Ambrohexal cough drops 7.5 mg / ml, 50 ml

Upute za korištenje Ambrohexal cough drops 7.5 mg / ml, 50 ml

Important notes (compulsory information):

Ambrohexal cough release 7.5 mg / ml. Active substance: Ambroxol hydrochloride. Areas of application: For mucousular treatment for acute and chronic diseases of the bronchi and the lungs with a tough mucus.

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


Instructions for use: Information for users
Ambrohexal® cough drops 7.5 mg / ml
Solution to take
Active substance: Ambroxolhydrochloride

Read the entire leaflet carefully before starting using this medicine, because it contains important information. Always take this medicine exactly as in this leaflet or exactly as your doctor or pharmacist statement.

• 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

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What is in this leaflet

1. What are Ambrohexal cough drops 7.5 mg / ml and what are you used for?
2. What should you drop before the use of ambrohexal cough drops Note 7.5 mg / ml?
3. How can Ambrohexal cough drops apply 7.5 mg / ml?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How can Ambrohexal cough drops be stored 7.5 mg / ml?
6. Content of the pack and further information

1. What are Ambrohexal cough drops 7.5 mg / ml and what are you used for?

AMBROHEXAL cough drops 7.5 mg / ml is a medicament for mucus solution on respiratory diseases with a tough mucus (Expector's). Ambrohexal cough drops 7.5 mg / ml are used for mucous-releasing treatment in acute and chronic diseases of the bronchi and the lungs with a tough mucus.

2. What should you get hust up before using Ambrohexal Note 7.5 mg / ml?

Ambrohexal cough drops 7.5 mg / ml must not be used if they are allergic to ambroxol hydrochloride, methyl-4-hydroxybenzoate, propyl-4-hydroxybenzoate, sodium metabisulfi T or one of the other other references mentioned in section 6. "Content of the package and other information" Ingredients of this medicine are.

Warnings and Precautions
Please talk to your doctor or pharmacist before applying ambrohexal cough drops 7.5 mg / ml. In very few cases, serious skin is reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) in the temporal relationship with the use of substances with a mucousacous effect (Expectorants) as ambroxol hydrochloride has been reported. In most cases, these could be explained by the basic disease of patients and / or the accompanying medication. In addition, in the initial stage of a Stevens-Johnson syndrome or a th initially, nonspecific flu-like symptoms, such as. B. Fever, body aches, rhinitis, cough and sore throat, occur. These non-specific flu-like initial symptoms may incorporate symptomatic treatment with coughing and cold drugs. Therefore, in the process of skin or mucosal damage, medical advice should be obtained without delay and the use of ambroxol hydrochloride is terminated.

Patients with impaired kidney and liver function
If you suffer from restricted renal function or a heavy liver disease, ambrohexal cough drops 7.5 mg / ml only applied to medical instructions. As for each medicine, which is metabolized by the liver and then excreted over the kidneys, in the presence of highly limited renal function, an accumulation of the metabolic products (metabolites) formed in the liver expected from Ambroxol expectedbe tet.

For some rare disorders of the bronchi, which are accompanied by excessive secretary collection (eg malignant zile syndrome), ambrohexal cough drops of 7.5 mg / ml should be used because of a possible secret break only under medical control.

children
Ambrohexal cough drops 7.5 mg / ml may be under 2 in children Years are applied only to medical statement.

Application of ambrohexal cough drops 7.5 mg / ml together 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.

Ambroxol / antitussiva
With simultaneous use of ambrohexal cough drops 7.5 mg / ml and coughing agents (antitussiva), due to the limited cough reflex, a dangerous secretary can arise, so that the simultaneous application should only be carried out after careful benefit-risk balancing.

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

pregnancy
Ambroxol reaches the unborn child. During pregnancy, you should not take this medicine, especially not during the first 3 months.

Lactation
The active substance Ambroxol passes into the breast milk in animal test. An application during lactation is not recommended.

Driving and ability to use machines
There are no evidence of influencing the ability to drive and the ability to serve machines; Corresponding studies have not been carried out.

3. How are Ambrohexal cough drops to apply 7.5 mg / ml?

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
Children up to 2 years
It will take 1 ml of solution for 2 times a day, accordingly 2 times 20 drops, occupied (corresponding to 15 mg of amber oxolhydrochloride / day).

Children from 2-5 years
It will take 1 ml of solution for 3 times a day, accordingly 3 times 20 drops, occupied (corresponding to 22.5 mg of ambroxol hydrochloride / day).

Children from 6-12 years
2 ml of solution for take 2-3 times a day, correspondingly 2-3 times 40 drops, taken (corresponding to 30-45 mg of ambroxol hydrochloride / day).

Adults and adolescents from 12 years
Usually during the first 2-3 days 3 times a day each 4 ml solution for taking, correspondingly 3 times 80 drops, taken (corresponding to 90 mg of ambroxol hydrochloride / day), then 4 ml of solution for take 2 times a day, corresponding to 2 times 80 Drop, occupied (corresponding to 60 mg of ambroxol hydrochloride / day).

inhalation
Adults and children over 5 years inhale 1-2 times a day 40-60 Drops (corresponding to 15-45 mg of ambroxol hydrochloride / day).
Children under 5 years inhale 1-2 times a day 40 drops (corresponding to 15-30 mg of amber oxolhydrochloride / day).

At the dosage for adults and adolescents
For 12 years, an increase in efficacy is possibly 8 ml of solution for 2 times a day (corresponding to 120 mg of amber oxolhydrochloride / day) possible.

Type and duration of the application
The preparation is a measuring cup, with divisions u. A. at 1, 2 and 4 ml. The solution for occupying it becomes or independent of meals in liquid (eg water, tea or juice) diluted. For inhalation, a suitable inhalation device must be used. Please note the application rule of the device manufacturer. If your clinical picture worsens or no improvement after 4-5 days, you should consult a doctor.

If you have used a larger amount of Ambrohexal cough drops 7.5 mg / ml than you should
Special disease phenomena of an overdose have not been reported so far. The disease signs observed in accidental overdose or drug controls stimwith the side effects, which can occur during the recommended dosage (see section 4. "Which side effects are possible?"). Please contact a doctor in the event of overdose, as a treatment of the disease signs may be required.

If you forget the application of Ambrohexal cough drops 7.5 mg / ml
If you have forgotten once to apply ambrohexal cough drops 7.5 mg / ml, or have applied too little, please use the application of ambrohexal cough drops 7.5 to the next time Mg / ml continues, as described in the dosage instructions.

If you cancel the application of Ambrohexal cough drops 7.5 mg / ml
In case of premature termination of treatment, the symptoms can worsen. 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.

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 1 000
Rarely:	1 to 10 treated from 10 000
Very rare:	less than 1 treated from 10 000
Not known:	Frequency on the basis of the available data does not estimate.

Side effects
Diseases of the immune system, the skin and the subcutaneous tissue
Rare: rash, hives
Not known: swelling of skin and mucosa, itching, heavy allergic (anaphylactic) reactions to shock, other hypersensitivity reactions

Diseases of the nervous system
Often: flavor disorders

Diseases of the gastrointestinal tract
Frequently: nausea, numbness in the mouth
Occasionally: vomiting, diarrhea, indigestion, abdominal pain, mouth dryness
Rare: dryness in the throat
Very rare: constipation, increased salivation

Respiratory diseases, the chest and mediastinum
Often: deafness in the throat
Very rare: increased fluid secretion from the nose
Unknown: breathnot (as signs of a hypersensitivity reaction)

Diseases of kidneys and urinary tract
Very rare: difficult urination

General diseases and complaints at the administration place
Occasionally: Fever, mucosal reactions

Methyl-4-hydroxybenzoate and propyl-4-hydroxybenzoate can cause hypersensitivity reactions, even late reactions.
Sodium metabisulfite can rarely cause hypersensitivity reactions and bronchial cramps (bronchospasms.

Countermeasures
In the first signs of an overpricular reaction, ambrohexal cough drops 7.5 mg / ml may not be applied again.

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 effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de, ads. By reporting side effects, you can help to provide more information about the security of this medicine.

5. What are ambrohexal cough drops to store 7.5 mg / ml?

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.
Store in the original packaging to protect the content from light!
Not over 25 ° C to store.

Note on durability after a break
After a break 12 months can be used.

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 ambrohexal cough drops 7.5 mg / ml contain
The active ingredient is amber oxolhydrochloride.
1 ml of solution for taking (about 20 drops) contains 7.5 mg of ambroxol hydrochloride.

The other ingredients are:
Citric acid monohydrate, methyl-4-hydroxybenzoate (ph.eur.), Sodium metabisulfite (ph.eur.), Sodium hydroxide solution, propyl 4-hydroxybenzoate (ph.eur.), Purified water

Like ambrohexal cough drops 7.5 mg / ml look and content of the pack
Ambrohexal cough drops 7.5 mg / ml is a clear, colorless solution for taking.
Ambrohexal cough drops 7.5 mg / ml is in packs of 50 ml and 100 ml solution available 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,
A company of Hexal AG
Otto-von-Guericke-Allee 1
39179 Bar life

Manufacturer of the measuring cup
Stella GmbH
H.J.-Müller-Str. 4
65343 Eltville

This leaflet was last revised in June 2013.

Source: Information of the leaflet
Status: 07/2014