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, pharmacist, or nurse.
  • 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

What Desloratadine Actavis is and what it is used for

What Desloratadine Actavis is

Desloratadine Actavis contains desloratadine which is an antihistamine .

How Desloratadine Actavis works

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

When to use Desloratadine Actavis

Desloratadine Actavis 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 Actavis 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.

What you need to know before you use Desloratadine Actavis

Do not take Desloratadine Actavis

  • 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 Actavis.

  • 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 Actavis

There are no known interactions between Desloratadine Actavis and other medicines.

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

Desloratadine Actavis with food, drink, and alcohol

Desloratadine Actavis can be taken with or without food.

Be careful if you take Desloratadine Actavis 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 Actavis 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.

How to use Desloratadine Actavis

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.

This medicine should be swallowed.

The tablet is swallowed whole.

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 Actavis.

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 Actavis then you should 

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

If you forget to use Desloratadine Actavis

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 Actavis

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 (the following 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
  • 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

No known frequency (cannot be calculated from the available data)

  • 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 to UV light in solariums.
  • changes in how the heartbeats
  • abnormal behavior
  • aggression
  • weight gain
  • increased appetite

Children

No known frequency (cannot be calculated from the available data)

  • slow heartbeat
  • change in how the heartbeats
  • abnormal behavior
  • aggression

5. How to store Desloratadine Actavis

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.

Blister:

No special storage instructions.

Bottles:

No special temperature instructions.

Close the bottle tightly. Sensitive to light.

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 (tablet) contains 5 mg 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.

Desloratadine Actavis 5 mg film-coated tablets are packaged in:

Blister packs of 7, 10, 14, 20, 21, 30, 50, 90 or 100 tablets.

Plastic bottles containing a desiccant and closed with a plastic cap: 30 and 100 tablets.

Do not swallow the desiccant.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavíkurvegur 76 78

220 Hafnarfjordur

Iceland

Manufacturer

Actavis Ltd.

BLB 016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

or

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

2600 Dupnitsa

Bulgaria

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienActavis Group PTC ehf.Iceland / Iceland / IcelandTel: +354 5503300 LithuaniaUAB Teva BalticsTel: +370 5266 0203
BulgariaOctavis FADTel: +359 24899585 Luxembourg / LuxemburgActavis Group PTC ehf.IcelandTel: +354 5503300
Czech RepublicTeva Pharmaceuticals CR, sroTel: + 420 251007111 HungaryTeva Gyógyszergyár Zrt.Tel .: +36 12886400

DenmarkTeva Denmark A / STel: +45 44985511
MaltaActavis Ltd.Tel: +356 21693533

GermanyActavis Group PTC ehf.IcelandTel: +354 5503300
The NetherlandsActavis Group PTC EHF.IcelandTel: +354 5503300
EestiUAB Teva Baltics Eesti subsidiaryTel: +372 6610801 NorwayTeva Norway ASTel: +47 66775590
GreeceSpecify ABEE:Ηλ: +30 2118805000 Austriaratiopharm Arzneimittel Vertriebs-GmbHTel: +43 1970070
SpainActavis Group PTC ehf.IcelandTel: +354 5503300 PolandTeva Pharmaceuticals Polska Sp. z ooTel: +48 223459300
FranceActavis Group PTC ehf.IcelandTel: +354 5503300 PortugalActavis Group PTC ehf.IcelandTel: +354 5503300
CroatiaPliva Hrvatska dooTel: +385 13720 000 RomaniaTeva Pharmaceuticals SRLTel: +40 212306524
IrelandActavis Ireland LimitedTel: +353 214619040 SloveniaPliva Ljubljana dooTel: +386 15890390
IcelandActavis Group PTC ehf.Phone: +354 5503300 Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 257267911
ItalyActavis Group PTC ehf.IcelandTel: +354 5503300 Finland / FinlandTeva Finland OyPuh / Tel: +358 201805900
LatviaUAB Teva Baltics subsidiary LatvijāTel: +371 67323666 United KingdomActavis UK LimitedTel: +44 1271385257

Further information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

Muhammad Nadeem

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