PACKAGE LEAFLET

Package leaflet: Information for the patient

Oftidorix 20 mg/ml + 5 mg/ml eye drops, solution

Dorzolamide / Timolol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Oftidorix is and what it is used for

2.    What you need to know before you use Oftidorix

3.    How to use Oftidorix

4.    Possible side effects

5.    How to store Oftidorix

6.    Contents of the pack and other information

1. What Oftidorix is and what it is used for

Oftidorix is a combination of two medicines: dorzolamide and timolol.

•    Dorzolamide belongs to a group of medicines called “carbonic anhydrase inhibitors”.

•    Timolol belongs to a group of medicines called “beta blockers.

Oftidorix is prescribed to lower raised pressure within the eye in the treatment of glaucoma when beta-blocker eye drops used alone are not adequate.

2. What you need to know before you use Oftidorix

Do not use Oftidorix:

■    if you are allergic to dorzolamide, timolol, beta-blockers or any of the other ingredients of this medicine (listed in section 6),

■    if you have now or have had in past respiratory problems such as asthma, severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or longstanding cough),

■    if you have severe kidney problems, or a prior history of kidney stones,

■    if you have a disturbance in the pH (acid/alkali balance) of your blood,

■    if you have a slowheart beat, disorders of heart rhythm (irregular heart beats) or heart failure.

If you think any of these apply to you, do not use Oftidorix until you have consulted your doctor.

Warnings and precautions

Before you use this medicine, tell your doctor if you have now or have had in the past

■    coronary heart disease - symptoms can include chest pain or tightness, breathlessness or choking, heart failure, low blood pressure (hypotension)

■    breathing problems, asthma or chronic obstructive pulmonary disease (lung disease which may cause wheeziness, difficulty in breathing and/or longstanding cough

■    poor blood circulation disease (peripheral arterial disease such as Raynaud’s disease or Raynaud’s syndrome)

■    diabetes as timolol may mask signs and symptoms of low blood sugar

■    overactivity of the thyroid gland as timolol may mask signs and symptoms

If you have a history of heart disease your doctor may wish to monitor your pulse rate and other signs of this disease while you are using Oftidorix.

Tell your doctor if you now have or have had liver problems, if you have muscle weakness or have been diagnosed as having myasthenia gravis.

If you develop conjunctivitis (redness and irritation of the eye[s]), swelling of the eye or eyelids, skin rash, or itching in and around the eye contact your doctor immediately. Such symptoms may be due to an allergic reaction or may be a side-effect of Oftidorix (See ‘Possible Side Effects’).

Tell your doctor if you develop an eye infection, receive an eye injury, have eye surgery, develop other reactions or worsening of symptoms.

If you wear soft contact lenses, it is important that your lenses are removed before using your eye drops and not put back into your eyes until 15 minutes after using your eye drops as the preservative benzalkonium chloride may possibly discolour the contact lenses.

Tell your doctor before you have an operation that you are using Oftidorix as timolol may change effects of some medicines used during anaesthesia.

Use in elderly

In studies with Dorzolamide/Timolol eye drops solution, the effects of Dorzolamide/Timolol eye drops solution were similar in both elderly and younger patients.

Children and adolescents

There is limited experience with Oftidorix in infants and children.

Other medicines and Oftidorix

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Oftidorix can affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.

Tell your doctor if you are using or intend to use

■    medicines to lower blood pressure (calcium channel blockers, beta-blockers, guanethidine)

■    heart medicine ( antiarrhythmics amiodarone or quinidine (used also to treat some types of malaria, or digoxin)

■    medicines to treat diabetes.

■    another carbonic anhydrase inhibitor such as acetazolamide. You may be taking this type of medicine by mouth, as eye drops, or by some other method

■    medicines to treat depression or another psychiatric illness (fluoxetine, paroxetine, MAO-inhibitors)

■    parasympathomimetic medicine which may have been prescribed to help you pass urineor to help restore normal movements through the bowel

■    narcotics such as morphine used to treat moderate to severe pain

■    large doses of aspirin.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Oftidorix if you are pregnant unless your doctor considers it necessary.

Do not use Oftidorix if you are breast-feeding. Dorzolamide and timolol may get into your milk.

Driving and using machines

Oftidorix may cause side effects such as blurred vision in some patients. Do not drive or use any tools or machines until the symptoms have cleared.

Oftidorix contains the preservative benzalkonium chloride.

•    Benzalkonium chloride may cause eye irritation

•    Benzalkonium chloride is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait until 15 minutes before re-insertion.

3. How to use Oftidorix

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The appropriate dosage and duration of treatment will be established by your doctor.

The recommended dose is one drop in the affected eye(s) two times a day, for example in the morning and in the evening.

After using Oftidorix, press a finger into the corner of your eye, by the nose (picture 1) for 2 minutes. This helps to stop active substance getting into the rest of the body.

Picture 1

If you use Oftidorix with another eye drop, leave at least 10 minutes between putting in Oftidorix and the other medicine.

Do not change the dosage of the drug without consulting your doctor. If you must stop treatment, contact your doctor immediately.

Do not allow the tip of the container to touch your eye or areas around your 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.

In order to secure correct dosage - the dropper tip should not be enlarged.

Instructions for use:

It is recommended that you wash your hands before putting in your eye drops.

It may be easier to apply your eye drops in front of a mirror.

Picture 2

1. Before using the medication for the first time, be sure that the tamper-proof seal on the bottle neck is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.

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2.    Take off the cap of the bottle.

3.    Tilt your head back and gently pull your lower eyelid down to form a small pocket between your eyelid and your eye.

4.    Invert the bottle, and squeeze it until a single drop is dispensed into the eye as directed by your doctor. DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.

5.    Repeat steps 3 & 4 with the other eye if instructed to do so by your doctor.

6.    Put the cap back on and close the bottle straight after you have used it.

If you use more Oftidorix than you should

It is important to keep to the dose your doctor has prescribed. If you put too many drops in your eye or swallow any of the contents of the bottle, you may feel unwell, for example you may become light-headed, have difficulty breathing, or feel that your heart rate has slowed. If you feel any of the above effects you should seek medical attention immediately.

If you forget to use Oftidorix

It is important to use Oftidorix as prescribed by your doctor.

If you miss a dose, apply it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule.

Do not use a double dose to make up for forgotten individual doses.

If you stop taking Oftidorix

If you want to stop using this medicine talk to your doctor first.

If you have any further questions on the use of this 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.

You can usually carry on taking the drops, unless the effects are serious. If you're worried, talk to a doctor or pharmacist. Do not stop using Oftidorix without speaking to your doctor.

If you develop allergic reactions including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, you should stop Oftidorix and talk to your doctor immediately.

The following side effects may be seen with Oftidorix:

Very Common (affects more than 1 user in 10):

Burning and stinging of the eyes, unusual taste

Common (affects 1 to 10 users in 100):

Redness and or swelling in and around the eye(s), watering or itching of the eye(s), irritation in and and/or itching around the eye(s), feeling of having something in the eye (corneal erosion), decreased corneal sensitivity (not realising of getting something in the eye and not feeling pain), dry eyes, blurred vision, headache, sinusitis (feeling of tension or fullness in the nose), nausea, and fatigue.

Uncommon (affects 1 to 10 users in 1,000):

Dizziness, fainting, depression, inflammation of the iris, blurred vision ( after withdrawal of medication dilate of the pupil of the eye, slow heartbeat, shortness of breath, indigestion, and kidney stones (often marked by a sudden onset of excruciating, cramping pain in low back and/or side, groin, or abdomen).

Rare (affects 1 to 10 users in 10,000):

Systemic lupus erythematosus (an immune disease which may cause an inflammation of internal organs), tingling or numbness of the hands or feet, trouble sleeping, nightmares, memory loss, increases in signs and symptoms of myasthenia gravis (muscle disorder), decreased sex drive, temporary shortsightedness which may resolve when treatment is stopped, eye pain, development of fluid under the retina (choroidal detachment following filtration surgery), drooping of the eyelids, double vision, eyelid crusting, swelling of the cornea (with symptoms of visual disturbances), low pressure in the eye, ringing noises in ear, low blood pressure, irregular heartbeat, chest pain, palpitations (a quicker and/or irregular heartbeat), oedema heart attack (heart arrest), stroke,, reduced blood flow to the brain (cerebral ischemia), swelling or coldness of your hands and feet and reduced circulation in your arms and legs, leg cramps and/or leg pain when walking (claudication), changes in the ECG (atrioventricular block), heart failure or respiratory failure (with symptoms like shortness of breath, feeling out of breath), runny or stuffed nose, nose bleed, bronchospasm (sudden difficulty in breathing), cough, throat irritation, dry mouth, diarrhoea, contact dermatitis, hair loss, psoriasis like rash or worsening of psoriasis, Peyronie’s disease (which may cause a curvature of the penis), allergic type reactions such as rash, hives, itching, in rare cases possible swelling of the face, lips, eyes and mouth, tongue or throat which may cause difficulty swallowing or breathing (angioedema and anaphylaxia), wheezing.

Not known (frequency cannot be estimated):

Low sugar levels in the blood (hypoglycaemia), changed sensation of taste, abdominal pain, vomiting, muscle pain not caused by exercise (myalgia), sexual dysfunction.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. Tell your doctor or pharmacist, particularly if you experience any changes/visual disturbance when using Oftidorix after eye surgery.

5. How to store Oftidorix

Keep this medicine out of the sight and reach of children.

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

This medicinal product does not require any special temperature storage conditions.

Oftidorix should be used within 28 days after the bottle is first opened. Therefore, you must throw away the bottle 4 weeks after you first opened it, even if some solution is left. To help you remember, write down the date that you opened it in the space on the carton.

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 environment.

6. Contents of the pack and other information

What Oftidorix contains

-    The active substances are Dorzolamide and Timolol. Each ml contains 20 mg dorzolamide (as 22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (as 6.83 mg of timolol maleate).

-    The other ingredients are Mannitol (E421), Hydroxy Ethyl Cellulose, Benzalkonium Chloride (as a preservative), Sodium Citrate (E331), Sodium Hydroxide (E524) for pH adjustment and Water for injection.

What Oftidorix looks like and contents of the pack

Your medicine is in the form of a sterile, clear, slightly viscous, colourless aqueous eye drop solution.

Oftidorix is presented in a white opaque medium density polyethylene bottle with a sealed low density polyethylene dropper tip and a high density polyethylene cap with tamper proof seal, containing 5 mL of the ophthalmic solution.

Pack size: 1, 3 or 6 bottles of 5ml each.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Jelfa S.A.

21 Wincentego Pola Str., 58-500 Jelenia Gora Poland

Manufacturer

Pharmathen S.A.

6 Dervenakion str., 15351 Pallini, Attiki Greece

Famar S.A., Plant A

63 Agiou Dimitriou Street, 174 56 Alimos Greece

This medicinal product is authorised in the Member States of the EEA under the following names:

Czech Republic Timdolux    20 mg/ml +    5    mg/ml ocni kapky, roztok

Hungary    Timdolux    20 mg/ml +    5    mg/ml oldatos szemcsepp

Bulgaria    O^ragopuKC 20 mg/ml + 5mg/ml Kanun 3a oun, pa3TBop

Latvia    Oftidorix 20 mg + 5 mg/ml acu pilieni, skidums

Lithuania    Oftidorix    20 mg/5mg/ml akiq lasai, tirpalas

Poland    Oftidorix

This leaflet was last revised in May 2012.

Detailed information on this medicine is available on the web site of {MA/Agency}

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