Fluidasa 150 mg hard capsules
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUIDASA 150 mg hard capsules
Mepyramine (mepyramine acetylsalicylate)
Read the entire leaflet carefully before you start taking this medicine.
- 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; do not give it to others, even if they have the same symptoms, as it could harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Fluidasa Capsules are and what they are used for
- Before taking Fluidasa Capsules
- How to take Fluidasa Capsules
- Possible side effects
- How to store Fluidasa Capsules
- Further information
1. What FLUIDASA CAPSULES is and what it is used for
This medicine contains mepyramine, which belongs to a group of medicines called antihistamines.
FLUIDASA CAPSULES is used for the treatment of bronchoconstriction in patients with acute and chronic bronchitis (inflammation of the bronchi).
2. Before taking FLUIDASA CAPSULES
Do not take Fluidasa Capsules:
- If you are allergic (hypersensitive) to mepivamine or to any of the other components of Fluidasa Capsules.
- If you have any liver disease.
- If you have urinary bladder obstruction.
- If you have symptomatic prostatic hypertrophy or urinary retention.
- If you have closed-angle glaucoma.
Take special care with Fluidasa Capsules:
- If you are sensitive to antihistamines (medicines for allergies), since patients sensitive to one antihistamine may also be sensitive to others.
- If you are an elderly patient, as you are more likely to experience side effects such as dizziness, sedation, confusion, low blood pressure, dry mouth, or urinary retention. If these effects are persistent or severe, inform your doctor, as treatment may need to be discontinued.
- Its use is not recommended in newborns or premature infants, as this age group is more sensitive to certain effects of the medicine, such as anticholinergic effects (e.g., central nervous system stimulation) and a higher tendency to seizures.
Use of other medicines:
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
In particular, inform your doctor if you are taking the following medicines, as their effects may be enhanced:
- Medicines belonging to the anticholinergic group (e.g., certain medicines used to relieve spasms or contractions of the stomach, intestine, or bladder).
- Medicines used to treat depression, such as monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, or maprotiline.
- If you need to undergo skin allergy tests, it is recommended to stop taking Fluidasa Capsules at least 72 hours before the test, as it may lead to false-negative results (negative results that are actually positive).
Taking Fluidasa Capsules with food and drinks:
Avoid consuming alcoholic beverages while taking this medicine, as it may enhance the effects of alcohol.
Pregnancy and breastfeeding:
Fluidasa Capsules are not recommended during pregnancy.
Fluidasa Capsules are not recommended during breastfeeding.
Consult your doctor or pharmacist before using any medicine.
Driving and operating machinery:
Fluidasa Capsules may cause drowsiness, affecting mental and/or physical ability. If you experience these effects, avoid driving vehicles or operating machinery.
3. How to take FLUIDASA CAPSULES
Fluidasa Capsules are administered orally.
Follow exactly the instructions for use of Fluidasa Capsules provided by your doctor. Consult your doctor or pharmacist if you have any doubts.
The usual dosage is as follows:
Adults: 1 or 2 capsules every 8 hours; that is, 3 to 6 capsules per day.
If you feel that the effect of Fluidasa Capsules is too strong or too weak, consult your doctor or pharmacist.
If you take more Fluidasa Capsules than you should:
If you have taken more Fluidasa Capsules than you should, consult your doctor or pharmacist immediately.
In cases of overdose, symptoms of anticholinergic effects may occur, such as clumsiness, unsteadiness, intense drowsiness, dryness of the mouth, nose or throat, flushing or redness, changes in the normal heart rhythm, central nervous system depression (hallucinations), or low blood pressure. Stimulant anticholinergic effects on the CNS are more likely in children.
In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone: 91 562 04 20.
If you forget to take Fluidasa Capsules:
Do not take a double dose to make up for missed doses.
Take your dose as soon as possible and continue taking it every day at the time indicated by your doctor.
4. Possible adverse effects
Like all medicines, Fluidasa Capsules may have adverse effects, although not everyone will experience them.
The adverse effects observed have been:
Very common (affects at least 1 in 10 patients): drowsiness.
Common (affects at least 1 in 100 patients): blurred vision, confusion, difficulty urinating, dizziness, dry mouth, increased heart rate, tinnitus, skin rash, stomach discomfort or pain.
Uncommon (affects at least 1 in 1,000 patients): blood disorders (discrasias) and changes in the normal heart rhythm.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of FLUIDASA CAPSULES
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Fluidasa Capsules after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or in household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Additional Information
Composition of Fluidasa Capsules
- The active substance is: mepivarine (acephylinate mepivamine). Each capsule contains 150 mg of mepivarine.
- The other components are: magnesium stearate.
Appearance of the medicinal product and contents of the pack
Blister pack containing 20 white and green hard capsules.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
Teofarma, S.r.l. - Via F. Lli Cervi, 8 – 27010 Valle Salimbene (PV) - Italy.
Manufacturer:
Teofarma, S.r.l. – Viale Certosa, 8/A - I-27100 Pavia – Italy
Other presentations
Fluidasa Solution. 250 ml bottle of oral solution.
Fluidasa Drops. 30 ml bottle of oral solution with dropper cap.
Fluidasa Injectable. Pack containing 10 vials of 5 ml.
This leaflet was approved in March 2011
Detailed and up-to-date information on this medicinal product is available on the website of the
Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/