Mastodon

Traumeel S® (Tablets, Solution, Ointment, Drops) Instructions for Use

ATC Code

V30 (Not assigned)

Clinical-Pharmacological Group

Homeopathic preparation used for inflammatory processes and injuries

Pharmacotherapeutic Group

Homeopathic agent

Pharmacological Action

A homeopathic remedy, the action of which is due to the components that make up its composition.

Indications

In the complex therapy of inflammatory diseases of various organs and tissues, especially of the musculoskeletal system (tenosynovitis, bursitis, styloiditis, epicondylitis, periarthritis and others); as well as post-traumatic conditions (soft tissue edema after surgery, dislocations, sprains).

ICD codes

ICD-10 code Indication
M65 Synovitis and tenosynovitis
M65.4 Tenosynovitis of styloid process of radius [de Quervain's syndrome]
M70 Soft tissue disorders related to use, overuse, and pressure
M71 Other bursopathies
M77 Other enthesopathies (epicondylitis)
M77.9 Enthesopathy, unspecified
M79.8 Other specified soft tissue disorders
R60.0 Localized edema
T14.3 Dislocation, sprain and strain of joint and ligament of unspecified body region
T14.9 Injury, unspecified
T88.9 Unspecified complication of surgical and medical care
ICD-11 code Indication
FB40.5 De Quervain's tenosynovitis
FB40.Z Tenosynovitis, unspecified
FB50.1 Bursitis associated with use, overuse or pressure
FB50.Z Bursitis, unspecified
FB55.Z Enthesopathy, unspecified
FB56.6 Other specified soft tissue disorders
MG29.0 Localized edema
ND56.3 Dislocation, sprain or strain of unspecified body region
ND56.Z Unspecified injury of unspecified part of trunk, limb or body region
NE8Z Injury or harm caused as a result of surgical or therapeutic interventions, not elsewhere classified, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets, Solution, Drops

The specific homeopathic preparation and its exact dose are always determined strictly individually.

The general rule: for acute pathological conditions, low decimal potencies are used; for chronic diseases and in children, higher (centesimal and millesimal) potencies are used.

In acute diseases, when low potencies are used, the homeopathic preparation can be applied every 5-10 minutes and 3-4 times a day, depending on the specific disease.

In chronic diseases, the frequency of administration can range from 3-4 times a day to 1-2 times a week and even less often, when using very high potencies.

The simultaneous use of two or more homeopathic preparations or a complex preparation is possible only as prescribed by a homeopathic doctor.

Ointment

For children from 3 years of age and adults, a sufficient amount of the ointment is applied in a thin layer to the skin of the painful areas of the body and rubbed in with light movements 2-3 times/day. An ointment dressing may be applied.

The course of treatment for post-traumatic conditions is 2 weeks or more; for inflammatory diseases – at least 3-4 weeks.

Adverse Reactions

When using the ointment, in some cases, hypersensitivity reactions (skin allergic reactions) may be observed.

Contraindications

  • Tuberculosis;
  • Leukemias;
  • Collagenoses;
  • Multiple sclerosis;
  • Acquired immunodeficiency syndrome (including HIV);
  • Autoimmune diseases;
  • Children under 3 years of age (due to insufficient clinical data);
  • Known hypersensitivity to common yarrow, German chamomile, pot marigold, common daisy, echinacea, mountain arnica or other plants of the Asteraceae family;
  • Increased individual sensitivity to the components of the drug.

Use in Pregnancy and Lactation

Use of the ointment is possible if the expected benefit to the mother outweighs the potential risk to the fetus and child. A doctor’s consultation is necessary.

Pediatric Use

Contraindicated in children under 3 years of age.

Special Precautions

To increase the effectiveness of treatment, it is recommended to take various dosage forms, for example, ointment, drops or tablets and solution for intramuscular and periarticular administration.

When taking homeopathic medicines, existing symptoms may temporarily worsen (primary aggravation). In this case, the patient should stop using the drug and consult a doctor.

In case of violation of the integrity of the skin and skin diseases, the ointment should be used after consultation with a doctor.

Drug Interactions

The use of homeopathic preparations does not exclude treatment with other medicines.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Biologische Heilmittel Heel, GmbH (Germany)

Dosage Form

Bottle Rx Icon Traumeel® S Homeopathic solution for intramuscular and periarticular administration: amp. 2.2 ml 5 or 100 pcs.

Dosage Form, Packaging, and Composition

Homeopathic solution for intramuscular and periarticular administration in the form of a colorless, transparent liquid without odor.

1 amp.
Arnica montana (Arnica) D2 2.2 µl
Calendula officinalis (Calendula) D2 2.2 µl
Hamamelis virginiana (Hamamelis) D1 0.22 µl
Achillea millefolium (Millefolium) D3 2.2 µl
Atropa bella-donna (Belladonna) D2 2.2 µl
Aconitum napellus (Aconitum) D2 1.32 µl
Mercurius solubilis Hahnemanni D6 1.1 µl
Hepar sulfuris (Hepar sulfuris calcareum) D6 2.2 µl
Chamomilla recutita (Chamomilla) D3 2.2 µl
Symphytum officinale (Symphytum) D6 2.2 µl
Bellis perennis D2 1.1 µl
Echinacea D2 0.55 µl
Echinacea purpurea D2 0.55 µl
Hypericum perforatum (Hypericum) D2 0.66 µl

Excipients: sodium chloride (for establishing isotonicity) about 9 mg/ml, water for injections – up to 2.2 ml.

2.2 ml (2.2 g) – ampoules of colorless glass (5) – plastic contour cell packs (1) – cardboard boxes.
2.2 ml (2.2 g) – ampoules of colorless glass (5) – plastic contour cell packs (20) – cardboard boxes.

Marketing Authorization Holder

Biologische Heilmittel Heel, GmbH (Germany)

Dosage Form

Bottle OTC Icon Traumeel® S Homeopathic ointment for external use: tubes 50 g or 100 g 1 pc.

Dosage Form, Packaging, and Composition

Homeopathic ointment for external use from white to yellowish- or pinkish-white in color, with a weak, characteristic odor; no rancid odor should be felt; homogeneous, without traces of physical instability (particle aggregation, phase separation, coagulation).

100 g
Arnica montana D3 1.5 g
Calendula officinalis Ø 0.45 g
Hamamelis virginiana Ø 0.45 g
Echinacea Ø 0.15 g
Echinacea purpurea Ø 0.15 g
Chamomilla recutita Ø 0.15 g
Symphytum officinale D4 0.1 g
Bellis perennis Ø 0.1 g
Hypericum perforatum D6 0.09 g
Achillea millefolium Ø 0.09 g
Aconitum napellus D1 0.05 g
Atropa bella-donna D1 0.05 g
Mercurius solubilis Hahnemanni D6 0.04 g
Hepar sulfuris D6 0.025 g

Excipients: liquid paraffin – 9.342 g, cetostearyl alcohol (type A) emulsifying – 8.007 g, white soft paraffin – 9.342 g, purified water – 60.579 g, ethanol (ethyl alcohol) 96% (by volume) – 9.335 g.

50 g – aluminum tubes (1) – cardboard boxes.
100 g – aluminum tubes (1) – cardboard boxes.

Marketing Authorization Holder

Biologische Heilmittel Heel, GmbH (Germany)

Dosage Form

Bottle OTC Icon Traumeel® S Homeopathic oral drops: 30 ml dropper bottle

Dosage Form, Packaging, and Composition

Homeopathic oral drops in the form of a transparent, colorless or light yellow liquid with the smell of ethanol.

100 g
Arnica montana D2 5 g
Calendula officinalis D2 5 g
Hamamelis virginiana D2 5 g
Achillea millefolium D3 5 g
Atropa bella-donna D4 25 g
Aconitum napellus D3 10 g
Mercurius solubilis Hahnemanni D8 10 g
Hepar sulfuris D8 10 g
Chamomilla recutita D3 8 g
Symphytum officinale D8 8 g
Bellis perennis D2 2 g
Echinacea D2 2 g
Echinacea purpurea D2 2 g
Hypericum perforatum D2 1 g

Excipients: ethanol (ethyl alcohol) about 35% (by volume).

30 ml – dark glass bottles with a built-in dropper (1) – cardboard boxes.

Marketing Authorization Holder

Biologische Heilmittel Heel, GmbH (Germany)

Dosage Form

Bottle OTC Icon Traumeel® S Homeopathic sublingual tablets: 50 pcs.

Dosage Form, Packaging, and Composition

Homeopathic sublingual tablets white or yellowish-white in color, sometimes with yellow, orange or gray inclusions, round, flat-cylindrical in shape, with a bevel; odor is practically absent.

1 tab.
Arnica montana D2 15 mg
Calendula officinalis D2 15 mg
Hamamelis virginiana D2 15 mg
Achillea millefolium D3 15 mg
Atropa bella-donna D4 75 mg
Aconitum napellus D3 30 mg
Mercurius solubilis Hahnemanni D8 30 mg
Hepar sulfuris D8 30 mg
Chamomilla recutita D3 24 mg
Symphytum officinale D8 24 mg
Bellis perennis D2 6 mg
Echinacea D2 6 mg
Echinacea purpurea D2 6 mg
Hypericum perforatum D2 3 mg

Excipients: magnesium stearate – 1.5 mg, lactose monohydrate – to obtain a tablet weighing about 0.302 g.

50 pcs. – plastic canisters (1) – cardboard boxes.

TABLE OF CONTENTS