Consumer Medicine Information

TIMPILO^®

5mL ophthalmic solution

timolol maleate/pilocarpine hydrochloride

What is in this leaflet

This leaflet answers some common questions about TIMPILO. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using TIMPILO against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What TIMPILO is used for

TIMPILO is used to lower raised pressure in the eye and to treat glaucoma. Glaucoma is a condition in which the pressure of fluid in the eye may be high. However, some people with glaucoma may have normal eye pressure. Also, some people with raised eye pressure may not have glaucoma.

Glaucoma is usually caused by a build up of the fluid, which flows through the eye. This build up occurs because the fluid drains out of your eye more slowly than it is being pumped in. Since new fluid continues to enter the eye, joining the fluid already there, the pressure continues to rise. This raised pressure may damage the back of the eye resulting in gradual loss of sight. Damage can progress so slowly that the person is not aware of this gradual loss of sight. Sometimes even normal eye pressure is associated with damage to the back of the eye.

There are usually no symptoms of glaucoma. The only way of knowing that you have glaucoma is to have your eye pressure, optic nerve and visual field checked by an eye specialist or optometrist. If glaucoma is not treated it can lead to serious problems. You may have no symptoms but eventually glaucoma can lead to total blindness. In fact, untreated glaucoma is one of the most common causes of blindness.

Although TIMPILO helps control your glaucoma it does not cure it.

TIMPILO is made up of two active ingredients, timolol maleate and pilocarpine hydrochloride. Timolol maleate lowers pressure in the eye by reducing the production of fluid. Pilocarpine hydrochloride works by improving the flow of fluid out of the eye.

Timolol maleate belongs to a family of medicines called beta-blockers.

TIMPILO is not addictive.

Before you use TIMPILO

When you must not use it

Do not use TIMPILO if you have an allergy to TIMPILO or any of the ingredients listed at the end of this leaflet.

Do not use TIMPILO if:

• you have asthma, or a history of asthma, chronic obstructive lung disease (emphysema) or other breathing problems
• you have certain heart conditions, such as a very slow heart rate, an irregular heartbeat, or heart failure.

Do not use TIMPILO if you are breast-feeding or intend to breast-feed.

Your baby may absorb this medicine from breast milk and therefore there is a possibility of harm to the baby.

Do not use TIMPILO if:

• your iris (coloured section of the eye) is inflamed
  If your iris is inflamed your eye would be painful and red with blurred vision.
• you have a history of detached retina
  The retina is the back part of the eye which if moved from its correct position causes sudden loss of vision.

Do not put the eye drops into your eye(s) while you are wearing soft contact lenses.
The preservative in TIMPILO (benzalkonium chloride) may be absorbed by soft contact lenses. Therefore TIMPILO should not be administered while wearing soft contact lenses. The contact lenses should be removed before application of the drops and not reinserted earlier than 15 minutes after use..

Do not use TIMPILO if:

• the seal around the cap is broken
• the bottle shows signs of tampering
• the expiry date on the pack has passed
  If you use this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start using TIMPILO, talk to your doctor.

Do not use TIMPILO in a child.

The safety and effectiveness of TIMPILO in children have not been established.

Before you start to use it

Tell your doctor if:

1. you are pregnant or intend to become pregnant
   Your doctor will discuss the possible risks and benefits of using TIMPILO during pregnancy and a decision can be made if you should or should not use it.
2. you have any medical conditions, especially the following:
   • heart disease
   • lung disease
3. you are already using another beta-blocker eye drop
   It is not recommended to use two beta-blocker eye drops at the same time.
4. you have a history of allergic problems, including eczema, hives or hay fever
5. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell them before you use any TIMPILO.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines and TIMPILO may interfere with each other. These include:-

• medicines for high blood pressure or other heart conditions, including a group of medicines called beta-blockers
• quinidine, a medicine used to treat irregular heart beats
• some other eye drops

These medicines may be affected by TIMPILO, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while using TIMPILO.

How to use TIMPILO

How much to use

Your doctor will tell you how many drops you need to use each day.

Use TIMPILO only when prescribed by your doctor.

The usual dose for adults is one drop of TIMPILO twice a day, in either one or both eyes.

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

Use TIMPILO every day, at about the same time each day, unless your doctor tells you otherwise.

Using your eye drops at the same time each day will have the best effect on your eye pressure. It will also help you remember when to use the eye drops.

After using TIMPILO, wait at least 5 minutes before putting any other eye drops in your eye(s).

How to use it

You may find it easier to put drops in your eye while you are sitting or lying down.

If you are wearing contact lenses, remove them before putting the drops in your eye.

There are two solutions in the bottle of TIMPILO that are separated by a plug. Before using TIMPILO for the first time, these solutions must be mixed together. Follow the steps recommended in the leaflet in the box. Note, when opening a new bottle of TIMPILO the bottom part of the bottle is removed first, not the cap.
Once the solutions are mixed, the drops are ready to be used.

1. Wash your hands well with soap and water.
2. Remove the lid (light mauve or mauve colour).
3. Hold the bottle upside down and place the thumb and middle finger on the sides.
4. Place the index finger on the bottom of the bottle.
5. Using your other hand, gently pull down your lower eyelid to form a pouch.
6. Tilt your head back and look up.
7. Put the tip of the bottle close to your lower eyelid. Do not allow the tip of the container to touch the eye or areas around the eye. It may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the container, keep the tip of the container away from contact with any surface.
8. Apply enough pressure on the bottom of the bottle with the index finger to put a single drop of medicine in the eye. Remove the index finger from the bottle.
9. Close your eye and keep it closed. Do not blink or rub your eye.
10. While your eye is still closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body. Ask your doctor for more specific instructions on this technique.
11. Replace the cap, sealing it tightly. Do not overtighten the cap.
12. Wash your hands again with soap and water to remove any residue.

Wait at least 15 minutes before replacing your contact lenses.

Be careful not to touch the dropper tip against your eye, eyelid or anything else to avoid contaminating the eye drops.

Contaminated eye drops may give you an eye infection.

You may feel a slight burning sensation in the eye shortly after using the eye drops. If this persists, or is very uncomfortable, contact your doctor or pharmacist.

How long to use it

TIMPILO helps control your condition but does not cure it. Therefore TIMPILO must be used every day. Continue using TIMPILO for as long as your doctor prescribes.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use the drops as soon as you remember, and then go back to using them as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not use double the amount to make up for the dose that you missed.

If you have trouble remembering to use your eye drops, ask your pharmacist for some hints.

If you use too much (overdose)

If you think that you or anyone else may have swallowed any or all of the contents of a bottle of TIMPILO, or used too many drops, immediately telephone your doctor or Poisons Information Centre (telephone 0800 POISON or 0800 764 766) for advice, or go to accident and emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.

If TIMPILO is accidentally swallowed, or if you use too many drops, you may feel light-headed or dizzy, you may faint, have a very slow pulse rate, have wheezing or difficulty breathing. Other effects include nausea, vomiting, stomach cramps, diarrhoea, headache, mental confusion and drooling.

While you are using TIMPILO

Things you must do

Have your eye pressure checked when your eye specialist says, to make sure TIMPILO is working.

If you develop an eye infection, receive an eye injury, or have eye surgery tell your doctor.

Your doctor may tell you to use a new container of TIMPILO because of possible contamination of the old one, or may advise you to stop your treatment with TIMPILO.

If you become pregnant while using TIMPILO, tell your doctor.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are using TIMPILO.

Things you must not do

Do not give TIMPILO to anyone else, even if they have the same condition as you.

Do not stop using TIMPILO without first talking to your doctor.

If you stop using your eye drops, your eye pressure may rise again and damage to your eye may occur.

Things to be careful of

Be careful driving, especially at night, or operating machinery until you know how TIMPILO affects you.

TIMPILO may affect your ability to see clearly at night or in poor lighting. TIMPILO may also cause blurred vision or dizziness in some people. Make sure you know how you react to TIMPILO or that your vision is clear before driving a car or operating machinery.

Adverse Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using TIMPILO.

TIMPILO helps most people with high eye pressure and glaucoma, but it may have unwanted adverse effects in a few people. All medicines can have adverse effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

Problems with your eye/s such as:

• blurred vision, double vision, or poor night vision
• allergic reactions including redness, swelling and/or itching of the eye
• burning and stinging of the eyes
• irritation or feeling of having something in the eye, dry eyes
• discharge
• short sightedness
• drooping of eyelid/s

Difficulty thinking or working because of:

• headache
• tiredness, weakness
• ringing or buzzing in the ears
• difficulty sleeping, nightmares
• changes in mood such as depression, memory loss

Stomach or bowel problems:

• feeling sick (nausea), upset stomach
• diarrhoea
• dry mouth

Changes in the way your hands and feet feel such as:

• cold hands or feet
• numbness, tingling and colour change (white, blue then red) in fingers when exposed to the cold (Raynaud's Phenomenon)
• numbness or tingling in the fingers or toes

Cough

Hair loss or thinning

Less desire for sex

These are usually mild adverse effects of TIMPILO.

Tell your doctor immediately if you notice any of the following:

• fast or irregular heart beats, also called palpitations
• dizziness and light-headedness, which may be due to low blood pressure
• skin rash, itching
• swelling of the hands, feet, ankles or legs

These may be serious adverse effects. You may need urgent medical attention.
Serious adverse effects are rare.

If any of the following happen, stop using TIMPILO and tell your doctor immediately or go to accident and emergency at your nearest hospital:

• wheezing, difficulty in breathing, shortness of breath
• very slow pulse, chest pain
• fainting
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing or swallowing
• severe and sudden onset of pinkish, itchy swellings on the skin, also called hives or nettlerash

These are serious adverse effects. You may need urgent medical attention. These adverse effects are rare.

Other adverse effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them.

After using TIMPILO

Storage

Keep your eye drops in a cool place where the temperature stays below 25°C. Do not freeze the eye drops.

Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills.

Do not carry the eye drops in pockets of your clothes.

Heat and dampness can destroy some medicines.

Keep the eye drops away from direct light.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not leave the lid off the bottle for any length of time to avoid contaminating the eye drops.

Disposal

Write the date on the bottle when you open and mix the eye drops, and throw any remaining solution out after four weeks.

Eye drops contain a preservative, which helps prevent germs growing in the solution for the first four weeks after opening the bottle. After this time there is a greater risk that the drops may become contaminated and cause an eye infection. A new bottle should be opened.

If your doctor tells you to stop using the eye drops or they have passed their expiry date, ask your pharmacist what to do with any remaining solution.

Product description

How does it come?

TIMPILO comes as eye drops in a 5 mL dropper pack. It is available in two strengths.

Ingredients

Active ingredients:

TIMPILO 2:

• timolol maleate, equivalent to timolol 0.5%
• pilocarpine hydrochloride 2%

TIMPILO 4:

• timolol maleate, equivalent to timolol 0.5%
• pilocarpine hydrochloride 4%

Inactive ingredients:

• sodium phosphate
• benzalkonium chloride as preservative

Supplier

TIMPILO is supplied in New Zealand by:

Merck Sharp & Dohme (New Zealand) Limited
P.O. Box 99851, Newmarket
Auckland
NEW ZEALAND
Tel: 0800 500 673

This leaflet was prepared in May 2003

CP-TPL-042003(200503)

^®Registered Trademark of Merck & Co Inc., Whitehouse Station, NJ, USA