Hox alpha®
Hard capsules
Active substance
Nettle leaf dry extract (19-33 : 1);
Extraction agent: 2-propanol 95% (V/V)
145 mg/hard capsule
For the full list of excipients, see section 6.1.
Capsule, hard
Colour: green
For the supportive treatment of rheumatic complaints.
Usual dose for adults and adolescents aged 12 years and older:
1 hard capsule, 3 times daily
Hox alpha hard capsules should be taken with sufficient liquid, preferably water, after meals.
If the symptoms persist for longer than four weeks while using the medicine, a doctor should be consulted.
Hypersensitivity to nettles or to any of the excipients of Hox alpha listed in section 6.1.
Disorders where reduced fluid intake is indicated (e.g. severe heart or kidney disease).
During concomitant administration of Hox alpha, the efficacy of coumarin-type anticoagulants may be attenuated. In patients taking such medicinal products, repeated monitoring of blood clotting parameters (INR, prothrombin time) should be undertaken during and approximately 2 weeks after the patient has stopped taking Hox alpha (see section 4.5 Interaction).
In the case of acute joint pain accompanied by redness, swelling or overheating of the joint or fever, a doctor should be consulted.
If the symptoms worsen during the use of the medicine, a doctor should be consulted.
Patients with diabetes taking Hox alpha should undergo repeated blood sugar monitoring (see section 4.8 Undesirable effects).
Children
There is insufficient information on the use of this medicinal product in children under 12 years. It must therefore not be used in children under 12 years.
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially “sodium-free”.
Antidiabetic agents
Interaction between Hox alpha and antidiabetic agents cannot be excluded.
Anticoagulants/vitamin K antagonists
Hox alpha contains vitamin K in small amounts. In patients receiving concomitant treatment with a vitamin K antagonist (phenprocoumon: trade name, e.g. Marcumar®, Marcuphen®, Falithrom® or warfarin: trade name Coumadin®) to affect blood clotting, the efficacy of these medicinal products may be attenuated. Therefore, repeated monitoring of blood clotting parameters (INR, prothrombin time) is necessary during use and for up to 2 weeks after discontinuation of Hox alpha.
To date, the use of nettle herb as a foodstuff has shown no evidence of any risks during pregnancy and breastfeeding. However, there are insufficient studies available on the use of Hox alpha in pregnancy and breastfeeding. Hox alpha is therefore not recommended for use during pregnancy and breastfeeding.
Hox alpha has no influence on the ability to drive and use machines.
The following frequencies are used for evaluating adverse reactions:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
Possible side effects
Uncommon: hypersensitivity reactions of the skin (e.g. in the form of pruritus, exanthema, urticaria) may occur.
Uncommon: gastrointestinal complaints such as nausea, diarrhoea and vomiting may occur.
Very rare: In patients with diabetes mellitus, there have been reports of an increase in blood sugar with the administration of nettle leaf or nettle herb preparations, which regressed upon discontinuation of the medicinal product.
Note: Uncommon: increased urinary urgency may occur.
At the first sign of a hypersensitivity reaction, the patient must discontinue taking Hox alpha.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via: Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices), Abt. Pharmakovigilanz (Department of Pharmacovigilance), Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website www.bfarm.de.
To date, there have been no reported cases with nettle leaf preparations. The symptoms described under Undesirable effects may occur in a more intense form. In the package leaflet, the patient is instructed to notify a doctor if they have taken excessive amounts of Hox alpha.
Pharmacotherapeutic group:
Herbal medicinal product for muscle and joint pain
ATC code: M09AP
The efficacy of nettle leaf preparations is documented by the preparation monograph for Urticae herba (nettle herb), Urticae folium (nettle leaves), published in the German Federal Gazette No. 76 of 23/04/1987.
According to phytotherapeutic principles, the entire drug is regarded as an active substance.
Toxicological properties
Acute, chronic and subchronic toxicity
Based on animal experiments, Hox alpha is largely non-toxic (LD50 in mice and rats more than 5 g/kg BW, oral administration). It produces no toxic effects at doses up to 2.7 g/kg BW over 4 weeks.
Toxicity to reproduction
No reproductive toxicity studies are available.
Quinolone yellow (E 104)
Gelatin
Purified water
Colloidal anhydrous silica
Hypromellose
Indigo carmine (E 132)
Macrogol 4000
Magnesium stearate (Ph.Eur.) [vegetable]
Microcrystalline cellulose
Sodium dodecyl sulphate
Povidone
Hydrated silica
Talc
Titanium dioxide (E 171)
None known.
24 months
Store in the original package in order to protect from light and moisture.
Do not store above 25°C.
Blister strips in folded boxes
Packs with 50 (N2), 60, 90, 100 (N3), 120, 180, 200 and 220 hard capsules
Not all pack sizes may be marketed.
No special requirements.
Strathmann GmbH & Co. KG
Postfach (PO Box) 610425
22424 Hamburg, Germany
Tel.: +49 (0)40 55 90 5 -0
Fax: +49 (0)40 (55)90 5 -100
E-mail: VL.Strathmann.Info@dermapharm.com
6873946.00.00
18/06/2003
October°2024
Available from pharmacies only