Vitafen 100mg Film-coated Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
12-12-2022
Summary of Product characteristics
(SPC)
12-12-2022
Active ingredient:
Aceclofenac
Available from:
Phoenix Labs
ATC code:
M01AB; M01AB16
INN (International Name):
Aceclofenac
Dosage:
100 milligram(s)
Pharmaceutical form:
Film-coated tablet
Administration route:
Oral use
Units in package:
Packs of 10, 20, 30, 40, 60 and 100
Prescription type:
Product subject to prescription which may be renewed (B)
Manufactured by:
Accord Healthcare Limited
Therapeutic area:
Acetic acid derivatives and related substances; aceclofenac
Therapeutic indications:
It is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Authorization status:
Marketed
Authorization date:
2015-04-10
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
VITAFEN 100 MG FILM-COATED TABLETS
ACECLOFENAC
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, pharmacist or
nurse.
•
This medicine has been prescribed for you. 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.
IN THIS LEAFLET:
1. WHAT VITAFEN IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VITAFEN
3. HOW TO TAKE VITAFEN
4. POSSIBLE SIDE EFFECTS
_5. _
HOW TO STORE VITAFEN
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT VITAFEN IS AND WHAT IT IS USED FOR
Vitafen contains the active substance Aceclofenac. Aceclofenac belongs
to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These
drugs reduce
inflammation and pain.
Vitafen is used to relieve pain and reduce redness and swelling
(inflammation) in patients
suffering from:
•
arthritis of the joints (osteoarthritis)
•
autoimmune disease that causes chronic inflammation of the joints
(rheumatoid
arthritis)
•
arthritis of the spine which can lead to the fusion of the vertebrae
(ankylosing
spondylitis).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VITAFEN
DO NOT TAKE VITAFEN
•
if you are allergic to aceclofenac or any of the other ingredients of
this medicine
(listed in section 6).
•
if you are allergic to aspirin or any other NSAIDs (such as ibuprofen,
naproxen or
diclofenac).
•
if you have taken aspirin or any other NSAIDs and experienced one of
the following:
-
asthma attack causing tightness in the chest, wheezing and difficulty
breathing.
-
runny nose, itching and/or sneezing (irritation of the nose).
-
raised red circular patchy rash on the skin which may have felt or
like a
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Summary of Product characteristics
Health Products Regulatory Authority
12 December 2022
CRN00D89Y
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitafen 100mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Aceclofenac 100mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
White to off-white, round shaped, biconvex, film-coated tablet
debossed with “100” on one side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vitafen 100mg tablets are indicated for the relief of pain and
inflammation in osteoarthritis, rheumatoid arthritis and
ankylosing spondylitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
The recommended dose is 200 mg daily, taken as two separate 100 mg
doses, one tablet in the morning and one in the
evening.
_PAEDIATRIC POPULATION_
There are no clinical data on the use of Vitafen in children and
therefore it is not recommended for use in children under 18
years of age.
ELDERLY
The elderly, who are more likely to be suffering from impaired renal,
cardiovascular or hepatic function and receiving
concomitant medication, are at increased risk of the serious
consequences of adverse reactions. If an NSAID is considered
necessary, the lowest effective dose should be used and for the
shortest possible duration. The patient should be monitored
regularly for GI bleeding during NSAID therapy.
The pharmacokinetics of Vitafen are not altered in elderly patients,
therefore it is not considered necessary to modify the dose
or dose frequency.
RENAL INSUFFICIENCY
There is no evidence that the dosage of Vitafen needs to be modified
in patients with mild renal impairment, but as with other
NSAIDs caution should be exercised (see Section 4.4).
HEPATIC INSUFFICIENCY
There is some evidence that the dose of Vitafen should be reduced in
patients with hepatic impairment and it is suggested that
an initial daily dose of 100 mg be used.
Undesirable effects may be minimised by using the lowest effectiv
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