LOKIT CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Teva Pharmaceuticals (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS OMEPRAZOLE 20,0 mg

Authorization status:

Registered

Authorization date:

2005-05-09

Patient Information leaflet

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PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S4
PATIENT INFORMATION LEAFLET
LOKIT (capsules)
Omeprazole
Contains sugar: sucrose (165,95 mg) and lactose anhydrous (2,99 mg).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING LOKIT
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
LOKIT has been prescribed for you personally and you should not share
your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET:
1.
WHAT LOKIT IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LOKIT
3.
HOW TO USE LOKIT
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LOKIT
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT LOKIT IS AND WHAT IT IS USED FOR:
LOKIT CAN BE USED FOR:
•
Ulcers in the upper part of the intestine (duodenal ulcer) or stomach
(gastric ulcer).
•
Ulcers which are infected with bacteria called _Helicobacter pylori_.
If you have this condition,
your doctor may also prescribe antibiotics to treat the infection and
allow the ulcer to heal.
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•
Ulcers caused by certain anti-inflammatory medicines. LOKIT can also
be used to stop
ulcers from forming if you are taking anti-inflammatory medicines.
•
A condition called Gastro-oesophageal reflux disease (GORD). This is
where acid from the
stomach escapes into the gullet (the tube which connects your throat
to your stomach)
causing pain, inflammation and heartburn.
•
Too much acid in the stomach caused by a growth in the pancreas
(Zollinger-Ellison
syndrome).
_IN CHILDREN: _
_Children over 1 year of age and weighing ≥ 20 kg_
Gastro-oesophageal reflux disease (GORD). This is where acid from the
stomach escapes into the
gullet (the tube which connects your throat to your stomach) causing
pain, inflammation and
heartburn.
In children, the symptoms of the condition can include the return of
stomach contents into the mouth
(regurgitation), being sick (vomiting) and poor weight gain.
2. WHAT YOU NEE

Summary of Product characteristics

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PROFESSIONAL INFORMATION
SCHEDULING STATUS:
S4
1. NAME OF THE MEDICINE:
LOKIT (capsules)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
LOKIT:
Each capsule contains Omeprazole 20 mg.
LOKIT contains sugar: sucrose (165,95 mg) and lactose anhydrous (2,99
mg).
Refer to section 6.1 for a full list of excipients.
3. PHARMACEUTICAL FORM:
LOKIT:
Size 2 hard gelatine capsules with a dark blue body and a light blue
cap, with LOKIT printed on both
shells, containing white to almost white uniformly rounded pellets.
4. CLINICAL PARTICULARS:
4.1 THERAPEUTIC INDICATIONS:
LOKIT IS INDICATED IN:
_Adults: _
•
Treatment of duodenal ulcer, including prevention of relapse, gastric
ulcer, and reflux
oesophagitis.
•
Long term management of reflux oesophagitis, and Zollinger-Ellison
syndrome.
•
Symptomatic relief of heartburn in patients with gastro-oesophageal
reflux disease (GORD)
and the short term relief of functional dyspepsia.
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•
_Helicobacter pylori_ positive duodenal ulcers, as part of an
eradication programme with
appropriate antibiotics.
•
Treatment of Non-steroidal Anti-inflammatory drugs (NSAIDs) associated
gastric and/or
duodenal ulcer and erosions.
•
Reduction of the risk to develop gastric and / or duodenal
ulcer/erosions, and reduction of the
risk of relapse for a previously healed gastric and/or duodenal
ulcer/erosions in patients on
NSAID treatment.
_Children weighing more than 20 kg: _
Short term (up to 3 months) treatment of severe ulcerative reflux
oesophagitis resistant to previous
medical treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
POSOLOGY:
THE RECOMMENDED DOSAGES FOR ADULTS ARE:
_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: _
If necessary, the dose can be increased to 20 to 40 mg once daily.
The above recommended dosage regimens are inclusive of _Helicobacter
pylori_ positive duodenal
ulcers as part of t