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PACKAGE LEAFLET: INFORMATION FORTHE USER

|9. Blink your eye a few times.

10.    If you think that you have missed your eye, then insert another drop.

11.    Repeat steps 5-10 above for your other eye if you have been told to use Pilocarpine Eye Drops 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

13.    Wash your hands.

If you are unsure on how to use Pilocarpine Eye Drops talk to your doctor or pharmacist.

How much to use Adults and the elderly

Your doctor will decide how much you need based on the severity of your condition and your response to treatment.

To treat glaucoma:_

The usual dose is one or two drops every six hours pr as prescribed by your doctor.

•    diarrhoea

•    increase in saliva

•    increased flow of tears

•    trembling or shaking

Common side effects are:

•    itching, smarting and a burning sensation around the eye

•    a red skin rash with itching (urticaria)

•    temporarily blurred vision

•    temporary short sightedness

•    difficulty in seeing in poor light

•    enlargement of the veins in the eye

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

You may not know if you have some of the side effects. Your doctor will detect them during examinations.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

When used before eye surgery:

The usual dose is one drop every five minutes or as directed by your doctor.

5. Storing Pilocarpine Eye Drops

Keep out of the reach and sight of children

To reverse the effect of drugs that make the pupil bf the eye get larger:

The usual dose is one drop every 5 minutes until |the pupil is normal or as directed by your doctor. Children

Use in children will only be considered if the child's doctor considers it essential.

If you use too many Pilocarpine Eye Drops

If you are at all concerned that you have used or been given too much of this medicine please tell your doctor.

If you swallow any Pilocarpine Eye Drops

Pilocarpine Eye Drops are for external use only. If you have swallowed or you suspect someone else has swallowed any Pilocarpine Eye Drops, contact your doctor or go to the accident and emergency department of your local hospital at once. Always [take the container and this leaflet with you if possible, even if empty.

If you miss a dose of Pilocarpine Eye Drops

If you miss a dose of Pilocarpine Eye Drops, use them as soon as you remember unless it is nearly Itime 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 Eye Drops You should keep using Pilocarpine Eye Drops 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 ^dvise you how to do this.

Make sure the container is properly closed after each use.

Store Pilocarpine Eye Drops in their original container to protect from moisture and away from direct light. Store below 25°C

Do not use Pilocarpine Eye Drops after the expiry date which is printed on the label. The expiry date refers to the last day of that month.

Dispose of this medicine four weeks after opening.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required.

I hese measures will help to protect the environment.

6. Further Information

What Pilocarpine Eye Drops contain

The active substance is Pilocarpine hydrochloride 0.5,1,2, 3 or 4% w/v

The other ingredients are benzalkonium chloride and purified water.

What Pilocarpine Eye Drops look like and contents of the pack

Pilocarpine Eye Drops are a clear, colourless and sterile solution supplied in a plastic dropper bottle. Each bottle contains 10ml of the solution.

Product Licence Holder:

Martindale Pharmaceuticals Ltd. Bampton Road, Harold Hill, Romford Essex RM3 8UG.UK

4. Possible side effects

Like all medicines, Pilocarpine Eye Drops are Suitable for most people, but they can sometimes tause side effects, although not everyone gets |them.

Some side effects can be serious Stop treatment with the eye drops and tell your doctor immediately if you notice any of the following rare symptoms:

•    bleeding within the front of the eye

! • detachment of the retina (the inner surface of_

the eye)

•    wheezing and breathing difficulties

•    change in blood pressure or changes in the way your heart beats

Manufacturers:

Martindale Pharmaceuticals Ltd. Bampton Road, Harold Hill, Romford Essex RM3 8UG.UK Farmigea S.p.A. Via G.B. Oliva 6/8,56121 Pisa, Italy

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.

Product licence numbers:

Pilocarpine Eye Drops 0.5% w/v PL 0156/0076 Pilocarpine Eye Drops 1 % w/v PL 0156/0079 -Pilo€arpine-Eye-Drops-2%-w/v-PD01-56/0Q80— Pilocarpine Eye Drops 3% w/v PL 0156/0077 Pilocarpine Eye Drops 4% w/v PL 0156/0078

This leaflet was last updated March 2011

Rare but less serious side-effects are:

•    feeling sick (nausea)

•    being sick (vomiting)

MARTINDALE PHARMA

Bampton Road, Harold Hill, Romford, RM3 8UG, UK

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Read all of this leaflet carefully before you start to use Pilocarpine Eye Drops. It contains important information

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, please ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your

In this leaflet:

1.    What Pilocarpine Eye Drops are and what are they usedfor

2.    Before using Pilocarpine Eye Drops

3.    How to use Pilocarpine Eye Drops

4.    Possible side effects

5.    Storing Pilocarpine Eye Drops

6.    Further information

1.    What Pilocarpine Eye Drops are and what are they 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 Eye Drops are used to treat certain forms of glaucoma (an increase in the pressure within the eye) and to reverse the effect of drugs that cause the pupil of the eye to get bigger.

2.    Before using Pilocarpine Eye Drops

Do not use Pilocarpine 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 are suffering from inflammation of the coloured part of the eye (acute iritis or anterior uveitis)

•    you are suffering from secondary glaucoma

•    you are wearing soft contact lenses.

Take special care with Pilocarpine eye drops if:

•    you are suffering from any heart problems

•    you have asthma

•    you have Parkinson's disease

•    you have problems in passing urine

•    you have high blood pressure

•    you have a stomach ulcer

•    you are pregnant or are breast-feeding f any of the above apply to you please consult your doctor before using Pilocarpine Eye Drops.

If you are unsure about how to use Pilocarpine Eye Drops talk to your doctor or pharmacist.

Taking other medicines

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

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 neostigmine) 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

•    medicines used to treat Parkinson's disease, such as benzatropine

•    antidepressents 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 or pharmacist.

Using Pilocarpine Eye Drops with food and drink

You are advised not to drink alcohol during your treatment with Pilocarpine Eye Drops. Pregnancy & breast-feeding

Pilocarpine Eye Drops should not be used if you are pregnant, trying to become pregnant or breast-feeding unless your doctor considers it essential.

Ask your doctor for advice before taking any medicine.

Effects on the ability to drive and use machines

Pilocarpine Eye Drops can cause difficulty in adapting to the dark. You should not drive or use machinery in poor light. The eye drops may also cause blurred vision. If this happens, you should not drive or operate machinery until you can see clearly. Important information about some of the ingredients of Pilocarpine Eye Drops This medicine contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses.

3. How to use Pilocarpine Eye Drops

Always use Pilocarpine Eye Drops exactly as your doctor has told you. Always complete a course of treatment. Do not stop because you feel better.

Soft contact lenses must not be worn during treatment with Pilocarpine Eye

Pilocarpine Eye Drops are for external use

Instructions for use

1.    Before opening a new bottle of Pilocarpine Eye Drops, please check that the safety strip on the bottom of the outer cap is unbroken.

2.    Twist the outer cap to break the seal

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.

5.    Tilt your head back and look up at the ceiling.

6.    Pull the lower lid of the eye out to form a small pocket between your eyelid and your eye.

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.

8.    Apply enough pressure to the bottle to release one to two drops, as directed by your doctor.

9.    Blink your eye a few times.

10.    If you think that you have missed your eye, then insert another drop.

11.    Repeat steps 5-10 above for your other eye if you have been told to use Pilocarpine Eye Drops in both eyes

Continued overleaf

12.    Replace the outer cap on the bottle, trying not to touch the applicator tip with anything, including the eye or your fingers

13.    Wash your hands.

f you are unsure on how to use Pilocarpine Eye Drops talk to your doctor or pharmacist. How much to use Adults and the elderly Your doctor will decide how much you need based on the severity of your condition and your response to treatment. To treat glaucoma:

The usual dose is one or two drops every six hours or as prescribed by your doctor. When used before eye surgery:

The usual dose is one drop every five minutes or as directed by your doctor.

To reverse the effect of drugs that make the pupil of the eye get larger:

The usual dose is one drop every 5 minutes until the pupil is normal or as directed by your doctor.

Children

Jse in children will only be considered if the child's doctor considers it essential. f you use too many Pilocarpine Eye

f you are at all concerned that you have used or been given too much of this medicine please tell your doctor. f you swallow any Pilocarpine Eye Drops Pilocarpine Eye Drops are for external use only. If you have swallowed or you suspect someone else has swallowed any Pilocarpine Eye Drops, contact your doctor or go to the accident and emergency department of your local hospital at once. Always take the container and this leaflet with you if possible, even if empty. f you miss a dose of Pilocarpine Eye

f you miss a dose of Pilocarpine Eye Drops, use them as soon as you remember unless t 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.

f you stop using Pilocarpine Eye Drops

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

4. Possible side effects

.ike all medicines, Pilocarpine Eye Drops are suitable for most people, but they can sometimes cause side effects, although not everyone gets them.

Some side effects can be serious Stop treatment with the eye drops and tell your doctor immediately if you notice any of the following rare symptoms:

•    bleeding within the front of the eye

•    detachment of the retina (the inner surface of the eye)

•    wheezing and breathing difficulties

•    change in blood pressure or changes in the way your heart beats

Rare but less serious side-effects are:

•    feeling sick (nausea)

•    being sick (vomiting)

•    increase in saliva

•    increased flow of tears

•    trembling or shaking Common side effects are:

•    itching, smarting and a burning sensation around the eye

•    a red skin rash with itching (urticaria)

•    temporarily blurred vision

•    temporary short sightedness

•    difficulty in seeing in poor light

•    enlargement of the veins in the eye

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

You may not know if you have some of the side effects. Your doctor will detect them during examinations.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5.    Storing Pilocarpine Eye Drops

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

Store Pilocarpine Eye Drops in their original container to protect from moisture and away from direct light. Store below 25°C Do not use Pilocarpine Eye Drops after the expiry date which is printed on the label. The expiry date refers to the last day of that month.

Dispose of this medicine four weeks after opening.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further Information

What Pilocarpine Eye Drops contain

The active substance is Pilocarpine hydrochloride 1,2 or 4% w/v The other ingredients are benzalkonium chloride and purified water.

What Pilocarpine Eye Drops look like and contents of the pack

Pilocarpine Eye Drops are a clear, colourless and sterile solution supplied in a plastic dropper bottle. Each bottle contains 10ml of the solution.

Product Licence Holder:

Martindale Pharmaceuticals Ltd. Bampton Road, Harold Hill, Romford Essex RM3 8UG.UK Manufacturer:

Tubilux Pharma S.p.A.

Via Costarica 20/22 00040 Pomezia (RM)

ITALY

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.

Product licence numbers:

Pilocarpine Eye Drops 1% w/v PL 0156/0079

Pilocarpine Eye Drops 2% w/v PL 0156/0080

Pilocarpine Eye Drops 4% w/v PL 0156/0078

This leaflet was last updated September 2014

MARTjNDALE PHARMA

Bampton Road, Harold Hill Romford RM3 BUG UK