DESLORATADINE STADA 0.5 mg/ml ORAL SOLUTION

2. What you need to know before taking Desloratadine STADA

Do not take Desloratadine STADA

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

Warnings and precautions

Consult 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 of Desloratadine STADA with other medicines.

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

Desloratadine STADA with food, drinks, and alcohol

Desloratadine STADA can be taken with or without food.

Be careful 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Fertility

There are no data available 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 use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities that require a state of alertness, such as driving a car or using machines, until you have determined your own response to the medicine.

Desloratadine STADA contains sorbitol

This medicine contains 103 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder 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 salt/cooking salt) per ml. This is equivalent to 38.54 mg of sodium in a 10 ml dose, which is equivalent to 1.927% of the maximum recommended daily intake of sodium for an adult.

3. How to take Desloratadine STADA

Follow exactly the administration instructions of this medicine 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 spoon) of oral solution once a day.

Children from 6 to 11 years of age:

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

Adults and adolescents from 12 years of age

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

In case the package containing the bottle of oral solution includes a dosing syringe, you can use it as an alternative to take the appropriate 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 can 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 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 schedule that depends on the evaluation of the history of your disease.

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 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 your doctor has told you. It is not expected that an accidental overdose will cause serious problems. However, in case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 right time, take it as soon as possible and then continue with the usual dosing schedule. Do not take a double dose to make up for forgotten doses.

If you stop taking Desloratadine STADA

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 side effects, stop taking this medicine and go to your doctor immediately.

In clinical trials in most children and adults, the side effects with desloratadine were approximately the same as with a solution or tablet that does not contain the active ingredient. However, the 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 that does not contain the active ingredient.

In 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:

Adults

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

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 the sun, even on cloudy days, and to ultraviolet light, for example, to the ultraviolet light of a sunbed
• change in heart 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 heart rhythm
• abnormal behavior
• aggression
• weight gain, increased appetite

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system included in the Spanish Medicines and Health Products Surveillance System: https://www.notificaram.es. By reporting side effects, 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 which is stated on the bottle after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and additional information

Composition of Desloratadine STADA

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

The other ingredients of the oral solution are:

Liquid sorbitol (E420) (non-crystallizing)

Propylene glycol

Citric acid monohydrate

Sodium citrate

Hypromellose 2910

Sucralose

Disodium edetate

Tuti fruti flavor

Purified water.

Appearance of the product and contents of the pack

Desloratadine STADA oral solution is presented as a clear, 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 type III amber glass bottles with a child-resistant plastic screw cap, with a multilayer coating of polyethylene or with a child-resistant plastic screw cap consisting of an outer layer and an inner layer of polypropylene and polyethylene, respectively. The bottles are then packaged in cardboard boxes. All presentations include a measuring spoon with marks for 2.5 ml and 5 ml doses or a dosing syringe for oral use with a final volume of 5 ml marked every 0.5 ml.

Not all 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium Desloratadine EG 0.5mg/ml drank

Denmark Desloratadin STADA

Finland Desloratadin STADA

Germany Desloratadin STADA 0.5 mg/ml Lösung zum Einnehmen

Hungary Desloratadine STADA

Luxembourg Desloratadine EG 0.5mg/ml soluzione buvable

Netherlands Desloratadine CF 0.5 mg/ml, drank

Portugal Desloratadina Ciclum

Spain Desloratadina STADA 0.5 mg/ml solución oral EFG

Date of last revision of this leaflet:November 2022

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