Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Antazoline sulfate, Xylometazoline hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Otrivine-Antistin contains two active ingredients. Xylometazoline hydrochloride is a decongestant and antazoline sulphate is an anti-allergic agent. Otrivine-Antistin helps to make your eyes feel more comfortable by relieving the redness and itching caused by allergies such as hay fever, or house dust allergy.
e Otrivine-Antistin Do not use Otrivine-Antistin:
Other medicines and Otrivine-Antistin Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Tell your doctor if you are taking any of the following:
your eye drops 1. Wash your hands 2. Remove the cap and hold the bottle between your thumb and forefinger 3. Tilt your head backwards 4. Rest one hand on your cheek and gently pull down your lower eyelid
5. Look upward 6. Squeeze the bottle to release one or two drops into the eye 7. Close your eye for a short time 8. Repeat for the other eye Note: Do not touch your eye or the surrounding area with the tip of the dropper. Follow the instructions carefully. If there is anything you do not understand, ask your pharmacist. If you need to use more than one kind of eye drops wait 5 minutes between treatments. Otrivine-Antistin should not be used for more than 7 consecutive days without talking to your doctor or pharmacist. If you use more Otrivine-Antistin than you should If you use Otrivine-Antistin for more than 7 days you may find that the itching, redness and/or swelling of the eyes or eyelids returns. Using too much Otrivine-Antistin, or using it for too long, or too often, can cause serious side effects, especially in children. If you accidentally swallow the eye drops consult a doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Otrivine-Antistin is suitable for most people, but, like all medicines, it can sometimes cause side effects. Uncommon (≥1/1,000 to <1/100):
Otrivine-Antistin Keep this medicine out of the sight and reach of children.
Do not store above 25°C. The drops are sterile until the seal on the bottle is broken. Do not use if the seal is broken when you receive the bottle. Take it back to the pharmacist. Do not use the drops for longer than 28 days after first opening the bottle. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. 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 Otrivine-Antistin contains
Otrivine Antistin Eye Drops comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Otrivine Antistin Eye Drops is antazoline sulfate, xylometazoline hydrochloride.
This leaflet reproduces the patient information leaflet approved for Otrivine Antistin Eye Drops, 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.
For the temporary relief of redness and itching of the eye due to seasonal and perennial allergies such as hay fever or house dust allergy.
Posology
Adults
1 or 2 drops instilled 2 - 3 times a day.
Paediatric population
Children aged 12 years and over: 1 drop instilled 2 to 3 times a day.
No specific studies are available in this patient group. Due to possible systemic effects, Otrivine-Antistin is not recommended for use in children younger than 12 years of age (see also section 4.4).
Elderly
1 drop instilled 2 to 3 times a day.
Otrivine-Antistin Eye Drops should not be used for more than seven consecutive days.
Method of administration
For local administration to the eye.
The dispenser remains sterile until the original closure is broken. Patients must be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures as this may contaminate the solution.
If more than one medication needs to be instilled in the eye, an interval of at least 5 minutes between application of the different medicinal products must be allowed.
- Hypersensitivity to the active substances to any of the excipients listed in section 6.1
- Presence of narrow angle glaucoma
- Use with contact lenses
- Use in patients receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment (see section 4.5)
Like other topically applied ophthalmic drugs, Otrivine-Antistin may be absorbed systemically and occasionally cause systemic sympathomimetic effects such as hypertension, nervousness, nausea, dizziness, headache, insomnia, palpitations, tachycardia, and arrhythmia.
Otrivine-Antistin should be used with caution in elderly patients with severe cardiovascular disease, including arrhythmia, poorly controlled hypertension or diabetes.
Use with caution in the presence of hypertension, cardiac irregularities, hyperthyroidism, diabetes mellitus or phaeochromocytomas.
Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias.
Otrivine-Antistin should also be used with caution in patients with conditions causing urinary retention such as prostatic hypertrophy and should also be used in caution in patients who are currently receiving other sympathomimetic drugs.
Not suitable for patients suffering from dry eyes without first seeking medical advice. Rebound hyperaemia may follow prolonged frequent use. Otrivine-Antistin should not be used without supervision over a long period of time.
If the symptoms do not improve after 2 days, medical advice should be sought to rule out the possibility of a bacterial infection. Inflammation arising from infection should receive appropriate anti-bacterial therapy.
Eye drops are not for injection. They should never be injected subconjunctivally, nor should they be directly introduced into the anterior chamber of the eye.
This medicine contains 2.8 micrograms benzalkonium chloride in each drop, which is equivalent to 0.1 mg/ml.
Benzalkonium chloride may cause eye irritation, especially with dry eyes or disorders of the cornea. Patients should be instructed to talk to a doctor if they feel abnormal eye sensation, stinging or pain in the eye after using this medicine.
This medicine contains boric acid.
This medicine should not be given to a child younger than 2 years without medical advice, as it contains boron and may impair fertility in the future.
This product should not be used in patients receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment (see section 4.3).
Sedating anti-histamines can enhance the sedating effects of CNS depressants including alcohol, hypnotics, opioid analgesics, anxiolytic sedatives and anti-psychotics. They also have an additive anti-muscarinic action with other anti-muscarinic drugs, such as atropine and some antidepressants. Otrivine-Antistin should be used with caution in patients receiving other medications such as digitalis, beta-adrenergic blockers, guanethidine, reserpine, methyldopa or anti-hypertensive agents. Concurrent use with halogenated anaesthetic agents such as chloroform, cyclopropane, halothane, enflurane or isoflurane may provoke or worsen ventricular arrhythmias.
In line with common practice, the use of medication during pregnancy is not recommended unless considered essential.
It is not known whether the active ingredients are distributed in human milk. It should therefore not be administered to nursing mothers or breast feeding should be interrupted for 48 hours after administration.
Any patient who experiences blurred vision should not drive or operate machines.
Otrivine-Antistin is generally well tolerated, but the following effects have been reported.
Adverse events are categorised by frequency as follows: 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) and very rare (<1/10,000), not known (frequency cannot be estimated from the available data).
System Organ Class
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
Immune system disorders
Hypersensitivity
Nervous system disorders
Headache;
Drowsiness
Eye disorders
Stinging sensation in eyes;
Blurred vision;
Mydriasis;
Eye irritation;
Ocular hyperaemia
Cardiac disorders
Tachycardia;
Palpitation;
Arrhythmia
Vascular disorders
Hypertension;
Pallor
Respiratory, thoracic and mediastinal disorders
Epistaxis
Gastrointestinal disorders
Nausea
Skin and subcutaneous tissue disorders
Sweating
Local allergic reactions (e.g. rash, oedema, pruritus) have been reported post-marketing.
Although administered via the topical route, systematic side effects may occur in sensitive patients:
- tachycardia (especially in small children), palpitations, arrhythmia, hypertension,
- occipital headache,
- nausea, paleness and sweating.
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. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Excessive dosage and/or prolonged or too frequent use of xylometazoline hydrochloride, especially in children, may cause adverse systemic effects. Excessive dosage in children may cause profound CNS depression possibly necessitating intensive supportive care. CNS depression, shock-like hypotension and coma have occurred following overdose of naphazoline and tetrahydrozoline; the possibility that this may occur with xylometazoline should be kept in mind.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Antazoline sulfate, Xylometazoline hydrochloride. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Antazoline sulfate, Xylometazoline hydrochloride. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Otrivine Antistin Eye Drops. 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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