(012) 654-8921 info@modhomco.co.za
Proprietary name and dosage form:

TRAUMEEL®S ORAL DROPS

Composition: 100 ml cont.:  Arnica Montana D2 5 ml;  Calendula officinalis D2 5 ml;  Hamamelis virginiana D2 5 ml;  Achillea millefolium D3 5 ml;  Atropa belladonna D4 25 ml;  Aconitum napellus D3 10 ml;  Mercurius solubilis Hahnemanni D8 10 ml;  Hepar sulfuris D8 10 ml;  Chamomilla recutita D3 8 ml;  Symphytum officinale D8 8 ml;  Bellis perennis D2 2 ml;  Echinacea angustifolia D2 2 ml;  Echinacea purpurea D2 2 ml;  Hypericum perforatum D2 1 ml.Contains 35 % v/v alcohol.
Indications: Traumeel® S is indicated in injuries such as sprains, dislocations, contusions, effusions of blood and effusions into a joint, fractures; post-operative and post-traumatic oedema and swelling of the soft tissues; inflammatory processes and degenerative processes associated with inflammation on the various organs and tissues, including, in particular, on the support and mobility apparatus (tendovaginitis, styloiditis, epicondylitis, bursitis, scapulohumeral periarthritis); arthrosis of the hip, knee and small joints; commotio cerebri acuta.
Contraindications: Traumeel® S is contraindicated in patients with a known hypersensitivity to one of the active ingredients or excipients, to Arnica, Chamomilla, Achillea millefolium or to other plants of the daisy (composite) family. As a matter of principle, Echinacea should not be used in progressive, systemic diseases such as tuberculosis, leukaemia or leukaemia-like diseases, inflammatory diseases of the connective tissue (collagen disease), autoimmune diseases, multiple sclerosis, AIDS, HIV infections or other chronic viral diseases.
Warnings: Warnings
Traumeel® S should not be administered for pain for more than 10 days for adults or 5 days for children unless directed by a medical practitioner. If pain persists or worsens, if new symptoms occur, or if redness or swelling is present, the patient should consult a medical practitioner because these could be signs of a serious condition. Traumeel® S should not be administered to children for the pain of arthritis unless directed by a medical practitioner.Special Precautions
Information for Patients:
No harmful or potentially hazardous side effects such as central nervous system depression are known. Traumeel® S is generally well-tolerated.Carcinogenesis:
No studies have been performed to evaluate the carcinogenicity of Traumeel® S. In world-wide post-marketing surveillance studies no evidence of carcinogenicity has been found (2).Paediatric Use:
Due to its alcohol content (35 vol.-% v/v ethyl alcohol), a medical practitioner should be consulted before using Traumeel® S in children below 12 years.
Interactions: Traumeel® S is not known to interact with other medications. Furthermore, the administration of an oral dosage form of Traumeel® S can be safely augmented by the application of a topical dosage form of Traumeel® S.Drug/Laboratory Test Interactions: Traumeel® S is not known to interact with any laboratory tests.
Pregnancy and lactation: If you are pregnant or breast feeding your baby please consult your doctor, pharmacist or other health care professional for advice before taking this medicine.
Dosage and directions for use: The dosage schedules listed below can be used as a general guide for the administration of Traumeel® S. Traumeel® S shows individual differences in clinical response. Therefore, the dosage for each patient should be individualized according to the patient’s response to therapy. The frequency of administration may be increased to 5 times daily for the treatment of acute symptoms in both children and adults, unless otherwise directed by a medical practitioner. The oral dosage forms of Traumeel® S should be administered at least 30 minutes after meals and when the oral cavity is free of food material. For best results, treatment with Traumeel® S should be initiated immediately following injury or at the first sign of symptoms. Traumeel® S may be administered until symptoms disappear. However, if symptoms persist or worsen, a medical practitioner should be consulted (see 8 Warnings).Adults and Children above 11 years: 10 drops orally 3 times daily; for swelling of the soft tissues 30 drops 3 times daily. Hold in mouth 10-15 seconds before swallowing.Infants and Children to 11 years: Due to its alcohol content (35 vol.-% v/v ethyl alcohol), a medical practitioner should be consulted before using Traumeel® S for children below 12 years.For best results, Traumeel® should be administered on an empty stomach.
Traumeel® S may be added to clear, non-sparkling water prior to administration.
Side Effects and Special Precautions: General:
Adverse effects with Traumeel® S are extremely rare. Traumeel® S exhibits no known adverse renal, hepatic, cardiovascular, gastrointestinal or central nervous system effects.Adverse Reactions:
In rare cases, patients with hypersensitivity to botanicals of the Compositae family may experience an allergic reaction after oral administration of Traumeel® S.Traumeel® S ingredients of the Compositae family are:
Arnica montana (mountain arnica)
Calendula officinalis (calendula)
Achillea millefolium (milfoil)
Chamomilla recutita (chamomile)
Bellis perennis (daisy)
Echinacea angustifolia (narrow-leafed cone flower)
Echinacea purpurea (purple cone flower)Side effects:
Hypersalivation may occur after administration, in which case the product should be discontinued. Hypersensitivity reactions or allergic skin reactions (redness, swelling and pruritus) can occur in individual cases in people with known hypersensitivity to plants of the composite family (e.g. Arnica, Chamomilla, Achillea millefolium), in which case the product should be discontinued, too. Skin rash and itching (pruritus), and in rare cases facial swelling, shortness of breath (dyspnoea), dizziness and a fall in blood pressure, have been observed after treatment with products containing Echinacea extracts.Not all side effects reported for this medicine are included in this leaflet.  Should your general health worsen or if you experience untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.
Registration number: U5540 (Act 101/1965).
Disclaimer: This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.

 

Proprietary name and dosage form:

TRAUMEEL®S GEL

Composition: 10 g gel contains:Arnica Montana                D3 0,15 g; Calendula officinalis Ø 0,045 g; Hamamelis virginiana Ø 0,045 g; Echinacea angustifolia Ø 0,015 g; Echinacea purpurea Ø 0,015 g; Chamomilla recutita Ø      0,015 g; Symphytum officinale e radice D4 0,01 g; Bellis perennis Ø 0,01 g;  Hypericum perforatum D6 0,009 g; Achillea millefolium Ø 0,009 g; Aconitum napellus D1 0,005 g; Atropa belladonna D1 0,005 g; Mercurius solubilis Hahnemanni D6 0,004 g; Hepar sulfuris D6 0,0025 g.Preservative:  17,9 % m/m ethyl alcohol.
Indications: For the temporary relief of arthritic pain, of symptoms associated with injuries (i.e. sports injuries, sprains, bruises) and inflammations of all kinds (i.e. tennis elbow).
Contraindications: Hypersensitivity to the active substances or to the excipients, or to botanicals of the Compositae family (Arnica).
Warnings:
Interactions: No interactions studies have been performed.
Pregnancy and lactation: If you are pregnant or breast feeding your baby please consult your doctor, pharmacist or other health care professional for advice before taking this medicine.
Dosage and directions for use: For external use only.Apply to the affected parts 1-2 times daily, or more often if necessary.A dressing may be applied.
Replace cap tightly.
Do not use on open wounds.Always tell your health care professional if you are taking any other medicine.  In the event of over dosage, consult your doctor or pharmacist.  If neither is available, contact the nearest poison control centre.
Side Effects and Special Precautions: Side Effects
In isolated cases, hypersensitivity reactions may occur.
Local allergic reactions (skin inflammation) have been reported.Special Precautions
Preservative: 17.9% m/m ethyl alcohol.
Not all side effects reported for this medicine are included in this leaflet.  Should your general health worsen or if you experience untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.
Registration number: To be allocated by Council.
Disclaimer: This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.

Proprietary name and dosage form:

TRAUMEEL®S OINTMENT

Composition: Each 100 g of ointment contains as active ingredients:  Arnica Montana D2 1,5 g;  Calendula officinalis Ø 0,45 g;  Hamamelis virginiana Ø 0,45 g;  Echinacea angustifolia 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 belladonna D1 0,05 g;  Mercurius solubilis Hahnemanni D6 0,04 mg; Hepar sulfuris D6 0,025 g.  Preservative:  13,8 % v/v alcohol.
Indications: Traumeel® S is indicated in injuries of all kinds (sports, accidents) such as sprains, dislocations, contusions, effusions of blood and effusions into a joint, fractures, etc; inflammatory processes and degenerative processes associated with inflammation on the various organs and tissues (e.g. periodontitis, suppuration of the gingival pockets, periodontosis), including, in particular, on the support and mobility apparatus (tendovaginitis, bursitis, scapulohumeral periarthritis); arthrosis of the hip, knee and small joints.
Contraindications: Traumeel® S is contraindicated in patients with a known hypersensitivity to one of the active ingredients or excipients or to plants of the daisy (compositae) family (e.g. Arnica, Chamomilla, Achillea millefolium).
Warnings: WarningsTraumeel® S should not be administered for pain for more than 10 days for adults or 5 days for children unless directed by a medical practitioner. If pain persists or worsens, if new symptoms occur, or if redness or swelling is present, the patient should consult a medical practitioner because these could be signs of a serious condition. Traumeel® S should not be administered to children for the pain of arthritis unless directed by a medical practitioner.Special PrecautionsInformation for Patients:
No harmful or potentially hazardous side effects such as central nervous system depression are known. Traumeel® S is generally well-tolerated.Carcinogenesis:
No studies have been performed to evaluate the carcinogenicity of Traumeel® S. In world-wide post-marketing surveillance studies no evidence of carcinogenicity has been found (2).Paediatric Use:
Traumeel® S can be safely administered to infants and children (see Dosage and Directions for Use).
Interactions: Traumeel® S is not known to interact with other medications.Drug/Laboratory Test Interactions: Traumeel® S is not known to interact with any laboratory tests.
Pregnancy and lactation: If you are pregnant or breast feeding your baby please consult your doctor, pharmacist or other health care professional for advice before taking this medicine.
Dosage and directions for use: The dosage schedules listed below can be used as a general guide for the administration of Traumeel® S. Traumeel® S shows individual differences in clinical response. Therefore, the dosage for each patient should be individualized according to the patient’s response to therapy. The frequency of administration may be increased to 5 times daily for the treatment of acute symptoms in both children and adults, unless otherwise directed by a medical practitioner. For best results, treatment with Traumeel® S should be initiated immediately following injury or at the first sign of symptoms. Traumeel® S may be administered until symptoms disappear. However, if symptoms persist or worsen, a medical practitioner should be consulted (see Warnings).Adults, Children and Infants: Apply ointment generously to the affected area 2 to 3 times daily.
Traumeel® S should be rubbed gently into the skin. Traumeel® S may be applied using mild compression bandaging (4) and/or occlusive bandaging (5). Sufficient ointment should be applied to cover the affected area, but should not be applied over large areas, over broken skin or directly into large open wounds.Always tell your health care professional if you are taking any other medicine.  In the event of over dosage, consult your doctor or pharmacist.  If neither is available, contact the nearest poison control centre.
Side Effects and Special Precautions: General:
Adverse effects with Traumeel® S are extremely rare. Traumeel® S exhibits no known adverse renal, hepatic, cardiovascular, gastrointestinal or central nervous system effects.Adverse Reactions:
In rare cases, patients with hypersensitivity to botanicals of the Compositae family may experience an allergic reaction after oral, topical or parenteral administration of Traumeel® S, (after parenteral administration anaphylactic reaction can occur). Traumeel® S ingredients of the Compositae family are:Arnica montana (mountain arnica)
Calendula officinalis (calendula)
Achillea millefolium (milfoil)
Chamomilla recutita (chamomile)
Bellis perennis (daisy)
Echinacea angustifolia (narrow-leafed cone flower)
Echinacea purpurea (purple cone flower)Side effects:
Hypersensitivity reactions may occur in individual cases. Local allergic reactions (cutaneous inflammation, redness, swelling and pruritus) have been reported. In this case the product should be discontinued.Not all side effects reported for this medicine are included in this leaflet.  Should your general health worsen or if you experience untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.
Registration number: U5684 (Act 101/1965).
Disclaimer: This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.

Proprietary name and dosage form:

TRAUMEEL®S TABLETS

Composition: Each 300 mg tablet contains as active ingredients:  Arnica Montana D2 15 mg; Calendula officinalis D2 15 mg;  Hamamelis virginiana D2 15 mg;  Achillea millefolium D3 15 mg; Atropa belladonna 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 angustifolia D2 6 mg;  Echinacea purpurea D2 6 mg;  Hypericum perforatum D2 3 mg.  Inactive ingredients: lactose, magnesium stearate.
Indications: This medicine is prepared in accordance with homeopathic principles and is proposed for use in injuries such as sprains, dislocations, contusions, effusions of blood and effusions into a joint, fractures; post-operative and post-traumatic oedema and swelling of the soft tissues; inflammatory processes and degenerative processes associated with inflammation on the various organs and tissues, including, in particular, on the support and mobility apparatus (tendovaginitis, styloiditis, epicondylitis, bursitis, scapulohumeral periarthritis); arthrosis of the hip, knee and small joints; commotio cerebri acuta.
Contraindications: Hypersensitivity to any of the ingredients, including excipients, or hypersensitivity to members of the Compositae family. Principally contraindicated for patients with progressive systemic disease such as tuberculosis, leukose, collagen disorders, multiple sclerosis, AIDS, HIV infection, and other autoimmune disorders.
Warnings: This preparation contains natural lactose. Although the quantity of lactose present is probably not sufficient to cause discomfort, a health professional should be consulted in strong cases of lactose intolerance. A temporary aggravation of the existing symptoms is possible after taking a homeopathic preparation.
Interactions: No interactions studies have been performed.
Pregnancy and lactation: If you are pregnant or breast feeding your baby please consult your doctor, pharmacist or other health care professional for advice before taking this medicine.
Dosage and directions for use: Adults and children over 3 years of age: Dissolve 1 tablet in the mouth 3 times daily.
Infants: Half the adult dose.Always tell your health care professional if you are taking any other medicine.  In the event of over dosage, consult your doctor or pharmacist.  If neither is available, contact the nearest poison control centre.
Side Effects and Special Precautions: Side Effects
Increased flow of saliva may occur after taking this medication; in such an event, do not continue therapy with this preparation. Hypersensitivity reactions may occur in individual cases.
The following have been observed among patients taking medication containing preparations from rudbeckia: rashes, itching, facial swelling (rare), acute respiratory distress, vertigo, and acute hypotension.Not all side effects reported for this medicine are included in this leaflet.  Should your general health worsen or if you experience untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.
Registration number: U5514 (Act 101/1965).
Disclaimer: This medicine has not been evaluated by the Medicines Control Council. This medicine is not intended to diagnose, treat, cure or prevent any disease.

More Info

Traumeel - Oral Drops PIL (Patient Information Leaflet) Traumeel S - Oral Drops PI (Package Insert) Traumeel - Tablets PIL (Patient Information Leaflet) Traumeel S - Tablets PI (Package Insert) Traumeel - Ointment PIL (Patient Information Leaflet) Traumeel S - Ointment PI (Package Insert)