Naprosyn-Plus

Naproxen USP & Esomeprazole USP

Composition:
Naprosyn-Plus® 375/20 Tablet: Each tablet contains delayed release Naproxen USP 375 mg & immediate release Esomeprazole Magnesium USP equivalent to Esomeprazole 20 mg.
Naprosyn-Plus® 500/20 Tablet: Each tablet contains delayed release Naproxen USP 500 mg & immediate release Esomeprazole Magnesium USP equivalent to Esomeprazole 20 mg.
Properties and Effects:
Naprosyn-Plus® Consists of an immediate release Esomeprazole Magnesium layer & an enteric coated Naproxen core. As a result Esomeprazole is released first into the stomach,
prior to the dissolution of Naproxen in the small intestine.
Naproxen is a NSAID with analgesic & antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor
that suppresses gastric acid secretion by specific inhibition of the H+/k+ –ATP ase in the gastric parietal cell by acting specifically on the proton pump, Esomeprazole blocks the final
step in acid production, thus reducing gastric acidity.
Indication & Uses:
It is indicated for the relief of signs & symptoms of osteoarthritis, rheumatoid arthritis & ankylosing spondylitis & to decrease the risk of developing gastric ulcers in patients at risk of
developing NSAID associated gastric ulcers.
Dosage & Administration:
Carefully consider the potential benefits & risks of Naprosyn-Plus® & other treatment options before deciding to use Naprosyn-Plus®. Use the lowest effective dose for the shortest
duration consistent with individual patient treatment goals. If a dose of Esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be
considered.

Indication Dose Frequency

Naprosyn-Plus® 375/20
Rheumatoid Arthritis, Osteoarthritis, 1 tablet twice daily
Ankylosing Spondylitis
Naprosyn-Plus® 500/20

* Do not split, chew, crush or dissolve the tablet. Naprosyn plus is to be taken at least 30 minutes before meals.
Elderly patients:
Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. Use caution when high doses
are required & some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly use the lowest effective dose.
Patients with Moderate to severe Renal impairment:
Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min).
Hepatic insufficiency:
Monitor patients with mild to moderate hepatic impairment closely & consider a possible dose reduction based on the Naproxen component of Naprosyn-Plus®. Naprosyn-Plus® is
not recommended in patients with severe hepatic impairment because Esomeprazole dosage should not exceed 20 mg daily in these patients.
Children:
Dosage in children less than 18 years has not been established.
Use in pregnancy & lactation:
In pregnancy:
Pregnancy category C. In late pregnancy, it should be avoided because it may cause premature closure of the ductus arteriosus.
In lactation:
Naprosyn-Plus® should not be used in nursing mothers due to the Naproxen component.
Side-effects:
In general, Naprosyn-Plus® is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal
pain, nausea etc.
Contraindications:
• Known hypersensitivity to any component of Naprosyn-Plus® or substituted benzimidazoles
• History of asthma, urticaria or other allergic–type reactions after taking aspirin or other NSAIDs
• Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
• Late pregnancy
Precautions:
Patients with known CV disease/risk factors may be at greater risk. Naprosyn-Plus® should be used with caution in patients with fluid retention or heart failure.
Drug interaction:
• Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers
• Concomitant use of Naprosyn-Plus® and warfarin may result in increased risk of bleeding complication.
• Esomeprazole inhibits gastric acid secretion & may interfere with absorption of drugs where gastric pH is an important determinant of bioavailability (eg. Ketoconazole, iron salts and
digoxin).
Overdose:
There is no clinical data on overdosage with Naprosyn-Plus®.
Overdose of Naproxen: Significant naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea,
transient alteration in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.
Overdose of Esomeprazole: The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor and intermittent clonic convulsions etc.
54121

Storage:
Store in a cool & dry place, protect from light.
Keep out of reach of children.

Packs:
Naprosyn-Plus® 375/20 Tablet : Each box contains 6X8’s tablets in Alu-Alu blister strip.
Naprosyn-Plus® 500/20 Tablet : Each box contains 5X8’s tablets in Alu-Alu blister strip.

® Registered Trade Mark

Version No. : 01

Manufactured by
Radiant Pharmaceuticals Limited
B-34 & 46, BSCIC Industrial Estate
Tongi, Gazipur, Bangladesh. PMR5412
 jqJPk´JKxj-käJx ®

jqJPk´JPéj ACFxKk S APxJKok´J\u ACFxKk

Ck˙JkjJÎ
jqJPk´JKxj-käJx ® 375/20 aqJmPua: k´KfKa aqJmPuPa rP~PZ KcPuAc KrKu\ jqJPk´JPéj ACFxKk 375 Ko.V´J. FmÄ AKoKcP~a KrKu\ APxJKok´J\u oqJVPjKv~Jo ACFxKk pJ APxJKok´J\u 20 Ko.V´J. Fr xofáuqÇ
jqJPk´JKxj-käJx ® 500/20 aqJmPua : k´KfKa aqJmPuPa rP~PZ KcPuAc KrKu\ jqJPk´JPéj ACFxKk 500 Ko.V´J. FmÄ AKoKcP~a KrKu\ APxJKok´J\u oqJVPjKv~Jo ACFxKk pJ APxJKok´J\u 20 Ko.V´J. Fr xofáuqÇ
èjJmuLÎ
jqJPk´JKxj-käJx ® F rP~PZ AKoKcP~a KrKuP\r APxJKok´J\u oqJVPjKx~JPor ˜r FmÄ fJr ßnfPr FP≤KrT ßTJPac jqJPk´JPéjÇ pJr lPu ãáhsJPπ jqJPk´JPéj ßmr ymJr kNPmt k´gPo APxJKok´J\u kJT˙KuPf ßmr y~Ç
jqJPk´JPéj FTKa Fj.Fx.F.IJA.Kc. pJr mqgJ S \ôrjJvT ‰mKvÓq rP~PZ jqJPk´JPéPjr ßoJc Im IqJTvj yPuJ FKa ßk´JˆJVäJK¥j ‰frLPf mJiJ ßh~Ç APxJKok´J\u FTKa ßk´Jaj kJŒ AjKyKmar pJ VqJKÓsT kqJrJAaJu ßTJPw
KjKhtÓnJPm H+/K+ -ATP-F\ ßT mJiJ k´JhJj TrJr oJiqPo FKxc KjÎxrj TKoP~ ßlPuÇ KjKhtÓnJPm ßk´Jaj kJPŒr Ckr TJ\ TrJr lPu APxJKok´J\u FKxc ‰frLr ßvw iJkPT mº TPr ßh~ lPu FKxKcKa TPo pJ~Ç
KjPhtvjJ S mqmyJrÎ
IKˆSIJgsJtAKax, KrCoJaP~c IJgsJtAKax FmÄ IqJjTJAPuJK\Ä ¸K¥uJAKax Fr uãe S CkxVt KjrxPj FmÄ ßp xTu ßrJVLr Fj.Fx.F.IJA.Kc ßxmj xÄKväÓ VqJKÓsT IJuxJr ymJr x÷JmjJ rP~PZ fJPhr VqJKÓsT IJuxJr
ToJPjJr ßãP© FKa KjPhtKvfÇ
ßxmjoJ©J S KmKiÎ
jqJPk´JKxj-käJx ® mqmyJPrr kNPmt Fr xJPg IjqJjq KYKT&xJr x÷Jmq xMKmiJ S IxMKmiJ xJmiJjfJr xJPg KmPmYjJ TrJ k´P~J\jÇ k´PfqT ßrJVLr KYKT&xJr \jq k´P~J\jL~ Kjoúfo ßxmjoJ©J KjiJtrj TrPf yPmÇ pKh 40 Ko.V´J.
Fr To APxJKok´J\Pur k´P~J\j y~ fPm Knjú SwMi xyTJPr KYKT&xJ TrPf yPmÇ

KjPhtvjJ oJ©J mqmyJr KmKi

IKˆSIJgsJtAKax, KrCoJaP~c IJgsJAKax ®
jqJPk´JKxj-käJx 375/20
IqJjTJAPuJK\Ä ¸K¥uJAKax 1Ka TPr aqJmPua KhPj hMA mJr
jqJPk´JKxj-käJx ® 500/20

* aqJmPuaKa nJñJ, ßYJwJ, KYmJPjJ IgmJ hsmLnëf TrJ pJPm jJÇ jqJPk´JKxj-käJx ® aqJmPuaKa UJmJr I∂f 30 KoKja kNPmt ßxmj TrPf yPmÇ
m~Û ßrJVLPhr \jq:
krLãJr oJiqPo \JjJ pJ~ ßp, pKhS xŒNet käJ\oJ oJ©J IkKrmfLtf gJPT KT∂M oMÜ IÄPvr jqJPk´JPéj m~Û ßrJVLPhr ßãP© mOK≠ kJ~Ç pUj Có oJ©Jr ßxmj k´P~J\j fUj xJmiJjfJr xJPg mqmyJr TrJ CKYf FmÄ m~Û
ßrJVLPhr ßãP© ßxmjoJ©J kKrmftPjr k´P~J\j yPf kJPrÇ ßpPyfá m~Û ßrJVLPhr ßãP© IjqJjq SwMi mqmyJr TrJ y~ ßxPyfá x÷Jmq Kjoúfo oJ©J mqmyJr TrJ CKYfÇ
oiqmfLt ßgPT Có KTcKj xoxqJr ßrJVLPhr ßãP©:
jqJPk´JPéj xÍKuf SwMièPuJ oiqmfLt ßgPT Có kptJP~r KTcKj xoxqJr ßrJVLPhr ßãP© (KâP~KaKjj KTî~JPr¿<30 .Ko.Ku/KoKja) KjPhtKvf j~Ç
ßykJKaT xoxqJ \Kjf ßrJVLPhr ßãP©:
I· yPf oiqmfLt ßykJKaT xoxqJr ßrJVLPhr ßãP© KjKmz kptPmãe TrPf yPm FmÄ jqJPk´JKxj-käJx® Fr ßnfr jqJPk´JPéPjr kKroJj KyPxm TPr oJ©J kMjÎ KjitJrj TrPf yPmÇ fLms ßykJKaT xoxqJr ßrJVLr ßãP©
jqJPk´JKxj-käJx® KjPhtKvf j~ TJrj FxTu ßrJVLr ßãP© APxJKok´J\u Fr oJ©J ‰hKjT 20 KoKuV´JPor ßmvL k´P~JV TrJ pJPm jJÇ
KvÊPhr ßãP©:
18 mZPrr To m~Û KvÊPhr ßãP© Fr oJ©J KjiJtKrf ßjAÇ
VnJtm˙J~ S ˜jqhJjTJPu mqmyJrÎ
VntJm˙J~:
ßk´VjqJK¿ TqJaJVKr Kx: VntJm˙Jr ßvPwr KhPT mqmyJr m\tj TrJ CKYf, TJrj FKa cJÖJx IJPatKrSxJPxr IkKref mPºr TJrj yPf kJPrÇ
˜jqhJjTJPu:
jqJPk´JPéj gJTJr TJrPj ˜jqhJjTJPu FKa mqmyJr TrJ CKYf j~Ç
kJvõtk´KfKâ~JÎ
xJiJrjf jqJPk´JKxj-käJx ® xMxyjL~Ç KTîKjTqJu asJ~JPu ßp xTu kJvõtk´KfKâ~J ßhUJ pJ~ (>5%) fJ yPuJ- APrJKxn VqJˆsJAKax, KcxPkkKx~J, VqJˆsJAKax, kJfuJ kJ~UJjJ, VqJKÓsT IJuxJr, ßkPar CkPrr IÄPv mqgJ,
mKo mKo nJm AfqJKhÇ
k´KfKjPhtvjJÎ
• jqJPk´JKxj-käJx ® Fr ßp ßTJj CkJhJj IgmJ k´Kf˙JKkf ßmjK\KocJ\u Fr xJPg k´KfKjPhtKvf yPuÇ
• IqJ\oJ, YMuTJKj gJTPu IgmJ IqJxKkKrj mJ IjqJjq Fj.Fx.F.IJA.Kc.Fr xJPg kNPmt YáuTJjL \JfL~ Kâ~J yP~ gJTPuÇ
• TPrJjJrL IJatJrL mJAkJx V´Jl&a xJ\tJrL YuJTJuLj Im˙J~Ç
• VnJtm˙Jr ßvPwr KhPTÇ
xftTfJÎ
Âh\Kjf xoxqJr ßrJVL IgmJ ÂhPrJPVr ^ÅMKT rP~PZ Foj ßrJVLPhr ßãP© xfTtfJ ImuÍj TrJ k´P~J\jÇ FZJzJS jqJPk´JKxj-käJx ® lîáAc KrPajvj S yJat ßlAur ßrJVLPhr ßãP© xJmiJjfJr xJPg mqmyJr TrJ CKYfÇ
csJV A≤JrqJTvjÎ
• Fj.Fx.F.IJA.Kc Fr xJPg mqmyJPrr lPu F.Kx.A. AjKyKmaPrr FK≤yJAkJrPajKxn APlÖ, cJAACPrKaT FmÄ KmaJ mäTJPrr TJptãofJ y∑Jx ßkPf kJPrÇ
• S~JrPlKrPjr xJPg mqmyJr TrPu rÜãre \Kjf xoxqJ mOK≠ TrPf kJPrÇ
• APxJKok´J\u VqJKÓsT FKxPcr CkJhJj TKoP~ ßh~ pJr lPu ßp xTu SwMPir mJP~JIqJPnAKuKmKuKa KjiJtrPjr \jq VqJKÓsT pH FTKa èrfôkNet Kmw~ fJPhr ßvJwj mqyf yPf kJPr (ßpoj: KTPaJPTJjJ\u, IJ~rj xæ, KcVKéj)Ç
oJ©JKiTqÎ
jqJPk´JKxj-käJx Fr oJ©JKiTqÎ
jqJPk´JKxj-käJx ® oJ©JKiPTqr ßTJj KTîKjTqJu ßcaJ kJS~J pJ~ jJÇ
jqJPk´JPéPjr oJ©JKiTq uãeèPuJ yu- ImxjúfJ, WMo WMo nJm, ßka mqJgJ, ßkPa I˝K˙, mMT\ôJuJ, mhy\o, mKo mKo nJm, xJoK~TnJPm KunJr Kâ~Jr kKrmftj, yJAPkJPk´JgKÍPjKo~J, ßrjJu xoxqJ, ßoaJmKuT FKxPcJKxx,
võJxTÓ, mKo yS~J AfqJKhÇ
APxJKok´J\Pur oJ©JKiTqÎ
uãeèPuJ yu- ßoJar TJptãofJ y∑Jx kJS~J, võJx KjPf xoxqJ, TJÅkMKj FmÄ A≤JrKoPa≤ ßTîJKjT TjnJuvj AfqJKhÇ
xÄrãeÎ
IJPuJ ßgPT hNPr bJ¥J S ÊÏ ˙JPj rJUMjÇ
54121

xTu k´TJr SwMi KvÊPhr jJVJPur mJAPr rJUMjÇ

xrmrJyÎ
jqJPk´JKxj-käJx ® 375/20 aqJmPuaÎ k´Kf mPé rP~PZ 6 X 8Ka aqJmPuPar IqJuM-IqJuM KmäˆJrÇ
jqJPk´JKxj-käJx ® 500/20 aqJmPuaÎ k´Kf mPé rP~PZ 5 X 8Ka aqJmPuPar IqJuM-IqJuM KmäˆJrÇ

Km˜JKrf fPgqr \jq AÄPr\L IÄv hsÓmqÇ

® ßrK\ˆsJct ßascoJTt

k´˜áfTJrT
ßrKcP~≤ lJotJKxCKaTqJu&x KuKoPac
Km-34 S 46, KmKxT Kv· FuJTJ
añL, VJ\LkMr, mJÄuJPhvÇ