Dorzopt Forte % w/v Eye Solution

DORZOPT FORTE is a sterile eye drops solution. The active substances are dorzolamide and timolol. Dorzolamide belongs to a group of medicines called "carbonic anhydrase inhibitors" and Timolol belongs to a group of medicines called “Nonselective beta-adrenergic receptor blocking medicines”. DORZOPT FORTE is prescribed to lower raised pressure in the eye in the treatment of glaucoma and ocular hypertension. Elevated pressure in the eye may damage the optic nerve resulting in deterioration of vision and possible blindness. There generally are few symptoms that you can feel to tell you whether you have elevated pressure within your eye. Your health care provider's examination is needed to determine this. If you have raised pressure in your eye, regular eye examinations and measurements of the pressure within your eyes will be necessary.

Do not use DORZOPT FORTE if you are hypersensitive (allergic) to dorzolamide and/or timolol or any of the other ingredients of DORZOPT FORTE (listed in section 6). If you have asthma or have ever had asthma. If you have chronic obstructive lung disease (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough). If you have certain heart diseases (such as slow heartbeat, heart failure or disorders of heart rhythm (irregular heartbeats)). If you have kidney disease or problems, or a prior history of kidney stones. If you have excess acidity of the blood caused by a build-up of chloride in the blood (hyperchloraemic acidosis).

Warnings and precautions

Take special care with DORZOPT FORTE. Tell your doctor or health care provider about any medical problems you have now or have had in the past, especially:

• Breathing problems, asthma and other lung problems and about any allergies to any medications.
• Coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure or low blood pressure.
• Poor blood circulation disease (called 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.
• Eye infection, receive an eye injury, have eye surgery, or develop a reaction including new or worsening symptoms.

If you develop any eye irritation or any new eye problems such as redness of the eye or swelling of the eyelids, contact your health care provider immediately. If you suspect that DORZOPT FORTE is causing an allergic reaction (e.g. skin rash, or redness and itching of the eye), stop its use and contact your health care provider immediately. If you wear soft contact lenses, you should consult your health care provider before using DORZOPT FORTE.

Do not share medicines prescribed for you with any other person. Always use DORZOPT FORTE exactly as your health care provider has told you. Check with your health care provider if you are not sure.

Dose

When this medicine is used alone, the recommended dose is one drop in the affected eye(s) in the morning and in the evening. If your health care provider has recommended you use this medicine with a beta-blocker eye drop to lower eye pressure, then the recommended dose is one drop of DORZOPT FORTE in the affected eye(s) in the morning and in the evening. Do not allow the tip of the container to touch the eye or areas around the eye. To avoid possible contamination, keep the tip of the container away from contact with any surface. Do not change the dosage of DORZOPT FORTE without consulting your doctor. If you must stop treatment, contact your doctor immediately. If you have the impression that the effect of DORZOPT FORTE is too strong or too weak, talk to your doctor or pharmacist.

Instructions for use

1. Before using the medicine for the first time, be sure the Safety Strip on the front of the bottle is unbroken. A gap between the bottle and the cap is normal for an unopened bottle.
2. First wash your hands, then tear off the Safety Strip to break the seal.
3. To open the bottle, unscrew the cap by turning it to the left. Do not pull the cap directly up and away from the bottle. Pulling the cap directly up will prevent your dispenser from operating properly.
4. Tilt your head back and pull your lower eyelid down slightly to form a pouch between your eye and eyelid.
5. Invert the bottle and press lightly with the thumb or index finger until a single drop is dispensed into the eye as directed by your health care provider. DO NOT LET YOUR EYE OR EYELID TOUCH THE DROPPER TIP.
6. After using DORZOPT FORTE press a finger into the corner of your eye, by the nose, or close your eyelids for 2 minutes. This helps to stop the medicine from getting into the rest of the body.
7. Repeat steps 4 and 5 in the other eye if instructed to do so by your health care provider.
8. Replace the cap by turning until it is firmly touching the bottle. Do not overtighten or you may damage the bottle and cap.
9. The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.
10. After you have used all doses, there will be some DORZOPT FORTE left in the bottle. You should not be concerned since an extra amount of this medicine has been added and you will get the full amount of DORZOPT FORTE that your health care provider prescribed. Do not attempt to remove the excess medicine from the bottle.

If you wear soft contact lenses, do not use the drops with your soft contact lenses in. After using the drops wait 15 minutes before putting your lenses back in. If you are using other eye drops, if you are using DORZOPT FORTE with another eye drop, the drops should be instilled at least 10 minutes apart.

If you use more DORZOPT FORTE than you should, in the event of overdosage, consult your health care provider. If not available, contact the nearest hospital or poison centre. If you put too many drops in your eye or swallow any of the contents of the bottle, among other effects, you may become light-headed, have difficulty breathing, or feel that your heart rate has slowed. Contact your health care provider immediately.

If you forget to use DORZOPT FORTE, do not use a double dose to make up for forgotten individual doses. It is important to use DORZOPT FORTE as prescribed by your health care provider. If you miss a dose, use 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.

If you stop using DORZOPT FORTE, DORZOPT FORTE should be used every day to work properly. If you stop using DORZOPT FORTE the pressure inside your eye may go up, therefore talk to your health care provider before stopping this treatment. If you have any further questions on the use of this medicine, ask your health care provider.

DORZOPT FORTE can have side effects. Not all side effects reported for DORZOPT FORTE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using DORZOPT FORTE, please consult your health care provider for advice. If any of the following happens, stop using DORZOPT FORTE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing or shortness of breath, wheezing, or severe skin reactions (Stevens Johnson syndrome, toxic epidermal necrolysis)
• rash or itching
• fainting.

These are very serious side effects. If you have them, you may have had a serious reaction to DORZOPT FORTE. You may need urgent medical attention or hospitalization.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Chest pain, changes in the way your heart beats (beating slower than normal, beating faster than normal)
• Difficulty breathing, constriction of the airways, feeling out of breath, shortness of breath
• Congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid build-up), oedema (fluid build-up), cerebral ischaemia (reduced blood supply to the brain), chest pain, forceful heartbeat that may be rapid or irregular (palpitations), heart attack.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• Headache
• Burning and stinging of the eyes, blurred vision, itchy eyes, tearing, redness of the eye(s), corneal erosion (damage to the front layer of the eyeball), swelling and/or irritation in and around the eye(s), feeling of having something in the eye(s), decreased corneal sensitivity (not realizing of getting something in the eye(s) and not feeling pain), pain in the eye(s), dry eye(s)
• Bitter taste in the mouth
• Painful, watery eyes, eyes sensitive to bright light, and bloodshot, and vision may be slightly blurred (Superficial punctuate keratitis)
• Sinusitis (feeling of tension and fullness in the nose)
• Nausea
• Feeling tired or weak, fatigue.

Less frequent side effects:

• Slowing of your heart rate
• Shortness of breath
• Visual changes
• Dizziness, memory loss, not being able to fall asleep, having bad dreams, feeling depressed, burning or prickling sensation that is usually felt in the hands, arms, legs, or feet, but can also occur in other parts of the body
• An increase in signs and symptoms of myasthenia gravis (muscle disorder)
• Decreased sex drive
• Detachment of the layer below the retina that contains blood vessels following from filtration surgery which may cause visual disturbances
• Eyelid crusting, swelling of the cornea
• Ringing noises in the ears
• Low blood pressure
• Raynaud's phenomenon, swelling or coldness of your hands and feet and reduced circulation in your arms and legs
• Cold hands and feet
• Runny nose, nose bleed
• Irritated and/or sore throat, dry mouth, difficulty breathing, coughing
• Diarrhoea
• Contact dermatitis, skin rash with white silvery coloured appearance (psoriasiform rash)
• Hair loss
• Peyronie’s disease (which may cause a curvature of the penis).

Side effects with frequency unknown:

• Irregular heartbeat, heart failure
• Having hallucinations
• Low blood sugar levels
• Stomach pain, vomiting
• Muscle pain not caused by exercise
• Foreign body sensation in the eye(s) (feeling like there is something in the eye).

If you notice any side effects not mentioned in this leaflet, please inform your health care provider.

Reporting of side effects

If you get side effects, talk to your health care provider. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of DORZOPT FORTE.

Store all medicines out of reach of children. Store at or below 30 °C. Do not use more than 28 days after opening. Once opened, solutions may become contaminated, which can cause eye infections. Therefore, you must throw away the bottle 4 weeks (28 days) 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 use this medicine after the expiry date which is printed on the carton and bottle after EXP. The expiry date refers to the last day of that month.