BUSCOPAN COMPOSITUM® is a drug based on N-butyl bromide of joscin and paracetamol.
THERAPEUTIC GROUP: Antispasmodics in association with analgesics.
IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects
Indications BUSCOPAN Compositum ®
BUSCOPAN COMPOSITUM® is indicated for the treatment of dysmenorrhoea and spastic and paroxysmal pains due to diseases of the gastro-intestinal or genitourinary tract.
Mechanism of action BUSCOPAN Compositum ®
The BUSCOPAN COMPOSITUM® owes its therapeutic action to two different active ingredients, able to act synergistically reducing the painful symptoms significantly.
- J-nine N-butyl bromide : partially absorbed by the small intestine after oral (8%) or rectal (3%) administration, it concentrates mainly on the gastro-intestinal, genito-urinary and hepato-biliary tract, where - thanks to its anticholinergic action - allows a smooth muscle relaxation releasing a spasmolytic effect.
After its therapeutic effect, about 50% is excreted at the kidney level.
- Paracetamol : taken orally it is absorbed in the intestine, reaching a plasma peak after 30 - 120 minutes, with a bioavailability that still stands at 65%, despite the first-pass metabolism. In an equally rapid and homogeneous way, paracetamol is distributed to various tissues, where it is able to produce an analgesic, antipyretic and weakly anti-inflammatory action. Mainly metabolised in the liver, it is subsequently excreted via the urine.
Studies show that the simultaneous administration of Joscina N-butyl bromide and Paracetamol does not disturb the absorption profile and the bioavailability of the compounds taken individually.
Studies carried out and clinical efficacy
The combination of paracetamol and hyoscine N-butylbromide, has been successfully used in the treatment of recurrent pain symptoms with dysmenorrhea. The study of 125 patients showed a significant reduction in pain from the first day of treatment.
A study of 712 patients suffering from irritable bowel syndrome showed that a prolonged treatment for 4 weeks with i-brine N-butyl bromide and paracetamol could guarantee a marked improvement in pain symptoms (in 81% of treated patients). The result was 10 percentage points higher than that recorded following treatment with only paracetamol or with only i-brine N-butylbromide.
In this study BUSCOPAN COMPOSITUM® was used in the treatment of acute renal colic in 47 patients. The results show that in 72.7% of cases there was a significant improvement in pain after 1h, with a relapse around 24 h after administration.
Method of use and dosage
BUSCOPAN COMPOSITUM ® 10 mg coated tablets + 500 mg: for adults and children over the age of 14, 1 - 2 tablets 3 times a day.
BUSCOPAN COMPOSITUM® suppositories of 10 mg + 800 mg: 1 suppository for 3-4 times a day
The use of BUSCOPAN COMPOSITUM® is not recommended for children under 10 years of age.
Warnings BUSCOPAN Compositum ®
The use of anticholinergics, therefore of BUSCOPAN COMPOSITUM ® must be carried out with caution in the elderly, in patients with autonomic nervous system disorders, in cardiac tachyarrhythmias, in arterial hypertension, in congestive heart failure, in hyperthyroidism and in carriers. of liver and kidney diseases.
Given the hepatic metabolism and the direct renal involvement of BUSCOPAN COMPOSITUM® it is suggested a more careful use, under strict medical supervision, in patients suffering from renal or hepatic insufficiency and from Gilbert's syndrome.
Contact your doctor before taking other medicines together with BUSCOPAN COMPOSITUM®
PREGNANCY AND BREASTFEEDING
To understand the potential risks associated with taking BUSCOPAN COMPOSITUM® during pregnancy or lactation, it is necessary to evaluate the effects of the individual active ingredients:
Joscina n-butyl bromide: animal studies have excluded harmful effects on pregnancy (health of women and fetus); however, it cannot be excluded that the active ingredient or its metabolites may pass into breast milk. In any case it is strongly suggested to consult your doctor about it and avoid its use in the first trimester of pregnancy .
Paracetamol: clinical studies conducted on pregnant or lactating patients have shown neither side effects nor contraindications derived from the use of paracetamol on both the mother and the child. It is known, however, that paracetamol is excreted in breast milk, but the absence of side or undesirable effects in the newborn has been repeatedly demonstrated when the active ingredient is taken at THERAPEUTIC DOSES.
Despite this, it is advisable to use this drug only in case of real needs and always after having heard the opinion of your doctor. Furthermore, the use of BUSCOPAN COMPOSITUM® during the first trimester of pregnancy is not recommended.
Interactions
The action of the BUSCOPAN COMPOSITUM ® can be altered by:
- Chloramphenicol, able to prolong the half-life of paracetamol and increase its toxicity;
- Anticoagulants, the absence of relevant clinical data always suggests strict medical supervision;
- Tricyclic antidepressants, accentuating their effect.
- AZT, with leukocyte decrease potentiation.
- Dopamine antagonists, reducing the effects of both drugs.
- Beta-adrenergic, enhancing the tachycardia effect.
- Drugs that slow gastric emptying, with alteration of pharmacokinetic properties.
It is recommended not to take antacids and alcohol during the treatment, in order to avoid the metabolism alterations of BUSCOPAN COMPOSITUM®
Contraindications BUSCOPAN Compositum ®
BUSCOPAN COMPOSITUM® is contraindicated in case of hypersensitivity to one of its components or metabolites, acute angle glaucoma, prostatic hypertrophy or other causes of urinary retention, pyloric stenosis and other conditions stenosing the gastrointestinal canal, paralytic ileus, ulcerative colitis, hepatocellular insufficiency, megacolon, reflux oesophagitis, intestinal atony of the elderly and debilitated subjects, myasthenia gravis and in children younger than 6 years and in the first trimester of pregnancy.
Undesirable effects - Side effects
Also in this case the side effects of BUSCOPAN COMPOSITUM ® can be associated with the side effects of the individual active ingredients:
Joscina N-butyl bromide:
therapeutic doses can determine:
dry mouth, alteration of sweating, altered ocular tone, difficulty with urination and drowsiness.
Overdoses can also be associated with:
appearance of tachycardia, alteration of cardiorespiratory function and cognitive abilities.
Skin rashes of various kinds can be associated with hypersensitivity to one of its components.
Paracetamol:
therapeutic doses can determine:
- skin reactions of various kinds and severity (erythema multiforme, Stevens-Johnson syndrome and epidermal necrolysis).
- hypersensitivity reactions such as angioedema, laryngeal edema, spasms of the bronchial musculature, anaphylactic shock;
- thrombocytopenia, leukopenia, liver and kidney function deficiencies, gastro-intestinal reactions and vertigo.
Overdoses can determine:
Poisoning (doses exceeding 10 grams of pure principle), cardiovascular collapse, kidney failure, anemia, cyanosis, tremors, insomnia, memory loss, convulsions and delirium.
Generally the first phase (first day) that characterizes the poisoning is characterized by nausea, sweating, vomiting, drowsiness and asthenia, and is followed by a transitory improvement and a drastic deterioration around the third, fourth day, characterized by alteration of functionality hepatic up to the hepatic coma.
