Coltovan

Package Leaflet: Information for the Patient

Coltowan, 10 mg, tablets

Ezetimibe

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Coltowan and what is it used for

Coltowan is a medicine used to lower high cholesterol levels.
Coltowan reduces the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. Additionally, Coltowan increases the levels of "good" cholesterol (HDL cholesterol). The medicine is used in patients for whom diet alone is not enough to control their cholesterol levels.
While taking this medicine, the patient should continue to follow a cholesterol-lowering diet.
Coltowan reduces the absorption of cholesterol in the gut. Coltowan has no effect on weight loss.
Coltowan enhances the action of statins, a group of medicines that reduce the amount of cholesterol produced by the body.
Cholesterol is one of several fatty substances found in the blood. Total cholesterol is mainly made up of LDL and HDL cholesterol fractions.
LDL cholesterol is often referred to as "bad" cholesterol because it can build up in the walls of arteries in the form of plaques. The accumulation of these plaques can eventually lead to narrowing of the arteries, which can cause a reduction in blood flow or blockage of blood flow to vital organs such as the heart and brain. Blockage of blood flow can cause a 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 the development of heart disease.
Triglycerides are another type of fat found in the blood that can increase the risk of developing heart disease.
Coltowan is used as an adjunct to diet in:

• - high cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial or non-familial]),
• - in combination with a statin, if cholesterol levels are not adequately controlled with statin therapy alone,
• - as monotherapy, if statin therapy is not appropriate or is not tolerated,
• - homozygous familial hypercholesterolemia, a genetic disorder that causes high cholesterol levels in the blood. The patient will be treated with a statin and may be treated with other therapies.

If the patient has heart disease, taking Coltowan in combination with another cholesterol-lowering medicine called a statin reduces the risk of heart attack, stroke, surgical procedures to increase blood flow to the heart, or hospitalization due to chest pain.

2. Important information before taking Coltowan

When taking Coltowan in combination with a statin, read the package leaflet for that medicine.

When not to take Coltowan:

• - if the patient is allergic to ezetimibe or any of the other ingredients of this medicine (listed in section 6).

When not to take Coltowan in combination with a statin:

• if the patient currently has liver problems,
• in case of pregnancy or breastfeeding.

Warnings and precautions

Before starting to take Coltowan, discuss it with a doctor or pharmacist.

• Tell the doctor about all conditions, including allergies.
• Before starting to take Coltowan in combination with a statin, the doctor should perform blood tests to assess liver function.
• The doctor may also perform blood tests to assess liver function after starting to take Coltowan in combination with a statin.

Coltowan is not recommended for use in patients with moderate or severe liver impairment.
The safety and efficacy of Coltowan in combination with certain cholesterol-lowering medicines, fibrates, have not been established.

Children and adolescents

Do not use this medicine in children and adolescents from 6 to 17 years of age, unless prescribed by a specialist due to lack of data on safety and efficacy.
Do not use this medicine in children under 6 years of age due to lack of data in this age group.

Coltowan and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
In particular, tell the doctor about taking any of the following medicines:

• cyclosporine (often used in patients who have had an organ transplant),
• medicines that prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants),
• colestyramine (also used to lower cholesterol levels), as it affects the action of Coltowan,
• fibrates (also used to lower cholesterol levels).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor before taking this medicine.
Do not take Coltowan in combination with a statin if the patient is pregnant, plans to become pregnant, or thinks they may be pregnant. If the patient becomes pregnant while taking Coltowan in combination with a statin, they should stop taking the medicine and consult a doctor immediately. There are no clinical data on the use of Coltowan without a statin during pregnancy. If the patient is pregnant, they should ask their doctor for advice before taking Coltowan.
Do not take Coltowan in combination with a statin while breastfeeding, as it is not known whether the medicine passes into breast milk. Coltowan should not be used in breastfeeding women, unless advised by a doctor.
The patient should ask their doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Coltowan is unlikely to affect the ability to drive or use machines.
However, consider that some people may experience dizziness after taking Coltowan.

Coltowan contains lactose

Coltowan tablets contain a sugar called lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

Coltowan contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Coltowan

Always take this medicine exactly as the doctor has told the patient. If the patient is not sure, they should ask their doctor or pharmacist.
Unless the doctor has told the patient otherwise, they should continue to take any other cholesterol-lowering medicines they have been taking.

• Before starting to take Coltowan, the patient should be on a cholesterol-lowering diet.
• While taking Coltowan, the patient should continue to follow a cholesterol-lowering diet.

The recommended dose is one 10 mg tablet of Coltowan per day, taken orally.
Coltowan can be taken at any time of day. The medicine can be taken with or without food.
If the doctor has prescribed Coltowan and a statin, both medicines can be taken at the same time. In this case, read the information on dosing in the package leaflet for that medicine.
If the doctor has prescribed Coltowan and another cholesterol-lowering medicine that contains the active substance colestyramine or any other medicine that contains a bile acid sequestrant, take Coltowan at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If the patient takes more Coltowan than they should

Consult a doctor or pharmacist.

If the patient forgets to take Coltowan

Do not take a double dose to make up for a forgotten tablet. Take the usual dose of Coltowan the next day at the usual time.

If the patient stops taking Coltowan

Discuss this with a doctor or pharmacist, as cholesterol levels may rise again.
If the patient has any further questions on the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should contact their doctor immediately if they experience unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems, including muscle breakdown, can be serious and life-threatening.

This can be a life-threatening condition.

The patient should seek medical help immediately if they experience allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing.

When taken alone, the following side effects have been reported:
Common (may affect up to 1 in 10 people): abdominal pain; diarrhea; bloating with gas; feeling tired.
Uncommon (may affect up to 1 in 100 people): increased levels of some liver or muscle enzymes in the blood; cough; indigestion; heartburn; nausea; joint pain; muscle cramps; neck pain; decreased appetite; pain; chest pain; flushing.
Additionally, when taken in combination with a statin, the following side effects have been reported:
Common (may affect up to 1 in 10 people): increased levels of some liver enzymes in the blood; headache; muscle pain, tenderness, or weakness.
Uncommon (may affect up to 1 in 100 people): tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness; pain in the arms and legs; unexplained tiredness or weakness; swelling, particularly of the hands and feet.
When taken in combination with fenofibrate, the following common side effect has been reported: abdominal pain.
Additionally, the following side effects have been reported (frequency not known: cannot be estimated from the available data):
dizziness; muscle pain, liver problems; allergic reactions, including rash and hives; red, raised rash, sometimes target-shaped (erythema multiforme); muscle pain, tenderness, or weakness; muscle breakdown; gallstones or gallbladder inflammation (may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; decreased platelet count, which may cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unexplained tiredness or weakness; shortness of breath.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse. 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail:
ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, the patient can help provide more information on the safety of the medicine.

5. How to store Coltowan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister package after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Coltowan contains

The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
The other ingredients are: lactose monohydrate, microcrystalline cellulose (type 102), magnesium stearate, povidone (K29/32), sodium croscarmellose, sodium lauryl sulfate,

What Coltowan looks like and contents of the pack

Coltowan tablets are white, round, flat, with a diameter of about 6 mm. On one side, there is the marking "CB3".
Coltowan, 10 mg, tablets are packaged in white, non-transparent PVC/PE/PVDC/PE/PVC//Aluminum blisters.
The blisters are packaged in a cardboard box with a patient leaflet.
Pack sizes: 15, 30, 45, 60, or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

GEDEON RICHTER POLSKA Sp. z o.o.
Poniatowskiego 5 Street
05-825 Grodzisk Mazowiecki
tel.: (22) 755 50 81

Manufacturer

Gedeon Richter Romania S.A.
99-105, Cuza Vodă Street,
540306 Târgu-Mureş,
Romania
To obtain more detailed information on the medicine and its names in other EU member states, contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
Poniatowskiego 5 Street
05-825 Grodzisk Mazowiecki
lekalert@grodzisk.rgnet.org
fax: +48 (22) 755 96 24
Date of last revision of the leaflet:October 2019
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