MOLSIDAIN 4 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Molsidain 4 mg Tablets

Molsidomine

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Molsidain 4 mg and what is it used for
2. What you need to know before you take Molsidain 4 mg
3. How to take Molsidain 4 mg
4. Possible side effects
5. Storage of Molsidain 4 mg
6. Contents of the pack and further information

1. What is Molsidain 4 mg and what is it used for

Molsidain 4 mg belongs to a group of medicines called "other vasodilators used in heart diseases".

Molsidain 4 mg is indicated for the treatment of severe angina (angina pectoris) resistant to usual dosing.

2. What you need to know before you take Molsidain 4 mg

Do not take Molsidain 4 mg

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe hypotension (low blood pressure)
• if you are breastfeeding
• if you are taking any medicines for erectile dysfunction, such as sildenafil, tadalafil, or vardenafil
• if you are taking medicines that stimulate soluble guanylate cyclase (medicines used to treat pulmonary hypertension) (see section "Other medicines and Molsidain 4 mg").

In case of doubt, consult your doctor or pharmacist.

Warnings and precautions

Other medicines and Molsidain 4 mg

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Contraindicated or not recommended use:

• with medicines for erectile dysfunction, such as sildenafil, tadalafil, or vardenafil, as there is a high risk of a drop in blood pressure (see section "Do not take Molsidain 4 mg")
• with medicines that stimulate soluble guanylate cyclase (medicines used to treat pulmonary hypertension) (see section "Do not take Molsidain 4 mg").

Use with caution when Molsidain is used with:

-medicines with a blood pressure lowering effect (antihypertensive medicines, hypotensive medicines, e.g., tricyclic antidepressants, neuroleptics), as well as alcohol, as it may enhance the hypotensive effects

• ergot alkaloids (mainly used as vasodilators and for uterine bleeding).

Taking Molsidain 4 mg with food, drinks, and alcohol

The tablets should be taken, if possible, after the main meals.

Concomitant consumption of Molsidain and alcohol should be avoided, as it may reduce reaction capacity.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Do not take this medicine during the first three months of pregnancy, unless your doctor tells you to.

If you are breastfeeding, do not take Molsidain, as this medicine is excreted in breast milk.

Driving and using machines

Molsidain 4 mg may decrease the ability to drive or use machines, especially at the start of treatment or if taken with alcohol.

Molsidain 4 mg contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Molsidain 4 mg

Follow exactly the administration instructions of Molsidain 4 mg indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

It is recommended to take one tablet (4 mg) three times a day after meals.

In certain cases of unstable angina, a fourth tablet may be necessary.

If you take more Molsidain 4 mg than you should

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount used, or consult your doctor or pharmacist immediately, or go to the emergency department of the nearest hospital. It is recommended to bring the packaging and the package leaflet of the medicine to the healthcare professional.

The symptoms of an overdose with Molsidain 4 mg can be: hypotension (low blood pressure) and bradycardia (slow heart rate). Treatment of the symptoms is recommended.

If you forget to take Molsidain 4 mg

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

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

The classification of side effects is based on the following frequencies: Very common (may affect more than 1 in 10 people); Common (may affect up to 1 in 10 people); Uncommon (may affect up to 1 in 100 people); Rare (may affect up to 1 in 1,000 people); Very rare (may affect up to 1 in 10,000 people); Frequency not known (cannot be estimated from the available data) have been:

General reactions:

Common: Headaches at the start of treatment; your doctor may adjust the dose individually, which could reduce or even eliminate this effect.

Vascular reactions:

Usually, molsidomine decreases blood pressure at rest, especially the systolic value (when the heart contracts to pump blood).

Rare: Symptomatic severe hypotension (circulatory collapse or shock).

Gastrointestinal reactions:

Rare: Nausea.

Immune system reactions:

Rare: Hypersensitivity reactions (allergy), such as skin reactions (rash) and bronchospasm (contraction of the bronchial muscles).

Very rare: Anaphylactic shock (severe allergic reaction that can put your life in danger).

Post-marketing experience

During the use of Molsidain after authorization, the following adverse reactions have been identified with a frequency of "not known" (cannot be estimated from the available data):

Immune system disorders:

Anaphylactic shock (severe allergic reaction that can put your life in danger).

Blood and lymphatic system disorders:

Thrombocytopenia (decrease in the number of platelets in the blood).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Molsidain 4 mg

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

Store below 25°C. Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Molsidain 4 mg

• The active substance is molsidomine. Each tablet contains 4 mg of molsidomine.
• The other ingredients are: lactose monohydrate, crospovidone, macrogol 6000, and magnesium stearate.

Appearance and packaging of the product

White, oblong, and scored tablets.

Each pack contains 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

sanofi-aventis, S.A.

Ctra C35 La Batlloria a Hostalric, km 63,69

17404 Riells i Viabrea (Girona)

Spain

Local representative

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Date of the last revision of this package leaflet:September 2016

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/