BUSCOPAN COMPOSITUM® is a drug based on hyoscine N-butylbromide and paracetamol.
THERAPEUTIC GROUP: Antispasmodics in association with analgesics.
Indications BUSCOPAN Compositum ®
BUSCOPAN COMPOSITUM® is indicated in the treatment of dysmenorrhea and spastic and paroxysmal pains due to diseases of the gastrointestinal or genitourinary tract.
BUSCOPAN Compositum ® action mechanism
BUSCOPAN COMPOSITUM® owes its therapeutic action to two different active ingredients, capable of acting synergistically, significantly reducing painful symptoms.
- Hyoscine N-butylbromide: partially absorbed by the small intestine after oral (8%) or rectal (3%) administration, it is mainly concentrated in the gastrointestinal, genitourinary and hepatobiliary tract, where - thanks to its anticholinergic action - allows a relaxation of the smooth muscles with a spasmolytic effect.
At the end of its therapeutic effect, about 50% is excreted in the kidney.
- Paracetamol: taken orally it is absorbed in the intestine, reaching a plasma peak after 30 - 120 minutes, with a bioavailability that is still 65%, despite the first pass metabolism.In an equally rapid and homogeneous way, the paracetamol is distributed to the various tissues, where it is able to produce an analgesic, antipyretic and slightly anti-inflammatory action. Metabolized mainly in the liver, it is subsequently excreted via the urine.
Studies show that the simultaneous administration of hyoscine N-butylbromide and paracetamol does not disturb the absorption profile and bioavailability of the compounds taken individually.
Studies carried out and clinical efficacy
THEnt J Clin Pharmacol Res. 2001;21:21-9.
Antispasmodic / analgesic associations in primary dysmenorrhea double-blind crossover placebo-controlled clinical trial.
de los Santos AR, Zmijanovich R, Pérez Macri S, Martí ML, By Girolamo G.
The combination of paracetamol and hyoscine N-butylbromide has been used successfully in the treatment of recurrent painful symptoms with dysmenorrhea. The study conducted on 125 patients showed a significant reduction in pain from the first day of treatment.
Fortschr Med. 1990 Aug 30; 108: 488-92.
[The treatment of irritable colon. Efficacy and tolerance of buscopan plus, buscopan, paracetamol and placebo in ambulatory patients with irritable colon]
Schäfer E, Ewe K.
A study conducted on 712 patients with irritable bowel syndrome has shown how prolonged treatment for 4 weeks with hyoscine N-butylbromide and paracetamol can guarantee a clear improvement in painful symptoms (in 81% of treated patients). The result was 10 percentage points higher than that recorded following treatment with paracetamol alone or with hyoscine N-butylbromide alone.
J Pak Med Assoc. December 1998; 48: 370-2.
Use of intravenous tenoxicam for the treatment of acute renal colic: comparison with Buscopan compositum.
NS al-Waili, Saloom KY
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 painful symptoms after 1 hour, with a relapse about 24 hours after administration.
Method of use and dosage
BUSCOPAN COMPOSITUM ® 10 mg + 500 mg coated tablets: for adults and children over 14 years of age, 1 - 2 tablets 3 times a day.
BUSCOPAN COMPOSITUM® 10 mg + 800 mg suppositories: 1 suppository 3-4 times a day
The use of BUSCOPAN COMPOSITUM® is not recommended for children under 10 years of age.
BUSCOPAN Compositum ® warnings
The use of anticholinergics, therefore of BUSCOPAN COMPOSITUM ® must be carried out 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 patients of liver and kidney diseases.
Given the hepatic metabolism and the direct renal involvement of BUSCOPAN COMPOSITUM®, a more careful use is suggested, under strict medical supervision, in patients suffering from renal or hepatic insufficiency and Gilbert's syndrome.
Contact your doctor before taking other drugs at the same time as BUSCOPAN COMPOSITUM®
PREGNANCY AND BREASTFEEDING
To understand the potential risks associated with taking BUSCOPAN COMPOSITUM® during pregnancy or breastfeeding, it is necessary to evaluate the effects of the individual active ingredients:
Hyoscine N-butylbromide: animal studies have excluded harmful effects on pregnancy (health of the woman and the fetus); however, it cannot be excluded that the active substance or its metabolites may pass into breast milk. In any case, it is strongly recommended 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 deriving from the use of paracetamol on both mother and baby. It is known, however, that paracetamol is excreted in breast milk, but it is the absence of side effects or unwanted effects in the newborn when the active principle is taken at THERAPEUTIC DOSES has been repeatedly demonstrated.
Despite this, it is advisable to resort to the use of 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 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 close medical supervision;
- Tricyclic antidepressants, accentuating their effect.
- AZT, with enhancement of the leukocyte decrease.
- Dopamine antagonists, reducing the effects of both drugs.
- Beta-adrenergics, enhancing the tachycardic effect.
- Drugs that slow down gastric emptying, with alteration of the pharmacokinetic properties.
It is advisable not to take antacids and alcohol during the treatment, in order to avoid alterations in the metabolism 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 esophagitis, intestinal atony of the elderly and debilitated subjects, Myasthenia gravis and in children under the age of 6 and in the first trimester of pregnancy.
Undesirable Effects - Side Effects
Also in this case, the undesirable effects of BUSCOPAN COMPOSITUM ® can be associated with the side effects of the individual active ingredients:
Hyoscine N-Butylbromide:
therapeutic doses can determine:
dry mouth, changes in sweating, changes in eye tone, difficulty in urination and sleepiness.
Overdoses can also be associated with:
appearance of tachycardia, impaired 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, larynx edema, spasms of the bronchial muscles, anaphylactic shock;
- thrombocytopenia, leukopenia, liver and kidney function deficiency, gastro-intestinal reactions and dizziness.
Overdoses can result:
Poisoning (doses over 10 g of pure ingredient), cardiovascular collapse, renal 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 transient improvement and a drastic worsening around the third, fourth day, characterized by alteration of the functionality hepatic up to hepatic coma.
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