Molsidain 2 mg tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: patient information
Molsidain 2 mg tablets
Molsidomine
Read the entire 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, and you must not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Molsidain 2 mg is and what it is used for
- What you need to know before taking Molsidain 2 mg
- How to take Molsidain 2 mg
- Possible side effects
- How to store Molsidain 2 mg
- Contents of the pack and other information
1. What Molsidain 2 mg is and what it is used for
Molsidain 2 mg belongs to a group of medicines known as "other vasodilators used in heart diseases".
Molsidain 2 mg is indicated for the prevention of angina attacks.
2. What you need to know before taking Molsidain 2 mg
Do not take Molsidain 2 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 medicine for erectile dysfunction, such as sildenafil, tadalafil, or vardenafil
- if you are taking soluble guanylate cyclase stimulators (medicines used to treat pulmonary hypertension) (see section “Other medicines and Molsidain 2 mg”).
If in doubt, consult your doctor or pharmacist.
Warnings and precautions
- if you have recently had a heart attack (myocardial infarction). In this case, you may take Molsidain, but only under strict medical supervision.
- if you have kidney or liver problems, your doctor may adjust your dose.
- if you are pregnant or trying to become pregnant, consult your doctor (see section “Pregnancy, breastfeeding, and fertility”).
Other medicines and Molsidain 2 mg
Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Contraindicated or not recommended use:
- with medicines for erectile dysfunction, such as sildenafil, tadalafil, or vardenafil, due to a high risk of blood pressure drop (see section “Do not take Molsidain 2 mg”)
- with soluble guanylate cyclase stimulators (medicines used to treat pulmonary hypertension) (see section “Do not take Molsidain 2 mg”).
Use with caution when Molsidain is taken together with:
- medicines that lower blood pressure (antihypertensives, hypotensive agents, e.g., tricyclic antidepressants, neuroleptics), as well as alcohol, as these may enhance the hypotensive effects
- ergot alkaloids (used mainly as vasodilators and for uterine bleeding).
Taking Molsidain 2 mg with food, drinks, and alcohol
The tablets should be taken, if possible, after the main meals.
You should avoid consuming alcohol at the same time as Molsidain, as it may reduce your reaction capacity.
Pregnancy, breastfeeding, and fertility
Consult your doctor or pharmacist before using any medicine.
Do not take this medicine during the first 3 months of pregnancy unless your doctor advises otherwise.
If you are breastfeeding, do not take Molsidain, as this medicine is excreted in breast milk.
Driving and using machines
Molsidain 2 mg may reduce your ability to drive or operate machinery, especially at the beginning of treatment or if alcohol is taken concomitantly.
Molsidain 2 mg contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Molsidain 2 mg
Follow exactly the administration instructions for Molsidain 2 mg given by your doctor. Consult your doctor or pharmacist if you have any doubts.
It is recommended to take one tablet (2 mg) twice daily after meals.
If you take more Molsidain 2 mg than you should
In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone (91) 562 04 20, indicating the medication and the amount taken, or immediately consult your doctor or pharmacist, or go to the nearest hospital emergency department. It is recommended to bring the medication packaging and leaflet to the healthcare professional.
Symptoms of poisoning due to overdose with Molsidain 2 mg may include: hypotension (low blood pressure) and bradycardia (decreased heart rate). Symptomatic treatment is recommended.
If you forget to take Molsidain 2 mg
Do not take a double dose to make up for forgotten doses.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The classification of adverse 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):
General reactions:
Common: Headaches at the beginning of treatment; your doctor may make an individual dose adjustment, which could reduce or even eliminate this effect.
Vascular reactions:
Molsidomine usually reduces blood pressure at rest, especially the systolic value (when the heart contracts to pump blood).
Rare: Severe symptomatic hypotension (decrease in blood pressure) (circulatory collapse or shock).
Gastrointestinal reactions:
Rare: Nausea.
Immune system reactions:
Rare: Hypersensitivity reactions (allergy), such as skin reactions (rash) and bronchospasm (contraction of bronchial muscles).
Very rare: Anaphylactic shock (severe allergic reaction that may be life-threatening).
Post-marketing experience
During the use of Molsidain after authorization, the following adverse reactions have been identified with "not known" frequency (cannot be estimated from the available data):
Immune system disorders:
Anaphylactic shock (severe allergic reaction that may be life-threatening).
Blood and lymphatic system disorders:
Thrombocytopenia (decrease in the number of platelets in the blood).
Reporting of 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 this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Molsidain 2mg
Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep 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. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Molsidain 2 mg
- The active substance is molsidomine. Each tablet contains 2 mg of molsidomine.
- The other components are: monohydrate lactose, crospovidone, macrogol 6000 and magnesium stearate.
Appearance of the product and contents of the pack
White, elongated, biconvex, scored tablets.
Each pack contains 60 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 most recent revision of this leaflet: September 2016
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/