NORMOFLUDIL FORTE 600 mg DISPERSIBLE TABLETS

Introduction

Patient Information Leaflet

Normofludil

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

Contents of the Leaflet:

1. What Normofludil forte is and what it is used for
2. What you need to know before taking Normofludil forte
3. How to take Normofludil forte
4. Possible side effects
5. Storage of Normofludil forte
6. Package contents and additional information

1. What Normofludil forte is and what it is used for

Acetylcysteine, the active ingredient of this medication, belongs to a group of medications called mucolytics, which act by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.

This medication is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, for adults.

You should consult a doctor if your condition worsens or does not improve after 5 days.

2. What you need to know before taking Normofludil forte

Do not take Normofludil forte

• If you are allergic to acetylcysteine or any of the other components of this medication (listed in section 6).
• Do not administer to children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Normofludil forte.

• If you have asthma or a severe respiratory disease, you should consult your doctor before taking this medication.
• The possible sulfur-like odor (like rotten eggs) of the medication is characteristic of the active ingredient, but it does not indicate that the medication is in poor condition.
• If you experience stomach discomfort when taking the medication, you should stop treatment and consult your doctor or pharmacist. Caution is recommended in patients with peptic ulcer or a history of peptic ulcer.
• During the first days of treatment, you may notice an increase in mucus and phlegm, which will decrease throughout the treatment.

Children and adolescents

Children and adolescents should not take this medication. There are other presentations more suitable for this population.

Other medications and Normofludil forte

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Concomitant therapy with nitroglycerin may cause headache and blood pressure control is recommended, as hypotension may be severe.

Concomitant administration with the antiepileptic carbamazepine may decrease the efficacy of carbamazepine.

Do not administer concomitantly with antitussive medications (for cough) or those that decrease bronchial secretions (such as antihistamines and anticholinergics), as this may cause an accumulation of fluidified mucus.

When taking any medication containing minerals such as iron or calcium, or any medication with antibiotics (such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you should separate the intake of Normofludil forte by at least 2 hours. It is not recommended to dissolve Normofludil forte with other medications.

Taking Normofludil forte with food and beverages

The intake of food and beverages does not affect the efficacy of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Its use should be avoided during breastfeeding.

Driving and using machines

There is no evidence of effects on the ability to drive and use machines.

Normofludil forte contains aspartame

This medication contains 35 mg of aspartame per tablet.

Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Normofludil forte

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

In adults: One tablet, once a day. Do not exceed the dose of one tablet per day.

Normofludil forte is taken orally.

Dissolve 1 dispersible tablet in a glass of water. Stir with a spoon before administration. The resulting solution is taken directly from the glass.

It is recommended to drink plenty of liquid throughout the day.

You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.

Use in children and adolescents

Children and adolescents should not take this medication. There are other presentations more suitable for this population.

If you take more Normofludil forte than you should

If you take more acetylcysteine than you should, you may notice: nausea, vomiting, burning and stomach pain, diarrhea, or any other adverse effect described in section 4.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

If you forget to take Normofludil forte

Do not take a double dose to make up for forgotten doses. In case of forgetting a dose, wait for the next one.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

The following side effects may occur:

Uncommon (may affect up to 1 in 100 patients): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, pruritus, increased body temperature, hypotension.

Rare (may affect up to 1 in 1,000 patients): somnolence, bronchospasm, respiratory distress, gastrointestinal disorders.

Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, hemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with the concomitant use of another medication.

Frequency not known (cannot be estimated from available data): facial swelling.

In case of any alteration in the skin or mucous membranes, the administration of acetylcysteine should be stopped immediately and medical assistance should be sought.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRam.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Normofludil forte

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions. Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Normofludil forte

• The active ingredient is acetylcysteine. Each tablet contains 600 mg of acetylcysteine.
• The other components (excipients) are: microcrystalline cellulose, hydroxypropylcellulose, crospovidone, aspartame (E-951), calcium carbonate, lemon flavor, orange flavor, and magnesium stearate.

Appearance of the product and package size:

White or almost white, round, flat, and beveled tablets.

Normofludil forte is available in packages of 20 dispersible tablets.

Marketing authorization holder and manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last revision of this leaflet:January 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.