be used;
• ischemic heart disease (coronary heart disease) or a high risk of developing ischemic heart disease (due to diabetes, a history of stroke or other vascular diseases). Ximve may prolong life by reducing the risk of heart disease, regardless of cholesterol levels in the blood.

In most people, high cholesterol does not cause any symptoms. Your doctor can assess your cholesterol level by ordering a simple blood test. You should regularly attend follow-up appointments, monitor your cholesterol level, 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 with transplanted organs)
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the lining of the uterus grows outside the uterus)

If you are unsure whether you are taking any of the above medicines, consult your doctor.

Warnings and precautions

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

• about all your illnesses, 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 can sometimes worsen the symptoms of the disease or cause myasthenia (see section 4).
Your doctor should perform a blood test before starting Ximve and during treatment if you have any liver problems. The test will 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. Tell your doctor if:

• 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 ever had muscle problems while taking cholesterol-lowering medicines called "statins" or fibrates
• you or a close relative have ever had a hereditary muscle disorder.

Tell your doctor or pharmacist 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 the 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 temporarily stop taking Ximve. Your doctor will inform you when it is safe to restart Ximve.

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

Also, tell your doctor or pharmacist about all the medicines you have taken recently, including those available without a prescription, especially those containing the following active substances:

• cyclosporine (often used in patients with transplanted organs)
• 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
• 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).

Similarly, tell your doctor or pharmacist about all the medicines you have taken recently, including those available without a prescription, especially those containing 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).

Also, inform any doctor who prescribes you 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, 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 take into account 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, 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.
Always take Ximve exactly as your doctor has told you. If you are unsure, ask 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 problems.
A dose of 80 mg is recommended only for adult patients with very high cholesterol levels in the blood and a high risk of heart disease, who have not achieved their target cholesterol level with lower doses.

Taking Ximve 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 treatment

Consult your doctor or pharmacist, as your cholesterol level may rise again.
If you have any further questions about taking Ximve, ask 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 inform 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 breakdown, which can lead to kidney damage; very rarely, this can be life-threatening
• allergic reactions (including anaphylaxis) that can cause difficulty breathing or dizziness
• severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS)
• inflammation of the liver (hepatitis) 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 (pancreatitis), often with severe abdominal pain.

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

• a severe allergic reaction that can cause difficulty breathing or dizziness (anaphylaxis)
• gynecomastia (breast enlargement in men)
• skin rash or mouth ulcers (drug-induced lupus-like reactions)
• muscle damage.

Rarely, the following side effects have been reported:

• decreased red blood cell count (anemia)
• numbness or weakness in the hands and feet
• headache, feeling of tingling, dizziness
• gastrointestinal problems (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting)
• skin rash, itching, hair loss
• weakness
• sleep disturbances (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 is not known:

• erectile dysfunction
• depression
• inflammation of the lungs, causing breathing problems, including persistent cough and (or) shortness of breath or fever
• tendon problems, 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 contact your doctor if you experience muscle weakness, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Additional possible side effects reported during the use of some statins:

• sleep disturbances, including nightmares
• sexual problems
• 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 in the muscles, which may not resolve after stopping Ximve (frequency not known).

Laboratory test results
Elevated 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, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 Ximve out of the sight and reach of children.
Do not use Ximve 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 pack 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 are marked with "SVT" on the side without the score line and "10" on the other side.
Ximve 20 mg - the tablets are marked with "SVT" on the side without the score line and "20" on the other side.
Ximve 40 mg - the tablets are marked with "SVT" on the side without the score line and "40" on the other side.
The tablets are packaged in blisters, which are placed 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
Phone: +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: