GUAPHANDM® 100ML SYRUP WARNING: !)j'-i~~~;:;:;;;;;:~-;;;;~;;;;==~ e A0 tak-e his product for pers~tent~or ThisIs. _ chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by physician. A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a physician. PRECAUTION~:~_~ __ Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or COMPOSITION: Syrup: Each 5 ml contains Guaifenesin (EP) 100 mg and Dextromethorphan Hydrobromide (USP) 10 mg. CLINICAL PHARMACOLOGY: Guaifenesin reduces the adhesiveness and surface tension of respiratory tract secretions, thereby easing their expectoration .Expectorant effect can reduce cough frequency. Dextromethorphan Hydrobromide acts centrally and elevates the threshold for coughing. In therapeutic dosage, Dextromethorphan Hydrobromide dose not inhibit ciliary activity. INDICATIONS: GUAPHAN OM has temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. CONTRAINDICATIONS: Do not take this product if you are hypersensitive to any of the ingredients. This medication should not be used for treatment of cough and cold symptoms in children under 6 years of age. ADVERSE REACTIONS: Drowsiness, dizziness and gastrointestinal disturbances. Parkinson disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a physician before taking this product. +use DURING PREGNANCY AND LACTATION: As with any drug, if you are pregnant or nursing a baby, seek the advice of a physician before using this product. DOSAGE: Adults and children 12 years and over: 10 ml every 4 hours. Children: 6 years to under 12 years: 5 ml every 4 hours. _ Do no exceed 6 doses in a 24 J - period. - STORAGE: Store at room temperature (15-25) °C. Do not use the drug after the expiry date printed on the package. PRESENTATION: 100 ml bo Ie. To Report any side effect(s) or Quality Problems: "ational Pharmacovigilance Center , PC) • Fax: +96&-1-205-7662 • E-mail: [email protected] • website: www.sfda.gov.salnpc • Al'!"J8CIc:rwt •• ~~"''JOfI''''''''''b~c:c:n-aryk:l ••.. .dDW.~u,a.;. • ~--=r":tocu"s~ .....-.:del ••• ad .....wa:or.~•• ~""IOC ~ • ~xao:...o x.-.:::._ ~ I'l; =----...., •••.. • :k<'U,:,r.o.onlif..-u:t patCJdd~~b,a.... · ~"'U..-:~ .•..• ~WC'JQ;,t~J'CU'dDca::Jr "-- out of •• f-..ch 01 c:h1IdrIwI Cou'd ofAnb ••••••• ~ ....-of .•.... _ R IYADH ~=--1-~ PliARMA - Manufactured by RIYADH PHARMA Medical and Cosmetic Products Co. Ltd. Riyadh, Saudi Arabia. RIYADHrfl 'HAlUlA I.:S:d Revised June 2011 GUAPHAN OM is a trademark ITEM CODE: PIL0441 ••••••••••• , •• we •• w ••.~•• _ •.• i_J••••• I =•• ,==,._•••__......••• =::i •••••• ~ ••••• l •••••• Y~'1'-.YA"I""~'" pharmacia pharmacia pharmacia

Guaphan Dm Syrup Patient Information Leaflet

Download PDF Report

Upload
pharmacia1com
View
49
Download
2

Embed Size (px)

DESCRIPTION

النشرة الداخلية

Citation preview

Page 1: Guaphan Dm Syrup Patient Information Leaflet

GUAPHANDM® 100ML SYRUP

WARNING: !)j'-i~~~;:;:;;;;;:~-;;;;~;;;;==~~=te A0 tak-e his product for pers~tent~or ThisIs. _

chronic cough such as occurs with smoking,asthma, chronic bronchitis, emphysema or ifcough is accompanied by excessive phlegm(mucus) unless directed by physician.A persistent cough may be a sign of a seriouscondition. If cough persists for more than oneweek, tends to recur, or is accompanied byfever, rash or persistent headache, consult aphysician.

PRECAUTION~:~_~ __Do not use this product if you are now takinga prescription monoamine oxidase inhibitor(MAOI) (certain drugs for depression,psychiatric or emotional conditions or

COMPOSITION:Syrup:Each 5 ml contains Guaifenesin (EP) 100 mgand Dextromethorphan Hydrobromide (USP)10 mg.

CLINICAL PHARMACOLOGY:Guaifenesin reduces the adhesiveness andsurface tension of respiratory tract secretions,thereby easing their expectoration .Expectoranteffect can reduce cough frequency.Dextromethorphan Hydrobromide actscentrally and elevates the thresholdfor coughing. In therapeutic dosage,Dextromethorphan Hydrobromide dose notinhibit ciliary activity.

INDICATIONS:GUAPHAN OM has temporarily relievescough due to minor throat and bronchialirritation as may occur with a cold and helpsloosen phlegm (mucus) and thin bronchialsecretions to make coughs more productive.

CONTRAINDICATIONS:Do not take this product if you arehypersensitive to any of the ingredients.This medication should not be used fortreatment of cough and cold symptoms inchildren under 6 years of age.

ADVERSE REACTIONS:Drowsiness, dizziness and gastrointestinaldisturbances.

Parkinson disease), or for 2 weeks afterstopping the MAOI drug. If you are uncertainwhether your prescription drug contains anMAOI, consult a physician before taking thisproduct.

+use DURING PREGNANCY AND LACTATION:As with any drug, if you are pregnant ornursing a baby, seek the advice of a physicianbefore using this product.

DOSAGE:Adults and children 12 years and over:10 ml every 4 hours.

Children:6 years to under 12 years: 5 mlevery 4 hours. _Do no exceed 6 doses in a 24 J -

period. -

STORAGE:Store at room temperature (15-25) °C.Do not use the drug after the expirydate printed on the package.

PRESENTATION:

100 ml bo Ie.

To Report any side effect(s) or Quality Problems:

"ational Pharmacovigilance Center , PC)• Fax: +96&-1-205-7662• E-mail: [email protected]• website: www.sfda.gov.salnpc

• Al'!"J8CIc:rwt •• ~~"''JOfI''''''''''b~c:c:n-aryk:l••.. .dDW.~u,a.;.

• ~--=r":tocu"s~ .....-.:del ••• ad .....wa:or.~••~""IOC ~

• ~xao:...o x.-.:::._ ~ I'l; =----...., •••..• :k<'U,:,r.o.onlif..-u:t patCJdd~~b,a....· ~"'U..-:~.•..•~WC'JQ;,t~J'CU'dDca::Jr"--out of •• f-..ch 01c:h1IdrIwI

Cou'd of Anb ••••••• ~....-of .•...._

R IYADH ~=--1-~PliARMA -

Manufactured by RIYADH PHARMAMedical and Cosmetic Products Co. Ltd.

Riyadh, Saudi Arabia.

RIYADHrfl'HAlUlA I.:S:d

Revised June 2011 GUAPHAN OM is a trademarkITEM CODE: PIL0441

••••••••••• , •• we •• w ••.~•• _ •.• i_J ••••• I =••,==,._ •••__......•••=::i •••••• ~ ••••• l •••••• Y~'1'-.YA"I""~'"

pharmacia