- It is contraindicated in patients with a history of allergic reaction to anticholonergic drug or its active 
 agents(Hyoscin-N-Butylbromide and paracetamol) and to any component. it should not be used in 
 presence of glaucoma, urinary retention due to prostate hypertrophy, mechanPic stenosis of the 
 gastrointestinal system, megacolon, myasthenia gravis and tachycardia

- Concurrent use of  Dwaspasm®-plus in safety  dose with drugs such as glutetimide, phenobarbitol, 
 phenytion, carbamazpine, 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  Dwaspasm®-plus with chloramphenicol  may be associated  with the increase  in 
 the half- life of paracetamol  and probably give  rise to the increase  in toxicity. 
- Dwaspasm®-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 )              
 

Pregnancy category. 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  Dwaspasm®-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  Dwaspasm®-plus  is 
   administrated  in excessive doses.

- Urinary retention, constipation due to slowness in the intestinal motility, and seldom dizziness and 
 are mild  and transient staggering observed in some  patients.
-Rarely  symptoms of atropinism are observed.  
-Other side effect specific  to anticholinergics: dry mouth, difficulty in  gulping, fatigueness, dilatation 
 of pupils, accommodation dysfunction, decrease in lacrimal secretion, photophobia, dry skin, and 
 rash, tachycardia following temporary   bradycardia, palpitation and arrhythmia.
- in case of an  unexpected side effect, consult  your physician.                              

 Over dosage :
-Symptoms: symptoms of  acute overdosing with  Hyoscin-N-Butylbromide are not  reported.
- The toxicity associated  with paracetamol, the other active agent  of  Dwaspasm®-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   Dwaspasm®-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 
 ,physo-stigmine 1 - 3 mg or repeated dose of neostigmine sulphate 0.5- 2mg should be 
 administered. 
 

- Due to presence of  Hyoscin-N-Butylbromide.  
- Dwaspasm®-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 condition,  Dwaspasm®-plus should be administrated under medical supervision or 
 the dose should  be decrease;
-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..

  Dwaspasm® -plus Tablets:
- Blister of 10 tablet  Pack of two  Blisters.
- hospital pack with different size.
 

 Store in a dry place at a temperature below  30oC.  Protect from  light