OTRIVINE ANTISTIN EYE DROPS XYLOMETAZOLINE 0.05% W/V ANTAZOLINE 0.5%W/V

Active substance: XYLOMETAZOLINE HYDROCHLORIDE

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Otrivine-Antistin® Eye Drops,
Xylometazoline 0.05%w/v & Antazoline 0.5%w/v
Patient Information Leaflet
Please read this leaflet carefully before you start to use the eye
drops. It contains important information. Keep the leaflet in a safe
place because you may want to read it again.
Do not share these eye drops with anyone else just in case you have an
eye infection which you could pass on.
If you have any other questions, or if there is something you don’t
understand, please ask your pharmacist.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Otrivine Antistin Eye Drops are and what they are used for
2. Things to consider before you start to use Otrivine Antistin
3. How to use Otrivine Antistin
4. Possible side effects
5. How to store Otrivine Antistin
6. Further information

1. What Otrivine Antistin Eye Drops are and what they are
used for
Otrivine Antistin Eye Drops contain two active ingredients.
Xylometazoline hydrochloride is a decongestant and antazoline sulphate
is an anti-allergic agent.
Otrivine Antistin Eye Drops 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.

2. Things to consider before you start to use Otrivine Antistin
DO NOT use Otrivine Antistin if:
• you think you may be allergic to any of the ingredients of the eye
drops (These are listed at the end of the leaflet.)
• you have a condition called narrow angle glaucoma
• you wear contact lenses of any type
• you are taking, or in the last 14 days have taken, one of a group of
anti-depressant drugs called monoamineoxidase inhibitors.
You should also ask yourself these questions before starting to
use Otrivine Antistin:
• Do you have high blood pressure, a heart condition, a thyroid problem
or diabetes?
• Are you pregnant or breast-feeding?
• Do you suffer from dry eyes?
• Do you have difficulty in urinating (passing water)?
• Do you have an adrenal tumour (phaeochromocytoma)?
If the answer to any of these questions is YES, talk to the pharmacist
because Otrivine Antistin might not be suitable for you.
Are you taking other medicines?
Some medicines can interfere with your treatment. This means medicines
you have bought yourself as well as medicines on prescription from
your doctor.
Tell your doctor if you are taking any of the following:
• Any drugs which may cause drowsiness including some painkillers,
sedatives, alcohol and antipsychotics
• Atropine and some antidepressants.
• Digoxin and some other drugs used for high blood pressure or anxiety
such as atenolol and propranolol.
• If you are going to have an anaesthetic you should tell your doctor
you are using Otrivine-Antistin.
Your doctor will know which medicines should be avoided whilst using
Otrivin-Antistin
Will there be any problems with driving or using machinery?
Some people may experience blurred vision after using Otrivine Antistin.
If you are affected, you should not drive or use machinery.
Other special warnings
The eye drops contain benzalkonium chloride as a preservative. This can
sometimes irritate the eyes.

3. How to use Otrivine Antistin
The usual dosage is:
Adults: One or two drops in each eye, two or three times each day.
Elderly and children 12 years and over: One drop in each eye, two
or three times each day.
These drops should not be used in children under 12.
Do not exceed stated dosage

If your symptoms have not improved after 2 days you must go and see
your doctor because Otrivine Antistin might not be the right medicine for
you. You may have an infection and need an antibiotic.
How to use 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.
What if you use too much?
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.

4. Possible side effects
Otrivine Antistin is suitable for most people, but, like all medicines, it can
sometimes cause side effects.
Sometimes people notice that the drops make their eyes sting.
Very occasionally people have noticed that their red eyes get worse, or
that they have blurred vision, headache, drowsiness or enlarged pupils.
Allergic reactions have been reported causing rash, swelling and itching
of the eye area and eye irritation.
Certain sensitive people have experienced changes in heart beat rhythm,
raised blood pressure, sleeplessness, nausea, pallor and sweating.
These effects are often mild. If they are severe or last for more
than a few days, or if you notice anything else not mentioned
here, please go and see your doctor.

5. How to store Otrivine Antistin
Keep all medicines out of the reach and sight of children.
Do not store the drops 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 the drops after the expiry date which is printed on the outside of the pack.
Do not throw them away with your normal household water or waste.
This will help to protect the environment.

6. Further information
These eye drops contain 0.05% w/v xylometazoline hydrochloride and
0.5% w/v antazoline sulphate. They also contain the inactive ingredients
benzalkonium chloride, boric acid, disodium edetate, sodium tetraborate and water for injections. Each bottle contains 10 ml of eye drops.
The product licence/authorisation holder is
Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
Otrivine Antistin Eye Drops are made by
Excelvision
Rue de la Lombardière
07100 Annonay
France
This leaflet was revised in November 2011.
If you would like any more information, or would like the leaflet in a
different format, please contact Medical Information at Spectrum THEA
Pharmaceuticals Ltd, telephone number 0845 521 1290.
Otrivine Antistin is a registered trade mark.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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