NAC

NAC 200 acute-1A Pharma effervescent tablets

Important notes (mandatory information)

NAC 200 akut - 1 A Pharma, effervescent tablets. Active ingredient: Acetylcysteine. Areas of application: for dissolving mucus and making it easier to cough up in respiratory diseases with viscous mucus.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


INSTRUCTIONS FOR USE: INFORMATION FOR USERS

NAC 200 akut - 1 A Pharma effervescent tablets
Active ingredient: Acetylcysteine 200 mg per effervescent tablet

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 4–5 days, consult your doctor.

What this package leaflet contains

1. WHAT IS NAC 200 AKUT – 1 A PHARMA AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING NAC 200 AKUT – 1 A PHARMA?
3. HOW SHOULD NAC 200 AKUT – 1 A PHARMA BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD NAC 200 AKUT – 1 A PHARMA BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS NAC 200 AKUT - 1 A PHARMA AND WHAT IS IT USED FOR?

NAC 200 akut - 1 A Pharma is a medicine for liquefying viscous mucus in the respiratory tract. NAC 200 akut - 1 A Pharma is used for dissolving mucus and making it easier to cough up in respiratory diseases with viscous mucus.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING NAC 200 AKUT - 1 A PHARMA?

NAC 200 akut - 1 A Pharma must not be taken if you are allergic to acetylcysteine or any of the other ingredients of this medicine listed in section 6. NAC 200 akut - 1 A Pharma must not be used in children under 2 years of age due to its high active ingredient content.

Warnings and precautions

Please talk to your doctor or pharmacist before taking NAC 200 akut - 1 A Pharma. Very rarely, the occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome has been reported in temporal connection with the use of acetylcysteine. If new skin and mucous membrane changes occur, you should therefore seek medical advice immediately and stop using acetylcysteine. Caution is advised if you suffer from bronchial asthma or have had or have a stomach or intestinal ulcer in the past. Caution is advised in patients with histamine intolerance. Long-term therapy should be avoided in these patients, as NAC 200 akut - 1 A Pharma influences histamine metabolism and can lead to intolerance symptoms (e.g. headache, runny nose, itching). The use of NAC 200 akut - 1 A Pharma can, especially at the beginning of treatment, lead to liquefaction and thus to an increase in the volume of bronchial secretion. If you are unable to cough this up sufficiently, your doctor will take appropriate measures for you.

Taking NAC 200 akut - 1 A Pharma with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Interaction studies have only been conducted in adults.

Antitussives (cough suppressants)

In the case of combined use of NAC 200 akut - 1 A Pharma and cough suppressants (antitussives), a dangerous accumulation of secretion can occur due to the restricted cough reflex, so the indication for this combination treatment should be made with particular care. Therefore, always consult your doctor before using this combination.

Activated charcoal

The use of activated charcoal can reduce the effect of acetylcysteine.

Antibiotics

Experimental studies have shown that antibiotics (tetracyclines, aminoglycosides, penicillins) are less effective when used with acetylcysteine. For safety reasons, antibiotics should therefore be taken separately and at a time interval of at least 2 hours. This does not apply to medicines containing the active ingredients cefixime and loracarbef. These can be taken at the same time as acetylcysteine.

Nitroglycerin

An increase in the vasodilatory and blood-thinning effect of glycerol trinitrate (nitroglycerin) has been reported when given together with acetylcysteine. If your doctor considers it necessary to treat you with nitroglycerin and NAC 200 akut - 1 A Pharma at the same time, they will monitor you for a possible drop in blood pressure (hypotension), which can be severe and may be indicated by a possible headache.

Changes in the determination of laboratory parameters

Acetylcysteine can influence the determination of salicylates. In urine tests, acetylcysteine can influence the results of the determination of ketone bodies.

Dissolving NAC 200 akut - 1 A Pharma at the same time as other medicines is not recommended.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Since there is insufficient experience with the use of acetylcysteine in pregnant women, you should only use NAC 200 akut - 1 A Pharma during pregnancy if your doctor considers it absolutely necessary.

Breastfeeding

There is no information on the excretion of acetylcysteine in breast milk. Therefore, you should only use NAC 200 akut - 1 A Pharma during breastfeeding if your doctor considers it absolutely necessary.

Driving and operating machinery

There are no special precautions to be taken.

NAC 200 akut - 1 A Pharma contains lactose, sorbitol and sodium compounds

Therefore, please only take NAC 200 akut - 1 A Pharma after consulting your doctor if you know that you suffer from an intolerance to certain sugars. 1 effervescent tablet contains 4.3 mmol (98.9 mg) sodium. If you are on a low-salt diet, you should take this into account.

3. HOW SHOULD NAC 200 AKUT - 1 A-PHARMA BE TAKEN?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

The following information applies unless your doctor has prescribed NAC 200 akut - 1 A Pharma differently. Please follow the instructions for use, otherwise NAC 200 akut -1 A Pharma will not work properly!

• Children aged 2 – 5 years: 2 – 3 times a day, 1/2 effervescent tablet each (equivalent to 200 – 300 mg acetylcysteine per day).
• Children and adolescents aged 6 – 14 years: 2 times a day, 1 each (equivalent to 400 mg acetylcysteine per day).
• Adolescents aged 14 years and older and adults: 2 – 3 times a day, 1 each (equivalent to 400 – 600 mg acetylcysteine per day).

Type and total duration of use

Take NAC 200 akut - 1 A Pharma after meals. The effervescent tablet can be divided into equal doses. Please dissolve the effervescent tablet in a glass of drinking water and drink the contents of the glass completely. If the symptoms worsen or if there is no improvement after 4 - 5 days, you should consult a doctor.

If you have taken more NAC 200 akut -1 A Pharma than you should

Overdosage can cause irritation in the gastrointestinal tract (e.g. abdominal pain, nausea, vomiting, diarrhoea). Serious side effects or symptoms of poisoning have not been observed even after massive overdosage of acetylcysteine. However, if you suspect an overdose of NAC 200 akut - 1 A Pharma, please inform your doctor.

If you forget to take NAC 200 akut - 1 A Pharma

If you have forgotten to take NAC 200 akut - 1 A Pharma once or have taken too little, please continue taking NAC 200 akut -1 A Pharma the next time, as described in the dosage instructions.

If you stop taking NAC 200 akut - 1 A Pharma

Please do not stop treatment with NAC 200 akut - 1 A Pharma without consulting your doctor. Your illness could get worse as a result.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can have side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 people treated
Common:	1 to 10 in 100 people treated
Uncommon:	1 to 10 in 1,000 people treated
Rare:	1 to 10 in 10,000 people treated
Very rare:	less than 1 in 10,000 people treated
Not known:	frequency cannot be estimated from the available data.

Side effects

General disorders and administration site conditions:

• Uncommon: headache, fever, allergic reactions (itching, hives, rash, shortness of breath, skin and mucous membrane swelling, rapid heartbeat and drop in blood pressure).
• Very rare: anaphylactic reactions up to shock.
• Not known: fluid retention in the face.

Ear and labyrinth disorders:

• Uncommon: tinnitus (ringing in the ears).

Respiratory, thoracic and mediastinal disorders:

• Rare: shortness of breath, bronchospasms – mainly in patients with hyperreactive bronchial system in bronchial asthma.

Gastrointestinal disorders:

• Uncommon: inflammation of the oral mucosa, abdominal pain, nausea, vomiting, heartburn and diarrhoea.
• Rare: indigestion.

Very rarely, bleeding has been reported in connection with the administration of acetylcysteine, sometimes in the context of hypersensitivity reactions. Very rarely, the occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome has been reported in temporal connection with the use of acetylcysteine. In most of these reported cases, at least one other medicine was taken at the same time, which could possibly increase the described effects on the mucous membrane. If new, serious skin and mucous membrane changes occur, you should therefore seek medical advice immediately and stop using NAC 200 akut - 1 A Pharma. You must not take NAC 200 akut - 1 A Pharma any more. Various studies have confirmed a decrease in platelet aggregation (clumping of certain blood components) during the use of acetylcysteine. The clinical significance of this is still unclear.

Countermeasures

If the first signs of a hypersensitivity reaction occur (see above), NAC 200 akut - 1 A Pharma must not be taken again. In this case, please consult a doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD NAC 200 AKUT - 1 A-PHARMA BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the sealed bag after "use by". The expiry date refers to the last day of the month indicated. Store effervescent tablets dry and protected from light! Do not store above 30°C. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What NAC 200 akut - 1 A Pharma contains

The active ingredient is acetylcysteine. 1 effervescent tablet contains 200 mg acetylcysteine. The other ingredients are: ascorbic acid (vitamin C), citric acid, lactose, mannitol (Ph.Eur.), sodium carbonate, sodium citrate (Ph.Eur.), sodium hydrogen carbonate, saccharin sodium, blackberry flavour (contains sorbitol).

What NAC 200 akut - 1 A Pharma looks like and contents of the pack

NAC 200 akut - 1 A Pharma are white, round, smooth effervescent tablets with a break notch on one side. NAC 200 akut - 1 A Pharma is available in packs of 20, 40, 50 and 80 effervescent tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Telephone: (089) 6138825-0

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben

This leaflet was last revised in February 2015.

Source: Information from the package leaflet
Status: 01/2020
Active ingredient: Acetylcysteine. Areas of application: for dissolving mucus and making it easier to cough up in respiratory diseases with viscous mucus.