ASSICCO 1 MG TABLETS, GLYCOPYRRONIUM BROMIDE 1 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - ASSICCO 1 MG TABLETS, GLYCOPYRRONIUM BROMIDE 1 MG TABLETS

Assicco

1mgand2mgTablets

Glycopyrronium Bromide

Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for them.

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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Assicco Tablets are and what they are used for
2. What you need to know before you give Assicco Tablets
3. How to use Assicco Tablets
4. Possible side effects
5. How to store Assicco Tablets
6. Contents of the pack and other information

1. What Assicco Tablets are and what they are used for

This medicine is called Glycopyrronium Bromide and 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.

Glycopyrronium Bromide 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 muscles or nerves. It is mainly caused by poor control of muscles in the face. Assicco Tablets act on the salivary glands to reduce production of saliva.

2. what you need to know before you give assicco tablets

Do not give Assicco Tablets if the child or adolescent:

is allergic (hypersensitive) to Glycopyrronium Bromide or any of the other ingredients of this medicine (listed in section 6), hasglaucoma (increased pressure in the eye),
has a condition called myasthenia gravis which leads to muscle weakness and fatigue,
has an obstruction of the stomach (pyloric stenosis) or bowel causing vomiting,
hasstomach ache and swelling (paralytic ileus),
is unable to completely empty the bladder (urinary retention), suffers from severe kidney disease, ispregnant or breastfeeding,
hasdiarrhoea (frequent, loose watery stools), hasulcerative colitis (inflammation of the intestine)
is taking any of the following medicines (see Other medicines and Assicco Tablets),

o potassium chloride solid dose products

o anticholinergic medicines

Warnings and precautions

Talk to your doctor or pharmacist before giving Assicco Tablets if the child or adolescent:

is suffering from heart disease, irregular heartbeats or high blood pressure
hasahigh temperature (fever)
haskidney problems or difficulty in passing urine
has an abnormal blood brain barrier (the layer of cells surrounding the brain)
has digestive disorders (constipation; chronic heartburn and indigestion)
has an inability to sweat normally

If you are not sure any of the above applies to the child or adolescent, talk to a doctor or pharmacist before giving Assicco Tablets.

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 Assicco Tablets 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.

MORNINGSIDE

HEALTHCARE

Check the child’s pulse if they seem unwell. Report a very slow or very fast heart rate to their doctor.

Children under 3 years

This medicine is formulated as an oral formulation and a dose specifically for use in children and adolescents aged 3 years and older.

Assicco Tablets are not recommended for children under 3 years of age.

Other medicines and Assicco Tablets

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines. This includes medicines you have bought without a prescription.

In particular taking Assicco Tablets with the following medicines can affect the way Assicco Tablets or the listed medicine works or can increase the risk of side effects:

potassium chloride solid oral dose (see section above “Do not give Assicco Tablets if the child or adolescent:”)
anticholinergic medicines (see section above “Do not give Assicco Tablets if the child or adolescent:”)
antispasmodics used to treat sickness or vomiting e.g.domperidone and metaclopramide
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 Assicco Tablets.

Long-term use

The long-term efficacy and safety of Assicco Tablets has not been studied beyond 24 weeks of use. Continued use of Assicco Tablets should be discussed with the child’s doctor every 3 months to check that Assicco Tablets is still right for the child.

Pregnancy, breast-feeding and fertility

This medicine is intended for use in children and adolescents. Assicco Tablets 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

Assicco Tablets may affect vision and co-ordination. This may affect performance at skilled tasks such as driving, riding a bicycle, or using machines. After receiving Assicco Tablets, the patient should not drive a vehicle, ride a bicycle or use a machine until the effect in their vision and co-ordination has completely recovered. Ask your doctor if you need further advice.

Information about ingredients of Assicco Tablets

This medicine contains Lactose. If you have been told by your doctor that your child has an intolerance to some sugars, contact the doctor before giving this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say it is essentially ‘sodium-free’.

3. how to use assicco tablets

Always give this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This medicine is for oral use only.

Swallow the tablet with water. The tablet may also be halved along the break-line in order to divide the dose into two equal halves.

This medicine should be given at least one hour before or two hours after a meal, or at consistent times in relation to food intake. Do not give with high fat foods.

Use in children and adolescents aged 3 years and older The initial dose will be calculated based on the weight of the child. The dose will be decided by the doctor using the table below as a guide, and will depend on both the effect of Assicco Tablets and any side effects the child may have. Section 4 includes possible side effects related to the use of Assicco Tablets (this is why several dose levels appear in the table below). These should be discussed with the child’s doctor, including the need for dose increases as the child grows, 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 Assicco Tablets remain appropriate treatment for them.

Weight	Dose Level 1	Dose Level 2	Dose Level 3	Dose Level 4	Dose Level 5
kg	(~0.02 mg/kg)	(~0.04 mg/kg)	(~0.06 mg/kg)	(~0.08 mg/kg)	(~0.1 mg/kg)
13–17	0.3 mg	0.6 mg	0.9 mg	1.2 mg	1.5 mg
18–22	0.4 mg	0.8 mg	1.2 mg	1.6 mg	2.0 mg
23–27	0.5 mg*	1.0 mg	1.5 mg	2.0 mg	2.5 mg
28–32	0.6 mg	1.2 mg	1.8 mg	2.4 mg	3.0 mg
33–37	0.7 mg	1.4 mg	2.1 mg	2.8 mg	3.0 mg
38–42	0.8 mg	1.6 mg	2.4 mg	3.0 mg	3.0 mg
43–47	0.9 mg	1.8 mg	2.7 mg	3.0 mg	3.0 mg
>48	1.0 mg	2.0 mg	3.0 mg	3.0 mg	3.0 mg

* 0.5mg dose can be achieved by taking % of a 1mg tablet. For doses which cannot be achieved using the tablet formulation, other pharmaceutical forms of glycopyrronium bromide are available.

The maximum recommended dose is 0.1 mg/kg three times daily not to exceed 1.5–3 mg per dose based upon weight (for further detail see Table above).

If you give more Assicco Tablets than you should If you give more of this medicine than the child has been prescribed, side effects are more likely. Consult the doctor or a pharmacist immediately or go to the emergency department of the nearest hospital. Always take any leftover tablets with you, as well as the container and label, so that the medical staff knows what you have given.

If you forget to give Assicco Tablets

If you forget to give a dose, give it as soon as possible. Then give the next dose at the correct time in accordance with the instructions given to you by the doctor. However, if the next dose is due, do not give the dose you have missed; just give the next dose as normal.

Do not give a double dose to make up for the forgotten one.

If you stop giving Assicco Tablets

If this is necessary it is best to reduce the dose gradually. Contact your doctor, pharmacist or nurse immediately for advice if they have not given directions to do this.

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 giving the medicine and seek medical advice immediately :

Allergic reaction (rash, itching, red raised itchy rash (hives), difficulty breathing or swallowing, dizziness) – frequency not known
Constipation (difficulty in passing stools) – very common
Difficulty in passing urine (urinary retention) – very common
Pneumonia (severe chest infection) – common

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 side effects : 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 side effects : 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 side effects : 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

Not Known: Side effects where frequency cannot be estimated from the available data

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 heart beat
inflammation and swelling of sinuses (sinusitis)
feeling sick (nausea)
dryskin
reduced ability to sweat, which can cause fever and heatstroke
urgent need to urinate

This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. how to store assicco tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater. 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 Assicco Tablets contain

The active substance is glycopyrronium bromide.

The other ingredients are lactose monohydrate, dibasic calcium phosphate, povidone, sodium starch glycolate and magnesium stearate.

What Assicco Tablets look like and contents of the pack

Assicco 1 mg Tablets are white to off white capsule shaped, flat, bevelled edge, scored tablets engraved with “I 21” on the scored side and plain on other side.

Assicco 2 mg Tablets are white to off white capsule shaped, flat, bevelled edge, scored tablets engraved with “I 22” on the scored side and plain on other side.

Tablets are supplied in pack sizes of 10, 14, 28, 30, 56, 60, 90 and 112 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Morningside Healthcare Ltd

Unit C, Harcourt Way

Leicester, LE19 1WP

Manufacturer

Morningside Pharmaceuticals Ltd

5 Pavilion Way Loughborough Leicestershire

LE11 5GW

This leaflet was last revised in January 2021.

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