Package Leaflet: Information for the Patient

Molsidain 4 mg Tablets

Molsidomine

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

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

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

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

2. What you need to know before you start taking 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 additional informationadditional information

Molsidain 4 mg belongs to a group of medicines called “other heart disease vasodilators”.

Molsidain 4 mgis indicated for the treatment of severe angina (angina) that is resistant to usual dosage.

Do not take Molsidain 4 mg

• if you are allergic to the active ingredient or to any of the other components of this medication(listed in section 6)
• if you have severe low blood pressure
• if you are breastfeeding
• if you are taking any medication to treat erectile dysfunction, such as sildenafil, tadalafil, or vardenafil
• if you are taking soluble guanylate cyclase stimulators (medications used to treat pulmonary hypertension) (see section “Other medications and Molsidain 4 mg”).

In case of doubt, consult your doctor or pharmacist.

Warnings and precautions

• if you have recently had a heart attack (myocardial infarction). In this case, you can take Molsidain as long as you do so under strict medical supervision.
• if you have kidney or liver problems, your doctor may adjust the dose.
• if you are pregnant or trying to become pregnant, consult your doctor (see section “Pregnancy, breastfeeding, and fertility”).

Other medications and Molsidain 4 mg

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

Contraindicated or not recommended use:

• with medications to treat erectile dysfunction, such as sildenafil, tadalafilo, or vardenafil, as there is a high risk of blood pressure drop(see section “Do not take Molsidain 4 mg”)
• with soluble guanylate cyclase stimulators (medications used to treat pulmonary hypertension) (see section “Do not take Molsidain 4 mg”).

Use with caution when Molsidain is used with:

-blood pressure-lowering medications (antihypertensive medications, hypotensive medications, for example tricyclic antidepressants, neuroleptics), as well as alcohol, as it may potentiate the hypotensive effects

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

Taking Molsidain 4 mg with food, drinks, and alcohol

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

Concurrent 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 medication.

Do not take this medication during the first three months of pregnancy, unless your doctor advises otherwise.

If you are breastfeeding a baby, do not take Molsidain as this medication is excreted through breast milk.

Driving and operating machinery

Molsidain 4 mg may reduce the ability to drive or operate machinery, especially at the beginning of treatment or when taking alcohol simultaneously.

Molsidain 4 mg contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for Molsidain 4 mg as 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 resistant to treatment, it may be necessary to take a fourth tablet.

If you take more Molsidain 4 mg than you should

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

The symptoms of a Molsidain 4 mg overdose may include hypotension (decreased blood pressure) and bradycardia (decreased heart rate). It is recommended to treat the symptoms.

If you forgot to take Molsidain 4 mg

Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The classification of adverse effects is based on the following frequencies:Muy frecuentes (may affect more than 1 in 10 people); Frecuentes (may affect up to 1 in 10 people); Poco frecuentes (may affect up to 1 in 100 people); Raros (may affect up to 1 in 1,000 people); Muy raros (may affect up to 1 in 10,000 people); Frecuencia no conocida (cannot be estimated from available data) have been:

General Reactions:

Frecuentes: Headaches at the start of treatment; your doctor may perform an individual dose adjustment, which could reduce or even eliminate this effect.

Vascular Reactions:

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

Raras: Severe hypotension (low blood pressure) with symptoms (circulatory collapse or shock).

Gastrointestinal Reactions:

Raras: Nausea.

Immunological System Reactions:

Raras: Hypersensitivity reactions (allergy), such as skin reactions (dermatitis) and bronchospasm (contraction of bronchial muscles).

Muy raras: Anaphylactic shock (severe allergic reaction that can put your life at risk).

Post-Marketing Experience

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

Immunological System Disorders:

Anaphylactic shock(severe allergic reaction that can put your life at risk).

Blood and Lymphatic System Disorders:

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in the prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Molsidain 4 mg

• The active ingredient is molsidomine. Each tablet contains 4 mg of molsidomine.
• The other components are: Lactose monohydrate, crospovidone, macrogol 6000, and magnesium stearate.

Appearance of the product and contents of the packaging

White, oval-shaped, and scored tablets.

Each package contains 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Responsible for manufacturing

sanofi-aventis, S.A.

Ctra C35 La Batlloria a Hostalric, km 63,69

17404 Riells i Viabrea (Gerona)

Spain

Local representative

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Last review date of this leaflet:September2016

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/