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 详细处方信息以本药内容附件PDF文件（201041322232217.pdf）的“原文Priscribing Information”为准
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部分中文TIMOPTOL-XE处方资料（仅供参考）

TIMOLOL MALEATE（马来酸噻吗洛尔）
　　本品主要成分及其化学名称为：主要成分是马来酸噻吗洛尔，其化学名为：（一）-1-（叔丁氨基）-3-［（4-吗啉基-1，2，5-噻二唑-3-基）氧］-2-丙醇顺丁稀二酸盐。
　　C13H24N4O3S·C4H4O4，
　　分子量：432.49
　　性状：本品为无色的澄明液体。
　　适应症：对原发性开角型青光眼具有良好的降低眼内压疗效。对于某些继发性青光眼，高眼压症，部分原发性闭角型青光眼以及其他药物及手术无效的青光眼，加用本品滴眼可进一—步增强降眼压效果。
　　用法用量：滴眼，一次1滴，一日1—2次，如眼压已控制，可改为一日1次。如原用其他药物，住改用本品治疗时．原药物不宜突然停用，应自滴用本品的第二天起逐渐停用
　　禁忌：
　　1．支气管哮喘者或有支气管哮喘史者，严重慢性阻塞性肺部疾病。2．窦性心动过缓，II或III度房室传导阻滞，明显心衰，心源性休克。3．对本品过敏者。
　　注意事项：
　　1．当出现呼吸急促、脉搏明显减慢、过敏等症状时，请立即停止使用本品。2．使用中若出现脑供血不足症状时应立即停药，3．心功能损害者，使用本品时应避免服用钙离子拮抗剂．4．对无心衰史的患者，如出现心衰症状应立即停药。5.正在服用儿茶酚胺耗竭药(如利血平)者，使用本品时应严密观察。6．冠状动脉疾患、糖尿病、甲状腺功能亢进和重症肌无力患者，用本品滴眼时需遵医嘱。7．本品慎用于自发性低血糖患者及接受胰岛素或口服降糖药治疗的患者，因p受体阻滞剂可掩盖低血糖症状。8．本品不宜单独用于治疗闭角型青光眼。9．与其他滴眼液联合使用时，请间隔lO分钟以上。10．定期复查眼压，根据眼压变化调整用药方案11．用前应摇匀，避免容器尖端接触眼睛，防止滴眼液污染。[孕妇及哺乳期妇女用药]本品对于孕妇的安全性尚未确定。滴眼后可在哺乳期妇女乳汁中测到本品，因对授乳婴儿具有多种潜在不良反应．需根据滴用本品对母亲的重要性决定终止哺乳或终止用药，[儿童用药]本品对于儿童的安全性和疗效尚未确定。
　　药物相互作用：
　　1．与肾上腺素合用可引起瞳孔扩大。2．不主张两种局部p受体阻断剂同时应用。3．本品与钙通道拮抗剂合用应慎重，囚可引起房室传导阻滞，左心室衰竭及低血压。肘心功能受损的患者，应避免两种药合并使用4．正在服用儿茶酚胺耗竭药(如利血平)者，使用本品时应严密观察，因可引起低血压和明显的心动过缓。5．本品与洋地黄类和钙通道拮抗剂合用可进一步延长房室传导时间。 6，本品与奎宁丁合用能引起心率减慢等全身p受休阻断的副作用。可能的原因是奎宁丁可抑制P450酶和CYPZD6对噻吗洛尔的代谢作用。
　　药理作用：
　　药理作用：马来酸噻吗洛尔是一种非选择性p—肾上腺能受体阻滞剂，没有明显的内源性拟交感活性和局麻作用，对心肌无直接抑制作用。本品为马来酸噻吗洛尔滴眼液．对高眼压患者和正常人均有降低眼内压作用、其降低眼内压的确切机理尚不清楚，眼压描记和房水荧光光度研究提示本品的降眼压作用与减少房水生成有关非临床毒理研究：致癌性：动物实验显示长期大量口服马来酸噻吗洛尔可使雄性大鼠肾卜腺嗜铬细胞瘤，雌性小鼠良性及恶性肺部肿瘤，良性子宫息肉及乳腺痛的发生率明显增高。生殖毒性：动物实验显示大剂量门服马来酸噻吗洛尔，对雄、雌性小鼠的生殖功能均无影响。
    孕妇及哺乳期妇女用药：本品对于孕妇的安全性尚未确定。滴眼后可在哺乳期妇女乳汁中测到本品，因对授乳婴儿具有多种潜在不良反应，需根据滴用本品对母亲的重要性决定终止哺乳或终止用药。
　　儿童用药：本品对于儿童的安全性和疗效尚未确定。
　　药物相互作用：1.与肾上腺素合用可引起瞳孔扩大。2.不主张两种局部β受体阻断剂同时应用。3.本品与钙通道拮抗剂合用应慎重，因可引起房室传导阻滞，左心室衰竭及低血压。对心功能受损的患者，应避免两种药合并使用。4.正在服用儿茶酚胺耗竭药（如利血平）者，使用本品时应严密观察，因可引起低血压和明显的心动过缓。5.本品与洋地黄类和钙通道拮抗剂合用可进一步延长房室传导时间。6.本品与奎宁丁合用能引起心率减慢等全身β受体阻断的副作用。可能的原因是奎宁丁可抑制P450酶和CYPZD6对噻吗洛尔的代谢作用。
　　药物过量：过量应用本品可引起类似全身应用β受体阻断剂的副作用，如头晕，头痛，气短，心动过缓，支气管痉挛及心搏停止。
　　包装：聚乙烯塑料眼药瓶。
　　贮藏：遮光，密闭保存。
　　药物毒理：药理作用： 马来酸噻吗洛尔是一种非选择性β-肾上腺能受体阻滞剂，没有明显的内源性拟交感活性和局麻作用。对心肌无直接抑制作用。本品为马来酸噻码洛尔滴眼液，对高眼压患者和正常人均有降低眼内压作用。其降低眼内压的确切机理尚不清楚，眼压描记和房水荧光光度研 究提示本品的降眼压作用与减少房水生成有关。 非临床毒理研究： 致癌性：动物实验显示长期大量口服马来酸噻吗洛尔可使雄性大鼠肾上腺嗜铬细胞瘤，雌牲小鼠良性及恶性肺部肿瘤，良性子宫息肉及乳腺癌的发生率明显增高。 生殖毒性：动物实验显示大剂量口服马来酸噻吗洛尔，对雄、雌性小鼠的生殖功能均无影响。 
　　药代动力学：动物实验显示，用0．5本品对家兔单剂量滴眼，房水和血中的药物峰浓度出现在用药后30分钟，半衰期为1．5小时。全身吸收的马来酸噻吗洛尔在肝内代谢，70％的药物原型随尿排出。对6个接受治疗者的血浆药物浓度测定显示，每日用0．5％本品滴眼2次，早晨滴药后的平均血浆峰浓度为0．46ng／ml，下午滴眼后约为0．35ng/ml.

TIMOPTOL-XE®
timolol maleate
2.5 mL ophthalmic solution

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What is in this leaflet
This leaflet answers some common questions about TIMOPTOL-XE. 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 TIMOPTOL-XE against the benefits they expect it will have for you.

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

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

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What TIMOPTOL-XE is used for
TIMOPTOL-XE 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 TIMOPTOL-XE helps control your glaucoma it does not cure it.

TIMOPTOL-XEis used, either alone or in combination with other eye drops or medicines, to lower raised pressure within your eye(s).

TIMOPTOL-XE lowers pressure in the eye by reducing the production of fluid.

TIMOPTOL-XE belongs to a family of medicines called beta-blockers.

TIMOPTOL-XE is not addictive.

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Before you use TIMOPTOL-XE
When you must not use it
Do not use TIMOPTOL-XE if you have an allergy to TIMOPTOL-XE or any of the ingredients listed at the end of this leaflet.

Do not use TIMOPTOL-XE 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 TIMOPTOL-XE if you are breastfeeding or plan to breastfeed.
Your baby may absorb this medicine from breast milk and therefore there is a possibility of harm to the baby.

Do not use TIMOPTOL-XE 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 TIMOPTOL-XE, talk to your doctor.

Do not use TIMOPTOL-XE in a child.
The safety and effectiveness of TIMOPTOL XE 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 TIMOPTOL-XE 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.if you wear soft contact lenses you should consult your doctor before using TIMOPTOL-XE
6.if you have had an allergy 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 TIMOPTOL-XE.

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 TIMOPTOL-XE may interfere with each other. These include:

•medicines for high blood pressure or heart conditions, including a group of medicines called beta-blockers
•digoxin, a medicine used to treat heart failure
•quinidine, a medicine used to treat irregular heart beats
•medicines to treat depression.
These medicines may be affected by TIMOPTOL-XE, or may affect how well it works. You may need different amounts of your medicines, 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 TIMOPTOL-XE.

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How to use TIMOPTOL-XE
How much to use
Your doctor will tell you how many drops you need to use each day. Use TIMOPTOL-XE only when prescribed by your doctor.

The usual dose for adults is one drop of TIMOPTOL-XE once a day, in either one or both eyes.

TIMOPTOL-XE contains a new delivery vehicle, gellan gum. This vehicle allows the eye drop to form a clear gel when it contacts the eye. This gel increases the contact time of timolol maleate with the eye. This means TIMOPTOL-XE needs to be administered only once a day.

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

Use TIMOPTOL-XE once a day, 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.

If your doctor recommends that you use TIMOPTOL-XE with another eye drop, use the other medicine at least 10 minutes before TIMOPTOL-XE.

Before opening the bottle for the first time make sure the two safety seals joining the cap to the bottle are not broken. If they are, do not use the bottle and return it to your pharmacist.

You will notice a small space between the cap and the bottle. This is normal.

How to use it
Before opening the bottle for the first time, make sure the two safety seals joining the cap to the bottle are not broken. If they are, do not use the bottle and return it to your pharmacist.

You will notice a small space between the cap and the bottle - this is normal.

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.

1.Wash your hands well with soap and water.
2.To open the bottle for the first time, hold the bottle upright, and turn the cap in the direction of the arrows until you can lift it off. This will break the two safety seals.
3.Locate the "finger press" area on the side of the bottle between the vertical lines.
4.Hold the bottle upside down in one hand, with your thumb or index finger over the "finger press" area and place the other finger on the other side of the bottle. Do not insert fingers into base of 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.Hold the bottle vertically and put the tip close to your lower eyelid. Do not let it touch your eye.
8.Release one drop into the pouch formed between your eye and eyelid by gently pressing on the "finger press" area.
9.Close your eye and keep it closed for a couple of minutes. 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. Do not blink or rub your eye.
10.Replace the cap. Turn it clockwise until firm resistance is felt (approximately one full turn). Do not over tighten the cap.
11.Wash your hands again with soap and water to remove any residue.
Wait at least 15 minutes before replacing your contact lenses.

These eye drops should be used at least 10 minutes before or after using any other eye preparation. Store the bottle away from direct sunlight, preferably in a cool place where the temperature stays below 30°C.

At the end of use, you will notice a small quantity of solution remaining in the bottle. This retained solution cannot be removed and is normal.

Discard any remaining solution 4 weeks after opening the bottle.

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
TIMOPTOL-XE helps control your condition but does not cure it. Therefore TIMOPTOL-XE must be used every day. Continue using TIMOPTOL-XE 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 TIMOPTOL-XE, or used too many drops, immediately telephone your doctor or National Poisons 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 TIMOPTOL-XE 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, or have wheezing or difficulty breathing.

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While you are using TIMOPTOL-XE
Things you must do
Have your eye pressure checked when your eye specialist says, to make sure TIMOPTOL-XE 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 TIMOPTOL-XE because of possible contamination of the old one, or may advise you to stop your treatment with TIMOPTOL-XE.

If you become pregnant while using TIMOPTOL-XE tell your doctor.

If you are about to be started on any new medicine tell your doctor and pharmacist that you are using TIMOPTOL-XE.

Things you must not do
Do not give TIMOPTOL-XE to anyone else, even if they have the same condition as you.

Do not stop using TIMOPTOL-XE without first talking to your doctor.

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

Things to be careful of
Be careful driving or operating machinery until you know how TIMOPTOL-XE affects you.

TIMOPTOL-XE may cause temporary blurred vision for 30 seconds to 5 minutes immediately after using the drops. Make sure that your vision is clear before driving a car or operating machinery.

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Adverse Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using TIMOPTOL-XE.

TIMOPTOL-XE 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 which generally lasts from 30 seconds to 5 minutes
•double 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
•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 TIMOPTOL-XE.

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 TIMOPTOL-XE 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.

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After using TIMOPTOL-XE
Storage
Keep your eye drops in a cool dry place where the temperature stays below 30°C.

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 the eye drops and throw out any remaining solution 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.

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Product description
How does it come?
TIMOPTOL-XE comes as eye drops in a 2.5 mL dropper pack. It is available in two strengths.

Ingredients
Active ingredient:
•TIMOPTOL-XE 0.25% - timolol maleate, equivalent to timolol 0.25%
•TIMOPTOL-XE 0.5% - timolol maleate, equivalent to timolol 0.5%
Inactive ingredients:
•gellan gum
•mannitol
•tromethamine
•benzododecinium bromide as preservative

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 详细处方信息以本药内容附件PDF文件（201041322232217.pdf）的“原文Priscribing Information”为准
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于2010年4月14日更新