FLUIDASA 150 mg HARD CAPSULES

2. Before you take FLUIDASA CAPSULES

Do not take Fluidasa Capsules:

• If you are allergic (hypersensitive) to mepifilina or any of the other ingredients of Fluidasa Capsules.

• If you have any liver disease.
• If you have urinary retention due to urethral obstruction.
• If you have symptomatic prostatic hypertrophy or urinary retention.
• If you have narrow-angle glaucoma.

Be cautious when taking Fluidasa Capsules:

• If you are sensitive to antihistamines (allergy medicines), as patients sensitive to one antihistamine may be sensitive to others.
• If you are elderly, 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 persist or worsen, inform your doctor, as the medication may need to be discontinued.
• It is not recommended for use in newborns or premature infants, as this age group is more sensitive to some effects of the medicine, such as anticholinergic effects (e.g., central nervous system stimulation) and a greater tendency to convulsions.

Using other medicines:

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

Especially, inform your doctor if you are taking the following medicines, as some effects may be increased:

• Medicines from the anticholinergic group (e.g., some medicines used for relief of stomach, intestine, or bladder spasms or contractions)
• Medicines used for the treatment of depression, such as monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, or maprotiline.
• If skin allergy tests need to be performed, it is recommended to discontinue the administration of Fluidasa Capsules at least 72 hours before starting the test, as it may give false-negative results (negative results that are actually positive).

Taking Fluidasa Capsules with food and drinks:

You should avoid consuming alcoholic beverages during the administration of this medicine, as it may increase the effects of alcohol.

Pregnancy and breastfeeding

It is not recommended to take Fluidasa Capsules during pregnancy.

It is not recommended to take Fluidasa Capsules during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

Fluidasa Capsules may cause drowsiness, affecting mental and/or physical ability. If you experience these effects, avoid driving vehicles or using machines.

3. How to take FLUIDASA CAPSULES

Fluidasa Capsules are administered orally.

Follow the administration instructions of Fluidasa Capsules exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The normal dose is as follows:

Adults:1 or 2 capsules every 8 hours; i.e., 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 such as clumsiness, instability, intense sleepiness, dry mouth, nose, or throat, flushing, or redness, variations in the normal heartbeat rhythm, central nervous system depression (hallucinations), or low blood pressure may appear. In children, anticholinergic stimulant effects on the central nervous system are more likely.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone: 91 562 04 20.

If you forget to take Fluidasa Capsules:

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

Take your dose as soon as possible and continue taking it every day at the time indicated by your doctor.

4. Possible side effects

Like all medicines, Fluidasa Capsules can cause side effects, although not everybody gets them.

The side effects found have been:

Very common (at least 1 in 10 patients): drowsiness.

Common (at least 1 in 100 patients): blurred vision, confusion, difficulty urinating, dizziness, dry mouth, rapid heartbeat, ringing in the ears, skin rash, discomfort or pain in the stomach.

Uncommon (at least 1 in 1,000 patients): abnormal blood conditions (dysscrasias) and variations in the normal heartbeat rhythm.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting side effects

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

5. Storing 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Further information

Composition of Fluidasa Capsules

• The active ingredient is: mepifilina (mepiramine acefyllinate). Each capsule contains 150 mg of mepifilina.
• The other ingredients are: magnesium stearate.

Appearance and packaging of the product

Blister pack containing 20 hard capsules, white and green in color.

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. Bottle of 250 ml oral solution.

Fluidasa Drops. Bottle of 30 ml oral solution and dropper cap.

Fluidasa Injectable. Package containing 10 ampoules of 5 ml.

This leaflet was approved in March 2011

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.es/