Desloratadine STADA 0.5 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Desloratadine STADA 0.5 mg/ml oral solution EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Desloratadine STADA is and what it is used for

2. What you need to know before taking Desloratadine STADA

3. How to take Desloratadine STADA

4. Possible side effects

5. How to store Desloratadine STADA

6. Contents of the pack and other information

1. What Desloratadine STADA is and what it is used for

What Desloratadine STADA is

Desloratadine STADA contains desloratadine, which is an antihistamine.

How Desloratadine STADA works

Desloratadine STADA oral solution is a non-sedating antiallergic medicine. It helps control allergic reactions and their symptoms.

When Desloratadine STADA should be used

Desloratadine STADA oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or dust mite allergy) in adults, adolescents, and children from 1 year of age. These symptoms include sneezing, runny or itchy nose, itching of the palate, and itchy, red eyes or tearing.

Desloratadine STADA oral solution is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and skin rashes.

Relief from these symptoms lasts for a full day, helping you continue your daily activities and maintain normal sleep periods.

2. What you need to know before taking Desloratadine STADA

DO NOT take Desloratadine STADA

• if you are allergic to desloratadine, or to any of the other ingredients of this medicine (listed in section 6), or to loratadine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Desloratadine STADA.

• if you have impaired kidney function.
• if you have a personal or family history of seizures.

Use in children and adolescents

Do not give this medicine to children under 1 year of age.

Other medicines and Desloratadine STADA

There are no known interactions between Desloratadine STADA and other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Desloratadine STADA with food, drinks, and alcohol

Desloratadine STADA can be taken with or without food.

Be cautious when taking Desloratadine STADA with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It is not recommended to take Desloratadine STADA oral solution if you are pregnant or breastfeeding a baby.

Fertility

There are no available data on male and female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended not to perform activities requiring mental alertness, such as driving a car or operating machinery, until you have determined how the medicine affects you.

Desloratadine STADA contains sorbitol

This medicine contains 103 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Desloratadine STADA contains propylene glycol

This medicine contains 102.3 mg of propylene glycol per ml.

Desloratadine STADA contains sodium

This medicine contains 3.854 mg of sodium (main component of table/cooking salt) per ml. This corresponds to 38.54 mg of sodium in a 10 ml dose, equivalent to 1.927% of the maximum recommended daily sodium intake for an adult.

3. How to take Desloratadine STADA

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Children

Children from 1 to 5 years of age:

The recommended dose is 2.5 ml (½ of a 5 ml spoonful) of oral solution once daily.

Children from 6 to 11 years of age:

The recommended dose is 5 ml (one 5 ml spoonful) of oral solution once daily.

Adults and adolescents aged 12 years and older

The recommended dose is 10 ml (two 5 ml spoonfuls) of oral solution once daily.

If the packaging containing the oral solution bottle includes an oral dosing syringe, you may alternatively use it to take the correct amount of oral solution.

Method of administration

This medicine is for oral use.

Swallow the dose of oral solution and then drink a little water. You may take this medicine with or without food.

Duration of treatment

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and how long you should take Desloratadine STADA oral solution.

If you have intermittent allergic rhinitis (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will recommend a treatment schedule based on the assessment of your medical history.

If you have persistent allergic rhinitis (symptoms present for 4 or more days per week and for more than 4 weeks), your doctor may recommend long-term treatment.

For urticaria, the duration of treatment may vary from patient to patient, and therefore you should follow your doctor's instructions.

If you take more Desloratadine STADA than you should

Take Desloratadine STADA oral solution only as directed by your doctor. An accidental overdose is not expected to cause serious problems. However, in case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Desloratadine STADA

If you forget to take your dose at the scheduled time, take it as soon as possible and then continue with your usual dosing schedule. Do not take a double dose to make up for missed doses.

If you stop taking Desloratadine STADA

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

During the marketing of desloratadine, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, skin rash, and swelling) have been reported. If you experience any of these serious adverse effects, stop taking this medicine immediately and consult your doctor without delay.

In clinical trials involving most children and adults, adverse effects with desloratadine were approximately the same as with a solution or tablet containing no active ingredient. However, in children under 2 years of age, the frequent adverse effects were diarrhea, fever, and insomnia, whereas in adults, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active ingredient.

In clinical trials with desloratadine, the following adverse effects were reported as:

Children

Frequent in children under 2 years of age: the following may affect up to 1 in 10 children

• diarrhea
• fever
• insomnia

Adults

Frequent: the following may affect up to 1 in 10 people

• fatigue
• dry mouth
• headache

During the marketing of desloratadine, the following adverse effects were reported as:

Adults

Very rare: the following may affect up to 1 in 10,000 people

• anaphylactic reaction (severe allergic reaction)
• angioedema (swelling of the deep layers of the skin)
• difficulty breathing
• palpitations
• tachycardia (rapid heartbeat)
• convulsions
• liver enzyme increases
• hepatitis (liver inflammation)
• rash
• pruritus (itching)
• urticaria (hives)
• alopecia (hair loss)
• hypersensitivity reactions
• somnolence (drowsiness)
• dizziness
• nausea
• myalgia (muscle pain)
• asthenia (weakness)
• malaise (general discomfort)
• increased appetite
• insomnia
• abnormal liver function tests
• weight increase
• elevated liver enzymes
• anaphylaxis
• anaphylactic shock
• angioedema
• dyspnea (difficulty breathing)
• palpitations
• tachycardia
• convulsions
• hepatitis
• rash
• pruritus
• urticaria
• alopecia
• hypersensitivity
• somnolence
• dizziness
• nausea
• myalgia
• asthenia
• malaise
• increased appetite
• insomnia
• abnormal liver function
• weight gain
• elevated liver enzymes

Frequency not known: frequency cannot be estimated from the available data

• unusual weakness
• yellowing of the skin and/or eyes
• increased sensitivity of the skin to sunlight, even on cloudy days, and to ultraviolet light, for example ultraviolet light from a sunbed
• change in heartbeat rhythm
• abnormal behavior
• aggression
• weight gain, increased appetite
• depressed mood
• dry eyes

Children

Frequency not known: frequency cannot be estimated from the available data

• slow heartbeat
• change in heartbeat rhythm
• abnormal behavior
• aggression
• weight gain, increased appetite

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if these adverse reactions are not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish System for Pharmacovigilance of Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Desloratadine STADA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Use only within 2 months after first opening the bottle.

Do not use this medicine if you notice any change in the appearance of the oral solution.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Desloratadina STADA

The active substance is desloratadine. Each ml of Desloratadina STADA contains 0.5 mg of desloratadine.

The other components of the oral solution are:

Sorbitol liquid (E420) (non-crystallizable)
Propylene glycol
Citric acid monohydrate
Sodium citrate
Hypromellose 2910
Sucralose
Disodium edetate
Fruity flavour (tutti frutti)
Purified water.

Appearance of the product and contents of the container

Desloratadina STADA oral solution is presented as a clear, colourless solution, free from foreign particles.

Desloratadina STADA oral solution is available in six different volume sizes: 50, 60, 100, 120, 150 and 300 ml, packed in amber glass type III bottles with child-resistant screw caps, either with a multilayer polyethylene lining or with a child-resistant screw cap consisting of an outer layer of polypropylene and an inner layer of polyethylene. The bottles are subsequently packaged in cardboard boxes. All presentations include a measuring spoon with markings for 2.5 ml and 5 ml doses or an oral dosing syringe with a total volume of 5 ml, marked every 0.5 ml.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
[email protected]

Manufacturer

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel, Germany

or

Delpharm Orleans
5 avenue de Concyr
45071 Orleans CEDEX 2, France

or

Balkanpharma Troyan AD
1 Krayrechna Str.
Troyan 5600
Bulgaria

or

H2 Pharma
21 rue Jacques Tati, ZAC La Croix Bonnet
Bois d’Arcy 78390
France

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

Belgium Desloratadine EG 0.5 mg/ml oral solution
Denmark Desloratadin STADA
Finland Desloratadin STADA
Germany Desloratadin STADA 0.5 mg/ml Lösung zum Einnehmen
Hungary Desloratadine STADA
Luxembourg Desloratadine EG 0.5 mg/ml soluzione buvable
Netherlands Desloratadine CF 0.5 mg/ml, oral solution
Portugal Desloratadina Ciclum
Spain Desloratadina STADA 0.5 mg/ml oral solution EFG

Date of the most recent review of this leaflet: November 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/