Label: information for the user

Acetilcisteine Viatris 200 mg oral powder for oral solution EFG

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

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you and should not be given to others, even if they have the same symptomsas you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

The active ingredient of this medication, Acetilcisteína, belongs to a group of medications known as mucolitics.

Acetilcisteína Viatris is used to thin out excessive and/or thick bronchial secretions. It is indicated for the supportive treatment of respiratory processes that involve excessive or thick mucus, such as:

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

- Atelectasis (reduction of lung volume) due to mucosal obstruction: pulmonary complications of cystic fibrosis and other related pathologies.

Do not take Acetilcisteína Viatris:

• If you are allergic to acetilcisteine and its derivatives, or to any of the other components of this medication (listed in section 6).
• Do not administer to children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeAcetilcisteínaViatris.

• If you are asthmatic or have a severe respiratory disease,you should consult with your doctor before taking this medication.
• The possible sulfurous smell (like rotten eggs) of the medication is due to the active ingredient, but it does not indicate that the medication is in poor condition.
• If you experience stomach discomfort while taking the medication, discontinue treatment and consult your doctoror pharmacist. Caution is recommended for patients with peptic ulcers or a history of peptic ulcers
• During the first few days of treatment, you may observe an increase in mucus and phlegm, which will decrease over time.

Children and adolescents

This medication cannot be taken by children under 2 years old.

Other medications and Acetilcisteína Viatris

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

• Concomitant therapy with nitroglycerin may cause headaches and hypotension, which can be severe.

• Concomitant administration with the antiepileptic carbamazepine may reduce the efficacy of carbamazepine.

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

• When taking medications containing minerals such as iron or calcium, or antibiotics such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate your intake of Acetilcisteine by at least 2 hours.

Do not dissolve acetilcisteine with other medications.

Acetilcisteína Viatris with food and beverages

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

Pregnancy, lactation, and fertility

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

It is recommended to avoid taking this medication during lactation.

Driving and operating machinery

There is no evidence of effectson the ability to drive and operate machinery.

Acetilcisteína Viatris contains sodium, sulfites, and benzyl alcohol

This medication containsless than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

This medication contains up to 0.006 mg of sulfites per dose. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

This medication contains 0.012 mg of benzyl alcohol per dose. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked to the risk of adverse effects that include respiratory problems (“breathing difficulty”) in children.

This product should not be used for more than one week in children under 3 years of age unless instructed 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).

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

Remember to take your medication.

Acetilcisteína Viatris is administered orally. The contents of the packets should be dissolved in sufficient water and should be ingested when it has completely dissolved.

Your doctor will indicate the duration of treatment with acetilcisteína.

The recommended dose is:

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

Use in children and adolescents

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

In cases of pulmonary complications of cystic fibrosis, the recommended average dose of acetilcisteína is as follows:

• Adults and children over 7 years: 200 mg (1 packet) to 400 mg (2 packets) of acetilcisteína every 8 hours.
• Children aged 2 to 7 years: 200 mg (1 packet) of acetilcisteína every 8 hours.

If you take more Acetilcisteína Viatris than you should

If you take more acetilcisteína than you should, you may notice: nausea, vomiting, heartburn 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Acetilcisteína Viatris

Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as possible. However, if there is little time left for the next dose, wait until then to continue treatment.

If you interrupt the Acetilcisteína Viatris treatment

Do not stop treatment before, as this will not achieve the desired effect.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects may occur:

Rarely(may affect up to 1 in 100 patients):

Hyper sensitivity, headache, tinnitus, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, pruritus, increased body temperature, hypotension.

Uncommon(may affect up to 1 in 1,000 patients):

Drowsiness, bronchospasm, respiratory difficulty, digestive discomfort.

Very Rare(may affect up to 1 in 10,000 patients):

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

Unknown Frequency(cannot be estimated from available data):

Swelling of the face.

In case of any alteration in the skin or mucous membranes, discontinue acetilcysteine administration immediately and seek medical assistance.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Acetilcisteína Viatris

- The active ingredient is acetilcisteína.Cada sobre contains 200 mg ofacetilcisteína.

-The other components are manitol (E-421), sacarina sódica, sílice coloidal anhidra, aroma de naranja (sulfitos, alcohol bencílico) and beta-caroteno.

Appearance of the product and content of the packaging

Acetilcisteína Viatris is packaged in paper and aluminum blisters with an internal polyethylene coating. It is presented in containers that contain 30 blisters.

Holder of the marketing authorization

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing

Farmasierra Manufacturing, S.L.

Carretera N-1, Km26,200

28700 -San Sebastián de los Reyes (Madrid)

Spain

Last review date of this leaflet:October 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/