Summary of product characteristics
1. NAZWA PRODUKTU LECZNICZEGO
Salicortex, 330 mg, tablets
2. SKŁAD JAKOŚCIOWY I ILOŚCIOWY
Each tablet contains 330 mg of Salix spp., cortex (willow bark).
1 tablet contains at least 20 mg of phenolic glycosides expressed as salicin.
See below for full list of excipients.
3. POSTAĆ FARMACEUTYCZNA
Tablet
4. SZCZEGÓŁOWE DANE KLINICZNE
Traditional herbal medicinal product with stated indications, derived solely from long-term use.
4.1. Indications for use
Traditionally used to relieve mild musculoskeletal pain, headaches and fevers in common colds.
4.2. Posology and method of administration
Posology
Adults
1 tablet, 3 times a day after meals. Wash down with plenty of warm fluid.
Children and adolescents
Do not use in children and adolescents under 18 years.
Method of administration
Oral
Duration of use:
- relieving joint and bone pain – no longer than 4 weeks
- headache – 1 day
- cold with fever – 3 days.
4.3. Contraindications:
Hypersensitivity to willow bark, salicylates or other non-steroid anti-inflammatory medications (e.g. history of angioedema, bronchospasm or chronic hives after taking salicylates or other non-steroid anti-inflammatory medications). Do not use in case of asthma, active peptic ulcers, third trimester of pregnancy, serious liver and/or kidney disorders, coagulation disorders, stomach and/or duodenum ulcers, and glucose-6-phosphate dehydrogenase deficiency.
Do not use in children and adolescents under 18 years.
4.4. Special warnings and precautions for use
Not intended to treat acute joint inflammations.
If fever exceeds 39° C, persists, is accompanied by a strong headache, or symptoms worsen, consult a doctor.
Not recommended for concomitant use with salicylates and other nonsteroidal anti-inflammatories without consulting a doctor.
4.5 Drug interactions and other interactions
Willow bark may intensify the acitivty of anticoagulants, such as coumarin derivatives.
4.6. Impact on fertility, pregnancy and lactation
Not recommended in the first and second trimester and during lactation. Salicylates pass the placenta and into breast milk. Do not use in the third trimester. No data on impact on fertility is available.
4.7. Impact on ability to drive vehicles and operate machinery
No studies have been performed.
4.8. Adverse effects
Hypersensitivity symptoms may occur, such as rash, itching, hives, asthma, eczema, and also digestive symptoms, such as nausea, vomiting, stomach ache, indigestion, heartburn and diarrhea. Frequency of occurrence is unknown.
Reporting suspected adverse effects:
After a medicinal product receives marketing authorisation, it is important to report suspected adverse effects. It allows for continuous monitoring of the medicinal product's risk-benefit ratio. Medical professionals should report all suspected adverse effects to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: + 48 22 49-21-301, fax: +48 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Adverse effects can also be reported to the marketing authorisation holder.
4.9. Overdose
No recorded cases of overdose.
5. WŁAŚCIWOŚCI FARMAKOLOGICZNE
5.1. Pharmacodynamics
Willow bark, which contains saligenin-derived phenolic glycosides, exhibits (having been metabolised into salicylic acid) anti-inflammatory, antipyretic and analgesic activity.
Willow bark and its extracts have been used traditionally as an antipyretic, analgesic and aid in rheumatic diseases.
5.2. Pharmacokinetics
No pharmacokinetic studies have been conducted.
Metabolism of main willow bark glycosides (salicins, saligenins and populins) after oral administration was examined. It was found that salicin metabolites excreted with urine were identical to those after administration of acetylsalicylic acid. Salicin is broken down by the β-glucosidase in the intestinal mucosa or the β-glucosidase in the gut microbiota. The decomposition product is saligenin, which is resorbed four times as strong as salicin. Saligenin is oxidised to salicylic alcohol, which in turn is transformed by the liver enzymes of the cytochrome P450 pathway into salicylic acid, found in blood in the ionised form.
The compounds created in subsequent processes are salicylic acid glucuronide,
2,5-dihydroxybenzoic acid, gentisic acid, salicyluric acid and gentisuric acid. As readily soluble compounds, metabolites are excreted through the kidneys, and the main product is salicyluric acid – a result of coupling with glycine.
5.3. Preclinical safety data
No preclinical trials have been conducted.
In acute toxicity studies on a willow bark extract containing 10% of phenolic glycosides, it was found that doses from 12 g to 20 g did not cause death in experimental animals.
No genotoxicity, carcinogenicity and fertility studies have been conducted.
6. DANE FARMACEUTYCZNE
6.1. List of excipients
Potato starch
Colloidal anhydrous silica
6.2. Incompatibilities
No data.
6.3. Expiry date
3 years
6.4. Special precautions for storage
Store closed in max. 25° C, keep away from children.
6.5. Box type and contents
Glass containers with polytethylene caps, polyethylene or polypropylene containers with polyethylene caps, with 20, 60 or 90 tablets.
Not all types of packaging need to be marketed.
6.6. Special precautions for disposal and use
No special requirements.
7. MARKETING AUTHORISATION HOLDER
- Labofarm Sp. z o.o.
ul. Lubichowska 176 b
83-200 Starogard Gdański
tel. 58 561 20 08
fax 58 561 20 16
e-mail: poczta@labofarm.com.pl
- MARKETING AUTHORISATION NUMBER
R/7174
- FIRST MARKETING AUTHORISATION ISSUE DATE / RENEWAL DATE
10.06.1997 / 11.10.2012
- DATE OF APPROVAL OR PARTIAL CHANGE OF SUMMARY OF PRODUCT CHARACTERISTICS
29.12.2016
PL