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Spongilla (Herbal raw material, Powder) Instructions for Use

ATC Code

D11AX (Other drugs used in dermatology)

Active Substance

Spongilla lacustris (Grouping name)

Clinical-Pharmacological Group

Drug of animal origin with local irritant, anti-inflammatory and analgesic action

Pharmacotherapeutic Group

Local irritant of natural origin

Pharmacological Action

A local irritant agent obtained from the freshwater sponge Spongilla, which represents colonies of coelenterate animals – Spongilla lacustris fragilis, Ephydatia fliviatilis.

The sponge lives only in exceptionally clean freshwater bodies with flowing water and at specific temperatures.

The skeleton of Spongilla consists of a looped network of silica needles bound together by an organic substance – spongin. It also includes phosphates, carbonates, and organic substances.

The action of Spongilla is based on mechanical irritation of the skin due to the content of silicon needles.

Indications

Apply externally for the symptomatic relief of pain and inflammation associated with musculoskeletal conditions and minor injuries.

  • Radiculitis
  • Arthritis
  • Rheumatism
  • Bruises

The therapeutic effect is achieved through counter-irritation, which modulates pain perception.

ICD codes

ICD-10 code Indication
M05 Seropositive rheumatoid arthritis
M15 Polyosteoarthritis
M19.9 Unspecified arthrosis
M54.1 Radiculopathy
M54.3 Sciatica
M54.4 Lumbago with sciatica
M79.0 Unspecified rheumatism
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
ICD-11 code Indication
8B93.Z Radiculopathy, unspecified
8E4A.1 Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
FA05 Polyosteoarthritis
FA0Z Osteoarthritis, unspecified
FA20.0 Seropositive rheumatoid arthritis
FA27.2 Palindromic rheumatism
FB51.3 Fibroblastic rheumatism
FB56 Specified soft tissue diseases, not elsewhere classified
ME84.20 Lumbago with sciatica
ME84.3 Sciatica
ND56.0 Superficial injury of unspecified body region

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 powder externally to the affected areas of the skin. Use as directed for the specific condition being treated.

The frequency of application is typically determined by the severity of symptoms and patient response. Discontinue use if excessive skin irritation, redness, or pain occurs.

Herbal raw material, Powder

Apply externally to the affected areas of the skin.

Adverse Reactions

The most common adverse reactions are localized and related to the product’s mechanism of action.

Possible reactions include transient skin hyperemia, erythema, and pruritus. Allergic reactions, including contact dermatitis, are possible, especially in individuals with known sensitivity.

Contraindications

Do not use under the following conditions.

  • Hypersensitivity to Spongilla or any component of the product.
  • Impaired skin integrity, including open wounds, cuts, abrasions, or severe dermatitis, at the sites of intended application.
  • Application to areas with active infection or acute inflammatory skin conditions.

Avoid contact with mucous membranes, such as the eyes and nose.

Drug Interactions

No specific drug interactions are known. Exercise caution when applying to the same area as other topical medications, as the mechanical irritation may alter skin permeability.

Concurrent use with other topical irritants or exfoliants may increase the risk of severe skin reactions.

Overdose

Overdose manifests as severe local skin reactions, including intense erythema, blistering, pain, and swelling.

In case of overdose, immediately discontinue use and thoroughly wash the affected area with water. Treatment is symptomatic and supportive. Seek medical attention if a severe reaction occurs.

Special Precautions

Do not apply Spongilla to the mucous membrane of the nose and eyes; wash off Spongilla with water in case of contact.

To exclude the occurrence of an allergic reaction, it is recommended to apply a minimal amount of the Spongilla solution to the inner surface of the arm.

Storage Conditions

Store at 2°C (36°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 Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Agrophitopharm, LLC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris powder Powder for preparation of suspension for external use: sachet 2.5 g.

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 2.5 g

2.5 g – laminated paper sachets 7×9 cm.

Marketing Authorization Holder

Apex, LLC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris powder Powder for preparation of suspension for external use: sachet 2.5 g.

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 2.5 g

2.5 g – laminated paper sachets 7×9 cm.

Marketing Authorization Holder

Ivan-Chai JSC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris Powder for preparation of suspension for external use: sachets 6 g

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 6 g

6 g – laminated paper sachets.
6 g – polymer bags.

Marketing Authorization Holder

Caspian NP, OJSC (Russia)

Dosage Forms

Bottle OTC Icon Spongilla lacustris Powder for preparation of suspension for external use: sachet 5 g
Powder for preparation of suspension for external use: sachet 10 g
Powder for preparation of suspension for external use: sachet 100 g

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 5 g

5 g – laminated paper sachets (1) – paper packs.


Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 10 g

10 g – laminated paper sachets (1) – paper packs.


Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 100 g

100 g – laminated paper sachets (1) – paper packs.

Marketing Authorization Holder

Lek S+, LLC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris powder Powder for preparation of suspension for external use: sachet 2.5 g

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 2.5 g

2.5 g – laminated paper sachets 7×9 cm.

Marketing Authorization Holder

Lenmedsnabs, LLC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris powder Powder for preparation of suspension for external use: sachet 2.5 g

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 2.5 g

2.5 g – laminated paper sachets 7×9 cm.

Marketing Authorization Holder

Lumi, LLC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris powder Powder for preparation of suspension for external use: sachet 2.5 g

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 2.5 g

2.5 g – laminated paper sachets 7×9 cm.

Marketing Authorization Holder

Narodnaya Meditsina Medical Company, LLC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris powder Powder for preparation of suspension for external use: sachet 2.5 g

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 2.5 g

2.5 g – laminated paper sachets 7×9 cm.

Marketing Authorization Holder

Nedra-Farm LLC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris powder Powder for preparation of suspension for external use: sachet 2.5 g.

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 2.5 g

2.5 g – laminated paper sachets 7×9 cm.

Marketing Authorization Holder

Reka-Pharm, CJS (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris Powder for external use: sachet 5 g

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 5 g

5 g – laminated paper bags.
5 g – polyethylene bags.

Marketing Authorization Holder

Travnik PZK (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris powder Powder for preparation of suspension for external use: sachet 2.5 g

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 2.5 g

2.5 g – laminated paper sachets 7×9 cm.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris (powder) Powder for preparation of suspension for external use: sachet 2.5 g

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 2.5 g

2.5 g – laminated paper sachets 7×9 cm.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris Powder for preparation of suspension for external use: 2.5, 5 or 10 g sachet

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 100 %

2.5 g – Heat-sealable bags – group packaging.
5 g – Heat-sealable bags – group packaging.
10 g – Heat-sealable bags – group packaging.

Marketing Authorization Holder

Pharmaceutical Factory Of St. Petersburg, PJSC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris Powder for external use 2.5 g: sachets 10 pcs.

Dosage Form, Packaging, and Composition

Powder for external use 1 sachet
Spongilla lacustris (animal sponges of the Spongillidae family) 2.5 g

2.5 g – laminated paper sachets (10) – cardboard packs.

Marketing Authorization Holder

Health Firm, LLC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris Powder for preparation of suspension for external use: sachets 5 g, 10 g or 20 g

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use of grayish-brown, grayish-green, yellowish-brown, yellowish-gray, brownish-green color; characteristic odor.

1 sachet
Spongilla lacustris (freshwater sponges of the Spongillidae family) 100 %

5 g – sachets (1) – cardboard packs.
10 g – sachets (1) – cardboard packs.
20 g – sachets (1) – cardboard packs.

Marketing Authorization Holder

Health Firm, LLC (Russia)

Dosage Forms

Bottle OTC Icon Spongilla lacustris Herbal raw material: bag 10 kg
Herbal raw material – powder: bag 10 kg

Dosage Form, Packaging, and Composition

Herbal raw material 1 bag
Spongilla lacustris (freshwater sponges of the Spongillidae family) 10 kg

10 kg – multi-layer paper bags.


Herbal raw material – powder 1 bag
Spongilla lacustris (freshwater sponges of the Spongillidae family) 10 kg

10 kg – multi-layer paper bags.

Marketing Authorization Holder

Fitofarm PKF, LLC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris powder Powder for preparation of suspension for external use: sachet 2.5 g.

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (freshwater sponges of the Spongillidae family) 2.5 g

2.5 g – laminated paper sachets 7×9 cm.

Marketing Authorization Holder

Ergopharm, LLC (Russia)

Dosage Form

Bottle OTC Icon Spongilla lacustris powder Powder for preparation of suspension for external use: sachet 2.5 g

Dosage Form, Packaging, and Composition

Powder for preparation of suspension for external use 1 sachet
Spongilla lacustris (freshwater sponges of the Spongillidae family) 2.5 g

2.5 g – laminated paper sachets 7×9 cm.

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