Molsidain 4 mg tablets
SpainTable of Contents
Package Leaflet: Information for the User
Introduction
Package Leaflet: Information for the Patient
Molsidain 4 mg Tablets
Molsidomine
Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.
-
Keep this leaflet, as you may need to read it again.
-
If you have any questions, consult your doctor or pharmacist.
-
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
-
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Molsidain 4 mg is and what it is used for
- What you need to know before taking Molsidain 4 mg
- How to take Molsidain 4 mg
- Possible adverse effects
- How to store Molsidain 4 mg
- Contents of the pack and other information
1. What Molsidain 4 mg is and what it is 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) resistant to usual dosages.
2. What you need to know before taking 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 medicine to treat 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 4 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 only 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 medicines and Molsidain 4 mg
Inform 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 to treat erectile dysfunction, such as sildenafil, tadalafil, or vardenafil, due to a high risk of blood pressure drop (see section “Do not take Molsidain 4 mg”)
- with soluble guanylate cyclase stimulators (medicines used to treat pulmonary hypertension) (see section “Do not take Molsidain 4 mg”).
Use with caution when Molsidain is taken together with:
- medicines that lower blood pressure (antihypertensive medicines, hypotensive agents, e.g. tricyclic antidepressants, neuroleptics), as well as alcohol, since they may enhance hypotensive effects
- ergot alkaloids (used mainly as vasodilators and for uterine bleeding).
Taking Molsidain 4 mg with food, drinks and alcohol
The tablets should be taken, preferably, after 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 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 4 mg may reduce the ability to drive or operate machinery, especially at the beginning of treatment or if alcohol is taken simultaneously.
Molsidain 4 mg contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Molsidain 4 mg
Follow exactly the administration instructions for Molsidain 4 mg provided by your doctor. If you have any doubts, consult your doctor or pharmacist.
It is recommended to take one tablet (4 mg) three times daily after meals.
In certain cases of refractory unstable angina, a fourth tablet may be required.
If you take more Molsidain 4 mg than you should
In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number (91) 562 04 20, indicating the medication and amount taken, or immediately consult your doctor or pharmacist, or go to the nearest hospital emergency department. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.
Symptoms of poisoning due to overdose with Molsidain 4 mg may include: hypotension (decreased blood pressure) and bradycardia (reduced heart rate). Symptomatic treatment is recommended.
If you forget to take Molsidain 4 mg
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody gets 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) and have been:
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 decreases blood pressure at rest, especially the systolic value (when the heart contracts to pump blood).
Rare: Symptomatic severe hypotension (low 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 (a 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 frequency "not known" (cannot be estimated from the available data):
Immune system disorders:
Anaphylactic shock (a 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 can also report them directly via 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 4 mg
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 container after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, 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 4 mg
- The active substance 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 pack
White, oblong, 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 most recent revision of this leaflet: September 2016
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/