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Movelat Gel

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MOVELAT GEL

mucopolysaccharide polysulphate (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.

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

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness or injury are the same as yours.

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

What is in this leaflet:

1. What Movelat Gel is and what it is used for

2. What you need to know before you use Movelat Gel

3.    How to use Movelat Gel

4.    Possible side-effects

5.    How to store Movelat Gel

6. Contents of the pack and other information

1. WHAT MOVELAT GEL IS AND WHAT IT IS USED FOR

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

Movelat Gel 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 GEL Do not use Movelat Gel:

•    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 Gel (listed in section 6)

•    if you have broken skin

•    on large areas of skin

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

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

-    Movelat Gel is for external use only. Do NOT swallow.

-    Do not exceed the dose stated in section 3.

-    Talk to    your    doctor    if your signs of injury or illness do not improve or get worse.

-    Talk to    your    doctor    before use    if you    are pregnant or breast-feeding.

-    Talk to    your    doctor    before use    if you    suffer from asthma.

-    Talk to    your    doctor    before use    if you    are using any prescribed medicines.

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

-    Wash your hands immediately after use.

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

See section 4 for information about possible side-effects.

Other medicines and Movelat Gel

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

Tell your doctor or pharmacist if you are taking, or 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 Gel should not be used during the first three or last three months of pregnancy.

3. HOW TO USE MOVELAT GEL

External use only. Do not swallow.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. If your doctor has prescribed this gel for you, the pharmacist will have printed your doctor’s instructions onto a label on the tube or carton. Read the label carefully to remind yourself of how your doctor wants you to use Movelat Gel.

•    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 gel you use will depend on the size of the area being treated.

•    Between 2 and 6 inches (5-15 cm) of gel should be gently massaged into the affected area at any one time.

•    You can apply Movelat Gel 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 Gel, unless this is the area being treated.

•    If you accidentally swallow some of this gel 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 Gel can cause side-effects, although not everybody gets them. Rarely, Movelat Gel can cause the following in sensitive individuals:

•    redness

•    burning sensation

•    a rash.

If any of these occur, STOP using the gel 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard Malta

www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine.

Please read the back of this leaflet.


GENUS PHARMACEUTICALS 25252001

“Trademark    9254748 1411 GB/MT

P


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5.HOW TO STORE MOVELAT GEL

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

Do not use Movelat Gel 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 Gel contains

The active substances are:

-    mucopolysaccharide polysulfate 0.2% w/w

-    salicylic acid 2.0% w/w.

The other ingredients are:

-    isopropyl alcohol

-    monoethanolamine

-    carbomer

-    disodium edetate

-    polyethylene glyceryl-oleate

-    rosemary oil

-    purified water.

What Movelat Gel looks like and the contents of the pack

Movelat Gel is a colourless gel available in aluminium lacquered tubes of 14, 40, 50, 80, 100 and 125 grams.

Not all pack sizes may be marketed.

PL 06831/0177 Movelat Gel MA 085/00201

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 March 2015.

"Trademark


GENUS PHARMACEUTICALS 25252001


Product

Title

Movelat Gel

Colours used

Fonts used

Component

Leaflet

Black

Helvetica 55 Roman

Pack Size

125g

Helvetica 75 Bold

IG code

25252001

Dimensions

148mm x 420mm

Proof No.

05 Date 16/01/2015