XIPOCOL 10 mg Film-Coated Tablets

Зміст інструкції

1. XIPOCOL 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What is XIPOCOL and what it is used for
   2. HOW TO TAKE XIPOCOL
   3. Possible side effects
   4. How to store XIPOCOL
   5. Package Contents and Other Information

XIPOCOL 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Simvastatina
Generic medicine
Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is XIPOCOL and what it is used for

XIPOCOL contains the active ingredient simvastatin. XIPOCOL is a medicine used to reduce levels of
total cholesterol, of "bad" cholesterol (LDL cholesterol) and of fatty substances called triglycerides in
the blood. In addition, XIPOCOL increases levels of "good" cholesterol (HDL cholesterol). XIPOCOL belongs to
the group of medicines called statins.
Cholesterol is one of the various fatty substances 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
the arteries forming plaques. Over time, this accumulation in the form of plaque can lead
to a narrowing of the arteries. This narrowing can slow down or block the flow of blood to
vital organs such as the heart and brain. This blockage of blood flow can cause a heart attack or
a 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 form of fat present in the blood that can increase the risk of heart
disease.
You must follow a diet to reduce cholesterol during therapy with this medicine.
XIPOCOL is used in addition to diet to reduce cholesterol if you have:

• increased levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia),
• an inherited disease (familial homozygous hypercholesterolemia) that increases your cholesterol levels in the blood. It is possible that you are also being treated with other treatments,
• coronary heart disease (CHD) or if you are at high risk of CHD (because you have diabetes, or have had a stroke, or have another disease of the blood vessels). XIPOCOL may prolong survival by reducing the risk of problems related to heart disease, regardless of cholesterol levels in the

Page 1to 8
blood.
In most people, no immediate symptoms appear due to high cholesterol. Your doctor can check your cholesterol with a simple blood test. See your doctor
regularly, keep track of your cholesterol levels and define goals to achieve with your doctor.

2. What you need to know before you take XIPOCOL
Do not take XIPOCOL:

• if you are allergic to the active ingredient 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 any medicine(s) with one or more of the following active ingredients:
• 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 patients undergoing organ transplantation),
• danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus develops outside the uterus);
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infection) orally or by injection. The combination of fusidic acid and XIPOCOL may cause serious muscle problems (rhabdomyolysis). Do not take more than 40 mg of XIPOCOL if you are taking lomitapide (used to treat a severe and rare genetic condition of cholesterol). Ask your doctor for advice if you are not sure whether the medicine you are taking is among those listed above.

Warnings and precautions
Talk to your doctor or pharmacist before taking XIPOCOL.
Tell your doctor:

• about all medical conditions including allergies,
• if you consume significant amounts of alcohol,
• if you have ever had a liver disease. In this case, XIPOCOL may not be suitable for you,
• if you are going to have surgery. You may need to stop taking XIPOCOL for a short period,
• if you are Asian, because a different dose may be appropriate for you,
• 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 that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to occur (see section 4).

The doctor will need to have a blood test done before giving you XIPOCOL and if you have symptoms of liver problems while taking XIPOCOL. This test is done to know if the liver is working
adequately.
The doctor may also prescribe blood tests to check liver function after starting
therapy with XIPOCOL.
During treatment with this medicine, your doctor will carefully check that you do not have
Page 2to 8
diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels
of sugars and fats in the blood, if you are overweight and have high blood pressure.
Tell your doctor if you have a serious lung disease.

Immediately contact your doctor if you experience unexplained muscle pain, tenderness or weakness. This is because, rarely, muscle problems can be serious and can
include muscle tissue damage with resulting kidney damage; very rarely, deaths have occurred.
The risk of muscle damage is greater at higher doses of XIPOCOL, especially with the 80
mg dose: The risk of muscle damage is also greater in some patients. Talk to your doctor if any
of the following conditions apply to you:

• consume significant amounts of alcohol,
• have kidney problems,
• have thyroid problems,
• are 65 years of age or older,
• are female,
• have ever had muscle problems while taking cholesterol-lowering medicines called “statins” or fibrates,
• you or a close family member suffers from an inherited muscle disease. You should also tell your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be needed for diagnosis and treatment of this condition.

Children and adolescents
The safety and efficacy of XIPOCOL have been studied in boys aged 10 to 17 years and in
girls who have started to have 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
more information ask your doctor.

Other medicines and XIPOCOL
Tell your doctor if you are taking, have recently taken or might take any other
medicines
Taking XIPOCOL 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 XIPOCOL”):

• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart treatment with XIPOCOL. Taking XIPOCOL with fusidic acid can rarely lead to weakness, tenderness or muscle pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4,
• Cyclosporine (often used in patients undergoing organ transplantation),
• danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus develops outside the uterus),
• medicines with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections),
• fibrates with active ingredients such as gemfibrozil and bezafibrate (used to reduce 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),

Page 3to 8

• nefazodone (used to treat depression),
• medicines with the active ingredient cobicistat,
• amiodarone (used to treat an irregular heartbeat),
• verapamil or diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart conditions),
• lomitapide (used to treat a severe and rare genetic condition of cholesterol),
• colchicine (used to treat gout).

As with the medicines listed above, tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including over-the-counter medicines. In particular, tell your doctor
if you are taking any medicine(s) with any of the following active ingredients:

• medicines with an active ingredient 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 tell your doctor who is prescribing you a new medicine that you are taking XIPOCOL.

XIPOCOL with food and drink
Grapefruit juice contains one or more substances that change the way the body uses
some medicines, including XIPOCOL. Consumption of grapefruit juice should be avoided.

Pregnancy and breastfeeding

Pregnancy
Do not use XIPOCOL if you are pregnant, if you are planning to become pregnant or if you suspect you are
pregnant. If you become pregnant while taking XIPOCOL, stop taking it immediately and
contact your doctor.

Breastfeeding
Do not use XIPOCOL during 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 impair your ability to drive or operate machinery. However, you
should be aware that dizziness has been reported after taking XIPOCOL.

XIPOCOL contains lactose
The tablets of XIPOCOL contain a sugar called lactose. If you have been diagnosed
with an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE XIPOCOL

The doctor will determine the appropriate tablet dosage for you, based on your condition, your current
treatment and your risk profile.
Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
During treatment with XIPOCOL, you should follow a diet to lower cholesterol levels.

Dosage
The recommended dose is XIPOCOL 10 mg, 20 mg or 40 mg by mouth once a day.

Adults
Page 4to 8
The initial dose is usually 10, 20 or, in some cases, 40 mg per day. The 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.
The doctor may prescribe lower doses, especially if you are taking some 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 ideal cholesterol level with lower doses.
Use in children and adolescents:
For children (ages 10-17 years), the usual recommended starting dose is 10 mg per day administered in the
evening. The maximum recommended dose is 40 mg per day.
Route of administration
Take XIPOCOL in the evening. You can take it independently of meals. Continue taking XIPOCOL
unless your doctor tells you to stop treatment.
If your doctor has prescribed XIPOCOL with another medicine to lower cholesterol 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 a missed tablet; just take your usual dose of XIPOCOL the next day at the usual time.

If you stop taking XIPOCOL
Talk to your doctor or pharmacist as your cholesterol may rise again.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, XIPOCOL can cause side effects, although not everybody gets them.
To describe how often side effects occur, the following terms are used:

• 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) In rare cases, the following serious side effects have been reported.

If any of the following serious side effects occur, you must stop treatment and
immediately contact your doctor or go to the nearest hospital emergency room:

• pain, tenderness, weakness or muscle cramps. In rare cases, these muscle problems can be severe and can include muscle tissue injury leading to kidney damage; and very rarely, cases of death have occurred;
• hypersensitivity reactions (allergies) including:
• swelling of the face, tongue and throat which can cause difficulty breathing (angioedema),
• severe muscle pain usually in the shoulders or hips,
• skin rash with weakness in the legs and muscles of the neck,
• pain or inflammation in the joints (polymyalgia rheumatica),
• inflammation of the blood vessels (vasculitis),

Pag. 5a 8

• unusual bruising, skin rash and swelling (dermatomyositis), hives, skin sensitivity to the sun, fever, flushing,
• shortness of breath (dyspnea) and feeling unwell,
• a collection of symptoms like lupus (which includes skin rash, joint disorders, and effects on blood cells)
• inflammation of the liver 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 that causes difficulty breathing or dizziness (anaphylaxis)

The following side effects have also been reported rarely:

• low red blood cell count (anemia),
• numbness or weakness in the arms and legs,
• headache, tingling sensation, dizziness,
• digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhea, nausea, vomiting),
• skin rash, itching, hair loss,
• blurred vision and impaired vision (may affect up to 1 in 1,000 people)
• skin rash that can occur 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 based on
the information available (frequency not known):

• erectile dysfunction,
• depression,
• inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath and fever,
• tendon problems, sometimes complicated by tendon rupture,
• myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles used for breathing),
• ocular myasthenia (a disease that causes weakness of the eye muscles).

See your doctor if you experience weakness in your arms or legs that gets worse after periods of activity,
double vision or drooping eyelids, difficulty swallowing or shortness of breath.
Further possible side effects reported with some statins:

• sleep disturbances, including nightmares,
• sexual difficulties,
• diabetes. This is more likely if you have high blood sugar and fat levels, if you are overweight and have high blood pressure. Your doctor will monitor you during treatment with this medicine.
• pain, tenderness or weakness in muscles that is constant, which may not disappear after stopping treatment with XIPOCOL (frequency not known), muscle rupture (may affect up to 1 in 10,000 people).
• gynecomastia (enlargement of the breasts in men) (may affect up to 1 person in
• 10,000)

Pag. 6a 8

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system reported at the address
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 which is stated on the packaging after Exp. The expiry
date refers to the last day of that month.
Store at a temperature below 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use .This will help protect the environment.

6. Package Contents and Other Information

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

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

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

Description of the appearance of XIPOCOL and package contents
XIPOCOL 10 mg film-coated tablets
Packs in PVC/PVDC/AL blisters in packs of 20 tablets.

XIPOCOL 20 mg film-coated tablets
Packs in PVC/PVDC/AL blisters in packs of 10 or 28 tablets.
Page 7to 8
XIPOCOL 40 mg film-coated tablets
Packs in PVC/PVDC/AL blisters in packs of 10 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer
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
Page 8to 8