This information is intended for use by health 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 Contraindications

• Hypersensitivity to the active substance.

• Glaucoma.

• Pregnancy (see section 4.6).

• Patients with mycotic or other skin infections.

4.4 Special warnings and precautions for use

Glycopyrrolate may cause tachycardia.

This product should be used with great caution in patients with cardiovascular disease, thyrotoxicosis, chronic bronchitis and obstructive disorders of the lower urinary tract like prostatic hypertrophy (see section 4.8).

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

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

Summary of Safety Profile-

Exercise care in patients with prostatic hypertrophy. Due to the effect of anticholinergics on mucous secretions, it is advisable not to treat people with chronic bronchitis. Occasionally difficulty in eating may occur and micturition may be temporarily affected for some hours after treatment

Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common: (>1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); Not known: cannot be estimated from the available data.

Tabulated list of adverse reactions

System Organ Class

Adverse reaction

Frequency

Immune system disorders

Hypersensitivity, Angioedema

Not known

Eye disorders

Vision blurred

Not known

Gastrointestinal disorders

Dry mouth

Abdominal discomfort

Not known

General disorders and administration site conditions

Smarting*

Not known

Nervous system disorders

Paraesthesia**

Not known

* Any recent cuts or cracks in the skin may smart when the current is increased at the start of iontophoresis, this can be avoided by covering the lesion with a thin smear of petroleum jelly

** This may occur in the immersed areas during treatment

Avoid over-exertion especially in hot weather, until any side effects have disappeared.

Reporting of suspected adverse reactions

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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 and other handling

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

MercuryPharm Ltd

4045, Kingswood Road,

City West Business Park,

Co Dublin, Ireland

8. Marketing authorisation number(s)

PL 15372/0003

9. Date of first authorisation/renewal of the authorisation

22/06/2010

10. Date of revision of the text

09/09/2016