Molsidomina Vzf

Package Leaflet: Information for the Patient

MOLSIDOMINA WZF, 2 mg, tablets

MOLSIDOMINA WZF, 4 mg, tablets

Molsidomine

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, or nurse.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Molsidomina WZF and what is it used for

Molsidomine dilates arterial vessels and relieves coronary artery spasm. It reduces the heart's need for oxygen and its workload, resulting in better exercise tolerance and reduced frequency of angina attacks.

• Indications for use of Molsidomina WZF:
• prevention and treatment of angina pectoris symptoms;
• coronary insufficiency;
• improving exercise tolerance in patients with ischemic heart disease.

2. Important information before taking Molsidomina WZF

When not to take Molsidomina WZF:

• if you are allergic to molsidomine or any other ingredient of this medicine (listed in section 6);
• if you have acute circulatory failure (shock, acute phase of myocardial infarction with low filling pressure, left ventricular failure associated with low filling pressure);
• if you have severe arterial hypotension;
• if you are pregnant, especially in the first three months;
• if you are breastfeeding;
• if you are taking sildenafil, tadalafil, vardenafil (medicines used for erectile dysfunction);
• if you are taking so-called stimulators of soluble guanylate cyclase (medicines that act on pulmonary artery dilation, facilitating blood flow to the lungs), due to increased risk of significant blood pressure reduction.

Molsidomina WZF is not suitable for the treatment of acute angina attacks.

Warnings and precautions

Before starting treatment with Molsidomina WZF, discuss with your doctor or pharmacist, or nurse, if the following warnings apply to you.

• Particular caution should be exercised in patients with severe heart function disorders (patients with so-called hypertrophic cardiomyopathy with outflow tract obstruction, constrictive pericarditis, or cardiac tamponade, with acute myocardial infarction and left ventricular dysfunction, with aortic and/or mitral stenosis).
• In the event of a myocardial infarction, Molsidomina WZF should only be administered under close medical supervision and strict monitoring of blood circulation.
• In patients with low blood pressure and elderly patients, especially those taking other vasodilating medications or dehydrated (e.g., after using diuretics), a sudden drop in blood pressure may occur. In cases of increased risk of hypotensive reaction, the doctor will closely monitor the patient's condition and may adjust the dosage of the medicine.
• Concomitant use of molsidomine and medicines used for erectile dysfunction (sildenafil, tadalafil, vardenafil) is contraindicated, as it may cause a significant, sudden, and dangerous drop in blood pressure with fainting and collapse - see above "When not to take Molsidomina WZF". You should discuss this with your doctor if you plan to take medicines for erectile dysfunction - see above "Warnings and precautions".
• In patients with liver or kidney failure, the doctor may modify the dosage of the medicine depending on the patient's condition. In patients with liver failure, the doctor may recommend starting treatment with a lower dose and gradually increasing it until the desired therapeutic effect is achieved. This applies especially to patients with liver failure taking vasodilating medications.

Molsidomina WZF and other medicines

Tell your doctor or pharmacist about all medicines you are taking or plan to take.

• Molsidomine may enhance the effect of vasodilating medicines (e.g., nitrates, beta-adrenolytics, calcium antagonists), which may cause excessive blood pressure reduction.
• Concomitant use of molsidomine and iloprost may strongly inhibit platelet aggregation.
• During treatment with molsidomine, it is contraindicated to take medicines used for erectile dysfunction (sildenafil, tadalafil, vardenafil), as it may cause a sudden, excessive, and dangerous drop in blood pressure - see above "When not to take Molsidomina WZF". You should discuss this with your doctor if you plan to take medicines for erectile dysfunction - see above "Warnings and precautions".
• Concomitant use of molsidomine and ergot alkaloids (medicines used for migraine, circulatory disorders, venous diseases) is not recommended, as they may counteract each other's therapeutic effects.
• Concomitant use of molsidomine and stimulators of soluble guanylate cyclase is contraindicated due to increased risk of arterial hypotension - see above "When not to take Molsidomina WZF".

Molsidomina WZF with food, drink, and alcohol

Tablets can be taken before meals, during meals, or after meals.

Tablets should be taken with a sufficient amount of liquid (about half a glass).

Alcohol enhances the effect of molsidomine. Do not consume alcohol while taking Molsidomina WZF.

Pregnancy, breastfeeding, fertility

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 molsidomine in pregnant women, especially in the first trimester, is contraindicated.

Molsidomine passes into breast milk.

Use of molsidomine in breastfeeding women is contraindicated.

There are no data on the effect of molsidomine on human fertility. Animal studies have not shown any negative effect on fertility.

Driving and operating machinery

Certain side effects (e.g., dizziness) may impair your ability to concentrate and react, and may pose a risk in situations where these abilities are particularly important (e.g., operating machinery or driving vehicles). You may perform these activities only with the explicit consent of your doctor. Consult your doctor before taking this medicine.

Molsidomina WZF 2 mg tablets contain

Molsidomina WZF 4 mg tablets contain

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

The medicine may cause allergic reactions.

Molsidomina WZF 2 mg contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

Molsidomina WZF 4 mg contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Molsidomina WZF

Always take this medicine exactly as your doctor or pharmacist has told you.

In case of doubts, consult your doctor or pharmacist.

The doctor will determine the dose and administration times individually, depending on the severity of the disease and the patient's activity rhythm.

The medicine can be taken before meals, during meals, or after meals.

Usually 1 to 2 mg 3 or 4 times a day (3 to 8 mg of molsidomine per day).

If necessary, the dose can be increased to 4 mg 3 or 4 times a day (12 to 16 mg of molsidomine per day).

Overdose of Molsidomina WZF

Symptoms of overdose, depending on its severity, are low blood pressure (hypotension), slowed heart rate, weakness, dizziness, drowsiness, collapse, and shock.

Procedure: contact a doctor. In case of overdose, the doctor may consider gastric lavage. If necessary, symptomatic treatment will be applied.

Missed dose of Molsidomina WZF

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

Stopping treatment with Molsidomina WZF

In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking the medicine and seek immediate medical attention or go to the nearest hospital emergency department if you experience allergic reactions, including:

hives, swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (see below).

Observed side effects are defined as follows:

Frequent (less than 1 in 10 people):

• headaches. They occur especially at the beginning of treatment and usually disappear during further treatment. Adjusting the dose by the doctor to the patient's condition may reduce or eliminate this side effect.

Rare (less than 1 in 1000 people):

• allergic reactions (e.g., skin reactions, bronchospasm);
• dizziness;
• significant blood pressure reduction. Molsidomine usually lowers resting blood pressure. In 1 to 10% of patients, undesirable blood pressure reduction occurs (e.g., dizziness), which may require dose reduction or treatment discontinuation - the doctor will decide. Rarely, significant blood pressure reduction with symptoms such as collapse and shock may occur;
• nausea;
• allergic skin reactions.

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

• anaphylactic shock (a severe allergic reaction with a sudden onset, accompanied by blood pressure reduction, tissue swelling, and shortness of breath).

Unknown (frequency cannot be estimated from available data):

• low platelet count (thrombocytopenia);
• facial flushing, skin rash;
• blood pressure reduction, especially when changing body position to upright.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the 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.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Molsidomina WZF

Store in a temperature below 25°C.

Store blisters in the outer packaging to protect from light.

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.

The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.

Medicines should not be disposed of 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 Molsidomina WZF 2 mg tablets contain

• The active substance of the medicine is molsidomine. Each tablet contains 2 mg of molsidomine.
• Other ingredients are: lactose monohydrate; sucrose; potato starch; orange yellow, lake (E 110); povidone K-25; magnesium stearate.

What Molsidomina WZF 4 mg tablets contain

• The active substance of the medicine is molsidomine. Each tablet contains 4 mg of molsidomine.
• Other ingredients are: lactose monohydrate; sucrose; potato starch; cochineal red, lake (E 124); povidone K-25; magnesium stearate.

What Molsidomina WZF looks like and contents of the package

Molsidomina WZF 2 mg: tablets of non-uniform light orange color, round, flat on both sides, with beveled edges and a notch on one side, facilitating division into equal doses.

Molsidomina WZF 4 mg: tablets of non-uniform pink color, round, flat on both sides, with beveled edges and a notch on one side, facilitating division into equal doses.

Molsidomina WZF is available in aluminum/PVC blisters of 30 tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.

Production Plant in Nowa Dęba

ul. Metalowca 2

39-460 Nowa Dęba

Date of last revision of the leaflet:December 2024