Desloratadine Teva 5 mg film-coated tablets EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 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 adverse effects
- 5. Storage of Desloratadine Teva
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Desloratadine Teva 5 mg film-coated tablets EFG
desloratadine
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Desloratadine Teva is and what it is used for
- What you need to know before taking Desloratadine Teva
- How to take Desloratadine Teva
- Possible side effects
- How to store Desloratadine Teva
- Contents of the pack and other information
1. 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 antiallergy medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When Desloratadine Teva should be used
Desloratadine Teva relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itching of the roof of the mouth, and itchy, red or watery eyes.
Desloratadine Teva is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and skin rash (hives).
Relief from these symptoms lasts for a full day, helping you carry on with your daily activities and normal sleep periods.
2. What you need to know before taking Desloratadine Teva
Do not take Desloratadine Teva
- if you are allergic (hypersensitive) to desloratadine or to any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Desloratadine Teva
- if you have impaired kidney function.
- if you have a personal or family history of seizures.
Use in children and adolescents
Do not give this medicine to children under 12 years of age.
Other medicines and Desloratadine
There are no known interactions between Desloratadine Teva and other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Taking Desloratadine Teva with food, drinks and alcohol
Desloratadine Teva can be taken regardless of meals.
Be cautious when taking Desloratadine Teva with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
It is not recommended that you take Desloratadine Teva if you are pregnant or breastfeeding a baby.
Fertility
There are no data available regarding male and female fertility.
Driving and using machines
At the recommended dose, this medicine is not expected to affect your ability to drive or use machinery. Although most people do not experience drowsiness, it is recommended not to perform activities requiring mental alertness, such as driving a car or operating machinery, until you have determined your individual response to the medicine.
Desloratadine Teva contains lactose
Desloratadine Teva contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take desloratadine Teva
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
Adults and adolescents aged 12 years and older
The recommended dose is one tablet once daily with water, with or without food.
This medicine is for oral use.
Swallow the tablet whole.
Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and how long you should take Desloratadine Teva.
If your allergic rhinitis is intermittent (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will recommend a treatment regimen based on an assessment of your medical history.
If your allergic rhinitis is persistent (symptoms present for 4 or more days per week and for more than 4 weeks), your doctor may recommend long-term treatment.
For urticaria, the duration of treatment may vary from patient to patient, and therefore you should follow your doctor's instructions.
If you take more Desloratadine Teva than you should
Take Desloratadine Teva only as your doctor has instructed. Accidental overdose is not expected to cause serious problems. However, if you take more Desloratadine Teva than prescribed, inform your doctor, pharmacist, or nurse immediately.
If you forget to take Desloratadine Teva
If you miss a dose at the scheduled time, take it as soon as possible, then continue with your usual dosing schedule. Do not take a double dose to make up for a missed dose.
If you stop taking Desloratadine Teva
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Desloratadina Teva can cause adverse effects, although not everyone will experience them.
During the marketing of Desloratadina Teva, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported. If you experience any of these serious adverse effects, stop taking this medicine and seek immediate medical attention.
In clinical trials in adults, adverse effects were approximately the same as with a placebo tablet. However, fatigue, dry mouth, and headache were reported more frequently than with a placebo tablet. In adolescents, headache was the most frequently reported adverse reaction.
In clinical trials with desloratadine, the following adverse effects were reported:
Frequent: the following may affect up to 1 in 10 people
- fatigue
- dry mouth
- headache
Adults
During the marketing of Desloratadina Teva, the following adverse effects have been reported as:
Very rare: the following may affect less than 1 in 10,000 patients
? severe allergic reactions | ? rash | ? strong or irregular heartbeat |
? rapid heartbeat | ? stomach pain | ? nausea |
? vomiting | ? upset stomach | ? diarrhea |
? dizziness | ? drowsiness | ? trouble sleeping |
? muscle pain | ? hallucinations | ? seizures |
? agitation with increased body movement | ? liver inflammation | |
? abnormal liver function tests |
Not known: frequency cannot be estimated from the available data
? unusual weakness | ? yellowing of the skin and/or eyes |
? increased sensitivity of the skin to sunlight, even on cloudy days, and to ultraviolet light, for example the ultraviolet light from a sunbed. | |
? changes in the way the heart beats | |
? abnormal behavior | |
? aggression | |
? weight gain | |
? increased appetite | |
? depressed mood | |
? dry eyes |
Children
Frequency not known: frequency cannot be estimated from the available data
? slow heartbeat | ? change in heart rhythm |
? abnormal behavior | ? aggression |
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of Desloratadine Teva
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after "EXP". The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Do not use this medicine if you notice any changes in the appearance of the tablets.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Desloratadine Teva
- The active substance is desloratadine 5 mg.
- The other components are microcrystalline cellulose, pregelatinized corn starch, talc, colloidal anhydrous silica, lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine (E132).
Appearance of the product and contents of the pack
Film-coated tablets, round, biconvex, blue in colour and smooth on both sides. 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 unit-dose perforated blisters of 50 x 1 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturer
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen,
Hungary
Pharmachemie B.V.
Swensweg 5,
2031 GA Haarlem,
The Netherlands
Merckle GmbH
Ludwig-Merckle-Strasse 3
D-89143 Blaubeuren
Germany
For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Teva Pharma Belgium N.V./S.A./AG Tel/Tel: +32 3 820 73 73 | Lithuania UAB Teva Baltics Tel: +370 5 266 02 03 |
Bulgaria Teva Bulgaria EOOD Tel: +359 2 489 95 85 | Luxembourg/Luxembourg Teva Pharma Belgium S.A./AG, Belgium/Belgium Tel/Tel: +32 3 820 73 73 |
Czech Republic Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111 | Hungary Teva Gyógyszergyár Zrt. Tel.: +36 1 288 64 00 |
Denmark Teva Denmark A/S Tlf: +45 44985511 | Malta Teva Pharmaceuticals Ireland, L-Ireland Tel: +44 2075407117 |
Germany TEVA GmbH Tel: +49 731 402 08 | Netherlands Teva Nederland B.V. Tel: +31 800 0228400 |
Estonia UAB Teva Baltics Estonia branch Tel: +372 661 0801 | Norway Teva Norway AS Tlf: +47 66 77 55 90 |
Greece Teva Hellas S.A. Tel: +30 210 72 79 099 | Austria ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 007 |
Spain Teva Pharma, S.L.U. Tel: +34 91 387 32 80 | Poland Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00 |
France Teva Santé Tel: +33 1 55 91 7800 | Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel: +351 214 76 75 50 |
Croatia Pliva Hrvatska d.o.o Tel: + 385 1 37 20 000 | Romania Teva Pharmaceuticals S.R.L Tel: +4021 230 65 24 |
Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117 | Slovenia Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390 |
Iceland Teva Finland Oy Finland Sími: +358 201805900 | Slovakia TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 2 5726 7911 |
Italy Teva Italia S.r.l. Tel: +39 02 8917981 | Finland/Suomi Teva Finland Oy |
Cyprus Teva Hellas S.A., Greece Tel: +30 210 72 79 099 | Sweden Teva Sweden AB Tel: +46 42 12 11 00 |
Latvia UAB Teva Baltics Tel: +371 673 23 666 | United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117 |
This leaflet has been reviewed in
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.