Spersallerg

Package Leaflet: Information for the User

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

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It 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, please tell your doctor or pharmacist. See section 4.

Contents of the Package 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, in particular
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 monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Before starting treatment with Spersallerg, discuss it with your doctor.
Be particularly careful when using Spersallerg:

• in elderly patients with severe cardiovascular disease, 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 tumors.
• in patients with dry eye syndrome,
• in patients with angle-closure glaucoma (overuse of vasoconstrictor eye drops may cause a rebound effect after they are stopped). 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.
MAOIs prolong and enhance the anticholinergic effect of antihistamines.
Sedating antihistamines may enhance the sedative effect of central nervous system depressants, including alcohol, sedatives, opioid analgesics, anxiolytics, and antipsychotics.
Concomitant use of other antimuscarinic agents, such as atropine and certain antidepressants (both tricyclic and MAOIs), may enhance their antimuscarinic effects.
Since systemic absorption is possible, caution should be exercised when administering Spersallerg with these medicinal products.
If it is necessary to administer more than one eye drop to the same eye, wait at least 5 minutes before administering the next eye drop.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Spersallerg should not be used during pregnancy unless advised 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 blurred vision.
Patients who experience such effects should not drive or operate machinery until the effects have resolved.

Spersallerg contains benzalkonium chloride

This may cause eye irritation.
Avoid contact with soft contact lenses.
Remove contact lenses before instillation and wait at least 15 minutes before reinserting them. The substance may discolour contact lenses.
Do not wear contact lenses in case of any eye irritation.

3. How to use Spersallerg

This medicine should always be used as directed by your doctor. If you are unsure, 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):Caution should be exercised and the dose limited to 1 to 2 drops per day. Spersallerg should not be used 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 rebound congestion and toxic papillary conjunctivitis.
After administration, 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 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 other;
• 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 tighten the bottle cap.

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

Overdose

Accidental ingestion of the contents of one bottle of Spersallerg is unlikely to have 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. Contact a 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 administration of Spersallerg is a feeling of burning and/or stinging, which is usually mild and transient.

Eye disorders

Burning and/or stinging after administration, as well as objective and subjective symptoms indicating a local allergic reaction. Discoloration of the iris, pupil dilation, blurred vision, acute conjunctivitis, chronic conjunctivitis, toxic papillary conjunctivitis, dry eye, rebound congestion after treatment, and angle-closure glaucoma may also occur.

Nervous system disorders

Headache, drowsiness, dizziness, tremor, and central nervous system stimulation may occur.

Cardiac disorders

Angina pectoris, hypertension, and tachycardia may occur.

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.
If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Adverse Reaction Monitoring 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
e-mail: ndl@urpl.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
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 below 25°C.
After opening the bottle, any unused solution should be discarded after 1 month.
Do not use after the expiry date stated on the packaging.
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 solution contains 0.5 mg antazoline hydrochloride and 0.4 mg 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, is a clear, colourless, and odourless 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 solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:
LABORATOIRES THÉA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
Manufacturer:
EXCELVISION
27, rue de la Lombardière
ZI la Lombardière
07100 Annonay
France
FARMILA-THEA Farmaceutici S.p.A.
Via Enrico Fermi, 50
20019 Settimo Milanese (MI)
Italy

To obtain more detailed information, please contact the representative of the marketing authorization holder:

Thea Polska Sp. z o.o.
ul. Cicha 7
00-353 Warsaw
Tel.: +48 22 642 87 77

Date of last revision of the leaflet: