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DOLLAS 100

Box / 3 blisters / 10 tablets
$6.00

COMPOSITION
   - 100 mg Tramadol

INDICATIONS
   Treatment of moderate to severe pain.

CONTRAINDICATIONS
   • Known hypersensitivity to tramadol or any of the excipients .
   • Acute poisoning by alcohol , hypnotics, analgesics, or psychotropic opoïdes .
   • Patients treated concurrently or who have been treated in the preceding 14 days by MAO inhibitors .
   • Treatment of weaning addicts
   • Pregnancy and lactation

DRUG INTERACTIONS
   • Do not combine Dollas to MAO inhibitors , mixed agonists antagonists (eg buprenorphine, nalbuphine , pentazocine ) , tricyclic  
   antidepressants, antipsychotics, such as serotonin selective reuptake inhibitors of serotonin , coumarins
(warfarin) and others known
   to inhibit CYP3A4 , such as ketoconazole and erythromycin medications.
   • Concomitant administration of Dollas with other central depressants, including alcohol .
   • Concomitant or prior cimetidine and carbamazepine.

WARNINGS AND PRECAUTIONS
   • Dollas should be used with particular caution in opioid dependent patients and in patients with head injury , shock , altered  
   consciousness without obvious cause disorders center or respiratory function , or an increase in
intracranial pressure.
   • In patients sensitive to opioids , the product should only be used with caution.
   • Convulsions have been reported in patients receiving Dollas at recommended doses. The increased risk of seizures if doses Dollas
   exceed the upper limit of the recommended daily intake ( 400mg) .
   May cause: The adverse events most frequently reported are nausea and dizziness,
   • Disorders of the cardiovascular system :
   - Few cases (< 1%): palpitations , tachycardia, orthostatic hypotension or arterial cardiovascular collapse.
   - Very rare cases (< 0.1%): bradycardia, increase in blood pressure.
   • disorders of the central and peripheral nervous system :
   - Frequently ( > 10%) : dizziness,
   - Occasionally (1-10 %) : headache, confusion.
   - Very rare cases (< 0.1%): changes in appetite paraesthesia , tremor , respiratory depression, epileptiform convulsions .
   • Psychiatric disorders:
   - Very rare cases (< 0.1%): hallucinations , confusion, sleep disturbances and nightmares.
   • Visual disturbances :
   - Very rare cases (< 0.1%): blurred vision
   • disorder of the respiratory system : The worsening of asthma has also been reported , although a causal relationship has not  
   been established.
   • Gastrointestinal disorders :
   - Frequently ( > 10%) : nausea.
   - Occasionally (1-10 %) : vomiting, constipation, dry mouth .
   - Few cases (< 1%): tops heart , gastrointestinal irritation (a feeling of gastric heaviness , fatulence ) .
   • Skin disorders and appendices :
   - Occasionally (1-10 %) : sweating .
   - Few cases (< 10%): skin reactions ( pruritus, rash , urticaria) .
   • Disorders of the neuromuscular system :
   Very rare ( <0.10 %) : muscle weakness.
   • Disorders of the hepatobiliary system :
   In some isolated cases, an increase in liver enzymes has been reported in the therapeutic use of Dollas .
   • Urinary System Disorders :
   - Very rare cases (< 0.1%): micturition disorders (dysuria and urinary retention) .
  Whole body :
   - Very rare cases (< 0.1%): allergic reactions.

DOSAGE
   Adults and adolescents older than 12 years:
   The usual starting dose is 100mg twice a day , morning and evening. If the level is inadequate analgesia , the dose may be  
   increased to 150mg or 200mg twice per day.
   The lowest effective analgesic dose should generally be chosen. A daily dose of 400mg of the active ingredient should not be   
   exceeded except in special clinical situations .
   children:
   Dollas is not appropriate to treat children under 12 years.
   Elderly patients ( up to age 75 )
   Removal of product may be delayed . Therefore the dosage range will be extended , if necessary , depending on the patient every 
   needs .
   Renal and hepatic impairment : Dollas is not recommended in patients with impaired renal and / or hepatic impairment . In 
   moderate renal and hepatic insufficiency, should discuss a longer dosing interval carefully .
   Tablets do not need to be fractionated should be chewed and taken over with a sufficient amount of beverage , without regard to  
   meals .


Store below 30 degree C


Registration no.: CAM 08L-562