Robinul 3g Powder for Solution for Iontophoresis – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Robinul 3g Powder for Solution for Iontophoresis

Robinul 5g Powder for Solution for Iontophoresis

Robinul 10g Powder for Solution for Iontophoresis

Glycopyrronium bromide 3g Powder for Solution for Iontophoresis Glycopyrronium bromide 5g Powder for Solution for Iontophoresis Glycopyrronium bromide 10g Powder for Solution for Iontophoresis

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

This Powder consists of Glycopyrrolate (glycopyrronium bromide) 100% w/w.

3 PHARMACEUTICAL FORM

White, crystalline powder.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Iontophoretic treatment of the plantar and palmar skin for idiopathic hyperhidrosis.

4.2 Posology and method of administration

Posology

A 0.05% solution in distilled water of Glycopyrrolate USP is applied to palmar or plantar skin. The procedure should be carried out as per instructions given in ‘Method of administration’.

Only one site should be treated at a time and only two sites in any one day. Treatments should not be repeated within seven days, but may be repeated later varying the precise conditions according to the recurrence and severity of hyperhidrosis. See also 'Special warnings and special precautions for use' below.

Method of administration: Iontophoresis

When treating the foot or hand, sufficient solution to cover the palm or sole is placed in a non-metallic container and the anode, of sheet metal larger in area than the part being treated, is placed in the solution. The sole or palm is separated from the anode by 5mm of plastic foam or a layer of lint or sponge sheet.

In all cases an electrical circuit is completed by placing another limb in lukewarm tap water containing the cathode, similarly shielded from direct contact with the skin.

Recommended average conditions are 90 volts DC at 10-20 mA for adults (including older patients) and 2-10 mA for children, for 12 minutes at each site, depending on the patient's skin tolerance, body weight and size

For instructions on reconstitution or dilution of medicinal product before administration, see section 6.6.

4.3. Contra-indications

Hypersensitivity to Glycopyrronium Bromide

Glaucoma

Iontophoresis is contraindicated in pregnancy, if in possession of a cardiac pacemaker or a similar device, peripheral neuropathy or in those with metal implants around the treatment area.

Any metallic jewellery should be removed from the treatment or prior to treatment.

Avoid use in diseased, damaged, inflamed or infected skin as this may increase systemic absorption

4.4. Special warnings and precautions for use

The risk of systemic antimuscarinic (anticholinergic) adverse effects is extremely low with topical use of glycopyrrolate due to its low lipid solubility and poor absorption through intact skin.

Systemic administration of glycopyrrolate may cause tachycardia, so caution is advised in patients with cardiac impairment / history of cardiac disease and hyperthyroidism. Caution is also advised for systemic use of antimuscarinic drugs in individuals susceptible to gastrointestinal disease, angle-closure glaucoma and urinary retention but there is no evidence that this is applicable to topical use of glycopyrrolate.

Glycopyrrolate has been shown to have a low volume of distribution and is unlikely to cross the blood brain barrier. It lacks central anticholinergic effects when administered intravenously so the risk of sedation with topical use is extremely low / negligible.

Although caution is advised with the systemic use of antimuscarinics in children, the elderly and Down’s syndrome, there is no evidence that this is relevant to the topical use of glycopyrrolate in these individuals.

Avoid treatment in patients with mycotic or other skin infections due to the potential increased in systemic absorption and systemic side effects.(see section 4.3)

The product should only be used by in iontophoretic technique.

Skin sensitisation has not been reported with topical use of glycopyrrolate however other antimuscarinic drugs have been reported to cause allergic contact dermatitis, therefore, treatment should be discontinued if a rash develops.

4.5. Interactions with other medicinal products and other forms of interaction

Not applicable

4.6 Fertility, Pregnancy and lactation

Pregnancy:

Do not use during pregnancy, as safety in this condition has not been established. (See section 4.3). Reproduction studies in rats and rabbits revealed no teratogenic effects from glycopyrrolate.

Fertility:

Diminished rates of conception and of survival at weaning were observed in rats, in a dose related manner. Studies in dogs suggest that this may be due to diminished seminal secretion, which is evident at high doses of glycopyrrolate. The significance of this for man is not clear.

4.7 Effects on ability to drive and use machines

Glycopyrrolate has moderate influence on the ability to drive and use machines. Since this drug may cause drowsiness, patients receiving glycopyrrolate should not drive or operate machinery immediately after treatment unless it has been shown not to affect their physical or mental ability.

4.8. Undesirable effects

The most serious adverse event reported is anaphylaxis but the frequency is unknown.

The most common adverse event reported is dry mouth (between 1 in 100 to 1 in 10 patients receiving glycopyrrolate powder are expected to experience dry mouth)

Adverse reactions associated with glycopyrrolate powder obtained from clinical studies and post-marketing surveillance are tabulated below.

Adverse events have been grouped according to frequency of occurrence based on as follows: 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); Frequency not known (cannot be estimated from the available data)

4.9 Overdose

Not appropriate for the product

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Quaternary ammonium antimuscarinic ATC Code: A03AB02

Glycopyrrolate is an anticholinergic agent. The pharmacological particulars of anticholinergic drugs are well documented in the scientific literature.

5.2 Pharmacokinetic properties

This product is indicated for use by Topical Iontophoresis for hyperhidrosis. Glycopyrrolate is a Quaternary Ammonium Compound and as such is absorbed through the skin in negligible amounts only.

5.3 Preclinical safety data

Nothing of relevance to the prescriber.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Not applicable - no other constituents present

6.2 Incompatibilities

Not applicable

6.3 Shelf life

48 months unopened. 14 days after reconstitution.

6.4 Special precautions for storage

There are no special storage precautions for this product.

6.5 Nature and contents of container

The product is presented in a screw cap amber bottle containing 3, 5 or 10g of glycopyrrolate USP.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

The product should only be used by specialist units experienced in IONTOPHORETIC technique. The electrodes and treated skin areas must be placed in non-metallic containers and separated carefully by layers of, for example, sponge or lint. Direct contact between electrodes and skin must be avoided otherwise burns may result. The current must be very slowly increased from zero mA and decreased to zero mA at the beginning and end of the treatment period respectively to avoid any Faradic discharge between the electrode and skin on removal of the patient's limb from the container of solution. Instruct patient that contact must not be broken during treatment. Prior to use in iontophoresis a stock solution of Glycopyrronium bromide powder (glycopyrrolate) may be made up with freshly boiled and cooled distilled or deionised water. Glycopyrrolate does hydrolyse slowly at pH 7 and it is recommended that stock solutions be discarded after not more than 14 days.

The solution must not be alkaline otherwise glycopyrrolate will hydrolyse more rapidly.

No specific requirements for disposal

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

7 MARKETING AUTHORISATION HOLDER

Mercury Pharmaceuticals Ltd,

Dashwood House, 69 Old Broad Street, London,

EC2M 1QS, United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 12762/0579

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

22/06/2010

10 DATE OF REVISION OF THE TEXT

03/11/2023