Betadrin Vzf

Package Leaflet: Information for the Patient

BETADRIN WZF, (1 mg + 0.33 mg)/ml, Nasal Drops, Solution
Diphenhydramine Hydrochloride + Naphazoline Nitrate

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

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3-5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Betadrin WZF and what is it used for

Betadrin WZF is a combination medicine containing two active substances - diphenhydramine (with antiallergic action) and naphazoline (which constricts dilated blood vessels). When applied to the nasal mucosa, the medicine reduces its swelling and congestion, reduces the amount of discharge, and facilitates its flow from the sinuses. This makes the feeling of a blocked nose and sinuses, which accompany allergies and colds, disappear.

Betadrin WZF is used:

• in acute inflammatory conditions of the nasal mucosa;
• in exacerbations of chronic rhinitis in the course of seasonal and year-round allergic rhinitis or colds.

The medicine acts symptomatically and is intended for temporary treatment.

2. Important information before using Betadrin WZF

When not to use Betadrin WZF

• if the patient is allergic to diphenhydramine hydrochloride, naphazoline nitrate, imidazole derivatives, or 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 adrenergic medicines (a group of medicines that includes naphazoline).

Warnings and precautions

Before starting to use Betadrin WZF, the patient should discuss it with their doctor or pharmacist.

• In patients with high blood pressure, heart rhythm disorders (irregular heartbeat), diabetes (elevated blood sugar), hyperthyroidism, prostatic hyperplasia, or the elderly, caution should be exercised due to the possibility of systemic effects.
• If during the use of the medicine, general symptoms such as dizziness, drowsiness, irregular heartbeat occur, which may suggest absorption of naphazoline (a component of Betadrin WZF), the medicine should be discontinued.
• The recommended duration of use and dosage of the medicine should be followed, as exceeding them may lead to increased swelling and discharge, as well as permanent changes in the nasal mucosa.
• The medicine should not be used in infants and children under 12 years of age.

Betadrin WZF and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The medicine should not be used concurrently with monoamine oxidase inhibitors (e.g., selegiline) or tricyclic antidepressants (e.g., imipramine, amitriptyline).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 WZF should be used with caution.

Driving and using machines

Betadrin WZF does not affect the ability to drive or operate machinery.

Betadrin WZF contains benzalkonium chloride and boric acid

The medicine contains 0.1 mg of benzalkonium chloride per ml of solution. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

The medicine should not be used in children under 12 years of age due to the boron content, which may affect fertility.

3. How to use Betadrin WZF

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• The medicine should be used only in the nose.
• For hygiene reasons, the medicine packaging should be used by only one patient.
• The medicine should not be used for more than 3 to 5 days. If after 3-5 days there is no improvement or the patient feels worse, they should consult their doctor.
• Doses greater than those recommended should not be used.

Adults and adolescents over 12 years of age:

1-3 drops into each nostril, not more often than every 4-6 hours.

Using a higher dose of Betadrin WZF than recommended

There are no data on acute overdose of nasal drops.

Prolonged or too frequent administration of the medicine in small children may lead to central nervous system depression, hypothermia, coma, or prolonged pupil dilation.

Accidental ingestion of the bottle contents, especially in children, may exceptionally cause excessive sedation with drowsiness, lowered body temperature, slowed heart rate, blood pressure fluctuations, and collapse.

One of the components of Betadrin WZF (naphazoline) may cause a sudden drop in blood pressure and a shock-like acceleration of heart rate.

Missing a dose of Betadrin WZF

A double dose should not be used to make up for a missed dose.

4. Possible side effects

Like all medicines, Betadrin WZF can cause side effects, although not everybody gets them.

Very rare (occurring in less than 1 in 10,000 people):

• drowsiness;
• irregular heartbeat;
• increased blood pressure;
• headaches and dizziness;
• nausea;
• excessive sweating;
• anxiety;
• weakness;
• increased blood sugar levels.

If general reactions or persistent local irritation occur, the medicine should be discontinued.

Prolonged use of the medicine may lead to secondary worsening of swelling and difficult-to-treat changes in the nasal mucosa.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the patient should inform their 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

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Betadrin WZF

Store in a temperature below 25°C.

Keep the bottle tightly closed.

The medicine should be kept out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and bottle after: EXP.

The expiry date refers to the last day of the month stated.

After opening the bottle, the shelf life of the medicine is 12 weeks.

Medicines should not be disposed of via wastewater or household waste.

Patients should ask their pharmacist how to dispose of medicines they no longer use.

This will help protect the environment.

6. Package contents and other information

What Betadrin WZF 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.
• The other ingredients are: benzalkonium chloride, disodium edetate, boric acid, sodium hydroxide 10% (to adjust pH), purified water.

What Betadrin WZF looks like and what the package contains

Betadrin WZF is a nasal drop in the form of a colorless, clear liquid.

A polyethylene bottle with a polyethylene dropper and a polyethylene cap with a guarantee ring, in a cardboard box.

1 bottle of 10 ml

Marketing authorization holder and manufacturer

Warsaw Pharmaceutical Works Polfa S.A.

ul. Karolkowa 22/24, 01-207 Warsaw

To obtain more detailed information, patients should contact their 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 the last update of the leaflet: