5 mg film-coated tablets 
desloratadine

Read all of this leaflet carefully before you start taking 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.

In this leaflet: 
1. What Desloratadine Mylan is and what it is used for  
2. What you need to know before you take Desloratadine Mylan  
3. How to take Desloratadine Mylan  
4. Possible side effects 
5. How to store Desloratadine Mylan 
6. Package contents and other information 

What Desloratadine Mylan is and what it is used for 

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

Desloratadine Mylan relieves the symptoms of allergic rhinitis ( inflammation of the nasal airways 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 Mylan is also used to relieve the symptoms of 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.

You need to talk to a doctor if you do not feel better or if you feel worse.

Desloratadine contained in Desloratadine Mylan 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 take Desloratadine Mylan 

Do not take Desloratadine Mylan:

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

Warnings and cautions

Talk to your doctor or pharmacist before using Desloratadine Mylan:

– if you have impaired kidney function.

– if you or someone in your family has had seizures.

If this applies to you, or if you are not sure, check with your doctor or pharmacist.

Children

Desloratadine tablets are not suitable for children under 12 years of age.

Other medicines and Desloratadine Mylan

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

Desloratadine Mylan with alcohol

Be careful if you take Desloratadine Mylan with alcohol.

Pregnancy and breastfeeding

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.

If you are pregnant or breast-feeding, taking Desloratadine Mylan is not recommended

Driving and using machines

At the recommended dose, Desloratadine Mylan is not expected to make you drowsy or less alert. In very rare cases, however, individuals become drowsy, which can affect their ability to drive or operate machinery.

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 Mylan contains para-orange aluminum lacquer (E 110) and sodium

Para-orange aluminum lacquer (E110) can cause allergic reactions.

Desloratadine Mylan contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.

How to take Desloratadine Mylan 

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

The recommended dose for adults and adolescents (12 years and older) is one tablet once a day. The tablet is swallowed whole with water, with or without food.

Regarding the length of the treatment, your doctor will determine the type of

allergic rhinitis you suffer from and decide how long to take Desloratadine Mylan.

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 take more Desloratadine Mylan then you should

Always take Desloratadine Mylan exactly as your doctor has told you. No serious problems are 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 take Desloratadine Mylan 

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 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. 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 .

If you notice any of the following side effects , stop taking this medicine immediately and contact your doctor or go to the nearest emergency room:

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

  • Severe allergic reactions such as difficulty breathing, shortness of breath, wheezing, itching , hives and swelling of the face, lips, tongue or other parts of the body and rash
  • Seizures
  • Liver disease (nausea, vomiting, loss of appetite, general malaise, fever, itching , yellowing of the skin and eyes, light stools, dark urine)

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

  • Changes in how the heart beats which can cause dizziness or fainting. This can be seen in tests that measure the electrical activity of the heart ( electrocardiogramor ECG ).

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.

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

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

  • fast heartbeat
  • vomiting
  • dizziness
  • muscle pain
  • restlessness with increased body movement
  • stomach ache
  • upset stomach
  • drowsiness
  • see, feel or hear something that does not exist (hallucinations)
  • throbbing or irregular heartbeat
  • nausea
  • diarrhea
  • difficulty sleeping
  • abnormal liver function tests

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

  • abnormal behavior
  • aggression
  • unusual weakness
  • increased sensitivity of the skin to sunlight, even in sunlight and to UV light, for example to UV light in solariums.
  • weight gain, increased appetite.

Additional side effects in children and adolescents

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

  • slow heartbeat

5. How to store Desloratadine Mylan

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

This medicine does not require any special storage instructions.

Do not use this medicine after the expiry date which is stated 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. Each tablet contains 5 mg of desloratadine.
  • The other ingredients in the tablet are: magnesium stearate, sodium lauryl sulphate, colloidal anhydrous silica, microcrystalline cellulose and pregelatinised maize starch.Tablet coating: polyvinyl alcohol, indigo carmine aluminum lacquer (E 132), para ‑ orange aluminum lacquer (E 110), macrogol, talc (E 553b) and titanium dioxide (E 171).See section 2 “Desloratadine Mylan contains para ‑ orange aluminum lacquer (E110) and sodium”.

What the medicine looks like and contents of the pack

Desloratadine Mylan is a blue, round, biconvex tablet with bevelled edges, marked “DE 5” on one side of the tablet and “M” on the opposite.

Desloratadine 5 mg film-coated tablets are packaged in blister packs of 2, 3, 5, 7, 10, 15, 20, 30, 50, 60, 90 and 100 tablets.

Not all packaging may be marketed.

Manufacturer:

McDermott Laboratories Limited to Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1 TL, UK

Mylan SAS, ZAC des Gaulnes, 360 Avenue Henri Shcneider, 69300 Meyzieu, France

Muhammad Nadeem

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