Deep Relief, Deep Relief Pain Relief Gel, Deep Relief Anti-Inflammatory Gel 5%w/w,3%w/w.

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IBUPROFEN, LEVOMENTHOL

Available from:

The Mentholatum Company Limited 1 Redwood Avenue, Peel Park Campus, East Kilbride, G74 5PE, Scotland, United Kingdom

ATC code:

M01AE01

INN (International Name):

IBUPROFEN 5 % (W/W) LEVOMENTHOL 3 % (W/W)

Pharmaceutical form:

GEL FOR CUTANEOUS ADMINISTRATION

Composition:

IBUPROFEN 5 % (W/W) LEVOMENTHOL 3 % (W/W)

Prescription type:

OTC

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Suspended

Authorization date:

2006-11-27

Patient Information leaflet

Patient Information Leaflet
Deep Relief
Anti-Inflammatory
Gel
Ibuprofen and Levomenthol
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR
YOU.
This medicine is available without prescription. However, you still
need to use Deep
RELIEF ANTI-INFLAMMATORY
Gel carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
YOU MUST SEE A DOCTOR IF YOUR SYMPTOMS DO NOT IMPROVE AFTER 2 WEEKS.
•
If any of the side effects gets severe or you notice any side effects
not listed in
this leaflet please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Deep Relief Anti-Inflammatory Gel is and what it is used for
2. Before you use Deep Relief Anti-Inflammatory Gel
3. How to use Deep Relief Anti-Inflammatory Gel
4. Possible side effects
5. How to store Deep Relief Anti-Inflammatory
Gel
6. Further information
1. WHAT DEEP RELIEF ANTI-INFLAMMATORY GEL IS AND WHAT IT IS USED FOR
Deep Relief Anti-Inflammatory Gel is a pain relieving gel to be
applied to the skin. It
is used for the Relief of:
•
Rheumatic pain (in muscles, tendons, joints or bones)
•
Muscular aches and pains
•
Pains and swellings such as strains, sprains and sports injuries.
Deep Relief Anti-Inflammatory
Gel contains two active ingredients.
•
Ibuprofen is one of a group of medicines called non-steroidal anti-
inflammatory drugs (NSAIDs) which provide effective pain relief and
reduce
both inflammation and swelling.
•
Levomenthol provides a soothing sensation to calm the pain.
2.
BEFORE YOU USE DEEP RELIEF ANTI-INFLAMMATORY GEL
DO NOT USE DEEP RELIEF ANTI-INFLAMMATORY GEL IF YOU:
•
have an allergy to ibuprofen, menthol, or any of the ingredients in
Deep Relief
Anti-Inflammatory
Gel (see end of Section 2 and Section 6)
•
have an allergy to aspirin or other pain-relieving medicines known as
non-
steroidal anti-inflammatory drugs (NSAIDs) including those you take
orally
by mouth
•
have asthma and know that aspirin or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Deep Relief
Deep Relief Pain Relief Gel
Deep Relief Anti-Inflammatory Gel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen
5.0% w/w
Levomenthol
3.0% w/w
For a full list of excipients, see 6.1
3.
PHARMACEUTICAL FORM
Gel for cutaneous administration
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Relief of rheumatic pain, muscular aches, pains and swellings such as
strains, sprains
and sports injuries.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For adults, the elderly and children over 12 years
Apply the gel over the affected area and massage gently until
absorbed. Repeat as
necessary, up to a maximum of three times a day. Not to be repeated
more frequently
than every four hours.
For each application use about ½ to 1½ inches (10 to 40mm) if using
the 20, 30, 50 or
100g sizes and use 1½ to 4 inches (40to 100mm) (containing 50-125mg
Ibuprofen) if
using the 15g size.
If no improvement is seen after two weeks, consult your doctor.
Children under 12 years
Not recommended.
For external use only
4.3.
CONTRA-INDICATIONS
Those patients known to be hypersensitive to ibuprofen, levomenthol,
or any of the
ingredients or sensitive to aspirin, or other NSAIDS including when
taken by mouth,
or asthmatic patients in whom aspirin or non-steroidal
anti-inflammatories are known
to precipitate asthmatic attacks, rhinitis or urticaria. Use on broken
skin or denuded
skin. Simultaneous use on the same site with any other topical
medicine. Use in the
presence of local infection. Use in the last trimester of pregnancy.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The gel should not be used on or near mucous membranes, nor near the
eyes.
Avoid contact with inflamed or broken skin. Discontinue use if rash or
irritation
develops. Not for use with occlusive dressings.
Always try on a small area first.
As it is known that oral Ibuprofen may worsen an existing renal
impairment, or
aggravate an active peptic ulcer, patients with a history of renal
problems or with a