Prescribing Information (UK and Republic of Ireland)

Sialanar® (400 mcg/ml glycopyrronium bromide, equivalent to 320 mcg/ml glycopyrronium) oral
solution. Please refer to the full Summary of Product Characteristics (SmPC) before prescribing.

Active ingredient: 1ml contains 400mcg glycopyrronium bromide (equivalent to 320 micrograms glycopyrronium).

Indication: Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.

Dosage: Start with approximately 12.8 micrograms/kg body weight of glycopyrronium per dose, three times per day. Increase dose weekly until efficacy is balanced with side effects. Titrate to maximum individual dose of 64 mcg/kg body weight glycopyrronium or 6 ml three times a day, whichever is less. Monitor at least 3 monthly for changes in efficacy and/or tolerability and adjust dose if needed. Not for patients less than 3 or over 17 years old as Sialanar® is indicated for the paediatric population only.

Renal impairment: Reduce dose by 30%, in mild/moderate renal failure.

Method of Administration: Oral use only. Dose at least one hour before or two hours after meals or at consistent times with respect to food intake. Avoid high fat food. Flush nasogastric tubes with 10 ml water.

Contraindications: Hypersensitivity to active substance or excipients; pregnancy and breast-feeding; glaucoma; urinary retention; severe renal impairment/dialysis; history of intestinal obstruction, ulcerative colitis, paralytic ileus, pyloric stenosis; myasthenia gravis; concomitant treatment with potassium chloride solid oral dose or anticholinergic drugs.

Undesirable effects: Adverse reactions more common with higher doses and prolonged use. In placebo-controlled studies (≥15%) dry mouth, constipation, diarrhoea and vomiting, urinary retention, flushing and nasal congestion. In paediatric literature; very  common: irritability, reduced bronchial secretions; common: upper respiratory tract infection, pneumonia, urinary tract infection, agitation, drowsiness, epistaxis, rash, pyrexia. The Summary of Product Characteristics should be consulted for a full list of side effects.

Special warnings and precautions: Monitor anticholinergic effects. Carer should stop treatment and seek advice in the event of constipation, urinary retention, pneumonia, allergic reaction, pyrexia, very hot weather or changes in behaviour. For continuous or repeated intermittent treatment, consider benefits and risks on case-by-case basis. Not for mild to moderate sialorrhoea. Use with caution in cardiac disorders; gastro-oesophageal reflux disease; pre-existing constipation or diarrhoea; compromised blood brain barrier; in combination with: antispasmodics, topiramate, sedating antihistamines, neuroleptics/antipsychotics, skeletal muscle relaxants, tricyclic antidepressants and MAOIs, opioids or corticosteroids. Sialanar contains 2.3 mg sodium benzoate (E211) in each ml. Patients require daily dental hygiene and regular dental checks. Thicker secretions may increase risk of respiratory infection and pneumonia. Moderate influence on ability to drive/use machines.

Fertility, pregnancy, and lactation: Use effective contraception. Contraindicated in pregnancy and breast feeding.

Legal classification: POM.

Further information available on request from the Marketing Authorisation Holder.

Date of last revision of prescribing information: May 2023

For the United Kingdom

Marketing Authorisation Holder: Proveca Pharma Ltd. 2 Dublin Landings, North Wall Quay, Dublin 1, Ireland. Pack Sizes & NHS price: Sialanar 250 ml bottle £320. Sialanar 60ml Bottle £76.80. Marketing Authorisation Numbers: Great Britain: PLGB 42588/0003. Northern Ireland: Sialanar 250 ml bottle - EU/1/16/1135/001; Sialanar 60ml Bottle - EU/1/16/1135/002

Adverse events should be reported. Reporting forms and information can be found at:
www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Proveca Limited.
Phone: +44 333 200 1866 E-mail: medinfo@proveca.com

For the Republic of Ireland

Marketing Authorisation Holder: Proveca Pharma Ltd. 2 Dublin Landings, North Wall Quay, Dublin 1, Ireland. Pack Sizes: Sialanar 250 ml Bottle. Sialanar 60ml Bottle (hospital use only). Marketing Authorisation Numbers: Sialanar 250 ml bottle - EU/1/16/1135/001; Sialanar 60 ml Bottle - EU/1/16/1135/002

Adverse events should be reported. Reporting forms and information can be found at: www.hpra.ie
Adverse events should also be reported to Proveca Limited.
Phone: +44 333 200 1866 E-mail: medinfo@proveca.com

UK-SIA-23-0107 | August 2023

Reporting of side effects

UK
If you/your child experience(s) any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard

Republic of Ireland
If you/your child experience(s) any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. Adverse event should be reported, reporting forms and information can be found at: www.hpra.ie.

By reporting side effects, you can help provide more information on the safety of this medicine.

Side effects should also be reported to Proveca Limited.
Phone: +44 333 200 1866 E-Mail: medinfo@proveca.com

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UK-SIA-23-0102 | August 2023