ACETYLCYSTEINE VIATRIS 600 mg EFFERVSCENT GRANULES
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Introduction
Package Leaflet: Information for the User
Viatris Acetylcysteine 600 mg Effervescent Granules
Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.
- Keep this package leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medication has been prescribed to you only and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
Contents of the Package Leaflet
- What Viatris Acetylcysteine is and what it is used for
- What you need to know before taking Viatris Acetylcysteine
- How to take Viatris Acetylcysteine
- Possible side effects
- Storage of Viatris Acetylcysteine
- Package Contents and Additional Information
1. What Viatris Acetylcysteine is and what it is used for
Acetylcysteine, the active ingredient of this medication, belongs to a group of medications called mucolytics.
Viatris Acetylcysteine is used to thin out excessive and/or thick bronchial secretions. It is indicated as a supportive treatment for respiratory processes that involve hypersecretion, 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, which reduces respiratory function).
- Atelectasis (decrease in lung volume) due to mucous obstruction: pulmonary complications of cystic fibrosis and other related conditions.
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 medication (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 Viatris Acetylcysteine.
- If you have asthma or a severe respiratory disease, you should consult your doctor before taking this medication.
- The possible sulfurous odor (like rotten eggs) of the medication is characteristic of the active ingredient, but it does not indicate that the medication is in poor condition.
- If you experience stomach discomfort when taking the medication, 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 over the course of treatment.
Children and Adolescents
This medication should not be taken by children under 2 years of age.
Other Medications and Viatris Acetylcysteine
Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.
- Concomitant therapy with nitroglycerin may cause headache and hypotension should be monitored, which can be severe.
- Concomitant administration with the antiepileptic carbamazepine may decrease the efficacy of carbamazepine.
- Do not take concomitantly with antitussive medications (for cough) or those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of thinned mucus.
- When taking any medication containing minerals such as iron or calcium, or any medication 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 medications.
Taking Viatris Acetylcysteine with Food and Drinks
Taking food and drinks does not affect the efficacy of this medication.
Pregnancy, Breastfeeding, and Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
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, Sulphites, and Benzyl Alcohol
This medication contains 157.3 mg of sodium in each sachet. This is equivalent to 7.87% of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.
This medication contains up to 0.0072 mg of sulphites in each sachet. It can rarely cause severe hypersensitivity reactions and bronchospasm.
This medication contains 0.014 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 indicated by your doctor or pharmacist.
Consult 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).
Consult 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 the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.
Remember to take your medication.
Viatris Acetylcysteine is administered orally. The contents of the sachets should be dissolved in sufficient water and ingested when completely dissolved.
Your doctor will indicate the duration of treatment with acetylcysteine.
The recommended dose is:
Adults and children over 7 years: 600 mg (1 sachet) per day. Do not exceed the dose of 600 mg (1 sachet) per day.
Use in Children
In children under 7 years, the dose of 600 mg is not recommended.
There are other presentations more suitable for this population.
Pulmonary complications of cystic fibrosis:
There are other presentations more suitable for this population.
If you take more Viatris Acetylcysteine than you should
If you take more Viatris 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 medication and the amount ingested.
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 close to the 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 intended effect.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible side effects
Like all medications, this medication can cause side effects, although not everyone will experience them.
The following side effects may occur:
Uncommon(may affect up to 1 in 100 patients):
Hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, urticaria, rash, angioedema, pruritus, increased body temperature, hypotension.
Rare(may affect up to 1 in 1,000 patients):
Somnolence, bronchospasm, respiratory distress, gastrointestinal 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, sometimes identified with the concomitant use of another medication.
Frequency not known(cannot be estimated from available data):
Facial swelling.
If you experience any skin or mucous membrane alterations, you should immediately stop taking acetylcysteine and seek medical attention.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Viatris Acetylcysteine
Keep this medication out of the sight and reach of children.
Do not store above 30°C.
Do not use this medication after the expiration date stated 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Package Contents and Additional Information
Composition of Viatris Acetylcysteine
- The active ingredient is acetylcysteine. Each sachet contains 600 mg of acetylcysteine.
- The other ingredients are mannitol (E-421), sodium saccharin, colloidal anhydrous silica, orange flavor (sulphites, benzyl alcohol, sodium), sodium hydrogen carbonate, citric acid, and maltodextrin.
Appearance of the Product and Package Contents
Viatris Acetylcysteine is packaged in paper and aluminum sachets with an internal polyethylene coating. It is presented in packages containing 20 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 about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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