Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Azelastine hydrochloride 0.5 mg/ml Eye drops solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Azelastine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Azelastine Eye drops 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 Eye drops 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 Eye drops 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 Eye drops is not suitable for treating eye infections.
2.
What you need to know before you take it
e Azelastine Eye drops
Do not use Azelastine Eye drops •
if you are allergic to azelastine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions Talk to your doctor or pharmacist before taking Azelastine Eye drops • 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 Eye drops. • if you wear contact lenses. Children and adolescents For the treatment of eye disorders caused by hayfever (seasonal allergic conjuctivitis): 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 Eye drops Although Azelastine Eye drops is not known to be affected by other medicines, tell your doctor or pharmacist if you are taking, have recently taken or might take 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 taking this medicine. Driving and using machines Your sight may become blurred for a short time after you use Azelastine Eye drops. If this happens, wait until your sight clears before you drive or use machinery. Azelastine Eye drops contains benzalkonium chloride This medicine contains 0.125 mg benzalkonium chloride in each ml. 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. 3.
How to take it
Azelastine Eye drops
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Remember: • Azelastine Eye drops 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 Eye drops may be taken 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. INSTRUCTIONS FOR USE Using the Blow fill seal container for the first time: Opening the bottle for the first time
1.
Turn the cap in counter clockwise direction. This will break the tamper-proof base ring (Fig.1).
2. Remove the tamper-proof base ring by retaining the cap on the container (Fig.2).
3. Tighten the cap on the nozzle completely by turning clockwise. The spike in the cap will pierce the tip of the bottle (Fig.3).
4. To open the bottle, remove the cap by turning it in the counter clockwise direction (Fig.4).
5. Tighten the cap on the container after every use (Fig.5).
Once the bottle has been opened in this way apply the eye drops as instructed below. Using your Eye drops To help you to use your drops correctly, you may find it useful to sit in front of a mirror so you can see what you are dosing for the first few times. 1. Wash your hands. 2. Gently wipe around your eyes with a tissues to remove any moisture (Fig. 6).
3. Unscrew the top of the bottle and check that the dropper is clean. 4. Gently pull your lower eye lid down (Fig. 7)
5. Carefully place the drop inside the middle of your lower eyelid (Fig. 8). Take care not to let the dropper touch your eye.
6. Release your lower eye lid and gently press on the inner corner of your eye against the bridge of your nose (Fig. 9). Keeping your finger pressed against your nose, slowly blink your eyes a few times to spread the drop across the surface of your eye.
7. Blot away any excess medicine with a tissue. 8. Repeat this for your other eye. Duration of treatment If possible, you should use Azelastine Eye drops regularly until your symptoms have disappeared. Do not take Azelastine Eye drops for more than 6 weeks. If you use more Azelastine Eye drops than you should If you put too much Azelastine Eye drops into your eyes you are unlikely to have any problems. If you are worried, contact your doctor. If you accidentally swallow Azelastine Eye drops, contact your doctor or nearest hospital casualty department as soon as possible.
If you forget to use Azelastine Eye drops Use your eye drops as soon as you remember, then take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you stop using Azelastine Eye drops If you interrupt the use of Azelastine Eye drops your symptoms are likely to return. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not every body gets them. These affects include:
- Common (may affect up to 1 in 10 people): Slight irritation (burning, itching, watering) in the eyes after putting in Azelastine Eye drops. 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, pharmacist or nurse. 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 By reporting side effects you can help provide more information on the safety of this medicine 5.
How to store it
Azelastine Eye drops
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 28 days. This medicine does not require any special storage conditions. 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 Azelastine Eye drops 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 (crystallising), sodium hydroxide and water for injections. What Azelastine Eye drops looks like and contents of the pack
Azelastine Eye drops is a clear, colourless solution, practically free from any visible particles. Azelastine Eye drops filled in 10 mL LDPE Blow fill seal (BFS) container with white colour polypropylene spiked cap having a tamper-proof base ring. One bottle contains either 6, 8 or 10ml eye drops, solution. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Brown & Burk UK Ltd 5 Marryat Close Hounslow West Middlesex TW4 5DQ UK. This leaflet was last revised on 09/2018
Frequently asked questions about Azelastine hydrochloride 0.5 mg/ml Eye drops solution
How do I take Azelastine hydrochloride 0.5 mg/ml Eye drops solution?
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.
What is the active substance in Azelastine hydrochloride 0.5 mg/ml Eye drops solution?
The active substance in Azelastine hydrochloride 0.5 mg/ml Eye drops solution is azelastine hydrochloride.
Are there equivalent medicines to Azelastine hydrochloride 0.5 mg/ml Eye drops solution?
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.
Where does this information come from?
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.
Can I get Azelastine hydrochloride 0.5 mg/ml Eye drops solution without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: azelastine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
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.
4.2. Posology and method of administration
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 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.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Azelastine hydrochloride Eye drops, solution is not intended for treatment of eye infections. Further warnings see 4.5 and 4.6.
Azelastine hydrochloride Eye drops, solution contains the preservative benzalkonium chloride.Benzalkonium chloride may cause eye irritation, especially with dry eyes or disorders of the cornea. Contact with soft contact lenses should be avoided. Contact lenses should be removed prior to application and the patient should wait at least 15 minutes before reinsertion. Known to discolour soft contact lenses.
4.5. Interaction with other medicinal products and other forms of interaction
No specific interaction studies have been performed.
Interaction studies at high oral doses of Azelastine have been performed however they bear no relevance to Azelastine hydrochloride Eye drops, solution, as systemic levels, after administration of the eye drops, are in the picogram range.
4.6. Fertility, pregnancy and lactation
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 Eye drops, solution during pregnancy.
Breast Feeding
Azelastine is excreted into the milk in low quantities. For that reason Azelastine hydrochloride Eye drops, solution is not recommended during lactation.
Fertility
Effects on human fertility have not been investigated.
4.7. Effects on ability to drive and use machines
The mild, transient irritation which can be experienced after application of Azelastine hydrochloride 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.
4.8. Undesirable effects
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
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Symptoms
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.
Management
Treatment of these disorders must be symptomatic. There is no known antidote.
💬 Ask about this leaflet
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.