Voltarol 50 mg Gastro-Resistant Tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Diclofenac sodium

Dostępny od:

Novartis Ireland Limited

Kod ATC:

M01AB; M01AB05

INN (International Nazwa):

Diclofenac sodium

Dawkowanie:

50 milligram(s)

Forma farmaceutyczna:

Gastro-resistant tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

Acetic acid derivatives and related substances; diclofenac

Status autoryzacji:

Marketed

Data autoryzacji:

1979-10-03

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
VOLTAROL® 50 MG GASTRO-RESISTANT TABLETS
(diclofenac sodium)
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, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it onto
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.
•
This medicine will be referred to as Voltarol in this leaflet.
WHAT IS IN THIS LEAFLET
1. What Voltarol is and what it is used for
2. What you need to know before you take Voltarol
3. How to take Voltarol
4. Possible side effects
5. How to store Voltarol
6. Contents of the pack and other information
1. WHAT VOLTAROL IS AND WHAT IT IS USED FOR
Diclofenac sodium, the active ingredient in Voltarol is one of a group
of medicines called “non-steroidal
anti-inflammatory drugs” (NSAIDs). NSAIDs reduce pain and
inflammation. They have no effect on the
causes of inflammation.
Voltarol is used to treat a number of painful conditions including:
•
joint or muscle pain
•
attacks of gout
•
pain and swelling after surgery
•
sprains, strains and other injuries
•
gynaecology problems such as period pain
•
painful ear, nose and throat infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOLTAROL
DO NOT TAKE VOLTAROL IF:
•
you think you may be allergic to diclofenac sodium or to any of the
other ingredients of Voltarol
(listed in Section 6). Signs of a hypersensitivity reaction include
swelling of the face and mouth
(angioedema), breathing problems, chest pain, runny nose, skin rash or
any other allergic type
reaction
•
you have now, or have ever had, a stomach (gastric) or duodenal
(peptic) ulcer, or bleeding in the gut
(digestive tract). This can include blood in vomit, bleeding

Charakterystyka produktu

Health Products Regulatory Authority
07 October 2022
CRN00D6H5
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Voltarol 50 mg Gastro-Resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Voltarol Tablets 50 mg contain 50mg diclofenac sodium.
Each tablet also contains 25mg lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Circular, slightly biconvex, light brown, gastro-resistant tablet with
bevelled edges, embossed ‘CG’ on one side and ‘GT’ on the
other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Relief of all grades of pain and inflammation in a wide range of
conditions.
Treatment of:

Inflammatory and degenerative forms of rheumatism: rheumatoid
arthritis, juvenile rheumatoid arthritis,
ankylosing spondylitis, osteoarthritis, spondylarthritis and psoriatic
arthropathy.

Acute attacks of gout.

Post-traumatic and post-operative pain, inflammation, and swelling,
e.g. following dental or orthopaedic surgery.

Painful and/or inflammatory conditions in gynaecology, e.g. primary
dysmenorrhoea or adnexitis and associated
menorrhagia.

As an adjuvant in severe painful inflammatory infections of the ear,
nose, or throat, e.g. pharyngotonsillitis, otitis. In
keeping with general therapeutic principles, the underlying disease
should be treated with basic therapy, as
appropriate. Fever alone is not an indication.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
The tablets should be swallowed whole with liquid, preferably before
meals, and must not be divided or chewed.
_Adults:_
_ _
Voltarol 50mg gastro-resistant tablets: 75-150mg daily in two or three
divided doses. The recommended maximum daily dose
of Voltarol is 150mg. This may be administered using a combination of
dosage forms, e.g. tablets and suppositories.
_Children and adolescents_
Children aged 1 year