NAC 600 akut-1A Pharma effervescent tablets

Important Information (Required Information)

NAC 600 akut - 1 A Pharma, effervescent tablets. Active ingredient: Acetylcysteine. Areas of application: for dissolving mucus and facilitating coughing up in respiratory diseases with viscous mucus.

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

NAC 600 akut - 1 A Pharma, effervescent tablets
Active ingredient: Acetylcysteine 600 mg per effervescent tablet

Read all of this leaflet carefully before you start taking 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 after 4—5 days.

What is in this leaflet

1. WHAT NAC 600 AKUT — 1 A PHARMA IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAC 600 AKUT — 1 A PHARMA
3. HOW TO TAKE NAC 600 AKUT — 1 A PHARMA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE NAC 600 AKUT — 1 A PHARMA
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT NAC 600 AKUT - 1 A PHARMA IS AND WHAT IT IS USED FOR

NAC 600 akut - 1 A Pharma is a medicine used to liquefy viscous mucus in the airways. NAC 600 akut - 1 A Pharma is used for dissolving mucus and facilitating coughing up in respiratory diseases with viscous mucus.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAC 600 AKUT - 1 A PHARMA

Do not take NAC 600 akut - 1 A Pharma if you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6). Due to the high active ingredient content, NAC 600 akut - 1 A Pharma must not be used in children under 14 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking NAC 600 akut - 1 A Pharma. Very rarely, the occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome has been reported in temporal association with the use of acetylcysteine. If new skin and mucosal changes occur, medical advice should therefore be sought immediately and the use of acetylcysteine should be discontinued. 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 600 akut - 1 A Pharma affects histamine metabolism and can lead to symptoms of intolerance (e.g. headache, runny nose, itching). The use of NAC 600 akut - 1 A Pharma can, especially at the beginning of treatment, lead to liquefaction and thus to an increase in the volume of bronchial secretions. If you are unable to cough this up sufficiently, your doctor will take appropriate measures.

Other medicines and NAC 600 akut - 1 A Pharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Interaction studies have only been performed in adults.

Antitussives (cough suppressants)

When NAC 600 akut - 1 A Pharma and cough suppressants (antitussives) are used in combination, a dangerous accumulation of secretions can occur due to the restricted cough reflex, so that the indication for this combination treatment should be made particularly carefully. Therefore, be sure to ask your doctor before combined use.

Activated charcoal

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

Antibiotics

Experimental studies indicate that acetylcysteine weakens the effect of antibiotics (tetracyclines, aminoglycosides, penicillins). For safety reasons, antibiotics should therefore be taken separately and at least 2 hours apart. 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 enhancement of the vasodilatory and blood-thinning effect of glycerol trinitrate (nitroglycerin) has been reported with simultaneous administration of acetylcysteine. If your doctor considers joint treatment with nitroglycerin and NAC 600 akut - 1 A Pharma necessary, they will monitor you for a possible drop in blood pressure (hypotension), which can be severe and may be indicated by headaches.

Changes in the determination of laboratory parameters

Acetylcysteine can affect the determination of salicylates. In urine tests, acetylcysteine can affect the results of the determination of ketone bodies. Dissolving NAC 600 akut - 1 A Pharma at the same time as other medicines is not recommended.

Pregnancy and

breast-feeding

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.

Pregnancy

Since there is insufficient experience with the use of acetylcysteine in pregnant women, you should only use NAC 600 akut - 1 A Pharma during pregnancy if your treating doctor considers it absolutely necessary.

Breast-feeding

There is no information on the excretion of acetylcysteine into breast milk. Therefore, you should only use NAC 600 akut - 1 A Pharma during breast-feeding if your treating doctor considers it absolutely necessary.

Driving and using machines

No special precautions are necessary.

NAC 600 akut - 1 A Pharma contains lactose,

sorbitol and sodium compounds

Therefore, please only take NAC 600 akut - 1 A Pharma after consulting your doctor if you know that you suffer from an intolerance to certain sugars. 1 effervescent tablet contains 6 mmol (139 mg) of sodium. If you are on a low-salt diet, you should take this into account.

3. HOW TO TAKE NAC 600 AKUT - 1 A PHARMA

Always take 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

The following information applies unless your doctor has prescribed NAC 600 akut - 1 A Pharma otherwise. Please follow the instructions for use, otherwise NAC 600 akut - 1 A Pharma cannot work properly! Adolescents from 14 years of age and adults take 1/2 effervescent tablet twice a day or 1 effervescent tablet once a day (corresponding to 600 mg acetylcysteine per day).

Method and duration of administration

Take NAC 600 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 entire contents of the glass. If the clinical picture worsens or no improvement occurs after 4 - 5 days, you should consult a doctor.

If you take more NAC 600 akut - 1 A Pharma

than you should

In the event of an overdose, symptoms of irritation in the gastrointestinal tract (e.g. abdominal pain, nausea, vomiting, diarrhea) may occur. Serious side effects or symptoms of poisoning have not been observed even after a massive overdose of acetylcysteine. If you suspect an overdose of NAC 600 akut - 1 A Pharma, please nevertheless inform your doctor.

If you forget to take NAC 600 akut - 1 A Pharma

If you have forgotten to take NAC 600 akut - 1 A Pharma or have taken too little, please continue taking NAC 600 akut - 1 A Pharma next time as described in the dosage instructions.

If you stop taking NAC 600 akut - 1 A Pharma

Please do not stop treatment with NAC 600 akut - 1 A Pharma without consulting your doctor. Your illness could worsen as a result.

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.

The following frequencies are used as a basis for evaluating side effects:
Very common:	more than 1 in 10 treated patients
Common:	1 to 10 in 100 treated patients
Uncommon:	1 to 10 in 1,000 treated patients
Rare:	1 to 10 in 10,000 treated patients
Very rare:	less than 1 in 10,000 treated patients
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, skin rash, shortness of breath, swelling of the skin and mucous membranes, accelerated heartbeat and drop in blood pressure).
• Very rare: anaphylactic reactions up to shock.
• Not known: water retention in the face.

Ear and labyrinth disorders:

• Uncommon: ringing in the ears (tinnitus).

Respiratory, thoracic and mediastinal disorders:

• Rare: shortness of breath, bronchospasm — predominantly in patients with hyperreactive bronchial system in bronchial asthma.

Gastrointestinal disorders:

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

Very rarely, the occurrence of bleeding in connection with the administration of acetylcysteine has been reported, partly as part of hypersensitivity reactions. Very rarely, the occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome has been reported in temporal association with the use of acetylcysteine. In most of these reported cases, at least one other drug was taken at the same time, which could possibly enhance the described effects on the mucous membrane. If new, serious skin and mucosal changes occur, you should therefore seek medical advice immediately and stop using NAC 600 akut - 1 A Pharma. You must not continue to take NAC 600 akut - 1 A Pharma. 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 (see above) occur, NAC 600 akut - 1 A Pharma must not be taken again. In this case, please contact a doctor.

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 to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE NAC 600 AKUT - 1 A PHARMA

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 carton and the sealed bag after "EXP". The expiry date refers to the last day of that month. Store effervescent tablets in a dry place and protect from light! Do not store above 30°C. 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 NAC 600 akut - 1 A Pharma contains

The active substance is acetylcysteine. 1 effervescent tablet contains 600 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 flavor (contains sorbitol).

What NAC 600 akut - 1 A Pharma looks like and contents of the pack

NAC 600 akut - 1 A Pharma are white, round, smooth effervescent tablets with a score line on one side. NAC 600 akut - 1 A Pharma is available in packs of 6, 10, 20 and 40 effervescent tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Phone: (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
As of: 04/2018
Active ingredient: Acetylcysteine. Areas of application: for dissolving mucus and facilitating coughing up in respiratory diseases with viscous mucus.