Sustamar

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SUSTAMAR®

Composition:

Active substance: Harpagophytum procumbens (Devil's Claw);

One film-coated tablet contains dry extract of Harpagophytum procumbens root (extractum Harpagophytum procumbens siccum) 4.5–5:1 (extractant – ethanol 60%) 480 mg;

Excipients: maize starch, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silicon dioxide, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide (E 171), iron oxide yellow (E 172).

Pharmaceutical form. Film-coated tablets.

Main physicochemical characteristics: oval, biconvex film-coated tablets of yellow color with a break line on both sides.

Pharmacotherapeutic group.

Medicinal products used in disorders of the musculoskeletal system.

ATC code M09AX.

Pharmacological properties.

Pharmacodynamics.

Chondroprotective properties are determined by the complex action of active substances of the extract of Martinea odorata, which inhibit not only inflammatory mediators but also mediators of cartilage destruction: TNF-α, IL-1β, matrix metalloproteinases, NO, and elastase. This provides anti-inflammatory and analgesic effects, inhibits the synthesis of inflammatory cytokines, promotes suppression of matrix metalloproteinases in chondrocytes, thereby suppressing inflammatory processes.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Used both as monotherapy and in comprehensive treatment of acute and chronic disorders of the musculoskeletal system, such as:

• conditions accompanied by back pain;
• inflammatory disorders of the musculoskeletal system (arthritis, tendinitis, tenosynovitis);
• degenerative-dystrophic joint diseases (coxarthrosis, gonarthrosis, spondyloarthrosis, and others);
• osteochondrosis and osteochondropathy;
• as a chondroprotective agent to prevent joint damage under intensive physical loads (sports, heavy labor).

Contraindications.

• Known hypersensitivity to harpagophytum or to any other components of the drug;
• gastric or duodenal ulcer.

Medical consultation is required in case of gallstone disease.

Interaction with medicinal products and other forms of interactions. Unknown.

Special precautions for use.

Instructions for diabetics

The amount of carbohydrates contained in one daily dose of the medicinal product amounts to 0.05 bread units.

Patients suffering from gastric or duodenal ulcer should not take Harpagophytum-containing products due to possible risk.

Special caution is required when administering Harpagophytum to patients with cardiovascular diseases.

Patients with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not use Sustamar®.

Use during pregnancy or breastfeeding.

Due to insufficient research, the product should not be used during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

When performing tasks requiring high concentration, possible adverse reactions affecting the nervous system—such as headache and dizziness (very rare)—should be taken into account (see section "Adverse reactions").

Dosage and Administration.

1 tablet twice daily during meals at regular intervals, taken with an adequate amount of water.

Duration of use: from 4 to 16 weeks.

Repeated courses are recommended twice a year (during spring and autumn periods of chronic disease exacerbations).

Children.

Due to insufficient research data, the use of the drug in children is not recommended.

Overdose.

Symptoms. To date, there have been no reported cases of poisoning with preparations of Martynia fragrans.

It is presumed that in individuals with lactose intolerance, ingestion of a large amount of the drug may cause gastrointestinal disturbances, including diarrhea.

Treatment. Discontinuation of the drug and symptomatic therapy.

Side effects.

Gastrointestinal tract (rare): diarrhoea, nausea, vomiting, abdominal pain.

Immune system (very rare): hypersensitivity (allergic skin reactions).

Nervous system (very rare): headache, dizziness, increased sweating.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 30 °C.

Keep out of reach of children.

Packaging.

10 tablets per blister, 2, 5 or 10 blisters per cardboard box.

Availability category. Over-the-counter.

Manufacturer.

Advans Pharma GmbH.

Manufacturer's address.

Wallenroder Str. 8-14, 13435 Berlin, Germany.

Marketing Authorisation Holder.

Esparma GmbH, Germany.

Address of the Marketing Authorisation Holder.

Bielefelder Strasse 1, 39171 Schielde-Tal, Germany.