TRANSPULMIN

TRANSPULMIN Cold Balm

Important notes (mandatory information)

Transpulmin Cold Balm, cream. Areas of application: for 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 consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Transpulmin Cold Balm 100 mg/g + 50 mg/g + 25 mg/g cream for use in adults and children
Active ingredients: cineole + levomenthol + racemic camphor

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.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist or the medical professional. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 – 5 days, contact your doctor.

What this package leaflet contains

1. WHAT IS TRANSPULMIN COLD BALM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING TRANSPULMIN COLD BALM?
3. HOW IS TRANSPULMIN COLD BALM USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD TRANSPULMIN COLD BALM BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS TRANSPULMIN COLD BALM AND WHAT IS IT USED FOR?

Transpulmin Cold Balm 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 BE AWARE OF BEFORE USING TRANSPULMIN COLD BALM?

Transpulmin Cold Balm must not be used:

• if you are allergic to the active ingredients cineole, levomenthol and racemic camphor or to the parabens methyl–4–hydroxybenzoate (Ph. Eur.) (E 218), propyl–4–hydroxybenzoate (Ph. Eur.) (E 216), sodium methyl–4–hydroxybenzoate (Ph. Eur.) (E 219) and sodium propyl–4–hydroxybenzoate (Ph. Eur.) (E 217) or any of the other ingredients listed in section 6 of this medicine.
• in the case of asthma, whooping cough, pseudocroup and other respiratory diseases associated with pronounced hypersensitivity of the respiratory tract. Inhalation of Transpulmin Cold Balm can lead to shortness of breath or trigger an asthma attack.
• for external application in the case of skin and childhood diseases with exanthema (rash), as well as on damaged skin, e.g. in the case of burns.
• in infants and toddlers under 2 years of age (risk of laryngospasm).
• for inhalation in children under 6 years of age.
• in children with an increased risk of seizures, due to the camphor content.
• during pregnancy and breastfeeding.

Warnings and precautions

Please talk to your doctor or pharmacist before using Transpulmin Cold Balm.

• Do not use on mucous membranes (including the nose) or in the eye area.
• Do not use on the face!
• Do not apply over a large area.
• Apply only to the chest and back, not to the lower body (abdomen and lumbar region).
• Do not use under an airtight bandage.
• Wash your hands thoroughly after use!

Transpulmin Cold Balm should only be used externally and for inhalation treatment! Transpulmin Cold Balm should only be used in the case of acute inflammation of the respiratory tract or acute pneumonia in addition to treatment of the underlying disease and in consultation with the attending physician.

Children

Due to the risk of scalding from hot water, you should never let children inhale unsupervised! Cineole, levomenthol and racemic camphor can cause laryngospasm in infants and children up to 2 years of age, resulting in severe breathing difficulties.

Use of Transpulmin Cold Balm together with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines, even if they are non-prescription medicines. Eucalyptus oil (the main component of which is cineole) activates 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, as a result of the absorption of larger amounts of active ingredients through the skin.

Pregnancy, breastfeeding and fertility

There is no data on the use of Transpulmin Cold Balm during pregnancy. Animal studies also provide insufficient information on whether treatment with Transpulmin Cold Balm has a harmful effect on pregnancy or the development of the offspring. There is insufficient information on whether Transpulmin Cold Balm or any of the active ingredients (cineole, levomenthol and racemic camphor) pass into breast milk. You must therefore not use Transpulmin Cold Balm during pregnancy and breastfeeding. There is no data on fertility.

Driving and operating machinery

No special precautions are required.

Transpulmin Cold Balm contains parabens

These can cause hypersensitivity reactions, including delayed reactions, and rarely bronchospasm.

3. HOW IS TRANSPULMIN COLD BALM USED?

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. Unless otherwise prescribed, rub about 4 cm of cream into the chest and back 2 - 4 times a day. For inhalation, several centimetres of cream are poured over hot (not boiling) water, depending on the severity of the symptoms and individual tolerance, and the vapours are inhaled for several minutes.

Use in children

Transpulmin Cold Balm must not be used in infants and toddlers under 2 years of age or as an inhalation in children under 6 years of age. If a menthol- and camphor-free application or inhalation is desired, the use of Transpulmin Cold Balm for children is recommended.

Elderly patients

No adjustment of the dose is necessary.

Transpulmin Cold Balm is a cream for application to the skin and for inhalation. Inhalation therapy is simplified and its effect intensified by using the special Transpulmin inhaler. If the special Transpulmin inhaler is not used for inhalation, it is advisable to keep the eyes closed or covered to avoid possible irritation of the conjunctiva. Care should be taken to ensure that children cannot come into contact with the rubbed-in areas of skin with their hands. The duration of use of Transpulmin Cold Balm depends on the type, severity and course of the disease. Do not use Transpulmin Cold Balm for longer than 3 - 5 days without medical advice. If symptoms persist, if you experience shortness of breath, headaches, fever and/or purulent/bloody sputum or nasal discharge, you must consult a doctor immediately. Please talk to your doctor or pharmacist if you have the impression that the effect of Transpulmin Cold Balm is too strong or too weak.

If you have used more Transpulmin Cold Balm than you should

Overdose symptoms are not to be expected in the case of intended use (rubbing in or inhalation). Overdosage after rubbing in can cause skin irritation. In addition, symptoms such as palpitations, hot flushes, weakness and dry mouth, diarrhoea and fever can occur in rare cases. In the case of external, large-scale use, poisoning symptoms can occur, such as kidney damage and damage to the central nervous system (CNS).

If you forget to use Transpulmin Cold Balm

Do not use double the amount if you have forgotten the previous application or have used too little, but continue to use it as prescribed by your doctor or as described in the instructions for use.

If you have used Transpulmin Cold Balm incorrectly

In the event of application errors, please inform a doctor if necessary. He/she can decide on any necessary measures. Swallowing the cream can lead to acute gastrointestinal symptoms such as vomiting or diarrhoea. Acute poisoning symptoms with nausea, vomiting, abdominal and headaches, dizziness, hot flushes/heat waves, seizures (convulsions), respiratory depression and coma have been observed after accidental ingestion of a larger amount. If a child accidentally swallows Transpulmin Cold Balm, it is important to consult a doctor immediately who can carry out the necessary treatment. Do not try to induce vomiting.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Mental disorders

Very rare: Hallucinations.

Nervous system disorders

Frequency not known: In the case of external, large-scale use, poisoning symptoms can occur, such as damage to the central nervous system (CNS), e.g. due to camphor. Camphor-containing ointments should not be used in children with an increased risk of seizures.

Respiratory, thoracic and mediastinal disorders

Frequency not known: Coughing and increased bronchospasm are possible during inhalation (also after external application). Inhalation (also inhalation of the vapours after external application) can itself trigger symptoms such as wheezing (stridor), shortness of breath (dyspnoea) and obstructive breathing difficulties. Bronchospasm can reflexively lead to asthma-like conditions and even respiratory arrest.

Skin and subcutaneous tissue disorders

Frequency not known: Skin irritation is possible after external application and after inhalation. Contact eczema and other hypersensitivities of the skin are possible.

Renal and urinary disorders

Frequency not known: In the case of external, large-scale use, poisoning symptoms can occur, such as kidney damage, e.g. due to camphor.

General disorders and administration site conditions

Frequency not known: Mucous membrane irritation can occur.

In appropriately sensitised patients, hypersensitivity reactions (including shortness of breath) can be triggered by cineole, levomenthol and racemic camphor. Cineole, levomenthol and racemic camphor can cause laryngospasm in infants and children up to 2 years of age, resulting in severe breathing difficulties. The parabens methyl-4-hydroxybenzoate (Ph. Eur.) (E 218), propyl-4-hydroxybenzoate (Ph. Eur.) (E 216), sodium methyl-4-hydroxybenzoate (Ph. Eur.) (E 219) and sodium propyl-4-hydroxybenzoate (Ph. Eur.) (E 217) can cause hypersensitivity reactions, including delayed reactions, and rarely bronchospasm.

Reporting of side effects

If you experience 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 on the safety of this medicine.

5. HOW SHOULD TRANSPULMIN COLD BALM BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the container and the folding box. The expiry date refers to the last day of the month indicated. Storage conditions Do not store above 25°C. Note on shelf life after opening: Transpulmin Cold Balm should not be used for longer than 12 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Transpulmin Cold Balm contains

The active ingredients are: cineole, levomenthol and racemic camphor. 1 g of cream contains 100 mg of cineole, 50 mg of levomenthol and 25 mg of racemic camphor. The other ingredients are: methyl-4-hydroxybenzoate (Ph. Eur.) (E 218), propyl-4-hydroxybenzoate (Ph. Eur.) (E 216), sodium methyl-4-hydroxybenzoate (Ph. Eur.) (E 219), sodium propyl-4-hydroxybenzoate (Ph. Eur.) (E 217), emulsifying glycerol monostearates (type II, 32/36, potassium salts), decyl oleate, yellow Vaseline, sodium edetate, camomile aroma (natural), highly dispersed silicon dioxide, purified water.

What Transpulmin Cold Balm looks like and contents of the pack

Transpulmin Cold Balm is a yellow-white cream. Transpulmin Cold Balm is available in packs of 40 g, 100 g cream and with 100 g cream + inhaler with 2 breathing masks in different sizes.

Pharmaceutical entrepreneur

MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg
Tel.: (06172) 888-01
Fax:(06172)888-27 40
E-mail: medinfo@medapharma.de
www.transpulmin.de

Manufacturer

MEDA Manufacturing
Avenue JF Kennedy
33700 Mérignac
France

This package leaflet was last revised in December 2016.

Source: Information from the package leaflet
Status: 12/2017
Areas of application: for external use to improve well-being in the case of colds of the respiratory tract (such as uncomplicated runny nose, hoarseness and uncomplicated bronchitis).