Fertility

Post marketing surveillance does not suggest an effect of tramadol on fertility.

Animal studies did not show an effect of tramadol on fertility. No study on fertility was accomplished with the combination of tramadol and paracetamol.

4.7 Effects on ability to drive and use machines
Tramadol may cause drowsiness or dizziness, which may be enhanced by alcohol or other CNS depressants. If affected, the patient should not drive or operate machinery.

This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

• The medicine is likely to affect your ability to drive

• Do not drive until you know how the medicine affects you

• It is an offence to drive while under the influence of this medicine

• However, you would not be committing an offence (called 'statutory defence') if:

o The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and

o It was not affecting your ability to drive safely

4.8 Undesirable effects
The most commonly reported undesirable effects during the clinical trials performed with the paracetamol/tramadol hydrochloride combination were nausea, dizziness and somnolence, observed in more than 10 % of the patients.
The frequencies are defined as follows:

Very common:
 ≥1/10
 
Common:
 ≥1/100 to <1/10
 
Uncommon:
 ≥1/1000 to <1/100
 
Rare:
 ≥1/10 000 to <1/1000
 
Very rare:
 <1/10 000
 
Unknown:
 Frequency cannot be estimated from the available data
 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Cardiac disorders:

• Uncommon: palpitations, tachycardia, arrythmia.

Eye disorders:
• Rare: vision blurred, miosis, mydriasis

Ear and labyrinth disorders:

• Uncommon: tinnitus

Gastro-intestinal disorders:

• Very common : nausea

• Common: vomiting, constipation, dry mouth, diarrhoea abdominal pain, dyspepsia, flatulence

• Uncommon: dysphagia, melaena

General disorders and administration site conditions:

• Uncommon: chills, chest pain

Investigations:

• Uncommon: transaminases increased

Metabolism and nutrition disorders:

• Unknown: hypoglycaemia

Nervous system disorders:
• Very common : dizziness, somnolence

• Common : headache trembling

• Uncommon : involuntary muscular contractions, paraesthesia, amnesia

• Rare : ataxia, convulsions, syncope, speech disorders.

Psychiatric disorders:

• Common : confusional state, mood altered, anxiety, nervousness, euphoric mood), sleep disorders

• Uncommon : depression, hallucinations, nightmares

• Rare : delirium, drug dependence.

Post marketing surveillance

very rare: abuse.

Renal and urinary disorders:

• Uncommon: albuminuria, micturition disorders