Lodine SR 600mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Etodolac

Disponibil de la:

Almirall Ltd

Codul ATC:

M01AB08

INN (nume internaţional):

Etodolac

Dozare:

600mg

Forma farmaceutică:

Modified-release tablet

Calea de administrare:

Oral

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 10010100; GTIN: 5021840010108

Prospect

ARTWORK INFORMATION PANEL DESCRIPTION: PIL Lodine 600mg 30 tab GB Mock up REGULATORY TEXT: uk-pl-lodine-Sep2022annotated
ITEM NUMBER: Mock up
MATERIAL SIZE: 160 x 250 mm
DESIGNER:
DATE: 27/09/2022
FONTS:
Graphik Regular / _Graphik Regular Italic_ /
GRAPHIK SEMIBOLD
MINIMUM FONT SIZE: 8 pt.
PREFIXES (EG.LOT/EXP) FONT SIZE:
LEADING: 3 mm
MANUFACTURER’S TECHNICAL CHECK
Manufacturer confirms the printability and technical compliance of
this packaging material for correct use during packaging process.
Date and Signature
NON PRINTING COLOURS
Die Cut
Adhesive
COLOUR REFERENCE IN
PMS BRIDGE
EQUATE WITH CMYK
PROOF:
ARTWORK INFORMATION PANEL
1
PRINTING COLOURS
Black
SPECIAL FINISHES
PACKAGE LEAFLET : INFORMATION FOR THE PATIENT
LODINE
600 MG
SR TABLETS
etodolac
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. 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 you doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Lodine is and what it is used for
2. What you need to know before you take Lodine
3. How to take Lodine
4. Possible side effects
5. How to store Lodine
6. Contents of the pack and other information
1. WHAT LODINE IS AND WHAT IT IS USED FOR
Lodine is used to treat the symptoms of rheumatoid arthritis and
osteoarthritis by reducing inflammation,
swelling, stiffness, and joint pain. Each tablet contains 600mg of the
active ingredient etodolac. In this
tablet, the medicine is released slowly which means that you only have
to take one tablet each day.
Lodine is one of a group of medicines called “non-steroidal
anti-inflammatory drugs” (NSAIDs) which
are usually taken to relieve the pain, st

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lodine 600 mg SR Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg of etodolac.
Excipients with known effect
Each tablet contains 109 mg lactose and 34 mg of sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Lodine SR Tablets are for oral administration. Each tablet is
capsular, oval
shaped light grey film coated, impressed on one side with Lodine SR600
and
contains etodolac 600mg in a sustained release formulation.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lodine (etodolac) is indicated for acute or long-term use in
rheumatoid
arthritis and osteoarthritis.
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 daily. If a lower dose is sufficient,
conventional Lodine capsules or tablets
may be used.
The safety of doses in excess of 600mg per day has not been
established.
No occurrence of tolerance or tachyphylaxis has been reported.
_ELDERLY:_ No change in initial dosage is generally required in the
elderly (see precautions).
The elderly 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.
_PAEDIATRIC POPULATION:_ Not recommended.
Method of administration
For oral administration.
To be taken preferably with or after food. Swallow the tablet whole
with a tumblerful of
water._ _
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Lodine should not be used in patients with severe heart failure.
Lodine should not be used in patients with active or history of
recurrent peptic ulceration or a
history of peptic ulcer disease (with two or more distinct e