Sialanar – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Sialanar, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you. − Keep this leaflet. You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s. − If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Sialanar is and what it is used for
Sialanar contains the active substance glycopyrronium.
Glycopyrronium belongs to a group of medicines known as quaternary ammonium anticholinergics, which are agents that block or reduce the transmission between nerve cells. This reduced transmission can de- activate the cells that produce saliva.
Sialanar is used to treat excessive production of saliva (sialorrhoea) in children and adolescents aged 3 years and older.
Sialorrhoea (drooling or excessive salivation) is a common symptom of many diseases of the nerves and muscles. It is mostly caused by poor control of muscles in the face. Acute sialorrhoea may be associated with inflammation, dental infections or infection s of the mouth.
Sialanar acts on the salivary glands to reduce production of saliva.
⚠️ 2. What you need to know before you give Sialanar
Do not give Sialanar if your child or adolescent: − is allergic to glycopyrronium or any of the other ingredients of this medicine (listed in section 6) − is pregnant or breast feeding − has glaucoma (raised pressure in the eye) − is unable to completely empty the bladder (urinary retention) − has severe kidney disease − has an obstruction of the stomach (pyloric stenosis) or bowel causing vomiting − has diarrhoea (frequent, loose watery stools) − has ulcerative colitis (inflammation of the intestine) − stomach ache and swelling (paralytic ileus) − has myasthenia gravis (muscle weakness and tiredness) 54 − is taking any of the following medicines (see section Other medicines and Sialanar) : potassium chloride solid oral dose; anticholinergic medicines .
Warnings and precautions
Talk to your doctor or pharmacist before using Sialanar if your child has:
- heart disease, heart failure, irregular heartbeats or high blood pressure
- digestive disorders (constipation; chronic heartburn and indigestion)
- a high temperature (fever)
- inability to sweat normally
- kidney problems or difficulty passing urine
- abnormal blood brain barrier (the layer of cells surrounding the brain) If you are not sure if any of the above applies to your child, talk to a doctor or pharmacist before giving Sialanar.
The carer should stop treatment and seek advice from the prescriber in the event of:
- pneumonia
- allergic reaction
- urinary retention
- changes in behaviour
- constipation
- fever Avoid exposing the child to hot or very warm temperature (hot weather, high room temperature) to avoid over heating and the possibility of heat stroke. Check with the child’s doctor during hot weather to see if the dose of Sialanar should be reduced.
Reduced salivation can increase the risk of dental disease therefore the child’s teeth should be brushed daily and they should have regular dental health checks.
Children with kidney problems may be given a lower dose using Sialanar oral solution.
Check the child’s pulse if they seem unwell. R eport a very slow or very fast heart rate to their doctor.
Long -term use The long-term efficacy and safety of Sialanar has not been studied beyond 24 weeks of use. Continued use of Sialanar should be discussed with the child’s doctor every 3 months to check that Sialanar is still right for the child.
Children under 3 years Do not give t his medicine to children under 3 years of age because it is formulated as an oral formulation and a dose specifically for use in children and adolescents aged 3 years and older.
Other medicines and Sialanar
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
In particular taking Sialanar with the following medicines can affect the way Sialanar or the listed medicine works or can increase the risk of side effects:
- potassium chloride solid oral dose (see section above “Do not give Sialanar if your child or adolescent:”)
- anticholinergic medicines (see section above “Do not give Sialanar if your child or adolescent:”)
- antispasmodics used to treat sickness or vomiting e.g. domperidone and metaclopramide 55 • topiramate used to treat epilepsy
- antihistamines , used to treat some allergies
- neuroleptics/antipsychotics (clozapine, haloperidol, phenothiazine), used to treat some mental illnesses
- skeletal muscle relaxants (botulinum toxin)
- antidepressants (tricyclic antidepressants)
- opioids used to treat severe pain
- corticosteroids, used to treat inflammatory diseases Talk to your doctor or pharmacist for further information about medicines to avoid whilst taking Sialanar.
Pregnancy and breast -feeding This medicine is intended for use in children and adolescents. Sialanar must not be given if the patient is pregnant (or could be pregnant), or is breast- feeding (see section 2 ‘Do not give’). Discuss with the child’s doctor whether there is a need for contraception.
Driving and using machines
Sialanar may affect vision and co- ordination. This may affect performance at skilled tasks such as driving, riding a bicycle, or using machines. After receiving Sialanar, the patient should not drive a vehicle, ride a bicycle or use a machine until the eff ect in their vision and co -ordination has completely recovered. Ask your doctor if you need further advice.
💊 3. How to use Sialanar
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Children and adolescents 3 years to less than 18 years:
Sialanar is available as orodispersible tablets (which dissolve in the mouth) and as a liquid. Your child should only switch between these forms if your child’s doctor tells them to. The dose of the tablet and the liquid may be different. Your child’s doctor will use a dosing tabl e (see below) to choose the right dose of the orodispersible tablet. Patients are usually started on the liquid and given a stable dose before switching to the orodispersible tablet.
After switching between forms, your child’s doctor may check that the medicine is working properly and monitor them for side effects.
Tell your child’s doctor if:
- your child’s symptoms are not as well controlled as before, or – your child has new or increased side effects Your child’s doctor may change their dose or advise them to use the liquid form if a more precise dose is needed.
Section 4 includes possible side effects related to the use of Sialanar. These should be discussed with the child’s doctor at all medical consultations, including those for dose increases and decreases, and at any other time should you be concerned.
The child should be monitored at regular intervals (at least every 3 months) to check that Sialanar is still the right treatment for them.
56 Weight ( Kg) Dose level 1 (mg) Dose level 2 (mg) Dose level 3 (mg) Dose level 4 (mg) Dose level 5 (mg) 13-17 ^ ^ ^ 0.68 0.68 18-22 ^ ^ 0.68 0.68 1.36 23-27 ^ 0.68 0.68 1.36 1.36 28-32 ^ 0.68 0.68 1.36 2.04 33-37 ^ 0.68 1.36 1.36 2.04 38-42 ^ 0.68 1.36 2.04 2.04 43-47 ^ 0.68 1.36 2.04 2.04 ≥48 0.68 1.36 2.04 2.04 2.04 ^ No orodispersible tablet is available for this weight and dosing level. Your child’s doctor should use another formulation, such as liquid, for these doses.
Give the dose prescribed by your doctor to the child three times each day.
The dose should be given 1 hour before meals or 2 hours after meals.
It is important that the dose is given at consistent times in relation to food intake. Do not give with high fat foods.
The orodispersible tablet should be administered without water.
Route of administration Sialanar should be taken by mouth. It is an orodispersible tablet, which means it dissolves in the mouth. The tablet should be placed on the tongue or in the buccal cavity (the space inside the mouth between the cheeks and teeth) and allowed to dissolve.
Instructions for use If your child requires the medicine through a feeding tube, the oral liquid formulation should be used. If you give more Sialanar than you should It is important to make sure an accurate dose is given each time in order to prevent harmful effects of Sialanar seen with dosing errors or overdose.
Seek medical advice immediately if the child is given too much Sialanar, even if the child seems well.
If you forget to give Sialanar Give the next dose when it is due. Do not give a double dose to make up for the forgotten dose.
If you stop giving Sialanar to your child Withdrawal effects are not expected when stopping Sialanar. The child’s doctor may decide to stop treatment with Sialanar if side effects cannot be managed by reducing the dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following serious side effects occur, stop using the medicine and seek urgent medical advice.
- Constipation (difficulty in passing stool) – very common
- Difficulty in passing urine (urinary retention) – very common
- Pneumonia (sever e chest infection) – common
- Allergic reaction (rash, itching, red raised itchy rash (hives), difficulty breathing or swallowing, dizziness) – frequency not known 57 The following side effects may be a sign of severe allergic reaction. If they occur, take the child to the nearest emergency medical facility and take the medicine with you.
- Swelling mainly of the tongue, lips, face or throat (possible signs of angioedema) – frequency
not known
Other side effects are
Very common (may affect more than 1 in 10 people)
- Dry mouth
- Difficulty in passing stools (constipation)
- Diarrhoea
- Being sick (vomiting)
- Flushing
- Nasal congestion
- Unable to completely empty the bladder (urinary retention)
- Reduced secretions in the chest
- Irritability
Common (may affect up to 1 in 10 people)
- Upper respiratory tract infection (chest infection )
- Pneumonia (severe chest infection)
- Urinary tract infection
- Drowsiness (sleepiness)
- Agitation
- Fever (pyrexia)
- Nose bleeds (epistaxis)
- Rash
Uncommon (may affect up to 1 in 100 people)
- Bad breath (halitosis)
- Fungal infection (thrush) of the throat (oesophageal candidiasis)
- Abnormal contractions of the digestive tract when food is ingested (gastrointestinal motility disorder)
- A disorder of the muscles and nerves in the intestine which causes an obstruction or blockage (pseudo-obstruction)
- Widening of the pupil of the eye ( mydriasis)
- Involuntary eye movement (nystagmus)
- Headache
- Dehydration
- Thirst in hot weather Other side effects that occur with anticholinergics but their frequency with glycopyrronium is
not known
- allergic reaction (rash, itching, red raised itchy rash (hives), difficulty breathing or swallowing, dizziness)
- severe allergic reaction (angioedema); signs include swelling mainly of the tongue, lips, face or throat
- restlessness; overactivity; short attention span; frustration; mood changes; temper outbursts or explosive behaviour; excessive sensitivity; seriousness or sadness; frequent crying episodes; fearfulness
- insomnia (difficulty in sleeping)
- raised pressure in the eye (which might cause glaucoma); photophobia (sensitivity to light); dry eyes
- slow heart rate followed by rapid heart rate, palpitations and irregular heartbeat
- inflammation and swelling of sinuses (sinusitis) 58 • feeling sick (nausea)
- dry skin
- reduced ability to sweat, which can cause fever and heatstroke
- urgent need to urinate Side effects can sometimes be difficult to recognise in patients with neurologic problems who cannot easily tell you how they feel.
If you think a troublesome side effect is occurring after increasing a dose, the dose should be decreased to the previous one used and your doctor contacted.
Tell your doctor if you notice any behavioural changes or any other changes in the child.
Reporting of side effects
If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store Sialanar
Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the blister foil after EXP . The expiry date refers to the last day of that month.
Sialanar should not be used if the packaging has been opened or damaged.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Sialanar contains
- The active substance is glycopyrronium.
Sialanar 0.68 mg orodispersible tablets : Each orodispersible tablet contains 0.85 mg glycopyrronium bromide equivalent to 0.68 mg of glycopyrronium.
Sialanar 1.36 mg orodispersible tablets : Each orodispersible tablet contains 1.7 mg glycopyrronium bromide equivalent to 1.36 mg of glycopyrronium.
- The other ingredients are: gelatin, mannitol (E421), poloxamer 188, sucralose, black cherry flavour, citric acid and purified water.
What Sialanar looks like and contents of the pack
Sialanar 0.68 mg orodispersible tablets are white to off white, circular, orodispersible tablet, debossed with a ‘single crescent’.
Sialanar 1.36 mg orodispersible tablets are w hite to off white, circular, orodispersible tablet, debossed with a ‘double crescent’.
59 The orodispersible tablets are supplied in blisters. The lidding foil over each tablet is peelable to allow easy removal of orodispersible tablet. The blisters are supplied in a cardboard carton.
Available pack sizes will be 30 or 60 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Proveca Pharma Ltd 2 Dublin Landings North Wall Quay Dublin 1 Ireland
Manufacturer
Medinfar Manufacturing S.A. Parque Industrial Armando Martins Tavares Rua Outeiro Da Armada No 5 Condeixa-A-Nova 3150-194 Portugal
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Sialanar (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/16/1135).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.