Fluidasa 5 mg/ml oral solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FLUIDASA 5 mg/ml oral solution

Mepifilin (mepyramine acefyllinate)

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 and you should not give it to other people, even if they have the same symptoms, as it may 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:

1. What Fluidasa Solution is and what it is used for
2. Before taking Fluidasa Solution
3. How to take Fluidasa Solution
4. Possible side effects
5. Storage of Fluidasa Solution
6. Further information

1. What FLUIDASA SOLUTION is and what it is used for

This medicine contains mephylline, which belongs to the group of medicines called antihistamines.

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

2. Before taking FLUIDASA SOLUTION

Do not take Fluidasa Solution if:

• You are allergic (hypersensitive) to mephylline or to any of the other components of Fluidasa Solution.
• You have any liver disease.
• You have urinary bladder obstruction.
• You have symptomatic prostatic hypertrophy or urinary retention.
• You have closed-angle glaucoma.
• You have fructose intolerance, as this medicine contains a sugar called sorbitol.

Take special care with Fluidasa Solution:

• 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 an increased tendency to seizures.

Use of other medicines:

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

In particular, inform your doctor if you are taking the following medicines, as they may enhance some of their effects:

• Medicines belonging to the anticholinergic group (e.g. some 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 testing, it is recommended to stop taking Fluidasa Solution at least 72 hours before the test, as it may lead to false-negative results (negative results that are actually positive).

Taking Fluidasa Solution with food and drinks:

Avoid consuming alcoholic beverages while taking this medicine, as it may enhance the effects of alcohol.

Pregnancy and breastfeeding:

The use of Fluidasa Solution is not recommended during pregnancy.

The use of Fluidasa Solution is not recommended during breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery:

Fluidasa Solution may cause drowsiness, affecting mental and/or physical abilities. If you experience these effects, avoid driving vehicles or operating machinery.

Important information about some of the components of Fluidasa Solution:

This medicine contains sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine. It may cause a mild laxative effect, as it contains 4 g of sorbitol per 15 ml dose.

Calorific value: 2.6 kcal/g of sorbitol.

It may cause allergic reactions (possibly delayed), as it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

3. How to take FLUIDASA SOLUTION

Fluidasa Solution is administered orally.

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

Consult your doctor or pharmacist if you have any doubts.

One 5 ml spoonful contains approximately 25 mg of mepifilin, and one 15 ml spoonful contains 75 mg of mepifilin.

The usual average dose is 8 mg per kg of body weight per day, with the total daily dose divided into 4 doses. The maximum dose is 18 mg per kg of body weight per day, with the total daily dose divided into 4 doses.

The usual dose, as a guideline and according to body weight, is as follows:

• Children under 5 years: 5 to 10 ml of solution, 3 or 4 times daily.
• Children over 5 years: 10 to 15 ml of solution, 3 or 4 times daily.
• Adults: 15 to 30 ml (one or two 15 ml spoonfuls) of solution, 4 times daily.

Instructions for correct administration

Measure the required amount of medication using the dosing cup provided, which is marked with 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 indicating your prescribed dose. After use, wash the dosing cup with water.

In infants, Fluidasa Drops are recommended.

If you feel that 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 prescribed, consult your doctor or pharmacist immediately.

In cases of overdose, symptoms of anticholinergic effects may occur, such as clumsiness, unsteadiness, deep sleep, dry mouth, nose or throat, flushing or redness, changes in the normal heart rhythm, central nervous system depression (hallucinations), or low blood pressure. In children, stimulant effects of the central nervous system due to anticholinergic activity are more likely.

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

If you forget to take Fluidasa Solution:

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

Take your missed dose as soon as possible and continue taking your medication at the times indicated by your doctor.

4. Possible adverse effects

Like all medicines, Fluidasa Solution may have adverse effects, although not everyone experiences them.

The adverse effects observed are:

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 (dyscrasias) 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 effects 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 SOLUTION

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Fluidasa solution after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Additional Information

Composition of Fluidasa solution

• The active substance is: mepifilin (acefilinato mepiramina). Each ml of solution contains 5 mg of mepifilin.
• The other components are: sodium saccharin, sorbitol (E-420), methyl p-hydroxybenzoate (E-218), propyl p-hydroxybenzoate (E-216), vanilla flavor, and purified water.

Appearance of the product and contents of the container

Amber glass bottle containing 250 ml of clear oral solution, accompanied by a 15 ml dosing cup.

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

27100 Pavia – Italy

Other presentations

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

Fluidasa Capsules. Pack containing 20 capsules.

Fluidasa Injectable. Package containing 10 vials of 5 ml each.

This patient information leaflet was approved in July 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/