Deep Relief gel

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ibuprofen; Levomenthol

Available from:

The Mentholatum Company Ltd

ATC code:

M01AE51

INN (International Name):

Ibuprofen; Levomenthol

Dosage:

50mg/1gram ; 30mg/1gram

Pharmaceutical form:

Cutaneous gel

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10030200; GTIN: 05011501080021 05011501015368 05011501000579

Patient Information leaflet

Continued overleaf
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
Ibuprofen & Levomenthol
ANTI-INFLAMMATORY GEL
FOR BACK, RHEUMATIC AND MUSCULAR PAIN
•
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 NSAIDs may
bring on an asthma attack, a runny nose (rhinitis),
itching or rashes
•
are more than 6 months pregnant
•
are breast feeding
•
have broken skin or your skin is infected or
inflamed.
DO NOT USE DEEP RELIEF ANTI-INFLAMMATORY GEL ON:
•
children under 12 years old
•
your lips, nostrils, eyes, genital or anal areas, or
other sensitive areas. If this occurs accidentally,
wash away with plenty of clean water.
•
the same area with other medicines that you put on
the skin.
DEEP RELIEF ANTI-INFLAMMATORY GEL is only for use on
the skin. Do not take by mouth.
TAKE SPECIAL CARE WITH DEEP RELIEF
ANTI-INFLAMMATORY GEL
See your doctor before using Deep Relief
Anti-inflammatory Gel if you:
•
have ever had allergic symptoms such as skin
rashes or itching caused by medicines or
cosmetics
•
have a kidney problem (now or in the past)
•
have a stomach ulcer (now or in the past)
•
are up to 6 months pregnant or think you might be
pregnant
•
are having problems conceiving or having fertility
treatment.
Avoid getting Deep Relief Anti-inflammatory Gel on or
near the eyes and other sensitive areas.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines. This
includes medicines you have bought without a
prescription.
See your doctor before using Deep Relief
Anti-inflammatory Gel if you are taking:
•
aspirin
•
any other pain relieving medicine
•
any other medicines regularly.
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

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
5% w/w / 3% w/w
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of gel contains 50 mg (5%) ibuprofen and 30 mg (3%) levomenthol.
Excipient with known effect: propylene glycol.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL
FORM
Gel for cutaneous administration.
Clear, colourless gel with the odour of menthol.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This product is indicated in adults and children aged over 12 years._
_
_ _
Relief of rheumatic pain, muscular aches, pains and swellings such as
strains,
sprains and sports injuries.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
FOR ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS
Method of administration
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 10 to 40mm (½ to 1½ inches) if using
the 20, 30, 50 or
100g sizes (CONTAINING 50-125MG IBUPROFEN) and use 40 to 100mm (1½ to
4 inches)
if using the 15g size.
If no improvement is seen after two weeks, consult your doctor.
For external use only.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in
section 6.1
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
Paediatric population
Not recommended for children under 12 years of age.
The gel should not be