5 mg film-coated tablets 
desloratadine

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.

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

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– 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.

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

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

When to use Desloratadine Stada

Desloratadine Stada 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, itchy and itchy, red or watery eyes.

Desloratadine Stada is also used to relieve symptoms associated with urticaria (a skin condition caused by allergies ). These symptoms include itching and hives.

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

Desloratadine contained in Desloratadine Stada may also be approved for the treatment of other conditions not mentioned in this product information. 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 STADA

Do not use Desloratadine STADA

  • if you are allergic to desloratadine, 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 Stada

  • 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 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 take any other medicines.

Desloratadine STADA with food, drink, and alcohol

Desloratadine Stada can be taken with or without food.

Be careful if you take Desloratadine Stada with alcohol.

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 Stada 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.

Desloratadine STADA contains isomalt (E953)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Desloratadine STADA

Always take this medicine exactly 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 with water, with or without food.

Method of administration

This medicine should be swallowed.

The tablet is swallowed whole.

Length of treatment

Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you are suffering from and decide how long to take Desloratadine Stada.

If your allergic rhinitis is recurrent (presence of symptoms for less than 4 days a week or less than 4 weeks), your doctor will recommend a treatment schedule based on the assessment of your medical history.

If your allergy is persistent (presence of symptoms for 4 days or more per week and more than 4 weeks), then your doctor may recommend a longer-term treatment.

In urticaria, the duration of treatment may vary from patient to patient and you should therefore follow your doctor’s prescription.

If you use more Desloratadine STADA then you should  

Take Desloratadine Stada as prescribed for you. No serious problems are to be expected in case of accidental overdose. However, if you take more Desloratadine Stada than you were prescribed, talk to a doctor, pharmacist, or nurse immediately.

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

If you forget to use Desloratadine STADA

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 STADA

If you have any further questions on the use of this product, 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, cases of severe allergic reactions (difficulty breathing, wheezing, itching , hives and swelling) have been reported in very rare cases. If you have any of these serious side effect is, 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, fatigue, dry 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 as:

Common (may affect up to 1 in 10 people):

  • fatigue
  • dry mouth
  • headache.

Adults

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

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
  • change in how the heart beats
  • abnormal behavior
  • aggression
  • weight gain, increased appetite.

Additional side effects in children and adolescents

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

  • slow heartbeat
  • change in how the heart beats.
  • abnormal behavior
  • aggression
  • weight gain, increased appetite.

5. How to store 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 carton and blister after EXP. The expiration date is the last day of the specified month.

Do not use this medicine if you notice any visible deterioration in the appearance of the tablets.

Do not store above 30 ° C.

Store in the original package. Moisture sensitive.

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. Each tablet contains 5 mg of desloratadine.

Other ingredients are:

Tablet core:

Isomalt (E 953)

Pregelatinized corn starch

Cellulose, microcrystalline

Magnesium oxide, heavy

Hydroxypropylcellulose

Crospovidone (type A)

Magnesium stearate

Tablet coating:

Polyvinyl alcohol

Titanium dioxide (E 171)

Macrogol / PEG 3350

Talc

Indigotine (E 132).

What the medicine looks like and the contents of the pack

Desloratadine Stada 5 mg film-coated tablets are blue, round, biconvex tablets about 6.5 mm in diameter.

Desloratadine Stada is packaged in blisters of polychlorotrifluoroethylene (PCTFE) / polyvinyl chloride (PVC) / Aluminum blister.

Packs of 7, 10, 15, 20, 30, 50, 60, 90, 100, 120, 150 and 180 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers:

Specifier AS

1, 28 Octovriou str.

Ag. Be careful

12351 Athens

Greece

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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