Pilocarpine Hydrochloride 2.0% w/v eye drops, solution – patient leaflet, side effects, dosage

1. WHAT PILOCARPINE

HYDROCHLORIDE EYE DROPS ARE AND WHAT THEY ARE USED FOR

Pilocarpine hydrochloride belongs to a group of medicines called miotics, these medicines affect muscles in the eye causing the pupil of the eye to get smaller.

Pilocarpine hydrochloride Eye Drops are used to treat primary angle closure glaucoma, a condition associated with a sudden and painful increase in pressure within the eye. Your doctor will make sure that this medicine is appropriately used.

1. 2. WHAT YOU NEED TO KNOW

BEFORE YOU USE PILOCAR-PINE HYDROCHLORIDE EYE DROPS

Do not use Pilocarpine hydrochloride eye drops if:

• you are allergic (hypersensitive) to Pilocarpine or any of the other ingredients in this medicine, which are listed in section 6 of this leaflet. - you suffer from certain types of acute or secondary glaucoma caused by the lens inside your eye; some medicines; and fluid, blood or inflammation in the back of the eye
• if you have any disorder in which you are to avoid constriction of the pupil of the eye (e.g., an acute inflammation of the iris of the eye)
• you are wearing soft contact lenses.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking this medicine if you have or are suffering from:

• darkly pigmented iris (may require higher strength or more frequent administration of eye drops)
• damage to the front of the eye (conjunctiva or cornea)
• pre-existing retinal disease (retinal detachment may occur)
• lung problems (e.g. asthma, chronic bronchitis and/or chronic obstructive pulmonary disease)
• serious heart problems (e.g. heart failure, irregular pulse, high blood pressure)
• over-active thyroid
• stomach or intestinal problems (e.g. spasm, ulcers)
• kidney problems (e.g. renal insufficien-cy, kidney stones, problems in passing urine)

• gallbladder or bile duct problems (e.g. gallstones)

  • seizures
  • Parkinson’s disease
  • cognitive problems (difficulties in learning, memory, perception, and problem solving) or mental problems If you are unsure about how to use this medicine, talk to your doctor, pharmacist or nurse.

Children, adolescents and the elderly

In patients under the age of 18 years, start treatment with 1% pilocarpine eye drops. After assessing efficacy and tolerability, the strength may be increased to 2% pilocarpine eye drops.

Other medicines and Pilocarpine hydrochloride eye drops

Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescrip-tion.

Some medicines can interfere with your treatment. Tell your doctor if you are taking any of the following:

• antihistamines (medicines used to treat allergies).
• anticholinesterases, (such as neostig-mine) which are medicines that affect the muscles and are used to treat diseases like myasthenia gravis. - medicines used to make the pupil larger and dry up the saliva in your mouth, such as atropine and phenyle-phrine.
• medicines used to treat Parkinson’s disease, anticholinergic drugs such as orphenadrine, procyclidine and trihexyphenidyl.
• antidepressants including tricyclic antidepressants (such as amitriptyline) and monoamine oxidase inhibitors (MAOI’s), a type of medicine used to treat severe depression.
• phenothiazines (medicines used to treat serious mental disorders) e.g. chlorpromazine.
• medicines used to treat high blood pressure (adrenergic blockers) such as guanethidine.

If you have any doubts about whether you should use this medicine talk to your doctor, pharmacist or nurse.

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, pharmacist or nurse for advice before taking this medicine.

Driving and using machines

Pilocarpine hydrochloride eye drops may affect your vision, in particular, you may have problems seeing well at night. If this happens to you, do not drive or use any tools or machines until you can see clearly.

This medicine contains 1.0 mg of the preservative benzalkonium chloride in each 10ml which is equivalent to 0.1 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove soft contact lenses, before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor, pharmacist or nurse.

3. HOW TO USE PILOCARPINE HYDROCHLORIDE EYE DROPS

Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. Your doctor will decide how much you need based on the severity of your condition and your response to treatment. Do not use more than once every 6 hours.

Always complete a course of treatment. Do not stop because you feel better. Use this medicine only in your eyes. PACKAGE LEAFLET: INFORMATION FOR THE USER

Pilocarpine Hydrochloride 2% w/v eye drops, solution ^{Adults (including the elderly)}

The usual dose is one drop in the affected eye every 6 hours until the raised intra-ocular pressure is controlled. No dosage restrictions are necessary in the elderly.

Children and adolescents:

The usual dose is one drop in the affected eye every 6 hours until the raised intra-ocular pressure is controlled. However, in patients under the age of 18 years, start treatment with 1% pilocar-pine eye drops. After assessing efficacy and tolerability, the strength may be increased to 2% pilocarpine eye drops.

Instructions for use:

1. 1.

   Twist the cap to break the seal and

   then remove the locking ring. 2. Do not use if the seal is already

   broken.

2. 3.

   Wash your hands well before use. 4. Remove the outer cap. If you are

   putting in the eye drops yourself, you should use a mirror.

3. 5.

   Tilt your head back and look up at

   the ceiling.

4. 6.

   Pull the lower lid of the eye out to

   form a small pocket between your eyelid and your eye.

5. 7.

   Hold the container between the

   thumb and middle finger of the other hand, turn the bottle upside down near to the eye, try not to touch the eye with the nozzle.

6. 8.

   Apply enough pressure to the bottle

   to release one drop of the medicine. 9. Immediately close your eyes once

   you are sure that you have correctly applied the drop in the eye. 10. If you think that you have missed

   your eye, then instill another drop. 11. Repeat steps 5-10 above for your

   other eye if you have been told to use this medicine in both eyes. 12. Replace the outer cap on the bottle,

   trying not to touch the applicator tip with anything, including the eye or your fingers.

7. 13. Wash your hands.

If you use more Pilocarpine hydrochloride eye drops than you should

If you feel you may have used too much of your medicine, contact your doctor, pharmacist, nurse or your nearest hospital casualty unit.

If you swallow any Pilocarpine hydrochloride eye drops

Use this medicine only in your eyes. If you have swallowed, or you suspect someone else has swallowed any Pilocarpine hydrochloride Eye Drops, contact your doctor, pharmacist, nurse or your nearest hospital casualty unit. Always take this leaflet and the medicine bottle with you if possible, even if empty.

If you forget to use Pilocarpine hydrochloride eye drops

If you miss a dose of this medicine, use them as soon as you remember unless it is nearly time for the next dose, then carry on using it as before. Do not take a double dose to make up for one you have missed.

If you stop using Pilocarpine hydrochloride eye drops

You should keep using this medicine for as long as your doctor has asked. Your treatment is helping your condition, even if you have not noticed a difference in how you feel. Should you need to stop your treatment, your doctor will advise you how to do this.

If you have any further questions on the use of the medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 patients):

• smarting, burning or stinging on instillation
• eye itching or discomfort
• red eye

• reduced vision especially in poor light - temporary short sightedness

  • headache and brow ache (especially in young patients at the beginning of treatment)

Rare (may affect up to 1 in 1,000 patients):

• swelling, redness or soreness of the eyelid and front of the eye (allergy) - sudden increase in pressure within the eye
• watery eyes
• detachment of the retina (the inner surface of the eye)
• increase in secretion of saliva and sweating
• trembling or shaking
• change in blood pressure or in the way your heart beats
• wheezing and breathing difficulties - feeling (nausea) or being sick (vomiting)
• diarrhoea
• excessive urination
• nasal discharge and sneezing You may not know if you have some of the side effects. Your doctor will detect them during examinations.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. 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 PILOCARPI-NE HYDROCHLORIDE EYE DROPS

Keep this medicine out of the sight and reach of children. Make sure the container is properly closed after each use.

Store bottle upright, below 25°C, and in the original carton in order to protect from light. Do not freeze.

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

Once you have opened the bottle it should be disposed of after 4 weeks. 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 environ-ment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pilocarpine hydrochloride eye drops contains

• The active substance is Pilocarpine hydrochloride 2.0% w/v
• The other ingredients are benzalkoni-um chloride, water for injection, hydrochloric acid (E507) and sodium hydroxide (E524).

What Pilocarpine hydrochloride eye drops looks like and contents of the pack

Pilocarpine hydrochloride Eye Drops are a clear, colorless and sterile solution with each bottle containing 10ml of the solution. Pilocarpine hydrochloride Eye Drops is supplied in a pack containing 1 plastic bottle each with a screw cap.

Marketing Authorisation Holder

Blumont Pharma Ltd

23 Moortown Close,

Grantham, NG31 9GG, UK

Manufacturer

Farmigea S.p.A,

Via Giovan Battista Oliva 6-8, 56121 Pisa, Italy

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This leaflet was last revised on 05/2025

PL 31103/0040

PIL SIZE: 135 x 425mm

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