4 MG/5 ML RIAXINE® SYRUP COMPOSITION: Syrup: Each 5 ml contains Hydrochloride (BP) 4 mg. CLINICAL PHARMACOLOGY: RIAXINE (Bromhexine Hydrochloride) is a clinically proven, systemically active mucolytic agent, which manifested by an increase in sputum production and expectoration. This action becomes evident after 2-3 days following therapy. RIAXINE makes the sputum thinner which leads to reducing sputum viscosity. Bromhexine INDICATIONS: RIAXINE is used for treatment of acute and chronic respiratory tract disorders associated with viscid mucus. CONTRAINDICATIONS: There are no absolute contraindication to Bromhexine. It is not indicated in subjects with individual ascertained hypersensitivity to Bromhexine. PRECAUTIONS: None. ADVERSE REACTIONS: Very mild occasional gastro-intestinal side effects may occur. 100 ML SPECIAL CARE: Administer with caution to patients with gastro-duodenal ulcer. EFFECTS ON DRIVING AND MACHINE USE: RIAXINE dose not influence driving capacity and vigilance when using machinery. STORAGE: Store at room temperature (15-25) °C, protected from light. Do not use the drug after the expiry date printed on the package. PRESENTATION: - - 100 ml bottles. - This is a medicament • A medicamen IS a product. which affects your heatth, and Its consumpllon contrary to instructions is dangerous or you. • Follow strictty the doctor's prescription, the method of use and the instructions of the pharmacist who sold the medicament. • The doctor and the pharmacist are experts in medicine, its benefits and risks. USE DURING PREGNANCY AND LACTATION: Bromhexine has no teratogenic effects, but it is advisable to avoid use during the rs trimester of pregnancy. DOSAGE: Adults : 5 to 10 ml ree times a day. Children: 2.5 to 5 ml three irnes a day. No toxic effects due to overdose are repo ed since the molecule is well tolerated even at high doses. • 0 no y yourselt Interrupt the penod of treatment prescribed for you. • Do not repeat tI1e same prescr 0ClC1SU.:g 00d0r'_ anufactured by RIYADH PHARMA edicaJ and Cosme 'c Products Co. Ltd. ;yadh, Saudi Arabia Revised Nov. 2004 RIAXINE is a trademark ITEM CODE: PIL0274 pharmacia pharmacia

Riaxine Syrup Patient Information Leaflet

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Page 1: Riaxine Syrup Patient Information Leaflet

4 MG/5 MLRIAXINE® SYRUP

COMPOSITION:Syrup:Each 5 ml containsHydrochloride (BP) 4 mg.

CLINICAL PHARMACOLOGY:RIAXINE (Bromhexine Hydrochloride) isa clinically proven, systemically activemucolytic agent, which manifested byan increase in sputum production andexpectoration. This action becomes evidentafter 2-3 days following therapy. RIAXINEmakes the sputum thinner which leads toreducing sputum viscosity.

Bromhexine

INDICATIONS:RIAXINE is used for treatment of acute andchronic respiratory tract disorders associatedwith viscid mucus.

CONTRAINDICATIONS:There are no absolute contraindication toBromhexine. It is not indicated in subjectswith individual ascertained hypersensitivityto Bromhexine.

PRECAUTIONS:None.

ADVERSE REACTIONS:Very mild occasional gastro-intestinal sideeffects may occur.

100 ML

SPECIAL CARE:Administer with caution to patients withgastro-duodenal ulcer.

EFFECTS ON DRIVING AND MACHINEUSE:RIAXINE dose not influence driving capacityand vigilance when using machinery.

STORAGE:Store at room temperature (15-25) °C,protected from light.Do not use the drug after the expiry dateprinted on the package.

PRESENTATION: --100 ml bottles. -

This is a medicament

• A medicamen IS a product. which affects yourheatth, and Its consumpllon contrary to instructionsis dangerous or you.

• Follow strictty the doctor's prescription, the methodof use and the instructions of the pharmacist whosold the medicament.

• The doctor and the pharmacist are experts inmedicine, its benefits and risks.

USE DURING PREGNANCY ANDLACTATION:Bromhexine has no teratogenic effects, butit is advisable to avoid use during the rstrimester of pregnancy.