PATIENT INFORMATION LEAFLET

FLUIDASA 150 mg Hard Capsules

Mepifilina (mepiramina acefilinato)

Read this 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 pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

This medication contains mepifilina which belongs to the group of antihistamine medications.

Fluidasa Cápsulas is used for the treatment of bronchospasm in patients with acute and chronic bronchitis(inflammation of the bronchi).

Do not take Fluidasa Capsules:

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

Capsules.

• If you have any liver disease.
• If you have urinary tract obstruction.
• If you have symptomatic prostatic hypertrophy or urinary retention.
• If you have closed-angle glaucoma.

Be especially careful with Fluidasa Capsules:

• If you are sensitive to antihistamines (allergy medications) as patients sensitive to one antihistamine may 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 if the medication needs to be discontinued.
• Do not recommend its use in newborns or premature children, as this age group is more sensitive to some effects of the medication, such as anticholinergic effects (e.g. central nervous system stimulation) and a higher tendency to seizures.

Use of other medications:

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

Especially, inform your doctor if you are using the following medications as they may potentiate some of their effects:

• Medications in the group of anticholinergic medications (e.g. some medications used for the relief of spasms or contractions of the stomach, intestine, or bladder)
• Medications used for the treatment of depression such as monoamine oxidase inhibitors (MAO), tricyclic antidepressants, or maprotiline.
• If skin allergy tests are 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 falsely negative results (negative results that are actually positive).

Fluidasa Capsules intake with food and beverages:

Avoid the consumption of alcoholic beverages during the administration of this medication as it may potentiate the effects of alcohol.

Pregnancy and lactation

Do not recommend taking Fluidasa Capsules during pregnancy.

Do not recommend taking Fluidasa Capsules during lactation.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines:

Fluidasa Capsules may cause drowsiness, altering mental and/or physical ability.If you noticethese effects avoid driving vehicles or operating machines.

Fluidasa Capsules is administered orally.

Follow exactly the administration instructions for Fluidasa Capsules 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; 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 such as clumsiness, instability, intense sleep, dryness of the mouth, nose, or throat, shortness of breath, or flushing, variations in the normal rhythm of the heartbeat, depression of the Central Nervous System (hallucinations), lowering of blood pressure. In children, anticholinergic effects of the CNS are more likely to be stimulating.

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

If you forgot to take Fluidasa Capsules:

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

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

Like all medications, Fluidasa Capsules may have adverse effects, although not everyone may experience them.

The adverse effects found have been:

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

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

Uncommon (in at least 1 in 1000 patients): abnormal or pathological blood conditions (discrepancies) and variations in the normal heart rhythm.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist..

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor, pharmacist, or nurse, even if it ispossibleadverse effects that do not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of reach and sight of children.

Do not store at a temperature above 25°C.

Do not use Fluidasa Capsules after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at your pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.This will help protect the environment.

Composition of Fluidasa Capsules

• The active ingredient is: mepifilina (mepiramina acefilinato). Each capsule contains 150 mg of mepifilina.
• The other components are: magnesium stearate.

Appearance of the product and contents of the package

Blister containing 20 hard white and green capsules.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Teofarma, S.r.l. - Via F. Lli Cervi, 8 – 27010 Valle Salimbene (PV) - Italy.

Responsible for manufacturing:

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.

Fluidasa Injectable. Package containing 10 ampoules of 5 ml.

This leaflet was approved in March 2011

The detailed and updated information on this medication is available on the website of the

Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es//