Ambrohexal cough release, 20 pcs

Upute za korištenje Ambrohexal cough release, 20 pcs

Important notes (compulsory information):

Ambrohexal cough-soluble effervescent tablets. 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-release effervescent tablets 60 mg
Active substance: Ambroxolhydrochloride

Read the entire leaflet carefully before you start taking 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.

What is in this leaflet

1. What are Ambrohexal cough-release effervescent tablets and what are you used for?
2. What should you pay attention to effervescent tablets before taking Ambrohexal cough-release?
3. What are Ambrohexal cough-release effervescent tablets?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How are Ambrohexal cough-release effervescent tablets to store?
6. Content of the pack and more information

1. What are Ambrohexal cough-soluble effervescent tablets and what are they used for?

Ambrohexal cough-soluble effervescent tablets is a medicine for mucus solution on respiratory diseases with a tough mucus (Expector's). Ambrohexal cough-soluble effervescent tablets are used for mucousular treatment in acute and chronic diseases of the bronchi and the lungs with a tough mucus.

2. What should you pay attention to effervescent tablets before taking Ambrohexal cough-release?

Ambrohexal cough-soluble effervescent tablets may not be taken

• if you allergic against ambroxol hydrochloride or one of the section 6. "Content of the pack and more information" stated other ingredients of this medicine are
• from children under 12 years.

Warnings and Precautions
Please talk to your doctor or pharmacist before taking ambrohexal cough-release effervescent tablets. In very few cases, serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) is in the time connection with the use of substances with a mucousuf-soluble 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 severe liver disease, ambrohexal cough-release effervescent tablets may only be taken towards medical statement. As for any medicinal product, which is metabolized by the liver and then excreted over the kidneys, an attachment can be accumulated in the presence of highly limited renal functionng of the metabolic products (metabolites) formed in the liver are expected from Ambroxol.

In some rare diseases of the bronchi, which are associated with excessive secretary collection (eg malignant Zilien syndrome), ambrohexal cough-release effervescent tablets should be used for a possible secret break only under medical control.

children
Ambrohexal cough-soluble effervescent tablets are not suitable for children under 12 due to the high active ingredient content.

Intake of Ambrohexal cough-release effervescent tablets 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-release effervescent tablets and coughing agents (antitussiva), a dangerous secretary can arise due to the limited cough reflex, 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.

Ambrohexal cough-release effervescent tablets contain lactose, sorbitol and sodium compounds
Please take Ambrohexal cough-soluble effervescent tablets only after consulting with your doctor if you are familiar with any intolerance to certain sugars. 1 effervescent tablet contains 5.5 mmol (126.6 mg) sodium. If you need to meet a saline diet, you should consider this.

3. What are Ambrohexal cough-release effervescent tablets?

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
Adults and adolescents from 12 years usually during the first 2-3 days will be 3 times a day 1/2 effervescent tablet (correspondingly 3 times 30 mg of ambroxol hydrochloride / day), then 2 times a day each 1/2 effervescent tablet (accordingly 2 times 30 mg of ambroxol hydrochloride / day). In the dosage for adults and adolescents from 12 years, an increase in efficacy is possibly by the administration of 2 times a day 1 effervescent tablet (corresponding to 120 mg of ambroxol hydrochloride / Day) possible.

Type and duration of the application
Effervescent tablets for producing a solution for taking ambrohexal cough-release effervescent tablets are taken to or independently of the meals in a glass of cold water dissolved. If your clinity is worsening or after 4-5 days no improvement occurs, you should consult a doctor.

If you take a greater amount of Ambro Hexal cough-release effervescent tablets than you should
Special disease phenomena of an overdose have not been reported so far. The disease demands observed in accidental overdose or drug manager votes with 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 to take Ambrohexal cough-release effervescent tablets
If you have forgotten to take Ambrohexal cough-release effervescent tablets, or have too little occupied, put them please continue to take AMBROHEXAL cough-release effervescent tablets as described in the dosing instructions.

If you stop taking Ambrohexal cough-release effervescent tablets
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
Unknown: swelling of skin and mucosa, itching, heavy allergic (anaphylactic) reactions to shock, others over-seasonal 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 on the administration place
Occasionally: Fever, mucosal reactions

Countermeasures
In the first signs of a hypersensitivity reaction, ambrohexal cough-release effervescent tablets must not be taken 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-release effervescent tablets?

Keep this medicine inaccessible to children.
You may not use this medicine after the expiration date specified on the folding box and the tube 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 moisture! Close tubes after tablet removal again!
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

As for ambrohexal cough-soluble effervescent tablets
The active ingredient is amber oxolhydrochloride.
1 effervescent tablet contains 60 mg of ambroxol hydrochloride.

The other ingredients are:
Citric acid, lactose, mannitol (pH.eur.), Sodium carbonate, sodium chloride, sodium citrate 2 H2O, sodium cyclamate, sodium bicarbonate, saccharine sodium 2 H2O, simeticon, sorbitol (ph.eur.), AromastofFE (cherry)

Note for diabetics
1 effervescent tablet contains 0.01 BE.

Like Ambrohexal cough-release effervescent tablets and content of the pack
Ambrohexal cough-soluble effervescent tablets are white, round effervescent tablets with one-sided breaker.
Ambrohexal cough-release effervescent tablets are in packs with 20 Effervescent tablets available.

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

This leaflet was last revised in June 2013.

Source: Information of the leaflet
Status: 07/2014