Package Leaflet: Information for The User

Tradimed® Vapour & Muscle Rub Cream

Peppermint Oil, Eucalyptus Oil, Rosemary Oil

What Tradimed® Vapour & Muscle Rub is and what it is used for Before you use T radimed® Vapour & Muscle Rub How to use Tradimed® Vapour & Muscle Rub Possible side effects

How to store Tradimed® Vapour & Muscle Rub Further information

1.    What Tradimed® Vapour &

Muscle Rub is and what it is used for

Tradimed® Vapour & Muscle Rub is a traditional herbal medicinal product used for the symptomatic relief of

•    nasal congestion and coughs due to colds,

•    muscular aches and pains, stiffness, based on traditional use only.

2.    Before you use Tradimed® Vapour & Muscle Rub

2.1    Do not use Tradimed® Vapour & Muscle Rub

•    if you have a known hypersensitivity to any of the active ingredients or any of the excipients in the product,

•    if you are pregnant or breast-feeding,

•    if you have gall bladder outlet obstruction, gall bladder inflammation, severe liver damage,

•    on broken or irritated skin,

•    in children under 12 years.

2.2    Take special care with Tradimed® Vapour & Muscle Rub

If the condition worsens, or if symptoms persist for more than one week (nasal congestion and coughs) or two weeks (muscular aches, pains, stiffness), or if adverse events not mentioned in the package leaflet occur, consult a qualified healthcare practitioner.

Avoid contact with eyes and mucous membranes. Discontinue use if redness, irritation or dry skin occurs.

2.3    Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

2.4    Pregnancy and breast-feeding

You must ask your doctor or pharmacist for advice before using Tradimed® Vapour & Muscle Rub. Tradimed® Vapour & Muscle Rub is not recommended for use by pregnant or breast-feeding women.

2.5    Driving and using machines

No special precautions are needed. This medicine should have no effect on your ability to drive and use machines.

3. How to take Tradimed® Vapour & Muscle Rub

Always use T radimed® Vapour & Muscle Rub exactly as instructed. You should check with your doctor or pharmacist if you are not sure.

3.1 How much Tradimed® Vapour & Muscle Rub to take

For cutaneous use only. Please ask your doctor or pharmacist if you think that

Tradimed® Vapour & Muscle Rub may be too strong or weak for you.

3.2    Adults, the elderly and children over 12 years of age:

Nasal congestion and coughs due to colds Apply approximately 6 cm of cream 3 to 5 times daily to the chest, throat and back and massage thoroughly into the skin.

Leave nightclothes loose for easy inhalation.

Muscular aches and pains stiffness Apply approximately 6 cm of cream 3 to 5 times daily gently to the affected area and massage thoroughly into the skin.

Wash hands after use.

Children under 12 years of age:

This medicine is not recommended for children under 12 years of age.

3.3    If you used more Tradimed® Vapour

& Muscle Rub than you should

If you have accidentally used more than the recommended dosage of Tradimed® Vapour & Muscle Rub this usually will not have any side effects. Continue to apply the usual dose at the usual time.

3.4    If you forget to take Tradimed® Vapour & Muscle Rub

Never use a double dose to make up for a missed dose. Use the next dose at the usual time.

If you have any further questions about taking this medicine, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tradimed® Vapour & Muscle Rub can cause side effects, although not everybody gets them.

•    allergic reactions, e.g., skin rash, skin reddening, blistering, hives, swelling, contact dermatitis, asthma

•    irritation of skin or mucous membranes as well as bronchial spasms

•    inhalation of essential oils containing cineol may cause coughing

Usually if you stop taking the medicine any side effects will disappear.

If any of the side effects become serious, or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

You can help to make medicines safer by reporting any side effects to the YellowCard Scheme at www.mhra.gov.uk/yellowcard. Alternatively you can get a paper YellowCard form from your GP's surgery or pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday-Friday).

5. How to store Tradimed® Vapour & Muscle Rub

Keep out of the reach and the sight of children.

Do not use the cream after the expiry date on the carton and the tube. The expiry date is the last day of that month.

Do not store above 25°C. Store in the original package.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.

6. Further Information

What Tradimed® Vapour & Muscle Rub

contains

The active ingredients in 10g cream are: 0.625 g peppermint oil (essential oil of Mentha * piperita L.)

0.625 g eucalyptus oil (essential oil of Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker)

0.40 g rosemary oil (essential oil of Rosmarinus officinalis L.).

The other ingredients are:

Medium-chain triglycerides, hard fat (Softisan 378), glyceryl stearate citrate (Imwitor 370), partial glycerides of saturated vegetable fatty acids (glyceryl cocoate, Imwitor 928), cetyl palmitate, xanthan gum, white beeswax, octyldodecanol and purified water.

What Tradimed® Vapour & Muscle Rub looks like and contents of the pack

Tradimed® Vapour & Muscle Rub is a white cream with characteristic odour of peppermint, eucalyptus and rosemary. Tradimed® Vapour & Muscle Rub comes in 10 g, 40 g and 100 g aluminium tubes.

THR Holder and Manufacturer

THR Holder:

Grunwalder Gesundheits-produkte GmbH, Ruhlandstr. 5, 83646 Bad Tolz, Germany.

Manufacturer: Grunwalder Gesundheits-produkte GmbH, Ruhlandstr. 5, 83646 Bad Tolz, Germany.    _

THR 18457/0014 certification mark

For a large print, Braille or audio version of this leaflet, please contact: PlantaPhile Ltd., 18 Hyde Gardens, Eastbourne, East Sussex, BN21 4PT, UK.

This leaflet was last revised in August 2013. ® Registered Trade Mark