Dosage and administration

Usual Dose: 2 tablets daily in 2 divided doses, mid-day and evening at meal times.

Acute Hemorrhoidal Attack: 6 tablets daily for the first 4 days, then 4 tablets daily for 3 days.

Contraindications

Hypersensitivity to any of the components of Daflon 500 mg.

Special Precautions

Hemorrhoidal Attack: The administration of Daflon 500 mg does not preclude treatment for other anal conditions.

The treatment must be short-term. If symptoms do not subside promptly, a proctological examination should be performed and the treatment should be reviewed.

Impairment of Fertility: Reproductive toxicity studies showed no effect on fertility in male and female rats.

Adverse Reactions

Summary of Safety Profile: Adverse Reactions reported with Daflon 500 mg in clinical trials are of mild

intensity. They consist mainly in gastrointestinal events (GI) (diarrhoea, dyspepsia, nausea, vomiting).

 

List of Adverse Reactions:

System Organ Class                     Frequency             Preferred Term

Nervous System Disorders             Rare                       Dizziness, Headache, Malaise

 

Gastrointestinal                              Common                Diarrhoea, Dyspepsia, Nausea, Vomiting

disorders                                         Uncommon            Colitis

Skin and Subcutaneous                  Rare                        Pruritus, Rash, Urticaria

 tissue Disorders                           Not known                Lip, eyelid oedema, exceptionally, Quincke's

                                                                                            оedema

Interactions

Incompatibilities: None.

Storage

Store below 30°C.

Shelf-Life: 3 years.

Presentation / Packing

Film-coated tab 500 mg x 30’s

 

INDOMETHACIN

Composition

Indomethacinum 10 g in ointment base up to 100 g.

Properties

The ointment exhibits anti-inflammatory and antiexudative properties. Being a prostaglandin synthesis inhibitor it exercises both keratolytic and antiseptic effect. The excellent resorption of this ointment ensures its therapeutic effect creating high tissue concentrations at the application areas.

Indications

Acute and chronic rheumatic polyarthritis, osteoarthrosis, Behterev's disease, degenerative articular diseases, discopathies, neuritis, plexitis, radiculitis, post-operative oedema, contusions, thrombophlebitis, hyperkeratolytic eczemas, herpes zoster, arthropathic psoriasis, climacteric keratosis etc.

Dosage and administration

Rub the affected joints or skin areas a few-centimetre-long tube squeeze of Indomethacin ointment, 2-3 times a day. Total daily amount should not exceed 15 cm for adults and 7.5 cm for children.

Contraindications

Drug allergy, peptic and duodenal ulcer, bronchial asthma, epilepsy, Parkinsonism, during pregnancy and breast feeding, leucopenia, haemorrhagic diathesis (thrombocytopenia and coagulopathy).

Side-effects

Allergic reactions, thrombocytopenia, agranulocytosis. Following long-term treatment, however rarely, headache, drowsiness, depressive states, hepatitis and pancreatitis can be observed especially in more susceptible patients.

Drug interactions

Therapeutic effect of Indomethacin decreases, if applied concurrently with salycilates. Probenecid suppresses renal excretion of indomethacin. The effect of Indomethacin is enhanced if applied in combination with glucocorticoids and pyrazolon derivatives.

Precautions

If treatment lasts longer than ten days, follow carefully the patient’s blood picture (leucocytes, thrombocytes). If applied in combination with antibiotics, anticoagulants or antidiabetic drugs ensure control of proper clinical and laboratory parameters.

Package

Ointment in aluminium tubes of 40 g.

Storage

At moderate temperature (15-30°C) in light-protected areas.

Shelf life

2 years.

Produced by

TROYAPHARM Co

 

DROTAVERINE

Composition

Drotaverine 40mg

Description:

Myotropic antispasmodic, a derivative of isoquinoline. Inhibits phosphodiesterase (PDE) IV, which leads to the accumulation of intracellular cyclic adenosine monophosphate (cAMP) and hence in inactivation of the myosin light chain kinase, resulting in smooth muscle relaxation. It has direct effect on smooth muscle can be used as an antispasmodic when contraindicated drugs from the group m-anticholinergics (angle-closure glaucoma, prostatic hyperplasia).

Indications

‒ Smooth muscle spasm urinary and biliary organs (kidney colic, pyelitis, tenesmus, biliary colic, intestinal colic, biliary dyskinesia and gallbladder hyperkinetic type, cholecystitis, postcholecystectomical syndrome).

‒ Spasm of smooth muscles of the gastrointestinal tract (usually as part of combination therapy): pilorospazm, gastro, gastric ulcer and duodenal ulcers, spastic constipation, spastic colitis, proctitis.

‒ Tensor headache.

‒ Dysmenorrhea, threatening miscarriage, threatening preterm delivery, postpartum contractions.

Contraindications

Hypersensitivity to the drug, pronounced hepatic and renal insufficiency, severe heart failure (low cardiac output syndrome), lactation.

This dosage form is not used in children younger than 3 years.

Due to the presence of the drug lactose monohydrate (milk sugar), its reception is contraindicated in congenital lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Precautions

Drotaverine should be used with caution in patients with arterial hypotension, atherosclerosis of the coronary arteries, prostatic hyperplasia, angle-closure glaucoma, pregnancy.

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