DOLOPLANT

DOLOPLANT for muscle and joint pain cream

Important notes (mandatory information)

Doloplant for muscle and joint pain cream. Areas of application: for the supportive treatment of rheumatic complaints and muscle pain.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Doloplant for muscle and joint pain cream for adults and adolescents aged 12 and over
Active ingredients: peppermint oil, eucalyptus oil, rosemary oil
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.

• 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 if you feel worse, talk to your doctor.

What this package leaflet contains

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

1. WHAT IS DOLOPLANT FOR MUSCLE AND JOINT PAIN AND WHAT IS IT USED FOR?

Herbal medicinal product for the external treatment of muscle and joint pain. Doloplant for muscle and joint pain is used externally for the supportive treatment of rheumatic complaints and muscle pain.

2. WHAT SHOULD YOU CONSIDER BEFORE USING DOLOPLANT FOR MUSCLE AND JOINT PAIN?

Doloplant for muscle and joint pain must not be used:

• if you are hypersensitive to peppermint oil, eucalyptus oil, rosemary oil or any of the other ingredients of this medicine listed in section 6.
• on damaged skin (e.g. injuries, burns, rash).
• if you suffer from shortness of breath due to narrowing of the airways (bronchial asthma), whooping cough, constricting laryngitis (pseudocroup).
• in other respiratory diseases that are associated with a pronounced hypersensitivity of the respiratory tract.
• in infants and toddlers under 2 years of age due to the risk of laryngospasm or respiratory arrest.

Warnings and precautions

In acute conditions, e.g. accompanied by redness, swelling or overheating, as well as in persistent complaints or if the complaints worsen during the use of Doloplant for muscle and joint pain or do not improve within 4 weeks, consult your doctor. Clean your hands thoroughly after using Doloplant for muscle and joint pain and avoid contact of the medicine with your eyes.

Children

Doloplant for muscle and joint pain must not be used in infants and toddlers under 2 years of age due to the risk of laryngospasm or respiratory arrest. There are no sufficient studies on the use in children up to 12 years of age. Therefore, Doloplant for muscle and joint pain should not be used in children of this age group.

Use of Doloplant for muscle and joint pain together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. However, no interactions are to be expected with proper external use.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. There are no sufficient studies on the use of Doloplant for muscle and joint pain during pregnancy. Therefore, you should not use this medicine during pregnancy. This medicine should not be used during breast-feeding, as there are no sufficient studies. It is not known whether the ingredients of the essential oils pass into breast milk.

Driving and using machines

No special precautions are required.

3. HOW TO USE DOLOPLANT FOR MUSCLE AND JOINT PAIN?

Always use Doloplant for muscle and joint pain exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. The recommended dose is: Adults and adolescents aged 12 and over apply a cream strand of approx. 6 cm to the affected parts of the body 3 to 5 times a day. 6 cm of cream strand contain 0.12 g peppermint oil, 0.12 g eucalyptus oil and 0.078 g rosemary oil.

Type of use

Apply the cream evenly and massage in thoroughly.

Duration of use

The duration of use depends on the symptoms and the underlying disease and is usually up to 4 weeks. For longer-term use, you should consult a doctor or pharmacist.

If you have used more Doloplant for muscle and joint pain than you should

Even with large-scale and long-term use, no undesirable effects are to be expected. In case of accidental ingestion, please notify your doctor, who will decide on appropriate measures.

If you forget to use Doloplant for muscle and joint pain

Do not use twice the amount if you have forgotten the previous application, but continue to use the prescribed dosage.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Immune system disorders

In appropriately sensitised patients, peppermint oil, eucalyptus oil and rosemary oil can trigger hypersensitivity reactions (including shortness of breath). The frequency is not known (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders

Hypersensitivity reactions of the skin with redness, rash (contact dermatitis) and itching. The frequency is not known (cannot be estimated from the available data).

What countermeasures should be taken in the event of side effects?
If you notice or suspect a side effect, do not use Doloplant for muscle and joint pain any further and please inform your doctor or pharmacist.

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 via the Federal Institute for Drugs and Medical Devices, Dept. 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 DOLOPLANT FOR MUSCLE AND JOINT PAIN?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube after "use by". The expiry date refers to the last day of the month indicated. Shelf life after first opening: The medicine can be used for 9 months after first opening. Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Doloplant for muscle and joint pain contains

The active ingredients are: peppermint oil, eucalyptus oil, rosemary oil. 10 g of cream contain: 0.625 g peppermint oil, 0.625 g eucalyptus oil, 0.40 g rosemary oil. The other ingredients are: medium-chain triglycerides, hard fat, glycerol(dihydrogencitrate)stearate, glycerolmono/dispeisefatty acid esters, cetyl palmitate (Ph. Eur.), xanthan gum, bleached wax, octyldodecanol (Ph. Eur.), purified water.

What Doloplant for muscle and joint pain looks like and contents of the pack

Doloplant for muscle and joint pain is a white cream available in tubes. Doloplant for muscle and joint pain is available in packs of 50 g cream and 100 g cream.

Pharmaceutical entrepreneur

Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Str. 4
76227 Karlsruhe
Telephone: 0800 000 52 58
Telefax: 0800100 9549
www.schwabe.de

Manufacturer

C.P.M. ContractPharma GmbH & Co. KG
Frühlingstraße 7
D-83620 Feldkirchen-Westerham

This package leaflet was last revised in November 2017.

Source: Information from the package leaflet
Status: 06/2018
Areas of application: for the supportive treatment of rheumatic complaints and muscle pain.