Clodifen Neuro




COMPOSITION

A capsule contains:

Active ingredients:

Diclofenac sodium 50 mg

Thiamine hydrochloride 50 mg

Pyridoxine hydrochloride 50 mg

Cyanocobalamin 0.25 mg

Excipients:

lysine hydrochloride, cellulose microcrystalline, silica colloidal anhydrous, magnesium stearate.

Capsule shell composition:

titanium dioxide, iron oxide yellow, iron oxide red, ponceau 4R, brilliant black, water purified, gelatin.

THERAPEUTIC INDICATIONS

- pain syndrome in non-rheumatic inflammations (after traumas, operative and dental interventions; in gynaecological disorders – primary algodismenorrhea, adnexitis; in inflammatory diseases of ENT organs - pharyngitis, tonsillitis, otitis);

- inflammatory and degenerative joint and spine disease (chronic polyarthritis, rheumatic and rheumatoid arthritis, ankylosing spondylitis, osteoarthrosis, spondyloarthrosis);

- neuritis and neuralgia (cervical syndrome, lumbago, ischias);

- acute gouty arthritis;

- rheumatoid involvement of soft tissues.

CONTRAINDICATIONS

- hypersensitivity to the drug components (including to other NSAIDs);

- acute erosive-ulcerative lesions of the gastrointestinal tract;

- gastrointestinal bleedings;

- intracranial bleedings;

- complete or incomplete combination of bronchial asthma, recurrent mucous membranes polyposis of nose and paranasal sinuses, and acetylsalicylic acid or other NSAIDs intolerability (including anamnesis);

- impaired haemopoiesis;

- severe hepatic failure;

- active liver disease;

- severe renal failure (creatinine clearance is less than 30 ml/min);

- progressive kidneys disease;

- severe heart failure;

- period after сoronary artery bypass surgery;

- confirmed hyperkalemia;

- hemostasis disturbances (including hemophilia);

- pregnancy and lactation;

- children under 12 years old.

ADVERSE EFFECTS

Digestive system: frequently - abdominal pains, sensation of abdominal bloating, diarrhea, nausea, constipation, flatulence, increase in liver enzyme levels; sometimes – stomatitis, dryness of mucous membranes, change of appetite.

Hemopoietic (blood-forming) organs: sometimes - anemia (including hemolytic and aplastic), leucopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura.

Central nervous system: frequently – headache, dizziness; sometimes - distribution of sleep; drowsiness, depression, irritability.

Organ of senses: frequently - tinnitus; sometimes - blurred vision, diplopia; taste disorder.

Respiratory system: sometimes - cough, bronchospasm, edematous laryngitis, pneumonitis.

Cardiovascular system: sometimes – increasing of blood pressure, congestive heart failure, extrasystole, chest pain.

Urinary system: frequently - fluid retention; sometimes – nephrotic syndrome, proteinuria, oliguria, hematuria, interstitial nephritis, renal papillary necrosis, acute renal failure, azotemia.

Dermatological reactions: frequently - skin itch, skin rash; sometimes - alopecia, urticaria, eczema, toxic dermatitis, erythema multiforme, toxic epidermal necrolysis, hyperphotosensitivity.

Allergic reactions: sometimes - anaphylactoid reactions, anaphylactic shock, lips and tongue swelling, allergic vasculitis.

Others: sometimes – worsening of infectious processes.

DOSAGE AND ADMINISTRATION

Clodifen Neuro capsules should be taken during a meal, not chewing and washing down with a large amount of liquid.

For adults the drug is prescribed as 1 capsule 3 times per day at the beginning of the treatment; as a maintenance dose it is recommended to take 1 capsule 1-2 times per day. The treatment duration depends on the nature and severity of the disease.

SPECIAL INDICATIONS

The drug should be applied with cautious in case of anemia, bronchial asthma, congestive heart failure, arterial hypertension, ischemic heart disease, edema syndrome, hepatic and renal insufficiency, alcoholism, inflammatory bowel disease, erosive-ulcerative lesions of the gastrointestinal tract in remission, diabetes mellitus, conditions after extensive surgeries, systemic connective tissue disorders, as well as to the elderly patients.

During the treatment with Clodifen Neuro it is necessary to perform a systemic control of peripheral blood picture, liver and kidneys function.

PREGNANCY AND LACTATION

The drug is contraindicated during pregnancy and lactation.

MANUFACTURED FORM AND PACKAGE

10 hard gelatin capsules in a blister.

3 blisters together with a leaflet in a carton box.

Musculo-Skeletal system

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