Ambroxol tab 30mg #20

Ambroxol Tablet 30 mg
Composition:

Each tablet contains Ambroxol hydrochloride – 30.0 mg.
Excipients: Lactose, microcrystalline cellulose, corn starch, magnesium stearate, colloidal anhydrous silica, povidone 30, talc.

Indications:

Ambroxol tablets are used in respiratory diseases where mucus is thick and sticky, and the disease is accompanied by difficulty in expectoration:

• Acute and chronic bronchitis

• Pneumonia

• Bronchial asthma

• Bronchiectasis

Contraindications:

Absolute contraindications:

• Hypersensitivity to ambroxol or any of the other components of the finished product

• Peptic ulcer of the stomach or duodenum

• Epileptic syndrome

• Children under 2 years of age (other dosage forms such as syrup are available for pediatric use)

Use during pregnancy and lactation:

Although no reliable data exist on adverse effects of ambroxol on the fetus or breastfed infants, use of this product during pregnancy (especially in the first trimester) and lactation is only permissible when the potential benefit to the mother outweighs the possible risk to the fetus or infant.

Method of administration and dosage:

Ambroxol tablets should be taken orally after meals with a sufficient amount of warm liquid (e.g., water, juice, or tea).

• Adults and children over 12 years:
  1 tablet 3 times daily (90 mg per day) for the first 2–3 days. Treatment is then continued with 1 tablet 2 times daily (60 mg per day).

• Children 6 to 12 years:
  Half a tablet 2–3 times daily (30–45 mg per day) for the first two days. Treatment is then continued with 1 tablet twice daily (30 mg per day).

Duration of treatment depends on the characteristics of the disease. Without a doctor’s recommendation, treatment should not exceed 4–5 days.

Side effects:

Rarely observed:

• Weakness

• Headache

• Dryness of the mouth and respiratory tract

• Salivation

• Rhinorrhea

• Stomach pain

• Nausea

• Vomiting

• Diarrhea

• Constipation

• Dysuria

• Skin rash (exanthema)

If any side effects occur, including those not mentioned in this leaflet, consult your doctor or pharmacist.

Overdose:

Ambroxol is generally well tolerated up to doses of 25 mg/kg.
Symptoms of overdose:

• Increased salivation

• Nausea

• Vomiting

• Decreased blood pressure

Treatment:

• Gastric lavage within the first 1–2 hours after ingestion

• Intake of fat-containing food

• Monitoring of hemodynamic parameters

• Symptomatic treatment if necessary

Storage conditions:

Store in a dry place, protected from light, out of the reach of children, at a temperature not exceeding 25°C.