Voltaren AKTÏ

Active material: Diclofenac
When ATH: M01AB05
CCF: NSAIDs
ICD-10 codes (testimony): J06.9, J10, K08.8, M25.5, M54, M79.1, N94.4, N94.5, R07, R50, R51, R52.0, R52.2
When CSF: 05.01.01.03.01
Manufacturer: NOVARTIS CONSUMER HEALTH S.A. (Switzerland)

Pharmaceutical form, composition and packaging

◊ Pills, Film-coated white, oblong, without smell.

Excipients: silicon dioxide, lactose monohydrate, corn starch, sodium carboxymethyl starch, polyvidone k-30, microcrystalline cellulose, magnesium stearate.

The composition of the shell: hypromellose 6cP, polymer 3cP, Titanium dioxide, macrogol 400, polysorbate 80, polymer 50cP, maltodextrin.

10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (2) – packs cardboard.

Pharmacological action

NSAIDs. Has expressed analgesic, anti-inflammatory and antipyretic effect.

The basis of the mechanism of action lies oppression activity of Cox (Cox-1 and Cox-2) with subsequent suppression of inflammation, reduced pain and feverish States.

After taking the pill Voltaren Emulgel^® Akti therapeutic effect develops through 15 m, that makes effective use of the drug for quick cupping pain and to reduce elevated body temperature.

Pharmacokinetics

Data for farmakokinetike Voltaren Emulgel^® Akti not available.

Testimony

Removing and reducing the pain of different origin, including:

-pain in muscles and joints (incl. back pain in various sections of the spine);

-headache and toothache;

— pain during menstruation.

To eliminate the symptoms of colds and flu:

-pain in the muscles, joints;

- Sore throat;

-increased body temperature.

Dosage regimen

The drug is prescribed inside.

To Adults and adolescents older 14 years starting dose is 25 mg (2 tab.) followed by 12.5-25 mg (1-2 tab.) every 4-6 h as needed. The maximum daily dose is 75 mg (6 tab.).

Tablets should be taken as a whole, without chewing and drinking water. To achieve maximum therapeutic effect the drug should be taken before meals.

Duration of use without a prescription Vol'tarena^® Akti when fever is 3 day, When bolevom syndrome – 5 days.

Side effect

Determining the frequency of side effects: often (> 1/100, < 1/10), sometimes (> 1/1000, < 1/100), rarely (> 1/10 000, < 1/1000), rarely (< 1/10 000, including isolated reports).

From the digestive system: often – nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia, increased levels of liver transaminases; rarely – gastritis, gastrointestinal bleeding, hematemesis, diarrhea, Melena with blood, ulcers stomach/intestines (with/without bleeding or perforation), hepatitis, jaundice; rarely – colitis (incl. colitis with blood, exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, pathology of esophagus, hiatal stricture, pancreatitis, Lightning (ful'minantnyj) hepatitis.

From the central and peripheral nervous system: often – headache, dizziness; rarely – drowsiness; rarely – paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, flavor violation, cerebrovascular disorders, the loss of orientation, depression, insomnia, nightmares, irritability, psychotic disorders.

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

From the hematopoietic system: rarely – thrombocytopenia, leukopenia, anemia (incl. hemolytic and aplastic anemia), agranulocytosis.

Allergic reactions: rarely – hives, anaphylactic and anaphylactoid reactions (including arterial hypotension and shock); rarely – erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), purpura, including allergic Purpure, angioedema (including swelling of the face).

From the senses: rarely – visual impairment (deterioration in focus, diplopia), tinnitus, amblyacousia.

Cardio-vascular system: rarely – palpitations, pain in sternum, heart failure, myocardial infarction, arterial hypertension, vasculitis.

The respiratory system: rarely – bronchial asthma (including Dyspnea); rarely – pneumonia.

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

Other: rarely – swelling.

Contraindications

- Bronchial asthma, urticaria or acute rhinitis history, caused by the admission of acetylsalicylic acid or other NSAIDS (eg, ibuprofen);

- The period after coronary artery bypass grafting;

-gastric ulcer or bowel lesion ulcerous in acute phase;

-ulcerous hemorrhage or perforation;

- Severe renal insufficiency;

- Severe hepatic impairment;

- Severe heart failure;

- III trimester of pregnancy;

- Children up to age 14 years;

- Hypersensitivity to the drug.

FROM caution the drug should be used in patients with ischemic heart disease, cerebrovascular diseases, Congestive heart failure, Dyslipidemia/Hyperlipidemia, diabetes, peripheral artery disease, at CC<60 mL/min, a history of development of ulcerative shock syndrome, long-term use of NSAIDs, in patients with severe somatic diseases, concomitant therapy with selective serotonin reuptake inhibitors, in elderly patients, Smokers, frequent drinkers.

Pregnancy and lactation

Adequate and well-controlled studies on the action of diclofenac and pregnancy has not been. Therefore, I and II trimestrah pregnancy drug appoint only in cases, When the potential benefits for a mother than the increased risk to the fetus.

Use of diclofenac, like other NSAIDS, contraindicated in the third trimester of pregnancy because of the risk of uterine atony and/or premature closure of the ductus arteriosus (ductus arteriosus).

Diclofenac, Like other NSAIDs, is the breast milk in small amounts. Therefore, Voltaren Emulgel^® Akti is not recommended during breastfeeding to prevent adverse effects in child.

Cautions

When taking NSAIDS, there is the likelihood of bleeding from DIGESTIVE TRACT, Ulcerative shock syndrome, sometimes some difficult perforation, without prior warning symptoms or existence of such attacks in the history of the patient. Data complications can have serious consequences especially for seniors. If you experience such symptoms, the drug should immediately cancel.

The risk of bleeding from the digestive tract increases with increasing doses of NSAIDS in patients with peptic ulcer history, especially in the case of complications of the disease bleeding and perforation, as well as in elderly patients. To reduce the risk of complications of therapy should be initiated and maintained at the level of the minimum effective dose, taking into account the possibilities of combination therapy using, providing a protective effect on gastric mucosa (eg, protonovogo pump inhibitor or misoprostol).

When prescribing diclofenac in patients with existing GASTROINTESTINAL pathology (ulcerous lesions, bleeding, perforation) in history, there is a need to conduct therapy with careful medical follow-up and compliance with special care.

Caution is advised to observe patients, who take drugs, that can increase the risk of ulcers or bleeding of the GASTROINTESTINAL TRACT, such as systemic corticosteroids, antykoahulyantы, inhibitors of platelet aggregation or selective serotonin reuptake inhibitors.

Patients, suffering from ulcerative colitis or Crohn's disease, therapy should be under careful medical supervision, tk. as a result of taking diclofenac may occur and the exacerbation of these diseases.

Use of diclofenac should be discontinued at the first sign of the emergence of skin rashes, lesions of the mucous membranes and other signs of hypersensitivity.

During the application of diclofenac, as well as other NSAIDS, in rare cases may occur are allergic, incl. anaphylactic/anaphylactoid reactions in patients, not previously applied diclofenac.

Diclofenac (in the same way as other NSAIDS) in conjunction with their pharmacological properties may mask symptoms, characteristic of infectious diseases.

Avoid the simultaneous application of diclofenac with systemic NSAIDS (in t. no. selective Cox-2 inhibitors), Since no data, confirming the favorable effect as a result of synergies, and the absence of data on possible side effects.

Caution must be exercised in the appointment of the drug patients older. Impaired or who have low body weight older patients to designate product in the minimum effective dose.

Tablets Voltaren Emulgel^® Akti contains lactose, Therefore, the drug is not recommended to appoint patients with rare congenital diseases, associated with impaired tolerance to galaktoze, severe lactase deficiency and violation of glucose-Galactose malabsorption.

Patients, asthmatic, seasonal allergic rhinitis, swelling of the nasal mucosa (nasal polyps), chronic obstructive lung disease or chronic respiratory tract infection (particularly associated with allergic rinitopodobnymi symptoms), reactions to drugs from the Group of NSAIDS in the form of asthma attacks (so-called “Aspirin” asthma), angioedema or hives develop more often than usual. Such patients should be careful (preparedness for urgent medical interventions).

When prescribing diclofenac in patients with impaired liver function, it is necessary to carry out careful monitoring, Since these patients may deteriorate. Against the background of the preparation use Voltaren Emulgel^® Akti, like other NSAIDS, may increase levels of one or more liver enzymes. Therefore, when long-term therapy showing regular study of the liver. If a breach of the liver functional parameters are saved or amplified, or, If a complaint or develop symptoms, indicating liver disease, as well as in the case of, If you experience other adverse reactions (incl. eozinofilija, rash), the drug should be discontinued. It must be borne in mind, that hepatitis against the backdrop of the admission of diclofenac may arise without prodromal'nyh phenomena.

You should use caution in patients with hepatic Porphyria, Since receiving diclofenac may trigger heart attack.

Because against the backdrop of NSAIDS reported fluid retention and edema, special caution is advised to observe patients with disabilities kidneys and hearts, with arterial hypertension in history, elderly patients, while receiving diuretics or medication, having a significant effect on renal function, as well as patients with a significant decrease in Bcc any etiology, eg, in the period before and after the massive surgical interventions. In such cases, the application of diclofenac as a precaution is recommended to monitor kidney function. After the cessation of therapy usually restores the original settings.

Voltaren^® Akti recommended briefly, within a few days. In appointing the drug for longer periods shows the systematic monitoring picture peripheral blood.

Voltaren^® Akti, Like other NSAIDs, may temporarily inhibit platelet aggregation. Therefore, in patients with impaired hemostasis requires careful monitoring of relevant laboratory values.

Diclofenac, Like other NSAIDs, may adversely affect female fertility, Therefore it is not recommended to apply the drug to women, seeking to get pregnant.

When taking Vol′tarena^® Akti during meal absorption diclofenac reduced. Therefore, the drug is not recommended to take during or immediately after a meal.

Effects on ability to drive vehicles and management mechanisms

During treatment, there may be some slowdown in the rate of psychomotor reactions. Patients, experiencing during dose dizziness or other unwanted reactions on the part of the CENTRAL NERVOUS SYSTEM, including the impairment, You should not drive vehicles or driving mechanisms.

Overdose

Symptoms: increased ad, renal failure, convulsions, respiratory depression, GASTROINTESTINAL complications.

Treatment: gastric lavage, administration of activated charcoal; symptomatic therapy and measures, to maintain body functions.

The use of diuretics, infusion solutions, dialysis appear to be ineffective if necessary removal from the body NSAIDS, because the drugs in this group are characterized by a high degree of bonding with blood plasma proteins.

Drug Interactions

While applying drugs lithium and lithium concentrations may increase Digoxin and digoxin in plasma.

Diclofenac (Like other NSAIDs) together with the admission of a weak or antigipertenzivei means (eg, beta-blockers, ACE inhibitors) may reduce the severity of antigipertenzivnogo actions. Simultaneous application of kalisberegath dioretikov can lead to increased levels of potassium in the blood serum.

The simultaneous use of other systemic NSAIDS or corticosteroids increases the number of side effects.

While receiving diclofenac with anticoagulants and platelet aggregation inhibitors, increases the risk of bleeding (in applying this combination requires particular caution).

In clinical studies found, It's possible the simultaneous use of diclofenac and gipoglikemicakih oral drugs the effectiveness the past does not change. However, isolated cases have been described as the development of hypoglycemia, and hyperglycemia, When requiring correction dose of hypoglycemic drugs.

You should be wary of Voltaren Emulgel^® Akti at intervals of less than 24 hours before or after taking methotrexate, Since methotrexate concentration in the blood may increase, that would increase its toxicity.

While the application of Cyclosporine in renal prostaglandins NPVS influence could lead to an increase in Cyclosporine Nephrotoxicity.

There have been sporadic reports of the development convulsing, caused by combined use of quinolones and NSAIDS.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C . Shelf life – 3 year.