Mentholatum Deep Heat Cream

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

EUCALYPTUS OIL, TURPENTINE OIL, METHYL SALICYLATE, MENTHOL

Dostupné z:

Colep Laupheim GmbH & Co.KG Fockestrasse 12, 88471 Laupheim, Germany

ATC kód:

M02AX

INN (Medzinárodný Name):

EUCALYPTUS OIL 1.97 % (W/W) TURPENTINE OIL 1.47 % (W/W) METHYL SALICYLATE 12.8 % (W/W) MENTHOL 5.91 % (W/W)

Forma lieku:

CREAM

Zloženie:

EUCALYPTUS OIL 1.97 % (W/W) TURPENTINE OIL 1.47 % (W/W) METHYL SALICYLATE 12.8 % (W/W) MENTHOL 5.91 % (W/W)

Typ predpisu:

OTC

Terapeutické oblasti:

TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2006-11-27

Príbalový leták

PACKAGE LEAFLET : INFORMATION FOR THE USER
MENTHOLATUM DEEP HEAT CREAM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. Nevertheless you
still need to use Mentholatum Deep
Heat Cream 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 is your symptoms do not improve.
-
If any side effects become serious or if you notice any side effect
not listed in this leaflet,
please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET:
1.
What Mentholatum Deep Heat Cream is and what it is used for
2.
Before you use Mentholatum Deep Heat Cream
3.
How to use Mentholatum Deep Heat Cream
4.
Possible side effects
5.
How to store Mentholatum Deep Heat Cream
6.
Further information
1.
WHAT MENTHOLATUM DEEP HEAT CREAM IS AND WHAT IT IS USED FOR
Mentholatum Deep Heat Cream is a non-greasy, pain relieving cream to
be applied to the skin. It is
used for the relief of muscular pains including:
-
Fibrositis (muscle tenderness or stiffness)
-
Muscle strains
-
Arthroses (pain in the joints)
2.
BEFORE YOU USE MENTHOLATUM DEEP HEAT CREAM
DO NOT USE MENTHOLATUM DEEP HEAT CREAM IF YOU HAVE AN ALLERGY
-
to menthol, eucalyptus oil, methyl salicylate, turpentine oil or any
of the other ingredients in
this medicine (listed in section 6).
-
to
PAINKILLERS
such as
ASPIRIN, IBUPROFEN
and other
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDS)
DO NOT USE MENTHOLATUM DEEP HEAT CREAM ON:
-
children under 5 years of age
-
your eyes or other sensitive areas. If this occurs accidentally wash
away with plenty of clean
water
-
broken or inflamed skin
Mentholatum Deep Heat Cream is only for use on the skin.
Do not take by mouth
TAKE SPECIAL CARE WITH MENTHOLATUM DEEP HEAT CREAM
See your doctor before using Mentholatum Deep Heat Cream if you:
-
are pregnant or breastfeeding
-
have asthma
Do not smoke or go near nak

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mentholatum Deep Heat Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Methyl salicylate
12.80% w/w
Racemic menthol
5.91% w/w
Eucalyptus oil
1.97% w/w
Turpentine oil
1.47% w/w
Excipients with known effect: wool fat (lanolin) 0.5%w/w, cetostearyl
alcohol
18.0%w/w and propylene glycol 1.0%w/w.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
White cream with the odour of menthol and methyl salicylate.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
In the local management of the symptoms of fibrositis, muscle strains
and arthroses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For adults and children over 5 years
Directions for use: Apply a thin layer to the affected part with
gentle massage 2 to 3
times daily.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section
6.1
Hypersensitivity to aspirin or other non-steroidal anti-inflammatory
drugs (including
when 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 and only on unbroken skin.
Avoid contact
with the eyes and sensitive areas of skin.
Always try on a small area first. Some people
may experience discomfort particularly those with sensitive skin or if
used in hot
weather or after a bath. Wash hands immediately after use.
This medicine contains 1mg propylene glycol in each 100mg which is
equivalent to
10mg in 1g of cream. Propylene glycol may cause skin irritation.
This medicine contains wool fat (lanolin) and cetostearyl alcohol
which may cause
local skin reactions (e.g. contact dermatitis).
Discontinue use if excessive irritation
or other unwanted effects occur
.
If symptoms
persist consult your doctor. Not to be used on children under 5 yea