|The most commonly reported adverse reactions are nausea and dizziness, both occurring in more than 10 % of patients.The frequencies are defined as follows:|
|Very common:Common:Uncommon:Rare:Very rare: Not known: ||≥1/10≥1/100 to <1/10≥1/1000 to <1/100≥1/10 000 to <1/1000 <1/10 000frequency cannot be estimated from the available data|
Immune system disordersRare: allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis
Cardiac disordersUncommon: cardiovascular regulation (palpitation, tachycardia). These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed.Rare: bradycardia
InvestigationsRare: increase in blood pressure
Vascular disordersUncommon: 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 disordersVery common: dizzinessCommon: headache, somnolenceRare: 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 disordersRare: changes in appetite
Psychiatric disordersRare: 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).
Eye disordersRare: miosis, vision blurred, mydriasis
Respiratory, thoracic and mediastinal disorders:Rare: respiratory depression, dyspneaIf 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.
Gastrointestinal disorders Very common: nauseaCommon: constipation, dry mouth, vomittingUncommon: retching, gastrointestinal discomfort (a feeling of pressure in the stomach, bloating), diarrhoea
Skin and subcutaneous tissue disorders:Common: hyperhidrosisUncommon: dermal reactions (e.g. pruritus, rash, urticaria)Musculo-skeletal disordersRare: motorial weaknessHepatobiliary disorders: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
General disordersCommon: fatigue
Reporting of suspected adverse reactionsReporting 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.