Excipient with known effect:
Dyestuff tartrazine (E 102) ……………………………………… .0.264 mg

Tradolan Retard 200 mg prolonged-release tablets
Each tablet contains 200 mg tramadol hydrochloride

Excipient with known effect:
Dyestuff tartrazine (E 102) 1 .1,407 mg

For a full list of excipients, see Excipients.

Only in exceptional treatment situations should more than 400 mg of tramadol hydrochloride be administered daily.

It is recommended that the dose be increased gradually to minimize temporary side effects. The dose is appropriate if adequate pain management is achieved without side effects, or with tolerable side effects, throughout the dosing interval.

Unless otherwise appropriate, the dosing instructions for Tradola Retard are:

Adults and adolescents over 12 years of age

The usual starting dose is 100 mg tramadol hydrochloride twice a day, in the morning and in the evening. If the pain does not improve, the dose is increased to 150 mg or 200 mg tramadol hydrochloride twice a day.

Tradola Retard should never be used for longer than is necessary to control pain. If long-term use is required due to the nature and severity of the underlying disease, the need for continued treatment with Tradola Retard should be carefully assessed at regular intervals (eg by discontinuing treatment).

Pediatric patients

Tradola Retard is not for use in children under 12 years of age.

Elderly patients

No dose adjustment is usually required in patients less than 75 years of age with no clinically apparent hepatic or renal impairment. In patients over 75 years of age, elimination may be slowed. Therefore, the dose interval should be extended as needed according to the patient’s needs.

Renal insufficiency / dialysis and hepatic insufficiency

Tramadol elimination is slowed in patients with renal and / or hepatic impairment. In these patients, the dosing interval should be carefully considered according to the patient’s needs. Tradola Retard is not recommended in patients with severe renal and / or hepatic impairment.

Method of administration

Orally.

Tradola Retard prolonged-release tablets should be taken every 12 hours and should be swallowed with plenty of fluids. The prolonged-release tablets should not be chewed. Tramadol can be taken with or without food.

• hypersensitivity to the active substance or to any of the excipients listed in
• patients with acute poisoning by alcohol, hypnotics, analgesics, opioids or psychotropic substances,
• patients who are taking or have taken monoamine oxidase inhibitors (MAOIs) in the last 14 days (see Interactions),
• patients with uncontrolled epilepsy
• drug detoxification.

Tradola Retard should be used with caution in patients with opioid dependence, skull injury, shock, decreased level of consciousness of unknown cause, impaired respiratory center or respiratory function, or increased intracranial pressure.

Tramadol should be used with caution in opioid-sensitive patients.

Caution should be exercised in patients with respiratory and / or respiratory disorders, or concomitant administration of other CNS depressants (see Interactions), or if the recommended dose is significantly exceeded (see Overdose), as the possibility of respiratory depression cannot be ruled out.

Sleep-related breathing problems

Opioids can cause sleep-related respiratory disorders, including central sleep apnea and sleep-related hypoxemia. Opioid use increases the risk of central sleep apnea in a dose-dependent manner. Reduction of the total dose of opioids should be considered in patients with central sleep apnea.

Some patients have already experienced seizures at therapeutic doses. The risk of seizures may be increased when the maximum recommended daily dose (400 mg) is exceeded. In addition, the risk of seizures may be increased in patients taking other medicinal products that lower the seizure threshold concomitantly with tramadol (see Interactions). Patients with epilepsy or a predisposition to epileptic seizures should only be treated with tramadol in cases of urgency.

Tolerance, mental and physical dependence can develop, especially with long-term use. Tradola Retard should only be given to short-term treatment under close supervision in patients who are prone to drug abuse or dependence.

When a patient no longer needs tramadol treatment, it may be advisable to reduce the dose gradually to avoid withdrawal symptoms.

Tradolan Retard is not a substitute for opioid-dependent patients. Although tramadol is an opioid agonist, it does not eliminate the symptoms of morphine withdrawal.