PATIENT INFORMATION LEAFLET

FLUIDASA 5 mg/ml oral solution

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 you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

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

Do not take Fluidasa Solution:

• If you are allergic (hypersensitive) to mepifilina or any of the other components of Fluidasa Solution.
• 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.
• If you have fructose intolerance because this medication contains a sugar called sorbitol.

Be especially careful with Fluidasa Solution:

• If you are sensitive to antihistamines (allergy medications) since patients sensitive to one antihistamine may be sensitive to others.
• If you are an elderly patient since 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 they need to discontinue the medication.
• 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 to relieve spasms or contractions of the stomach, intestines, or bladder)
• Medications used to treat depression, such as monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, or maprotiline.
• If skin allergy tests are to be performed, it is recommended to discontinue the administration of Fluidasa Solution at least 72 hours before starting the test, as it may give falsely negative results (negative results that are actually positive).

Fluidasa Solution with food and beverages:

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

Pregnancy and lactation

Do not recommend taking Fluidasa Solution during pregnancy.

Do not recommend taking Fluidasa Solution during lactation.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines:

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

Important information about some of the components of Fluidasa Solution

This medication contains sorbitol. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. It may produce a mild laxative effect because it contains 4 g of sorbitol per 15 ml dose.

Caloric value: 2.6 kcal/g of sorbitol.

It may produce allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

Fluidasa Solution is administered orally.

Follow exactly the administration instructions for Fluidasa Solution indicated by your doctor.

Consult your doctor or pharmacist if you have doubts.

1 measure of 5 ml contains approximately 25 mg of mepifilina and 1 measure of 15 ml contains 75 mg of mepifilina.

The normal average dose is 8 mg per kg of weight per day, divided into 4 doses. The maximum dose is 18 mg per kg of weight per day, divided into 4 doses.

The normal dose, as a guide and in relation to weight, is as follows:

- Children under 5 years: 5 to 10 ml of the solution, 3 or 4 times a day.

- Children over 5 years: 10 to 15 ml of the solution, 3 or 4 times a day.

- Adults: 15 to 30 ml (one or two measures of 15 ml) of the solution, 4 times a day.

Instructions for correct administration

Take the amount of medication to be taken using the dosing cup that has the following measurements: 2.5 ml, 5 ml, 7.5 ml, 10 ml, and 15 ml. Fill it with the solution up to the line that indicates your dose. After use, wash the dosing cup with water

Ininfantsit is recommended to use Fluidasa Drops.

If you think the effect of Fluidasa Solution is too strong or too weak, consult your doctor or pharmacist.

If you take more Fluidasa Solution than you should:

If you have taken more Fluidasa Solution than you should, consult your doctor or pharmacist immediately.

In cases of overdose, symptoms of anticholinergic effects such as clumsiness, instability, intense sleep, dry mouth, nose, or throat, suffocation or redness, variations in the normal heart rhythm, depression of the Central Nervous System (hallucinations), low blood pressure. In children, anticholinergic effects on 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 Solution:

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 Solution may have adverse effects, although not everyone will 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 is apossibleadverse effect not listed 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 on 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 solution 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 the SIGRE collection point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.This will help protect the environment.

Fluidasa Solution Composition

• The active ingredient is: mepifilina (mepiramina acefilinato). Each ml of solution contains 5 mg of mepifilina.
• The other components are: sodium saccharin, sorbitol (E-420), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), vanilla essence and purified water.

Product Appearance and Packaging Content

Topaz bottle containing 250 ml of transparent oral solutionaccompanied by a 15 ml dosing cup

Marketing Authorization Holder and Manufacturer Responsible:

Marketing Authorization Holder:

Teofarma, S.r.l.

Via F. Lli Cervi, 8

27010 Valle Salimbene (PV) – Italy

Manufacturer Responsible:

Teofarma S.r.l.

Viale Certosa, 8/A

27100 Pavia – Italy

Other Presentations

Fluidasa Drops. Bottle of 30 ml oral solution with dropper.

Fluidasa Capsules. Package of 20 capsules.

Fluidasa Injectable. Package containing 10 ampoules of 5 ml.

This leaflet was approved in July 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/