Ambrohexal 7.5 mg/ml cough solution 50 ml

Ambrohexal is an expectorant cough medicine. It loosens congested and sticky secretions from the bronchial wall and makes it easier to cough up. By reducing the viscosity and activating the ciliated epithelium, the removal of mucus should be promoted.

Areas of application
to support acute and chronic diseases of the respiratory tract that are associated with a disorder of mucus formation and transport such as

• acute and chronic inflammation of the bronchial mucosa (bronchitis)
• asthmaähnliche (asthmoide) Bronchitis
• Bronchial asthma with disorders of secretion elimination

If you don't feel better or feel worse after 4 to 5 days, contact your doctor.

Contraindications

Ambrohexal must not be taken

• if you are allergic to ambroxol hydrochloride or any of the other ingredients of this medicine listed in section 6
• if you have an existing stomach or duodenal ulcer
• if you are an asthmatic with sulfite hypersensitivity

Interactions

Using Ambrohexal with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Cough-suppressing medicines (antitussives):
If Ambrohexal is used together with medicines that inhibit the urge to cough (antitussives), a dangerous build-up of secretions can occur due to the restricted cough reflex. You may therefore only use Ambrohexal together with antitussive medicines if your doctor has expressly ordered this.

Medicines for the treatment of bacterial infections (antibiotics):
The simultaneous use of Ambrohexal and medicines against bacterial germs (antibiotics such as amoxicillin, cefuroxime, doxycycline and erythromycin) leads to a higher concentration of antibiotics in the lung tissue.

The ingredient sulfite is a reactive compound. Mixtures with other medicines should therefore be avoided.

Application

Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist tells you. Check with your doctor or pharmacist if you are unsure.

The recommended dose is:
Adults
and adolescents over 12 years of age
take 4 ml 3 times a day at the start of treatment, corresponding to 80 drops 3 times a day. For long-term use, the dose can be reduced to 2 ml 3 times a day, equivalent to 40 drops 3 times a day.

Children:
Infants up to 2 years receive 1 ml twice a day, equivalent to 20 drops twice a day. Children aged 2 to 6 years receive 1 ml 3 times a day, equivalent to 20 drops 3 times a day.
Children aged 6 to 12 years receive 2 ml 2 – 3 times a day, corresponding to 40 drops 2 – 3 times a day.

For inhalation
, adults, adolescents and children over 6 years of age
inhale 2 - 3 ml 1 - 2 times a day or 40 - 60 drops 1 - 2 times a day.

Toddlers and children under 6 years of age
inhale 2 ml 1 - 2 times daily, equivalent to 40 drops 1 - 2 times daily.

Ambrohexal may only be given to infants under 2 years of age on medical advice.

Kidney and/or liver disease:
If there is severe impairment of kidney function (renal insufficiency) or liver function (liver insufficiency), a lower dose or a longer interval between applications should be chosen after consultation with the doctor.

Method of administration
To be taken orally or for inhalation.
It is recommended to take the solution diluted with tea, fruit juice or water after meals. The preparation comes with a measuring cup with graduations of 1 - 10 ml.
A suitable inhalation device must be used for inhalation (observe the instructions for use). When using Ambrohexal in the respirator (inhalation device), physiological saline solution can be added to the solution in a ratio of 1:1, thereby achieving optimal humidification.
Since inhaling aerosols too deeply can cause a cough, you should breathe in and out normally when inhaling. For particularly sensitive patients, warming the inhalant to body temperature is recommended. Patients with bronchial asthma should use a bronchospasmolytic before inhalation with Ambrohexal (ask your doctor).

Mixing Ambrohexal with other solutions should be avoided.

Duration of application
The duration of application must be decided individually depending on the area of ​​application and the course of the disease.
If you don't feel better after 4 to 5 days or even feel worse, contact your doctor.

During treatment with Ambrohexal you should drink plenty of fluids (e.g. juice, tea, water). This will support the expectorant effect of Ambrohexal.

Side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Common (may affect up to 1 in 10 people)

• Taste changes
• nausea
• Numbness in the mouth/throat

Uncommon (may affect up to 1 in 100 people)

• Vomit
• Diarrhea
• Indigestion
• stomach pain
• Dry mouth

Rare (may affect up to 1 in 1,000 people)

• Hypersensitivity reactions
• skin rash
• Hives

Not known (frequency cannot be estimated from available data)

• Allergic reactions including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissue, mucous membrane or tissue under the mucous membrane) and itching
• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis)
• Dryness of the throat

Due to the alkyl-4-hydroxybenzoate (paraben) content, hypersensitivity reactions can occur in predisposed patients, particularly on the skin, mucous membranes and eyes.
Due to the sodium disulfite content (preservative), hypersensitivity reactions can occur in individual cases, particularly in asthmatics, which can manifest themselves as vomiting, diarrhea, shortness of breath, acute asthma attack, impaired consciousness or life-threatening failure of the circulatory system (shock). These reactions can vary greatly from person to person and can also lead to life-threatening conditions.

composition

The active ingredient is ambroxol hydrochloride.
1 ml solution (corresponding to 20 drops) contains 7.5 mg ambroxol hydrochloride.

The other ingredients are:
citric acid, sodium disulfite (E 223), sodium hydroxide, methyl 4-hydroxybenzoate (E 218), propyl 4-hydroxybenzoate (E 216), purified water

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