Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Spersallerg
(0.5 mg + 0.4 mg)/ml, eye drops, solution
Antazoline hydrochloride + Tetryzoline hydrochloride
Read the entire leaflet before using the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Spersallerg is and what it is used for
Important information before using Spersallerg
How to use Spersallerg
Possible side effects
How to store Spersallerg
Contents of the pack and other information

1. What Spersallerg is and what it is used for

Spersallerg is used in the treatment of allergic inflammatory conditions of the conjunctiva, particularly inflammatory conditions associated with hay fever and reactions to pollen allergens.

2. Important information before using Spersallerg

When not to use Spersallerg

if the patient is allergic to antazoline and (or) tetryzoline or to any of the other ingredients of this medicine (listed in section 6);
if the patient is taking medicines from the group of MAO inhibitors.

Warnings and precautions
Before starting treatment with Spersallerg, consult your doctor.
Exercise special caution when using Spersallerg:

in elderly patients with severe cardiovascular diseases, patients with arrhythmia, poorly controlled hypertension or diabetes,
in patients with diabetes,
in patients with hypertension,
in patients with hyperthyroidism,
in patients with arrhythmias or tachycardia,
in patients with chromaffin cell tumours (phaeochromocytoma),
in patients with dry eye syndrome,
in patients with closed-angle glaucoma (overuse of vasoconstrictor medicines may provoke rebound hyperaemia after discontinuation).

If symptoms persist for more than 3 to 4 days, worsen, or if eye pain and blurred vision occur during treatment with Spersallerg, the patient should consult a doctor.

Children
Spersallerg should not be used in children under 2 years of age.

Spersallerg and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines the patient intends to use.
MAO inhibitors prolong and intensify the anticholinergic effects of antihistamines.
Antihistamines with sedative effects may enhance the sedative effect of central nervous system (CNS) depressants, including alcohol, hypnotics, opioid analgesics, anxiolytics, sedatives and antipsychotics.
Concomitant use of other antimuscarinic agents, such as atropine and certain antidepressants (both tricyclic antidepressants and MAO inhibitors), may increase antimuscarinic effects.
Since systemic absorption of the medicine is possible, caution should be exercised when administering Spersallerg together with these medicines.
If more than one medicine needs to be instilled into the same eye, wait at least 5 minutes before administering the next medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Spersallerg should not be used during pregnancy unless specifically prescribed by a doctor.
It is not known whether the active substances of Spersallerg pass into breast milk. Caution should be exercised when using Spersallerg during breastfeeding.

Driving and operating machinery
Spersallerg may cause drowsiness, dizziness, somnolence or visual disturbances.
Patients experiencing such adverse effects should not drive or operate machinery until symptoms have resolved.

Spersallerg contains benzalkonium chloride
The medicine contains 0.0023 mg of benzalkonium chloride per dose.
Benzalkonium chloride may be absorbed by soft contact lenses and may alter their colour. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, particularly in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging or pain in the eye occur after using the medicine, consult a doctor.

3. How to use Spersallerg

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
The recommended dose of Spersallerg is:
Adults and adolescents: 1 drop 2 to 3 times daily for 14 days.
Children (over 2 years of age): Exercise caution and limit the dosage to 1 to 2
drops per day. Spersallerg should not be used in children under 2 years of age.
There are insufficient data on the use of Spersallerg in elderly patients.
Spersallerg should not be used for longer than 14 days, as this may lead to rebound hyperaemia and toxic granular conjunctivitis.
After instillation, it is recommended to press the inner corner of the eye with the index finger or close the eyes for 3
minutes. This prevents the medicine from passing through the tear duct into the nose or throat, increasing the amount of medicine
remaining in the eye and enhancing its local action.
Method of administration:

tilt the head backwards;
hold the open bottle in one hand and gently pull down the lower eyelid with a finger of the other hand;
direct the dropper tip towards the eye without touching it;
gently squeeze the bottle to release 1 drop into the eye corner;
gently press the corner of the closed eyelid for 1–2 minutes to prevent the drop from passing through the tear duct into the throat;
immediately close the bottle tightly after use.

To avoid contamination of the contents, do not let the dropper tip touch the eye, eyelid, or any other surface.
Overdose
Accidental oral ingestion of the contents of one bottle of Spersallerg is unlikely to cause serious consequences in an adult. In children, especially those under 2 years of age, nausea, drowsiness, arrhythmia and/or tachycardia, and possibly shock may occur.
Following overdose with tetriazoline, central nervous system depression, shock due to hypotension, and coma have been reported.
In case of accidental overdose by oral ingestion, induce vomiting. Contact a doctor or pharmacist immediately.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
The most common adverse reaction following instillation of the medicine is a sensation of burning and/or stinging, which is mild and transient in nature.

Eye disorders
Sensation of burning and/or stinging after instillation, as well as subjective and objective symptoms indicating a local allergic reaction. Other possible reactions include: iris pigment dispersion, pupil dilation, blurred vision, acute conjunctivitis, chronic conjunctivitis, toxic granular conjunctivitis, dry eye, rebound hyperemia after discontinuation of treatment, reactive hyperemia, and angle-closure glaucoma.

Nervous system disorders
Possible reactions include: headache, drowsiness, dizziness, tremor, and central nervous system stimulation.

Cardiac disorders
Possible reactions include: angina pectoris, hypertension, and tachycardia.

General disorders and administration site conditions
A burning sensation in the eye has been reported. Sweating may also occur.

Immune system disorders
Very rarely, hypersensitivity reactions may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps to increase knowledge about the safety of this medicine.

5. How to store Spersallerg

Keep the medicine out of sight and reach of children.
Store below 25°C.
After 1 month from opening the bottle, any unused solution should be discarded.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Spersallerg contains

The active substances are antazoline hydrochloride and tetrazoline hydrochloride. 1 ml of solution contains 0.5 mg of antazoline hydrochloride and 0.4 mg of tetrazoline hydrochloride.
Other ingredients: benzalkonium chloride, hydrochloric acid diluted, hypromellose, sodium chloride, water for injections.

What the medicine looks like and contents of the pack
Spersallerg eye drops, solution, is a clear, colourless and odourless aqueous solution.
It is supplied in a polyethylene bottle with a dropper, closed with a screw cap, and presented in a cardboard box.
The bottle contains 10 ml of solution.
For further information, contact the marketing authorisation holder or the parallel importer:
Marketing authorisation holder in Bulgaria, country of export:
Laboratoires Théa
12 rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France
Manufacturer:
Farmila-Théa Farmaceutici S.p.A.
Via E. Fermi 50, 20019 Settimo Milanese (MI), Italy
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in Bulgaria, country of export: 20010735
Parallel import authorisation number: 147/25