Molsidomina Vzf

Leaflet attached to the packaging: patient information

MOLSIDOMINA WZF, 2 mg, tablets

MOLSIDOMINA WZF, 4 mg, tablets

Molsidominum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist, or nurse.
• 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, 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 the heart's workload, which provides better exercise tolerance and reduces the 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 the patient is allergic to molsidomine or any other component of this medicine (listed in section 6);
• if the patient has acute circulatory failure (shock, acute phase of myocardial infarction with low filling pressure, left ventricular failure associated with low filling pressure);
• if the patient has severe arterial hypotension;
• if the patient is pregnant, especially in the first three months;
• if the patient is breastfeeding;
• if the patient is taking sildenafil, tadalafil, vardenafil (medicines used for erectile dysfunction);
• if the patient is taking so-called stimulators of soluble guanylate cyclase (medicines that act on the dilation of pulmonary arteries - blood vessels connecting the heart to the lungs,

facilitating the heart's pumping of blood to the lungs), due to the increased risk of a significant drop in blood pressure.

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

Warnings and precautions

Before starting treatment with Molsidomina WZF, the patient should discuss with their doctor or pharmacist, or nurse, if the following warnings apply to them.

• 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 close monitoring of blood circulation.
• In patients with low blood pressure and elderly patients, especially those taking other vasodilating medications or dehydrated (e.g., after taking diuretics), a sudden drop in blood pressure may occur. In cases of increased risk of a 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 - see above "When not to take Molsidomina WZF". The patient should discuss this with their doctor if they plan to take medicines for erectile dysfunction - see above "Warnings and precautions".
• Before recommending the use of molsidomine, the doctor will instruct the patient not to take medicines for erectile dysfunction and molsidomine at the same time, not to take molsidomine for at least 24 hours after taking sildenafil or vardenafil, and at least 48 hours after taking tadalafil.
• 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 with food, drink, and alcohol

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

The 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

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

Molsidomine passes into breast milk.

The use of molsidomine in breastfeeding women is contraindicated.

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

Driving and operating machinery

Certain side effects (e.g., dizziness) may impair the patient's 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). The patient may only perform these activities with the explicit consent of their doctor. Consult your doctor before taking this medicine.

Molsidomina WZF 2 mg tablets contain

Molsidomina WZF 4 mg tablets contain

If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their 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

This medicine should always be taken according to the doctor's or pharmacist's recommendations. If in doubt, 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).

Taking a higher dose of Molsidomina WZF than recommended

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

Procedure: contact a doctor. If an excessive dose of the medicine has been taken, the doctor may consider gastric lavage. If necessary, symptomatic treatment will be applied.

Missing a dose of Molsidomina WZF

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

Stopping treatment with Molsidomina WZF

If you have 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 an allergic reaction, 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 drop in blood pressure. Molsidomine usually lowers resting blood pressure. In 1 to 10% of patients, an undesirable drop in blood pressure (e.g., dizziness) occurs, which may require a dose reduction or discontinuation of treatment - the doctor will decide. Rarely, a significant drop in blood pressure with symptoms such as fainting 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 drop in blood pressure, swelling of tissues, shortness of breath).

Unknown (frequency cannot be estimated from available data):

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse. 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:

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 gather more information on the safety of this medicine.

5. How to store Molsidomina WZF

Store in a temperature below 25°C.

Store the blisters in the outer packaging to protect from light.

Keep the medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister. The expiry date stated on the carton and blister is the last day of the given 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 does 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 does 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; coschenille red, lake (E 124); povidone K-25; magnesium stearate.

What does Molsidomina WZF look like and what does the packaging contain

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