Spersallerg

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Spersallerg

(0.5 mg + 0.4 mg)/ml, eye drops, solution
Antazoline hydrochloride + Tetryzoline hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Spersallerg and what is it used for
• 2. Important information before using Spersallerg
• 3. How to use Spersallerg
• 4. Possible side effects
• 5. How to store Spersallerg
• 6. Contents of the pack and other information

1. What is Spersallerg and what is it used for

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

2. Important information before using Spersallerg

When not to use Spersallerg

• if you are allergic to antazoline and/or tetryzoline or any of the other ingredients of this medicine (listed in section 6);
• if you are taking MAO inhibitors.

Warnings and precautions

Before starting to use Spersallerg, discuss it with your doctor.
Be particularly careful 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 tumors.
• in patients with dry eye syndrome,
• in patients with angle-closure glaucoma (overuse of vasoconstrictor medications may cause a recurrence of hyperemia after their withdrawal).

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

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
MAO inhibitors prolong and enhance the anticholinergic effect of antihistamines.
Sedating antihistamines may enhance the sedative effect of central nervous system depressants, including alcohol, sedatives, opioids, anxiolytics, and antipsychotics.
Concomitant use of other antimuscarinic medications, such as atropine and certain antidepressants (both tricyclic and MAO inhibitors), may enhance their antimuscarinic effects.
Since systemic absorption is possible, caution should be exercised when administering Spersallerg with these medications.
If it is necessary to instill more than one medication into the same eye, wait at least 5 minutes before administering the next medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Spersallerg should not be used during pregnancy unless 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 using machines

Spersallerg may cause drowsiness, dizziness, somnolence, or visual disturbances.
Patients who experience such side effects should not drive or operate machinery until the 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 change their color. Remove contact lenses before instillation and wait at least 15 minutes before reinserting.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience any abnormal sensations in the eye, stinging, or eye pain after using the medicine, consult your doctor.

3. How to use Spersallerg

Always use this medicine exactly as your doctor has told you.
In case of doubt, consult your doctor or pharmacist.
The recommended dose of Spersallerg is:
Adults and adolescents:1 drop 2 to 3 times a day for 14 days.
Children (over 2 years of age):Use with caution and limit the dose to 1 to 2 drops per day. Do not use Spersallerg in children under 2 years of age.
There are no adequate studies on the use of Spersallerg in elderly patients.
Spersallerg should not be used for more than 14 days, as this may cause a recurrence of hyperemia and toxic papillary conjunctivitis.
After administration, it is recommended to press the inner corner of the eye with your index finger or close your eyes for 3 minutes. This prevents the medicine from passing through the tear duct into the nose or throat and increases the amount of medicine that remains in the eye and acts locally.
Method of administration:

• tilt your head back;
• hold the open bottle in one hand and gently pull down the lower eyelid with the index 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;
• gently press the corner of the closed eyelid for 1-2 minutes to prevent the drop from entering the tear duct;
• after use, immediately close the bottle tightly.

To prevent contamination of the contents, do not touch the dropper tip to the eye, eyelid, or any other surface.

Overdose

Unintentional oral ingestion of the contents of one bottle of Spersallerg should not have any 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. After overdose of tetryzoline, central nervous system depression, hypotensive shock, and coma have been reported.
In case of accidental overdose after oral ingestion, induce vomiting. Consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Spersallerg can cause side effects, although not everybody gets them.
The most common side effect after instillation of Spersallerg is a feeling of burning and/or stinging, which is usually mild and transient.

Eye disorders

Burning and/or stinging after instillation, as well as objective and subjective symptoms indicating a local allergic reaction. The following may also occur: dispersion of iris pigment, mydriasis, blurred vision, acute conjunctivitis, chronic conjunctivitis, toxic papillary conjunctivitis, dry eye, rebound hyperemia after treatment, reactive hyperemia, angle-closure glaucoma.

Nervous system disorders

The following may occur: headache, drowsiness, dizziness, tremor, and central nervous system stimulation.

Cardiac disorders

The following may occur: angina pectoris, hypertension, and tachycardia.

General disorders and administration site conditions

Burning sensation in the eye has been reported. Sweating may also occur.

Immune system disorders

Hypersensitivity reactions may occur very rarely.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Spersallerg

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

6. Contents of the pack and other information

What Spersallerg contains

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

What Spersallerg looks like and contents of the pack

Spersallerg, eye drops, solution, is a clear, colorless, and odorless aqueous solution.
It is available in a polyethylene bottle with a dropper, closed with a screw cap, in a cardboard box.
The bottle contains 10 ml of solution.
For more detailed information, contact the marketing authorization holder or parallel importer:

Marketing authorization holder in Bulgaria, the 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 20010735

Parallel import authorization number: 147/25

Date of approval of the leaflet: 24.04.2025

[Information about the trademark]