Traumaplant

TRAUMAPLANT pain cream

Important notes (mandatory information)

Traumaplant Pain Cream. Active ingredient: Comfrey preparation. Areas of application: for bruises and sprains (in sports and accident injuries), muscle and joint pain resulting from blunt injuries.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Traumaplant Pain Cream for use in children aged 6 and over, adolescents and adults
Active ingredient: Comfrey preparation (1 g comfrey preparation from fresh Symphytum x uplandicum herb/10 g cream)

Read the entire package leaflet carefully before you start using this medicine, as 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 notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 3 – 4 days, contact your doctor.

What this package leaflet contains

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

1. WHAT IS TRAUMAPLANT PAIN CREAM AND WHAT IS IT USED FOR?

Traumaplant Pain Cream is a herbal medicine for the external treatment of blunt injuries. Traumaplant Pain Cream is used for bruises and sprains (in sports and accident injuries), muscle and joint pain resulting from blunt injuries.

2. WHAT SHOULD YOU CONSIDER BEFORE USING TRAUMAPLANT PAIN CREAM?

Traumaplant Pain Cream must not be used if you are allergic to comfrey or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Traumaplant Pain Cream. If the symptoms do not improve within 3 - 4 days of treatment with Traumaplant Pain Cream, a doctor should be consulted.

General notes

Contact with the eyes and mucous membranes should be avoided.

Children

As there is insufficient data for this age group, the use of Traumaplant Pain Cream in children under 6 years of age is not recommended.

Use of Traumaplant Pain Cream with other medicines

When used as directed, Traumaplant Pain Cream has not been known to interact with other agents. Inform your doctor or pharmacist if you are using, have recently used or intend to use other medicines.

Pregnancy and breast-feeding

There are no adequate studies on the use of Traumaplant Pain Cream during pregnancy and breast-feeding. Therefore, Traumaplant Pain Cream should not be used during pregnancy and breast-feeding.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Traumaplant Pain Cream

Sorbic acid can cause localized skin irritation (e.g. contact dermatitis). Propylene glycol can cause skin irritation.

3. HOW TO USE TRAUMAPLANT PAIN CREAM?

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. For application to the skin in children aged 6 and over, adolescents and adults.

The recommended dose is

Age Dosage
Children aged 6 to under 12 years Up to 3 times daily
Adolescents aged 12 and over and adults Several times daily

Apply Traumaplant Pain Cream to the skin over the affected tissue according to the recommended dosage. Traumaplant Pain Cream is particularly suitable for ointment dressings. Traumaplant Pain Cream should be used for a maximum of 3 weeks, depending on the symptoms.

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

Skin and subcutaneous tissue disorders

In very rare cases, skin redness may occur, which is individually related to patients with extremely sensitive skin or with an allergic disposition to a component of Traumaplant Pain Cream. In general, these skin reactions subside quickly. Due to the content of sorbic acid, irritation, such as dermatitis, may occur in predisposed patients.

Immune system disorders

In the event of a specific allergic reaction, a doctor should be consulted.

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 on the safety of this medicine.

5. HOW TO STORE TRAUMAPLANT PAIN CREAM?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the tube fold and on the folding box after "Usable until". The expiry date refers to the last day of the month. Storage conditions: Do not store above 25°C. Note on shelf life after opening: Shelf life after opening: 6 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Traumaplant Pain Cream contains

The active ingredient is: Preparation from fresh Symphytum x uplandicum herb [comfrey preparation]. 10 g cream contains: 1 g preparation from fresh Symphytum x uplandicum herb (2 - 3 : 1) [comfrey preparation] consisting of: 0.4 g pressed juice from fresh Symphytum x uplandicum herb (3 - 8 : 1) and 0.6 g extract from the pressed residue from fresh Symphytum x uplandicum herb (3 - 10 : 1); Extraction agent: Ethanol 30 % (VA/). The other ingredients are: Macrogol-20-glycerol monostearate, glycerol mono/di (palmitate, stearate), octyldodecanol, isopropyl myristate, propylene glycol, dimethicone 100, rosemary oil, all-rac-a-tocopherol acetate, citric acid, purified water, preservative: sorbic acid, hydroxyethyl salicylate.

Note

Traumaplant Pain Cream does not contain any harmful pyrrolizidine alkaloid levels. Traumaplant Pain Cream is therefore not subject to the restrictions on the use of medicines containing pyrrolizidine alkaloids.

What Traumaplant Pain Cream looks like and contents of the pack

Original packs with 50 g, 100 g and 150 g cream.

Pharmaceutical entrepreneur

Cassella-med GmbH & Co. KG
Gereonsmühlengasse 1
50670 Cologne
Telephone: 0800 /1652-200
Fax: 0800/1652-700
E-mail: dialog@cassella-med.eu

Marketing Authorisation Holder

Harras Pharma Curarina Arzneimittel GmbH
Am Harras 15
81373 Munich

Manufacturer

Klosterfrau Berlin GmbH
Motzener Str. 41
12277 Berlin

This package leaflet was last revised in May 2016.

Source: Package leaflet information
Status: 01/2018
Active ingredient: Comfrey preparation. Areas of application: for bruises and sprains (in sports and accident injuries), muscle and joint pain resulting from blunt injuries.