Voltaren Acti - instructions for use, doses, side effects, contraindications

Excipients: silicon dioxide 8,025 mg, lactose monohydrate 33,450 mg, starch corn 99,750- 101,745 mg, sodium carboxymethyl starch 26,700 mg, povidone K-30 4,050 mg, microcrystalline cellulose 13,500 mg, magnesium stearate 2,025 mg.

Sheath: white coating mixture sepifilm LP 770 6.0 mg (hypromellose 3.9 mg, microcrystalline cellulose 0.6 mg, stearic acid 0.6 mg, titanium dioxide (E 171) 0.9 mg).

Description:Tablets of oblong form of white color practically without a smell.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:

Voltaren® Act contains an active ingredient diclofenac potassium, which has pronounced analgesic, anti-inflammatory and antipyretic properties.

After taking the Voltaren® Act tablets, the action begins after 15 minutes, which makes the drug very effective for eliminating the pain syndrome and lowering the temperature. The mechanism of action of the drug is based on inhibiting the activity of cyclooxygenases (COX 1 and COX 2), followed by a decrease in the inflammatory process, pain and fever.

Indications:

Pain syndrome of different origin:

■ Pain in muscles and joints (back pain in different parts of the spine, etc.),

■ Headache and toothache,

■ Pain during menstruation.

Contraindications:

Hypersensitivity to diclofenac and other components of the drug; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance acetylsalicylic

acid or other NSAIDs (including in the anamnesis); period after aortocoronary shunting; gastric or intestinal ulcer in the exacerbation stage, inflammatory bowel disease, ulcerative bleeding or perforation; III trimester of pregnancy; severe heart failure, ischemic heart disease (IHD), diseases of peripheral arteries,chronic heart failure, arterial hypertension; active liver disease, liver failure, progressive kidney disease, severe renal failure (creatinine clearance less than 30 ml / min); confirmed hyperkalemia, lactase deficiency, lactose intolerance, glucose-galactose malabsorption; children's age till 14 years.

Carefully:

Cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes, smoking, creatinine clearance less than 60 ml / min. Amnestic data on the development of gastrointestinal ulceration, advanced age, prolonged use of NSAIDs, frequent use of alcohol, severe somatic diseases, concomitant therapy with selective serotonin reuptake inhibitors.

Pregnancy and lactation:

Clinical studies to study the effect of diclofenac during pregnancy have not been conducted. Therefore, in the I and II trimesters of pregnancy, the drug is prescribed only if the potential benefit to the mother's health exceeds the risk to the fetus. The use of diclofenac, like other NSAIDs, is contraindicated in the third trimester of pregnancy because of possible atony of the uterus and / or premature closure of the ductus arteriosus.

Diclofenac, like other NSAIDs, penetrates into breast milk in small amounts. Therefore, Voltaren® Acti is not recommended for breastfeeding to prevent unwanted effects in a child.

Dosing and Administration:

Inside.

For adults and children over 14 years of age:

The initial intake of 2 tablets with the subsequent intake of 1-2 tablets every 4-6 hours as needed. The maximum daily dose is 6 tablets (75 mg). Tablets should be taken whole, not liquid, squeezed with water. To achieve maximum therapeutic effect, the drug should be taken before meals.

The drug should be taken in no more than 3 days to reduce the temperature and not more than 5 days to ease the pain without consulting a doctor. If the temperature does not decrease within the specified periods and the pain persists, then you should immediately call your doctor.

Side effects:

Classification of incidence of adverse reactions:

Often (≥1/10); often (≥1 / 100, <1/10); infrequently (≥ 1/1000, <1/100); rarely (≥1 / 10000, <1/1000); rarely (<1/10000), including individual messages.

Violations from the blood and lymphatic system:

Very rarely: thrombocytopenia, leukopenia, anemia (including hemolytic and aplastic anemia), agranulocytosis.

Immune system disorders:

Rarely: hypersensitivity, anaphylactic and anaphylactoid reactions (including lowering blood pressure and shock).

Very rarely: angioedema (including face swelling).

Disorders of the psyche:

Very rarely: loss of orientation, anxiety, depression, insomnia, nightmares, irritability, psychotic disorders.

Impaired nervous system: Often: headache, dizziness.

Rarely: drowsy.

Very rarely: paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disorders, cerebrovascular disorders.

Disorders from the side of the organ of vision:

Very rarely: visual disturbances (impaired focus, diplopia).

Hearing disorders and labyrinthine disturbances:

Often: vertigo.

Very rarely: ringing in the ears, hearing impairment.

Disorders from the cardiovascular system:

Infrequent: myocardial infarction, heart failure, increased blood pressure, palpitations, chest pain. *

Very rarely: lowering blood pressure, vasculitis.

Disturbances from the respiratory system, chest and mediastinal organs:

Rarely: bronchial asthma (including dyspnea).

Very rarely: pneumonitis.

Disorders from the gastrointestinal tract:

Often: nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, decreased appetite, increased activity of "liver" transaminases.

Rarely: gastritis, gastrointestinal bleeding, vomiting of blood, diarrhea with an admixture of blood, melena, gastric / intestinal ulcers (with / without bleeding or perforation), hepatitis, jaundice.

Very rarely: colitis (including colitis with blood, exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, esophageal pathology, the appearance of diaphragm-like strictures in the intestine, pancreatitis, fulminant (fulminant) hepatitis, liver necrosis, hepatic insufficiency.

Disturbances from the skin and subcutaneous tissues:

Often: rash.

Rarely: urticaria.

Very rarely: bullous dermatitis, rashes in the form of blisters, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (acute toxic epidermolysis), erythroderma (exfoliative dermatitis), alopecia, photosensitivity reactions; purpura, Shenlaine-Henoch disease, itching.

Disorders from the kidneys and urinary tract:

Very rarely: acute renal failure, hematuria and proteinuria, tubulointerstitial nephritis; nephrotic syndrome; papillary necrosis.

Common violations:

Rarely: edema.

* The incidence of adverse reactions reflects long-term treatment data using a high dose (150 mg daily). It is expected that the incidence of adverse reactions will be lower with short-term treatment and a low dose (up to 75 mg daily).

Overdose:

In acute poisoning with non-steroidal anti-inflammatory drugs, therapeutic measures are aimed primarily at maintaining vital functions of the body and eliminating symptoms of poisoning.

Treatment:

Symptomatic treatment is carried out with increased blood pressure, the development of renal failure, seizures, respiratory depression, complications of the gastrointestinal tract. Specific measures, such as the introduction of diuretics, dialysis, the introduction of infusion solutions, are ineffective in removing from the body non-steroidal anti-inflammatory drugs due to the high level of binding them to blood plasma proteins.

In case of suspicion of diclofenac poisoning, Activated carbon and make a gastric lavage.

Interaction:

Lithium: with simultaneous application diclofenac can increase the concentration of lithium in blood plasma.

Digoxin: with simultaneous application diclofenac can increase the concentration of digoxin in the blood plasma.

Diuretic and antihypertensives: diclofenac, as well as other NSAIDs, with simultaneous admission with diuretic or antihypertensive agents (eg, beta-blockers, inhibitors of angiotensin converting enzyme (ACE) can reduce the severity of hypotensive action. Therefore, this combination of drugs should be used with caution, and the arterial pressure in such patients (especially in the elderly) should be measured regularly. Patients should receive sufficient fluid; because of the increased risk of nephrotoxicity after the initiation of combined treatment and periodically during treatment, kidney function should be monitored, especially with diuretics and ACE inhibitors. Simultaneous use with potassium-sparing diuretics, cyclosporine, tacrolimus or trimethoprim may lead to an increase in the serum potassium concentration, so the potassium content of the blood should be checked frequently.

NSAIDs and glucocorticosteroids: simultaneous use of diclofenac and other systemic NSAIDs or glucocorticosteroids may increase the incidence of adverse events on the part of the gastrointestinal tract.

Anticoagulants and antiplatelet agents: requires special caution, since The simultaneous use of diclofenac with these drugs increases the risk of bleeding.

Selective serotonin reuptake inhibitors: simultaneous use of diclofenac and other systemic NSAIDs and selective serotonin reuptake inhibitors may increase the risk of gastric bleeding.

Hypoglycemic drugs: in clinical studies it was found that simultaneous use of diclofenac and hypoglycemic drugs for oral administration is possible, while the efficacy of the latter does not change.

However, the development of individual cases of development of both hypoglycemia and hyperglycemia is known, which required a change in the dose of hypoglycemic drugs during the application of diclofenac.

Methotrexate: caution should be exercised in prescribing NSAIDs less than 24 hours before or after taking methotrexate,as in such cases the concentration of methotrexate in the blood can increase and its toxic effect may be intensified. Cyclosporine: the effect of NSAIDs on the synthesis of prostaglandins in the kidneys can enhance the nephrotoxicity of cyclosporine. Antibacterial agents, quinolone derivatives: there are separate reports on the development of seizures in patients receiving concurrently derivatives of quinolone and NSAIDs.

Interactions with food: The level of absorption of diclofenac decreases when it is taken with food. For this reason, it is not recommended to take the drug directly during or immediately after a meal.

Powerful inhibitors of isoenzyme CYP2C9: it is recommended to use caution when prescribing diclofenac along with inhibitors CYP2C9 (such as voriconazole), since this can lead to a significant increase in the plasma concentration of diclofenac and its effect due to inhibition of diclofenac metabolism.

Phenytoin: with the simultaneous use of phenytoin and diclofenac, it is recommended to monitor the plasma concentration of phenytoin because of the possible enhancement of the phenytoin effect.When used simultaneously with cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin, the frequency of hypoprothrombinemia increases.

Special instructions:

When taking non-steroidal anti-inflammatory drugs, there is a possibility of developing gastrointestinal bleeding, ulcers of the gastrointestinal tract, sometimes complicated by perforation, without previous warning signs or the presence of similar attacks in the patient's anamnesis. These complications can have serious consequences especially for the elderly. If these symptoms occur, the drug should be immediately discontinued. The risk of developing gastrointestinal bleeding increases with increasing doses of NSAIDs in patients with a history of peptic ulcer, especially if the disease is complicated by bleeding and perforation, as well as in elderly patients. To reduce the risk of complications, therapy should be initiated and administered with minimally effective doses, taking into account the possibility of using combination therapy with protector drugs (eg, proton pump inhibitors or misoprostol).When appointing diclofenac, patients with an existing gastrointestinal pathology (ulcer, bleeding, perforation) in a history should be treated with careful medical supervision and observance of special care. Caution is recommended for patients who simultaneously take medications that may increase the risk of ulcers or bleeding of the gastrointestinal tract, such as systemic glucocorticosteroids, anticoagulants, platelet aggregation inhibitors, or selective serotonin reuptake inhibitors. For patients with ulcerative colitis or Crohn's disease, therapy should be performed under close medical supervision, as diclofenac can exacerbate these diseases.

The use of diclofenac should be discontinued at the first signs of skin rash, lesions of the mucous membranes and when other indications hypersensitivity.

During the application of diclofenac, as well as other NSAIDs, in rare cases, allergies may occur, including anaphylactic / anaphylactoid reactions in patients who have not previously used diclofenac. Diclofenac, as well as other NSAIDs, in connection with the pharmacological action can mask the symptoms characteristic of infectious diseases. The simultaneous use of diclofenac with systemic NSAIDs (including selective inhibitors of cyclooxygenase-2) should be avoided, since there is no evidence of a beneficial effect as a result of synergy, and there are no data on possible side effects. Care should be taken when using the drug in elderly patients. Weak or low-fat elderly people are recommended to prescribe the drug at the lowest effective dose. When diclofenac is prescribed, patients with impaired liver function should be closely monitored, as the condition of such patients may worsen. During the application of Voltaren® Acti, as well as other NSAIDs, the activity of one or more "hepatic" enzymes may increase. Therefore, long-term therapy with the drug shows a regular study of liver function. If violations from the functional indicators of the liver persist or worsen, or if complaints or symptoms develop,indicating liver disease, and also if other side effects (eg, eosinophilia, rash, etc.) occur, the drug should be discontinued. It should be borne in mind that hepatitis against diclofenac may occur without prodromal phenomena. Care should be taken in patients with hepatic porphyria, as taking diclofenac can provoke an attack. Since the use of NSAIDs has been reported on fluid retention and the appearance of edema, special care should be taken in patients with impaired renal and cardiac function, history of arterial hypertension, elderly patients, concomitant diuretics or drugs that have a significant effect on kidney function, and also patients who have a significant reduction in the volume of circulating blood plasma of any etiology, for example, before and after massive surgical interventions. In such cases, when using diclofenac as a precautionary measure, monitoring of renal function is recommended. After discontinuation of therapy, renal function indicators usually normalize.

Voltaren® Acti is recommended for several days. When the drug is prescribed for a longer time, a systematic control of the peripheral blood pattern is shown. Voltaren® Acti, like other NSAIDs, may temporarily inhibit platelet aggregation. Therefore, patients with hemostasis disorders need careful monitoring of relevant laboratory parameters. Diclofenac, like other NSAIDs, can have a negative effect on female fertility, so it is not recommended to use the drug for women planning pregnancy. The use of all NSAIDs, including diclofenac, especially at high doses and with long-term treatment, may be associated with a slight increase in the risk of developing serious cardiovascular thrombotic complications (including myocardial infarction and stroke). To minimize the potential risk of developing adverse cardiovascular complications in patients taking NSAIDs, especially in patients with cardiovascular risk factors, the dose should be selected individually, starting with the lowest effective dose, and should be taken for as short a period as possible.Meta-analysis and pharmacoepidemiological data indicate a slight increase in the risk of arterial thrombosis (eg, myocardial infarction) associated with the use of diclofenac, especially at high doses (150 mg per day) and during prolonged treatment. The available data do not indicate an increased risk when using a low dose of diclofenac (up to 75 mg / day) to 5 days for pain relief or up to 3 days for lowering body temperature.

Effect on the ability to drive transp. cf. and fur:During the period of treatment, a slight decrease in the rate of psychomotor reactions is possible. Patients experiencing dizziness or other unpleasant sensations from the central nervous system, including visual impairment, should not drive or operate machinery.

Form release / dosage:

Tablets, film-coated 12.5 mg.

Packaging:

10 tablets in matt or clear blister of polyvinyl chloride / polychlorotrifluoroethylene / polyvinyl chloride from

aluminum foil on the back. For 1 or 2 blisters together with instructions for use are placed in a cardboard box.

For 10 tablets in a blister of polyamide / aluminum / polyvinyl chloride with aluminum foil on the back.For 1 or 2 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:Store at a temperature not exceeding 25 ° C in a place inaccessible to children.

Shelf life:Shelf life 3 years. It is not recommended to use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N014201 / 01

Date of registration:08.02.2008 / 02.03.2016

Expiration Date:Unlimited

The owner of the registration certificate:Новартис Консьюмер Хелс САНовартис Консьюмер Хелс СА Switzerland

Manufacturer: & nbsp

NOVARTIS FARMACEUTICA, S.A. Spain

Representation: & nbspNovartis Consumer Helms Ltd.Novartis Consumer Helms Ltd.

Information update date: & nbsp06.03.2017

Illustrated instructions

Instructions

Voltaren® Acti (Voltaren® Acti)