scheduling status s4 ). - drreddys.com · scheduling status proprietary name (and dosage form) omez...

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SCHEDULING STATUS PROPRIETARY NAME (and dosage form) OMEZ 10 (capsule) OMEZ 20 (capsule) OMEZ 40 (capsule) COMPOSITION OMEZ 10: Each capsule contains omeprazole 10 mg OMEZ 20: Each capsule contains omeprazole 20 mg OMEZ 40: Each capsule contains omeprazole 40 mg The other ingredients in OMEZ are black iron oxide printing ink, crospovidone , gelatin, hydroxypropyl- methylcellulose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer type C, poloxamer , povidone, triethyl citrate and the following capsule colourants: Omez 10: FD&C Blue #1, Red #40, Yellow #6, D&C Red #28, titanium dioxide, yellow iron oxide Omez 20: Black iron oxide, FD&C Blue #1, Yellow #6, Red #40, D&C Red #28, titanium dioxide Omez 40: FD&C Blue #1, Yellow #6, Red #40, D&C Red #28, titanium dioxide, yellow iron oxide PHARMACOLOGICAL CLASSIFICATION A 11.4.3 Medicines acting on the gastrointestinal tract – Other PHARMACOLOGICAL ACTION Omeprazole is an inhibitor of the gastric proton pump + + (H , K -ATPase). It inhibits both basal and stimulated gastric acid secretion by parietal cells, whether induced by acetylcholine, gastrin or histamine. Omeprazole has no effect on acetylcholine, histamine or gastric receptors. Pharmacokinetics Orally administered omeprazole is well absorbed but to a variable extent. Absorption of omeprazole takes place in the small intestine and is usually completed within three to six hours. Bioavailability depends on dose and gastric pH and may reach 70 % with repeated administration. Food has no influence on the bioavailability of omeprazole. Omeprazole is more than 95 % bound to plasma proteins. Clearance from the circulation is by hepatic metabolism with a plasma half-life of 30 to 90 minutes. Hepatic metabolism occurs primarily via the cytochrome P450 (CYP) isoform (CYP2C19). The inactive metabolites are excreted mainly in the urine (80 %) whilst the remaining 20 % are excreted via the faeces. The average half-life of the terminal phase of the plasma concentration-time curve is approximately 40 minutes. There is no change in plasma half-life during treatment. The inhibition of acid secretion is related to the area under the plasma concentration- time curve (AUC) and not to the actual plasma concentration at a given time. INDICATIONS OMEZ is indicated in Adults v Treatment of duodenal ulcer, including prevention of relapse gastric ulcer and reflux oesophagitis. v Long-term management of reflux oesophagitis and Zollinger-Ellison Syndrome. v Symptomatic relief of heartburn in patients with gastro-oesophageal reflux disease (GORD) and the short-term relief of functional dyspepsia. v Helicobacter pylori-positive duodenal ulcers as part of an eradication programme with appropriate antibiotics. v Treatment of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric and/or duodenal ulcer/erosions. v Reduction of the risk to develop gastric and/or duodenal ulcer/erosions and reduction of the risk of relapse for previously healed gastric and/or duodenal ulcer/erosions in patients on NSAID treatment. Children Short-term (up to 3 months) treatment of severe ulcerative reflux oesophagitis resistant to previous medical treatment. CONTRAINDICATIONS Hypersensitivity to any of the ingredients Safety in pregnancy and lactation has not been established WARNINGS Symptomatic response to OMEZ therapy does not preclude the presence of gastric ulcer or malignancy or a malignant disease of the oesophagus. The administration of OMEZ in this situation may delay diagnosis (see Special Precautions). Hepatic impairment may require a reduction in dose (see DOSAGE AND DIRECTIONS FOR USE). There is very limited experience with the use of OMEZ in children. The long-term safety of OMEZ in patients with renal and/or hepatic impairment has not been established. This medicine may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents. INTERACTIONS OMEZ is metabolised via the hepatic P450 cytochrome enzyme system, which may affect the metabolism of other medications metabolised by these enzymes, when given concomitantly. The elimination of diazepam, warfarin and phenytoin may be prolonged when OMEZ is given concomitantly. Monitoring of INR and phenytoin serum levels is recommended and dosage reductions may be necessary when OMEZ is given concomitantly. There is a possible interaction of OMEZ with digoxin and a 10 % increase in digoxin bioavailability may be expected. There may be interactions with other medicines, which are also metabolised via the cytochrome P450 enzyme system. PREGNANCY AND LACTATION Safety in pregnancy and lactation has not been established (see CONTRAINDICATIONS). DOSAGE AND DIRECTIONS FOR USE OMEZ is recommended to be given in the morning and swallowed whole with a half glass of liquid. The capsules should not be chewed or crushed. RECOMMENDED DOSAGES FOR ADULTS Duodenal ulcer 20 mg once daily for two to four weeks. In some duodenal ulcer patients refractory to other treatment regimens, 40 mg once daily may be effective. Prevention of relapse in patients with duodenal ulcer 10 mg once daily. If necessary the dose can be increased to 20 mg or 40 mg once daily. The above recommended dosage regimens are inclusive of Helicobacter pylori-positive duodenal ulcers as part of the eradication programme with appropriate antibiotics. Gastric ulcer and reflux oesophagitis 20 mg once daily for four to eight weeks. In some gastric ulcer and reflux oesophagitis patients refractory to other treatment regimens, 40 mg once daily may be effective. For the long-term management of patients with reflux oesophagitis the recommended dose is 20 mg once daily. If necessary the dose can be increased to 20 mg or 40 mg once daily. In patients with severe or symptomatic recurrent reflux oesophagitis treatment can be continued with OMEZ at a dosage of 20 mg once daily. NSAID-associated gastroduodenal lesions with or without continued NSAID treatment 20 mg once daily. In most patients healing occurs within 4 weeks. For patients who may not be fully healed after the initial course healing usually occurs during a further 4 weeks of treatment. Prevention of NSAID-associated gastroduodenal lesions and dyspeptic symptoms 20 mg once daily. Symptomatic gastroesophageal reflux disease 20 mg daily. Patients may respond adequately to 10 mg daily, therefore individual dose adjustments should be considered. If symptom control has not been achieved after 2 weeks of treatment with 20 mg daily further investigation is recommended. Zollinger-Ellison Syndrome 60 mg once daily. The dosage should be adjusted individually and treatment continued as long as it is clinically indicated. With doses above 80 mg daily the dose should be divided and given twice daily. There is very limited experience with the use of OMEZ in children (see WARNINGS). Severe ulcerative reflux oesophagitis in children from one year and older Recommended dosages: Weight: Dosage: 10 - 20 kg: 10 mg once daily. If needed increase to 20 mg once daily >20 kg: 20 mg once daily. If needed increase to 40 mg once daily Elderly Dose reductions are not necessary in elderly patients. The long-term safety of OMEZ in patients with renal and hepatic impairment has not been established (see WARNINGS). Impaired renal function Dose reductions are not necessary in renal impairment. Impaired hepatic function Bioavailability and plasma half-life of OMEZ are increased in patients with impaired hepatic function, therefore a daily dose of 10 – 20 mg is generally sufficient. SIDE-EFFECTS AND SPECIAL PRECAUTIONS Side-effects Blood and lymphatic system disorders Rare: Leucopenia, thrombocytopenia, agranulocytosis, pancytopenia Endocrine disorders Rare: Gynaecomastia Metabolic and nutritional disorders Rare: Hyponatraemia Psychiatric disorders Rare: Reversible mental confusion, agitation, aggression, depression and hallucinations (predominantly in severely ill patients) Nervous system disorders Common: Headache (severe enough to cause discontinuation in some patients) Uncommon: Dizziness, somnolence, insomnia, parasthaesias Eye disorders Rare: Blurred vision Vascular disorders Rare: Peripheral oedema Respiratory, thoracic and mediastinal disorders Rare: Bronchospasm Gastrointestinal disorders Common: Diarrhoea (severe enough to require discontinuation of therapy in some patients), constipation, abdominal pain or colic, nausea, vomiting, flatulence Rare: Dry mouth, stomatitis, oesophageal candidiasis, taste disturbances Hepato-biliary disorders Uncommon: Raised liver enzymes Rare: Hepatitis with or without jaundice, hepatic encephalopathy Skin and subcutaneous tissue disorders Uncommon: Skin rash, urticaria, pruritus Rare: Photosensitivity, bullous eruption, toxic epidermal necrolysis, Stevens-Johnson syndrome, alopecia, erythema multiforme Musculoskeletal, connective tissue and bone disorders Rare: Asthenia, arthralgia, myalgia Renal and urinary disorders Rare: Interstitial nephritis Other Uncommon: Malaise Rare: Hypersensitivity reactions (e.g. fever, angioedema, bronchospasm, interstitial nephritis) and anaphylactic shock Special precautions Effects related to acid inhibition During long-term treatment gastric glandular cysts have been reported in increased frequency. These physiological changes result from pronounced inhibition of gastric acid secretion. Decreased gastric acidity increases gastric counts of bacteria normally present in the gastro-intestinal tract. Treatment with OMEZ may lead to an increased risk of gastro-intestinal infections such as Salmonella and Campylobacter. In the presence of symptoms such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, or melaena, and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with OMEZ may alleviate symptoms and delay diagnosis. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT Blurred vision, confusion, diaphoresis, flushing, headache, malaise, nausea and tachycardia have been reported from overdosage with omeprazole. There is no specific antidote for overdose with omeprazole. Treatment is symptomatic and supportive. Due to extensive protein binding omeprazole is not readily dialysable. Patients in whom overdose is confirmed or suspected should be referred for medical practitioner/doctor consultation. IDENTIFICATION OMEZ 10: Off-white to pale yellow elliptical to spherical enteric-coated pellets, filled in a hard gelatin capsule with opaque lavender coloured cap and opaque yellow coloured body. “Omeprazole 10 mg” imprinted with black ink on cap and “R157” imprinted with black ink on body. OMEZ 20: Off-white to pale yellow elliptical to spherical enteric-coated pellets, filled in a hard gelatin capsule with opaque lavender coloured cap and opaque iron grey coloured body. “Omeprazole 20 mg” imprinted with black ink on cap and “R158” imprinted with black ink on body. OMEZ 40: Off-white to pale yellow elliptical to spherical enteric-coated pellets, filled in a hard gelatin capsule with opaque yellow coloured cap and opaque purple coloured body. “Omeprazole 40 mg” imprinted with black ink on cap and “R159” imprinted with black ink on body. PRESENTATION OMEZ 10: White HDPE bottles containing 30 capsules OMEZ 20: White HDPE bottles containing 30 capsules OMEZ 40: Blister packaging containing 14 capsules White HDPE bottles containing 30 capsules STORAGE INSTRUCTIONS Store at or below 25 °C. Protect from light and moisture. Keep the capsules in the original bottle and keep tightly closed. KEEP OUT OF REACH OF CHILDREN. REGISTRATION NUMBERS OMEZ 10: 34/11.4.3/0299 OMEZ 20: 34/11.4.3/0300 OMEZ 40: 34/11.4.3/0301 NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION Dr. Reddy's Laboratories (Pty) Ltd The Place, South Wing 1 Sandton Drive Sandton 2196 South Africa DATE OF PUBLICATION OF THE PACKAGE INSERT April 2007 S4 OMEZ South Africa 150043193 Page 1 of 2 NOT TO BE PRINTED VERSION : 1 (03-08-2012) NOT TO BE PRINTED VERSION : 2 (13-08-2012) Corrections done NOT TO BE PRINTED VERSION : 3 (13-08-2012) Corrections done NOT TO BE PRINTED VERSION :4 (14-08-2012) Corrections done NOT TO BE PRINTED VERSION : 5 (14-08-2012) Corrections done PANTONE CODES Black C Open Size : 615 x 140 mm 40 % Black Version No : 5 Folded size :140 x 30 mm

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Page 1: SCHEDULING STATUS S4 ). - drreddys.com · SCHEDULING STATUS PROPRIETARY NAME (and dosage form) OMEZ 10 (capsule) OMEZ 20 (capsule) OMEZ 40 (capsule) COMPOSITION OMEZ 10: Each capsule

SCHEDULING STATUS

PROPRIETARY NAME (and dosage form)

OMEZ 10 (capsule)

OMEZ 20 (capsule)

OMEZ 40 (capsule)

COMPOSITION

OMEZ 10: Each capsule contains omeprazole 10 mg

OMEZ 20: Each capsule contains omeprazole 20 mg

OMEZ 40: Each capsule contains omeprazole 40 mg

The other ingredients in OMEZ are black iron oxide printing ink, crospovidone , gelatin, hydroxypropyl-methylcellulose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer type C, poloxamer , povidone, triethyl citrate and the following capsule colourants:

Omez 10: FD&C Blue #1, Red #40, Yellow #6, D&C Red #28, titanium dioxide, yellow iron oxide

Omez 20: Black iron oxide, FD&C Blue #1, Yellow #6, Red #40, D&C Red #28, titanium dioxide

Omez 40: FD&C Blue #1, Yellow #6, Red #40, D&C Red #28, titanium dioxide, yellow iron oxide

PHARMACOLOGICAL CLASSIFICATIONA 11.4.3 Medicines acting on the gastrointestinal tract – Other

PHARMACOLOGICAL ACTIONOmeprazole is an inhibitor of the gastric proton pump

+ +(H , K -ATPase). It inhibits both basal and stimulated gastric acid secretion by parietal cells, whether induced by acetylcholine, gastrin or histamine.Omeprazole has no effect on acetylcholine, histamine or gastric receptors.

PharmacokineticsOrally administered omeprazole is well absorbed but to a variable extent. Absorption of omeprazole takes place in the small intestine and is usually completed within three to six hours. Bioavailability depends on dose and gastric pH and may reach 70 % with repeated administration. Food has no influence on the bioavailability of omeprazole.

Omeprazole is more than 95 % bound to plasma proteins. Clearance from the circulation is by hepatic metabolism with a plasma half-life of 30 to 90 minutes. Hepatic metabolism occurs primarily via the cytochrome P450 (CYP) isoform (CYP2C19). The inactive metabolites are excreted mainly in the urine (80 %) whilst the remaining 20 % are excreted via the faeces. The average half-life of the terminal phase of the plasma concentration-time curve is approximately 40 minutes. There is no change in plasma half-life during treatment. The inhibition of acid secretion is related to the area under the plasma concentration-time curve (AUC) and not to the actual plasma concentration at a given time.

INDICATIONS

OMEZ is indicated in

Adultsv Treatment of duodenal ulcer, including prevention of

relapse gastric ulcer and reflux oesophagitis.v Long-term management of reflux oesophagitis and

Zollinger-Ellison Syndrome.v Symptomatic relief of heartburn in patients with

gastro-oesophageal reflux disease (GORD) and the short-term relief of functional dyspepsia.

vHelicobacter pylori-positive duodenal ulcers as part of an eradication programme with appropriate antibiotics.

v Treatment of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric and/or duodenal ulcer/erosions.

vReduction of the risk to develop gastric and/or duodenal ulcer/erosions and reduction of the risk of relapse for previously healed gastric and/or duodenal ulcer/erosions in patients on NSAID treatment.

ChildrenShort-term (up to 3 months) treatment of severe ulcerative reflux oesophagitis resistant to previous medical treatment.

CONTRAINDICATIONSHypersensitivity to any of the ingredientsSafety in pregnancy and lactation has not been established

WARNINGS

Symptomatic response to OMEZ therapy does not preclude the presence of gastric ulcer or malignancy or a malignant disease of the oesophagus. The administration of OMEZ in this situation may delay diagnosis (see Special Precautions).Hepatic impairment may require a reduction in dose (see DOSAGE AND DIRECTIONS FOR USE).

There is very limited experience with the use of OMEZ in children.

The long-term safety of OMEZ in patients with renal and/or hepatic impairment has not been established.

This medicine may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.

INTERACTIONS

OMEZ is metabolised via the hepatic P450 cytochrome enzyme system, which may affect the metabolism of other medications metabolised by these enzymes, when given concomitantly. The elimination of diazepam, warfarin and phenytoin may be prolonged when OMEZ is given concomitantly.Monitoring of INR and phenytoin serum levels is recommended and dosage reductions may be necessary when OMEZ is given concomitantly. There is a possible interaction of OMEZ with digoxin and a 10 % increase in digoxin bioavailability may be expected.There may be interactions with other medicines, which are also metabolised via the cytochrome P450 enzyme system.

PREGNANCY AND LACTATIONSafety in pregnancy and lactation has not been established (see CONTRAINDICATIONS).

DOSAGE AND DIRECTIONS FOR USE

OMEZ is recommended to be given in the morning and swallowed whole with a half glass of liquid. The capsules should not be chewed or crushed.

RECOMMENDED DOSAGES FOR ADULTS

Duodenal ulcer20 mg once daily for two to four weeks.In some duodenal ulcer patients refractory to other treatment regimens, 40 mg once daily may be effective.

Prevention of relapse in patients with duodenal ulcer

10 mg once daily.

If necessary the dose can be increased to 20 mg or 40 mg once daily.

The above recommended dosage regimens are inclusive of Helicobacter pylori-positive duodenal ulcers as part of the eradication programme with appropriate antibiotics.

Gastric ulcer and reflux oesophagitis20 mg once daily for four to eight weeks.In some gastric ulcer and reflux oesophagitis patients refractory to other treatment regimens, 40 mg once daily may be effective.For the long-term management of patients with reflux oesophagitis the recommended dose is 20 mg once daily. If necessary the dose can be increased to 20 mg or 40 mg once daily.In patients with severe or symptomatic recurrent reflux oesophagitis treatment can be continued with OMEZ at a dosage of 20 mg once daily.

NSAID-associated gastroduodenal lesions with or without continued NSAID treatment20 mg once daily.In most patients healing occurs within 4 weeks. For patients who may not be fully healed after the initial course healing usually occurs during a further 4 weeks of treatment.

Prevention of NSAID-associated gastroduodenal lesions and dyspeptic symptoms20 mg once daily.

Symptomatic gastroesophageal reflux disease20 mg daily.Patients may respond adequately to 10 mg daily, therefore individual dose adjustments should be considered.If symptom control has not been achieved after 2 weeks of treatment with 20 mg daily further investigation is recommended.

Zollinger-Ellison Syndrome60 mg once daily.The dosage should be adjusted individually and treatment continued as long as it is clinically indicated. With doses above 80 mg daily the dose should be divided and given twice daily.

There is very limited experience with the use of OMEZ in children (see WARNINGS).

Severe ulcerative reflux oesophagitis in children from one year and older

Recommended dosages:

Weight: Dosage:

10 - 20 kg: 10 mg once daily. If needed increase to 20 mg once daily

>20 kg: 20 mg once daily. If needed increase to 40 mg once daily

Elderly

Dose reductions are not necessary in elderly patients.

The long-term safety of OMEZ in patients with renal and hepatic impairment has not been established (see WARNINGS).

Impaired renal functionDose reductions are not necessary in renal impairment.

Impaired hepatic function

Bioavailability and plasma half-life of OMEZ are increased in patients with impaired hepatic function, therefore a daily dose of 10 – 20 mg is generally sufficient.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS

Side-effects

Blood and lymphatic system disordersRare: Leucopenia, thrombocytopenia, agranulocytosis, pancytopenia

Endocrine disordersRare: Gynaecomastia

Metabolic and nutritional disordersRare: Hyponatraemia

Psychiatric disordersRare: Reversible mental confusion, agitation, aggression, depression and hallucinations (predominantly in severely ill patients)

Nervous system disordersCommon: Headache (severe enough to cause discontinuation in some patients)Uncommon: Dizziness, somnolence, insomnia, parasthaesias

Eye disordersRare: Blurred vision

Vascular disordersRare: Peripheral oedema

Respiratory, thoracic and mediastinal disordersRare: Bronchospasm

Gastrointestinal disordersCommon: Diarrhoea (severe enough to require discontinuation of therapy in some patients), constipation, abdominal pain or colic, nausea, vomiting, flatulence Rare: Dry mouth, stomatitis, oesophageal candidiasis, taste disturbances

Hepato-biliary disordersUncommon: Raised liver enzymes Rare: Hepatitis with or without jaundice, hepatic encephalopathy

Skin and subcutaneous tissue disordersUncommon: Skin rash, urticaria, pruritus Rare: Photosensitivity, bullous eruption, toxic epidermal necrolysis, Stevens-Johnson syndrome, alopecia, erythema multiforme

Musculoskeletal, connective tissue and bone disordersRare: Asthenia, arthralgia, myalgia

Renal and urinary disordersRare: Interstitial nephritis

OtherUncommon: Malaise Rare: Hypersensitivity reactions (e.g. fever,angioedema, bronchospasm, interstitial nephritis) and anaphylactic shock

Special precautions

Effects related to acid inhibitionDuring long-term treatment gastric glandular cysts have been reported in increased frequency. These physiological changes result from pronounced inhibition of gastric acid secretion. Decreased gastric acidity increases gastric counts of bacteria normally present in the gastro-intestinal tract. Treatment with OMEZ may lead to an increased risk of gastro-intestinal infections such as Salmonella and Campylobacter.In the presence of symptoms such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, or melaena, and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with OMEZ may alleviate symptoms and delay diagnosis.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTBlurred vision, confusion, diaphoresis, flushing, headache, malaise, nausea and tachycardia have been reported from overdosage with omeprazole. There is no specific antidote for overdose with omeprazole.Treatment is symptomatic and supportive.Due to extensive protein binding omeprazole is not readily dialysable. Patients in whom overdose is confirmed or suspected should be referred for medical practitioner/doctor consultation.

IDENTIFICATION

OMEZ 10: Off-white to pale yellow elliptical to spherical enteric-coated pellets, filled in a hard gelatin capsule with opaque lavender coloured cap and opaque yellow coloured body. “Omeprazole 10 mg” imprinted with black ink on cap and “R157” imprinted with black ink on body.

OMEZ 20: Off-white to pale yellow elliptical to spherical enteric-coated pellets, filled in a hard gelatin capsule with opaque lavender coloured cap and opaque iron grey coloured body. “Omeprazole 20 mg” imprinted with black ink on cap and “R158” imprinted with black ink on body.

OMEZ 40: Off-white to pale yellow elliptical to spherical enteric-coated pellets, filled in a hard gelatin capsule with opaque yellow coloured cap and opaque purple coloured body. “Omeprazole 40 mg” imprinted with black ink on cap and “R159” imprinted with black ink on body.

PRESENTATION

OMEZ 10: White HDPE bottles containing 30 capsules

OMEZ 20: White HDPE bottles containing 30 capsules

OMEZ 40: Blister packaging containing 14 capsulesWhite HDPE bottles containing 30 capsules

STORAGE INSTRUCTIONS

Store at or below 25 °C. Protect from light and moisture.

Keep the capsules in the original bottle and keep tightly closed.

KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS

OMEZ 10: 34/11.4.3/0299

OMEZ 20: 34/11.4.3/0300

OMEZ 40: 34/11.4.3/0301

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATIONDr. Reddy's Laboratories (Pty) LtdThe Place, South Wing1 Sandton DriveSandton 2196South Africa

DATE OF PUBLICATION OF THE PACKAGE INSERTApril 2007

S4

OMEZ South Africa 150043193 Page 1 of 2

NOT TO BE PRINTED

VERSION : 1 (03-08-2012)

NOT TO BE PRINTED

VERSION : 2 (13-08-2012)

Corrections done

NOT TO BE PRINTED

VERSION : 3 (13-08-2012)

Corrections done

NOT TO BE PRINTED

VERSION :4 (14-08-2012)

Corrections done

NOT TO BE PRINTED

VERSION : 5 (14-08-2012)

Corrections done

PANTONE CODES

Black C

Open Size : 615 x 140 mm

40 % Black

Version No : 5 Folded size :140 x 30 mm

Page 2: SCHEDULING STATUS S4 ). - drreddys.com · SCHEDULING STATUS PROPRIETARY NAME (and dosage form) OMEZ 10 (capsule) OMEZ 20 (capsule) OMEZ 40 (capsule) COMPOSITION OMEZ 10: Each capsule

SKEDULERINGSTATUS

EIENDOMSNAAM (EN DOSEERVORM)

OMEZ 10 (kapsule)

OMEZ 20 (kapsule)

OMEZ 40 (kapsule)

SAMESTELLING

OMEZ 10: Elke kapsule bevat omeprasool 10 mg

OMEZ 20: Elke kapsule bevat omeprasool 20 mg

OMEZ 40: Elke kapsule bevat omeprasool 40 mg

Die ander bestanddele in Omez is swart ysteroksied drukink, kruispovidoon, gelatien, hidroksipropiel-metielsellulose, magnesiumstearaat, mannitol, meglumien, meta-akrielsuur kopolimeer tipe C, polaksameer, povidoon, tri-etielsitraat en die volgende kapsuul kleurstowwe:

Omez 10: FD&C Blou #1, Rooi #40, Geel #6, D&C Rooi #28, titaandioksied, geel ysteroksied

Omez 20: Swart ysteroksied, FD&C Blou #1, Geel #6, Rooi #40, D&C Rooi #28, titaandioksied

Omez 40: FD&C Blou #1, Geel #6, Rooi #40, D&C Rooi #28, titaandioksied, geel ysteroksied

FARMAKOLOGIESE KLASSIFIKASIEA 11.4.3 Medisyne wat op die gastroïntestinale kanaal werk - Ander

FARMAKOLOGIESE WERKING

Omeprasool is ʼn onderdrukker van die gastriese + +protonpomp (H , K - ATPase). Dit inhibeer sowel basale

as gestimuleerde suurafskeiding deur die pariëtale selle hetsy geïnduseer deur asetielcholien, gastrien of histamien. Omeprasool het geen effek op asetielcholien-, histamien- of gastrienreseptore nie.

FarmakokinetikaOraal toegedien is omeprasool goed geabsorbeer

maar tot ʼn wisselende mate. Absorpsie van omeprasool vind plaas in die dunderm en is gewoonlik volledig geabsorbeer binne drie tot ses ure. Die biobeskikbaarheid van omeprasool hang van die dosis en gastriese pH af en kan moontlik 70 % bereik met herhaaldelike toediening. Voedsel het geen invloed op die biobeskikbaarheid van omeprasool nie.Meer as 95 % van omeprasool is aan plasmaproteïene gebind. Opruiming vanuit die sirkulasie is deur hepatiese metabolisme met ’n plasmahalfleeftyd van 30 tot 90 minute. Hepatiese metabolisme gebeur hoofsaaklik via die sitochroom P450 (SIP) isovorm (SIP2C19). Die onaktiewe metaboliete word hoofsaaklik in die uriene uitgeskei (80 %) terwyl die oorblywende 20 % via die feses uitgeskei word. Die gemiddelde terminale fase halfleeftyd van die plasmakonsentrasie-tydkurwe is ongeveer 40 minute. Daar is geen verandering in die plasmahalfleeftyd tydens behandeling nie. Die onderdrukking van suurafskeiding hou verband met die oppervlak onder die plasmakonsentrasie-tydkurwe (AOK) en nie met die werklike plasmakonsentrasie op ’n gegewe tydstip nie.

INDIKASIES

OMEZ is aangedui by

Volwassenesv Behandeling van maagsere, insluitend voorkoming

van terugval-maagseer en refluksesofagitis. v Langtermyn beheer van refluksesofagitis en

Zollinger-Ellisonsindroom.v Simptomatiese verligting van sooibrand by pasiënte

met gastroësofageale reflukssiekte (GERS) en die korttermyn verligting van funksionele dispepsie.

vHelicobacter pylori-positiewe duodenale ulkusse as

deel van ʼn uitwissingsprogram met geskikte antibiotika.

v Behandeling van nie-steroϊede anti-inflammatoriese geneesmiddel (NSAIG)geassosieerde gastriese en/of duodenaleulkus/erosies.

v Vermindering van die risiko om gastriese en/of duodenale ulkus/erosies te ontwikkel en vermindering van die risiko van terugkeer van vorige geneesde gastriese en/of duodenale ulkus/erosies by pasiënte op NSAIG-behandeling.

Kinders

Korttermyn (vir tot 3 maande) behandeling van ernstige ulseratiewe refluksesofagitis bestand teen vorige mediese behandeling.

KONTRA-INDIKASIES

Hipersensitiwiteit teenoor enige van die bestanddele.Veiligheid tydens swangerskap en borsvoeding is nie bepaal nie.

WAARSKUWINGS

Simptomatiese respons op behandeling met OMEZ sluit nie die teenwoordigheid van maagseer of kwaadaardigheid of kwaadaardige siekte van die esofagus uit nie. Die toediening van OMEZ in hierdie situasie kan moontlik diagnose vertraag (sien Spesiale Voorsorgmaatreëls). Ingekorte lewerfunksie kan moontlik 'n laer in dosis benodig (sien DOSIS EN GEBRUIKSAANWYSINGS).

Daar is baie beperkte ondervinding met die gebruik van OMEZ by kinders.

Die langtermyn veiligheid van OMEZ by pasiënte met ingekorte nier-en/of lewerfunksie is nie bepaal nie.

Hierdie medisyne kan moontlik lei tot lomerigheid en verswakte konsentrasie wat moontlik deur die gelyktydige inname van alkohol of ander sentrale senuweestelsel-onderdrukkers vererger kan word. Pasiënte behoort, veral met aanvang van behandeling, aangeraai te word teen bestuur van voertuie of beheer van masjinerie of teen uitvoer van potensiële gevaarlike take waar konsentrasieverlies tot ongelukke kan lei.

INTERAKSIES

OMEZ word deur middel van die hepatiese P450-sitochroom ensiemsisteem gemetaboliseer, wat moontlik die metabolisme van ander medikasies wat ook deurmiddel van hierdie ensieme gemetaboliseer word, kan affekteer wanneer hulle saam toegedien word. Die uitskeiding van diasepam, warfarien en fenitoïen kan verleng word wanneer OMEZ bykomend toegedien word. Monitering van INV en fenitoïen serumvlakke word aanbeveel en vermindering van die dosis kan moontlik nodig wees wanneer OMEZ bykomend toegedien word. Daar is 'n moontlike

interaksie van OMEZ met digoksien en ʼn 10 % toename in digoksien biobeskikbaarheid kan verwag word. Daar kan moontlik interaksies wees met ander medisynes wat ook via die sitochroom P450-ensiemsisteem gemetaboliseer word.

SWANGERSKAP EN LAKTASIEVeiligheid tydens swangerskap en borsvoeding is nie bepaal nie (sien KONTRA-INDIKASIES).

DOSIS EN GEBRUIKSAANWYSINGS

Dit word aanbeveel dat OMEZ in die oggend toegedien word en dat dit heel afgesluk word met ’n halwe glas vloeistof. Die kapsule moet nie gekou of vergruis word nie.

AANBEVOLE DOSERINGS VIR VOLWASSENES

Duodenale ulkus20 mg eenkeer per dag vir twee tot vier weke.By party pasiënte met duodenale ulkusse wat nie op ander behandelinge reageer nie, kan 40 mg eenkeer per dag moontlik effektief wees

Voorkoming van terugkeer by pasiënte met duodenale ulkus10 mg eenkeer per dag.Indien nodig, kan die dosis verhoog word tot tussen 20 mg en 40 mg daagliks.Die bogenoemde doseringsregimen sluit in Helicobacter pylori-positief duodenale ulkusse as deel van die eradikasie programme met geskikte antibiotika.

Maagseer en refluksesofagitis

20 mg eenkeer per dag vir vier tot agt weke.

By party pasiënte met duodenale ulkusse en refluksesofagitis wat nie op ander behandeling reageer nie kan 40 mg eenkeer per dag moontlik effektief wees.

Vir die langtermyn beheer van pasiënte met refluksesofagitis, is die aanbevole dosis 20 mg eenkeer per dag. Indien nodig, kan die dosis verhoog word tot tussen 20 mg en 40 mg daagliks.Vir pasiënte met ernstige of simptomatiese terugkerende refluksesofagitis, kan behandeling met OMEZ voortgesit word teen ’n dosis van 20 mg eenkeer per dag.

NSAIG-geassosieerde gastroduodenale letsels met of sonder volgehoue NSAIG-behandeling

20 mg eenkeer per dag.By meeste pasiënte vind genesing plaas binne 4 weke. Vir dié pasiënte wat nog nie heeltemal genees is nie na

die eerste kursus, vind genesing gewoonlik plaas na ʼn verdere 4 weke van behandeling.

Voorkoming van NSAIG-geassosieerde

gastroduodenale letsels en dispepsiese simptome 20 mg eenkeer per dag.

Simptomatiese gastro-esofagealesiekte

20 mg eenkeer per dag.

Aangesien pasiënte op 10 mg daagliks moontlik genoegsaam kan respondeer, behoort individuele dosis-aanpassings in ag geneem te word.

Indien beheer van simptome nog nie bereik is na 2 weke van behandeling met 20 mg daagliks nie, word verdere opvolg aanbeveel.

Zollinger-Ellisonsindroom

60 mg eenkeer per dag.

Die dosis moet aangepas word volgens die individuele behoeftes van elke pasiënt en behandeling moet volgehou word vir so lank as wat dit klinies nodig is.

Daar is beperkte ondervinding met die gebruik van OMEZ by kinders (sien WAARSKUWINGS).

Ernstige ulseratiewe refluksesofagitis by kinders van ouderdom een jaar en ouerAanbevole doserings:Gewig: Dosering:10 - 20 kg: 10 mg eenkeer per dag. Indien nodig verhoog tot 20 mg daagliks> 20 kg: 20 mg eenkeer per dag. Indien nodig verhoog tot 40 mg daagliks

BejaardesVerlaging van dosis vir bejaardes is nie nodig nie.

Die veiligheid van OMEZ oor die langtermyn by pasiënte met ingekorte nier- en lewerfunksie is nie bepaal nie (sien WAARSKUWINGS).

Pasiënte met ingekorte nierfunksieGeen aanpassing in die dosis word vir pasiënte met ingekorte nierfunksie benodig nie.

Ingekorte lewerfunksieOmdat die biobeskikbaarheid en plasmahalfleeftyd van OMEZ langer is by pasiënte met ingekorte lewerfunksie, is ’n daaglikse dosis van 10 – 20 mg gewoonlik voldoende.

NEWE-EFFEKTE EN SPESIALE

VOORSORGMAATREËLS

Newe-effekte

Bloed en limfatiese sisteem-afwykingsRaar: Leukopenie, trombositopenie, agranulositose, pansitopenie

EndokrienafwykingsRaar: Ginekomastie

Metaboliese en voeding-afwykingsRaar: Hiponatremie

Psigiatriese afwykingsRaar: Omkeerbare verstandelike verwarring, agitasie, aggressie, depressie en hallusinasies (hoofsaaklik in ernstige siek pasiënte)

Senuweestelsel-afwykingsAlgemeen: Hoofpyn (ernstig genoeg om staking van medikasie te veroorsaak by sekere pasiënte)

Dikwels: Duiseligheid, slaperigheid, slaaploosheid, parastesie

OogafwykingsRaar: Dowwe visie

Vaskulêre afwykingsRaar: Perifere edeem

Respiratoriese, torakale en mediastinale

afwykingsRaar: Brongospasma

Gastroïntestinale afwykingsAlgemeen: Diarree (ernstig genoeg om staking van medikasie te veroorsaak by sekere pasiënte), hardlywigheid, abdominale pyn of koliek, naarheid, braking, winderigheid Raar: Droë mond, stomatitis, esofogeale kandidiase, smaak versteurings

Hepato-biliêre afwykingsMinder dikwels: Verhoogde lewerensieme Raar: Hepatitis met of sonder geelsug, hepatiese enkefalopatie

Vel-en subkutane-weefsel-afwykingsMinder dikwels: Veluitslag, urtikarie, pruritus Raar: Fotosensitiwiteit, bulleus-erupsie, toksiese epidermale nekrolise, Stevens-Johnson-sindroom, alopesie, eriteem multiforme

Muskuloskeletaal-, bindweefsel- en

beenafwykingsRaar: Astenie, artralgie, mialgie

Renale en urinêre afwykingsRaar: Interstisiële nefritis

AnderMinder dikwels: Malaise Raar: Hipersensitiwiteitsreaksies (bv. koors, angioedeem, brongospasma, interstitiële nefritis) en anafilaktiese skok

Spesiale voorsorgmaatreëls

Effekte verwant aan suur-onderdrukking:‘n Toename in die voorkoms van gastriese kliersists is gedurende langtermyn-behandeling aangemeld. Hierdie fisiologiese veranderinge is die gevolg van die sterk inhibisie van gastriese suur sekresie. Verlaagde gastriese suurheid verhoog die gastriese telling van bakter ië normaalweg teenwoord ig in d ie spysverteringskanaal. Behandeling met OMEZ kan moontlik lei tot 'n verhoogde risiko van gastroïntestinale infeksies soos Salmonella en Campylobacter.Indien simptome soos aansienlike nie-doelbewuste gewigsverlies, herhaaldelike braking, disfagie, hematemese of melena voorkom, en waar daar 'n gastriese ulkus vermoed word of bevestig is, moet kwaadaardigheid uigeskakel word, aangesien behandeling met OMEZ moontlik simptome kan verlig en sodoende diagnose vertraag.

BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VIR DIE BEHANDELING DAARVANDowwe visie, verwarring, diaforese, blosing, hoofpyn, malaise, naarheid en tagikardie is aangemeld van oordosering met omeprasool. Daar is geen spesifieke teenmiddel vir oordosering met omeprasool. Behandeling is simptomaties en ondersteunend.As gevolg van ekstensiewe proteïenbinding, is omeprasool nie maklik dialiseerbaar nie. Pasiënte by wie oordosering óf bevestig óf vermoed is, behoort aan ’n mediese praktisyn/geneesheer verwys te word vir konsultasie.

IDENTIFIKASIE

OMEZ 10: Naaswit tot bleek-geel elliptiese tot sferiese enteriesbedekte korrels in ’n harde gelatienkapsule met ’n ondeursigtige lilapers-kleurige doppie en ondeursigtige geel romp. “OMEPRAZOLE 10 mg” is met swart ink op die doppie gedruk en “R157” met swart ink op die romp.

OMEZ 20: Naaswit tot bleek-geel elliptiese tot sferiese enteriesbedekte korrels in ’n harde gelatienkapsule met ’n ondeursigtige lilapers-kleurige doppie en ondeursigtige ystergrys romp. “OMEPRAZOLE 20 mg” is met swart ink op die doppie gedruk en “R158” met swart ink op die romp.

OMEZ 40: Naaswit tot bleek-geel elliptiese tot sferiese enteriesbedekte korrels in ’n harde gelatienkapsule met ’n ondeursigtige ryk-geel doppie en ondeursigtige pers romp. “OMEPRAZOLE 40 mg” is met swart ink op die doppie gedruk en “R159” met swart ink op die romp.

AANBIEDING

OMEZ 10: Wit HDPE bottels met 30 kapsules

OMEZ 20: Wit HDPE bottels met 30 kapsules

OMEZ 40: Stulpverpakking met 14 kapsulesWit HDPE bottels met 30 kapsules

BERGINGSINSTRUKSIESBerg by of benede 25 °C. Beskerm teen lig en vog.

Hou die kapsules in die stulpblaaie en hou die stulpblaaie in die karton tot benodig vir gebruik.Hou die kapsules in die oorspronklike bottels en hou dig toe.

HOU BUITE BEREIK VAN KINDERS.

REGISTRASIENOMMERS

OMEZ 10: 34/11.4.3/0299

OMEZ 20: 34/11.4.3/0300

OMEZ 40: 34/11.4.3/0301

NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE SERTIFIKAAT VAN REGISTRASIEDr. Reddy's Laboratories (Edms) Bpk"The Place", SuidvleuelSandtonrylaan 1Sandton 2196South Africa

DATUM VAN PUBLIKASIE VAN VOUBILJET

April 2007

S4

OMEZ South Africa 150043193 Page 2 of 2

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PANTONE CODES

Black C

Open Size : 615 x 140 mm

40 % Black

Version No : 5 Folded size :140 x 30 mm