Zidenac

Package Leaflet: Information for the Patient

Zidenac, 1 mg/ml, Oral Drops, Solution

Dimetindene Maleate

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

• This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.
• Keep this package 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 package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is Zidenac and what is it used for
• 2. Important information before taking Zidenac
• 3. How to take Zidenac
• 4. Possible side effects
• 5. How to store Zidenac
• 6. Contents of the package and other information

1. What is Zidenac and what is it used for

Zidenac contains the active substance dimetindene maleate. It belongs to a group of medicines called antihistamines. It counteracts the action of histamine, which is a substance released by the body during allergic reactions. Zidenac relieves itching and irritation caused by skin rash, reduces swelling, and relieves symptoms of allergic rhinitis, such as runny nose, sneezing, nasal itching, and eye itching and tearing.

Zidenac is used to treat symptoms of allergic diseases:

• skin: urticaria, itching of various origins, endogenous eczema, if the doctor has previously diagnosed these diseases in the patient,
• respiratory system: seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis (e.g., allergy to house dust, animal hair, feathers), if the doctor has previously diagnosed these diseases in the patient. Zidenac relieves itching associated with infectious diseases (e.g., chickenpox), if the doctor has previously diagnosed these diseases in the patient or after an insect bite or sting.

Zidenac is indicated for use in adults, adolescents, and children from 1 year of age and older. Zidenac is indicated for allergic rhinitis in adults, adolescents, and children 6 years of age and older.

• 1. year of age and older. Zidenac is indicated for allergic rhinitis in adults, adolescents, and children 6 years of age and older.

If after 3 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Zidenac

When not to take Zidenac:

Zidenac should not be given to infants under 1 year of age.

Warnings and precautions

Before starting to take Zidenac, the patient should discuss it with their doctor or pharmacist if they have:

• glaucoma,
• urinary retention (caused by e.g., prostate enlargement),
• epilepsy.

Elderly patients should consult their doctor before taking this medicine, as there is a greater likelihood of side effects, such as increased heart rate, dry mouth, blurred vision, constipation, excitement, or fatigue. Elderly patients should be cautious when taking Zidenac. Zidenac should not be taken by elderly patients who show signs of disorientation.

Children and adolescents

Zidenac should not be taken by children under 1 year of age.

It has been observed that antihistamines may cause excitability (easier agitation) in younger children. The doctor should be consulted regarding children under 12 years of age taking Zidenac.

Zidenac with food, drink, and alcohol

Like many other antihistamines, Zidenac may enhance the effects of alcohol.

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 taking this medicine.

If the patient is pregnant, they should take Zidenac only on the advice of a doctor.

Zidenac should not be taken during breastfeeding.

Driving and using machines

Like other antihistamines, Zidenac may cause drowsiness, reduce concentration, and slow down reactions in some people. This is especially true when taken with alcohol. In such cases, the patient should avoid driving, operating machinery, or performing other activities that require increased concentration.

Zidenac contains propylene glycol E 1520, sodium, and benzoic acid E 210

• This medicine contains 200 mg of propylene glycol in a single dose (40 drops), which corresponds to 100 mg/ml.
• This medicine contains less than 1 mmol (23 mg) of sodium per dose (40 drops), which means the medicine is considered "sodium-free".
• This medicine contains 2 mg of benzoic acid in a single dose (40 drops), which corresponds to 1 mg/ml.

3. How to take Zidenac

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Do not exceed the recommended dose.

If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Zidenac should not be taken for more than 14 days without consulting a doctor.

Adults and adolescents over 12 years of age

20 to 40 drops 3 times a day.

The recommended dose for patients with a tendency to drowsiness is 40 drops at night and 20 drops in the morning.

Children

Children from 1 to 12 years of age

The recommended daily dose is 2 drops per kilogram of body weight per day, divided into 3 doses (e.g., 8 drops 3 times a day for a 2-year-old child weighing 12 kg). Detailed information can be found in the dosing table below.

Elderly patients (over 65 years of age)

The same dose as for adults can be taken.

How to take Zidenac

To release the drops, the bottle with the dropper should be held vertically downwards.

If there are difficulties with dripping, the bottom of the bottle should be tapped several times with a finger.

The drops should be taken undiluted (e.g., on a teaspoon). Zidenac drops should not be exposed to high temperatures. If the child is fed with a spoon, Zidenac drops are given undiluted on a small teaspoon.

Overdose of Zidenac

In case of overdose or accidental ingestion by a child, the patient should immediately contact their doctor.

Missing a dose of Zidenac

If a dose is missed, it should be taken as soon as possible, unless it is less than 2 hours until the next dose. Then the patient should continue taking the medicine according to the recommended dosing schedule. A double dose should not be taken to make up for a missed dose.

4. Possible side effects

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

If any of the following symptoms occur, which may be symptoms of an allergic reaction, the patient should STOP taking Zidenac and seek medical help immediately.

• Shortness of breath or swallowing problems.
• Swelling of the face, lips, tongue, or throat.
• Severe skin itching with red rash or hives, muscle cramps. These side effects are very rare (may occur less often than in 1 in 10,000 people).

Other side effects that may occur are usually mild and temporary.

Side effects are more common at the beginning of treatment.

Very common(may occur more often than in 1 in 10 people):

• Fatigue.

Common(may occur less often than in 1 in 10 people):

• Drowsiness, nervousness.

Rare(may occur less often than in 1 in 1000 people):

• Restlessness.
• Headache, dizziness.
• Digestive problems, nausea, dry mouth and throat.

Reporting side effects

If the patient experiences any side effects, including those not listed in the package leaflet, they should inform their 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

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

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

5. How to store Zidenac

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

Store in a temperature below 25°C. The bottle should be stored in the outer packaging to protect it from light.

Do not use this medicine after the expiry date stated on the packaging after "EXP".

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

The shelf life after first opening the immediate packaging is 6 months.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Zidenac contains

• The active substance of Zidenac is dimetindene maleate. 1 ml of Zidenac drops contains 1 mg of dimetindene maleate.
• The other ingredients are: propylene glycol (E 1520), disodium phosphate dodecahydrate, citric acid monohydrate, benzoic acid (E 210), disodium edetate, sodium saccharin (E 954), purified water.

What Zidenac looks like and contents of the package

Zidenac, oral drops, solution is a clear, colorless, and odorless solution.

Zidenac, oral drops are packaged in an orange glass type III bottle with a dropper made of LDPE, a cap made of PP, and a protective cap made of LDPE that prevents children from accessing the contents, in a cardboard box.

Package sizes: 20 ml, 50 ml, 3×20 ml.

Not all package sizes may be marketed.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.

Hvězdova 1716/2b

140 78 Prague 4

Czech Republic

Manufacturer

Mipharm S.P.A.

Via Bernardo Quaranta 12

20141 Milan, Italy

Winthrop Arzneimittel GmbH

Brüningstraße 50

65926 Frankfurt am Main, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:

Dimetinden Zentiva

Portugal, Poland:

Zidenac

Czech Republic:

MONIRET

For more detailed information on the medicine, the patient should contact the representative of the marketing authorization holder in Poland:

Glenmark Pharmaceuticals Sp. z o.o.

ul. Dziekońskiego 3

00-728 Warsaw

Tel: +48 22 35 12 500

Email: [email protected]

Date of last revision of the package leaflet: