PATIENT INFORMATION LEAFLET

FLUIDASA 20 mg/ml Oral Solution Drops

Mepifilina (mepiramine acefilinate)

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

Do not take Fluidasa Drops:

• If you are allergic (hypersensitive) to mepifilina or to any of the other components of Fluidasa Drops.
• If you have any liver disease.
• If you have urinary tract obstruction.
• If you have symptomatic benign prostatic hyperplasia or urinary retention.
• If you have closed-angle glaucoma.

Be especially careful with Fluidasa Drops:

• 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 it is more likely that you will experience side effects such as dizziness, sedation, confusion, low blood pressure, dry mouth, or urinary retention. If these side effects are persistent or severe, you should inform your doctor if the medication needs 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 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 Drops at least 72 hours before starting the test, as it may give falsely negative results (negative results that are actually positive).

Fluidasa Drops and food and beverages:

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

Pregnancy and breastfeeding:

It is not recommended to take Fluidasa Drops during pregnancy.

It is not recommended to take Fluidasa Drops during breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery:

Fluidasa Drops may induce drowsiness, so you should refrain from driving or operating hazardous machinery if necessary.

Important information about some of the components of Fluidasa Drops:

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

Fluidasa Drops is administered orally.

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

Consult your doctor or pharmacist if you have any doubts.

1 drop contains approximately 1 mg of mepifilina.

Infants:The usual average dose is 3 mg per kg of body weight per day, divided into 4 doses. In general, as a guideline and in relation to weight, it is equivalent to 3 to 6 drops every 6 hours. The maximum recommended dose is 6 mg per kg of body weight per day, divided into 4 doses.

As a guideline, you can follow the doses in the following table for infants:

Children::The usual average dose is 8 mg per kg of body weight per day, divided into 4 doses. In general, as a guideline and in relation to weight, it is equivalent to 15 to 30 drops every 6 hours.

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

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

As a guideline, you can follow the doses in the following table for children:

If you take more Fluidasa Drops than you should:

If you have taken more Fluidasa Drops 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, shortness of breath, or flushing, variations in the normal heart rhythm, depression of the Central Nervous System (hallucinations), low blood pressure. In children, CNS stimulant anticholinergic effects are more likely.

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

If you forgot to take Fluidasa Drops:

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 Drops 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 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 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 Drops 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.

Composition of Fluidasa Drops

• The active ingredient is: mepifilina (mepiramina acefilinato). Each drop contains approximately 1 mg of mepifilina. 20 drops are equivalent to 1 ml.
• The other components are: sodium saccharin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), vanilla essence, and purified water.

Appearance of the product and contents of the package

Topaz bottle containing 30 ml of transparent oral solution and a dropper cap.

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 Capsules. Package of 20 capsules.

Fluidasa Injectable. Package containing 10 ampoules of 5 ml.

This prospectus was approved in July 2022

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