PINIMENTHOL

PINIMENTHOL Cold Ointment Eucal./Pine./Menth.

Important notes (mandatory information)

Pinimenthol Cold Ointment. Areas of application: for external use and inhalation to improve well-being in the case of colds of the respiratory tract (such as uncomplicated runny nose, hoarseness and uncomplicated bronchitis).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Pinimenthol Cold Ointment for adults and adolescents aged 12 and over
Active ingredients: Eucalyptus oil, pine needle oil, levomenthol
Herbal medicinal product

Read the entire package leaflet/instructions for use carefully, as it contains important information for you. This medicine is also available without a doctor's prescription. To achieve the best possible treatment results, Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol must be used as prescribed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor.

This package leaflet contains

1. WHAT IS PINIMENTHOL COLD OINTMENT EUCALYPTUS OIL PINE NEEDLE OIL MENTHOL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING PINIMENTHOL COLD OINTMENT EUCALYPTUS OIL PINE NEEDLE OIL MENTHOL?
3. HOW SHOULD PINIMENTHOL COLD OINTMENT EUCALYPTUS OIL PINE NEEDLE OIL MENTHOL BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD PINIMENTHOL COLD OINTMENT EUCALYPTUS OIL PINE NEEDLE OIL MENTHOL BE STORED?
6. HOW IS PINIMENTHOL COLD OINTMENT EUCALYPTUS OIL PINE NEEDLE OIL MENTHOL COMPOSED AND WHAT PACK SIZES ARE AVAILABLE?
7. WHO IS THE MARKETING AUTHORISATION HOLDER FOR PINIMENTHOL COLD OINTMENT EUCALYPTUS OIL PINE NEEDLE OIL MENTHOL?

1. WHAT IS PINIMENTHOL COLD OINTMENT EUCALYPTUS OIL PINE NEEDLE OIL MENTHOL AND WHAT IS IT USED FOR?

Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol is a herbal medicinal product for colds of the respiratory tract. Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol is used for external use and inhalation to improve well-being in the case of colds of the respiratory tract (such as uncomplicated runny nose, hoarseness and uncomplicated bronchitis).

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING PINIMENTHOL COLD OINTMENT EUCALYPTUS OIL PINE NEEDLE OIL MENTHOL?

Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol must not be used:

• if you are hypersensitive to any of the ingredients,
• if you are pregnant or breastfeeding,
• in children under 12 years of age,
• in bronchial asthma, whooping cough and other respiratory diseases that are associated with pronounced hypersensitivity of the respiratory tract (inhalation can lead to constriction of the bronchial muscles),
• for inhalation in the case of acute inflammation of the respiratory tract and acute pneumonia,
• for external use in the case of skin rash and on damaged skin, e.g. in the case of burns.

Special care should be taken when using Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol if you are using this medicine:

• inhalation: Due to the risk of scalding, the inhalant should not be reheated after cooling! Observe the instructions for use for the Pinimenthol Inhaler!
• pregnant and breastfeeding: It is not known whether the use of Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol has negative effects on pregnancy and breastfeeding. You should therefore not use this medicine during pregnancy and breastfeeding (see information under 2).

Warnings:

• Do not apply to mucous membranes (including the nose) or in the eye area.
• Do not apply to the face.
• Wash your hands thoroughly after use.
• Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol should only be used externally and for inhalation treatment.

Due to the risk of scalding (delayed boiling), the inhalant should not be prepared on a stove or in a microwave, not used on a stove and not reheated after cooling. Cetyl stearyl alcohol can cause localised skin irritation (e.g. contact dermatitis).

Interactions with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. Eucalyptus oil induces the foreign substance-degrading enzyme system in the liver. The effects of other medicines can therefore be weakened and/or shortened. This cannot be ruled out in the case of large-scale and/or long-term use due to the absorption of larger amounts of active ingredients through the skin.

3.HOW SHOULD PINIMENTHOL COLD OINTMENT EUCALYPTUS OIL PINE NEEDLE OIL BE USED?

Always use Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Type of use

For external use and for preparing inhalations. Unless otherwise prescribed by your doctor, the usual dose is:

• for rubbing in: rub or gently massage a 3-4 cm long strand of Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol into the chest and back 2 to 4 times a day.
• for inhalation: put a 5 cm long strand of Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol into a suitable container (e.g. the Pinimenthol Inhaler) 1 to 3 times a day, pour hot water over it and inhale the essential oils for several minutes.

When using the Pinimenthol Inhaler

A maximum of 150 ml of water is added to the inhaler.

If symptoms persist for more than 3-5 days, in the case of shortness of breath, headache, fever or purulent/bloody sputum or nasal discharge, a doctor must be consulted urgently. When inhaling, it is advisable to close or cover your eyes to avoid possible irritation of the conjunctiva. The hot water that is necessary for the evaporation of the essential active ingredients and for inhalation should be handled with the utmost care.

If you have used more Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol than you should (massive overdose)

Overdose symptoms are not to be expected in the case of proper external use or inhalation. Excessive inhalation can cause coughing and shortness of breath. After discontinuing inhalation, the symptoms subside. Accidental ingestion of larger amounts of Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol can cause considerable discomfort (e.g. vomiting, abdominal pain, drowsiness). In this case, even if no symptoms have yet occurred, you should contact your doctor. This applies in particular if a small child has swallowed larger amounts of Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol. Milk or alcohol should not be drunk in the event of an overdose, as these can promote the absorption of the active ingredients of Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol into the blood.

If you forget to use Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol

Even if you have forgotten to use it, you should continue to use this medicine as prescribed without increasing the dose.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol can have side effects. The list includes all known side effects under treatment with eucalyptus oil, pine needle oil and levomenthol, including those under higher dosage or long-term therapy.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated patients
Common:	1 to 10 in 100 treated patients
Uncommon:	1 to 10 in 1,000 treated patients
Rare:	1 to 10 in 10,000 treated patients
Very rare:	less than 1 in 10,000 treated patients
Not known:	frequency cannot be estimated from the available data.

Irritations or hypersensitivity reactions (reddening of the skin, rash, itching) can occur on the skin and mucous membranes. Coughing or difficulty breathing due to triggering or intensification of a bronchospasm (constriction of the bronchi) is possible. If you observe any of the above side effects, please inform your doctor so that he/she can decide on the severity and any necessary measures.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the safety of this medicine.

5. HOW SHOULD PINIMENTHOL COLD OINTMENT EUCALYPTUS OIL PINE NEEDLE OIL MENTHOL BE STORED?

Keep medicines out of the reach of children. The expiry date is printed on the folding box and tube. Do not use this pack after this date. The shelf life after opening is 12 months. Do not store above 30°C.

6. HOW IS PINIMENTHOL COLD OINTMENT EUCALYPTUS OIL PINE NEEDLE OIL MENTHOL COMPOSED AND WHAT PACK SIZES ARE AVAILABLE?

100g cream contains: Active ingredients: 20.00g eucalyptus oil, 17.78g pine needle oil, 2.72g levomenthol. The other ingredients are: Purified water; alpha-(hexadecyl/octadecyl)-omega-hydroxypoly(oxyethylene)-12, white petrolatum, ceresine, glycerol monostearate 40-55, heptamethylnonane, glycerol 85%, cetyl stearyl alcohol (Ph. Eur.), octyldodecanol (Ph. Eur.), citric acid-glycerol monooleate-glycerol monostearate-L(+)-6-O-palmitoylascorbic acid-all-rac-a-tocopherol-lecithin (2.5:7.5:20:20:25:25), sodium edetate (Ph. Eur.).

Pinimenthol Cold Ointment Eucalyptus Oil Pine Needle Oil Menthol is available in packs of 20g (N1), 50g (N2), 100g (N3), 100g + inhaler (N3) cream.

7. WHO IS THE MARKETING AUTHORISATION HOLDER FOR PINIMENTHOLERKÄLTUNGSSALBE EUCALYPTUSÖL KIEFERNNADELÖL MENTHOL?

Pharmaceutical entrepreneur and manufacturer

Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Str. 4
76227 Karlsruhe
Telephone: 08000005258
Telefax: 08001009549
www.schwabe.de

This package leaflet was last revised in 01/2014.

Source: Information from the package leaflet
Status: 10/2017
Areas of application: for external use and inhalation to improve well-being in the case of colds of the respiratory tract (such as uncomplicated runny nose, hoarseness and uncomplicated bronchitis).