- 100 mg Tramadol
Treatment of moderate to severe pain.
• 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
• 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
• 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.
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 .
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
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
Store below 30 degree C
Registration no.: CAM 08L-562