Acetylcysteine Normon 600 mg dispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylcysteine Normon 600 mg dispersible tablets EFG

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

• 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 only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Acetylcysteine Normon is and what it is used for
2. What you need to know before taking Acetylcysteine Normon
3. How to take Acetylcysteine Normon
4. Possible side effects
5. How to store Acetylcysteine Normon
6. Contents of the pack and other information

1. What Acetilcisteína Normon is and what it is used for

Acetylcysteine, the active substance of this medicine, belongs to a group of medicines called mucolytics and is used to liquefy excessive and/or thick bronchial secretions.

Acetilcisteína Normon is indicated to facilitate the elimination of excess mucus and phlegm in respiratory conditions characterized by excessive or thick mucus secretion, such as acute and chronic bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, pulmonary complications of fibrosis, and other related pathologies.

2. What you need to know before starting Acetylcysteine Normon

Do not take Acetylcysteine Normon

• If you are allergic to acetylcysteine or to 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 Acetylcysteine Normon:

If you have asthma or suffer from a serious respiratory disease, you should consult your doctor before taking this medicine.

The possible sulfurous odor (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, stop treatment and consult your doctor. Caution is advised 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 gradually decrease during the course of treatment.

Use with caution in long-term treatment of patients with histamine intolerance.

Children

This medicine is contraindicated in children under 2 years of age.

Other medicines and Acetylcysteine Normon

Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 take together 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 with antibiotics such as (amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines), separate their administration from acetylcysteine by at least 2 hours.

Dissolving acetylcysteine with other medicines is not recommended.

Taking Acetylcysteine Normon with food and drink

Taking food and drink does not affect the effectiveness of this medicine.

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.

Acetylcysteine Normon contains aspartame

This medicine contains 35 mg of aspartame per tablet.

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

3. How to take Acetylcysteine Normon

Follow exactly the instructions for use of this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The dispersible tablets must be dissolved in a glass of water and should be taken once completely dissolved. It is recommended to drink plenty of fluids throughout the day.

The recommended daily dose for adults and children over 7 years of age is 600 mg of acetylcysteine: 1 tablet of Acetylcysteine Normon 600 mg once daily (600 mg of acetylcysteine once daily), or 3 doses of 200 mg every 8 hours (for this latter option, other more suitable formulations are available), without exceeding the daily dose of 600 mg.

Use in children

Children between 2 and 7 years of age:

The 600 mg dose is not recommended.

Other more suitable formulations are available for administration to this population.

It is contraindicated in children under 2 years of age.

If you take more Acetylcysteine Normon than you should

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

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience 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 identified with at least the concomitant use of another medicinal product.

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

If any changes occur in the skin or mucous membranes, acetylcysteine administration 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 Acetylcysteine Normon

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. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acetylcysteine Normon

• The active substance is acetylcysteine. Each dispersible tablet contains 600 mg of acetylcysteine.
• The other components (excipients) are: microcrystalline cellulose, hydroxypropylcellulose (E-463), crospovidone, aspartame (E-951), calcium carbonate (E-170), lemon flavour, orange flavour, and magnesium stearate.

Appearance of the product and contents of the pack

Acetylcysteine Normon 600 mg are white or almost white, round, flat, bevelled dispersible tablets.

Acetylcysteine Normon is available in blister packs containing 20 or 30 dispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation 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: April 2021

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging.

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85923/P_85923.html