Acetylcysteine Viatris 200 mg granules for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetylcysteine Viatris 200 mg effervescent granules for oral solution EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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, because 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.

Leaflet contents

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

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

Acetylcysteine, the active substance of this medicine, belongs to a group of medicines called mucolytics.

Acetilcisteína Viatris is used to fluidify excessive and/or thick bronchial secretions. It is indicated as supportive treatment in respiratory conditions associated with hypersecretion, or excessive or thick mucus, such as:

• Acute and chronic bronchitis (inflammation of the bronchi).

• Chronic Obstructive Pulmonary Disease (COPD).

• Emphysema (inflammation of the lung alveoli, leading to reduced respiratory function).

• Atelectasis (reduction in lung volume) due to mucus obstruction: pulmonary complications of cystic fibrosis and other related disorders.

2. What you need to know before you start taking Acetylcysteine Viatris

Do not take Acetylcysteine Viatris:

• If you are allergic to acetylcysteine and its derivatives, or to any of the other components 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 Viatris.

• If you have asthma or suffer from a serious respiratory disease, you should consult your doctor before taking this medicine.
• The possible sulfur-like odor (resembling rotten eggs) of the medicine is characteristic of the active substance and does not indicate that the medicine is in poor condition.
• If you experience stomach discomfort while taking the medicine, stop treatment and consult your doctor or pharmacist. Caution is advised in patients with peptic ulcer or history of peptic ulcer.
• During the first few days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease over the course of treatment.

Children and adolescents

This medicine must not be taken by children under 2 years of age.

Other medicines and Acetylcysteine Viatris

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

• Concomitant therapy with nitroglycerin may cause headache, and hypotension—which may be severe—should be monitored.
• Concomitant administration with the antiepileptic carbamazepine may lead to reduced 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 containing antibiotics such as amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and certain tetracyclines, separate their administration from Acetylcysteine by at least 2 hours.

Dissolving acetylcysteine with other medicines is not recommended.

Taking Acetylcysteine Viatris with food and drinks

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might 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 use of machines

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

Acetylcysteine Viatris contains sodium, sulfites and benzyl alcohol

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; hence, it is essentially “sodium-free”.

This medicine contains up to 0.006 mg of sulfites in each sachet. Sulfites may rarely cause severe hypersensitivity reactions and bronchospasm.

This medicine contains 0.012 mg of benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of adverse effects including respiratory problems (“gasping syndrome”) in children.

This product should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

3. How to take Acetylcysteine Viatris

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

Remember to take your medicine.

Acetylcysteine Viatris is administered orally. The contents of the sachets must be dissolved in a sufficient amount of water and taken once completely dissolved.

Your doctor will indicate the duration of treatment with acetylcysteine.

The recommended dose is:

• Adults and children over 7 years: 200 mg (1 sachet), 3 times daily every 8 hours. Do not exceed a daily dose of 600 mg (3 sachets) per day.

Use in children and adolescents

• For children aged between 2 and 7 years: The recommended doses are lower and this formulation is not suitable, although this formulation may be used in cases of pulmonary complications of cystic fibrosis.

In case of pulmonary complications of cystic fibrosis, the recommended average dose of acetylcysteine is as follows:

• Adults and children over 7 years: from 200 mg (1 sachet) to 400 mg (2 sachets) of acetylcysteine every 8 hours.
• Children between 2 and 7 years: 200 mg (1 sachet) of acetylcysteine every 8 hours.

If you take more Acetylcysteine Viatris than you should

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

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

If you forget to take Acetylcysteine Viatris

Do not take a double dose to make up for missed doses. Take the missed dose as soon as possible. However, if it is almost time for your next dose, wait until then and continue your regular dosing schedule.

If you stop taking Acetylcysteine Viatris

Do not stop treatment prematurely, as otherwise you will not achieve the intended effect.

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 can 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 reaction, anaphylactic shock, haemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell's 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 skin or mucous membrane changes occur, 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 Acetylcysteine Viatris

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 CAD or EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Acetylcysteine Viatris

• The active substance is acetylcysteine. Each sachet contains 200 mg of acetylcysteine.
• The other components are mannitol (E-421), sodium saccharin, anhydrous colloidal silica, orange flavour (containing sulfites, benzyl alcohol), and beta-carotene.

Appearance of the medicine and contents of the pack

Acetylcysteine Viatris is supplied in sachets made of paper and aluminium with an inner polyethylene coating. It is available in packs containing 30 sachets.

Marketing Authorisation Holder

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer

Farmasierra Manufacturing, S.L.

Carretera N-1, Km 26,200

28700 - San Sebastián de los Reyes (Madrid)

Spain

Date of the most recent revision of this leaflet: October 2023

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