ADCO-ROZNAL CAPSULES

Riik: Lõuna-Aafrika Vabariik

keel: inglise

Allikas: South African Health Products Regulatory Authority (SAHPRA)

Saadav alates:

Adcock Ingram Limited

Annus:

See ingredients

Ravimvorm:

CAPSULES

Koostis:

EACH CAPSULE CONTAINS LANSOPRAZOLE 30,0 mg

Volitamisolek:

Registered

Loa andmise kuupäev:

2005-11-07

Infovoldik

ADCOCK INGRAM LIMITED
ADCO-ROZNAL, capsules
Contains 30 mg lansoprazole per capsule_ _
PROPOSED PATIENT INFORMATION LEAFLET
Date of submission: 15 January 2021
1.3.2 Adco-Roznal Clean proposed PIL
Page 1 of 8
1.3.2 CLEAN PROPOSED PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
ADCO-ROZNAL, 30 mg, Capsules
LANSOPRAZOLE
Contains sugar (sucrose 203,8 mg) and sugar alcohol (mannitol 12,55
mg).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ADCO-ROZNAL
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
ADCO-ROZNAL 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 ADCO-ROZNAL is and what it is used for
2. What you need to know before you take ADCO-ROZNAL
3. How to take ADCO-ROZNAL
4. Possible side effects
5. How to store ADCO-ROZNAL
6. Contents of the pack and other information
1. WHAT ADCO-ROZNAL IS AND WHAT IT IS USED FOR
ADCO-ROZNAL is used for:
•
Treatment of duodenal and stomach ulcers.
S4
ADCOCK INGRAM LIMITED
ADCO-ROZNAL, capsules
Contains 30 mg lansoprazole per capsule_ _
PROPOSED PATIENT INFORMATION LEAFLET
Date of submission: 15 January 2021
1.3.2 Adco-Roznal Clean proposed PIL
Page 2 of 8
•
Treatment of inflammation of your oesophagus (the tube which connects
your throat to your
stomach) (reflux oesophagitis).
•
Treatment of infections caused by the bacteria _Helicobacter pylori_
when given in combination
with antibiotics.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADCO-ROZNAL
DO NOT TAKE ADCO-ROZNAL:
•
If you are hypersensitive (allergic) to lansoprazole or any of the
other ingredients of ADCO-
ROZNAL (listed in section 6).
•
If you are pregnant and breastfeeding (see PREGNANCY, BREASTFEEDING
AND FERTILITY).
•
If you have liver problems.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH ADCO-ROZNAL:
•
If your child has to take ADCO-RO

Toote omadused

ADCOCK INGRAM LIMITED
ADCO-ROZNAL, capsules
Contains 30 mg lansoprazole per capsule_ _
PROPOSED PROFESSIONAL INFORMATION
Date of submission: 15 January 2021
1.3.1.1 Adco-Roznal clean proposed PI
Page 1 of 9
1.3.1.1 CLEAN PROPOSED PROFESSIONAL INFORMATION
SCHEDULING STATUS
1 NAME OF THE MEDICINE
ADCO-ROZNAL 30 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 30 mg lansoprazole.
Contains sugar (sucrose 203,8 mg) and sugar alcohol (mannitol 12,55
mg).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
No. 1 hard capsules of gelatine, opaque white cap and body, containing
white or almost white
spherical microgranules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADCO-ROZNAL is indicated for:
•
The short-term treatment of gastric and duodenal ulcers and reflux
oesophagitis.
•
Helicobacter pylori-positive duodenal ulcers in conjunction with
appropriate antibiotics as part
of an eradication programme.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADCO-ROZNAL should preferably be taken before a meal.
GASTRIC ULCER:
S4
ADCOCK INGRAM LIMITED
ADCO-ROZNAL, capsules
Contains 30 mg lansoprazole per capsule_ _
PROPOSED PROFESSIONAL INFORMATION
Date of submission: 15 January 2021
1.3.1.1 Adco-Roznal clean proposed PI
Page 2 of 9
30 mg once a day for up to eight weeks.
DUODENAL ULCER:
30 mg once a day for up to four weeks.
ADCO-ROZNAL is indicated for Helicobacter pylori- positive ulcers, as
part of an eradication
program with appropriate antibiotics.
OESOPHAGITIS DUE TO GASTRO-OESOPHAGEAL REFLUX:
30 mg once a day for four weeks. Depending on the endoscopic results,
a repeat course of 4
weeks may be necessary.
ELDERLY PATIENTS:
No dose adjustment is necessary. However, 30 mg per day is the maximum
daily dose.
RENAL IMPAIRMENT:
No dose adjustment is necessary in renal failure; this also applies to
patients on dialysis.
If symptom control has not been achieved after four weeks of treatment
with the prescribed daily
dose, further investigation is recommended.
PAEDIATRIC POPULATION: