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ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES

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About the medicine

How to use ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.
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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.

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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/

Online doctors for ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES

Discuss questions about ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
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  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
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  • Preventive consultations and check-up planning.
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  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
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  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
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If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

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  • rashes, allergic reactions, redness, insect bites
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  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

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Dr. Lokchiri’s professional training includes:

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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
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  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
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She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
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Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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Frequently Asked Questions

Is a prescription required for ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES?
ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES?
The active ingredient in ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES is acetylcysteine. This information helps identify medicines with the same composition but different brand names.
Who manufactures ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES?
ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES is manufactured by Viatris Pharmaceuticals S.L.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ACETYLCYSTEINE VIATRIS 200 mg ORAL SOLUTION GRANULES?
Other medicines with the same active substance (acetylcysteine) include ACETYLCYSTEINE ABEX 600 mg EFFERVSCENT TABLETS, ACETYLCYSTEINE ALTER 600 mg EFFERVSCENT TABLETS, ACETYLCYSTEINE AUROVITAS 200 mg EFFERVSCENT TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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