ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Viatris Acetylcysteine 200 mg Granules for Oral Solution EFG

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

Viatris Acetylcysteine is used to make bronchial secretions more fluid and easier to cough up. It is indicated as a supportive treatment for respiratory processes with hypersecretion, excessive or thick mucus, such as:

• Acute and chronic bronchitis (inflammation of the bronchi).
• Chronic Obstructive Pulmonary Disease (COPD).
• Pulmonary emphysema (inflammation of the lung alveoli, which reduces respiratory function).

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

2. What you need to know before taking Viatris Acetylcysteine

Do not take Viatris Acetylcysteine:

• 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

Talk to your doctor or pharmacist before starting to take Viatris Acetylcysteine.

• If you have asthma or a severe respiratory disease, you should consult your doctor before taking this medicine.
• The possible sulfurous smell (like rotten eggs) of the medicine is characteristic of the active substance, but it does not mean that the medicine is in poor condition.
• If you experience stomach discomfort when taking the medicine, stop treatment and consult your doctor or pharmacist. Caution is recommended 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 decrease as treatment progresses.

Children and adolescents

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

Other medicines and Viatris Acetylcysteine

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

• Concomitant therapy with nitroglycerin may cause headache and hypotension should be monitored, which can be severe.

• Concomitant administration with the antiepileptic carbamazepine may cause a decrease in the efficacy of carbamazepine.

• Do not take concomitantly with antitussive medicines (for cough) or those that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidized mucus.

• When taking any medicine that contains minerals such as iron or calcium, or any medicine with antibiotics such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate the intake of Viatris Acetylcysteine by at least 2 hours.

It is not recommended to dissolve acetylcysteine with other medicines.

Taking Viatris Acetylcysteine with food and drinks

Taking food and drinks does not affect the efficacy of this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

Viatris Acetylcysteine contains sodium, sulfites, and benzyl alcohol

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

This medicine contains up to 0.006 mg of sulfites in each sachet. Rarely, it can 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 linked to 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 advised by your doctor or pharmacist.

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

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

3. How to take Viatris Acetylcysteine

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine.

Viatris Acetylcysteine is administered orally. The contents of the sachets should be dissolved in sufficient water and ingested 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 a day, every 8 hours. Do not exceed the dose of 600 mg (3 sachets) per day.

Use in children and adolescents

• For children between 2 and 7 years: The recommended doses are lower, and this presentation is not suitable, although this presentation can 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 Viatris Acetylcysteine than you should

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

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 medicine and the amount taken.

If you forget to take Viatris Acetylcysteine

Do not take a double dose to make up for forgotten doses. Take the forgotten dose as soon as possible. However, if it is almost time for the next dose, wait until then to continue treatment.

If you stop taking Viatris Acetylcysteine

Do not stop treatment before, as you will not achieve the expected effect.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

Uncommon(may affect up to 1 in 100 people):

Hypersensitivity, headache, ringing in the ears, 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 people):

Somnolence, bronchospasm, respiratory distress, gastrointestinal disorders.

Very rare(may affect up to 1 in 10,000 people):

Allergic reaction, anaphylactic shock, hemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with the concomitant use of another drug.

Frequency not known(cannot be estimated from the available data):

Facial swelling.

If you experience any skin or mucous membrane disorders, you should immediately stop taking acetylcysteine and seek medical attention.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Viatris Acetylcysteine

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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Viatris Acetylcysteine

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

Appearance of the product and pack contents

Viatris Acetylcysteine is available in paper and aluminum sachets with an internal polyethylene coating. It is presented in packs containing 30 sachets.

Marketing authorization holder

Viatris Pharmaceuticals, S.L.U.

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 last revision of this package leaflet:October 2023

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