Desloratadine Actavis
desloratadine
desloratadine
Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Desloratadine Actavis is and what it is used for
What you need to know before you take Desloratadine Actavis
How to take Desloratadine Actavis
Possible side effects
How to store Desloratadine Actavis
Contents of the pack and other information
Desloratadine Actavis contains desloratadine which is an antihistamine.
Desloratadine Actavis is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.
Desloratadine Actavis relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, 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 palate, and itchy, red or watery eyes.
Desloratadine Actavis is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.
Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.
if you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine.
Talk to your doctor, pharmacist or nurse before taking Desloratadine Actavis:
if you have poor kidney function.
if you have medical or familial history of seizures.
Do not give this medicine to children less than 12 years of age.
There are no known interactions of Desloratadine Actavis with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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 nursing a baby.
There is no data available on male/female fertility.
At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicinal product.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet once a day 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 are suffering from and will determine for how long you should take Desloratadine Actavis.
If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your doctor will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.
If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your doctor may recommend you a longer term treatment.
For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your doctor.
Take Desloratadine Actavis only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Desloratadine Actavis than you were told to, tell your doctor, pharmacist or nurse immediately.
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 have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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 in breathing,
wheezing, itching, hives and swelling) have been reported very rarely. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.
In clinical studies in adults, side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache were reported more often than with a dummy tablet. In adolescents, headache was the most commonly reported side effect.
In clinical studies with desloratadine, the following side effects were reported as: 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 were reported as:
Very rare: the following may affect up to 1 in 10,000 people
severe allergic reactions • rash • pounding or irregular heartbeat
fast heartbeat • stomach ache • feeling sick (nausea)
vomiting • upset stomach • diarrhoea
dizziness • drowsiness • inability to sleep
muscle pain • hallucinations • seizures
restlessness 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 the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium
changes in the way the heart beats
abnormal behaviour
aggression
weight increased
increased appetite
depressed mood
dry eyes
Children
Not known: frequency cannot be estimated from the available data
slow heartbeat
abnormal behaviour
change in the way the heart beats
aggression
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting
system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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, bottle label and blister after ‘EXP’. The expiry date refers to the last day of that month.
Blisters:
This medicine does not require any special storage conditions.
Bottles:
This medicine does not require any special temperature storage conditions. Keep the bottle tightly closed in order to protect from light.
Tell your pharmacist if you notice any change in the appearance of the tablets.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is desloratadine. Each film-coated tablet (tablet) contains 5 mg desloratadine.
The other ingredients are:
Tablet core: Microcrystalline cellulose, starch (pregelatinised), mannitol, talc, magnesium stearate. Tablet coating: Hypromellose 6cP, titanium dioxide (E171), macrogol 6000, indigo carmine aluminum lake (E132).
Blue coloured, round, with diameter of 6 mm, biconvex, film-coated tablets with the marking ‘LT’ engraved on one side.
Desloratadine Actavis 5 mg film-coated tablets are packed in: Blister packs: 7, 10, 14, 20, 21, 30, 50, 90 or 100 tablets.
Plastic bottles containing a desiccant and closed with a plastic cap: 30 or 100 tablets. Do not swallow the desiccant.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Actavis Group PTC ehf. Reykjavíkurvegi 76-78
220 Hafnarfjörður Iceland
Manufacturer
Actavis Ltd.
BLB 015-016 Bulebel Industrial Estate Zejtun ZTN 3000
Malta
or
Balkanpharma-Dupnitsa AD 3 Samokovsko Shosse Str. 2600 Dupnitsa
Bulgaria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
UAB Teva Baltics Tel: +370 52660203
Тева Фарма ЕАД Teл: +359 24899585
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111
Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien
Tél/Tel: +32 38207373
Teva Gyógyszergyár Zrt. Tel: +36 12886400
Teva Denmark A/S Tlf: +45 44985511
Teva Pharmaceuticals Ireland L-Irlanda
Tel: +44 2075407117
Teva Nederland B.V. Tel: +31 8000228400
UAB Teva Baltics Eesti filiaal Tel: +372 6610801
Teva Norway AS Tlf: +47 66775590
Specifar A.B.E.E.
Τηλ: +30 2118805000
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Teva Pharma, S.L.U. Tel: +34 913873280
Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
Teva Santé
Tél: +33 155917800
Teva Pharma - Produtos Farmacêuticos, Lda. Tel: +351 214767550
Pliva Hrvatska d.o.o. Tel: +385 13720000
Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Teva Pharmaceuticals Ireland Tel: +44 2075407117
Pliva Ljubljana d.o.o. Tel: +386 15890390
Teva Pharma Iceland ehf. Sími: +354 5503300
TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Teva Italia S.r.l. Tel: +39 028917981
Teva Finland Oy
Puh/Tel: +358 201805900
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000
Teva Sweden AB Tel: +46 42121100
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
Teva Pharmaceuticals Ireland Ireland
Tel: +44 2075407117
Taking into account the PRAC Assessment Report on the PSUR(s) for desloratadine, the scientific conclusions of the CHMP are as follows:
In view of available data from the literature including in some cases a close temporal relationship, a positive de-challenge and/or re-challenge and in view of a plausible mechanism of action, the PRAC considers a causal relationship between desloratadine and depressed mood is at least a reasonable possibility. The PRAC concluded that the product information of products containing desloratadine should be amended accordingly.
As described in the literature and signal section of some MAHs, WHO identified a potential safety signal of dry eyes for desloratadine during the reporting period. Based on the anticholinergic properties of desloratadine and strengthened by the reports with a short time to onset and both de- and rechallenges described, the PRAC considers that “eye dryness” should be considered for inclusion in the product labels and patient leaflets.
The CHMP agrees with the scientific conclusions made by the PRAC.
On the basis of the scientific conclusions for desloratadine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing desloratadine is unchanged subject to the proposed changes to the product information.
The CHMP recommends that the terms of the marketing authorisation(s) should be varied.