Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients with rare hereditary problems of galactose intolerance e.g. galactosaemia should not take this medicine.
Urapidil Stragen contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Urapidil Stragen 90 mg contains also Ponceau 4R (E214) red colouring which may cause allergic reactions.
The antihypertensive action of urapidil can be exacerbated by concomitant administration of alpha-receptor blockers including those given for urological conditions, vasodilators and other blood pressure lowering drugs, and in conditions involving hypovolaemia (diarrhoea, vomiting) and alcohol.
The combination of urapidil with baclofen should be considered cautiously, as baclofen can increase the antihypertensive effect.
Cimetidine administered concomitantly inhibits the metabolism of urapidil. Urapidil serum concentration is likely to increase by 15%, so that dosage reduction should be considered
Consideration should be given to the following concomitant administration:
As no adequate experience yet exists of combining treatment with ACE inhibitors, this is not at the moment recommended.
Urapidil Stragen during pregnancy is not recommended. There is no adequate data from the use of urapidil in pregnant women. Studies in animals have shown reproductive toxicity without teratogenicity (section 5.3). Because of the limitations of the studies, the potential risk for humans is unknown.
In the absence of data on excretion into mother’s milk, breast-feeding is not recommended in case of treatment with urapidil.
This medicinal product has minor influence on the ability to drive and use machines. The response to treatment may vary from one patient to another. This applies most particularly at the start of treatment, after changes to treatment, or in the event of concomitant alcohol intake.
In the assessment of undesirable effects, the following frequency ranges are used: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Very rare: Thrombocytopenia*
Uncommon: Palpitations; tachycardia; bradycardia; feeling of pressure or pain in the chest (similar to angina pectoris)
Common: Nausea
Uncommon: Vomiting; diarrhoea; dry mouth
Uncommon: Fatigue
Very rare: Oedema
Very rare: Reversible increase in liver-specific enzymes
Common: Dizziness; headache, vertigo
Uncommon: Sleep disturbances
Very rare: Restlessness
Very rare: Increased urge to urinate or exacerbation of urinary incontinence
Rare: Priapism
Rare: Nasal congestion
Uncommon: Sweating
Rare: Symptoms of cutaneous allergic reactions (pruritus, rashes, exanthema)
Uncommon: Orthostatic dysregulation
* In very rare cases, a reduction in thrombocyte count has been observed simultaneously with administration of Urapidil Stragen. No causal relationship with the urapidil treatment has been established – for example by immune haematological tests.
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 the national reporting system listed in Appendix V.
Not applicable.
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