Pyridostigmine Bromide 12mg/ml Oral Solution – patient leaflet, side effects, dosage

1. What Pyridostigmine Bromide 12mg/ml Oral Solution is and what it is used for

Pyridostigmine Bromide 12mg/ml Oral Solution contains the active ingredient pyridostigmine bromide. It is used for the treatment of myasthenia gravis in adults and children and also in adults to treat paralytic ileus (a rare form of constipation). In patients who suffer from myasthenia gravis, muscles quickly become tired and weak and, in severe cases, the muscles may become paralysed.

Myasthenia gravis is caused by over activity of a protein in the body called cholinesterase. This medicine belongs to a group of medicines known as cholinesterase inhibitors which stop the over activity of cholinesterase. This helps muscles to work properly.

2. What you need to know before you take Pyridostigmine Bromide 12mg/ml Oral Solution

Do not take Pyridostigmine Bromide 12mg/ml Oral Solution:

• If you are constipated or cannot urinate, unless your doctor has told you to use this medicine. This is because this medicine is only used for some types of constipation. (see section 1).
• If you are allergic (hypersensitive) to pyridostigmine bromide or any of the other ingredients of this medicine (listed in section 6) or bromides. Warnings and precautions

Talk to your doctor before taking this medicine if you:

• Suffer from asthma or other chest problems such as wheeziness, difficulty in breathing or chronic cough
• Have recently had a heart attack (blocking of the blood vessels of the heart), have a slow heart beat or any other heart condition
• Have low blood pressure
• Have a stomach ulcer
• Have epilepsy (seizures)
• Have Parkinson’s disease (a disease that slows the movement and affects co-ordination)
• Have kidney problems
• Have an overactive thyroid gland (hyperthyrodism)
• Suffer from a condition called vagotonia (this is a condition where overactivity of the vagus nerve causes symptoms such as slow heart rate, low blood pressure, constipation, sweating and painful muscle spasms).
• Have had an operation to remove your thymus gland.

There is no evidence to suggest that this medicine has any special effects on elderly patients. However, elderly patients may be more susceptible to changes in their regular heart beat than the young adult. Other medicines and Pyridostigmine Bromide 12mg/ml Oral Solution

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines including medicines obtained without prescription.

This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines. In particular, tell your doctor if you are taking any of the following medicines:

• Antimuscarinics (e.g. atropine, hyoscine)
• Steroids or other immunosuppressant medicines
• Medicines used to treat irregular heart beat
• Antibiotics
• Medicines used to treat malaria (e.g. chloroquine, hydroxychloroquine)
• Lithium (a drug used to treat certain types of depression)
• Medicines containing methylcellulose
• Local and general anaesthetics

If you are going to have surgery

Tell your doctor that you are taking this medicine as it can stop the effect of some medicines used to relax muscles during surgery (e.g. pancuronium, vecuronium). This medicine can also prolong the effect of other muscle relaxants (e.g. suxamethonium). Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Since there is insufficient experience with respect to the use of this medicine in pregnant women, you should only take it if your doctor considers it essential. Intravenous administration of anticholinesterases (the substance group to which pyridostigmine bromide belongs) during pregnancy may induce preterm labour. The risk of preterm labour is higher in the final phase of pregnancy. It is unknown if oral administration constitutes a similar risk of preterm labour.

This medicine passes into breast milk in small amounts and due regard should be paid to the possible effects on the breast-feeding infant.

The safety of Pyridostigmine Bromide 12mg/ ml Oral Solution in human fertility has not been established.

Driving and using machines

The sharpness of your eyesight may be reduced when you take this medicine. Do not drive or operate machines if this medicine affects your ability to see clearly.

Pyridostigmine Bromide 12mg/ml Oral Solution contains sodium, sorbitol, propylene glycol, sodium benzoate and glycerol

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium- free’. This is equivalent to less than 115 mg per 5ml dose. At maximum daily dose (100ml), this medicine contains 304mg sodium. This should be taken into consideration by patients on controlled sodium diet if taking more than 7.5ml dose.

This medicine contains 140 mg sorbitol in each ml which is equivalent to 700 mg in 5ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

This medicine contains 3.84 mg propylene glycol in each ml which is equivalent to 19.2 mg in 5ml. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.

This medicine contains 1.27 mg sodium benzoate in each ml which is equivalent to 6.35 mg in 5ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

This medicine also contains glycerol which may cause headache, stomach upset and diarrhoea. For a list of all ingredients, see section 6.

3. How to take Pyridostigmine Bromide 12mg/ml Oral Solution

Your medicine should be swallowed.

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

This medicine can also be administered via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. See “Taking this medicine

via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes ”. Do not use with a tube which is made of latex. There is further information in the Summary of Product Characteristics (SmPC). Ask your doctor, pharmacist or nurse for this information.

The dose will depend on your illness, your needs and on your age as follows:

For myasthenia gravis

Your medicine takes 30 to 60 minutes to start working after you have taken it.

The effect of each dose should last about four hours during the day and about six hours at night. You should try to take your medicine so that it can work when your muscles are needed most, for example, when you get up and about 30 to 60 minutes before a meal.

Use in adults

• The usual adult dose is 2.5 ml to to 10 ml of solution to be taken five to six times daily, or higher doses if needed, as recommended by your doctor. Use in children
• For children under 6 years, the usual starting dose is 2.5 ml of solution.
• For children aged 6 to 12 years, the usual starting dose is 5 ml of solution. Your doctor will then gradually increase the dose until maximum improvement is seen. In children the total dose per day is usually 2.5 ml to 30 ml of solution. For paralytic ileus (constipation)

Use in adults

• The usual adult dose is 5 to 20 ml of solution per day.

Use in patients with a kidney or liver disorder

Your doctor will decide at what dose to start your medicine and will increase the dose until maximum improvement is seen.

Measuring your dose

This medicine contains a plastic dosing pipette to measure the right amount of solution prescribed for you. The numbers up the side show how many millilitres (ml) of solution you have inside the pipette.

1. 1. Open the bottle: press the plastic screw cap down whilst turning the bottle anti-clockwise (figure 1).
2. 2. Ensure the plunger of the pipette is fully depressed then insert it into the solution (figure 2).
3. 3. Holding the body of the pipette with one hand, fill the pipette by drawing the plunger upwards with the opposite hand until the mark on the plunger corresponds to the amount prescribed by your doctor (figure 3). The marks are at every 1ml and intermediate marks at every 0.1ml.
4. 4.

   Remove the pipette from the bottle, place into your mouth and slide the plunger down. Drink the solution immediately.

   If you need to take more solution to ensure you have the correct dose, wash the pipette first then repeat steps 2 to 4. When you have taken all of your dose, close the bottle with the screw cap, wash and dry the pipette and place both the bottle and pipette back into the carton.

Taking this medicine via nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes

1. 1. Ensure that the enteral feeding tube is free from obstruction before administration.
2. 2. Flush the enteral tube with 5ml of water.
3. 3. Administer the required dose of Pyridostigmine Bromide 12mg/ml Oral Solution with a suitable measuring device. Do not use the dosing pipette provided.
4. 4. Flush the enteral tube with 5ml of water. If you take more Pyridostigmine Bromide 12mg/ ml Oral Solution than you should

Symptoms of overdose may include stomach cramps, wave-like muscle contractions along your digestive tract, diarrhoea, a feeling of sickness and vomiting, increased production of mucus and saliva, sweating and constriction of the pupil of your eye.

Other symptoms may include slower heartbeat, muscle cramps and muscle twitches. You may also experience muscle weakness similar to that caused by myasthenia gravis. If you experience any of these symptoms or you take too much, or if someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away. If you forget to take Pyridostigmine Bromide 12mg/ml Oral Solution

If you forget to take one of your daily doses, take it as soon as you remember, and take the next dose at the normal time. Do not take a double dose to make up for a forgotten dose. If you miss more than a single dose, you should contact your doctor for advice.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Rare side effects (may affect up to 1 in 1,000 people) include:

• rash

  The following are possible side effects of unknown frequency.

• visual disturbance, producing more tears than usual
• an irregular heart beat, heart block, low blood pressure, fainting
• producing more phlegm than usual combined with constriction of the airways
• feeling sick, vomiting, diarrhoea, stomach cramps, producing more saliva than usual
• excessive sweating
• muscle weakness and twitching, shaking, muscle cramps
• sudden compelling urge to urinate

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This incldues any possible effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard 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 Pyridostigmine Bromide 12mg/ml Oral Solution

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 and bottle. The expiry date refers to the last day of that month.

Store below 25°C.

Keep the bottle in the outer carton in order to protect from light.

Use within 28 days after first opening the bottle. 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 Pyridostigmine Bromide 12mg/ml Oral Solution contains

The active substance is pyridostigmine bromide. Each millilitre (ml) of this medicine contains 12 mg of pyridostigmine bromide.

The other ingredients are acesulfame potassium (E950), citric acid anhydrous (E330), glycerol (E422), hydroxyethyl cellulose, sodium benzoate (E211), trisodium citrate dihydrate (E331), sorbitol 70% solution (E420), raspberry flavour (contains propylene glycol (E1520)) and purified water. What Pyridostigmine Bromide 12mg/ml Oral Solution looks like and contents of the pack

Your medicine is a clear, slightly viscous liquid. It is supplied in amber glass bottles containing 150 ml per bottle. The bottle is contained within a carton which also includes a 5 ml dosing pipette. The pipette is marked with a scale with markings at every 1ml and intermediate marks at every 0.1ml. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Horizon Pharmaceuticals Limited

35 Grimwade Avenue, Croydon, CR0 5DJ, UK Manufacturer

Apollo Pharma Ltd, Unit 1, Irwell Works, Lower Woodhill Road, Bury, BL8 1AA, UK.

For any information about this medicine, please contact the Marketing Authorisation Holder or local distributor.

This leaflet was last revised in September 2021