ezolvin syrup patient information leaflet

Ezolvin ~~ Side Effects EZOLVI erated though it may cause mild ga al disturbances, transient rise in liver es. Also hypersensitivity reactions ----....-f'flStY-ocetJf like skin fashes--~flgio-oedemcr.~---'" - - - - Name of the Product EZOLVIN Tablets. EZOLVIN Syrup. - - Composition Each EZOLVIN tablet contains: Bromhexine HCI 8 mg. Each 5 ml of EZOLVIN syrup contains: Bromhexine HCI 4 mg. Presentation EZOLVIN tablets available in blister packs of 20 tablets. EZOLVIN syrup available in glass bottles size of 60 & 100 rnl. Indications EZOLVIN is a mucolytic used in the treatment of acute & chronic respiratory diseases associatedwith productive cough in which there is abnormal mucus secretion or transport It is suitable to be taken with antibiotics in cases of respiratory infections. EZOLVIN works by reducing the viscosity of the mucus, increasing its mass & activating the epithelial ciliated cells leading to facilitate expectoration by coughing as in cases of: o€ Bronchial Asthma. ___ ~';-Prl:>FeflGRitiswith BFOAchospasnr.--- ~ Emphysema . .,{ Acute & Chronic Pneumonia. Dosage & Administration ~ Children < 2 years: 1/4 teaspoonful (1.25 ml) of EZOLVIN syrup three times daily. o€ Children 2-5 years: 1/2 EZOLVIN tablet, twice daily or 1/2 teaspoonful (2.5 ml) of EZOLVIN syrup three times daily. at Children 5-10 years: 1/2 EZOLVIN tablet, or 1 teaspoonful (5 ml) of EZOLVIN syrup three times daily. o€ Adults & children >10 years: 1 EZOLVIN tablet, or 2 teaspoonful (10 ml) of EZOLVIN syrup three ti es daily. Precautions EZOLVIN should be taken with caution in patients history of peptic ulcer & severe hepatic or re al impairment. Care should be taken if EZOLVIN is given for lactating or pregnant women especially in the first trimester. Contra indications EZOLVI s Id no be used for patients suffering from hypersensitivity 0 Bromhexine or who have acute pep ulcer. Drug Interactions CoPcurrent use of Bromhexine with antibiotics ncrease their penetration into lung tissues & bronchial secretions. Pharmacokinetics EZOLVIN is rapidly absorbed after oral administration, peak plasma concentration occurs in one hour. It is excreted mainly in the urine. Overdosage No symptoms 0 overdosage were reported, but if occur symptomatic treatment is required. Storage Conditions Store belo 25°C, protect from light. • A medicine isa product that affects your health, and its consumption c to instructions isharmful to you. • Follow strictly the doctor's prescription, the method of useand tnstrucuo-a of the pharmacist who dispensed the medicine. • The doctor and the pharmacist are experts in medicine, its benefits and harms. • Do not stop taking this medication, unless advised by your doctor. • Do not repeat the same prescription without consulting your doctor. Keep medicine out of reach of cnndren, Council of Arab Health Ministers - Union of Arab Pharmacists Kuwait Saudi Pharmaceutical Industries Co. Review Date: MARCH/200B ."'0 ff"lfonl :~Ij-."'o rfvfo·,f/r/f:....uLA-~~14....i..b...o..1-.j~-~,.s.JI4J~ 1r·D' :1/"'~lj.oO.,Jl-ol...i.....AJ1 oolT :,",:,.~ P.O.Box: 5512 Safat - Postal Code: 13056 State of Kuwait - Subhan . Industrial Area - Tel, .965 24745012/3/4 . Fax: .965 24745361 www.kspico.com pharmacia pharmacia pharmacia pharmacia

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Ezolvin~~

Side EffectsEZOLVI erated though it may causemild ga al disturbances, transient risein liver es. Also hypersensitivity reactions

----....-f'flStY-ocetJf like skin fashes--~flgio-oedemcr.~---'"

----Name of the ProductEZOLVIN Tablets.EZOLVIN Syrup.

--CompositionEach EZOLVIN tablet contains:Bromhexine HCI 8 mg.Each 5 ml of EZOLVIN syrup contains:Bromhexine HCI 4 mg.

PresentationEZOLVIN tablets available in blister packs of20 tablets.EZOLVIN syrup available in glass bottles sizeof 60 & 100 rnl.

IndicationsEZOLVIN is a mucolytic used in the treatmentof acute & chronic respiratory diseasesassociatedwith productive cough in which thereis abnormal mucus secretion or transportIt is suitable to be taken with antibiotics in casesof respiratory infections.EZOLVIN works by reducing the viscosity of themucus, increasing its mass & activating theepithelial ciliated cells leading to facilitateexpectoration by coughing as in cases of:o€ Bronchial Asthma.

___ ~';-Prl:>FeflGRitiswith BFOAchospasnr.---~ Emphysema ..,{ Acute & Chronic Pneumonia.

Dosage & Administration~ Children < 2 years:

1/4 teaspoonful (1.25 ml) of EZOLVIN syrupthree times daily.

o€ Children 2-5 years:1/2 EZOLVIN tablet, twice daily or 1/2teaspoonful (2.5 ml) of EZOLVIN syrup threetimes daily.

at Children 5-10 years:1/2 EZOLVIN tablet, or 1 teaspoonful(5 ml) of EZOLVIN syrup three times daily.

o€ Adults & children >10 years:1 EZOLVIN tablet, or 2 teaspoonful(10 ml) of EZOLVIN syrup three ti es daily.

PrecautionsEZOLVIN should be taken with caution in patients

history of peptic ulcer & severe hepatic orre al impairment. Care should be taken ifEZOLVIN is given for lactating or pregnant womenespecially in the first trimester.

Contra indicationsEZOLVI s Id no be used for patients sufferingfrom hypersensitivity 0 Bromhexine or who haveacute pep ulcer.

Drug InteractionsCoPcurrent use of Bromhexine with antibiotics

ncrease their penetration into lung tissues& bronchial secretions.

PharmacokineticsEZOLVIN is rapidly absorbed after oraladministration, peak plasma concentration occursin one hour. It is excreted mainly in the urine.

OverdosageNo symptoms 0 overdosage were reported,but if occur symptomatic treatment is required.

Storage ConditionsStore belo 25°C, protect from light.

• A medicine is a product that affects your health, and its consumption c to instructions is harmful to you.• Follow strictly the doctor's prescription, the method of use and tnstrucuo-a of the pharmacist who dispensed the medicine.• The doctor and the pharmacist are experts in medicine, its benefits and harms.• Do not stop taking this medication, unless advised by your doctor.• Do not repeat the same prescription without consulting your doctor.

Keep medicine out of reach of cnndren,

Council of Arab Health Ministers - Union of Arab Pharmacists

Kuwait Saudi Pharmaceutical Industries Co .

Review Date: MARCH/200B

."'0 ff"lfonl :~Ij-."'o rfvfo·,f/r/f:....uLA-~~14....i..b...o..1-.j~-~,.s.JI4J~ 1r·D' :1/"'~lj.oO.,Jl-ol...i.....AJ1 oolT :,",:,.~P.O.Box: 5512 Safat - Postal Code: 13056 State of Kuwait - Subhan . Industrial Area - Tel, .965 24745012/3/4 . Fax: .965 24745361

www.kspico.com

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