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Movelat Relief Cream

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Document: leaflet MAH BRAND 2_PL 06831-0176 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

MOVELAT RELIEF CREAM

mucopolysaccharide polysulfate (MPS) 0.2% w/w and salicylic acid 2.0% w/w

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    If you get any side-effects, talk to your doctor or pharmacist. This includes any possible side-effects not listed in this leaflet. See section 4.

-    You must talk to a doctor if your signs of illness or injury do not improve.

What is in this leaflet

1.    What Movelat Relief Cream is and what it is used for

2.    What you need to know before you use Movelat Relief Cream

3.    How to use Movelat Relief Cream

4.    Possible side-effects

5.    How to store Movelat Relief Cream

6.    Contents of the pack and other information

1. WHAT MOVELAT RELIEF CREAM IS AND WHAT IT IS USED FOR

Movelat Relief Cream contains the active substances mucopolysaccharide polysulfate (MPS) and salicylic acid.

Movelat Relief Cream is a mild to moderate anti-inflammatory and analgesic (pain-relieving) preparation which, when applied to the skin, provides relief from muscular pain and stiffness, sprains and strains, and pain due to rheumatic and non-serious arthritic conditions.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE MOVELAT RELIEF CREAM Do not use Movelat Relief Cream:

•    if you are allergic (hypersensitive) to mucopolysaccharide polysulfate, salicylic acid (or any other aspirin-like medicine) or other related painkillers known as non-steroidal anti-inflammatory drugs (NSAIDS). This is particularly important if you suffer from asthma

•    if you are allergic to any of the other ingredients of Movelat Relief Cream (listed in section 6)

•    if you have broken skin, infected skin or eczema

•    on large areas of skin

•    on or near sensitive areas such as the mouth, eyes or ano-genital regions.

Movelat Relief Cream should NOT be used on children under the age of 12 years old. Warnings and precautions

-    Movelat Relief Cream is for external use only. Do NOT swallow.

-    Do not exceed the dose stated in section 3.

-    Talk to your doctor or pharmacist before using Movelat Relief Cream:

° if your signs of injury or illness do not improve or get worse.

° if you are pregnant or breast-feeding.

° if you suffer from asthma.

° if you have pre-existing renal/kidney damage.

° if you are using any prescribed medicines.

-    You may experience discomfort if you have sensitive skin, use the cream in hot weather or after a bath.

-    Wash your hands immediately after use.

-    Stop using this cream if you experience irritation or other unwanted effects.

See section 4 for information about possible side-effects.

Other medicines and Movelat Relief Cream

Tell your doctor or pharmacist if you are using coumarin anti-coagulants (medicines for thinning the blood, such as Warfarin), as Movelat Relief Cream may affect the way that such anti-coagulants work.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Movelat Relief Cream should not be used during the first three or last three months of pregnancy or on the breast area during breast-feeding/lactation.

Movelat Relief Cream contains cetostearyl alcohol

This may cause local skin reactions (for example contact dermatitis).

3. HOW TO USE MOVELAT RELIEF CREAM

External use only. Do not swallow.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Before use, pierce the tube seal with the spiked top of the cap.

Push and turn the spiked end of the cap firmly into the nozzle until you hear a click. The amount of cream you use will depend on the size of the area being treated. Between 2 and 6 inches (5-15 cm) of cream should be gently massaged into the affected area at any one time.

You can apply Movelat Relief Cream up to four times a day.

Do not exceed this dose.

Some people experience discomfort, particularly those with sensitive skin or if used in hot weather or after a bath.

Remember to wash your hands after applying Movelat Relief Cream, unless this is the area being treated.

If you accidentally swallow some of this cream you should contact your doctor or a hospital casualty department. You may experience rapid breathing, a ringing sound in the ears, deafness, light-headedness or sweating.

4. POSSIBLE SIDE-EFFECTS

Like all medicines, Movelat Relief Cream can cause side-effects, although not everybody gets them.

Rarely, Movelat Relief Cream can cause the following in sensitive individuals:

•    redness

•    burning sensation

•    a rash.

If any of these occur, STOP using the cream and tell your doctor or pharmacist. Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

GENUS PHARMACEUTICALS 25254702 9254745 1602 GB/MT


Malta

www.medicinesauthority.gov.mt/adrportal

Please read the back of this leaflet.

'Trademark

5. HOW TO STORE MOVELAT RELIEF CREAM

Keep this medicine out of the sight and reach of children.

Do not use Movelat Relief Cream after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month. Store below 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Movelat Relief Cream contains

The active substances are:

-    mucopolysaccharide polysulfate 0.2% w/w

-    salicylic acid 2.0% w/w.

The other ingredients are:

-    glycerol 85%

-    stearic acid

-    anhydrous eucerine

-    myristyl alcohol

-    emulsifying cetostearyl alcohol

-    ethanolamine

-    thymol

-    isopropyl alcohol

-    purified water.

What Movelat Relief Cream looks like and the contents of the pack

Movelat Relief Cream is a white cream available in aluminium lacquered tubes of 14, 40, 50, 80, 100 and 125 grams.

Not all pack sizes may be marketed.

P

PL 06831/0176 Movelat Relief Cream MA 085/00202

Marketing Authorisation Holder:

Genus Pharmaceuticals

Linthwaite, Huddersfield, HD7 5QH, UK.

Manufacturers:

Mobilat Produktions GmbH

Luitpoldstrasse 1, 85276 Pfaffenhofen, Germany.

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel, Germany.

This leaflet was last revised in February 2016.

'Trademark


GENUS PHARMACEUTICALS


25254702