ACC juice 20 mg / ml solution for taking, 200 ml

Instructions for use for ACC juice 20 mg / ml solution for taking, 200 ml

Important notes (compulsory information):

ACC juice 20 mg / ml, solution. Active ingredient: acetylcystein. Applications: To the mucus solution and cough relief on respiratory diseases with a tough mucus in children from 2 years, adolescents and adults.

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


LEAFLET: INFORMATION FOR THE USER

ACC Juice 20 mg / ml, Solution to use for adults, adolescents and children from 2 years
Active substance: acetylcystein

Read the entire leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine as described in this leaflet or just as your doctor or pharmacist is directed.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If you do not feel better or even worse after 4-5 days, contact your doctor.

What is in this leaflet

1. What is Acc juice and what is he applied for?
2. What should you consider before taking ACC Juice?
3. How to take ACC juice?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep ACC juice?
6. Content of the pack and more information

1. What is ACC Juice and what is he applied for?

ACC juice contains the active ingredient acetylcysteine and liquefies tough mucus in the airways. ACC juice is applied to the mucus solution and cough relief on respiratory diseases with a tough mucus in children from 2 years, adolescents and adults.

2. What should you consider before taking ACC Juice?

ACC juice may not be taken if you:

• allergic to acetylcysteine, methyl-4-hydroxybenzoate (Ph.eur.) Or one of the other ingredients of this medicine referred to in section 6,
• notice a deterioration of heavy asthma,
• Have gastric and small intestine ulcers.

ACC juice may not be used in children under 2 years.

Warnings and Precautions:
Please talk to your doctor or pharmacist before taking ACC juice if you:

• Skin and mucosal changes notice. Very rarely reported on the occurrence of heavy skin reactions such as Stevens-Johnson syndrome and Lyell syndrome in the temporal connection with the use of acetylcysteine. For newness of skin and mucosal changes, medical advice should therefore be obtained immediately and the use of acetylcysteine should be stopped.
• to asthma bronchial suffer. See section "ACC Juice may not be taken".
• had a stomach or small intestine ulcer in the past or have. See section "ACC Juice may not be taken".
• suffer from a hypersensitivity to histamine.

A longer-term therapy should be avoided in these patients, since ACC juice can influence the histamine metabolism and lead to intolerance phenomena (eg headaches, rods, itching.

Children:
In children under 3 years, this medicine may only be administered according to the clerk.

Taking ACC juice along with other medicines:
Inform your doctor or pharmacist if you take / use other medicines, recently taken / applied / applied or intend to take / use other medicines.

Hustlestillers:
Combined use of ACC juice and coughing agents, a hazardous secretary can arise due to the restricted cough reflex. The indication for this combination treatment should be made particularly carefully. Therefore, ask your doctor before a combined application.

Antibiotics:
Experimental studies provide evidence of an efficacy weakening of antibiotics (tetracycline, aminoglycosides, penicillins) by acetylcysteine. For security reasons, therefore, the intake of antibiotics should be separated and time delayed in a minimum of 2 hours. This does not affect medicines with the active ingredients Cefixim and Loracbef. These can be taken simultaneously with acetylcysteine.

Activated carbon:
The use of activated carbon can reduce the effect of acetylcysteine.

Nitroglycerin:
The simultaneous administration of acetylcysteine may be able to enhance the vascular-expanding and blood-diluting effect of glyceroltrinitrate (nitroglycerin). If your doctor considers a common treatment with nitroglycerin and ACC juice necessary, he will monitor them on a potentially occurring blood pressure (hypotension) that can be serious and can indicate through potentially occurring headaches.

Changes in the determination of laboratory parameters:
Acetylcysteine can influence the salary determination of salicylates. In urinary examinations, acetylcysteine can influence the results of the determination of ketone bodies.

Products containing salts of metals such as calcium, iron or gold:
These products should be separated and at a distance of at least Be taken 2 hours.

Pregnancy and breast feeding period:
If you are pregnant or breastfeeding, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:
Since there are no sufficient experiences with the use of acetylcysteine in pregnant women, they should only apply ACC juice during pregnancy if their attending physician considers this absolutely necessary.

Latving:
There is no information on the excretion of acetylcysteine in the breast milk. Therefore, you should only apply ACC juice during lactation if your attending physician considers this absolutely necessary.

Driving and ability to operate machines:
ACC juice has no influence on the ability to drive and the ability to serve machines.

ACC juice contains methyl 4-hydroxybenzoate (ph.eur.):
Methyl-4-hydroxybenzoate (ph.eur.) May cause hypersensitivity reactions, even late reactions. See also section "ACC Juice may not be taken“.

3. How to take ACC juice?

Always take this medicine exactly as described in this leaflet or just according to the consultation made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. The recommended dose is, as far as your doctor ACC juice has not prescribed: Please keep yourself on the application regulations, since ACC juice can not act properly! Children from 2-5 years 2-3 times a day each 5 ml, children from 6-14 years 2 times a day each 10 ML, adults and adolescents from 14 years 2-3 times a day each 10 ML. 10 ml Solution for taking correspond to half a measuring cup or 2 syringe fillings.

Type of application:
Take ACC juice after meals. The taking of ACC juice takes place with the help of an oral application syringe or with a measuring cup, which are included with the pack.

Dosage with the help of the application syringe:

1. Open the child-safe closure of the bottle by depression and simultaneous left-turning of the lid.
2. Press the enclosed perforated plug into the bottle neck. If it is not possible for you to push into the plug completely, place the cap and turn it. The plug connects the dosing syringe with the bottle and remains in the bottleneck.
3. Insert the dosing syringe firmly into the opening of the plug. The syringe flask is supposed to stuck up to the stop in the syringe.
4. Carefully turn the bottle with the inserted dosing syringe. Slowly pull the syringe piston down to the prescribed number of milliliters (ml). Show air bubbles in the upstream solution, press the piston back into the syringe and fill again slowly. If more than 5 ml were prescribed per intake, the dosing syringe must be filled several times.
5. Put the bottle upright with the inserted dosing syringe and pull out the syringe out of the perforated plug.
6. You can empty the solution directly from the dosing syringe into the mouth of the child or give it to a spoon. In the direct administration in the mouth, the child should sit upright. The syringe is best emptied slowly against the inside of the cheek, so that the child does not swallow. Clean the dosing syringe after taking by repeated filling and emptying with clear water.

Duration of application:
If you do not feel better or even worse after 4-5 days, contact your doctor. If you feel that the effect of ACC juice is too strong or too weak, contact your doctor or pharmacist.

If you have taken a greater amount of ACC juice than you should:
For overdose, irritating phenomena in the gastrointestinal area, such as. As abdominal pain, nausea, vomiting, diarrhea, occur. Serious side effects or poisoning phenomena have not been observed after massive overdosing of acetylcysteine. If you suspect an overdose with ACC Juice, please notify your doctor yet.

If you forget to take ACC Juice:
If you have forgotten ACC juice or have taken too little, please continue taking ACC juice as described in the dosing instructions next time.

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

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other. Stop taking ACC juice and contact your doctor if you notice signs of an allergic reaction.

Occasionally (can concern up to 1 of 100 treated):

• allergic reactions with signs such as itching, quaddle formation, rash; Breathlessness; Heartock acceleration, blood pressure reduction.

Very rare (can be up to 1 out of 10,000 treated):

• heavy allergic reactions to anaphylactic shock.

Other possible side effects can occur with the following frequencies:
Occasionally (can concern up to 1 of 100 treated):

• Headache
• Fever
• Oral mucosal inflammation
• Stomach pain
• Nausea, vomiting
• Diarrhea
• Heartbeat acceleration
• Blood pressure
• Itching, quaddle formation, rash
• generalized rash
• painful swelling of the skin, predominantly on the face
• Earrings

Rarely (can concern up to 1,000 treated):

• Shortness
• Bronchospasms - predominantly in patients with hyperreactive bronchial system at asthma bronchiale
• Indigestion

Very rare (can be up to 1 out of 10,000 treated):

• Bleeding, partly in the context of hypersensitivity reactions

Unknown (frequency based on the available data not estimable):

• Water accumulations on the face, caused by suppressionssigen liquid
• Decrease of platelet aggregation (combination of certain blood components)

Very rarely reported on the occurrence of heavy skin reactions such as Stevens-Johnson syndrome and Lyell syndrome in the temporal connection with the use of acetylcysteine. In most of these reported cases, at least another drug was taken simultaneously, by which the effects described may be enhanced. For newness of serious skin and mucosal changes, you should therefore seek medical advice without delay and end the application of ACC juice. You can not take ACC juice further. Methyl-4-hydroxybenzoate (Ph.eur.) May cause hypersensitivity reactions, even late reactions. See also Section 2. "ACC juice must not be taken“.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also have side effects directly to the Federal Institute for Medicines and Medical Devices Dept. Pharmacovigilance Kurt-Georg-Kiesinger-Allee 3 D-53175 Bonn Website: Www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep ACC juice?

Keep this medicine inaccessible to children. You may not use this medicine after the expiration date specified on the folding box and the label according to "until". The expiration date refers to the last day of the specified month. This medicinal product does not require special storage conditions. After a break: not more than 25 ° C store. Application within 15 days. Do not dispose drugs in the wastewater or household waste. Ask your pharmacist how to dispose of the medicine if you do not use it anymore. You help to protect our environment.

6. Content of the pack and further information

What ACC Juice contains:
The active ingredient is acetylcystein. Each ml solution for taking contains 20 mg acetylcysteine. The other ingredients are: Methyl 4-hydroxybenzoate (ph.eur.), Sodium benzoate, sodium date (Ph.eur.), Saccharin sodium, Carmelose sodium (Ph.eur.), Sodium hydroxide solution (10%), cherry aroma, purified water.

Like ACC juice looks and content of the pack:
ACC juice is a clear, slightly viscous solution for taking in a brown glass bottle (glass type III), sealed with a polypropylene screw cap, with an application syringe and a measuring cup. Pack sizes: 100 ml and 200 ml solution for taking. Not all pack sizes may be placed on the market.

Pharmaceutic entrepreneur:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Telephone: (08024) 908-0
Fax: (08024) 908-1290
E-mail: [email protected]

Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Bar life

This leaflet was last revised in September 2015.

Source: Information of the leaflet
Status: 05/2016