Otrivine-Antistin Eye Drops

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Xylometazoline hydrochloride; ANTAZOLINE SULFATE

Available from:

Laboratoires Thea

ATC code:

S01GA; S01GA53

INN (International Name):

Xylometazoline hydrochloride; ANTAZOLINE SULFATE

Dosage:

0.05 %w/v + 0.5 percent weight/volume

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Sympathomimetics used as decongestants; xylometazoline, combinations

Authorization status:

Marketed

Authorization date:

1983-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OTRIVINE-ANTISTIN
®
EYE DROPS,
XYLOMETAZOLINE 0.05% W/V & ANTAZOLINE 0.5% W/V
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse have
told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 2 days.
WHAT IS IN THIS LEAFLET
1. What Otrivine-Antistin is and what it is used for
2. What you need to know before you use Otrivine-Antistin
3. How to use Otrivine-Antistin
4. Possible side effects
5. How to store Otrivine-Antistin
6. Contents of the pack and other information
1. WHAT OTRIVINE-ANTISTIN IS AND WHAT IT IS USED 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OTRIVINE-ANTISTIN
DO NOT USE OTRIVINE-ANTISTIN:
- if you are allergic to xylometazoline hydrochloride or antazoline
sulphate or any of the other
ingredients of this medicine (listed in section 6)
- if you have a condition called narrow angle glaucoma
- if you wear contact lenses of any type
- if you are taking, or in the last 14 days have taken, one of a group
of anti-depressant drugs called
monoamineoxidase inhibitors.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using
Otrivine-Antistin:
- if you have high blood pressure, a heart condition (e.g. long QT
syndrome), a thyroid problem or
diabetes
- if you are pregna

Summary of Product characteristics

Health Products Regulatory Authority
23 July 2021
CRN00CDJ0
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Otrivine-Antistin Eye Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Xylometazoline hydrochloride 0.05 % w/v
Antazoline sulphate 0.5 % w/v
Excipients with known effect: Benzalkonium chloride (0.1 mg/ml), boric
acid (30 mg/ml).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops solution (Eye Drops).
Clear, colourless aqueous eye drops solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of conjunctival hyperaemia and oedema
associated with conjunctivitis of allergic origin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
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 into the eye, an
interval of 5 minutes between application of the different
medicinal products must be allowed.
4.3 CONTRAINDICATIONS
o Hypersensitivity to the active substances or to any of the
excipients listed in section 6.1
o Presence of narrow angle glaucoma
o Use with contact lenses
o Use in patients receiving monoamine oxidase inhibitors or within 14
days of stopping such treatment
Health Products Regulatory Authority
23 July 2021
CRN00CDJ0
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Like other topically applied ophthalmic drugs, Otrivine-Antis