The most commonly reported adverse reactions are nausea and dizziness, both occurring in more than 10 % of patients.
The frequencies are defined as follows:
≥1/100 to <1/10
≥1/1000 to <1/100
≥1/10 000 to <1/1000
frequency cannot be estimated from the available data
Immune system disorders
Rare: allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis
Uncommon: cardiovascular regulation (palpitation, tachycardia). These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed.
Rare: increase in blood pressure
Uncommon: cardiovascular regulation (postural hypotension or cardiovascular collapse). These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed.
Nervous system disorders
Very common: dizziness
Common: headache, somnolence
Rare: paraesthesia, tremor, convulsions, muscle contractions involuntary, coordination abnormal, syncope, speech disorders.
Convulsion occurred mainly after administration of high doses of tramadol or after concomitant treatment with medicinal products which can lower the seizure threshold. (see section 4.4 and 4.5).
Metabolism and nutrition disorders
Rare: changes in appetite
Rare: hallucination, confusional state, sleep disturbance, delirium, anxiety and nightmares. Psychic adverse reactions may occur following administration of ZYDOL SR which vary individually in intensity and nature (depending on personality and duration of treatment). These include changes in mood (usually euphoric mood, occasionally dysphoria), changes in activity (usually suppression, occasionally increase) and changes in cognitive and sensorial capacity (e.g. decision behaviour, perception disorders). Drug dependence may occur. Symptoms of drug withdrawal syndrome, similar to those occurring during opiate withdrawal, may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms. Other symptoms that have very rarely been seen with tramadol discontinuation include: panic attacks, severe anxiety, hallucination, paraesthesias, tinnitus and unusual CNS symptoms (i.e. confusional state, delusions, depersonalization, derealization, paranoia).
Rare: miosis, vision blurred, mydriasis
Respiratory, thoracic and mediastinal disorders:
Rare: respiratory depression, dyspnea
If the recommended doses are considerably exceeded and other centrally depressant substances are administered concomitantly (see section 4.5), respiratory depression may occur.
Worsening of asthma has been reported, though a causal relationship has not been established.
Very common: nausea
Common: constipation, dry mouth, vomitting
Uncommon: retching, gastrointestinal discomfort (a feeling of pressure in the stomach, bloating), diarrhoea
Skin and subcutaneous tissue disorders:
Uncommon: dermal reactions (e.g. pruritus, rash, urticaria)
Rare: motorial weakness
In a few isolated cases hepatic liver enzyme increasedhas been reported in a temporal connection with the therapeutic use of tramadol.
Renal and urinary disorders:
Rare: micturition disorder (dysuria and urinary retention)
Metabolism and nutrition disorders:
Not known: hypoglycaemia
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie, e-mail: firstname.lastname@example.org.