Koenzim Q10 forte

Package Leaflet: Information for the Patient

Coenzyme Q10 forte, 100 mg, soft capsules(Ubidecarenone)
Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be taken according to the description in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist.
• If after a few days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

1. What is Coenzyme Q10 forte and what is it used for
2. Important information before taking Coenzyme Q10 forte
3. How to take Coenzyme Q10 forte
4. Possible side effects
5. How to store Coenzyme Q10 forte
6. Package contents and other information

1. What is Coenzyme Q10 forte and what is it used for

The active substance of Coenzyme Q10 forte is ubidecarenone (also known as coenzyme Q₁₀).
Ubidecarenone is found in all animal and plant organisms and is necessary for the proper functioning of the body. It is a strong antioxidant that increases energy production and utilization in cells, especially in the heart muscle and skeletal muscles. It eliminates free radicals in the body and has stabilizing and toning properties on the immune system.
Coenzyme Q10 forte is used as an adjunct in:

• cardiovascular diseases, such as cardiomyopathy and heart failure,
• ischemic heart disease, hypertension, arrhythmias,
• prevention of overtraining syndrome in sports,
• supplementation of coenzyme Q₁₀deficiency, e.g., in people taking statins (cholesterol-lowering drugs) for a long time,
• neurodegenerative diseases (e.g., Parkinson's disease, Huntington's disease) and conditions of reduced physical and mental performance associated with the aging process.

2. Important information before taking Coenzyme Q10 forte

Do not take Coenzyme Q10 forte if:

• you are allergic to ubidecarenone or any other component of this medicine (listed in section 6).

3. How to take Coenzyme Q10 forte

Take according to the doctor's or pharmacist's recommendations.
Dosage:

• Usually 1 capsule 1-2 times a day.

Capsules should be taken during meals, with an adequate amount of fluid.
Do not exceed the recommended daily dose.

4. Possible side effects

Like all medicines, Coenzyme Q10 forte can cause side effects, although not everybody gets them.
Possible side effects:

• Rarely: gastrointestinal disorders (e.g., nausea, diarrhea).
• In very rare cases: allergic reactions (e.g., rash, itching, swelling).

In case of side effects, stop taking the medicine and consult a doctor.

5. How to store Coenzyme Q10 forte

Store at room temperature (up to 25°C), in a dry and dark place.
Store the medicine out of the reach of children.

6. Package contents and other information

1 capsule contains 100 mg of ubidecarenone.
Other ingredients: soybean oil, gelatin, glycerol, purified water, yellow iron oxide (E172).
The package contains 30 soft capsules.
Responsible entity: Polpharma S.A.ul. Pelplińska 19, 83-200 Starogard Gdański
To obtain additional information, contact the responsible entity.

Coenzyme Q10 forte and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Coenzyme Q10 forte:

• may enhance the effect of diuretics, digitalis glycosides, and nitrates,
• increases the antioxidant effect of vitamin E and shows enhanced effects with L-carnitine in terms of metabolism and circulation,
• may prolong the action of enalapril and nitrendipine (blood pressure-lowering drugs),
• may reduce the risk of side effects associated with statin (cholesterol-lowering) therapy and prevent the depressive effect on the heart muscle caused by some drugs (from the beta-adrenolytic group),
• reduces the toxic effect of anticancer antibiotics (anthracyclines) on the heart,
• may inhibit the anti-aggregatory and anticoagulant effect of warfarin.

Coenzyme Q10 forte with food

Coenzyme Q10 forte should be taken after meals, as the absorption of ubidecarenone from the gastrointestinal tract is largely dependent on the presence of fat.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Use of Coenzyme Q10 forte during pregnancy and breastfeeding is contraindicated.

Driving and operating machinery

Coenzyme Q10 forte has no effect on the ability to drive vehicles or operate machinery.

Coenzyme Q10 forte contains sorbitol

If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

Coenzyme Q10 forte contains allergens

The medicine may cause increased activity of aminotransferases (indicators important in the diagnosis of liver damage).
In some people, taking more than 100 mg of ubidecarenone per day may cause insomnia.

Coenzyme Q10 forte - composition

Active substance: ubidecarenone 100 mg
Other ingredients: soybean oil, gelatin, glycerol (moisturizing substance), purified water, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Coenzyme Q10 forte - packaging

30 soft capsules

Responsible entity

Biofarm S.A. ul. Tadeusza Sadkowskiego 1A, 05-363 Józefów

Marketing authorization number

Authorization No. 1887/2006

Missed dose of Coenzyme Q10 forte

Do not take a double dose to make up for a missed dose.

Stopping Coenzyme Q10 forte treatment

In cases of long-term use, do not stop taking the product abruptly without prior consultation with a doctor.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like any medicine, this medicine can cause side effects, although not everybody gets them.
Not very common (occurring in 1 to 10 patients out of 1,000):

• discomfort in the upper abdomen, loss of appetite, nausea, diarrhea.

Very rare (occurring in less than 1 in 10,000 patients):

• redness of the skin, allergic reactions.

If you experience any side effects, including any possible side effects not listed in the leaflet, consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (current address, phone number, and fax www. Department:) e-mail: adr@urpl.gov.pl

5. How to store Coenzyme Q10 forte

Store in the original packaging, at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Ask your pharmacist to help with disposal.

6. Package contents and other information

Medicinal product name: Coenzyme Q10 forte
Pharmaceutical form: capsules
Package contents: 30 capsules
Responsible entity: Polpharma S.A.ul. Pelplińska 19, 83-200 Starogard Gdański
Manufacturer: Polpharma S.A.ul. Pelplińska 19, 83-200 Starogard Gdański

Coenzyme Q10 forte is an oval capsule with a smooth, shiny surface, red in color with orange filling.

One package of the medicine contains 30 or 60 capsules.

Responsible entity and manufacturer PHARMACEUTICAL COMPANY HASCO-LEK^®S.A.

51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel. (22) 742 00 22
email: informacjoleku@hasco-lek.pl

Date of last update of the leaflet:

PPF HASCO-LEK S.A. Office in Warsaw
Department of Registration and Clinical Trials of Medicines
HEAD
MSc pharmacist Małgorzata Han-Marek