Tab Erwin

Leaflet
Erwin 50mg/75mg Tablets

PREGNANCY AND LACTATION:
is contra-indicated in pregnancy (see Contra-indications) and during lactation
50mg/75mg Tablets KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The toxic dose of has not been determined and there is no experience of over-dosage, intensification of the pharmacological
effects may occur with over-dosage. Management of acute poisoning with essentially consists of supportive and symptomatic
measures. It is reasonable to take measures to reduce absorption of any recently consumed drug by forced emesis, gastric lavage
COMPOSITION: or activated charcoal
50mg Tablets
Each tablet contains: STABILITY: See expiry on pack
Diclofenac sodium BP (enteric coated) ..........50mg
Misoprostol MS ...........................................200mcg PRESENTATION:
50mg tablets are available in blister packs of 20 tablets
75mg Tablets 75mg tablets are available in blister packs of 20 tablets
Each tablet contains:
Diclofenac sodium BP (enteric coated) ..........75mg INSTRUCTIONS:
Misoprostol MS ...........................................200mcg To be swallowed whole with water
Keep out of reach of children
PHARMACOLOGICAL ACTION: Avoid exposure to heat, light and humidity
Diclofenac is a non-steroidal anti-inflammatory drug with anti-inflammatory and analgesic properties. Misoprostol is used for the Store at 25° or below
prophylaxis of NSAIDs induced gastric and duodenal ulceration. The pharmacokinetic profiles of diclofenac and misoprostol administered Improper storage may deteriorate the medicine
are similar to the profiles when the two drugs are administered as separate tablets
INDICATIONS:
Diclofenac is indicated for the treatment of sign and symptoms of osteoarthritis, rheumatoid arthritis, acute musculoskeletal disorders.
Misoprostol is indicated for the prevention of NSAID induced gastric and duodenal ulceration
DOSAGE AND DIRECTIONS FOR USE:

Adults
50mg Tablets: One tablet to be taken with food, two to three times daily
75mg Tablets: One tablet to be taken with food, two times daily
Tablet to be swallowed whole with water
OR
As directed by the physician
CONTRA-INDICATIONS:
is contra-indicated in patients with active gastro-intestinal bleeding and in patients with known gastric and/or duodenal
ulceration. is contra-indicated in pregnancy as it may increase uterine tone and contractions in pregnancy which could
produce miscarriage. Also, it may cause premature closure of the ductus arteriosus
is contra-indicated during lactation Manufactured by:
is contra-indicated in patients with a known hypersensitivity to diclofenac, aspirin, other NSAIDs and misoprostol SAMI PHARMACEUTICALS (PVT) LTD.
F-95, S.I.T.E., Karachi-Pakistan
WARNINGS: www.samipharmapk.com
should not be used in pre-menopausal women unless they use effective contraception and have been advised of the risks
of taking the product if pregnant
Elderly/Renal Impairment/Hepatic Impairment

No adjustment of dosage is necessary in the elderly or in patients with hepatic impairment or mild to moderate renal impairment as
pharmacokinetics are not altered to any clinically relevant extent. Nevertheless, patients with severe renal or hepatic impairment should
be closely monitored
Children
The safety and efficacy of in children has not been established
SIDE-EFFECTS:
Gastro-intestinal: Abdominal pain, diarrhoea, nausea, dyspepsia, flatulence, vomiting, gastritis, constipation, eructation and gastro
duodenal ulcerations/erosions
Magnesium containing antacids may aggravate the diarrhoea caused by
Liver: Clinically significant elevations of SGPT, SGOT, alkaline phosphatase or bilirubin have been observed in association with
without symptomatic evidence of hepatic disease
Kidney: As a class, NSAIDs have been associated with renal pathology such as papillary necrosis and interstitial nephritis
Female reproductive system: Menorrhagia, intermenstrual bleeding and vaginal bleeding have been reported in pre-menopausal
women and vaginal bleeding in post-menopausal women
Other adverse effects: Headache, dizziness, skin rashes and allergic reactions including anaphylaxis may occur
SPECIAL PRECAUTIONS:
may decrease platelet aggregation and prolong bleeding time. This effect should be considered when bleeding times are
determined
Fluid retention and edema have been observed in patients taking NSAIDs, including . Therefore, should be used
with caution in patients with compromised cardiac function or conditions predisposing to fluid retention.
In patients with renal, cardiac or hepatic impairment, caution is required since the use of NSAIDs, including , may result in
deterioration of renal function. The dose should be kept as low as possible and renal function should be monitored.
All patients who are receiving long-term treatment with NSAIDs, including , should be monitored as a precautionary measure
(e.g. renal, hepatic function and blood counts)
DRUG INTERACTIONS:
may attenuate the natriuretic efficacy of diuretics due to inhibition of intrarenal synthesis of prostaglandins. Concomitant
treatment with potassium-sparing diuretics may be associated with increased serum potassium levels.
Hence serum potassium should be monitored
Steady state plasma lithium and digoxin levels may be increased
Pharmacodynamic studies with diclofenac have shown no potentiation of oral hypoglycemic and anticoagulant drugs. However, as
interactions have been reported with other NSAIDs, caution and adequate monitoring are nevertheless advised.
Caution is advised when methotrexate is administered concurrently with because of possible enhancement of its toxicity
as a result of an increase of methotrexate plasma levels

Tab Erwin

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Tab Erwin

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Leaflet

Erwin 50mg/75mg Tablets

DOSAGE AND DIRECTIONS FOR USE:

Elderly/Renal Impairment/Hepatic Impairment

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