5 mg film-coated tablets
desloratadine

1. What Flynise is and what it is used for

What Flynise is

Flynise contains desloratadine which is an antihistamine.

How Flynise works

Flynise 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 Flynise

Flynise 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 and older. These symptoms include sneezing, runny or itchy nose, palate itching, and itchy, red, or watery eyes.

Flynise can also be prescribed by a doctor for use to relieve symptoms of urticaria ( itching, redness, and number and size of hives ).

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

You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

Desloratadine contained in Flynise 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.

2. What you need to know before using Flynise

Do not use Flynise

  • 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 Flynise:

  • 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 Flynise

There are no known interactions between Flynise and other medicines.

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

Flynise with food, drink, and alcohol

Flynise can be taken with or without food.

Be careful if you take Flynise 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 Flynise 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.

3. How to use Flynise

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 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.

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

If you use more Flynise than you should 

Take Flynise exactly 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 use Flynise

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 Flynise

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, 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
  • 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
  • yellowing of the skin and/or eyes

Additional side effects are in 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 Flynise

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, can label and blister after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Tell your pharmacist 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: microcrystalline cellulose, pregelatinized starch, mannitol, talc, and magnesium stearate. Tablet coating: Hypromellose 6cP, titanium dioxide (E171), macrogol 6000, indigo carmine aluminum lacquer (E132).

What the medicine looks like and the contents of the pack

Blue-colored, round, with a diameter of 6 mm, biconvex, film-coated tablets marked “LT” engraved on one side.

Flynise 5 mg film-coated tablets are packaged in:

Blister packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21 and 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76 78

220 Hafnarfjörður

Iceland

Manufacturer

Actavis Ltd.

B16 Bulebel Industrial Estate

Zejtun ZTN 08

Malta

Muhammad Nadeem

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