АКЕТИЛКИСТЕИНА 600 MG Effervescent tablet
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Инструкция по применению AKETILKISTEINA ALTER
Содержание инструкции
ACETILCISTEINA ALTER 600 mg effervescent tablets
N-acetylcysteine
Generic medicine
Read this leaflet carefully before you start taking this medicine as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What ACETILCISTEINA ALTER is and what it is used for
- 2. What you need to know before you take ACETILCISTEINA ALTER
- 3. How to take ACETILCISTEINA ALTER
- 4. Possible side effects
- 5. How to store ACETILCISTEINA ALTER
- 6. Contents of the pack and other information
1. What is ACETILCISTEINA ALTER and what it is used for
ACETILCISTEINA ALTER contains the active ingredient N-acetylcysteine, which belongs to a
group of medicines called mucolytics, used to facilitate the elimination of mucus from the
respiratory tract and to a group of medicines called antidotes used to counteract the toxic effect of
certain substances.
ACETILCISTEINA ALTER is indicated for the treatment of respiratory diseases
characterized by an increase in the production of dense and viscous mucus (dense and
viscous hypersecretion) such as:
- Inflammation of the bronchi (acute bronchitis, chronic bronchitis and its exacerbations);
- pathology of the pulmonary alveoli (pulmonary emphysema);
- cystic fibrosis (mucoviscidosis);
- dilatation of the bronchi (bronchiectasis).
ACETILCISTEINA ALTER is used as an antidote in particular for
- accidental or intentional poisoning with paracetamol, an anti-inflammatory medicine;
- pathology affecting the urinary tract (uropathy) caused by chemotherapeutic drugs such as ifosfamide and cyclophosphamide.
2. What you need to know before taking ACETILCISTEINA ALTER
Do not take ACETILCISTEINA ALTER
- if you are allergic to N-acetylcysteine or any of the other ingredients of this medicine (listed in section 6);
- if you are pregnant or breastfeeding unless after careful evaluation by your doctor (See section “Pregnancy and breastfeeding”). Warnings and precautionsTalk to your doctor or pharmacist before taking ACETILCISTEINA ALTER. Take this medicine with caution and always under the control of your doctor in the following cases:
- if you suffer from an inflammatory disease of the bronchi called bronchial asthma. Stop taking ACETILCISTEINA ALTER immediately if you have constriction of the bronchial muscles (bronchospasm). Also consult your doctor if these disorders have occurred in the past;
- if you are intolerant to histamine, allergic reactions (hypersensitivity) may occur during therapy with ACETILCISTEINA ALTER;
- if you suffer from or have suffered from a problem in the stomach or intestines called a peptic ulcer, especially if you are taking other medicines that can cause problems in the stomach (gastrolesive drugs) together with ACETILCISTEINA ALTER. This medicine may increase the volume of bronchial mucus (bronchial secretions), especially at the beginning of treatment. Therefore, if this occurs and you are unable to eliminate the bronchial secretions (expectorate) through coughing, consult your doctor who will indicate a method for eliminating mucus (postural drainage or bronch aspiration). If you notice a sulfurous odor, do not worry as this does not indicate alteration of the preparation, but is due to N-acetylcysteine. Laboratory tests: N-acetylcysteine may interfere with some blood and urine tests (colorimetric dosage for the determination of salicylates and tests to determine ketones). Tell your doctor that you are taking this medicine before undergoing these tests. Other medicines and ACETILCISTEINA ALTERTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take this medicine if you are taking:
- cough medicines (antitussives), as they can lead to an accumulation of mucus inside the bronchi. Take this medicine with caution and consult your doctor if you are taking any of the following medicines:
- activated charcoal used to treat digestive disorders or to eliminate intestinal gas (flatulence), as it may reduce the effectiveness of ACETILCISTEINA ALTER;
- medicines used for the treatment of infections (antibiotics) taken orally (with the exception of loracarbef). Take these medicines at least two hours apart from ACETILCISTEINA ALTER;
- nitroglycerin, used for some heart disorders. The use of this medicine at the same time as ACETILCISTEINA ALTER may cause a decrease in blood pressure (hypotension) and headache. In this case, your doctor will monitor you closely. Pregnancy and breastfeedingIf you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Take this medicine if you are pregnant or breastfeeding only if
strictly necessary and under the direct supervision of your doctor.
Driving and using machines
ACETILCISTEINA ALTER does not affect the ability to drive vehicles and use machinery.
ACETILCISTEINA ALTER contains sodium
This medicine contains 194 mg of sodium (the main component of table salt) per dose.
This is equivalent to 9.7% of the maximum recommended daily intake with the diet of an
adult.
3. How to take ACETILCISTEINA ALTER
Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
Treatment of respiratory diseases:
The recommended dose is 1 tablet (600 mg) per day, preferably in the evening. The doctor may
advise you to modify the frequency and dose of administrations, but without exceeding the
maximum daily dose of 600 mg.
The duration of therapy ranges from 5 to 10 days and in chronic forms, the doctor will evaluate whether to continue the
therapy, for a few months.
Treatment of accidental or intentional poisoning with paracetamol:
The recommended initial dose is 140 mg of N-acetylcysteine per kg of body weight, to be
administered as soon as possible, within 10 hours of taking paracetamol. Subsequently, the
dose is 70 mg of N-acetylcysteine per kg of body weight at intervals of 4 hours for 1-3 days.
Treatment of pathology affecting the urinary tract (uropathy) caused by chemotherapeutic
drugs such as ifosfamide and cyclophosphamide.
The recommended dose is 4 g of N-acetylcysteine per day to be divided into 4 doses of 1 g, in
patients undergoing a chemotherapy cycle with ifosfamide and cyclophosphamide for 5 days every 28
days.
Instructions for use of ACETILCISTEINA ALTER
Dissolve one tablet in a glass containing a little water, stirring if necessary with a
teaspoon. Do not mix other drugs with the ACETILCISTEINA ALTER solution.
If you take more ACETILCISTEINA ALTER than you should
No cases of overdose have been reported. Symptoms of overdose may include nausea,
vomiting and diarrhea.
In case of ingestion/taking an excessive dose of this medicine, immediately inform your
doctor or go to the nearest hospital.
If you forget to take ACETILCISTEINA ALTER
Do not take a double dose to compensate for the missed tablet.
If you have any doubts about the use of this medicine, consult 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)
- allergic reactions (hypersensitivity);
- headache;
- ringing in the ears (tinnitus);
- increased heart rate (tachycardia);
- vomiting;
- diarrhoea;
- inflammation of the mouth (stomatitis);
- abdominal pain;
- nausea;
- urticaria, skin rash;
- swelling of the face, lips, mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema);
- itching;
- fever (pyrexia);
- low blood pressure.
Rare(may affect up to 1 in 1,000 people)
- bronchial muscle contractions (bronchospasm);
- difficulty breathing (dyspnoea);
- digestive difficulties (dyspepsia).
Very rare(may affect up to 1 in 10,000 people)
- severe allergic reactions (anaphylactic shock, anaphylactic/anaphylactoid reaction);
- bleeding (haemorrhage).
Not known(frequency cannot be estimated from available data)
- swelling (oedema) of the face.
In very rare cases, severe skin reactions (Stevens Johnson syndrome or
Lyell syndrome) have occurred. If you experience changes in the mucous membranes or skin, stop taking the
medicine and consult your doctor.
Also consult your doctor if you experience a prolonged bleeding time (reduced
platelet aggregation).
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store ACETILCISTEINA ALTER
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What ACETILCISTEINA ALTER contains
- The active ingredient is N-acetylcysteine: 1 effervescent tablet contains 600 mg of N-acetylcysteine.
- The other ingredients are: anhydrous citric acid (E 330), maltodextrin, sodium hydrogen carbonate E 500 ii), orange aroma, leucine (E 641), sodium saccharin (E 954 ii). Description of the appearance of ACETILCISTEINA ALTER and contents of the packACETILCISTEINA ALTER 600 mg effervescent tablets are white, round, flat, with an average diameter of 25 mm. Polypropylene tube with a polyethylene cap equipped with a desiccant: 15 effervescent tablets. The box contains two tubes of 15 tablets Marketing Authorisation Holder and ManufacturerMarketing Authorisation Holder: LABORATORI ALTER S.R.L. VIA EGADI, 7 20144 MILANO
Manufacturer:
E-Pharma Trento S.p.A.
Via Provina 2
- 38123 – Trento Italy
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- Страна регистрации
- Форма выпускаEffervescent tablet, 600 MG
- Код АТХR05CB01
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги AKETILKISTEINA ALTERФорма выпуска: Injectable solution, 300 MG/3 MLДействующее вещество: АцетилцистеинПроизводитель: SANDOZ S.P.A.Отпускается по рецептуФорма выпуска: Powder for oral solution, 100 MGДействующее вещество: АцетилцистеинПроизводитель: SANDOZ S.P.A.Отпускается без рецептаФорма выпуска: Oral solution powder, 600 MGДействующее вещество: АцетилцистеинПроизводитель: HEXAL A/SОтпускается по рецепту
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Действующее вещество AKETILKISTEINA ALTER — Ацетилцистеин. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
AKETILKISTEINA ALTER производится компанией LABORATORI ALTER S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
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