Busconil® plus
Anti-Cramping ... Pain reliever
  • Hyoscin-N-Butylbromide is a semisynthetic derivative of scopolamine, and has an antimuscarinic effect where it has peripheral anticholinergic and para-sympatholytic actions having a ganglion-blackade effect on the visceral smooth muscle, and inhibiting the muscarinic effect of acetylcholine.
  • Due to these basic characteristics, it has a specific anti-spasmolytic effect on the smooth muscle of gallbladder tract, urogential system organs and gastrointestinal tract.
  • The analgesic effect of paracetamol increases the analgesic effect resulting from the spasmolytic effect, combining the spasmolytic and analgesic effect. This combined efficacy is valuable in the treatment of paroxymal pain in smooth muscle.
  • After oral administration, Hyoscin-N-Butylbromide is absorbed 8 to 10%. Although it has a very short half life, it reaches to high tissue concentrations particulry in liver, kidney and gastrointestinal tract tissues due to its high affinity.
  • Nearly half of the amount absorbed after oral administration (8 - 10%) is metabolized in the liver. Following oral administration, 0.7 to 2% is execreted in urine .
  • Hyoscin-N-Butylbromide is quaternary ammonium compound and has a low lipid solubility. It is entirely ionized under normal pH levels in the body liquids. Thus it penetrates less from the cell barrier, and it has a limited passage to the blood  brain barrier and intraocular liquids.
  • Paracetamol is rapidly absorbed through gastrointestinal tract and it diffuses equally to the tissues. It first transforms into glucuronide through conjugation, and subsequently metabolized in liver, which in turn in-activate paractamol.
  • The elimination half-life of paracetamol is approximately 2 - 4 hours, which is longer in children. It is principally excreted by the kidney.  

Each film coated tablet of Busconil® Plus contains: 

  • Hyoscin-N-Butylbromide             10   mg
  • Paracetamol                         500 mg

Busconil® Plus is used in the following conditions:

  • Gastrointestinal spasm, stomach or duodenum ulcers, colonic spasm, irritable bowel and colitis.
  • Pains of gallblabber spasm and gallstones. 
  • Urethra sphincter spasms, urolithiasis, spasms during cystoscopy, cystourethroscopy, and pyleography.
  • Dysmenorrhea, uterus spasm, and soft tissue spasm during delivery.
  • It is contraindicated in patients with a history of allergic reaction to anticholinergic drug or its active agents (Hyoscin-N-Butylbromide and paracetamol) and to any component. It is  contraindicated in patients with myasthenia gravis, megacolon, glaucoma or obstructive prostatic hypertrophy.
  • Concurrent use of  Busconil® Plus in safety dose with drugs such as glutetimide, phenobarbitol, phenytion, carbamazepine, or rifampicin  including the microsomal enzymes in the liver may result in damage to the liver.
  • During concurrent use with drugs delaying gastric emptying time, absorption of paracetamol slows down, and thus its onset is delayed.While agents like metoclopramide increase the absorption by speeding up the gastric flow.
  • Concurrent use of Busconil® Plus with chloramphenicol may be associated with the increase in the half- life of paracetamol and probably give rise to the increase in toxicity.
  • Busconil® Plus should be administrated 1 hour after or befor antacids or anti-diureic drugs. Also concurrent use with antiparkinsonism drugs, anticholinergic, imipramine type antidepressants, phenothiazine type neuroleptics, H1 type antihistaminics and disopramides increase efficacy of the anticholinergic (Hyoscin-N-Butylbromide).   
  • There is no clinical safety evidence for use during pregnancy: In case of absolute indication, both probable damage on the fetus and probable benefits of drug use should be carefully taken into consideration.
  • No sufficient data is available about the safety of anticholinergic drugs during lactation. Therefore, it is not recommended for use.
  • On other hand, paracetamol excreted in the breast milk without any negative effect in therapeutic dose.  
  • Skin rash occurs infrequently during treatment with Busconil® Plus. Very rarely allergic reactions in the form of exanthema or allergic thrombocytopenia or leucopoenia are observed.
  • Bronchospasm  may occur in asthma stimulation by analgesics.
  • There is a risk of hepatotoxicity due to paracetamol effect when Busconil® Plus is administrated in excessive doses.
  • Tachycardia, xerostomia (dry mouth), diarrhea, nausea, skin reactions (e.g. urticaria, rash, erythema, pruritus), and other hypersensitivity, angioedema, dyspnea, urinary retention, hypohidrosis, heat sensation /transpiration.
  • In case of an unexpected side effect, consult your physician.

Overdosage :

  • Symptoms: symptoms of  acute overdosing with Hyoscin -N- Butylbromide are not reported.
  • The toxicity associated  with paracetamol, the other active agent of  Busconil® Plus (approximately more than 20 tablets) may result in circulatory collapse, acute renal insufficiency, and jaundice or hepatic coma.
  • High dose of paracetamol increase the risk of hepatic necrosis. If any nausea, vomiting, loss of appetite or gastric pain occurs after oral administration of Busconil® Plus, it should be immediately discontinued and consulted with a physician. It should be kept in mind that symptoms of  intoxication may appear a few days after the first signs.        

Treatment: in case of overdosing:

  • active coal should be administrated following the vomitive procedure or gastric lavage, and subsequently a supportive and symptomatic therapy should be initiated. Oral administration of L-methionine, also decrease the risk of damage to the liver. If the blood paracetamol levels are over 120ng/ml of 4 hours after the administration of the drug, it is better  to transfer the patient to a medical center expertised in parecetamol toxicity. In the meantime, in  order to dispose of the anticholinergic effect associated with Hyoscin -N-Butylbromide, physostigmine 1 - 3 mg or repeated dose of neostigmine sulphate 0.5- 2mg should be administered. 

-If the physician does not offer another therapeutic protocol:

  • Recommended dose in adults is 1- 2 tablets 3 times daily.
  • Tablet should not be chewed, and should be taken with plenty of water with or without food.  
  • Daily dose should not exceed 6 tablets.
  • It should not be given to children less than 10 years of age.

-The use of Busconil® Plus in long periods without any medical control should be avoided. 

  • Due to presence of  Hyoscin-N-Butylbromide, Busconil® Plus should be carefully used only under the supervision of a physician in the  events of prostate hypertrophy, liver or kidney failure, coronary insufficiency or various arrhythmic conditions, hyperthyroidism, conditions where viscosity of the bronchial secretion increase, paralytic ileus, and atonic ileus due to aging.
  • Under following conditions, Busconil® Plus should be administrated
  • under medical supervision or the dose should  be decreased;
    *Failure in liver functions due to chronic alcohol intake or history of hepatitis, liver failure.
    *Geriatric patient: they may exhibit reactions such as agitation or drowsiness even to the smallest doses of anticholinergic drugs.
  • Operating machinery or driving a motor vehicle is not recommended in patients undergoing treatment with anticholinergic drugs, since those drugs can rarely lead to drowsiness, dizziness, and blurry vision.
  • Administration with alcohol should be avoided.
  • Busconil® Plus tablets: Blister of 10 tablet, pack of two blisters.
  • Store in a dry place at a temperature below 25ºC. Protect from light.