Package Leaflet: Information for the Patient

Desloratadine Pensa 5 mg Film-Coated Tablets

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

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

2. What you need to know before you start taking Desloratadine Pensa

3. How to take Desloratadine Pensa

4. Possible side effects

5. Storage of Desloratadine Pensa

6. Contents of the pack and additional informationadditional information

What is Desloratadina Pensa

Desloratadina Pensa contains desloratadine, which is an antihistamine.

How Desloratadina Pensa works

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

When to use Desloratadina Pensa

Desloratadina Pensa 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 and adolescents 12 years of age and older. These symptoms include sneezing, runny nose or nasal itching, palate itching, eye redness or tearing.

Desloratadina Pensa 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 to continue your daily activities and normal sleep periods.

Do not takeDesloratadina Pensa

- 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

Consult your doctor, pharmacist or nursebefore starting to take Desloratadina Pensa:

?If you have impaired renal function.

?If you have a personal or family history of seizures.

Children and adolescents

Do not administer this medicine to children under 12 years of age.

Desloratadina Pensa with other medicines

No known interactions of Desloratadina Pensa with other medicines.

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

Desloratadina Pensa with food, drinks and alcohol

Desloratadina Pensa can be taken regardless of meals.

Be careful when taking Desloratadina Pensa with alcohol.

Pregnancy, breastfeeding and fertility

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

Do not take Desloratadina Pensa if you are pregnant or breastfeeding a baby.

Fertility

No data available on male and female fertility.

Driving and operating machinery

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

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

Adults and adolescents 12 years of age and older:

The recommended dose is one tablet once a day with water, with or without food.

This medication is for oral use

Swallow the tablet whole.

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

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 based 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 duration of treatment may vary from patient to patient, and you should follow your doctor's instructions.

If you take more Desloratadina Pensa than you should

Take Desloratadina Pensa only as your doctor has instructed. An accidental overdose is not expected to cause serious problems.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Desloratadina Pensa

If you forget to take your dose at the usual 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 the missed dose.

If you interrupt treatment with Desloratadina Pensa

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

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

During the marketing of Desloratadina Pensa, very rarely reported cases of severe allergic reactions (difficulty breathing, hissing, itching, 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 adults, side effects were approximately the same as with a placebo tablet. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo tablet. In adolescents, headache was the most frequently reported adverse reaction.

In clinical trials with desloratadina, the following side effects were reported as:

Frequent: may affect up to 1 in 10 people

?fatigue

?dry mouth

?headache

Adults

During the marketing of Desloratadina Pensa, the following side effects were reported as:

Rare: may affect up to 1 in 10,000 people

?severe allergic reactions

?skin rash

?strong or irregular heartbeats

?rapid heartbeats

?stomach pain

?nausea (urge to vomit)

?vomiting

?upset stomach

?diarrhea

?dizziness

?drowsiness

?difficulty sleeping

?muscle pain

?hallucinations

?seizures

?agitation with increased body movement

?inflammation of the liver

?alteration of liver function tests

Unknown frequency: cannot be estimated from 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 tanning bed

?change in heart rhythm

?abnormal behavior

?aggression

?weight gain, increased appetite

?depressed mood

?dry eyes

Children

Unknown frequency: cannot be estimated from available data

?slow heart rate

?change in heart rhythm

?abnormal behavior

?aggression

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System of 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 packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature; store in the original packaging to protect it from light.

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

• The active ingredient is desloratadine. Each tablet contains 5 mg of desloratadine.
• The other components are: Microcrystalline cellulose, partially pregelatinized cornstarch, magnesium stearate, and anhydrous colloidal silica.

Coating: Opadry blue 03A30735 which consists of: Hypromellose 6cP, titanium dioxide (E171), microcrystalline cellulose, stearic acid, Indigotin, and Indigo Carmín (E132)

Appearance of the product and contents of the packaging

Blue-coated tablets, round, biconvex, with a diameter of 6.5 mm and a thickness of 3.2 mm.

Desloratadine Pensa 5 mg coated tablets are presented in PVC/PE/PVDC – Aluminum or PVC/PCTFE (Transparent) - Aluminum blisters of 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Last review date of this leaflet:May 2022

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