Diclovit^® (Gel, Suppositories) Instructions for Use

ATC Code

M01AB05 (Diclofenac)

Active Substance

Diclofenac

Clinical-Pharmacological Group

NSAID

Pharmacotherapeutic Group

Anti-inflammatory and antirheumatic agents; non-steroidal anti-inflammatory and antirheumatic agents; acetic acid derivatives and related substances

Pharmacological Action

NSAID. It has a pronounced anti-inflammatory, analgesic, antipyretic, and antiplatelet effect, the mechanism of which is due to the inhibition of COX-1 and COX-2 activity, leading to a disruption of arachidonic acid metabolism and suppression of prostaglandin synthesis at the site of inflammation.

In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac contributes to a significant reduction in the severity of pain, morning stiffness, and joint swelling, which improves the functional state of the joints. It helps to increase the range of motion in the affected joints.

In traumatic and postoperative pain, the drug reduces pain, as well as the severity of inflammatory reactions.

In primary dysmenorrhea, it alleviates pain and reduces bleeding.

Pharmacokinetics

After rectal administration, C_max is reached after 30 min.

In patients with chronic hepatitis or compensated liver cirrhosis, the pharmacokinetic parameters of diclofenac do not change.

Indications

• Inflammatory and degenerative joint diseases (including rheumatoid arthritis, ankylosing spondylitis, juvenile arthritis, psoriatic arthritis, acute and chronic gouty arthritis);
• Rheumatic soft tissue lesions;
• Post-traumatic pain syndrome (including traumatic bruises, sprains of ligaments, muscles, and tendons);
• Muscle and joint soreness caused by heavy physical exertion;
• Lumbago;
• Sciatica;
• Neuralgia;
• Postoperative pain;
• Primary dysmenorrhea, adnexitis;
• Migraine attacks;
• Renal and biliary colic;
• Infectious and inflammatory diseases of the ENT organs with severe pain syndrome (including pharyngitis, tonsillitis, otitis);
• Fever.

ICD codes

Dosage Regimen

Suppositories

Adults are prescribed 1 supp. (50 mg) 2 times/day. The maximum daily dose is 150 mg (3 supp.).

Migraine attacks: 100 mg (2 supp.) at the first signs of an attack. If necessary, 100 mg (2 supp.) is prescribed again. If treatment needs to be continued in the following days, the daily dose should not exceed 150 mg (3 supp.) per day.

Suppositories are inserted into the rectum after spontaneous bowel emptying or after a cleansing enema. After insertion, the patient should remain in a lying position for 20-30 minutes. The duration of the treatment course is determined by the doctor individually depending on the severity of the disease.

Gel

A small amount of gel (2-4 g, which corresponds to a gel strip of 1-2 cm) is applied 2-3 times in a thin layer to the skin area over the inflammation site and gently rubbed until completely absorbed.

The duration of drug use is up to 14 days; in some cases, a longer course of therapy is possible.

Adverse Reactions

From the digestive system: gastralgia, nausea, vomiting, diarrhea, stomach pain, dyspepsia, constipation, flatulence, anorexia, increased activity of liver transaminases, gastrointestinal bleeding, hepatitis (including with jaundice), fulminant hepatitis, pancreatitis, nonspecific colitis with bleeding, exacerbation of ulcerative colitis or Crohn’s disease.

From the CNS and peripheral nervous system: headache, dizziness, increased fatigue, perception disorders, paresthesia, memory impairment, disorientation, decreased visual acuity, diplopia, hearing loss, tinnitus, insomnia, irritability, convulsions, depression, anxiety, nightmares, tremor, psychotic reactions, taste disorders.

From the urinary system: acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.

From the hematopoietic system: thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, aplastic anemia.

Dermatological reactions: rash, bullous eruptions, eczema, erythema multiforme, exfoliative dermatitis, alopecia, purpura.

Allergic reactions: bronchospasm, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), allergic purpura, photosensitivity, systemic anaphylactic reactions (including shock).

Other: edema, impotence, chest pain, palpitations, increased blood pressure.

Local reactions: irritation of the colon mucosa, mucous discharge mixed with blood, pain during defecation.

Occurring side effects depend on individual sensitivity, the magnitude of the applied dose, and the duration of treatment.

Contraindications

• Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase;
• Gastrointestinal bleeding, rectal bleeding;
• Hematopoietic disorders of unclear genesis;
• Hemorrhoids, proctitis;
• “aspirin triad”;
• Pregnancy;
• Children under 6 years of age;
• Hypersensitivity to diclofenac sodium, acetylsalicylic acid, and other NSAIDs.

Use with caution in inducible acute hepatic porphyria, impaired renal and liver function, heart failure, during lactation (breastfeeding).

Use in Pregnancy and Lactation

Diclovit^® is contraindicated for use during pregnancy.

Use in Hepatic Impairment

Use with caution in inducible acute hepatic porphyria, impaired liver function.

Use in Renal Impairment

Use with caution in impaired renal function.

Special Precautions

If side effects occur, the use of the drug should be discontinued.

Overdose

Symptoms: dizziness, headache, hyperventilation, clouding of consciousness; in children – myoclonic convulsions, nausea, vomiting, abdominal pain, bleeding, impaired liver and kidney function.

Treatment: activated charcoal is prescribed, and if necessary, symptomatic therapy is carried out.

Drug Interactions

With simultaneous use with Diclovit^®, the plasma concentrations of digoxin, phenytoin, or lithium preparations may increase.

When used together, Diclovit^® reduces the effect of diuretics and antihypertensive agents.

With simultaneous use of Diclovit^® and potassium-sparing diuretics, hyperkalemia may be observed.

When used together with NSAIDs and corticosteroids, the risk of adverse reactions from the gastrointestinal tract increases.

With simultaneous use with acetylsalicylic acid, a decrease in the concentration of diclofenac in the blood serum is possible.

When used together with Diclovit^®, the likelihood of the nephrotoxic effect of cyclosporine increases.

When using antidiabetic agents together with Diclovit^®, the risk of hypo- or hyperglycemia increases (if it is necessary to use such a combination, blood glucose levels should be monitored).

When using methotrexate within 24 hours before or after using Diclovit^®, an increase in the plasma concentration of methotrexate and an increase in its toxic effects are possible.

When used together with anticoagulants, monitoring of blood coagulation parameters is necessary.

Reduces the effectiveness of hypnotic agents.

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.

Dispensing Status

The drug is dispensed by 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.