Azelastin-Comod

Each drop of about 30 µL contains 0.015 mg Azelastine hydrochloride.
Excipients/Inactive Ingredients: Disodium edetate, Hypromellose, Sorbitol, Sodium hydroxide (for pH-adjustment) and Water for injections.

Pharmacology: Mechanism of action: Azelastin-COMOD contains the active ingredient azelastine hydrochloride, which belongs to a group of medicines called antiallergics (antihistamines). Antihistamines work by preventing the effects of substances such as histamine that the body produces as part of an allergic reaction. Azelastine has been shown to reduce inflammation of the eye.

Azelastin-COMOD can be used to treat symptoms of acute allergic conjunctivitis in adults.

Always use the medicine exactly as directed by the doctor or pharmacist. Check with the doctor or pharmacist if the patient is not sure.
Remember: Azelastin-COMOD should only be applied to the eyes.
The recommended dose is: The usual dosage in adults is one drop in each eye twice a day (in the morning and evening), which can be increased, if necessary, up to four times a day. Treatment is stopped when symptoms have resolved. It is not recommended to use it for more than 6 weeks because there is no data available for use for more than 6 weeks. Consult a doctor if symptoms do not improve within 48 hours.
How to use Azelastin-COMOD: Wash the hands.
Take a clean tissue and gently wipe around the eyes to remove moisture.
Step 1. Remove the cap before use. Before the first application, turn the Azelastin-COMOD bottle with its tip down and press onto the bottom of the bottle until the first drop appears at the nozzle. Now the bottle is ready for further use.
Step 2. Hold the bottle upside down with the thumb on the shoulder of the bottle and the other fingers on the bottom of the bottle.
Step 3. Support the hand holding the COMOD-bottle with the other hand.
Step 4. Lean the head back slightly, gently pull down the lower eyelid and apply a strong and quick pressure on the middle of the bottom of the bottle. This activates the mechanism for the release of one drop. Because of the special COMOD valve system, size and speed of each drop are the same independently on how much pressure is applied. When applying the fluid, avoid any contact between the tip of the bottle and the eye or the skin. Slowly close the eyes to allow the fluid to spread evenly on the eye surface.
Step 5. After instilling Azelastin-COMOD release the lower eyelid and press with the finger on the corner of the eye closest to the nose. While doing this, blink several times with the eyes to distribute the eye drops on the eyeball. Remove surplus eye drops afterwards.
Step 6. Replace cap immediately after use. Take care that the dropper tip is dry.
Duration of treatment: If possible, the patient should use Azelastin-COMOD regularly until symptoms have disappeared.
Do not use Azelastin-COMOD for more than 6 weeks.
If the patient uses more Azelastin-COMOD than it should: If the patient puts too much Azelastin-COMOD into the eyes, it is unlikely to have any problems. If the patient is worried, contact the doctor. If the patient accidentally swallows Azelastin-COMOD, contact the doctor or nearest hospital casualty department as soon as possible.
If the patient forgets to use Azelastin-COMOD: Use the eye drops as soon as the patient remembers, then take the next dosage at the usual time. Do not use a double dose to make up for a missed dose.
If the patient stops using Azelastin-COMOD: If the use of Azelastin-COMOD is interrupted, the symptoms are likely to return.
If the patient has further questions on the use of the medicine, ask the doctor or pharmacist.

Do not use Azelastin-COMOD: If the patient is allergic to azelastine hydrochloride or any of the other ingredients of the medicine (listed in the Description).

Azelastin-COMOD is not suitable for treating eye infections.
Talk to the doctor or pharmacist before using Azelastin-COMOD: If the patient is not sure whether the eye disorders are caused by an allergy. In particular, if only one eye is affected; if vision is impaired; or if the eye hurts and does not have any symptoms in the nose, the patient may have an infection rather than an allergy.
If the complaints worsen or last longer than 48 hours without remarkable improvement despite the use of Azelastin-COMOD.
If the patient wears contact lenses.
Driving and using machines: The sight of the patient may become blurred for a short time after using Azelastin-COMOD. If this happens, wait until the sight clears before driving or using machinery.
Use in Pregnancy & Lactation: If the patient is pregnant or breast-feeding, may be pregnant, or is planning to have a baby, ask the doctor or pharmacist for advice before using Azelastin-COMOD.
Use in Children: For the treatment of eye disorders caused by hay fever (seasonal allergic conjunctivitis): Do not give the medicine to children below 4 years of age, because safety and efficacy have not been established.
For the treatment of eye disorders caused by an allergy (non-seasonal (perennial) allergic conjunctivitis): Do not give the medicine to children below 12 years of age, because safety and efficacy have not been established.

If the patient is pregnant or breast-feeding, may be pregnant, or is planning to have a baby, ask the doctor or pharmacist for advice before using Azelastin-COMOD.

Like all medicines, Azelastin-COMOD can cause side effects, although not everybody will have them.
The side effects include: Common (may affect up to 1 in 10 people): Slight irritation (burning, itching, watering) in the eyes after putting in Azelastin-COMOD. The side effects will not last long.
Uncommon (may affect up to 1 in 100 people): A bitter taste in the mouth. The side effect will quickly disappear, especially when patients consume soft-drinks.
Very rare (may affect up to 1 in 10,000 people): An allergic reaction (such as rash and itching).
Reporting of side effects: If the patient has any side effects, talk to the doctor or pharmacist. Including any possible side effects not listed previously.

Although Azelastin-COMOD is not known to be affected by other medicines, tell the doctor or pharmacist if the patient is using, has recently used, or might use any other medicines.

Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines that the patient no longer uses. The measures will help protect the environment.

Do not store above 30°C.
Once opened: With proper care, Azelastin-COMOD can be used up to 12 weeks after the first opening.

Ophthalmic Decongestants, Anesthetics, Anti-Inflammatories

S01GX07 - azelastine ; Belongs to the class of other ophthalmologic antiallergics.

K