PULMOTIN

PULMOTIN cold ointment

Important notes (mandatory information)

Pulmotin Cold Ointment.. Areas of application: external use 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 ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Pulmotin Cold Ointment
Herbal medicinal product

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. This medicine is available without a prescription.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If your symptoms worsen or do not improve after 3-5 days, contact your doctor.

What this package leaflet contains

1. WHAT IS PULMOTIN COLD OINTMENT AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING PULMOTIN COLD OINTMENT?
3. HOW TO USE PULMOTIN COLD OINTMENT?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE PULMOTIN COLD OINTMENT?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS PULMOTIN COLD OINTMENT AND WHAT IS IT USED FOR?

Pulmotin Cold Ointment is a herbal medicinal product for colds of the respiratory tract. Pulmotin Cold Ointment is used externally 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 CONSIDER BEFORE USING PULMOTIN COLD OINTMENT?

Pulmotin Cold Ointment must not be used:

• if you are hypersensitive to any of the ingredients.
• due to the content of camphor and cineole, do not use in infants and toddlers under 30 months (risk of laryngospasm).
• in bronchial asthma and whooping cough, as well as pseudocroup and other respiratory diseases that are associated with pronounced hypersensitivity of the respiratory tract, inhalation of Pulmotin Cold Ointment can lead to constriction of the bronchial muscles.
• in skin and childhood diseases with exanthema as well as on damaged or inflamed skin, e.g. in the case of burns or open wounds,
• in children with an increased risk of seizures.

Warnings and precautions

Do not apply to mucous membranes such as the nose and mouth or in the eye area. Do not apply to the face. Wash hands thoroughly after use. For external use only. Do not swallow. Also observe the notes under 3. "How to use Pulmotin Cold Ointment".

Children and adolescents

This medicine should not be used in infants and toddlers under 30 months.

Use of Pulmotin Cold Ointment together with other medicines

Eucalyptus oil stimulates the liver's foreign substance-degrading enzyme system. The effect of other medicines can therefore be weakened and/or shortened. This interaction has been described for aminopyrine (aminophenazone), zoxazole(-amide), amphetamine and phenobarbital. If you are taking other medications, please ask your doctor or pharmacist.

Pregnancy and breast-feeding

Due to insufficient studies, the medicine should not be used during pregnancy and breast-feeding.

Driving and using machines

No special precautions are required.

3. HOW TO USE PULMOTIN COLD OINTMENT?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Pulmotin Cold Ointment is an ointment for application to the skin. Rub the chest and back with Pulmotin Cold Ointment 3 times a day until the ointment has been well absorbed by the skin. Adults take a 5 cm long strip of ointment per application. In children, no more than a 3 cm long strip of ointment should be applied per treatment. Please remove any grease residue from the skin daily. To avoid skin irritation, treatment should not be carried out immediately after washing in infants and people with sensitive skin. Care should be taken to ensure that children do not come into contact with the skin areas rubbed with Pulmotin Cold Ointment with their hands. Pulmotin Cold Ointment should be used until the cold symptoms improve. In the case of symptoms that persist for more than 3 - 5 days, shortness of breath, headache, fever or purulent/bloody sputum or nasal discharge, a doctor must be consulted urgently.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Irritation of the skin and mucous membranes, coughing and increased bronchospasm are possible with inhalation (also external rubbing). Inhalation (also inhalation of vapours after external rubbing) can itself trigger symptoms such as wheezing, shortness of breath and difficulty breathing due to narrowing of the bronchi. Reflexively, a bronchial spasm can lead to asthma-like conditions up to respiratory arrest. Hallucinations have been reported in isolated cases. Contact eczema and other hypersensitivities of the skin are possible. Redness of the treated skin area is harmless. In the case of external, large-scale use, poisoning symptoms can occur, such as kidney damage and damage to the central nervous system, e.g. due to camphor.

Countermeasures

If you observe any of the above side effects, discontinue use of Pulmotin Cold Ointment and inform your doctor (immediately) so that the severity and any necessary measures can be determined. At the first signs of a hypersensitivity reaction (e.g. skin rash), the medicine should not be used any further.

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 provide more information about the safety of this medicine.

5. HOW TO STORE PULMOTIN COLD OINTMENT?

Keep this medicine out of the reach of children. Do not use the medicine after the expiry date which is stated on the tube and the folding box. The expiry date refers to the last day of the month indicated. Shelf life after opening: 6 months. Storage conditions: None.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pulmotin Cold Ointment contains

10g ointment contains: Active ingredients: Eucalyptus oil 0.50 g, racemic camphor 0.20 g, star anise oil 0.15 g, thyme oil 0.03 g, thymol 0.03 g, conifer oil 50 0.125 g (contains 50% isobornyl acetate and 50% a mixture of limonene, linalool, linalyl acetate, (+)-alpha-pinene, beta-pinene, cineole and dodecanol). The other ingredients are: White petrolatum, hard paraffin.

What Pulmotin Cold Ointment looks like and contents of the pack

Pulmotin Cold Ointment is a white, translucent ointment and is available in pack sizes of 25 g and 50 g.

Pharmaceutical entrepreneur and manufacturer

Serumwerk Bernburg AG
Hallesche Landstraße 105 b
06406 Bernburg
Phone: 03471 8600
Fax: 03471 860408

This leaflet was last revised in August 2017.

Source: Information from the package leaflet
Status: 11/2022
Areas of application: external use to improve well-being in the case of colds of the respiratory tract (such as uncomplicated runny nose, hoarseness and uncomplicated bronchitis).