5 mg film-coated tablets 
defloration

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– Contact pharmacy staff if you need more information and advice.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

– You must contact a doctor if the symptoms worsen or do not improve within 7 days.

This leaflet contains information about: 
1. What Desloratadine ABECE is and what it is used for 
2. What you need to know before you use Desloratadine ABECE 
3. How to use Desloratadine ABECE 
4. Possible side effects 
5. How to store Desloratadine ABECE 6. Contents of the pack 
and other information 

What Desloratadine ABECE is and what it is used for

Desloratadine Abece contains desloratadine which is an antihistamine .

How Desloratadine ABECE works

Desloratadine Abece is an anti-allergic drug that does not make you drowsy. It helps keep your allergic reactions and their symptoms under control. 

When to use Desloratadine ABECE

Desloratadine Abece relieves the symptoms of allergic rhinitis ( inflammation of the nasal mucosa caused by allergies, such as hay fever or allergies to dust mites) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, palate itching, and itchy, red, or watery eyes. 

Relieving these symptoms lasts all day and helps you maintain normal daily activities and normal sleep.


Desloratadine Abuse can also be prescribed to relieve symptoms associated with urticaria (a skin condition caused by allergies ). These symptoms include itching and hives. 

Desloratadine contained in Desloratadine Abece may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions. 

What you need to know before you use Desloratadine ABECE

Do not take Desloratadine ABECE

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Desloratadine Abece

  • if you have impaired kidney function  
  • if you or someone in your family has had seizures.

Children and young people

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

Other medicines and Desloratadine ABECE

There is no known interaction between Desloratadine Abece and other medicines. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Desloratadine ABECE with food, drink, and alcohol

Desloratadine Abece can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Taking Desloratadine Abece is not recommended if you are pregnant or breast-feeding.

Fertility

There are no fertility data for men and women.

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 feel drowsy, it is recommended that you do not perform activities that require sharp attention, such as driving a vehicle or using machinery until you know how you react to the medicine.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Desloratadine ABECE

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Adults and adolescents (12 years and older):

The recommended dose is one tablet once a day.

The tablet is swallowed whole with water. Can be taken with or without food.

Contact a doctor if the improvement is not seen after 7 days of treatment.

Desloratadine Abece should be used for a maximum of 3 consecutive months unless your doctor prescribes otherwise.

If you use more Desloratadine ABECE then you should  

Take Desloratadine Abece as prescribed for you. No serious problems are to be expected in case of accidental overdose.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Desloratadine ABECE

If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop using Desloratadine ABECE

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

4. Possible side effects

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

During the marketing of Desloratadine Abece, cases of severe allergic reactions(difficulty breathing, wheezing, itching, hives, and swelling) have been reported in very rare cases. If you experience any of these side effects are, stop taking the drug and seek immediate emergency medical attention.

In clinical trials in adults, the side effects were about the same as with an inactive tablet. However, fatiguedry mouth, and headache were reported more often than with an inactive tablet. In adolescents, headache was the most commonly reported side effect.

In clinical trials with desloratadine, the following side effects have been reported:

Common (the following may affect up to 1 in 10 people)

  • fatigue
  • dry mouth
  • headache.

During the marketing of desloratadine, the following side effects have been reported:

Very rare (may affect up to 1 in 10,000 people)

  • severe allergic reactions
  • fast heartbeat
  • vomiting
  • dizziness
  • muscle pain
  • restlessness with increased body movement
  • rash
  • stomach ache
  • upset stomach
  • drowsiness
  • hallucinations
  • hepatitis
  • throbbing or irregular heartbeat
  • nausea
  • diarrhea
  • difficulty sleeping
  • seizures
  • abnormal liver function tests

Has been reported (occurs in an unknown number of users):

  • unusual weakness
  • yellowing of the skin and/or eyes
  • increased sensitivity of the skin to sunlight, even in sunlight and to UV light, for example for UV light in solarium
  • changes in how the heartbeats
  • abnormal behavior
  • aggression
  • weight gain
  • increased appetite.

Children

Has been reported (occurs in an unknown number of users):

  • slow heartbeat
  • changes in how the heartbeats
  • abnormal behavior
  • aggression.

5. How to store Desloratadine ABECE

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

Store in the original package. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is desloratadine 5 mg
  • The other ingredients are microcrystalline cellulose, partially pregelatinized maize starch, magnesium stearate, colloidal anhydrous silica, hypromellose 6 cp, titanium dioxide (E171), stearic acid, indigo carmine aluminum lacquer (E132), purified water

What the medicine looks like and the contents of the pack

Blue, round biconvex, film-coated tablet with a  diameter of 6.5 mm, smooth on both sides.

Carton containing blister (PVC / PCTFE (ACLAR) film and smooth aluminum foil or PVC / PE / PVDC aluminum foil) with 5, 10, 20, 30, 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder 

Evolan Pharma AB

Box 120

182 12 Danderyd

Manufacturer 

Genepharm SA

11 miles Marathon Avenue,

153 51 Pallini Attikis

Greece 

Muhammad Nadeem

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