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 side effects that are not mentioned in this information. See section 4.

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

What Desloratadine Teva is and what it is used for

What Desloratadine Teva is

Desloratadine Teva contains desloratadine which is an antihistamine .

How Desloratadine Teva works

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

When to use Desloratadine Teva

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

Desloratadine Teva 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 take Desloratadine Teva

Do not take Desloratadine Teva

  • if you are allergic to desloratadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before taking Desloratadine Teva

  • 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 Teva

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

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

Desloratadine Teva with food, drink, and alcohol

Desloratadine Teva can be taken with or without food.

Be careful if you take Desloratadine Teva 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 Teva 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.

Desloratadine Teva contains lactose

Desloratadine Teva contains lactose. 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 take Desloratadine Teva

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 Teva.

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 Teva then you should

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

If you forget to take Desloratadine Teva

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 Teva

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 Teva, 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 users:

  • fatigue
  • dry mouth
  • headache.

Adults

During the marketing of Desloratadine Teva, the following side effects have been reported:

Very rare The following may occur in less than 1 in 10,000 users:

  • severe allergic reactions
  • rash
  • throbbing or irregular heartbeat
  • fast heartbeat
  • stomach ache
  • nausea
  • vomiting
  • upset stomach
  • diarrhea
  • dizziness
  • drowsiness
  • difficulty sleeping
  • muscle pain
  • hallucinations
  • cramps
  • restlessness with increased body movement
  • hepatitis
  • 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
  • changes in how the heartbeats
  • abnormal behavior
  • aggression
  • weight gain
  • increased appetite

Children

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

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

5. How to store Desloratadine Teva

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.

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 5 mg desloratadine.
  • The other ingredients are microcrystalline cellulose, pregelatinized maize starch, talc, colloidal anhydrous silica, lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine (E132), shellac, propylene glycol.

What the medicine looks like and the contents of the pack

Blue, round, biconvex film-coated tablet – marked with “D5” on one side and smooth on the other. 
Desloratadine Teva 5 mg film-coated tablets are available in packs of 7, 10, 14, 20, 21, 28, 30, 40, 50, 60, 90, 100 and 105 film-coated tablets and in perforated blister cards of 50 x 1 film-coated tablets (single dose ). 
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Teva BV

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer:

Teva Pharmaceutical Works Private Limited Company 
Pallagi off 13, 
4042 Debrecen, 
Hungary

or

TEVA UK Ltd 
Brampton Road, Hampden Park, Eastbourne, 
East Sussex, BN22 9AG, 
UK

or

Pharmachemie BV 
Swensweg 5, 
2031 GA Haarlem, The 
Netherlands

or

Merckle GmbH 
Ludwig-Merckle-Strasse 3 
D-89143 Blaubeuren 
Germany

Further information on this medicine can be obtained from the representative of the marketing authorization holder:

Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel: +32 38207373 LithuaniaUAB Teva BalticsTel: +370 52660203
BulgariaOctavis FADTel: +359 24899585 Luxembourg / LuxemburgTeva Pharma Belgium NV / SA / AG Belgique / BelgienTel: +32 38207373
Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251007111 HungaryTeva Gyógyszergyár Zrt.Tel: +36 12886400
DenmarkTeva Denmark A / STel: +45 44985511 MaltaTeva Pharmaceuticals IrelandL ‑ IrelandTel: +353 19127700
GermanyTEVA GmbHTel: +49 73140208 The NetherlandsTeva Nederland BVTel: +31 8000228400
EestiUAB Teva Baltics Eesti subsidiaryTel: +372 6610801 NorwayTeva Norway ASTel: +47 66775590
GreeceSpecify ABEE:Ηλ: +30 2118805000 Austriaratiopharm Arzneimittel Vertriebs-GmbHTel: +43 1970070
SpainTeva Pharma, SLUTel: +34 913873280 PolandTeva Pharmaceuticals Polska Sp. z ooTel: +48 223459300
FranceTeva HealthTel: +33 155917800 PortugalTeva Pharma – Pharmaceutical Products Lda.Tel: +351 214767550
CroatiaPliva Hrvatska dooTel: + 385 13720000 RomaniaTeva Pharmaceuticals SRLTel: +4021 230 65 24
IrelandTeva Pharmaceuticals IrelandTel: +353 19127700 SloveniaPliva Ljubljana dooTel: +386 15890390
IcelandAlvogen ehf.Phone: +354 5222900 Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 257267911
ItalyTeva Italia SrlTel: +39 028917981 Finland / FinlandSanoSwiss UABPuh / Tel: +370 70001320
LatviaUAB Teva Baltics subsidiary LatvijāTel: +371 67323666 United KingdomTeva UK LimitedTel: +44 1977628500

Muhammad Nadeem

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