Method of administration

Oral use

Tablets must be swallowed whole, with a sufficient quantity of liquid. They must not be broken or chewed.

4.3 Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1,

- acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs,

- Tramadol hydrochloride/Paracetamol should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal (see 4.5. Interactions with other medicinal products and other forms of interaction),

- severe hepatic impairment,

- epilepsy not controlled by treatment (see. 4.4. Special Warnings).

4.4 Special warnings and precautions for use
Warnings:

- In adults and adolescents 12 years and older. The maximum dose of 8 tablets of Tramadol hydrochloride/Paracetamol should not be exceeded. In order to avoid inadvertent overdose, patients should be advised not to exceed the recommended dose and not to use any other paracetamol (including over the counter) or tramadol hydrochloride containing products concurrently without the advice of a physician.

- In severe renal insufficiency (creatinine clearance <10 ml/mm), Tramadol hydrochloride/Paracetamol is not recommended.

- In patients with severe hepatic impairment Tramadol hydrochloride/Paracetamol should not be used ( See Section 4.3). The hazards of paracetamol overdose are greater in patients with non-cirrhotic alcoholic liver disease. In moderate cases prolongation of dosage interval should be carefully considered.

- In severe respiratory insufficiency, Tramadol hydrochloride/Paracetamol is not recommended.

- Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms.

- Convulsions have been reported in tramadol-treated patients susceptible to seizures or taking other medications that lower the seizure threshold, especially selective serotonin re-uptake inhibitors, tricyclic antidepressants, antipsychotics, centrally acting analgesics or local anaesthesia. Epileptic patients controlled by a treatment or patients susceptible to seizures should be treated with this medicine only if there are compelling circumstances. Convulsions have been reported in patients receiving tramadol at the recommended dose levels. The risk may be increased when doses of tramadol exceed the recommended upper dose limit

- Concomitant use of opioid agonists-antagonists (nalbuphine, buprenorphine, pentazocine) is not recommended (see 4.5 Interactions with other medicinal products and other forms of interaction).

Precautions for use

Tolerance and physical and/or psychological dependence may develop, even at therapeutic doses. The clinical need for analgesic treatment should be reviewed regularly (see section 4.2). In opioid-dependent patients and patients with a history of drug abuse or dependence, treatment should only be for short period and under medical s