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ACC (Sand.Pharma) 200 PULVERIS PACIŅĀS 200MG/3G N20

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-28
ACC-SAND-drug/medicine -powderaproximate price on "ACC (Sand.Pharma) 200 PULVERIS PACIŅĀS 200MG/3G N20" in Riga city, Latvia is:
  • 5.90€  6.38$  5.06£  681Rub  67.9SEK  25PLN  23.35₪ 

ACC 200 PULVERIS PACIŅĀS 200MG/3G N20


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -powder ACC (Sand.Pharma) 200 PULVERIS PACIŅĀS 200MG/3G N20     Recheck

Reģ. Nr.: 00-0285

ATC codeR05CB01 

Active substances: Acetylcysteinum

 


Vendor, principal: Hexal Ag/salutas Pharma Gmbh
No prescription needed/Patient care products, dressings, gloves, medical devices,...

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ACC 200mg  pulveris iekšķīgi lietojama šķīduma pagatavošanai N20



ACC 200MG N20

Package leaflet: Information for the user

ACC 100 mg, 100 mg effervescent tablets ACC 200 mg, 200 mg effervescent tablets

Acetylcysteine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

1.   What ACC is and what it is used for
2.   What you need to know before you use ACC
3.   How to use ACC
4.   Possible side effects
5.   How to store ACC
6.   Contents of the pack and other information

1. What ACC is and what it is used for

Acetylcysteine is a derivative of the amino acid cysteine. Acetylcysteine has a phlegm-loosening effect on the bronchial region.
ACC effervescent tablets are used for loosening phlegm.

2. What you need to know before you use ACC Do not use ACC

-   if you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6);
-   if you have a gastric ulcer;
-   due to large content of the active substance, ACC 200 mg effervescent tablets are not suitable for children under 2 years of age.

Warnings and precautions

Ask your doctor or pharmacist for advice before using ACC.
ACC effervescent tablets contain sodium compounds.
Patients on a salt-free (low sodium) diet should take the sodium content of the tablet into consideration (see ACC with food and drink).
Patients with a history of bronchial asthma or peptic ulcer must be careful when using acetylcysteine.
In very rare cases, severe skin reactions such as Stevens-Johnson syndrome and Lyell’s syndrome have been reported in connection with using acetylcysteine. If changes occur in the skin or mucous membranes, immediately talk to a doctor and stop using acetylcysteine.
Using acetylcysteine, especially at the beginning of treatment, may cause loosening of phlegm and an increase in the amount of bronchial secretion. If you are unable to cough out sufficient quantities of phlegm, the doctor will implement suitable measures.

Other medicines and ACC

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Antibiotics
A large number of antibiotics are known to be physically incompatible with acetylcysteine or to be inactivated by acetylcysteine. As a safety precaution, oral antibiotics should be administered separately and with an interval of at least two hours.
Antitussive agents
A combination of acetylcysteine and antitussive medicines causes the risk of secretion retention due to suppressing the cough reflex. Therefore, using this combination should be carefully considered.
Nitroglycerin
The concomitant use of ACC may strengthen the vasodilatory and blood-thinning effect of nitroglycerin.

ACC with food and drink

A note to patients on a salt-free diet (with limited sodium content):
One ACC 100 mg effervescent tablet contains 4.2 mmol (95.9 mg) of sodium.
One ACC 200 mg effervescent tablet contains 4.3 mmol (98.8 mg) of sodium.
ACC effervescent tablets should be taken after a meal.
The effervescent tablets should be dissolved in a glass of water before use.
Note
The phlegm-loosening effect of ACC effervescent tablets is supported by drinking plenty of fluids.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Due to the lack of sufficient data about the use of acetylcysteine in pregnant women and breastfeeding mothers, the medicine can only be used in these situations under a doctor’s order.

ACC contains lactose.

If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.
Advice for diabetics
One ACC effervescent tablet contains 0.01 carbohydrate exchange units.

ACC contains sodium.

Patients on a low sodium (salt-free) diet should account for the sodium content of the medicine.

3. How to use ACC

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 400-600 mg of acetylcystein per day.
For loosening phlegm in case of acute upper respiratory tract diseases:
for adults and adolescents over 14 years of age, 400-600 mg per day as a single dose or
divided into 2-3 doses;
for children aged 6-14 years, 300-400 mg per day, divided into 2-3 doses; for children aged 2-6 years, 200-300 mg per day, divided into 2-3 doses;
In case of mucoviscidosis:
for children over 6 years of age, 600 mg per day, divided into 3 doses; for children aged 2-6 years, 400 mg per day, divided into 4 doses.
In patients weighing more than 30 kg, the dose may be increased to up to 800 mg per day.
The tablet is taken after a meal, dissolved in V2 glass of water.
Duration of treatment: In case of acute diseases, 5-7 days; in case of chronic bronchitis and mucoviscidosis, the treatment must last longer for prophylactic treatment of the infection.
If you feel that the effect of ACC effervescent tablets is too strong or too weak, talk your doctor or pharmacist.

If you use more ACC than you should

In case of an acetylcysteine overdose, you may develop diarrhoea, nausea and vomiting.
If overdose symptoms occur, talk to a doctor.

If you forget to use ACC

Do not take a double dose to make up for a forgotten dose.

If you stop using ACC

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are grouped based on incidence as follows:
Very common: (t 1/10)
Common:   (t 1/100 to < 1/10)
Uncommon:   (t 1/1,000 to < 1/100)
Rare:   ft 1/10,000 to < 1/1,000)
Very rare   (< 1/10,000)
Unknown (cannot be estimated from available data)
Immune system disorders
Uncommon:   Hypersensitivity reactions
Very rare: Anaphylactic shock, anaphylactic/anaphylactoid reactions
Nervous system disorders
Uncommon: Headache
Ear and labyrinth disorders Uncommon: Murmur in the ears
Cardiac disorders
Uncommon: Accelerated heart rate
Vascular disorders
Uncommon:   Reduced blood pressure
Very rare: Bleeding
Respiratory, chest, and mediastinal disorders
Rare:   Dyspnoea, bronchospasm
Gastrointestinal disorders
Uncommon:   Nausea, vomiting, diarrhoea, abdominal pain
Rare:   Indigestion
Skin and subcutaneous tissue disorders
Uncommon:   Urticaria, skin rash, angioedema, itching, exanthema
General disorders and administration site reactions
Uncommon:   Fever
Unknown: Facial swelling
Different studies have described decreased platelet aggregation in the presence of acetylcysteine; however, its clinical relevance is yet to be determined.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ACC

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 25 °C and protect from moisture and light.
After taking out a tablet, tightly seal the tube!
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What ACC contains

-   The active substance is acetylcysteine.
-   The excipients are ascorbic acid (vitamin C), citric acid, lactose monohydrate, D-mannitol, sodium citrate, sodium bicarbonate, anhydrous sodium carbonate, sodium saccharine, aroma agents (dewberry).

What ACC looks like and contents of the pack

The package contains 20 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Sandoz d.d.
Verovškova 57 1000 Ljubljana Slovenia
Manufacturer:
Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Sandoz d.d. Estonian branch Pärnu mnt 105 11312 Tallinn Phone: +372 6652 400

This leaflet was last revised in December 2014






  Instruction, annotation source for medicine: State Agency of Medicines, Estonia





• Medicaments images are for illustrative purposes only and may differ from the actual product.


[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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