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PUNCTO RUB CREAM - summary of medicine characteristics

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Summary of medicine characteristics - PUNCTO RUB CREAM

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Puncto Rub cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

10 g cream contains:

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.)

For a full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Cutaneous cream.

White with characteristic odour of peppermint, eucalyptus and rosemary.

CLINICAL PARTICULARS

4.1 Therapeutic indications

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.

4.2 Posology and method of administration

For cutaneous use only.

Adults, the Elderly and Children over 12 years:

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:

The use in children under 12 years of age is not recommended (see Section 4.4 Special warnings and precautions for use.

Duration of use:

Nasal congestion and coughs due to colds

If the symptoms worsen or persist for more than one week a doctor or qualified health care practitioner should be consulted.

Muscular aches and pains, stiffness

If the symptoms worsen or persist for more than 2 weeks a doctor or qualified health care practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to any of the active ingredients, to menthol or any of the excipients. Patients with

obstruction of the bile duct or intestinal tract,

cholangitis,

liver disease,

gallstones and any other biliary disorders

4.4 Special warnings and precautions for use

Do not exceed the stated dose. For cutaneous use only.

This medicine is not recommended for children under 12 years of age because data are not sufficient and medical advice should be sought.

If the condition worsens, or if symptoms persist for more than one week (nasal congestion and coughs) or two weeks (muscular aches, pains, stiffness), a doctor or qualified healthcare practitioner should be consulted.

Do not swallow or place in nostrils. Avoid contact with eyes and mucous membranes. Do not apply to broken or irritated skin. Discontinue use if redness, irritation or dry skin occurs.

If dyspnoea, fever or purulent sputum occurs, a doctor or a qualified healthcare practitioner should be consulted.

If articular pain accompanied by swelling of joint, redness or fever are present a doctor or a qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction None known.

4.6 Fertility, Pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been undertaken.

4.8 Undesirable effects

The following adverse reactions have been reported:

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

The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or qualified healthcare practitioner should be consulted.

4.9 Overdose

4.9 Overdose

No cases of overdose have been reported.

Overdosage may result in skin irritation. Accidental swallowing of the cream might cause gastrointestinal symptoms such as nausea, vomiting and diarrhoea.

Supportive and symptomatic treatment should be provided as appropriate.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

5.3 Preclinical safety data

Monoterpenes contained in the preparation pass the placental barrier. Small amounts of essential oils may pass into the breast milk.

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

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

Water, purified

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Aluminium tubes of 10 g, 40 g and 100 g. Not all pack sizes may be marketed.

6.6 Special precautions for disposal

6.6 Special precautions for disposal

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements

7 MARKETING AUTHORISATION HOLDER

MIT Gesundheit GmbH, Stechbahn 20–22, 47533 Kleve, Germany

8 MARKETING AUTHORISATION NUMBER(S)

THR 27060/0001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

29/01/2013