Optitrin 20 mg/5 mg Solution

OPTITRIN is a sterile eye drop that contains two active substances known as dorzolamide and timolol used to lower the pressure in the eye in different ways. OPTITRIN 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 are generally a few symptoms that you can feel to tell you whether you have elevated pressure within your eye. Your doctor'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 OPTITRIN:

• If you are hypersensitive (allergic) to dorzolamide and/or timolol or any of the other ingredients in OPTITRIN.
• If you suffer from asthma or have ever had asthma.
• If you suffer from chronic obstructive lung disease.
• If you suffer from heart diseases such as sinus bradycardia, sick sinus syndrome, sinoatrial block, second- or third-degree atrioventricular block not controlled with pacemaker, overt cardiac failure and cardiogenic shock.
• If you have severe kidney disease or metabolic acidosis (condition known as hyperchloraemic acidosis).
• OPTITRIN contains the preservative benzalkonium chloride, which may be deposited in soft contact lenses. Therefore, OPTITRIN should not be used while wearing these lenses. The lenses should be removed before application of the drops and not be reinserted earlier than 15 minutes after use.
• The safety of OPTITRIN in pregnancy and breastfeeding has not been established.

Warnings and precautions

Take special care with OPTITRIN if:

• Regular ophthalmological examination is required when using OPTITRIN.
• Inform your doctor about any medical or eye problems you have now or have had in the past, especially conditions such as breathing problems (e.g., asthma or chronic obstructive pulmonary disease), heart disease (e.g., heart rate disturbances), vascular disease (e.g., poor blood circulation), diabetes or overactivity of your thyroid gland. Notify your doctor immediately if you notice any deterioration of these diseases or start to experience any side effects since starting your therapy with OPTITRIN.
• Inform your doctor if you develop any eye irritation, any new eye problems such as redness of the eye or swelling of the eyelids or an eye infection, received an eye injury, have had eye surgery or develop a reaction including new or worsening symptoms while using OPTITRIN.
• Tell your doctor about any allergies or allergic reactions including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing. If you suspect that OPTITRIN is causing an allergic reaction or hypersensitivity, stop using OPTITRIN immediately and contact your doctor.
• Tell your doctor before you have an operation that you are using OPTITRIN as timolol may change effects of some medicines used during anaesthesia.
• Tell your doctor if you have muscle weakness or have been diagnosed with a condition known as myasthenia gravis.
• If you wear soft contact lenses, you should consult your doctor before using OPTITRIN.
• If you have a history of kidney stones, you may be at an increased risk of developing kidney stones while using OPTITRIN.

Children and adolescents

OPTITRIN should not be used in children less than 2 years of age. There is limited experience with OPTITRIN in children between 2 and 6 years of age. However, safety and efficacy data with this solution is insufficient to recommend a safe and effective dose.

Other medicines and OPTITRIN

Always tell your healthcare professional if you are taking any other medicine. (This includes all complementary or traditional medicines). Please inform your healthcare professional if you are currently taking any of the following medicines:

• Taking medicine to lower blood pressure or to treat heart disease (such as calcium channel blockers, beta-blockers or digoxin).
• Taking medicines to treat a disturbed or irregular heartbeat such as calcium channel blockers, beta-blockers or digoxin.
• Using another eye drop that contains a beta-blocker.
• Taking another carbonic anhydrase inhibitor such as acetazolamide.
• Taking monoamine oxidase inhibitors (MAOIs) which are used to treat depression.
• Taking a parasympathomimetic medicine which may have been prescribed to help you pass urine. Parasympathomimetics are also a particular type of medicine which is sometimes used to help restore normal movements through the bowel.
• Taking medicines such as morphine used to treat moderate to severe pain.
• Taking medicines to treat diabetes.
• Taking antidepressants known as fluoxetine and paroxetine.
• Taking a sulpha medicine.
• Taking quinidine (used to treat heart conditions and some types of malaria).

Do not share medicines prescribed for you with any other person. Always use OPTITRIN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults

The appropriate dosage and duration of treatment with OPTITRIN will be established by your doctor. The usual dose is one drop in the affected eye(s) in the morning and in the evening.

If you are using OPTITRIN with another eye drop, the drops should be instilled at least 10 minutes apart. Do not change the dose of OPTITRIN without consulting your doctor. When substituting OPTITRIN for another ophthalmic antiglaucoma agent(s), discontinue the other agent(s) after proper dosing on one day, and start OPTITRIN on the next day. If you must stop the treatment of OPTITRIN, contact your doctor.

Method of administration

Step 1: The tamper-proof seal on the bottle neck must be unbroken before the product is being used for the first time. A gap between the bottle and the cap is normal for an unopened bottle.

Step 2: The cap of the bottle should be taken off.

Step 3: The patient’s head must be tilted back, and the lower eyelid must be pulled gently down to form a small pocket between the eyelid and the eye.

Step 4: The bottle should be inverted and squeezed until a single drop is dispensed into the eye. The eye or eyelid must not be touched with the dropper tip.

Step 5: Steps 3 & 4 should be repeated with the other eye if it is necessary.

Step 6: The cap must be put back on and the bottle must be closed straight after it has been used.

Your doctor will tell you how long your treatment with OPTITRIN will last. If you have the impression that the effect of OPTITRIN is too strong or too weak, tell your doctor or pharmacist.

If you use more OPTITRIN than you should

If you put too many drops in your eye or swallow any of the contents of the bottle, among other effects, you may become lightheaded, have difficulty breathing, or feel that your heart rate has slowed. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to use OPTITRIN

Do not take a double dose to make up for forgotten individual doses. If you stop using OPTITRIN your doctor will decide how long your treatment with OPTITRIN will last. Do not stop your treatment with OPTITRIN without consulting your doctor first.

OPTITRIN can have side effects. Not all side effects reported for OPTITRIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking OPTITRIN, please inform your health care provider for advice.

If any of the following happens, stop taking OPTITRIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to OPTITRIN. You may need urgent medical attention.

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

• Corneal erosion, when the layer of cells on the surface of the cornea, called epithelium, loosens from the layer underneath. This is painful and makes your vision blurry or hazy. Corneal erosion pain may start suddenly, often when you first wake in the morning.
• Respiratory failure, a condition in which your blood doesn't have enough oxygen or has too much carbon dioxide.
• Stevens-Johnson syndrome (severe skin reaction), a rare, serious disorder of the skin and mucous membranes. It's usually a reaction to medication that starts with flu-like symptoms, followed by a painful rash that spreads and blisters. Then the top layer of affected skin dies, sheds and begins to heal after several days.
• Toxic epidermal necrolysis (severe skin reaction), a life-threatening skin disorder characterized by a blistering and peeling of the skin.
• Shortness of breath.
• Bronchospasm, tightening of the muscles that line the airways (bronchi) in your lungs.
• Increase in signs and symptoms of myasthenia gravis (a condition in which the muscles become weak and tire easily).
• Cerebrovascular accident (a stroke).
• Cerebral ischaemia (a condition where the blood flow to the brain is decreased).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor or health care provider if you notice any of the following:

Frequent:

• Burning and stinging
• Conjunctival injection
• Blurred vision
• Ocular itching
• Tearing
• Taste perversion
• Sinusitis
• Headache
• Eyelid inflammation
• Eyelid irritation
• Nausea
• Unusual tiredness or weakness (asthenia)

Less frequent:

• Contact dermatitis
• Formation of stony concretions in the bladder or urinary tract
• Runny nose
• Feeling of pins and needles (paraesthesia)
• Nosebleed (epistaxis)
• Dry mouth
• Throat irritation
• Vomiting
• Indigestion (dyspepsia)
• Diarrhoea
• Abdominal pain
• Palpitations (feeling a sensation that the heart is racing)
• Depression
• Insomnia
• Nightmares
• Memory loss
• Hallucination
• Low sex drive
• Painful erections (caused by Peyronie’s disease)
• Tinnitus (a ringing or other persistent noise in the ears)
• An unusual hair loss or thinning (alopecia)
• Low sugar levels in the blood (hypoglycaemia)
• Aching muscles (myalgia)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. 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 OPTITRIN.

Store all medicines out of sight and reach of children. Store at or below 25 ºC (room temperature). Do not use more than 28 days after opening. Keep the container in the outer carton in order to protect from light. Do not use OPTITRIN after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month. Return all unused medicines to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).