Capsici annui tinctura (Tincture) Instructions for Use
ATC Code
M02AB (Capsaicin and similar agents)
Active Substance
Capsicum (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Drug with local irritant and analgesic action
Pharmacotherapeutic Group
Drugs for external use for muscle and joint pain; capsaicin and similar agents
Pharmacological Action
A herbal remedy. It has a local warming, irritant, and counterirritant effect, which is provided by capsaicin, an alkaloid-like amide of cayenne pepper. The action is directed at the endings of peripheral nerves in the skin.
Capsaicin has an antibacterial effect and is active against Bacillus cereus, Bacillus subtilis, Clostridium sporogenes, Clostridium tetani, Streptococcus pyogenes.
Indications
Apply externally as a local irritant and counterirritant for the symptomatic relief of pain associated with the following conditions:
- Neuralgia
- Radiculitis
- Myositis
- Lumbago
- Lumbosacral radiculopathy
ICD codes
| ICD-10 code | Indication |
| M54.1 | Radiculopathy |
| M54.3 | Sciatica |
| M54.4 | Lumbago with sciatica |
| M60 | Myositis |
| M79.1 | Myalgia |
| M79.2 | Neuralgia and neuritis, unspecified |
| ICD-11 code | Indication |
| 8B93.Z | Radiculopathy, unspecified |
| 8E4A.1 | Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system |
| FB30 | Infectious myositis |
| FB32 | Other specified disorders of muscle |
| FB3Z | Disorder of muscle, unspecified |
| FB56 | Specified soft tissue diseases, not elsewhere classified |
| FB56.0 | Granuloma of soft tissue due to foreign body, not elsewhere classified |
| FB56.2 | Myalgia |
| ME84.20 | Lumbago with sciatica |
| ME84.3 | Sciatica |
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. |
Apply the tincture externally only. Rub a small amount into the affected skin area one to two times per day.
Frequency of application should not exceed twice daily. Avoid applying excessive amounts of the product.
Wash hands thoroughly with soap and water immediately after application to prevent accidental transfer to eyes, mucous membranes, or other sensitive areas.
Adverse Reactions
Expected local reactions include a sensation of warmth, burning, or tingling at the application site, which usually diminishes with repeated use.
Possible adverse reactions include allergic reactions (severe burning, itching, rash, urticaria) and contact dermatitis.
Discontinue use and seek medical attention if severe skin irritation, blistering, or signs of a severe allergic reaction occur.
Drug Interactions
No specific drug interactions are known. Exercise caution when using concurrently with other topical medications applied to the same area, as this may increase the risk of skin irritation.
Avoid applying other topical products, especially those containing counterirritants or capsaicin, to the same treatment site.
Inform your physician about all medications you are using before initiating treatment.
Contraindications
Do not use this product under the following conditions:
- Hypersensitivity to cayenne pepper (Capsicum) or any component of the preparation.
- Presence of dermatological diseases, open wounds, or broken skin at the intended application site.
- Children under 12 years of age.
Avoid application to mucous membranes and areas of acute skin inflammation.
Overdose
Overdose manifests as severe burning pain, erythema, and skin blistering.
In case of accidental ingestion, seek immediate medical attention. For topical overdose, discontinue use immediately.
Remove the product from the skin by washing the area thoroughly with soap and water; using vegetable or cooking oil may help dissolve capsaicin before washing. Apply a cool compress to alleviate burning.
Use in Pregnancy and Lactation
During pregnancy and breastfeeding, it should be used after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.
Pediatric Use
Contraindicated for use in children under 12 years of age.
Special Precautions
Avoid contact with eyes.
Cayenne pepper preparations should not be applied to mucous membranes, open wounds, and damaged or inflamed areas of the skin. If the product gets into the mouth or nose, they must be thoroughly rinsed with water.
Storage Conditions
Store at 15°C (59°F) to 25°C (77°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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Tincture 100 g/1 l: bottle 25 ml
Marketing Authorization Holder
Begrif, LLC (Russia)
Dosage Form
 |
Capsici annui tinctura | Tincture 100 g/1 l: bottle 25 ml |
Dosage Form, Packaging, and Composition
| Tincture | 1 l |
| Crushed fruits of cayenne pepper | 100 g |
25 ml – dark glass bottles (1) – cardboard packs.
Tincture 100 g/1 l: bottle 50 ml
Marketing Authorization Holder
Institute Of Medicine And Standardization, LLC (Russia)
Dosage Form
|
Capsici annui tinctura | Tincture 100 g/1 l: bottle 50 ml |
Dosage Form, Packaging, and Composition
| Tincture | 1 l |
| Crushed fruits of cayenne pepper | 100 g |
50 ml – dark glass bottles (1) – cardboard packs.
Tincture: 25 mL, 50 mL, or 100 mL bottle or dropper bottle.
Marketing Authorization Holder
Institute Of Medicine And Standardization, LLC (Russia)
Manufactured By
RFK, CJS (Russia)
Dosage Form
|
Capsici annui tinctura | Tincture: 25 mL, 50 mL, or 100 mL bottle or dropper bottle. |
Dosage Form, Packaging, and Composition
Tincture in the form of a clear reddish-yellow liquid.
| 1000 ml | |
| Crushed fruits of cayenne pepper | 100 g |
Excipients : ethanol (ethyl alcohol) 90% – a sufficient quantity to obtain 1000 ml of tincture.
25 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
25 ml – dropper bottles (1) – cardboard packs.
50 ml – dropper bottles (1) – cardboard packs.
100 ml – dropper bottles (1) – cardboard packs.
0.5 l – polyethylene canisters for hospitals.
1 l – polyethylene canisters for hospitals.
3 l – polyethylene canisters for hospitals.
5 l – polyethylene canisters for hospitals.
Tincture for external use: dropper tube 25 mL, bottle 25 mL with dropper cap.
Marketing Authorization Holder
Obnovlenie Pfc, JSC (Russia)
Dosage Form
|
Capsici annui tinctura | Tincture for external use: dropper tube 25 mL, bottle 25 mL with dropper cap. |
Dosage Form, Packaging, and Composition
Tincture for external use in the form of a clear liquid from yellowish-red to red in color, with a characteristic odor; sediment formation is allowed during storage.
| 1 l | |
| Fruits of cayenne pepper | 100 g |
Excipients : ethanol (ethyl alcohol) 90% – to obtain 1000 ml of the preparation.
25 ml – dropper tubes (1) – cardboard packs.
25 ml – dark glass bottles (1) with a dropper cap – cardboard packs.
Tincture 100 g/1 l: bottle 25, 50, or 100 ml, canisters 5 l.
Marketing Authorization Holder
Tver Pharmaceutical Factory, PJSC (Russia)
Dosage Form
|
Capsici annui tinctura | Tincture 100 g/1 l: bottle 25, 50, or 100 ml, canisters 5 l. |
Dosage Form, Packaging, and Composition
| Tincture | 1 l |
| Crushed fruits of cayenne pepper | 100 g |
25 ml – dark glass bottles (1) – cardboard packs.
50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.
5 l – polyethylene canisters – cardboard packs.
Tincture 100 g/1 L: 25 mL bottle or dropper bottle.
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Capsici annui tinctura | Tincture 100 g/1 L: 25 mL bottle or dropper bottle. |
Dosage Form, Packaging, and Composition
| Tincture | 1 l |
| Crushed fruits of cayenne pepper | 100 g |
25 ml – orange glass bottles (1) – cardboard packs.
25 ml – orange glass dropper bottles (1) – cardboard packs.
25 ml – polyethylene terephthalate bottles (1) – cardboard packs.
18 kg – glass bottles.
18 kg – polyethylene canisters.
Tincture 100 g/1 l: bottle 25 ml
Marketing Authorization Holder
Yaroslavl Pharmaceutical Factory, CJSC (Russia)
Dosage Form
|
Capsici annui tinctura | Tincture 100 g/1 l: bottle 25 ml |
Dosage Form, Packaging, and Composition
| Tincture | 1 l |
| Crushed fruits of cayenne pepper | 100 g |
25 ml – dark glass bottles (1) – cardboard packs.
![Capsici annui tinctura [Tincture] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Capsici annui tinctura [Tincture] 2")