As for all pain medications, the dosage of tramadol should be adapted to the intensity of the pain and to the clinical response of each patient

Acute pain

The dose is 100 mg (2 tablets) followed by 50 or 100 mg (1 or 2 tablets) every 4-6 hours without exceeding 400 mg / 24 h (8 tablets). Br>

Chronic pain

The dose of attack is 50 or 100 mg (1 or 2 tablets) followed by 50 or 100 mg (1 or 2 tablets) every 4-6 hours without exceeding 400 mg / 24 h (8 tablets).

· From 75 years old, it is recommended to increase the interval between catches (all, 9 hours).

· In case of liver failure: reduce the unit dose by half, or increase the interval between catches by 2 times (every 12 hours).
· In case of renal insufficiency: increase the interval between catches by 2 times (every 12 hours for creatinine clearance

Avoid using tramadol if creatinine clearance is
Like other products of this class, tramadol has anti-cough properties. The effects on the gastrointestinal tract are low at therapeutic doses. The respiratory depressant effects of tramadol are lower than those of morphine. The studies carried out in animals have shown a potential of dependence, reduced compared to that of morphine, and a very low tolerance potential

The possible alteration of vigilance may render the driving of vehicles dangerous, and the use of machinery, especially in the case of concomitant absorption of alcoholic beverages or nervous system depressant medicines. >

· Known hypersensitivity to tramadol or opiates.

· Acute poisoning or overdose with systemic depressant products, central nervous system (alcohol, hypnotics, other analgesics ...)

· Concurrent or recent (stoppage of less than 15 days) treatment by MAOIs

· Severe respiratory insufficiency

· Severe hepatocellular insufficiency

· Child under the age of 15.

· Breast-feeding, if long-term treatment is required (see section Pregnancy and breast-feeding).
· No treatment-controlled epilepsy (see Warnings and Precautions for Use).

· Combination with buprenorphine, nalbuphine and pentazocine (see section Interactions with other medicinal products and other forms of interaction).
· Due to the presence of aspartam, this drug is contraindicated in case of phenylketonuria.

THIS MEDICINE MUST NOT BE GENERALLY USED

· During pregnancy

· In combination with carbamazepine.

Special warnings

Prolonged use over several months may eventually lead to a state of dependence. In patients with predisposed conditions, treatment should be carried out under strict medical supervision.








Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.

Precautions for use

Tramadol should only be used after careful evaluation of the benefit / risk ratio, depending on the origin of the pain and the patient's profile (see section Preclinical safety data).
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Tramadol should be used with caution in patients with intracranial hypertension, cranial trauma, impaired consciousness without obvious cause, central or respiratory function disorders
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This medicinal product contains 214 mg sodium per dosage unit: take this into account in people on a strictly sodium-containing diet.
This medicinal product contains lactose and aspartame

Associations, contraindicated

+ Non-selective MAOIs (iproniazide)

Risk of onset of a syndrome: serotonergic: diarrhea, tachycardia, sweating, tremors, confusion or even coma.
Treatment with tramadol should be completed within 15 days prior to initiation of treatment with .


By extrapolation from non-selective MAOIs

Risk of onset of a syndrome: serotonergic: diarrhea, tachycardia, sweating, tremors, confusion or even coma.
+ Selective BAIs B, selegiline

Signs of central excitation, suggestive of serotonergic syndrome, diarrhea, tachycardia, sweating, trembling, confusion or even coma.
+ Linézolid

By extrapolation from non-selective MAOIs

Risk of onset of a syndrome: serotonergic: diarrhea, tachycardia, sweating, tremors, confusion or even coma.
Associations, deprecated

+ Morphine-agonist-antagonists (buprenorphine, nalbuphine, pentazocine)

Decreased analgesic effect by competitive blocking of receptors with risk of developing withdrawal syndrome

+ Alcohol

Alcohol enhancement of the sedative effect of morphine analgesics

The alteration of alertness may make dangerous the driving of vehicles and the use of machinery.

Avoid drinking alcoholic beverages and medicines containing alcohol

+ Carbamazepine

Risk of decrease in plasma concentrations of tramadol

+ Naltrexone

Risk of decreased effect, analgesic. If necessary, increase the doses of the morphine derivative.
Associations to be taken into account

+ Other analgesics, opioid agonists, morphine-like cough; (dextromethorphan, noscapine, pholcodine), antitussives; true opioids (codeine, ethylmorphine)

Increased risk of depression, respiratory may be fatal in case of overdose

+ Benzodiazepines

Increased risk of depression, respiratory may be fatal in case of overdose

+ Barbiturates

Increased risk of depression, respiratory may be fatal in case of overdose

Other medicinal products; sedatives: other opioid analgesics, barbiturates, benzodiazepines, antidepressants, sedatives (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), antihistamines H1; sedatives, anxiolytics other than benzodiazepines (meprobamate), hypnotics, neuroleptics, central antihypertensives , Thalidomide, baclofen

Increased depression, central. The alteration of alertness can make dangerous the driving of vehicles and the use of machines.

+ Selective inhibitors, serotonin reuptake (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)

Risk of onset of seizures and / or serotonergic syndrome

+ Venlafaxine

Risk of onset of seizures and / or serotonergic syndrome

Medicinal products lowering the threshold seizure, including antidepressants (tricyclics, selective reuptake inhibitors, serotonin), neuroleptics (phenothiazines, butyrophenone), mefloquine, bupropion


Increased risk of seizures

Not applicable.

Signs of overdose include: myosis, vomiting, cardiovascular collapse, depression, respiratory failure, stopping, respiratory, coma and convulsions

The first therapeutic gestures will be the maintenance of respiratory and cardiovascular functions and emergency transfer in hospitals

Naloxone may be used in case of respiratory depression under cover of respiratory function control

Diazepam can be used in case of convulsions

The tramadol is little or no hemodialysable.

Pregnancy

· In humans, there is not enough data to assess the teratogenic effect of tramadol during the first trimester of pregnancy. Fetotoxicity due to maternal toxicity was observed.

· It is preferable not to use BIODALGIC 50 mg effervescent tablets during the first trimester of pregnancy. As from the second quarter, prudent use is punctually possible.
As for other analgesics, opiates

· During the last trimester, chronic use of tramadol may induce withdrawal syndrome in newborns, regardless of dosage. At the end of pregnancy, high doses, even for short-term treatment, may result in respiratory depression in the newborn.

Breastfeeding

Approximately 0.1% of the dose of tramadol administered to the mother is secreted into the milk. Tramadol administration appears to be safe for the newborn and if treatment is required for several days, breast-feeding should be discontinued. In the case of long-term treatment with tramadol, breast-feeding is contraindicated (see section Contraindications).
It is to note cases of

· Neuropsychic disorders (in function of individual reactivity and, mainly in the elderly) type, confusion and exceptionally hallucinatory type and / or delirium

· Seizures mainly; after high doses or, after concomitant treatment with drugs, which can lower the seizure threshold or who, themselves trigger seizures (see Warnings and; precautions) .

The most frequently encountered undesirable effects are those of the class of opiates such as

· Nausea, vomiting

Headache, dizziness, hypersudation, feeling uncomfortable

· Dry mouth

· Constipation in case of taking, prolonged.

More rarely have been reported

· Abdominal pain, rash, asthenia, euphoria, minor vision disorders

· Disorders of cardiovascular regulation: tachycardia, hypotension, palpitations, elevated pressure, arterial pressure

Very rarely have been reported

· Anaphylactic reaction, urticaria, angioedema, bronchospasm as well as exceptional cases of shock, anaphylactic can be fatal

· Micturition disorders with type of dysuria and / or urinary retention

· Disorders of the respiratory rate. Respiratory depression may occur if administered doses exceed the recommended doses or if other centrally administered depressants are administered concomitantly


· Other withdrawal symptoms have been rarely reported, including panic attack, severe anxiety, hallucinations, paresthesias, tinnitus, other CNS disorders
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In some isolated cases, an increase in liver enzymes has been reported in the treatment of tramadol.


The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the ratio, benefit / risk of the drug. Health professionals report any suspected adverse effects via the national reporting system: National Agency for Safety, Medicines and Health Products (ANSM) and Network of Regional Centers for Pharmacovigilance - Website: www.ansm .sante.fr.