Mentholatum Deep Heat Cream

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Methyl salicylate; Racementhol; Eucalyptus oil; Turpentine oil

Dostupné z:

Colep Laupheim GmbH & Co KG

ATC kód:

M02AC

INN (Medzinárodný Name):

Methyl salicylate; Racementhol; Eucalyptus oil; Turpentine oil

Dávkovanie:

0 percent weight/weight

Forma lieku:

Cream

Terapeutické oblasti:

Preparations with salicylic acid derivatives

Stav Autorizácia:

Marketed

Dátum Autorizácia:

1990-07-16

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

Health Products Regulatory Authority
20 February 2020
CRN009JFH
Page 1 of 3
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 - contains wool fat (lanolin) 0.5% w/w, cetostearyl alcohol
18% 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 an 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 per