Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Azelastine contains the active substance 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. Azelastine can be used to treat and prevent eye disorders which you get with hayfever (seasonal allergic conjunctivitis) in adults and children aged 4 years and above. Azelastine can be used for eye disorders caused by an allergy to substances such as house dust mites or animal hair (perennial allergic conjunctivitis) in adults and children aged 12 years and above. Azelastine is not suitable for treating eye infections.
Warnings and precautions Talk to your doctor or pharmacist before using Azelastine - if you are not sure whether your eye disorders are caused by an allergy. In particular if only one eye is affected; if your vision is impaired; or the eye hurts and you do not have any symptoms in your nose, you 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 Azelastine. - if you wear contact lenses. Children and adolescents For the treatment of eye disorders caused by hayfever (seasonal allergic conjunctivitis): Do not give this 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 this medicine to children below 12 years of age, because safety and efficacy have not been established. Other medicines and Azelastine Although Azelastine is not known to be affected by other medicines, tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Driving and using machines Your sight may become blurred for a short time after you use Azelastine. If this happens, wait until your sight clears before you drive or use machinery. Azelastine contains benzalkonium chloride Azelastine contains 0.125mg/ml benzalkonium chloride as preservative. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine 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 the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
1. Wash your hands 2. Gently wipe around your eyes with a tissue to remove any moisture.
Remember: • Azelastine should only be applied to the eyes. The recommended dose is: Eye disorders caused by hayfever (seasonal allergic conjunctivitis) • Use in adults and children aged 4 years and above • The usual dose is one drop in each eye in the morning and evening. If you anticipate contact with pollen, the usual dose of Azelastine may be administered as a preventive measure before going outside. Eye disorders caused by an allergy (non-seasonal (perennial) allergic conjunctivitis) • Use in adults and children aged 12 years and above • The usual dose is one drop in each eye in the morning and evening. If your symptoms are severe, your doctor may increase your dose to one drop in each eye, up to four times a day. Relief of symptoms of allergic conjunctivitis should be noticed after 15-30 minutes. Instruction for use To help you put in your eye drops correctly, you may find it useful to sit in front of a mirror so you can see what you are doing for the first few times. Instructions for use:
3. Avoid touching the eye (or any other surface) with the tip of the bottle 4. These drops are supplied in a plastic bottle with an insert cap assembly, with a tamper proof dust cover. When using the bottle for the first time, snap off the dust cover by turning it clockwise to break the seal.
5. Unscrew the inner cap. Check that the dropper is clean.
10. Blot away any excess medicine with a tissue
6. Tilt your head back and look at the ceiling 7. Gently pull your lower eyelid downwards to form a pocket between your eyelid and eye.
8. Hold the bottle upside down above the eye and gently squeeze the bottle to release a drop inside the middle of lower eyelid. Take care not to let the dropper touch your eye.
9. Release your lower eye lid and gently press on the inner corner of your eye against the bridge of your nose. Keeping your finger pressed against your nose, slowly blink your eyes a few times to spread the drop across the surface of your eye.
11. Repeat this for your other eye 12. Recap the bottle after every use, tighten the inner cap on the nozzle Duration of treatment If possible, you should use Azelastine regularly until your symptoms have disappeared. Do not use Azelastine for more than 6 weeks. If you use more Azelastine than you should If you put too much Azelastine into your eyes you are unlikely to have any problems. If you are worried, contact your doctor. If you accidentally swallow Azelastine, contact your doctor or nearest hospital casualty department as soon as possible. If you forget to use Azelastine Use your eye drops as soon as you remember, then administer the next dose at the usual time. Do not administer a double dose to make up for a missed dose. If you stop using Azelastine If you interrupt the use of Azelastine your symptoms are likely to return. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines this medicine can cause side effects, although not everybody gets them. These effects include: • Common (may affect up to 1 in 10 people): Slight irritation (burning, itching, and watering) in the eyes after putting in Azelastine. This should not last long. • Uncommon (may affect up to 1 in 100 people): A bitter taste in your mouth. This should quickly disappear especially if you have a soft drink. • Very rare (may affect up to 1 in 10,000 people): An allergic reaction (such as rash and itching). Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card
What Azelastine looks like and contents of the pack
Azelastine is a clear, colourless solution.
Marketing Authorisation Holder: FDC Pharma Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE, UK Tel: + 44 (0) 1489 565222 Fax: + 44 (0) 1489 565222 E-mail: [email protected]
Manufacturer: FDC International Ltd., Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE, UK
PL number: 35638/0007
in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle label and the outer carton. The expiry date refers to the last day of that month. Once opened: Do not use this medicine if the bottle has been open for longer than 4 weeks. Do not store above 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Azelastine contains The active substance is azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015 mg azelastine hydrochloride. The other ingredients are benzalkonium chloride, disodium edetate, hypromellose, liquid sorbitol (E420i), sodium hydroxide (E524) and water for injections.
Each carton contains one bottle of Azelastine. Each bottle contains 8ml Azelastine eye drops, solution.
This leaflet was last revised in February 2021.
Azelastine hydrochloride 0.5 mg/ml Eye drops, solution comes as eye drops containing 0.5mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Azelastine hydrochloride 0.5 mg/ml Eye drops, solution is azelastine hydrochloride.
Medicines with the same active substance, strength and form include: Azelastine hydrochloride 0.5 mg/ml Eye drops solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Azelastine hydrochloride 0.5 mg/ml Eye drops, solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Treatment and prevention of the symptoms of seasonal allergic conjunctivitis in adults and children 4 years and older.
Treatment of the symptoms of non-seasonal (perennial) allergic conjunctivitis in adults and children 12 years and older.
Seasonal allergic conjunctivitis: The usual dosage in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. If allergen exposure is anticipated Azelastine hydrochloride 0.5 mg/ml Eye drops, solution should be administered prophylactically, prior to the exposure.
Non-seasonal (perennial) allergic conjunctivitis: The usual dosage in adults and children 12 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily.
As safety and efficacy have been demonstrated in clinical trials for a period of up to 6 weeks, the duration of any course should be limited to a maximum of 6 weeks.
Patients should be advised to contact their doctor if symptoms worsen or do not improve after 48 hours.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Azelastine hydrochloride 0.5 mg/ml Eye drops, solution is not intended for treatment of eye infections. Further warnings see 4.5 and 4.6.
Azelastine hydrochloride 0.5 mg/ml Eye drops, solution contains 0.125mg/ml Benzalkonium chloride as preservative which may be deposited in soft contact lenses. Hence, Azelastine hydrochloride 0.5 mg/ml Eye drops, solution should not be used while wearing these lenses. The lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after use.
Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Azelastine hydrochloride 0.5 mg/ml Eye drops, solution should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.
No specific interaction studies with Azelastine hydrochloride 0.5 mg/ml Eye drops, solution have been performed.
Interaction studies at high oral doses of Azelastine have been performed however they bear no relevance to Azelastine hydrochloride 0.5 mg/ml Eye drops, solution, as systemic levels, after administration of the eye drops, are in the picogram range.
Fertility
Effects on human fertility have not been investigated
Pregnancy
There is insufficient information available to establish the safety of azelastine in human pregnancy. At high oral doses azelastine has shown to induce adverse effects (foetal death, growth retardation and skeletal malformation) in experimental animals. Local ocular application will result in minimal systemic exposure (picogram range). However, caution should be exercised when using Azelastine hydrochloride 0.5 mg/ml Eye drops, solution during pregnancy.
Breast feeding
Azelastine is excreted into the milk in low quantities. For that reason Azelastine hydrochloride 0.5 mg/ml Eye drops, solution is not recommended during lactation.
The mild, transient irritation which can be experienced after application of Azelastine hydrochloride 0.5 mg/ml Eye drops, solution is unlikely to affect vision to any greater extent. However, if there are any transient effects on vision, the patient should be advised to wait until this clears before driving or operating machinery.
The assessment of undesirable effects is based on the following frequencies:
Very common (≥ 1/10)
Common (≥1/100 to < 1/10)
Uncommon (≥1/1,000 to < 1/100)
Rare (≥1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Not known (cannot be estimated from the available data)
Immune system disorders
Very rare: Allergic reactions (such as rash and pruritus).
Nervous system disorders
Uncommon: Bitter taste
Eye disorders
Common: Mild, transient irritation in the eye
Reporting of suspected adverse reactions
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
No specific reactions after ocular overdosage are known, and with the ocular route of administration, overdosage reactions are not anticipated.
There is no experience with the administration of toxic doses of azelastine hydrochloride in humans. In the case of overdose or intoxication, disturbances of the central nervous system are to be expected based on the results of animal experiments. Treatment of these disorders must be symptomatic. There is no known antidote.
Ask anything about Azelastine hydrochloride 0.5 mg/ml Eye drops, solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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