Mentholatum Deep Heat Spray, cutaneous spray solution

País: Malta

Idioma: anglès

Font: Medicines Authority

Disponible des:

The Mentholatum Company (Ireland) Limited Ground Floor, 71 Lower Baggot Street Dublin, D02 P593 , Ireland

Codi ATC:

M02AX

Designació comuna internacional (DCI):

ETHYL SALICYLATE 5 % (W/W) HYDROXYETHYL SALICYLATE 5 % (W/W) METHYL NICOTINATE 1.6 % (W/W) METHYL SALICYLATE 1 % (W/W)

formulario farmacéutico:

CUTANEOUS SPRAY, SOLUTION

Composición:

ETHYL SALICYLATE 5 % (W/W) HYDROXYETHYL SALICYLATE 5 % (W/W) METHYL NICOTINATE 1.6 % (W/W) METHYL SALICYLATE 1 % (W/W)

tipo de receta:

OTC

Área terapéutica:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Estat d'Autorització:

Authorised

Data d'autorització:

2006-11-27

Informació per a l'usuari

MENTHOLATUM DEEP HEAT SPRAY
®
CUTANEOUS SPRAY SOLUTION
FAST RELIEF FROM RHEUMATIC PAIN, MUSCULAR ACHES AND STRAINS
Deep Heat Spray is a pain relieving, warming spray to be used on the
skin. It is recommended for the
relief of pain in muscles, tendons, joints or bones, lower back and
thigh pain, sprains or strains. It can
be used before and after exercise.
DIRECTIONS FOR USE:
ADULTS AND CHILDREN OVER 5 YEARS ONLY.
•
Always try on a small area first and use sparingly.
•
Shake can well before use.
•
Hold the nozzle not less than 15cm (6”) from the site of pain and
spray in 2-3 short bursts. Massage
is not required. Protect the face when spraying around the
neck/shoulders.
•
Repeat up to 3 times per day.
•
Wash your hands after use.
•
Do not inhale.
CAUTION
:
DO NOT USE:
•
If you are allergic to any of the ingredients
•
If you are allergic to pain relievers such as aspirin, ibuprofen or
other anti-inflammatories.
•
On children under 5 years old
•
On broken skin, your eyes or other sensitive areas of skin
SEE YOUR DOCTOR BEFORE USE
: if you are
•
pregnant
•
breast feeding
•
asthmatic
•
taking medicines that thin the blood (e.g. warfarin), prevent clots
(e.g. aspirin) or any other
prescribed medicines
STOP USING if excessive irritation, allergic reaction or other
unwanted effects occur. Skin burns, blisters
and temporary skin redness, rashes or burning sensation may occur.
IF SYMPTOMS PERSIST CONSULT YOUR DOCTOR.
Some people may experience discomfort, particularly those with
sensitive skin or if used in hot
weather/after a hot bath.
If you get any side effects talk to your doctor. You can also report
side effects at www.imb.ie.
FOR EXTERNAL USE ONLY
ACTIVE INGREDIENTS: (W/W)
Methyl nicotinate 1.6%, 2-hydroxyethyl salicylate 5.0%, Methyl
salicylate 1.0%, Ethyl salicylate 5.0%
Also contains: Isopropyl alcohol, Butane
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Store below 30 °C.
Do not use after the expiry (EXP) date shown on the bottom of the can.
Ask your pharmacist how to
dispose of me

Fitxa tècnica

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Mentholatum Deep Heat Spray, cutaneous spray solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methyl
Nicotinate
1.60 %w/w 2-Hydroxyethyl Salicylate 5.00 %w/w Methyl Salicylate 1.00
%w/w
Ethyl Salicylate
5.00 %w/w For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cutaneous spray, solution
Clear, colourless solution with a characteristic odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of muscular pain, bursitis and tendinitis,
including rheumatic
pain, strains, sprains, fibrositis, lumbago and sciatica.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and Children over 5 years of age:
Spray onto the parts affected when necessary, before or after
exercise.
Hold spray aperture about 15 centimetres (6 inches) from the skin of
the affected area.
Spray in 2-3 short bursts up to 3 times per day.
Children 5 years of age and under:
Not to be used on children under 5 years of age.
4.3
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
Hypersensitivity to aspirin or other non-steroidal anti-inflammatory
drugs (including when
Page 2 of 6
taken by mouth) especially where associated with a history of asthma.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not use if you are allergic to any of the ingredients or medicines
like aspirin.
Consult your doctor before use if you are pregnant, breast-feeding,
asthmatic or on any
prescribed medicines.
For external use only. Not to be sprayed onto broken skin. Avoid
inhalation and contact
with the eyes and sensitive areas of the skin. Always try on a small
area first. Always use
sparingly since some people may experience discomfort particularly
those with sensitive
skin or if used in hot weather or after a bath.
Page 3 of 6
Protect the face when spraying around the neck and shoulders.
Discontinue use if excessive irritation or
other unwanted effects occur. If symptoms persist consult your doctor.
Not to be used on children under 5 years of