ACETYLCYSTEINE AUROVITAS 200 mg EFFERVSCENT TABLETS
How to use ACETYLCYSTEINE AUROVITAS 200 mg EFFERVSCENT TABLETS
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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
Leaflet:information for the user
Acetylcysteine Aurovitas 200 mg effervescent tablets EFG
Read the entire leaflet carefully before starting to take this medication,as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any doubts, consult your doctor, pharmacist, or nurse.
- 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, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What is Acetylcysteine Aurovitas and what is it used for
- What you need to know before taking Acetylcysteine Aurovitas
- How to take Acetylcysteine Aurovitas
- Possible side effects
5 Conservation of Acetylcysteine Aurovitas
- Package contents and additional information
1. What is Acetylcysteine Aurovitas and what is it used for
Acetylcysteine Aurovitas contains the active ingredient acetylcysteine, which liquefies the viscous mucus of the respiratory tract.
Acetylcysteine is used to expelmucus and relievecoughin cases of colds in adults, adolescents, and children from 2 years of age.
2. What you need to know before taking Acetylcysteine Aurovitas
Do not take Acetylcysteine Aurovitas
- if you are allergicto acetylcysteine or any of the other components of this medication (listed in section 6).
- Do not administer to children under 2 years of age.
- Children and pregnant women with phenylketonuria should not take this medication (phenylketonuria is a congenital metabolic error).
Warnings and precautions
Consult your doctor or pharmacist before starting to take acetylcysteine.
- Bronchial asthma.
If you have bronchial asthma, acetylcysteine should be taken under close medical supervision because it can cause narrowing of the airways (bronchospasm). If you experience such symptoms, stop using acetylcysteine immediately.
- Past or current stomach or intestinal ulcers.
If you have or have had a peptic ulcer, as acetylcysteine can irritate the gastric lining. Especially if you use other medications that irritate the gastric lining.
- Changes in skin and mucous membranes.
Very rarely, serious skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been reported in relation to the use of acetylcysteine. If new changes in the skin and mucous membranes occur, you should consult a doctor without delay and stop using acetylcysteine.
- As the thick phlegm becomes more fluid, its volume will increase, especially at the start of treatment. If you cannot cough up this fluid phlegm efficiently, you should consult a doctor so that appropriate measures can be taken to remove the phlegm.
- Hypersensitivity to histamine.
Long-term treatment should be avoided in these patients, as this medication influences histamine metabolism and may cause intolerance symptoms (e.g., headache, nasal discharge, itching).
- Inability to expectorate mucus
Mucolytics may obstruct the airways of children under 2 years of age due to their characteristics and limited ability to cough up sputum. Therefore, children under 2 years of age should not use mucolytics.
Other medications and Acetylcysteine Aurovitas
Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.
This applies particularly to:
- Cough suppressants
The combined use of acetylcysteine with cough suppressants may cause a dangerous accumulation of secretion due to the reduction of the cough reflex. A particularly careful diagnosis is required for this combined treatment. It is essential that you ask your doctor before using this combination.
- Antibiotics
Experimental studies show evidence of a weakening effect of antibiotics (tetracyclines, aminoglycosides, penicillins) due to acetylcysteine. For safety reasons, antibiotics should be taken separately and with an interval of at least 2 hours. This does not apply to medications with the active ingredients cefixime or loracarbef. These can be taken with acetylcysteine at the same time.
- Activated charcoal
- Glyceryl trinitrate: a medication also known as nitroglycerin, used to dilate blood vessels.
Your doctor will monitor if you have low blood pressure, which could be severe and could be detected by headache.
- Carbamazepine
When used at the same time as carbamazepine, the effects of carbamazepine may be reduced due to the decrease in plasma levels.
Laboratory tests
Tell your doctor that you are taking acetylcysteine if you need a test for:
may affect the determination of:
- Salicylates: medications for treating pain, inflammation, or rheumatism,
- ketone bodies in urine.
Pregnancy andbreastfeeding
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.
Pregnancy
Since there is not enough experience with the use of this medication in pregnant women, you should only use acetylcysteine during pregnancy if your doctor considers it absolutely necessary.
Breastfeeding
There is no information available on the excretion of acetylcysteine in breast milk. You should
therefore use this medication during breastfeeding only if your doctor considers it absolutely necessary.
Driving and using machines
the influence of this on the ability to drive or use machines is not known.
Acetylcysteine Aurovitascontains lactose
If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
Acetylcysteine Aurovitascontains aspartame
This medication contains 3 mg of aspartame in each effervescent tablet.
Aspartame (E951) contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.
Acetylcysteine Aurovitas contains sodium
This medication contains 23.274 mg of sodium (main component of table/cooking salt) in each effervescent tablet. This is equivalent to 1.17% of the maximum recommended daily intake of sodium for an adult.
3. How to take Acetylcysteine Aurovitas
Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.
The recommended dose, unless your doctor prescribes otherwise, is:
Adults and children over 7 years: 1 effervescent tablet 3 times a day.
Children from 2 to 7 years: 1 effervescent tablet 2 times a day.
Method of administration
Dissolve the effervescent tablet in half a glass of water and drink the solution immediately.
It is recommended that patients who have difficulty expelling phlegm (elderly and debilitated patients) take the effervescent tablet in the morning.
Duration of treatment
Do not use this medication for more than 14 days without consulting your doctor.
If your symptoms worsen or do not improve after 4-5 days, you should consult your doctor.
If you take moreAcetylcysteine Aurovitasthan you should
In case of overdose, stomach and intestinal irritations may occur, such as abdominal pain, nausea, vomiting, diarrhea.
To date, no serious side effects or symptoms of intoxication have been observed, even in the case of massive overdose. However, if an overdose with acetylcysteine is suspected, please inform your doctor.
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 Acetylcysteine Aurovitas
Do not take a double dose to make up for forgotten doses. Simply take your next dose at the usual time.
If you have any other doubts 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.
Stop taking Acetylcysteine Aurovitas and contact your doctorif signs of allergy or a severe skin reaction appear.
Uncommon(may affect up to 1 in 100 people)
- Allergic reactions.
Very rare(may affect up to 1 in 10,000 people)
- Severe allergic reactions, including shock.
- Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Other possible side effects may occur with the following frequencies:
Uncommon(may affect up to 1 in 100 people)
- Headache.
- Fever.
- Inflammation of the inner lining of the mouth.
- Abdominal pain.
- Nausea, vomiting.
- Diarrhea.
- Ringing or buzzing in the ears.
- Accelerated heartbeats.
- Reduced blood pressure.
- Itching, hives, skin rash.
- Generalized rash.
- Severe, mostly painful, inflammation of the deep layers of the skin, mainly on the face.
Rare(may affect up to 1 in 1,000 people)
- Difficulty breathing.
- Bronchospasm - predominantly in patients with hyperreactive bronchial system in the presence of bronchial asthma.
- Indigestion.
Very rare(may affect up to 1 in 10,000 people)
- Bleeding.
Frequency not known(frequency cannot be estimated from available data)
- Inflammation of the tissue in the face caused by excess fluid.
- Reduction of blood platelet accumulation.
Reporting side effects
If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this 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. Conservation of Acetylcysteine Aurovitas
Keep this medication out of sight and reach of children.
Do not use this medication after the expiration date shown on the strips and packaging after CAD. The expiration date is the last day of the month indicated.
Store below 30°C.
Keep in the original packaging to protect it from light.
Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.
6. Package contents and additional information
Composition of Acetylcysteine Aurovitas
- The active ingredient is acetylcysteine.
Each effervescent tablet contains 200 mg of acetylcysteine.
- The other components are: Ascorbic acid, citric acid, sodium hydrogen carbonate, crospovidone (Type-B), lactose monohydrate, orange flavor (contains flavoring preparations, flavoring substances, natural flavoring substances, maltodextrin, gum arabic (E 414), butylated hydroxyanisole (E 320)), peppermint flavor (contains flavoring preparations, natural flavoring substances, maltodextrin, gum arabic (E 414)), aspartame (E951), leucine.
Appearance of the product and package contents
Effervescent tablets.
Acetylcysteine Aurovitas 200 mg effervescent tablets EFG:
White, round, beveled tablets, smooth on one side and with a score line on the other side. The tablet can be divided into equal doses.
Acetylcysteine Aurovitas 200 mg effervescent tablets are available in strips (composite film strips - PAPER/AL/PE).
Package sizes:
Strips: 10, 20, 30, and 60 effervescent tablets.
Not all package sizes may be marketed.
Marketing authorization holder and manufacturer
Marketing authorization holder
Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
O
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal
This medication is authorized in the member states of the European Economic Area with the following names:
Belgium: Acetylcysteine AB 200mg bruistabletten / comprimés effervescents / Brausetabletten
Spain: Acetylcysteine Aurovitas 200 mg effervescent tablets EFG
Netherlands: Acetylcysteine Auro 200mg, bruistabletten
Portugal: Acetylcysteine Generis
Date of the last revision of thisleaflet: 05/2022
Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://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 doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to ACETYLCYSTEINE AUROVITAS 200 mg EFFERVSCENT TABLETSDosage form: EFFERVESCENT TABLET, 600 mgActive substance: acetylcysteineManufacturer: Kern Pharma S.L.Prescription not requiredDosage form: EFFERVESCENT TABLET, 600 mgActive substance: acetylcysteineManufacturer: Laboratorios Alter S.A.Prescription requiredDosage form: ORAL SOLUTION/SUSPENSION, 200 mgActive substance: acetylcysteineManufacturer: Aurovitas Spain, S.A.U.Prescription required
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