azelastine |

Latin name

Allergodil

Release form

Eye drops 0.05%.

6 ml solution in a bottle of translucent high-density polyethylene with a dropper made of low-density polyethylene with a white cap of high-density polyethylene.

1 bottle, together with instructions for use, is placed in a cardboard box.

Pharmacological action

Antiallergic.

Pharmacological properties: Azelastine is a potent long-acting antiallergic. When applied to the mucous membrane of the eye, additional anti-inflammatory and membrane-stabilizing effects are manifested. No clinically significant effect on the QT (QTc) interval was detected.

Pharmacokinetics: maximum plasma azelastine concentrations are very low and are detected at or below the measurement limit.

Indications

prevention and treatment of seasonal allergic conjunctivitis

treatment of non-seasonal (year-round) allergic conjunctivitis.

Contraindications

Hypersensitivity to the active substance or other components of the drug

Age up to 3 years srd.

Use during pregnancy and lactation

Use in the first trimester of pregnancy is not recommended, and in the second and third trimesters and during lactation it is possible if the possible benefit to the mother outweighs the risk to the fetus / baby.

Special instructions

Contact lenses are not recommended when using eye drops.

Effect on ability to drive vehicles. In case of blurred vision immediately after instillation of the drug, you should refrain from driving and engaging in activities requiring increased attention until it is restored.

Composition

Active ingredient Azelastine hydrochloride.

Dosage and administration of

Seasonal allergic conjunctivitis:

in the absence of other doctor's recommendations for adults and children from 4 years old, instill 2 times a day (morning and evening), 1 drop in each eye. If necessary, increase the dose to 4 times a day, one drop in each eye. The drug is used until the symptoms disappear, but not more than 6 weeks. In case of the alleged exposure to the allergen, the drug is used for prophylactic purposes.

Non-seasonal (year-round) allergic conjunctivitis:

in the absence of other doctor's recommendations for adults and children from 4 years old, instill 2 times a day (morning and evening), 1 drop in each eye. If necessary, increase the dose to 4 times a day, one drop in each eye.

Duration of use - no more than 6 weeks.

Side effects of

The frequency of side effects is defined as follows: Very often:> 1/10

Often: <1/10> 1/100

Infrequently: <1/100> 1/1000

Rarely: <1/1000> 1/10000

Very rare: <1/10000.

Local: often - transient blurred vision, conjunctivitis

rarely - burning sensation in the eye.

General: infrequently - a feeling of bitterness in the mouth

is very rare - allergic reactions, headache, asthma, dyspnea, fatigue, flu-like symptoms, pharyngitis, itching, rhinitis.

Drug Interactions

Not detected. In the case of concomitant therapy with other eye drops, they should be instilled into the eyes with an interval of at least 15 minutes.

Overdose

There is no overdose on the drug.

Storage conditions

At a temperature not exceeding 25 C. Keep out of reach of children.

Shelf life

3 years. After opening the bottle, the drug should be used within 4 weeks.

Do not use after the expiration date printed on the package.

Active ingredient srdl kp Azelastine

Conditions of release from drugstores

Without prescription

dosage form

eye drops

Prescribing

Prescribing

Pregnant II and III trimester as prescribed by the doctor, For adults, Children over 4 years old

Meda Farma GmbH and Ko.KG, Switzerland