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Package Leaflet: Information for The User

Puncto® Rub Cream

Peppermint Oil, Eucalyptus Oil, Rosemary Oil

In this leaflet:

1.    What Puncto® Rub is and what it is used for

2.    Before you use Puncto® Rub

3.    How to use Puncto® Rub

4.    Possible side effects

5.    How to store Puncto® Rub

6.    Further information

1.    What Puncto® Rub is and what it

is used for

Puncto® 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 Puncto® Rub

2.1    Do not use Puncto® 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 Puncto® 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 Puncto® Rub. Puncto® Rub is not recommended for if you are 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 Puncto® Rub

Always use Puncto® Rub exactly as instructed. You should check with your doctor or pharmacist if you are not sure.

3.1    How much Puncto® Rub to take

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

Children under 12 years of age:

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

3.3    If you used more Puncto® Rub than

you should

If you have accidentally used more than the recommended dosage of Puncto® 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 Puncto® 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, Puncto® Rub can cause side effects, although not everybody gets them.

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

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

•    inhalation of essential oils containing cineol may cause coughing

6. Further Information

What Puncto® Rub contains

The active ingredients in 10g cream are: 0.625 g peppermint oil (essential oil of Mentha x 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 Puncto® Rub looks like and contents of the pack

Puncto® Rub is a white cream with characteristic odour of peppermint, eucalyptus and rosemary.

Puncto® Rub comes in 10 g, 40 g and 100 g aluminium tubes.

THR Holder and Manufacturer

THR Holder: MIT Gesundheit GmbH, Stechbahn 20-22, 47533 Kleve, Germany.

Manufacturer: MIT Gesundheit GmbH, Stechbahn 20-22, 47533 Kleve, Germany.

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

5. How to store Puncto® 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.

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).

For a large print, Braille or audio version of this leaflet, please contact: MIT Gesundheit GmbH, Stechbahn 20-22, 47533 Kleve, Germany.

This leaflet was last revised in December 2014.

^® Registered Trade Mark