Teoptic® 2% w/v Eye Drops, Solution – patient leaflet, side effects, dosage

1. What Teoptic is and what it is used for

Teoptic is available in two different strengths containing either 1% or 2% of the active ingredient, carteolol hydrochloride.

The recommended dose is one drop into the affected eye twice daily. After using Teoptic, press a finger into the corner of your eye, by the nose (picture 3) for 2 minutes. This helps to stop carteolol hydrochloride getting into the rest of the body.

Carteolol hydrochloride is one of a group of drugs called beta-blockers which can help to reduce pressure in the eye. Teoptic is used to treat conditions such as glaucoma (increased pressure in the eye).

Use in children and adolescents

Teoptic eye drops are not recommended for children.

2. What you need to know before you use Teoptic

How to use Teoptic

• Wash your hands before using the drops
• Remove the cap from the dropper bottle

Do not use Teoptic:

• Make sure that the tip of the bottle does not

• if you are allergic to carteolol hydrochloride, beta-blockers or to any of the other ingredients of this medicine (listed in section 6.)

  touch anything

• Hold the bottle in one hand between the

• 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 long-standing cough)

  thumb and forefinger

• Tilt your head back, and use your other

  forefinger to pull down the lower eyelid

• if you have a slow heart beat, heart failure or disorders of heart rhythm (irregular heart beats).
• Place the dropper tip close to your eye, but

Warnings and precautions

not touching the eye or lid, and gently

squeeze the bottle to release one drop into

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

your eye

• coronary heart disease (symptoms can include chest pain or tightness, breathlessness or choking), heart failure

• disturbances of heart rate such as slow heart beat

  • Close your eyelid and gently press the

• breathing problems, asthma or chronic obstructive pulmonary disease

  corner of your eye with your forefinger for

• poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome)

  two minutes

• diabetes as carteolol hydrochloride may mask signs and symptoms of low blood sugar

• overactivity of the thyroid gland as carteolol hydrochloride may mask signs and symptoms

  • Replace the cap and wash your hands.

If you forget to use Teoptic

If you forget to use your eye drops, put them in as soon as possible. Do not take a double dose to make up for a forgotten dose.

If you use more Teoptic than you should

If you use too much or if you accidentally swallow the eye drops, see your doctor at once or go to your nearest hospital casualty department. Take your medicine with you.

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 Teoptic 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 a doctor or pharmacist. Do not stop using Teoptic without speaking to your doctor.

Like other medicines applied into eyes, carteolol hydrochloride is absorbed into the blood. This may cause similar side effects as seen with ‘intravenous’ and/or ‘oral’ as applicable beta-blocking agents. Incidence of side effects after topical ophthalmic administration is lower than when medicines are, for example, taken by mouth or injected. Listed side effects include reactions seen within the class of beta-blockers when used for treating eye conditions:

• Generalized allergic reactions including swelling beneath the skin that can occur in areas such as the face and limbs, and can obstruct the airway which may cause difficulty swallowing or breathing, hives or itchy rash, localized and generalized rash, itchiness, severe sudden life-threatening allergic reaction.
• Low blood glucose levels.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss.
• Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of myasthenia gravis (muscle disorder), dizziness, unusual sensations like pins and needles, and headache.
• Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), inflammation of the eyelid, inflammation in the cornea, blurred vision and detachment of the layer below the retina that contains blood vessels following filtration surgery which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye stay half closed), double vision, unusual sensitivity to light.
• Slow heart rate, chest pain, palpitations, oedema (fluid build up), changes in the rhythm or speed of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid build up), a type of heart rhythm disorder, heart attack, heart failure.
• Low blood pressure, Raynaud’s phenomenon, cold hands and feet.
• Constriction of the airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, cough.
• Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
• Muscle pain not caused by exercise.
• Sexual dysfunction, decreased libido.
• Muscle weakness/tiredness, feeling of discomfort, feeling of tension or fullness in the nose, cheeks and behind your eyes, sometimes with a throbbing ache, fever, stuffy nose and loss of the sense of smell (sinusitis).

If any of the side effects get serious, or if you notice any side effects not mentioned in this leaflet, please, tell your doctor or pharmacist.

5. How to store Teoptic

• Keep out of the sight and reach of children.
• Do not store above 25ºC.
• The drops are sterile until the seal on the bottle is broken.
• Do not use if the seal is broken when you receive the bottle. Take it back to the pharmacist.
• Do not use the drops for longer than 28 days after first breaking the seal.
• Do not use the drops after the expiry date which is printed on the bottle and carton. The expiry date refers to the last day of that month.
• If your doctor tells you to stop using Teoptic, please take any left back to your pharmacist to be destroyed. Only keep the drops if the doctor tells you to.
• Do not throw away any medicines via wastewater. 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 Teoptic contains

Teoptic eye drops come in two strengths, containing 1% or 2% w/v of the active ingredient, carteolol hydrochloride. They also contain the inactive ingredients benzalkonium chloride (a preservative) and sodium chloride, monosodium phosphate, disodium phosphate and purified water for injections.

What Teoptic looks like and contents of the pack

Teoptic is a clear, colourless sterile solution in a 5 ml plastic dropper bottle.

This product is manufactured by Otsuka Pharmaceuticals s.a. Avda Diagonal, 609-615, 08028 Barcelona, Spain. It is procured from within the EU and repackaged by Mediwin Limited. Product Licence Holder Mediport Limited, 13 Martello Enterprise Centre, Courtwick Lane, Littlehampton, West Sussex, BN17 7PA, United Kingdom.

POM

PL No 18980/0826 - Teoptic 1% w/v Eye Drops, Solution

PL No 18980/0827 - Teoptic 2% w/v Eye Drops, Solution

TEOPTIC is a registered Trademark of Otsuka Pharmaceutical Co., Ltd

Date of leaflet preparation: 19/07/2012

Lot: xxxx

MCP-0826-0827v3