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.

Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

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

What Desloratadine Sandoz is and what it is used for

What Desloratadine Sandoz is

Desloratadine Sandoz contains desloratadine which is an antihistamine .

How Desloratadine Sandoz works

Desloratadine Sandoz 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 Sandoz

Desloratadine Sandoz relieves the symptoms of allergic rhinitis ( inflammation of the nasal mucosa caused by allergies, such as hay fever or allergy 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.

Desloratadine Sandoz can also be prescribed by a doctor for use to relieve 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.

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

What you need to know before you take Desloratadine Sandoz

Do not take Desloratadine Sandoz

  • 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, pharmacist, or nurse before taking Desloratadine Sandoz:

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

Children and young people

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

Other medicines and Desloratadine Sandoz

There is no known interaction between Desloratadine Sandoz and other medicines.

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

Desloratadine Sandoz with food, drink, and alcohol

Desloratadine Sandoz can be taken with or without food.

Be careful if you take Desloratadine Sandoz 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 Sandoz 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 sharpened 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 take Desloratadine Sandoz

Always take 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 with water, with or without food.

This medicine should be swallowed.

The tablet is swallowed whole.

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

If you need to use Desloratadine Sandoz for more than 3 months, consult a doctor to find out if the symptoms have another cause.

If you take more Desloratadine Sandoz then you should

Take Desloratadine Sandoz exactly as described in this leaflet or as your doctor or pharmacist has told 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 take Desloratadine Sandoz

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 taking Desloratadine Sandoz

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, 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 effects 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:

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:

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

  • Severe allergic reactions
  • Rash
  • Throbbing or irregular heartbeat
  • Fast heartbeat
  • Stomach pain
  • Nausea
  • Vomiting
  • Upset stomach
  • Diarrhea
  • Dizziness
  • Drowsiness
  • Difficulty sleeping
  • Muscle pain
  • Hallucinations
  • Cramps
  • Restlessness with increased body movement
  • Liver inflammation
  • Abnormal liver function tests

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

  • Abnormal behavior
  • Aggression
  • Abnormal 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 heartbeats
  • Weight gain
  • Increased appetite.

Children

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

  • Abnormal behavior
  • Aggression
  • Slow heartbeat
  • Change in how the heartbeats
  • Weight gain
  • Increased appetite.

5. How to store Desloratadine Sandoz

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. or EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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

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 film-coated tablet contains 5 mg of desloratadine.
  • Other ingredients are Tablet core: maize starch, microcrystalline cellulose, hypromellose, colloidal anhydrous silica, hydrogenated vegetable oil (type 1).Tablet coating: Opadry Blue 03B50689 (hypromellose E464, titanium dioxide E171, macrogol 400 E1521, indigotin E132).

What the medicine looks like and the contents of the pack

Light blue, round, biconvex film-coated tablet, marked with “5” on one side.

Diameter 6.50 ± 0.10 mm.

Desloratadine Sandoz is supplied in blisters consisting of OPA / Al / PVC / Al or PVC / Aclar / Al.

Pack sizes (single pack):

1×1, 2×1, 3×1, 5×1, 7×1, 10×1, 14×1, 15×1, 20×1, 21×1, 30×1 film-coated tablets

Pack sizes:

1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer:

Lek Pharmaceuticals dd, Trimline 2 D, 9220 Lendava, Slovenia

Muhammad Nadeem

Leave a Reply