Ceclova 75 mg / 20 mg modified-release hard capsules

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Omeprazole; DICLOFENAC SODIUM

Disponibil de la:

Temmler Pharma GmbH

Codul ATC:

M01AB; M01AB55

INN (nume internaţional):

Omeprazole; DICLOFENAC SODIUM

Dozare:

75/20 milligram(s)

Forma farmaceutică:

Capsules Modified Release

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Acetic acid derivatives and related substances; diclofenac, combinations

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2018-07-20

Prospect

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palde-ceclova-75-mg--20-mg-aug2019-cleaned-26.08.2019
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Dok-Nr.: TA020198261531580005
PACKAGE LEAFLET: INFORMATION FOR THE USER
CECLOVA 75 MG / 20 MG MODIFIED-RELEASE HARD
CAPSULES
DICLOFENAC SODIUM/OMEPRAZOLE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, please ask your doctor or
pharmacist.

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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ceclova is and what it is used for
2.
What you need to know before you take Ceclova
3.
How to take Ceclova
4.
Possible side effects
5.
How to store Ceclova
6.
Contents of the pack and other information
1. WHAT CECLOVA 75 MG / 20 MG IS AND WHAT IT IS USED FOR
Ceclova has been prescribed for you to relieve the pain and swelling
caused by rheumatoid arthritis,
osteoarthritis or ankylosing spondylitis and it may help to protect
against the risk of irritation or ulceration
of the stomach or intestines.
Ceclova is indicated in adults who have already been treated with the
combination of diclofenac and
omeprazole as separate tablets with the same strength as Ceclova.
Ceclova contains two active substances in a single capsule, diclofenac
sodium (75 mg) and omeprazole
(20 mg):

Diclofenac belongs to a group of medicinal products called
Non-Steroidal Anti-Inflammatory drugs
(NSAIDs) which are used to reduce pain and inflammation of joint
disorders. Although diclofenac
relieves the pain and inflammation, it can also reduce the amount of
natural protective substances
called prostaglandins in the stomach or duodenum (peptic ulcers).

Omeprazole belongs to a gr

Caracteristicilor produsului

Health Products Regulatory Authority
26 November 2019
CRN0099T9
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceclova 75 mg / 20 mg modified-release hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release hard capsules contains 75 mg diclofenac sodium
(25 mg as gastro-resistant pellets and 50 mg as
prolonged release pellets) and 20 mg of omeprazole (gastro-resistant
pellets).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release capsule, hard.
Elongated 21.5 mm x 6.9 mm hard gelatine capsules with pink opaque cap
and yellow opaque body, filled with white to light
yellow pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ceclova is indicated for symptomatic treatment of rheumatoid
arthritis, osteoarthritis and ankylosing spondylitis in adult
patients at risk of developing NSAID associated gastric and/or
duodenal ulcers, who are adequately controlled with diclofenac
and omeprazole.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The dose is one capsule daily (diclofenac 75 mg/ omeprazole 20 mg).
In patients switching to Ceclova the symptoms should be adequately
controlled with separately administered monocomponent
preparations of the same doses as contained in this combination. If
symptoms are not controlled by a once daily dosing, the
therapy regime must be changed by switching to one or more alternative
products. Patients should not take more than one
capsule of Ceclova 75 mg / 20 mg per day, as this would lead to
over-exposure to omeprazole.
Undesirable effects may be minimised by using the shortest duration
necessary to control symptoms (see section 4.4).
Treatment should be continued to achieve individual treatment goals,
reviewed at regular intervals and discontinued if no
benefit seen.
Special populations
_Patients with renal impairment _
In patients with mild to moderate renal impairment Ceclova should be
used cautiously and renal function should be monitored
closely (see section 5.2).
Ceclova is c