Package Leaflet: Information for the patient

Desloratadine STADA 0.5 mg/ml oral solution EFG

Read this 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What you need to know before you start taking Desloratadine STADA
2. How to take Desloratadine STADA
3. Possible side effects

1. Storage of Desloratadine STADA

Contents of the pack and additional information

What is Desloratadina STADA

Desloratadina STADA contains desloratadine, which is an antihistamine.

How Desloratadina STADA works

Desloratadina STADA oral solution is an antiallergic medication that does not cause drowsiness. It helps control the allergic reaction and its symptoms.

When to use Desloratadina STADA

Desloratadina 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 aged 1 year and older. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness, or tearing.

Desloratadina STADA oral solution is also used to relieve symptoms associated with urticaria (skin disease caused by an allergy). These symptoms include itching and skin hives.

The relief of these symptoms lasts a full day and helps you continue your daily activities and normal sleep periods.

Do not take Desloratadina STADA

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Desloratadina STADA.

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

Use in children and adolescents

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

Other medicines and Desloratadina STADA

No known interactions of Desloratadina STADA with other medicines.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Desloratadina STADA with food, drinks, and alcohol

Desloratadina STADA can be taken with or without food.

Be careful when taking Desloratadina STADA with alcohol.

Pregnancy, breastfeeding, and fertility

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.

Desloratadina STADA oral solution is not recommended if you are pregnant or breastfeeding a baby.

Fertility

No data available on male and female fertility.

Driving and operating machines

At the recommended dose, this medicine is not expected to affect your ability to drive or operate machines. Although most people do not experience drowsiness, it is recommended not to perform activities that require a state of alertness, such as driving a car or operating machines, until you have determined your own response to the medicine.

Desloratadina STADA contains sorbitol

This medicine contains 103 mg of sorbitol per ml.

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

Desloratadina STADA contains propylene glycol

This medicine contains 102.3 mg of propylene glycol per ml.

Desloratadina STADA contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Children

Children aged 1 to 5 years:

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

Children aged 6 to 11 years:

The recommended dose is 5 ml (a 5 ml spoonful) of oral solution once a day.

Adults and adolescents 12 years of age and older)

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

In the case that the package containing the oral solution bottle includes a dosing syringe, you can use it alternatively to take the appropriate amount of oral solution.

Administration Form

This medication is for oral use.

Swallow the oral solution dose and then drink a little water. You can take this medication with or without food.

Treatment Duration

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

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment plan that will depend on the evaluation of your disease history.

If your allergic rhinitis is persistent (presence of symptoms for 4 or more days a week and for more than 4 weeks), your doctor may recommend long-term treatment.

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

If you take more Desloratadina STADA than you should

Take Desloratadina STADA oral solution only as your doctor has indicated. A accidental overdose is not expected to cause serious problems. However, in case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Desloratadina STADA

If you forgot 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 compensate for the missed doses.

If you interrupt treatment with Desloratadina STADA

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

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

During the marketing of desloratadine, very rarely reported cases of severe allergic reactions (difficulty breathing, wheezing, itching, skin rashes, and swelling) have been communicated. If you experience any of these severe side effects, stop taking this medicine and seek immediate medical attention.

In clinical trials in most children and adults, the side effects of desloratadine were approximately the same as those of a solution or tablet without an active ingredient. However, frequent side effects in children under 2 years of age were diarrhea, fever, and insomnia, while in adults, fatigue, dry mouth, and headache were reported more frequently than with a tablet without an active ingredient.

During clinical trials with desloratadine, the following side effects were reported:

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 side effects were reported as:

Adults

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

Unknown frequency: the frequency cannot be estimated from the available data

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

Children

Unknown frequency: the frequency cannot be estimated from the available data

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Use only within the 2 months following the first opening of the bottle.

Do not use this medication if you observe any change in the appearance of the oral solution.

Medications should not be disposed of through drains or in the trash. Deposit containers and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Desloratadine STADA

The active ingredient is desloratadine. Each ml of Desloratadine STADA contains 0.5 mg of desloratadine.

The other components of the oral solution are:

Liquid sorbitol (E420) (non-crystallizable)

Propylene glycol

Citric acid monohydrate

Sodium citrate

Hypromellose 2910

Sucralose

Disodium edetate

Tutti fruti flavor

Purified water.

Appearance of the product and contents of the package

Desloratadine STADA oral solution is presented as a transparent and colorless solution, free of foreign substances.

Desloratadine STADA oral solution is presented in six different volume sizes: 50, 60, 100, 120, 150, and 300 ml, packaged in amber-colored type III glass bottles with a child-resistant plastic screw cap, with a multi-layer polyethylene coating or a child-resistant plastic screw cap consisting of an outer and inner layer of polypropylene and polyethylene, respectively. 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 final volume of 5 ml marked every 0.5 ml.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer Marketing authorization holder

STADA, S.L. Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) [email protected]

Responsible 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 with the following names:

BelgiumDesloratadine EG 0.5mg/ml drink

DenmarkDesloratadin STADA

FinlandDesloratadin STADA

GermanyDesloratadin STADA 0.5 mg/ml Solution for oral use

HungaryDesloratadine STADA

LuxembourgDesloratadine EG 0.5mg/ml oral solution

NetherlandsDesloratadine CF 0.5 mg/ml, drink

PortugalDesloratadina Ciclum

SpainDesloratadina STADA 0.5 mg/ml oral solution EFG

Last review date of this leaflet:November 2022

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/