Arthrofon^® (Tablets) Instructions for Use

Marketing Authorization Holder

Materia Medica Holding NPF, LLC (Russia)

Contact Information

MATERIA MEDICA HOLDING NPF LLC (Russia)

ATC Code

M01 (Anti-inflammatory and antirheumatic agents)

Dosage Form

Arthrofon®

Sublingual tablets: 100 pcs.

Dosage Form, Packaging, and Composition

Sublingual tablets from white to almost white in color, flat-cylindrical in shape, with a score and a bevel; on the flat side with a score, the inscription MATERIA MEDICA is applied, on the other flat side, the inscription ARTHROFON is applied.

* EMD – units of modifying action.

Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.

20 pcs. – contour cell packs (5) – cardboard cartons.

Clinical-Pharmacological Group

Drug used for inflammatory and inflammatory-dystrophic diseases of the musculoskeletal system

Pharmacotherapeutic Group

Anti-inflammatory agent

Pharmacological Action

Experimental and clinical studies have proven that the drug modulates the production and functional activity of endogenous tumor necrosis factor alpha (TNF-α) in rheumatoid arthritis, osteoarthritis, osteochondrosis, and back pain. It has anti-inflammatory and analgesic effects. By reducing the production of a number of pro-inflammatory cytokines and inflammatory mediators, it prevents the progression of inflammatory tissue damage and target organs in inflammatory-degenerative joint diseases.

Clinical efficacy and safety

The efficacy of therapy for rheumatoid arthritis (RA) and osteoarthritis was assessed based on the dynamics of clinical and laboratory examination results, standard scale scores, questionnaires, and tests aimed at determining the severity of joint inflammation and pain syndrome.

All conducted clinical studies revealed the anti-inflammatory and analgesic activity of the drug Arthrofon^® and confirmed the high efficacy of this drug in the treatment of RA and osteoarthritis.

The drug Arthrofon^® has pronounced anti-inflammatory activity and effectively and significantly reduces the main indicators of joint inflammation in RA and osteoarthritis: overall pain intensity, duration of morning stiffness, joint count, Ritchie’s articular index, joint swelling index, number of swollen joints, and Lee’s functional index. The overall pain intensity decreased by an average of 60% relative to baseline values, the duration of morning stiffness by 52.3%, joint count by 40.4%, Ritchie’s articular index by 43.5%, joint swelling index by 62.9%, number of swollen joints by 48.6%, and Lee’s functional index by 23.9%.

Analysis of the dynamics of the WOMAC index, both its total value and individual indices of pain, stiffness, and physical function, confirmed the high efficacy of the drug Arthrofon^® for osteoarthritis of the knee joints.

Assessment of the dynamics of disease activity according to the DAS-28 index, as well as the dynamics of the number of tender and swollen joints, and the duration of morning stiffness, confirmed the efficacy of the drug Arthrofon^® when prescribed at 2 tablets 4 times/day for 24 weeks in RA. After completion of therapy, a significant decrease in these indicators was observed. Thus, the DAS-28 index decreased on average by 22.5% from baseline values, the number of tender joints by 43.0-45.2%, the number of swollen joints by 57.6-58.2%, and the duration of morning stiffness by 44.2%.

The reduction in the severity of clinical symptoms of RA and osteoarthritis when taking the drug Arthrofon^® was combined with a significant decrease in the level of laboratory indicators of inflammation: TNF-α, CRP, and ESR. Thus, although the laboratory indicators did not reach the values of healthy individuals by the end of the course of therapy, the pronounced decrease in these indicators when taking the drug Arthrofon^® indicates an improvement in the health status of patients and positive dynamics.

Complex therapy for RA, including the drug Arthrofon^® and diclofenac, leads to more pronounced positive results compared to monotherapy with Arthrofon^® or diclofenac alone, which is expressed in the maximum reduction in the duration of morning stiffness and the WOMAC index in patients taking Arthrofon^® together with diclofenac.

During the studies, no adverse reactions with a reliable connection to the investigational drug were identified. No negative impact of the investigational therapy on laboratory parameters was noted. No cases of interaction of the drug Arthrofon^® with drugs of various classes were identified. The investigational therapy was well tolerated by patients.

Preclinical safety data

Preclinical safety studies, including assessment of toxicity after single and repeated administration, genotoxicity, reproductive toxicity, immunotoxicity, as well as sensitizing and local irritant properties, did not reveal the presence of toxic or potentially hazardous effects of the drug Arthrofon^® in humans.

Pharmacokinetics

Pharmacokinetic studies are impossible due to the complex composition of the drug.

Indications

Arthrofon^® is indicated for use in adults

• Rheumatoid arthritis;
• Osteoarthritis (including spondyloarthrosis) and other joint diseases.

ICD codes

Dosage Regimen

Orally, not during meals. Hold the tablet in the mouth until completely dissolved.

The recommended dose for adults is 2 tablets per dose.

The drug should be taken 2 times a day, in the morning and in the evening.

For pronounced pain syndrome in the first 2-4 weeks of therapy, taking the drug up to 4 times/day as part of complex therapy is recommended. When the condition improves, gradually switch to taking 2 tablets 2 times/day.

The recommended duration of drug use is up to 6 months.

During an exacerbation, it is used as part of complex therapy (with non-steroidal anti-inflammatory drugs). During remission, the drug can be used as monotherapy. Long-term (course) use of the drug contributes to a longer period of remission.

Adverse Reactions

Possible reactions of increased individual sensitivity to the components of the drug.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients included in the drug;
• Age under 18 years;
• Lactase deficiency, hereditary galactose intolerance, glucose-galactose malabsorption.

Use in Pregnancy and Lactation

Pregnancy

The safety of using the drug Arthrofon^® in pregnant women has not been studied. During pregnancy, the drug should be used only if the intended benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

The safety of using the drug Arthrofon^® during lactation has not been studied. During lactation, the drug should be used only if the intended benefit to the mother outweighs the potential risk to the child.

Pediatric Use

The use of the drug is contraindicated under the age of 18 years (due to the lack of clinical experience).

Special Precautions

On days 3-5 after the start of treatment, a moderately pronounced transient increase in pain syndrome or local manifestations of inflammation is possible, which does not require changes in the pharmacotherapy regimen. In some cases, with a pronounced increase in pain syndrome or local signs of inflammation, it is necessary to temporarily reduce the dose to 1-2 tablets/day.

Excipients

The drug contains lactose, therefore patients with rare hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this drug.

Effect on the ability to drive vehicles and mechanisms

No negative effect of the drug Arthrofon^® on the ability to drive vehicles (including bicycles, scooters, etc.) and other potentially dangerous mechanisms has been identified.

Overdose

In case of overdose, dyspeptic phenomena are possible, caused by the excipients included in the drug.

Drug Interactions

No cases of incompatibility with other drugs have been reported to date. Combination of the drug with non-steroidal anti-inflammatory agents is possible.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

During the period of use of the drug, store the contour cell pack in the cardboard carton provided by the manufacturer.

Dispensing Status

The drug is dispensed without a prescription.

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.