AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension Timolol - United Kingdom[英国药品]

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AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension Timolol

2015-03-01 22:39:05 来源: 作者: 【大中小】浏览:476次评论:0条

For doctors

What is it and how is it used?

AZARGA is used to treat high pressure in the eye. This pressure can lead to an illness called glaucoma.

AZARGA is a combination of treatments for glaucoma.
It contains two active substances which work together to reduce pressure within the eye.

What do you have to consider before using it?

Do not use AZARGA

Take special care with AZARGA

Using other medicines

AZARGA can affect or be affected by other medicines you are taking, including other eye drops for the treatment of glaucoma. Tell your doctor if you are taking or intend to take medicines to lower blood pressure, heart medicines, medicines to treat diabetes, medicines to treat gastric ulcers, or antifungal, antiviral or antibiotic medicines.

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

Pregnancy and breast-feeding

You should not use AZARGA if you are pregnant or might get pregnant. Talk to your doctor before you use AZARGA.

If you are breast-feeding, you can use AZARGA.
Ask your doctor for advice before taking any medicine.

Driving and using machines

Do not drive or use machines until your vision is clear. You may find that your vision is blurred for a time just after using AZARGA.

One of the active ingredients may impair the ability of elderly patients to perform tasks requiring mental alertness and/or physical coordination. If affected take care when driving or using machines.

Important information about some of the ingredients of AZARGA

There is a preservative in AZARGA (benzalkonium chloride) that can discolour soft lenses and may cause eye irritation. Therefore, do not wear contact lenses whilst using AZARGA. Wait 15 minutes after using AZARGA before putting your lenses back in.

How is it used?

Always use AZARGA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is

Adults: One drop in the affected eye or eyes, twice a day-morning and night.
Only use AZARGA in both eyes if your doctor told you to. Take it for as long as your doctor told you to.

If a drop misses your eye, try again.

If you use more AZARGA than you should, rinse your eye with warm water. Do not put in any more drops until it is time for your next regular dose.

If you forget to use AZARGA, continue with the next dose as planned. Do not use a double dose to make up for the forgotten dose. Do not use more than one drop in the affected eye(s) twice daily.

If you stop using AZARGA without speaking to your doctor, the pressure in your eye will not be controlled which could lead to loss of sight.

If you are using other eye drops, wait at least 5 minutes between using AZARGA and the other drops.

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

What are possible side effects?

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

You can usually carry on taking the drops, unless the effects are serious. If you are worried, talk to your doctor or pharmacist.

The following side effects have been seen with AZARGA:

Common side effects
(affects 1 to 10 users in 100)

Effects in the eye: blurred vision, eye irritation, eye pain, abnormal sensation in eyes

General side effects: bad taste

Uncommon side effects
(affects 1 to 10 users in 1,000)

Effects in the eye: eye surface inflammation with surface damage-inflammation inside the eye-red eye-itchy eye-eyelid itching-redness-swelling, or crusting-eye discharge-eye allergy-dry eye-tired eyes

General side effects: chronic lung disease-decreased blood pressure-throat irritation-cough-difficulty sleeping-skin inflammation-redness or itching-runny nose-hair disorder

Additionally:

AZARGA is a combination of 2 currently marketed medicines.Side effects that have been observed with the individual medicines which may occur with AZARGA are as follows:

Effects in the eye: damage to the optic nerve-increased pressure in eye-deposits on the eye surface-corneal disorder-decreased eye sensation-inflammation or infection of the conjunctiva-abnormal, double or reduced vision-increased pigmentation of the eye-growth on surface of eye-increased tear production-eye swelling-sensitivity to light-decreased growth or number of eyelashes-drooping of the eyelids-inflammation of the eyelid glands

General side effects:

Heart and circulation: changes in heart rate or rhythm-chest pain-reduced heart function-stopping of the heart-increased blood pressure-decreased blood flow to the brain-stroke-swelling of the extremities

Respiratory: shortness of breath or difficulty breathing-cold symptoms-chest congestion-sinus infection-sneezing-stuffy nose-dry nose-nose bleeds-asthma

Nervous system and general disorders: depression-difficulty with memory-headache-nervousness-irritability-tiredness-shaking-feeling abnormal-fainting-dizziness-drowsiness-generalised or severe weakness

Gastric: nausea-vomiting-diarrhoea-intestinal gas or abdominal pain-inflammation of the throat-dry or abnormal sensation in mouth-decreased taste sensation-indigestion-stomach ache

Blood: abnormal liver function values-increased blood chlorine levels, or decreased red blood cell count as seen in a blood test

Allergy: increased allergic symptoms

Ear: ringing in the ears-sensation of spinning or dizziness

Skin: itching- rash-abnormal or decreased skin sensation-loss of hair

Muscular: generalised back, joint, or muscle pain-muscle spasms-pain in extremities-muscle weakness

Kidney: kidney pain such as lower back pain-frequent urination

Reproduction: decreased sex drive-male sexual difficulty

Metabolism: low blood sugar

If any of these side effects gets serious or if you notice any side effects not listed, please tell your doctor or pharmacist.

How should it be stored?

Keep outof the reach and sight of children.

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

This medicine does not require any special storage conditions.

Throw away the bottle 4 weeks after first opening to prevent infections, and use a new bottle. Write down the date of opening on the bottle label and carton label in the space provided.

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

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For doctors

What is it?

Azarga is an eye drop suspension that contains two active substances, brinzolamide and timolol.

What is it used for?

Azarga is used to reduce intra-ocular pressure (IOP, pressure inside the eye). It is used in adults with open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) or ocular hypertension (when the pressure in the eye is higher than normal). Azarga is used when treatment with a medicine containing only one active substance has been tried but has not reduced the IOP sufficiently.
The medicine can only be obtained with a prescription.

How is it used?

Azarga is given as one drop into the affected eye(s) twice a day. The suspension needs to be shaken well before use.

How does it work?

Raised IOP causes damage to the retina (the light-sensitive surface at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. This can result in serious vision loss and even blindness. By lowering the pressure, Azarga reduces the risk of damage.
Azarga contains two active substances, brinzolamide and timolol. The two substances work by reducing the production of the aqueous humour (the watery fluid in the eye) in different ways. Brinzolamide is a carbonic anhydrase inhibitor that works by blocking an enzyme called carbonic anhydrase, which produces bicarbonate ions in the body. Bicarbonate is required for the production of the aqueous humour. Brinzolamide has been authorised in the European Union (EU) as Azopt since 2000. Timolol is a beta-blocker that has been commonly used to treat glaucoma since the 1970s. The combined effect of the two substances is greater than either substance used alone.

How has it been studied?

The effects of Azarga were first tested in experimental models before being studied in humans. Azarga has been studied in two main studies involving a total of 960 adults with open-angle glaucoma or ocular hypertension. The first was a six-month study comparing Azarga with brinzolamide and with timolol used on their own in 523 patients. The second was a 12-month study comparing Azarga with the combination of timolol and dorzolamide (another carbonic anhydrase inhibitor) in 437 patients. In both studies, the main measure of effectiveness was the change in IOP over the first six months of treatment. IOP was measured in ‘millimetres of mercury’ (mmHg).

What benefits has it shown during the studies?

Azarga was more effective than either of the active substances used alone and was as effective as the combination of timolol and dorzolamide. In the first study, IOP fell from around 21 mmHg by 8.0 to 8.7 mmHg in the patients using Azarga. This compared with 5.1 to 5.6 mmHg in those using brinzolamide and 5.7 to 6.9 mmHg in those using timolol. In the second study, IOP had fallen from around 26 mmHg by around 8.3 mmHg after six months in both groups of patients.

What is the risk associated?

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that combining the two active substances in Azarga simplifies therapy and helps patients to stick to their treatment. The Committee decided that Azarga’s benefits are greater than its risks for the decrease of IOP in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. The Committee recommended that Azarga be given marketing authorisation.