Xipocol

XIPOCOL 10 mg film-coated tablets (active substance: simvastatin)
XIPOCOL 20 mg film-coated tablets (active substance: simvastatin)
XIPOCOL 40 mg film-coated tablets (active substance: simvastatin)

PATIENT INFORMATION LEAFLET: Information for the patient

XIPOCOL 10 mg film-coated tablets, 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What XIPOCOL is and what it is used for

XIPOCOL contains the active substance simvastatin. XIPOCOL is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fats called triglycerides in the blood. In addition, XIPOCOL increases levels of "good" cholesterol (HDL cholesterol). XIPOCOL belongs to a group of medicines called statins.

Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol consists mainly 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 building up in the arteries and protects against heart disease.

Triglycerides are another type of fat in the blood that can increase the risk of heart disease.

You must follow a cholesterol-lowering diet while taking this medicine.

XIPOCOL is used in addition to diet to lower cholesterol if you have:

• elevated cholesterol levels in the blood (primary hypercholesterolemia) or elevated levels of fats in the blood (mixed hyperlipidemia),
• an inherited disease (homozygous familial hypercholesterolemia) that increases your blood cholesterol levels. You may also be receiving other treatments,
• coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, have had a stroke, or have another blood vessel disease). XIPOCOL can prolong survival by

XIPOCOL 10 mg film-coated tablets (p.a. simvastatin)
XIPOCOL 20 mg film-coated tablets (p.a. simvastatin)
XIPOCOL 40 mg film-coated tablets (p.a. simvastatin)
reducing the risk of heart disease-related problems, regardless of cholesterol levels in the blood.

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

2. What you need to know before taking XIPOCOL

Do not take XIPOCOL:

• if you are allergic to the active substance 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 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),
  • 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);
• 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 XIPOCOL can cause serious muscle problems (rhabdomyolysis). Do not take more than 40 mg of XIPOCOL 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 among those listed above.

Warnings and precautions

Talk to your doctor or pharmacist before taking XIPOCOL.

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, XIPOCOL may not be suitable for you,
• if you are due to undergo surgery. You may need to stop taking XIPOCOL temporarily,
• if you are of Asian origin, 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), since statins may sometimes worsen myasthenia or cause its onset (see section 4).

Your doctor should perform a blood test before you start taking XIPOCOL and if you develop symptoms of liver problems while taking XIPOCOL. This test checks whether your liver is functioning properly.

Your doctor may also prescribe blood tests to monitor liver function after starting treatment with XIPOCOL.

During treatment with this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

Inform your doctor if you have a serious 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 XIPOCOL, 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 during treatment with cholesterol-lowering medicines called "statins" or fibrates,
• you or a close family member has a hereditary muscle disease. In addition, 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 XIPOCOL have been studied in boys and girls 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 XIPOCOL). XIPOCOL has not been studied in children under 10 years of age. For further information, consult your doctor.

Other medicines and XIPOCOL

Inform your doctor if you are taking, have recently taken, or might take any other medicine.

Taking XIPOCOL with any of the following medicines may increase the risk of muscle problems (some of which have already been listed in the section "Do not take XIPOCOL"):

• 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 ZOCOR. Taking ZOCOR with fusidic acid may rarely lead to weakness, muscle tenderness, or muscle pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4,
• Cyclosporine (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 containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates with active substances such as gemfibrozil and benzafibrate (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

XIPOCOL 10 mg film-coated tablets (p.a. simvastatin)
XIPOCOL 20 mg film-coated tablets (p.a. simvastatin)
XIPOCOL 40 mg film-coated tablets (p.a. simvastatin)
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),
• ribociclib (used to treat breast cancer),
• palbociclib (used to treat breast cancer).

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 clotting, 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 a new medicine that you are taking XIPOCOL.

XIPOCOL with food and drink

Grapefruit juice contains one or more substances that alter how the body processes certain medicines, including XIPOCOL. Consumption of grapefruit juice should be avoided.

Pregnancy and breastfeeding

Pregnancy

Do not use XIPOCOL during pregnancy, if you are planning a pregnancy, or if you suspect you are pregnant. If you become pregnant while taking XIPOCOL, stop treatment immediately and contact your doctor.

Breastfeeding

Do not use XIPOCOL 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

XIPOCOL is not expected to affect your ability to drive or operate machinery. However, you should be aware that dizziness has been reported after taking XIPOCOL.

XIPOCOL contains lactose

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

3. HOW TO TAKE XIPOCOL

Your doctor will determine the appropriate tablet dosage for you, based on your condition, current treatment, and risk profile.
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
XIPOCOL 10 mg film-coated tablets (p.a. simvastatin)
XIPOCOL 20 mg film-coated tablets (p.a. simvastatin)
XIPOCOL 40 mg film-coated tablets (p.a. simvastatin)
During treatment with XIPOCOL, you must follow a diet aimed at lowering cholesterol levels.
Dosage
The recommended dose is XIPOCOL 10 mg, 20 mg, or 40 mg taken orally once daily.
Adults
The usual starting 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, up to a maximum of 80 mg per day. Do not take more than 80 mg per day.
Your doctor may prescribe a lower dose, 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 levels 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 per day.
Method of administration
Take XIPOCOL in the evening. It can be taken with or without food. Continue taking XIPOCOL unless your doctor tells you to stop.
If your doctor has prescribed XIPOCOL together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must take XIPOCOL at least 2 hours before or 4 hours after taking the bile acid sequestrant medicine.
If you take more XIPOCOL than you should
Contact your doctor or pharmacist.
If you forget to take XIPOCOL
Do not take a double dose to make up for the missed tablet; take only your usual dose of XIPOCOL at the next scheduled time.
If you stop taking XIPOCOL
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, XIPOCOL may 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, or cramps. In rare cases, these muscle problems can be severe and may include muscle tissue damage leading to kidney injury; and very

XIPOCOL 10 mg film-coated tablets (p.a. simvastatin)
XIPOCOL 20 mg film-coated tablets (p.a. simvastatin)
XIPOCOL 40 mg film-coated tablets (p.a. simvastatin)
rarely, cases of death have been reported;

• 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,
  • 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,
• lupus-like symptoms (including skin rash, joint disorders, 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 difficulty breathing or dizziness (anaphylaxis)

The following side effects have also been reported, but are rare:

• reduction in red blood cell count (anaemia),
• numbness or weakness in arms and legs,
• headache, tingling sensation, dizziness,
• digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
• skin rash, itching, hair loss,
• blurred vision and impaired vision (may affect up to 1 in 1,000 people),
• skin rash which may appear on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people),
• weakness,
• difficulty falling asleep (very rare),
• poor memory (very rare), memory loss, confusion.

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

• erectile dysfunction,
• depression,
• lung inflammation causing breathing problems including persistent cough and/or shortness of breath and fever,
• tendon problems, 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 shortness of breath.
Other possible side effects reported with some statins:

• sleep disorders, including nightmares,
• sexual difficulties,

XIPOCOL 10 mg film-coated tablets (p.a. simvastatin)
XIPOCOL 20 mg film-coated tablets (p.a. simvastatin)
XIPOCOL 40 mg film-coated tablets (p.a. simvastatin)

• 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.
• persistent muscle pain, tenderness, or weakness, which may not resolve after stopping treatment with XIPOCOL (frequency not known), muscle rupture (may affect up to 1 in 10,000 people).
• gynaecomastia (enlargement of breast tissue in men) (may affect up to 1 in 10,000 people)

Laboratory findings
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 the website
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 XIPOCOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the last day of that month.
Store below 25°C.
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. Package contents and other information

What XIPOCOL contains
XIPOCOL 10 mg film-coated tablets
The active substance is simvastatin.
Each tablet contains: simvastatin 10 mg
The other components are: monohydrate lactose, pregelatinized starch, butylated hydroxyanisole, ascorbic acid,
monohydrate citric acid, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropylcellulose,
titanium dioxide, talc, yellow iron oxide, red iron oxide.
XIPOCOL 20 mg film-coated tablets
The active substance is simvastatin.
Each tablet contains: simvastatin 20 mg
The other components are: monohydrate lactose, pregelatinized starch, butylated hydroxyanisole, ascorbic acid,
monohydrate citric acid, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropylcellulose,
titanium dioxide, talc, yellow iron oxide.
XIPOCOL 40 mg film-coated tablets
The active substance is simvastatin.
Each tablet contains: simvastatin 40 mg
XIPOCOL 10 mg film-coated tablets (active substance simvastatin)
XIPOCOL 20 mg film-coated tablets (active substance simvastatin)
XIPOCOL 40 mg film-coated tablets (active substance simvastatin)
The other components are: monohydrate lactose, pregelatinized starch, butylated hydroxyanisole, ascorbic acid,
monohydrate citric acid, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropylcellulose,
titanium dioxide, talc, red iron oxide.

Description of the appearance of XIPOCOL and pack sizes
XIPOCOL 10 mg film-coated tablets
Packaged in PVC/PVDC/AL blisters in packs containing 20 tablets.
XIPOCOL 20 mg film-coated tablets
Packaged in PVC/PVDC/AL blisters in packs containing 10 or 28 tablets.
XIPOCOL 40 mg film-coated tablets
Packaged in PVC/PVDC/AL blisters in packs containing 10 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
MARKETING AUTHORIZATION HOLDER
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
Pomezia (Rome) – Italy

MANUFACTURER
XIPOCOL 10 mg film-coated tablets:
Special Product’s Line S.p.A.
Pomezia site: Via Campobello, 22 – 00071 Pomezia (RM), Italy
XIPOCOL 20 mg and 40 mg film-coated tablets
Special Product’s Line S.p.A.
Anagni site: Via Fratta Rotonda Vado largo, 1 - 03012 Anagni (FR), Italy