Voltaren Acti (Diclofenac) 12.5mg 10 tablets

The composition and form of issue: 

Tablets, film-coated. 1 tablet contains:

diclofenac potassium 12 5 mg

excipients: silicon dioxide, lactose monohydrate, corn starch, sodium carboximetilkrahmal, polyvidon K30, MCC, magnesium stearate 

the composition of the shell: hypromellose 6cP, 3cP hypromellose, titanium dioxide, macrogol 400, Polysorbate 80, hypromellose 50cP, maltodextrin 

in packages contour cell 10 PCs in carton packs of 1 or 2 packs.

Description pharmaceutical form:

Tablets, film-coated white color, oblong, odorless.

Feature:

NSAIDs.

Description pharmacological action:

The basis of the mechanism of action is the inhibition of activity of cyclooxygenase (COX-1 and COX-2) with subsequent suppression of inflammation, reduction of pain and fevers.

After taking the pills Voltaren Acti therapeutic effect develops within 15 min, making effective use of the drug for quick relief of pain and lower elevated body temperature.

Indications:

• removing and reducing pain of various origins (including: sore muscles and joints, including back pain in different parts of the spine head and a toothache pain during menstruation)
• to eliminate the symptoms of colds and flu: (pain in muscles, joints sore throat with fever).

Contraindications:

• hypersensitivity to the drug
• attacks of asthma, urticaria or acute rhinitis in history, caused by taking acetylsalicylic acid or other NSAIDs (e.g. ibuprofen)
• since the coronary artery bypass surgery
• peptic ulcer, or ulcerative lesions of intestine in the acute phase
• ulcer bleeding or perforation
• renal failure severe
• severe liver failure
• severe heart failure
• III trimester of pregnancy
• children up to age 14 years.

With caution should use the drug in patients with coronary artery disease, cerebrovascular disease, congestive heart failure, dyslipidemia/hyperlipidemia, diabetes, peripheral arterial disease, with creatinine Cl <60 ml/min, the history data about the development of ulcerative lesions of the gastrointestinal tract, long-term use of NSAIDs, patients with severe somatic diseases, concomitant therapy with selective inhibitors of serotonin reuptake, elderly patients, smokers often consume alcohol.

Application of pregnancy and breast-feeding:

Adequate and well-controlled studies on the action of diclofenac in pregnancy has not been conducted. Therefore, in I and II trimestrah pregnancy drug appoint only in cases when the potential benefit of therapy for the mother outweighs the increased risk to the fetus.

The use of diclofenac, like other NSAIDs, contraindicated in the third trimester of pregnancy because of possible uterine atony and/or premature closure of the ductus arteriosus (ductus arteriosus).

Diclofenac, like other NSAIDs, excreted in breast milk in small amounts. Therefore, Voltaren Acti is not recommended during the breastfeeding period to prevent unwanted effects in the baby.

Side effects:

Determination of the frequency of side effects: often — &ge1/100 but <1/10 sometimes &ge1/1000 and <1/100 rare &ge1/10 000 but <1/1000), very rare, including private messages is <1/10 000.

From the digestive system: often — nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia, increased levels of hepatic transaminases rare — gastritis, gastrointestinal bleeding, hematemesis, diarrhea, melena, blood, ulcers of the stomach/intestine (hemorrhage or perforation with or without them), hepatitis, jaundice very rarely — colitis (including colitis with blood, aggravation of ulcerative colitis or Crohn’s disease), constipation, stomatitis, glossitis, pathology of the esophagus stricture esophageal opening of the diaphragm, pancreatitis, fulminant (fulminant) hepatitis.

CNS and peripheral nervous system: often — headache, dizziness, rarely — drowsiness, rarely — paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disorders, cerebrovascular disorders, loss of orientation, depression, insomnia, nightmares, irritability, psychotic disorder.

Dermatological reactions: often — rash, very rarely — precipitation in the form of bubbles, eczema, erythroderma (exfoliative dermatitis), hair loss, photosensitivity.

With the hematopoietic system: rarely — thrombocytopenia, leukopenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis.

Allergic reactions: rare — urticaria, anaphylactic and anaphylactoid reactions (including hypotension and shock) very rare — erythema multiforme, Stevens-Johnson syndrome, Lyell’s syndrome (toxic epidermal necrolysis), purpura, including allergic purpura, angioedema (including face oedema).

From the sensory organs: very rarely — visual disturbances (decrease of focus, diplopia), tinnitus, hearing impairment.

From the side of cardiovascular system: very rarely — palpitations, chest pain, heart failure, myocardial infarction, arterial hypertension, vasculitis.

The respiratory system: rarely — bronchial asthma (including dyspnoea) very rare pneumonia.

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

Other: rarely — swelling.

Drug interactions:

With simultaneous use of drugs lithium and digoxin may increase the concentration of lithium and digoxin in plasma.

Diclofenac (and other NSAIDs) when administered simultaneously with a diuretic or antihypertensive agents (e.g. beta-blockers, ACE inhibitors) may reduce the severity of antigipertenzivnogo actions. The simultaneous use of kalisberegath dioretikov can lead to increased levels of potassium in the blood serum.

The simultaneous use of other systemic NSAIDs or corticosteroids leads to an increase in the number of side effects.

The simultaneous administration of diclofenac with anticoagulants and inhibitors of platelet aggregation increases the risk of bleeding (when applying this combination requires special care).

In clinical researches it is established that the simultaneous use of diclofenac and oral hypoglycemic drugs, with the effectiveness of the latter is not changed. However, the described individual cases of development of hypoglycemia and hyperglycemia, which required correction doses of hypoglycemic drugs.

You should be wary of Voltaren Acti with an interval of less than 24 hours before or after taking methotrexate, because the methotrexate concentration in the blood may increase, which will lead to increased toxicity.

While the use of cyclosporine the effect of NSAIDs on PG kidneys can lead to an increase nephrotoxicity of cyclosporine.

There are isolated reports of convulsions caused by the combined use of quinolones and NSAIDs.

Method of application and dose:

Inside, before meals. Tablets should be taken whole, without chewing and drinking water.

For adults and adolescents over 14 years of age the initial dose is 25 mg (2 table.) followed by administration of 12, 5-25 mg (1-2 table.) every 4-6 hours as needed. The maximum daily dose is 75 mg (6 tab.).

Without prescription duration of use of Voltaren Acti in fever is 3 days, in pain to 5 days.

Overdose:

Symptoms: high blood pressure, kidney failure, seizures, respiratory depression, complications from the blood.

Treatment: gastric lavage, the appointment of activated carbon symptomatic therapy, and measures aimed at the maintenance of body functions.

The use of diuretics, infusion solutions, dialysis seem ineffective, if necessary, elimination from the body NSAIDs, because the drugs in this group are characterized by a high degree of bonding with blood plasma proteins.

Special instructions:

When taking NSAIDs, there exists the likelihood of bleeding from the gastrointestinal tract, ulcerative lesions of the gastrointestinal tract, sometimes complicated by perforation, without previous warning symptoms or existence of such attacks in the anamnesis of the patient. These complications can have serious consequences especially for the elderly. If you experience such symptoms, the drug should be discontinued immediately.

The risk of bleeding from the digestive tract increases with increasing doses of NSAIDs in patients with peptic ulcer disease in anamnesis, especially in the case of complications of the disease by bleeding and perforation, and in patients of advanced age. To reduce the risk of complications, therapy should be initiated and maintained at minimum effective dose, taking into account the possibility of using combined therapy with the use of funds, providing a protective effect on the mucous membrane of the stomach (such as proton pump inhibitors or misoprostol).

When assigning diclofenac to patients with existing gastrointestinal diseases (ulcerative lesions, bleeding, perforation) in history it is necessary to conduct therapy under close medical supervision and compliance with special caution.

Caution is recommended in patients who are concomitantly receiving medicinal products that may increase the risk of ulcers or gastrointestinal bleeding, such as systemic corticosteroids, anticoagulants, inhibitors of platelet aggregation or selective inhibitors of serotonin reuptake.

Patients suffering from ulcerative colitis or Crohn’s disease, therapy should be under careful medical supervision, because as a result of ingestion of diclofenac may occur in the aggravation of these diseases.

The use of diclofenac should be discontinued at the first sign of a skin rash, lesions of the mucous membranes and for any other signs of hypersensitivity.

During the application of diclofenac, like other NSAIDs, in rare cases may be allergic, including anaphylactic/anaphylactoid reactions in patients who had not previously applied diclofenac.

Diclofenac (and other NSAIDs) in connection with its pharmacological properties may mask symptoms, characteristic of infectious diseases.

Avoid the simultaneous application of diclofenac with systemic NSAIDs (including selective COX-2 inhibitors), since there is no data, confirming the favorable effect as a result of synergies, and there are no data about possible side effects.

Care should be taken when administering the drug to elderly patients. Weak or have low body weight elderly patients, it is recommended to prescribe the drug in the minimum effective dose.

Tablets Voltaren Acti contains lactose, so the drug is not recommended to appoint patients with rare congenital diseases associated with impaired tolerance to galactose, severe lactase deficiency and malabsorption of glucose-galactose.

In patients suffering from bronchial asthma, seasonal allergic rhinitis, swelling of nasal mucous membrane (polyps of the nasal mucosa), chronic obstructive pulmonary disease or chronic infection of the respiratory tract (particularly associated with allergic rinita-like symptoms), reactions to drugs from the group of NSAIDs in the form of asthma attacks (so-called “aspirin asthma”), angioedema, or urticaria develop more often than usual. Such patients are advised to be particularly careful (readiness for urgent medical interventions).

When assigning diclofenac to patients with impaired liver function careful monitoring because the condition of such patients can deteriorate. On the background of the drug Voltaren Acti, like other NSAIDs, may increase the level of one or more liver enzymes. Therefore, when long-term therapy showing regular study of the liver. If violations from functional indicators of a liver remain or amplify, or if complaints or develop symptoms indicating liver disease, or if you experience other side reactions (including eosinophilia, rash), the drug should be discontinued. It must be borne in mind that hepatitis in patients receiving diclofenac may occur without prodromal phenomena.

Use caution in patients with hepatic porphyria, since taking diclofenac may trigger an attack.

Because the background of the use of NSAIDs was reported fluid retention and edema, particular caution is recommended to patients with impaired renal function and heart arterial hypertension in anamnesis, elderly patients, while receiving diuretics or medication, have a significant effect on renal function, patients with a significant decrease in BCC any etiology, for example in the period before and after the massive surgical interventions. In such cases, the use of diclofenac as a precaution is recommended to monitor renal function. After cessation of therapy the original settings are usually restored.

Voltaren Acti is recommended to use short, within a few days. In appointing the drug for a longer time shows the systematic monitoring picture peripheral blood.

Voltaren Acti, like other NSAIDs, may temporarily inhibit platelet aggregation. Therefore, in patients with disorders of hemostasis requires careful monitoring of relevant laboratory parameters.

Diclofenac, like other NSAIDs, may have a negative effect on female fertility and is not recommended to apply the drug to women seeking to get pregnant.

While taking Voltaren Acti during food absorption of diclofenac is reduced. So the drug is not recommended during or immediately after a meal.

Effects on ability to drive vehicles and management mechanisms

During treatment there may be some decrease the speed of psychomotor reactions. Patients experiencing while taking the drug, dizziness or other adverse reactions CNS, including visual disturbances, should not drive vehicles or operate machinery.