Diclofenac/Misoprostol Cipla 75 mg/0,2 mg Tablett med modifierad frisättning

Riik: Rootsi

keel: rootsi

Allikas: Läkemedelsverket (Medical Products Agency)

Toimeaine:

diklofenaknatrium; misoprostol

Saadav alates:

Cipla Europe NV

ATC kood:

M01BX

INN (Rahvusvaheline Nimetus):

diclofenac sodium; misoprostol

Annus:

75 mg/0,2 mg

Ravimvorm:

Tablett med modifierad frisättning

Koostis:

diklofenaknatrium 75 mg Aktiv substans; misoprostol 0,2 mg Aktiv substans; laktosmonohydrat Hjälpämne

Retsepti tüüp:

Receptbelagt

Toote kokkuvõte:

Förpacknings: Blister, 20 tabletter; Blister, 30 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 100 tabletter; Blister, 120 tabletter; Blister, 140 tabletter

Volitamisolek:

Avregistrerad

Loa andmise kuupäev:

2016-01-28

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
DICLOFENAC/MISOPROSTOL CIPLA 75 MG/200 MICROGRAMS MODIFIED RELEASE
TABLETS
(Diclofenac sodium/misoprostol)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Diclofenac/Misoprostol Cipla is and what it is used for
2.
What you need to know before you use Diclofenac/Misoprostol Cipla
3.
How to take Diclofenac/Misoprostol Cipla
4.
Possible side effects
5.
How to store Diclofenac/Misoprostol Cipla
6.
Contents of the pack and other information
1
WHAT DICLOFENAC/MISOPROSTOL CIPLA IS AND WHAT IT IS USED FOR
Diclofenac/Misoprostol Cipla helps to relieve the pain and swelling of
RHEUMATOID ARTHRITIS
and
OSTEOARTHRITIS
, and may help to protect patients at risk of irritation or ulceration
of the stomach or
intestines.
This medicinal product contains diclofenac sodium and misoprostol.
Diclofenac sodium belongs
to a group of medicinal products called Non-Steroidal
Anti-Inflammatory drugs (NSAIDs).
Although NSAIDs relieve the pain, they can reduce the amount of
natural protective substances
called prostaglandins in the stomach lining.
This means that NSAIDs can lead to stomach upsets or stomach ulcers.
This medicinal product
also contains misoprostol which is very similar to these
prostaglandins and may help protect your
stomach.
This medicinal product is used in adults.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE DICLOFENAC/MISOPROSTOL CIPLA
DO NOT TAKE DICLOFENAC/MISOPROSTOL CIPLA IF YOU:
•
have had an allergic reaction such as a skin rash, swelling

Toote omadused

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diclofenac/Misoprostol Cipla 75 mg/200 micrograms modified release
tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified release tablet consists of a gastro-resistant core
containing 75 mg diclofenac
sodium surrounded by an outer mantle containing 200 micrograms
misoprostol.
Excipients with known effects
Each modified release tablet contains 30 mg lactose monohydrate.
Each modified release tablet contains 3 mg hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Modified-release tablet.
White, circular, biconvex uncoated tablet plain on one side and
debossed with “DM1” on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Diclofenac/Misoprostol Cipla 75 mg/200 micrograms modified release
tablets are indicated for
patients who require the non-steroidal anti-inflammatory drug
diclofenac together with
misoprostol.
The diclofenac sodium component of this medicinal product is indicated
for the symptomatic
treatment of osteoarthritis and rheumatoid arthritis. The misoprostol
component of this medicinal
product is indicated for patients with a special need for the
prophylaxis of NSAID-induced gastric
and duodenal ulceration.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
_Adults_
One tablet to be taken with food, two times daily.
_Elderly/renal, cardiac and hepatic impairment_
2
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, elderly patients and patients with renal,
cardiac or hepatic impairment
should be closely monitored (see section 4.4 and section 4.8).
_Paediatric population_
The safety and efficacy of Diclofenac/Misoprostol Cipla 75 mg/200
micrograms modified re