Normofludil Forte 600 mg dispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: patient information

Normofludil®forte 600 mg dispersible tablets acetylcysteine

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

• You should consult a doctor if you worsen or do not improve after 5 days.

Leaflet contents:

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 adverse effects
5. How to store Normofludil forte
6. Contents of the pack and other information

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

Acetylcysteine, the active substance in this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, making it less thick and helping its removal.

This medicine is indicated to help remove excess mucus and phlegm in colds and flu, for adults.

You should consult a doctor if you worsen or do 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 ingredients of this medicine (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 suffer from a serious respiratory disease, you should consult your doctor before taking this medicine.
• The possible sulphurous odour (like rotten eggs) of the medicine is characteristic of the active substance and does not indicate that the medicine is spoiled.
• If you experience stomach discomfort while taking the medicine, you should stop treatment and consult your doctor or pharmacist. Caution is advised in patients with peptic ulcer or a history of peptic ulcer.
• During the first few days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease during the course of treatment.

Children and adolescents

Children and adolescents should not take this medicine. There are other formulations more suitable for this population.

Other medicines and Normofludil forte

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

Concomitant therapy with nitroglycerin may cause headache and the occurrence of hypotension, which may be severe, should be monitored.

Concomitant administration with the antiepileptic carbamazepine may lead to a reduction in the efficacy of carbamazepine.

Do not administer simultaneously with antitussive medicines (for cough) or those that reduce bronchial secretions (such as antihistamines and anticholinergics), as this may cause accumulation of liquefied mucus.

When taking medicines containing minerals such as iron or calcium, or medicines containing antibiotics such as (amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you should separate the administration of these medicines from Normofludil forte by at least 2 hours. Dissolving Normofludil forte with other medicines is not recommended.

Taking Normofludil forte with food and drink

Taking this medicine with food and drink does not affect its efficacy.

Pregnancy and breastfeeding

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

Its use should be avoided during breastfeeding.

Driving and using machines

There is no evidence of effects on the ability to drive or operate machinery.

Normofludil forte contains aspartame

This medicine contains 35 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Normofludil forte

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

In adults: One tablet once daily. 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 should be taken directly from the glass.

It is recommended to drink plenty of fluids 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

This medicine must not be used in children and adolescents. There are other formulations more suitable for this population.

If you take more Normofludil forte than you should

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

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

If you forget to take Normofludil forte

Do not take a double dose to make up for a missed dose. If you miss a dose, wait until the next scheduled dose.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects may occur:

Uncommon (may affect up to 1 in 100 patients): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhoea, 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, breathing difficulty, gastrointestinal discomfort.

Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, haemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes reported with concomitant use of at least one other medicinal product.

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

If any changes occur in the skin or mucous membranes, administration of acetylcysteine must be stopped immediately and medical advice sought.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRam.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Normofludil forte

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

This medicine does not require any special storage conditions. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Normofludil forte

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

Appearance of the product and pack size:

White or almost white, round, flat, bevelled tablets.

Normofludil forte is available in packs containing 20 dispersible tablets.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: January 2023

Detailed 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/.