Expiration date: 06/2026

The composition and form of issue: 

Suppositories for rectal application, 1 supp. contains:

diclofenac sodium 0, 05 g

excipients: witepsol — 1, 26 g 

in a contour acheikova package 5 PCs in a pack 2 packs cardboard.

Gel, 1 tube contains:

diclofenac sodium 1 g

excipients: lactic acid 40% isopropyl alcohol ethyl alcohol 95% pyrosulfite sodium hydrosulfite carbopol (carbomer) 2, 2I, 2II-nitrilotriethanol purified water to 100 g 

in tubes of aluminum 20 and 30 grams in a cardboard bundle 1 tuba.

Description pharmaceutical form:

Suppositories white or white with kremovatam white color, torpedo-shaped.

Gel — a translucent, colourless or with a yellowish or kremovatam with white.

Feature:

NSAIDs.

Pharmacokinetics:

After rectal absorbed within 30 min, enters into the General circulation and distributed to tissues and organs. Excreted in the kidney.

Description pharmacological action:

Inhibits COX, in consequence of which inhibits formation of PG, which are involved in the development of inflammation, pain and fever. Has antiplatelet action. In rheumatic diseases reduces joint pain at rest and during movement, morning stiffness and swelling of joints, increases range of motion. In traumatic and postoperative pain reduces pain at rest and during movement, and inflammatory edema.

When used in the form of suppositories

In primary dysmenorrhea reduces pain and bleeding.

When used in gel form

It has a local anti-inflammatory and analgesic effects. Water-alcohol-based gel additionally has local anesthetic effect.

Indications:

Both dosage forms:

• inflammatory and degenerative lesions of the joints (rheumatoid arthritis, ankylosing spondylitis, Reiter's disease, psoriatic arthritis, gout)
  
• rheumatic defeated soft tissues
  
• lumbago
  
• neuralgia.
  

Suppositories:

• inflammatory and degenerative destruction of extra-articular tissues (bursitis, tenosynovitis, synovitis)
  
• scapulohumeral periarthritis
  
• lumbalgia, myalgia
  
• primary disalgomenorea, adnexitis, perimetritis
  
• fever
  
• inflammation, pain and swelling after dental, orthopedic, gynecological and other interventions
  
• migraine attacks
  
• renal and hepatic colic
  
• infectious-inflammatory diseases of ENT organs with expressed pain syndrome (pharyngitis, tonsillitis, otitis media).
  

Gel:

• PTSD (traumatic injuries, sprains, muscles and tendons)
  
• soreness of muscles and joints, caused by heavy physical exertion
  
• sciatica.
  

Contraindications:

Both dosage forms

• hypersensitivity including aspirin or other NSAIDs
  
• peptic ulcer or duodenal ulcer in acute phase
  
• violation of hematopoiesis of unknown etiology
  
• erosivno-azwenne shock syndrome (in the acute stage)
  
• "aspirinova" asthma, "aspirin" triad
  
• pregnancy
  
• children up to age 6 years.
  

With caution:

• induced acute hepatic porphyria
  
• infringement of functions of kidneys and liver.
  

Suppositories

• hemorrhoids
  
• of rectal bleeding.
  

With caution:

• the period of breastfeeding.
  

Gel

• violation of the integrity of the skin
  
• pregnancy
  
• the period of breastfeeding.
  

With caution:

• heart failure.
  

Side effects:

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

Local reactions: irritation of the mucous membrane of the large intestine, mucus mixed with blood, pain when urinating.

From the digestive system: gastralgia, nausea, vomiting, diarrhea, gastro colic, dyspepsia, flatulence, anorexia, increased liver transaminases, gastrointestinal bleeding (hematemesis, melena), hepatitis with jaundice or without it, fulminant hepatitis, pancreatitis, nonspecific colitis with bleeding, exacerbation of ulcerative colitis or Crohn's disease, constipation.

From the nervous system: headache, dizziness, fatigue, impaired perception, paresthesia, loss of memory, loss of sense of direction, decreased visual acuity, diplopia, hearing loss, tinnitus, insomnia, irritability, convulsions, depression, anxiety, "dreadful" dreams, tremor, psychotic reactions, a violation of taste sensations.

The skin: skin rashes, bullous eruptions, eczema, polymorphic erythema, erythroderma (exfoliative dermatitis), alopecia, photosensitivity, purpura.

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

Organs of hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, aplastic anemia.

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

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

Drug interactions:

Gel. You should consult your doctor when using even any NSAIDs.

Suppositories. While the use of the drug Diklovit with digoxin, phenytoin or lithium preparations can increase the levels in plasma of these drugs with diuretics and antihypertensives — reduced the effect of the latter with potassium-sparing diuretics — may be hyperkalemia with other NSAIDs or glucocorticoids increases the risk of side effects from the gastrointestinal tract with acetylsalicylic acid — decreased concentration of diclofenac in serum with cyclosporine — increased toxic effects of the latter on the kidneys with antidiabetic drugs — you may experience Hypo - or hyperglycemia (when this combination of funds is necessary to control the level of glucose in the blood) with methotrexate for 24 hours before or after taking it — can lead to increasing concentrations of methotrexate and an increase in its toxic action of anticoagulants — requires regular monitoring of blood clotting.

Method of application and dose:

Suppositories

Rectally, preferably after spontaneous bowel movement or enema. After the introduction of the drug should stay in bed for 20-30 min. in Adults and adolescents from 15 years — 1 supp. 2-3 times a day. The drug use Diklovit with oral forms of diclofenac sodium. In this case, the total daily dose of diclofenac sodium should not exceed 150 mg.

When algodismenoree (at first symptoms) initial dose of 50-100 mg/day (1 supp. 1-2 times a day), if necessary, the dose may be increased over several menstrual cycles up to 150 mg (1 supp. 3 times a day).

A migraine attack — 100 mg (2 supp.) at the first sign of attack. If necessary — re-100 mg (2 supp.). If necessary, continue the treatment on subsequent days, the daily dose should not exceed 150 mg (3 supp.) a day.

The duration of treatment determines the physician depending on the severity of the disease.

Gel

Externally. 2-4 g of gel (stripe — 1-2 cm) is applied 2-3 times a day a thin layer on the skin over the inflammation and gently rubbed until complete absorption.

The duration of treatment — no more than 14 days, the extension of treatment may, after consultation with the doctor. After applying the gel, you must wash your hands.

Precautions:

Suppositories

Caution: anemia, asthma, congestive heart failure, hypertension, ischemic heart disease, edematous syndrome, hepatic or renal failure, alcoholism, inflammatory bowel disease, erosive-ulcerative diseases of the gastrointestinal tract without exacerbation, diabetes, condition after extensive surgery induced porphyria, elderly, diverticulitis, systemic diseases of connective tissue.

Gel

Avoid contact of gel with eyes and mucous membranes.