Cromobex 2,0 % Solution

CROMOBEX contain the active substance sodium cromoglicate. This belongs to a group of medicines called anti - allergic medicines. CROMOBEX are used to treat red, watery, itchy eyes caused by allergies such as hay fever, house dust mites and pet hair.

Do not use CROMOBEX: If you are hypersensitive (allergic) to sodium cromoglycate, benzalkonium chloride or any of the other ingredients of CROMOBEX (listed in section 6).

Warnings and precautions

Take special care with CROMOBEX:

• Do not use if the bottle has been opened before you are given it.
• Throw the bottle away 1 month after first opening it or if the solution stops looking clear.

Other medicines and CROMOBEX

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before using CROMOBEX. Safety and efficacy of CROMOBEX during pregnancy and breastfeeding have not been established.

Driving and using machines

CROMOBEX may cause stinging or blurred vision when first used. If you experience blurred vision, wait until your vision clears before driving a vehicle or using machinery.

CROMOBEX contains benzalkonium chloride This medicine contains 0,00306 mg benzalkonium chloride in each drop (0,0306 mL) which is equivalent to 0,1 mg/mL. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of your contact lenses. You should remove your contact lenses before using CROMOBEX and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of your eye). If you feel an abnormal eye sensation, stinging or pain in your eye after using CROMOBEX, talk to your doctor.

Always use CROMOBEX exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. The usual dose for adults and children is: 1 – 2 drops into each eye 4 times daily. You should use the eye drops regularly, as therapy with CROMOBEX is essentially prophylactic (used to prevent eye allergies).

Apply your eye drops in the following way:

1. Before using your CROMOBEX you should wash your hands.
2. You may find it helps to sit in front of a mirror, so that you can see what you are doing. Tilt your head backwards, gently pull down your lower eyelid and carefully place one or two CROMOBEX drops in the space between the eyelid and the eye. Take care not to touch the dropper with your eye or fingers.
3. Release the eyelid and blink a few times to make sure the liquid covers the whole surface of your eye.
4. Repeat the procedure with your other eye and then replace the cap on the bottle. Be careful not to touch the tip of the bottle on your eye or any other surface. Eye drops, if handled wrongly, can become contaminated by bacteria and cause eye infections. If you develop any other eye condition while using CROMOBEX, you should see your doctor immediately.

If you use more CROMOBEX than you should In the event of an overdosage, or if someone accidentally swallowed the eye drops, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and the rest of the remaining CROMOBEX with you so the doctor will know what you have taken. If you forget to use CROMOBEX Use your drops as soon as you remember and then carry on in the usual way. Do not use a double dose to make up for forgotten individual doses. If you have any further questions on the use of CROMOBEX eye drops, ask your doctor or pharmacist.

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

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

• Swelling of your 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 CROMOBEX. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Difficulty breathing, breathlessness.

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

• Stinging or burning in your eyes, blurring of eye sight.

Side effects occurring with an unknown frequency:

• Headache.

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 Reactions Reporting Form”, found online under SAHPRA’s publications: http://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of CROMOBEX.

• Store at or below 25 °C.
• Protect from light.
• Store all medicines out of reach of children.
• Do not use after the expiry date printed on the container.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).