COMPOSITION :
Exovon® Tablet 8 mg, each tablet contains : Bromhexine HCl 8 mg.
INDICATION :
As a mucolytic to facilitate productive cough.
DOSAGE AND ADMINISTRATIONS :
- Adults and children > 10 years : 1 tablet, 3 times daily.
- Children 5 – 10 years : ½ tablet, 3 times daily.
- Children 2 – 5 years : ½ tablet, 2 times daily.
CONTRAINDICATION :
Hypersensitive to Bromhexine HCl.
WARNINGS AND PRECAUTIONS :
- There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP) associated with the administration of Bromhexine HCl. If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, Bromhexine HCl treatment should be discontinued immediately and medical advice should be sought.
- Careful use in patients with peptic ulcers and pregnant women especially in the first trimester.
- Lactating women.
DRUG INTERACTIONS :
Concomitant administration with antibiotics (Amoxicillin, Cefuroxime, Doxycycline) leads to higher antibiotic concentration.
ADVERSE REACTIONS :
-
- Nausea, diarrhea, gastrointestinal disturbance, bloating can occur but usually mild. Headache, vertigo, sweating and skin rashes have been reported. Increase of transaminase can also occur.
- Immune system disorder
Rare : Hypersensitivity reactions.
Not known : Anaphylactic reactions including anaphylactic shock, angioedema and pruritus.
- Skin and subcutaneous tissue disorders
Rare : Rash, urticaria.
Not known : Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/ toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
PRESENTATION :
Exovon® Tablet 8 mg Box, 10 strips @ 10 tablets Reg. No. DTL7802320010A1
STORAGE :
STORE BELOW 30ºC
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
