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

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medcine 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• ■ 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 Glycopyrronium bromide tablets are and what they are used for

• 2. What you need to know before you take Glycopyrronium bromide tablets

• 3. How to take Glycopyrronium bromide tablets

• 4. Possible side effects

• 5. How to store Glycopyrronium bromide tablets

• 6. Contents of the pack and other information

• 1. WHAT GLYCOPYRRONIUM BROMIDE TABLETS ARE AND WHAT THEY ARE USED FOR

Glycopyrronium bromide (the active substance in Glycopyrronium bromide tablets) belongs to a group of medicines called 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 tablets are used to treat excessive production of saliva (sialorrhoea) in patients suffering from long term neuroligical disorders which have occurred in childhood, in patients 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 infections of the mouth. Glycopyrronium bromide tablets act on the salivary glands to reduce production of saliva.

2. what you need to know before you take glycopyrronium bromide tablets

DO NOT take Gtycopynonium bromide tablets If you:

• ■ are allergic to glycopyrronium bromide or any of tbe other ingredients of this medicine (listed in section 6)

• ■ are pregnant or breast feeding

• ■ suffer from glaucomafincre­asedpressurein­theeye)

• ■ are unable to completely empty the bladder (urinary retention)

• ■ have severe kidney disease

• ■ have an enlarged prostate gland (prostatic hypertrophy)

• ■ have an obstruction of the stomach (pyloric stenosis) or bowel causing vomiting

• ■ have ulcerative colitis (inflam mation of the I ntestine)

• ■ have diarrhoea (frequent, loose watery stools)

• ■ have stomach ache and swelIing (paralytic ileus)

• ■ have myasthenia gravis (muscle weakness and fatigue)

• ■ are over 65 years of age

• ■ are taking any of the following medicines (see section Other medicines and Glycopyrronium bromide tablets):

o potassium chloride solid oral dose;

o anticholinergic medicines.

Tell your doctor if you are not sure about any of the above.

Wamfrigs and precautions

Talk to your doctor or pharmacist before taking Glycopyrronium bromide tablets If you (or the patient) have:

• ■ heart disease, Irregular heartbeats or high blood pressure, because this medicine can cause a change to your normal heart rate

• ■ digestive disorders (constipation, chronic heartburn and indigestion)

• ■ a high temperature (fever), as this medicine will reduce the amount you may sweat, making it harder for your body to cool down

• ■ inability to sweat normally

• ■ kidney problems or difficulty passing urine, because this medicines dose may need to be reduced.

• ■ abnormal blood brain barrier (the layer of cells surrounding the brain)

If you are not sure if any of the above applies to you, talk to a doctor or pharmacist before taking this medicine.

Avoid exposure to hot or very warm temperature (hot weather, high room temperature) to avoid overheating and the possibility of heat stroke. Check with the patient's doctor during hot weather to see if the dose of this medicine should be reduced.

Reduced salivation can increase the risk of dental disease, therefore the patient’s teeth should be brushed daily and they should have regular dental checks.

Patients with kidney problems may be given a lower dose.

If you (or the patient) feel unwell, check your pulse and report any slow or very fast heart rate to your doctor.

Chlltfren under 3 years

This medicine is NOT recommended for use in children under 3 years of age (see section 3).

Other medicines and Glycopyrronium bromide tablets

Tell your doctor or pharmacist if you or your patient are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Glycopyrronium bromide tablets with the following medicines can affect the way Glycopyrronium bromide tablets or the listed medicines work or can increase the risk of side effects:

• ■ potassium chloride solid oral dose (see section above „DO NOT taka Gtycopynonium bromide tablets If you:“)

• ■ anticholinergic medicines (see section above "DO NOT taka Gtycopyrronlum bromide tablets If you:”)

• ■ antispasmodics used to treat sickness or vomiting e.g. domperidone and

metacl opramide

• ■ topiramate, used to treat epilepsy

• ■ antihistamines such as promethazine, used to Heat some allergies

• ■ neuroleptics/an­tipyschotics (clozapine, haloperidol, phenothiazine), used to treat some mental illnesses

• ■ skeletal muscle relaxants (botulinum toxin)

• ■ antidepressants such as amitriptyline, clomipramine, lofepramine or imipramine (known as tricyclic antidepressants)

• ■ opioids used to treat severe pain

• ■ corticosteroids, used to treat Inflammatory disease (eg. prednisolone)

Talk to your doctor or pharmacist for further information about any medicines to avoid or if you are in doubt about any of the above medicines.

Long twin use

Long term efficacy and safety of Glycopyrronium bromide tablets has not been studied beyond 24 weeks of use. Continued use should be discussed with the patient’s doctor every 3 months to check that Glycopyrronium bromide tablets are still right for the patient.

Pregnancy and breast-feeding

Glycopyrronium bromide tablets must not be given if the patient is pregnant or thinks they may be pregnant or is breastfeeding (see section 2 'Do not take1). Discuss with the patient’s doctor whether there is a need for contraception.

Driving and using machines

Glycopyrronium bromide tablets may affect vision and co-ordination. This may affect the performance of skilled tasks such as driving, riding a bicycle, or using machines. If you are affected in this way, DO NOT drive, ride a bike or operate machinery until your vision and co-ordination is completely recovered. If there is any doubt, ask your doctor for advice.

Glycopyrronium bromide tablets contain lactose and sodlwn

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free1.

3. how to take glycopyrronium bromide tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

This medicine is for oral use only and should be given at least one hour before or two hours after a meal. If the patients specific needs determine that co-administration with food is required, it is important to give glycopyrronium bromide at consistent times in relation to food intake. Do not give this medicine with high fat foods. If you (or the patient) have trouble with swallowing, an oral solution may be more appropriate.

Chlltfren and adolescents aged 3 years and older and aiMts who have suffered from neuroligical disorders from childhood

The initial dose will be calculated based on the weight of the patient. Dose increases will be decided by the patient’s doctor, using the table below as a guide, and will depend on both the effect of gtycopynonium bromide tablets and any side effects the patient is experiencing, which is why several dose levels appear on the table below. Section 4 includes possible side effects related to the use of glycopyrronium bromide tablets. These should be discussed with the patient's doctor, including those for dose increases and decreases, and at any other time should you be concerned.

Glycopyrronium bromide tablets are recommended for short-term intermittent use.

The patient should be monitored at regular intervals (at least every 3 months) to check that glycopyrronium bromide tablets are still the right treatment for them.

Wel^it (kg)	Dose level 1	Doss level 2	Dose level 3	Dose level 4	Dose levels
13–17	0.3mg	0.6mg	0.9mg	1.2mg	1.5mg
18–22	0.4mg	0.8mg	1.2mg	1.6mg	2.0mg
23–27	0.5mg	1.0mg	1.5mg	2.0mg	2.5mg
28–32	0.6mg	1.2mg	1.8mg	2.4mg	3.0mg
33–37	0.7mg	1.4mg	2.1 mg	2.8mg	3.0mg
38–42	0.8mg	1.6mg	2.4mg	3.0mg	3.0mg
43–47	0.9mg	1.8mg	2.7mg	3.0mg	3.0mg
>48	1.0mg	2.0mg	3.0mg	3.0mg	3.0mg

The tablet product may not be suitable for certain dose levels.

Dose adjustments should be conducted in discussion with the caregiver to assess both the effectiveness of this medicine and any undesirable effects experienced until an acceptable maintenance dose is achieved.

Chlltfren wider the age of 3 MUST NOT take Glycopyrronium bromide tablets.

if you take more Glycopyironiwii bromide tablets than you should

If you take more than the prescribed amount of this medicine, consult your doctor or get medical advice Immediately. Always take any leftover medicine with you, as well as the container and label, so that the medical staff know what you have been given.

If you forget to take Glycopynonlum bromide tablets

If you remember later on that day, take that day's dose as usual. If the next dose is due, DO NOT take a double dose to make up for a forgotten dose. If you are not sure, ask your doctor or pharmacist.

If you stop taking Glycopynonlum bromide tablets

Your doctor will tell you how long to take the treatment for. DO NOT stop earlier than you are told, even if you feel better.

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 medical advice Immedateiy

• ■ Constipation {difficulty in passing stool) – very common

• ■ Difficulty in passing urine (urinary retention) – very common

• ■ Pneumonia (severe chest infection) – common

• ■ Allergic reaction (rash, itching, red raised itchy rash (hives), difficulty breathing or swallowing, dizziness) – frequency not known

The following side effects may be a sign of severe allergic reaction. If they occur, take the child/patient to the nearest emergency 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 11n 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 11n 10 people)

• ■ Upper respiratory tract i nfection (chest I nfection)

• ■ Pneumonia (severe chest infection)

• ■ Urinary tract infection

• ■ Drowsiness (sleepiness)

• ■ Agitation

• ■ Fever (pyrexia)

• ■ Nose bleeds (epistaxis)

• ■ Rash

Uncommon side effects (may affect up to 1 ki 100 people)

• ■ Bad breath (halitosis)

• ■ Fu ngal i nfection (th rush) of the throat (oesophageal cand idiasis)

• ■ 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 wtth 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; signs include swelling mainly of the tongue, lips, face or throat (angioedema)

• ■ restlessness; over activity; short attention span; frustration; mood changes; temper outbursts or explosive behaviour; excessive sensitivity; seriousness or sadness; frequent crying episodes; fearfulness

• ■ insom nia {difficulty in sleep i ng)

• ■ 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

• ■ Inflam mation and swell I ng of sinuses (sinusitis)

• ■ feeling sick (nausea)

• ■ dry skin

• ■ reduced ability to sweat, which can cause fever and heatstroke

• ■ urgent need to urinate.

5. how to store glycopyrronium bromide tablets

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

Do not use Glycopyrronium bromide tablets after the expiry date, which is stated on the pack. The expiry date refers to the last day of that month.

After opening the container, Glycopyrronium bromide tablets can be used for 3 months.

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

B. CONTENTS OF THE PACK AND OTHER INFORMATION

What Glycopyrronium bromide tablets contain

The active substance is glycopyrronium bromide.

Each 1 mg tablet contains 1 mg of glycopyrronium bromide.

Each 2 mg tablet contains 2 mg of glycopyrronium bromide.

The other ingredients are: calcium hydrogen phosphate dihydrate, lactose anhydrous, povidone, sodium starch glycolate and magnesium stearate.

What Glycopyrronium bromide tablets look like and contents of the pack

Glycopyrronium bromide 1 mg tablets are white to off-white round scored unseated tablets, engraved with GP and T on either side of the score line and plain on the other. The tablet can be divided into equal halves.

Glycopynonlum bromide 2 mg tablets are white to off-white round scored unseated tablets, engraved with GP & “2“ on either side of the score line and plain on the other. The tablet can be divided into equal halves.

Tablets are supplied in pack sizes of 10,14,28, 30,56,60, 90 and 100 tablets. Not all pack sizes may be marketed.

Marketkig Authorisation Holder

Somex Pharma, Ilford, Essex, IG3 8BS.

Manufacturer

Somex Pharma

Ilford, Essex

IG3 8RA.UK

This leaflet was last revised in 02/2021.