REGURIN XL Prolonged-release capsule, hard Ref.[9721] Active ingredients: Trospium

One capsule once daily (equivalent to 60 mg of trospium chloride per day).

Regurin XL 60 mg should be taken with water on an empty stomach at least one hour before a meal.

Renal impairment

Data on the use of Regurin XL 60 mg are not available for patients with renal impairment. Trospium chloride is mainly excreted unchanged by the kidneys. An increase in plasma levels is documented for the immediate release formulation. For the prolonged release formulation an appropriate level of dose adjustment is not known for renally impaired patients and the product is therefore not recommended for use in renally impaired patients (see section 4.4 and 5.2).

Hepatic impairment

Data on patients with mild and moderate impairment of liver function are only available for the immediate release formulation of trospium chloride, but not for the prolonged release formulation. These patients should be treated with caution. Regurin XR 60 mg should not be given to patients with severe hepatic impairment (see section 4.4 and 5.2).

The need for continued treatment should be reassessed at regular intervals of 3-6 months.

Regurin XL 60 mg is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy.

After administration of a maximum single dose of 360 mg trospium chloride as immediate release preparation to healthy volunteers, dryness of the mouth, tachycardia and disorders of micturition were observed to an increased extent. No manifestations of severe overdose or intoxication in humans have been reported to date. Exaggerated anticholinergic symptoms are to be expected as signs of intoxication following administration of trospium chloride as an extended release preparation as well.

In the case of intoxication the following measures should be taken:

• gastric lavage and reduction of absorption (e.g. activated charcoal)
• local administration of pilocarpine to glaucoma patients
• catheterisation in patients with urinary retention
• treatment with a parasympathomimetic agent (e.g. neostigmine) in the case of severe symptoms
• administration of beta blockers in the case of insufficient response, pronounced tachycardia and/or circulatory instability (e.g. initially 1 mg propranolol intravenously along with monitoring of ECG and blood pressure).

• 3 years packaged in PVC/Aclar/aluminium blister or PVC/aluminium blister.
• 4 years packaged in PVC/PVDC/aluminium blister.

This medicinal product does not require any special storage conditions.

Polyvinylchloride (PVC)/aluminium blister, Polyvinylchloride/Polyvinylidenchloride (PVC/PVDC)/aluminium blister or PVC/Aclar/aluminium blister.

Packs of 4, 7, 10, 14, 28, 30, 56, 60, 84, 90, 100 and 10x28 capsules.

Sample packs of 4.

Not all pack sizes may be marketed.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.