Package leaflet: Information for the patient

BETADRIN, (1 mg + 0,33 mg)/ml, eye drops, solution
Diphenhydramini hydrochloridum + Naphazolini nitras
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Betadrin is and what it is used for

Betadrin is a combination medicine containing two active substances:
diphenhydramine (with antiallergic action) and naphazoline (which constricts dilated blood vessels). The medicine relieves local symptoms of conjunctival inflammation (redness, pain, tearing), particularly when caused by allergy.
Betadrin is used:

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

2. Important information before using Betadrin

When not to use Betadrin:

if the patient is allergic to diphenhydramine hydrochloride and/or naphazoline nitrate or to any of the other ingredients of this medicine (listed in section 6);
if the patient has narrow-angle glaucoma (increased eye pressure);
if the patient is allergic to sympathomimetic drugs (a group of medicines which includes naphazoline).

Warnings and precautions
Before starting to use Betadrin, consult a doctor or pharmacist.

This medicine should not be used in chronic conjunctivitis. It may be used briefly during an exacerbation of chronic conjunctivitis.
Caution is advised in patients with hypertension, cardiac arrhythmias, hyperthyroidism, benign prostatic hyperplasia, or in elderly patients, due to the possibility of systemic effects.
Persistence of eye irritation or pain for longer than 72 hours is an indication to discontinue the medicine.
The recommended duration of treatment and dosage must be strictly observed. Exceeding the recommended dose may lead to worsening of swelling and increased secretions, as well as development of permanent changes in the corneal epithelium.
Use of the medicine is not recommended in infants and children under 6 years of age.

Betadrin and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Do not use this medicine concurrently with antidepressants belonging to the group of monoamine oxidase inhibitors (e.g. selegiline) or tricyclic antidepressants (e.g. imipramine, amitriptyline).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
Betadrin should be used with caution in breastfeeding women.

Driving and operating machinery
This medicine may impair vision; therefore, it should be used with caution in people who drive vehicles or operate machinery.

Betadrin contains benzalkonium chloride
The medicine contains 0.1 mg of benzalkonium chloride per ml of solution. Benzalkonium chloride may be absorbed by soft contact lenses and may change 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, especially in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or eye pain occur after using the medicine, consult a doctor.

3. How to use Betadrin

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
This medicine is intended for ophthalmic use.
Use in adults and children over 6 years of age:
1-2 drops into the conjunctival sac as needed, every 6-8 hours.
Without medical advice, this medicine should not be used for longer than 3-5 days.
Method of administration
This medicine is intended for external use only – locally into the conjunctival sac.
Do not touch the dropper tip, as this may contaminate the contents of the bottle.

Wash hands thoroughly before instilling the drops.
Unscrew the cap from the bottle.
Tilt the head backward and gently pull down the lower eyelid to form a pouch between the eyelid and the eyeball.
Invert the bottle and gently press with the thumb or index finger on the side of the bottle until one drop is dispensed into the eye. Do not let the dropper tip touch the eye or eyelids. If the drop misses the eye, instill another drop.
After instillation of Betadrin, gently press on the inner corner of the eye for about 2 minutes. This helps prevent systemic absorption of the medicine.
If the doctor has prescribed instillation in the other eye as well, repeat steps 3, 4, and 5.
The dropper is designed to accurately measure the drops; therefore, do not enlarge the opening of the dropper.
After instillation, replace the cap on the bottle. Do not overtighten.

Overdose of Betadrin
There are no data regarding acute overdose of eye drops administered locally.
Prolonged or excessively frequent use in young children may lead to central nervous system depression, hypothermia (lowered body temperature), coma, and prolonged pupil dilation.
Accidental ingestion of the bottle contents may exceptionally cause sudden drop in blood pressure and increased heart rate.
Missed dose of Betadrin
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The most commonly occurring symptoms are transient and include:

burning sensation;
itching;
conjunctival hyperaemia;
eye pain;
visual disturbances.

Rarely, the following may occur:

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

If general reactions occur or local irritation persists, the medicine should be discontinued.
Prolonged use of the medicine may lead to secondary aggravation of swelling and increased tearing, as well as local changes in the corneal epithelium.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store Betadrin

Store below 25 °C.
Keep the bottle tightly closed.
Store the medicine in a place invisible and inaccessible to 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 stated month.
The label on the packaging shows EXP, which stands for expiry date, and Lot, which stands for batch number.
Usable period after first opening the bottle: 4 weeks.
Medicines must 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 packaging and other information

What the medicine Betadrin contains

The active substances 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: benzalkonium chloride, solution; disodium edetate; boric acid; sodium hydroxide 10% (for pH adjustment); purified water.

What Betadrin looks like and contents of the pack
Betadrin is a sterile eye drop solution, appearing as a colourless, clear liquid.
The pack contains 2 polyethylene bottles with 5 ml of solution each, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
Karolkowa 22/24, 01-207 Warsaw
For further information, please contact the local representative of the Marketing Authorisation Holder:
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
Karolkowa 22/24, 01-207 Warsaw
tel. 22 691 39 00