BUSCOPAN COMPOSITUM 20CPR RIV

BUSCOPAN COMPOSY

active ingredients

Buscopan Compositum 10 mg + 500 mg coated tablets A coated tablet contains: Active ingredients: N-butylbromide 10 mg, paracetamol 500 mg Buscopan Compositum 10 mg + 800 mg A suppository contains: Active ingredients: N-butylbromide of joscine 10 mg, paracetamol 800 mg Excipient with known effects: sodium. For the full list of excipients, see paragraph 6.1.

Excellent

Covered tablets: Nucleus: microcrystalline cellulose, sodium carmellose, corn starch, etylcellulose, colloidal silica, magnesium stearate. Coating: ipromellose, polyacrylate, titanium dioxide, macrogol 6000, talc, silicone-antifoam agent. Supposes: glyceride esters of saturated fatty acids, soy lecithin.

Therapeutic indications

Paroxysmal pain in the gastrointestinal tract, spastic pain, biliary tract dyskinesis.

Contraindications

Buscopan Compositum is contraindicated in case of: - hypersensitivity to the active ingredients (N-butylbromuro of joscine and paracetamol), to non-steroidal anti-inflammatory drugs or any of the excipients listed in paragraph 6.1; - acute angle glaucoma; - prostate hypertrophy or other causes of urinary retention; - mechanical stenosis of the gastrointestinal tract; - pyloric stenosis and other conditions stenosant the gastroenteric channel; - paralytical or obstructive; - megacolon; - ulcerative colitis; - esophagi by reflux; - intestinal atonia of the elderly and debilitated subjects; - myasthenia grave; - pediatric age; - paracetamol-based products are contraindicated in patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and those suffering from severe hemolytic anemia; - severe hepatocellular insufficiency (Child - Pugh C). The use of Buscopan Compositum is contraindicated in case of rare hereditary conditions that may be incompatible with a product excipient (see paragraph 4.4). Buscopan Compositum 10 mg + 800 mg supposedly should not be used in patients with a history of soy allergy or peanuts.

Population

The following dosage is recommended for adults, unless otherwise prescribed: Covered tablets 1-2 tablets 3 times a day. Do not exceed 6 tablets daily. Tablets should not be chewed, but swallowed whole with enough water. Supposes 1 supposes 3-4 times a day. Do not exceed 4 assumptions per day. Duration of treatment Buscopan Compositum should not be taken for more than three days if not following a prescription (see paragraph 4.4). Pediatric population The use of Buscopan Compositum is not recommended in children under 10 years of age. The simultaneous administration of other drugs containing paracetamol may require a posological adjustment, see paragraph 4.4.

Conservation

Covered tablets: keep at a temperature below 25°C. Suppose: keep at a temperature below 30°C.

Warnings

Buscopan Compositum should not be taken for more than 3 days if not indicated by your doctor. Invite the patient to contact the doctor if the pain persists or worsens, if new symptoms occur, or if it arises redness or swelling because these may be symptoms of a serious condition. In the case of severe abdominal pain of unknown origin that persists, worse or is accompanied by symptoms such as fever, nausea, vomiting, alteration of intestinal movements, expansive abdomen, decrease of blood pressure, fainting or blood in the feces, immediately turn to the doctor. To prevent overdose, it is necessary to ensure that other medications taken at the same time do not contain paracetamol, one of the active ingredients of Buscopan Compositum. It may cause liver damage if the recommended dose for paracetamol is exceeded (see paragraph 4.9). Buscopan Compositum should be used with caution in case of: • glucose-6-phosphate dehydrogenase deficiency; • liver dysfunction (e.g. due to chronic alcohol abuse, hepatitis); • chronic use of alcohol even in recent cessation;• renal function compromised; • Gilbert syndrome; • mild to moderate hepatocellular insufficiency (Child - Pugh A/B); • low glutathione reserves. Carefully administer in subjects with kidney or liver failure. Under these conditions Buscopan Compositum should only be administered under medical control, if necessary, reducing the dose or prolonging the interval between individual administrations. The blood count and kidney and liver function must be monitored after prolonged use. Wide use of analgesics, especially at high doses, can induce headaches that should not be treated with increased doses of medicine. Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. The treatment must be suspended at the first signs of a reaction of hypersensitivity following the administration of Buscopan Compositum. Severe skin reactions: with the use of Buscopan Compositum potentially fatal reactions such as Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (NET). Patients should be informed about signs and symptoms and carefully monitored for skin reactions. If symptoms or signs of Stevens-Johnson syndrome occur, toxic epidermal necrolysis (e.g. progressive skin rash associated with bladders or mucosa lesions), the patient must immediately suspend treatment with Buscopan Compositum and consult a doctor. Hepatotoxicity with paracetamol can also occur at therapeutic doses, after short-term treatment and in patients without pre-existing liver dysfunction (see paragraph 4.8). A sudden interruption of analgesics after prolonged use at high doses can cause withdrawal symptoms (e.g. headache, fatigue, nervousness), which usually settle within a few days. Resumption of analgesics must be subject to medical advice, and remission of withdrawal symptoms. Due to the potential risk of anti-linergical complications, it should be used with caution in patients predisposed to closed-angle glaucoma, in patients subject to blockages of the intestinal or urinary tract and in those prone to tachyrithmia with turbe of the autonomous central nervous system, in tachyrithmias, arterial hypertension, congestive heart failure and hyperthyroidism. All antimuscarinics reduce the volume of bronchial secretions; therefore they must be used with caution in subjects with obstructive chronic inflammatory diseases of the respiratory system. During treatment with paracetamol before taking any other medication check that does not contain the same active ingredient, since if the paracetamol is taken in high doses severe adverse reactions may occur, see paragraph 4.2. Invite the patient to contact the doctor before associating any other medication. See also paragraph 4.5. Buscopan Compositum 10 mg + 500 mg tablets contains 4.32 mg sodium per tablet, i.e. less than 1mmole (23 mg) sodium, so it is essentially “without sodium”.

Interactions

Use with extreme caution and under strict control during chronic treatment with drugs that can determine the induction of hepatic monoxygenases or in case of exposure to substances that may have such an effect (e.g. rifampin, cimetidine, anti-epileptic hypnotics such as glutetimmide, phenobarbital, carbamazepine, phenytoin). The same situation occurs with potentially hepatotoxic substances and alcohol abuse. Concurrent cloramfenicle administration may lead to an extension of chloramphenicol half-life, with the risk of increasing its toxicity. Paracetamol can increase the risk of bleeding in patients taking warfarin and other vitamin K antagonists. Patients taking vitamin K paracetamol and antagonists must be monitored for appropriate coagulation and bleeding. Co-administration of flucloxacillin with paracetamol can lead to metabolic acidosis, in patients who present risk factors of glutathione depletion. Concurrent use of paracetamol and zidovudine (AZT or retrovir) increases the tendency to reduce leukocytes (neutropenia). Then Buscopan Compositum must be taken together with zidovudine only under medical control. The intake of probenecid inhibits the binding of the paracetamol to glucuronic acid, thereby reducing the clearance of the paracetamol approximately of a factor of 2. The dose of paracetamol should therefore be reduced during the concurrent administration with probenecid. Colestramine reduces the absorption of paracetamol. The anti-linergical effect of medicines such as tri and tetracyclic antidepressants, antihistamines, antipsychotics, chinidine, amantadine, disopiramide and other anti-linergics (e.g. thiotrope, ipratrope, substances similar to atropine) can be enhanced by Buscopan Compositum. Concurrent treatment with dopamine antagonists, such as metoclopramide, can lead to a reduction in the effect of both drugs on the gastrointestinal tract. Tachycardia induced by β-adrenergic drugs can be upgraded by Buscopan Compositum. The tachycardial effects of beta-adrenergic agents can be intensified by Buscopan Compositum. Interference with laboratory exams Paracetamol intake may affect the determination of uric acid by means of the method of phosphotungstic acid and glycemia by means of the method of oxidase-peroxidase glucose. In addition to oral use: Drugs that slow gastric emptying (e.g. propantelin) can reduce the absorption rate of the paracetamol, delaying the therapeutic effect; on the contrary, drugs that increase gastric emptying speed (e.g. metoclopramide or domperidone) involve an increase in the absorption rate of paracetamol.

Effects

Adverse reactions are listed below by classification for systems and organs and by frequency, according to the following categories: Very common: ≥ 1/10 Municipality: ≥ 1/100, Emolinfopoietic system pathologies Not known: pancitopenia, agranulocytosis, thrombocytopenia, neutropenia, leukopenia, hemolytic anemia. Immune disorders, skin and subcutaneous tissue disorders Not common: skin reactions, abnormal sweating, itching, nausea. Rare: erythema, decreased blood pressure including shock. Very rare: hives, rash, esantema, severe skin reaction (such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and generalized exantematic pustolosis (AGEP)). Not known: anaphylactic shock, anaphylactic reactions, skin reaction from drug, dispnea, hypersensitivity, angioedema, fixed eruption from drug. Heart disease. Rare: tachycardia. Respiratory, chest and mediastinic pathologies. Notable: spasms of bronchial muscles (especially in patients with a history of bronchial asthma or allergy). Gastrointestinal diseases. Not common: dry mouth. Hepatobiliary diseases. Notable: increased transaminasis, hepatitis citolitica that can lead to acute liver failure. Kidney and urinary pathologies. Not known: urinary retention. With the use of paracetamol cases of multiform erythema have been reported. Angioedema, edema of larynx have been reported. The following side effects have also been reported: anemia, alterations of liver and hepatitis function, alterations to the kidney (acute renal failure, interstitial nephritis, hematuria, anuria), gastrointestinal reactions and dizziness. Drowsiness, midriasis, tamodation turbs, increased eye tone, constipation and urination difficulties were also reported. Further adverse reactions only for the assumptions Gastrointestinal diseases. Do not note: anorettale nuisance. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Due to the overdose of paracetaminophen the elderly, small children, patients with liver disorders, chronic alcohol consumption or chronic malnutrition, as patients treated with enzyme induction medicines are subjected to greater risk of intoxication, even with fatal outcome. Synonyms Joscine N-butylbromide In case of overdose, anticholinergic effects were observed. Paracetamol In cases of chronic intoxication, hemolytic anemia, cyanosis, weakness, dizziness, paresthesia, tremors, insomnia, headache, loss of memory, irritative phenomena of the central nervous system, delirium and seizures can be manifested. Symptoms usually occur during the first 24 hours and include pallor, nausea, vomiting, anorexia and abdominal pain. Patients can then manifest a temporary subjective improvement but the slightly possibly indicative abdominal pain of liver damage may persist; a considerable increase in transaminasis, jaundice, coagulation disorders, hypoglycemia and passage to the liver coma could occur. A single dose of paracetamol of approximately 6 g or more in adults or 140 mg/kg in children can cause hepatocellular necrosis. This can induce complete irreversible necrosis and subsequently hepatocellular insufficiency, gastrointestinal bleeding, metabolic acidosis, encephalopathy and intravascular coagulation scattered which can in turn progress until coma and death. Competitive increases of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin with reduction of protrombine levels and an increase in protrombine time, which occurs 12 - 48 hours after ingestion. Clinical symptoms of liver damage are normally noticeable after 2 days and reach a maximum after 4 - 6 days. Acute kidney failure with acute tubular necrosis can also develop in the absence of severe liver damage. Other non-hepatic symptoms such as myocardial abnormalities, pancitopenia and pancreatititis have also been reported to be checked after a paracetamol overdose. Therapy Joscine N-butylbromide If required, parasimpaticomimetic drugs must be administered. In cases of glaucoma an ophthalmological visit must be made urgently. Cardiovascular complications must be treated according to the usual therapeutic principles. In case of respiratory paralysis, intubation and artificial breathing should be considered. For urinary retention cateterization may be necessary. In addition, appropriate support measures should be used as needed. Paracetamol Where paracetamol intoxication is suspected, the intravenous administration of SH group donors such as N-acetylcysteine within the first 10 hours of ingestion is indicated. Although N-acetylcysteine is more effective if administered within this period, it can still offer some degrees of protection if administered 48 hours after ingestion; in this case, it should be taken longer. The plasma concentration of the paracetamol can be lowered with dialysis. Quantitative analysis of the plasma concentration of paracetamol is recommended. Further measures will depend on the severity, nature and course of clinical symptoms of paracetamol intoxication and must follow standard protocols of intensive care.

Pregnancy

There is no adequate data on the use of Buscopan Compositum during pregnancy. The long experience with the two substances in monotherapy indicated insufficient evidence of adverse effects during pregnancy in the woman. After the use of the N-butylbromide of joscina, pre-clinical studies in rats and rabbits showed no embryotoxic or teratogenic effects. During pregnancy potential data on the overdose of the paracetamol did not show increased risk of malformations. Reproduction studies to investigate oral use did not show signs that suggest fetotoxicity malformations. Epidemiological studies on neurological development in children exposed to paracetamol in uterus show non-conclusive results. If clinically necessary, under normal conditions of use, paracetamol can be taken during pregnancy after careful examination of the risk-benefit ratio. During pregnancy, paracetamol should not be taken for prolonged periods, at high doses, or in combination with other medicines since safety has not been confirmed in such cases. Therefore, Buscopan Compositum is not recommended during pregnancy.

Food

The safety of the N-butylbromide during breastfeeding has not yet been established. Paracetamol is excreted in breast milk. However, it is predictable that in therapeutic doses it does not determine unwanted effects in the newborn. The decision to continue or suspend breastfeeding or to continue or suspend treatment with Buscopan Compositum must be taken considering the benefits of breastfeeding for the child and the benefits of the treatment with Buscopan Compositum for the mother.

Fertility

No studies on the effects on fertility in humans have been conducted (see section 5.3).

Source: Farmadati