Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

TRAMADOL HYDROCHLORIDE 50MG ORODISPERSIBLE TABLETS

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Tramadol Hydrochloride 50 mg orodispersible tablets.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of tramadol hydrochloride. Also contains 20mg aspartame. For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Orodispersible tablets.

4.
4.1.

CLINICAL PARTICULARS
Therapeutic indications
Treatment of moderate to severe pain.

4.2

Posology and method of administration
As with all analgesic drugs, the dose of Tramadol Hydrochloride 50mg orodispersible tablets should be adjusted according to the severity of the pain and the clinical response of the individual patient. Adults and children aged 12 years and over Oral administration: Acute pain: An initial dose of 100 mg is usually necessary. This can be followed by doses of 50 or 100 mg not more frequently than 4 hourly, and duration of therapy should be matched to

clinical need.

Pain associated with chronic conditions: Use an initial dose of 50 mg and then titrate dose according to pain severity. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported (see section 4.4 Special warnings and special precautions for use). A total daily dose of 400 mg should not be exceeded except in special clinical circumstances. Elderly: The usual dosages may be used although it should be noted that in volunteers aged over 75 years the elimination half-life of tramadol was increased by 17% following oral administration. Renal impairment/renal dialysis: The elimination of tramadol may be prolonged. The usual initial dosage should be used. For patients with creatinine clearance < 30 ml/min, the dosage interval should be increased to 12 hours. Tramadol is not recommended for patients with severe renal impairment (creatinine clearance < 10 ml/min). As tramadol is only removed very slowly by haemodialysis or haemofiltration, postdialysis administration to maintain analgesia is not usually necessary. Hepatic impairment: The elimination of tramadol may be prolonged. The usual initial dosage should be used but in severe hepatic impairment the dosage interval should be increased to 12 hours. Children under 12 years: Not recommended. The tablet disperses rapidly in the mouth and is then swallowed. Alternatively, the tablet can be dispersed in half a glass of water, stirred and drunk immediately independently of meals.

4.3.

Contraindications
Tramadol Hydrochloride 50 mg orodispersible tablets should not be administered to patients who have previously demonstrated hypersensitivity to it or in cases of acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or

psychotropic drugs. In common with other opioid analgesics it should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal. Tramadol must not be administered during breastfeeding if long term treatment, i.e. more than 2 to 3 days, is necessary (section 4.6). Tramadol Hydrochloride 50 mg orodispersible tablets is contraindicated in patients with epilepsy not adequately controlled by treatment and for use in narcotic withdrawal treatment.

4.4.

Special warnings and precautions for use
Warnings: At therapeutic doses, Tramadol Hydrochloride 50 mg orodispersible tablets has the potential to cause withdrawal symptoms. Rarely cases of dependence and abuse have been reported. At therapeutic doses withdrawal symptoms have been reported at a reporting frequency of 1 in 8,000. Reports of dependence and abuse have been less frequent. Because of this potential the clinical need for continued analgesic treatment should be reviewed regularly. In patients with a tendency to drug abuse or dependence, treatment should be for short periods and under strict medical supervision. Tramadol Hydrochloride 50 mg orodispersible tablets is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, it cannot suppress morphine withdrawal symptoms. Precautions: Tramadol Hydrochloride 50 mg orodispersible tablets should be used with caution in patients with head injury, increased intracranial pressure, severe impairment of hepatic and renal function and in patients prone to convulsive disorders or in shock. Convulsions have been reported at therapeutic doses and the risk may be increased at doses exceeding the usual upper daily dose limit. Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling reasons. The risk of convulsions may increase in patients taking tramadol and concomitant medication that can lower the seizure threshold (see section 4.5 Interaction with other medicinal products and other forms of interaction). Care should be taken when treating patients with respiratory depression, or if concomitant CNS depressant drugs are being administered, as the possibility of respiratory depression cannot be excluded in these situations. At therapeutic doses respiratory depression has infrequently been reported. In one study using a nitrous oxide/opioid (tramadol) anaesthetic technique (with only intermittent administration of enflurane as required), tramadol was reported to enhance intra-operative recall. Hence its use during potentially very light planes of general anaesthesia should be avoided.

Two recent studies of tramadol administration during anaesthesia comprising continuous administration of isoflurane did not show clinically significant lightening of anaesthetic depth or intra-operative recall. Therefore providing the current practice of administering continuous, potent (volatile or intravenous) anaesthetic agents is followed, Ethypharm Tramadol may be used intra-operatively in the same way as other analgesic agents are routinely used. The ingredient aspartame contains a source of phenylalanine which may be harmful to people with phenylketonuria.

4.5

Interaction with other medicinal products and other forms of interaction
Concomitant administration of Tramadol Hydrochloride 50mg orodispersible tablets with other centrally acting drugs, including alcohol, may potentiate CNS depressant effects. Simultaneous administration with cimetidine is associated with clinically insignificant changes in serum concentrations of tramadol. Therefore no alteration of the Tramadol Hydrochloride 50mg orodispersible tablets regimen is recommended for patients receiving chronic cimetidine therapy. Simultaneous administration of carbamazepine markedly decreases serum concentrations of tramadol to an extent that a decrease in analgesic effectiveness and a shorter duration of action may occur. Tramadol may increase the potential for both selective serotonin reuptake inhibitors (SSRIs) and tricyclic antidepressants (TCAs) to cause convulsions (see sections 4.4 Special warnings and special precautions for use and 5.2 Pharmacokinetic properties). There is a theoretical possibility that tramadol could interact with lithium. There have been no reports of this potential interaction. The analgesic effect of tramadol is in part mediated by inhibition of the re-uptake of norepinephrine and enhancement of the release of serotonin (5-HT). In studies the pre- or postoperative application of the antiemetic 5-HT3 antagonist ondansetron increased the requirements of tramadol in patients with postoperative pain.

4.6.

Pregnancy and lactation
Pregnancy: In humans, there are no sufficient data to assess malformative effect of tramadol when given during the first trimester of pregnancy. Animal studies have not shown any

teratogenic effects, but at high doses, foetotoxicity due to maternotoxicity appeared (See 5.3 Preclinical data). Tramadol crosses the placenta, therefore as with other opioid analgesics, chronic use of tramadol during the third trimester may induce a withdrawal syndrome in newborn. At the end of pregnancy, high dosages, even for short term treatment, may induce respiratory depression in new-born. There is inadequate evidence available on the safety of tramadol in human pregnancy, therefore Tramadol Hydrochloride 50 mg orodispersible tablets should not be used in pregnant woman. Lactation: Tramadol and its metabolites are found in small amounts in human breast milk. An infant could ingest 0.1 % of the dose given to the mother. Tramadol Hydrochloride 50 mg orodispersible tablets should not be administered during breast feeding.

4.7

Effects on ability to drive and use machines
Tramadol Hydrochloride 50mg orodispersible tablets may cause drowsiness and this effect may be potentiated by alcohol and other CNS depressants. Ambulant patients should be warned not to drive or operate machinery if affected.

4.8

Undesirable effects
Gastrointestinal system: Nausea, vomiting and occasionally dry mouth. Both diarrhoea and constipation have been reported. In controlled trials the incidence of constipation is lower than that of comparator agents.

Central nervous system and psychiatric: Tiredness, fatigue, drowsiness, somnolence, dizziness, headache, confusion, hallucinations and infrequently respiratory depression. Dependence, dysphoria and convulsions have been reported rarely (see section 4.5 Interactions). Physical dependence: Dependence, abuse and withdrawal reactions have been reported. Typical opiate withdrawal reactions include agitation, anxiety, nervousness, insomnia, hyperkinesia,

tremor and gastrointestinal symptoms (see sections 4.4 Special warnings and special precatuions for use and 4.2 Posology and method of administration).

Allergic/anaphylactoid reaction: Dyspnoca, wheezing, broncho spasm and worsening of existing asthma. Other adverse events: Diaphoresis, urticaria and pruritus have been reported. Skin rashes, tachycardia, orthostatic hypotension, increase in blood pressure, bradycardia, flushing, syncope and anaphylaxis have been rarely reported. Cases of blood dyscrasias have been rarely observed during treatment with tramadol, but causality has not been established.

4.9

Overdose
Symptoms of overdosage are typical of other opioid analgesics, and include miosis, vomiting, cardiovascular collapse, sedation and coma, seizures and respiratory depression. Supportive measures such as maintaining the patency of the airway and maintaining cardiovascular function should be instituted ; naloxone should be used to reverse respiratory depression; fits can be controlled with diazepam. Tramadol is minimally eliminated from the serum by haemodialysis or haemofiltration. Therefore treatment of acute intoxication with Tramadol Hydrochloride 50mg orodispersible tablets with haemodialysis or haemofiltration alone is not suitable for detoxification.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Tramadol Hydrochloride 50mg orodispersible tablets is a centrally acting analgesic. It is a non selective pure agonist at mu, delta and kappa opioid receptors with a higher affinity for the mu receptor. Other mechanisms which may contribute to its analgesic

effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release.

5.2

Pharmacokinetic properties
The half-life of the terminal elimination phase (t c) was 6.0 1.5 hours in young volunteers. Tramadol pharmacokinetics show little age dependence in volunteeers up to the age of 75 years. In volunteers aged over 75 years, t c was 7.0 1.6 hours on oral administration. Since tramadol is eliminated both metabolically and renally, the terminal half-life t c may be prolonged in impaired hepatic or renal function. However, the increase in the t c values is relatively low if at least one of these organs is functioning normally. In patients with liver cirrhosis t c tramadol was a mean of 13.3 4.9 hours; in patients with renal insufficiency (creatinine clearance 5 ml/min) it was 11.0 3.2 hours.

5.3.

Preclinical safety data
In single and repeat-dose toxicity studies (rodents and dogs) exposure to tramadol 10 times that expected in man is required before toxicity (hepatotoxicity) is observed. Symptoms of toxicity are typical of opioids and include restlessness, ataxia, vomiting, tremor, dyspnoea and convulsions. Exposure to tramadol (> that expected in man), in lifetime toxicity studies in rodents did not reveal any evidence of carcinogenic hazard, and a battery of in-vitro and invivo mutagenicity tests were negative. No teratogenic effects have been observed in animal tests (rat and rabbit: the dosage of Tramadol given has been up to seven times higher than the dosage given to humans). Minimal embryo toxic effects (delayed ossification) were observed in the tests. No effect was observed on the fertility or the development of the offspring in the tests.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients
ethylcellulose N7, copovidone, colloidal hydrated silica, mannitol (E421),

crospovidone, aspartame (E951), mint rootbeer flavouring, magnesium stearate.

6.2

Incompatibilities
None known.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Store in the original package

6.5

Nature and contents of container
Polyamide/aluminium/poly(vinylchloride) and aluminium blister packs Boxes of 10, 20, 28, 30, 40, 50, 56, 60 and 100 tablets. Not all pack sizes may be marketed

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER

Pharmaceutical Works POLPHARMA S.A. 19, Pelpli ska Str., 83-200 Starogard Gda ski, Poland

8

MARKETING AUTHORISATION NUMBER(S)
PL 25124/0001

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/12/2007

10

DATE OF REVISION OF THE TEXT
13/09/2011

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide