Betadrin

Leaflet attached to the packaging: patient information

BETADRIN (1 mg + 0.33 mg)/ml, eye drops, solution
Diphenhydramine hydrochloride + Naphazoline nitrate

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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Betadrin and what is it used for

Betadrin is a combination medicine that contains two active substances: diphenhydramine (with antiallergic action) and naphazoline (which constricts dilated blood vessels). The medicine removes local inflammatory symptoms of the conjunctiva (redness, pain, tearing), especially if they are caused by an allergy.
Betadrin is used:

• in acute inflammatory conditions of the conjunctiva in the course of seasonal and perennial allergic conjunctivitis;
• in inflammatory conditions associated with irritation of the conjunctiva due to the use of contact lenses, sun exposure, cigarette smoke, contact with pool water, etc.

2. Important information before using Betadrin

When not to use Betadrin:

• if you are allergic to diphenhydramine hydrochloride and/or naphazoline nitrate or any of the other ingredients of this medicine (listed in section 6);
• if you have narrow-angle glaucoma (increased pressure in the eyes);
• if you are allergic to adrenergic medicines (a group of medicines that includes naphazoline).

Warnings and precautions

Before starting to use Betadrin, discuss it with your doctor or pharmacist.

• The medicine should not be used in the case of chronic conjunctivitis. It may be used for a short time in the case of exacerbation of chronic conjunctivitis.
• Patients with hypertension, heart rhythm disorders, hyperthyroidism, prostatic hyperplasia, and the elderly should be cautious due to the possibility of systemic effects.
• Prolonged symptoms of eye irritation or pain lasting longer than 72 hours are an indication to discontinue the medicine.
• It is necessary to follow the recommended treatment time and not exceed the recommended doses, as this may lead to increased edema and secretion, as well as the formation of permanent changes in the eye epithelium.
• The medicine is not recommended for use in infants and children under 6 years of age.

Betadrin and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use.
Do not use the medicine at the same time as monoamine oxidase inhibitors (e.g., selegiline) or tricyclic antidepressants (e.g., imipramine, amitriptyline).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
The medicine may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
In breastfeeding women, Betadrin should be used with caution.

Driving and using machines

The medicine may impair vision, and therefore, it should be used with caution in people who drive vehicles and operate machines.

Betadrin contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride in each ml of solution. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Contact lenses should be removed before instillation and not reinserted for at least 15 minutes. Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer on the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, consult a doctor.

3. How to use Betadrin

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The medicine is intended for use in the eyes.

Use in adults and children over 6 years of age:

1-2 drops into the conjunctival sac as needed every 6-8 hours.
Without a doctor's recommendation, the medicine should not be used for more than 3-5 days.

Method of administration

The medicine is intended for external use only - locally into the conjunctival sac.
Do not touch the tip of the dropper, as this may contaminate the contents of the bottle.

• 1. Before instilling the medicine, wash your hands thoroughly.
• 2. Remove the cap from the bottle.

• 3. Tilt your head back and pull the lower eyelid down to create a pocket between the eyelid and the eye.
• 4. Invert the bottle and gently press the thumb or index finger on the wall until one drop of the medicine falls into the eye. Do not touch the dropper tip to the eye or eyelids. If the drop does not get into the eye, instill another one.
• 5. After instilling the medicine, gently press the inner corner of the eye for about 2 minutes. This will help prevent the medicine from being absorbed into the body.
• 6. If the doctor has recommended instilling the medicine into the other eye, repeat the actions from points 3, 4, and 5.
• 7. The dropper is designed to accurately measure drops, so do not enlarge the opening of the dropper.
• 8. After instillation, screw the bottle cap back on. However, do not screw it on too tightly.

Using more than the recommended dose of Betadrin

There are no data on acute overdose of eye drops used locally in the eye.
Prolonged or too frequent administration of the medicine in small children may lead to central nervous system depression, hypothermia (lowering of body temperature), coma, prolonged dilation of the pupil.
Accidental ingestion of the contents of the bottle may exceptionally cause a sudden drop in blood pressure, accelerated heart rate.

Missing a dose of Betadrin

Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Betadrin can cause side effects, although not everybody gets them.
The most common side effects are transient symptoms, such as:

• burning;
• itching;
• conjunctival hyperemia;
• eye pain;
• visual disturbances.

Rarely, the following may occur:

• drowsiness;
• palpitations;
• hypertension;
• headache and dizziness;
• nausea;
• increased intraocular pressure.

If general reactions or local irritation persist, the medicine should be discontinued.
Long-term use of the medicine may lead to secondary exacerbation of edema and increased tearing, as well as local changes in the eye epithelium.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, e-mail: ndl@urpl.gov.pl. Side effects 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 Betadrin

Store in a temperature below 25°C.
Keep the bottle tightly closed.
Store the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Shelf life after first opening the bottle: 4 weeks.
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 Betadrin contains

• -The active substances of the medicine are diphenhydramine hydrochloride and naphazoline nitrate. Each ml of solution contains 1 mg of diphenhydramine hydrochloride and 0.33 mg of naphazoline nitrate.
• Other ingredients are: benzalkonium chloride, disodium edetate, boric acid, sodium hydroxide 10% (to adjust pH); purified water.

What Betadrin looks like and contents of the pack

Betadrin is a sterile eye drop solution in the form of a colorless, transparent liquid.
The pack contains 2 polyethylene bottles of 5 ml solution each, in a cardboard box.

Marketing authorization holder and manufacturer

Warsaw Pharmaceutical Works Polfa S.A., ul. Karolkowa 22/24, 01-207 Warsaw. For more detailed information, please contact the local representative of the marketing authorization holder: Warsaw Pharmaceutical Works Polfa S.A., ul. Karolkowa 22/24, 01-207 Warsaw, tel. 22 691 39 00.

Date of last revision of the leaflet: