ADDOFIX * 30CPR RIV 10MG

ADDOFIX * 30CPR RIV 10MG

Therapeutic indications

Symptomatic treatment of spastic-painful manifestations of the gastrointestinal and genito-urinary tract.

Dosage and method of use

The following dosages are recommended for adults and children over the age of 14. 1–2 coated tablets 3 times a day. Single doses can be increased according to the physician's judgment. In children between the ages of 6 and 14, it is necessary to consult a doctor and follow his instructions exactly. Method of administration The tablets should be taken whole with an adequate amount of water.

Contraindications

ADDOFIX tablets are contraindicated in case of: - Hypersensitivity to the active substance or to any of the excipients. - Acute angle glaucoma. - Prostatic hypertrophy or other causes of urinary retention. - Pyloric stenosis and other conditions stenosing the gastrointestinal canal. - Paralytic ileus, ulcerative colitis, megacolon. - Reflux esophagitis. - Intestinal atony of the elderly and debilitated subjects. - Myasthenia gravis. - Cardiac tachyarrhythmias. - Children under the age of 6.

Side effects

Many of the listed side effects can be attributed to the anticholinergic properties of ADDOFIX. The anticholinergic side effects of ADDOFIX are generally mild and self-limiting. Immune system disorders: Frequency uncommon: skin reactions, hives, itching. Frequency not known: anaphylactic shock, anaphylactic reactions, dyspnoea, skin rash, erythema and other manifestations of hypersensitivity. Cardiac disorders: Frequency uncommon: tachycardia. Gastrointestinal disorders: Frequency uncommon: dry mouth. Constipation has also been observed. Skin and subcutaneous tissue disorders: Frequency uncommon: changes in sweating. Renal and urinary disorders: Frequency rare: urinary retention. Eye disorders: mydriasis, accommodation disturbances, increased ocular tone. Nervous system disorders: drowsiness. High doses can lead to signs of central stimulation and more serious signs of interference with the nervous system, state of consciousness and cardiorespiratory function.

Special warnings

If you have severe abdominal pain of which the cause is not known, which persists or worsens, or which occurs in conjunction with other symptoms such as fever, nausea, vomiting, changes in bowel movement, abdominal tenderness, decreased blood pressure, fainting or blood in the feces, you need to seek immediate medical attention. Anticholinergics can prolong gastric emptying time and cause stasis of the antrum. Administration of anticholinergic drugs such as ADDOFIX may cause an increase in intraocular pressure in patients in whom acute angle glaucoma has not been diagnosed and therefore has not been treated. Therefore, in case patients experience eye pain and redness with loss of vision after administration of ADDOFIX, they should urgently consult an ophthalmologist. All antimuscarinics reduce the volume of bronchial secretions; this must be taken into account in the case of subjects with chronic obstructive inflammatory diseases of the respiratory system. Anticholinergics should be used with caution in the elderly, in patients with disorders of the autonomic nervous system, in cardiac tachyarrhythmias, in arterial hypertension, in congestive heart failure, in hyperthyroidism and in those with liver and kidney disease. Caution should also be used in patients with acute angle glaucoma as well as in patients susceptible to intestinal and urinary stasis and in those prone to tachyarrhythmias. Due to the possibility that anticholinergics may reduce sweating, ADDOFIX should be administered with caution to patients with pyrexia. Treatment with high doses should not be abruptly stopped. Minor side effects can be controlled by appropriately reducing the dose; the appearance of important secondary manifestations requires the interruption of therapy. The medicine contains sucrose therefore patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency, should not take this medicine.

Pregnancy and breastfeeding

There are limited data from the use of hyoscine N-butylbromide in pregnant women. As a precautionary measure, it is preferable to avoid the use of ADDOFIX during pregnancy and breastfeeding. There is insufficient information on the excretion of ADDOFIX and its metabolites in human milk.

Expiration and retention

This medicine does not require any special storage conditions

Interactions with other drugs

The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, phenothiazines, butyrophenones, antihistamines, quinidine, antipsychotics, amantadine, diisopyramide and other anticholinergics (eg tiotropium, ipratropium and atropine-like compounds) can be enhanced by ADDOFIX. Concomitant treatment with dopamine antagonists, such as metoclopramide, may result in a reduction in the effect of both drugs on the gastrointestinal tract. Tachycardia induced by β-adrenergic drugs may be accentuated by ADDOFIX. Do not drink alcohol during therapy. Since antacids can reduce intestinal absorption of anticholinergics, these drugs should not be administered concurrently.

Overdose

Symptoms Anticholinergic effects (such as urinary retention, dry mouth, redness of the skin, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances) may occur in case of overdose. Therapy If necessary, administer parasympathomimetic drugs. In case of glaucoma it is necessary to urgently refer to an ophthalmology specialist. Cardiovascular complications must be treated according to the usual therapeutic principles. In case of respiratory paralysis: evaluate the opportunity to resort to intubation, artificial respiration. In case of orthostatic hypotension, it is sufficient for the patient to lie down. Catheterization may be required for urinary retention. In addition, if necessary, appropriate supportive care should be undertaken.

Active principles

Coated tablets One coated tablet contains: active ingredient: 10 mg hyoscine butylbromide. Excipients: sucrose For a full list of excipients, see section 6.1

Excipients

Coated tablets: Core: anhydrous calcium hydrogen phosphate, maize starch, pregelatinised starch, silica dioxide, tartaric acid, stearic acid. Coating: povidone, sucrose, talc, titanium dioxide, macrogol 6000, carnauba wax, spray-dried acacia.