Desloratadine Actavis
Italy
Table of Contents
Patient Information Leaflet
Desloratadina Actavis 5 mg film-coated tablets
desloratadine
Please read this entire leaflet carefully before taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What Desloratadina Actavis is and what it is used for
- What you need to know before taking Desloratadina Actavis
- How to take Desloratadina Actavis
- Possible side effects
- How to store Desloratadina Actavis
- Contents of the pack and other information
1. What Desloratadina Actavis is and what it is used for
What Desloratadina Actavis is
Desloratadina Actavis contains desloratadine, which is an antihistamine.
How Desloratadina Actavis works
Desloratadina Actavis is an antiallergic medicine that does not cause drowsiness. It helps control your allergic reaction and its symptoms.
When Desloratadina Actavis should be used
Desloratadina Actavis relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by allergy, for example hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny nose, itchy nose, itchy palate, watery eyes, itchy and watery eyes.
Desloratadina Actavis is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.
Relief from these symptoms lasts throughout the day, helping you resume your normal daily activities and improving your sleep.
2. What you need to know before taking Desloratadine Actavis
Do not take Desloratadine Actavis
- if you are allergic to desloratadine, to any of the other ingredients of this medicine (listed in section 6), or to loratadine.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Desloratadine Actavis:
- if you have reduced 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 Actavis
No interactions between Desloratadine Actavis and other medicines are known.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Desloratadine Actavis with food, drinks and alcohol
Desloratadine Actavis can be taken with or without food.
Use caution when taking Desloratadine Actavis with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of Desloratadine Actavis is not recommended if you are pregnant or breastfeeding. Fertility
There are no data available regarding effects on male/female fertility.
Driving and using machines
At the recommended dose, this medicine is not expected to affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended that you avoid activities requiring mental alertness, such as driving a vehicle or operating machinery, until you know how this medicine affects you.
3. How to take Desloratadine Actavis
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
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 Actavis.
If your allergic rhinitis is intermittent (symptoms present for less than 4 days per week or for less than 4 weeks), your doctor will prescribe 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 prescribe long-term treatment.
In the case of urticaria, the duration of treatment may vary from patient to patient; therefore, follow your doctor's instructions.
If you take more Desloratadine Actavis than you should
Take Desloratadine Actavis only if it has been prescribed for you. Serious problems following accidental overdose are not expected. However, if you take more Desloratadine Actavis than prescribed, inform your doctor, pharmacist, or nurse immediately.
If you forget to take Desloratadine Actavis
If you forget to take your dose at the prescribed time, take it as soon as possible and then continue your treatment as usual. Do not take a double dose to make up for the missed dose.
If you stop treatment with Desloratadine Actavis
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
During the marketing of desloratadine, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, hives and swelling) have been reported. If you notice any of these serious side effects, stop taking the medicine and contact a doctor immediately.
In clinical studies in adults, side effects were similar to those observed with an inactive tablet (placebo). However, tiredness, dry mouth and headache occurred more frequently than with an inactive tablet (placebo). In adolescents, headache was the most commonly reported side effect.
In clinical studies with desloratadine, the following side effects have been reported as:
Common: may affect up to 1 in 10 people
- tiredness
- dry mouth
- headache
Adults
- During the marketing of desloratadine, the following side effects have been reported as:
- Very rare: may affect up to 1 in 10,000 people
- serious allergic reactions • skin rash • pounding or irregular fast heartbeat • stomach ache • stomach disturbances • feeling unwell
- vomiting • sleepiness (nausea)
- dizziness • hallucinations • diarrhoea
- muscle pain • inflammation of the liver (hepatitis) • difficulty sleeping (insomnia)
- restlessness with increased body movement • seizures • changes in 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 UV light, for example from sunbeds
- changes in heartbeat rhythm
- abnormal behaviour
- aggression
- weight gain
- increased appetite
- depressed mood
- dry eyes
Children
Not known: frequency cannot be estimated from the available data
- slowing of the heartbeat
- changes in heartbeat rhythm
- abnormal behaviour
- aggression
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V.
Reporting side effects can help provide more information on the safety of this medicine.
5. How to store Desloratadina Actavis
Keep this medicine out of the sight and reach of children.
Do not use Desloratadina Actavis after the expiry date stated on the packaging, bottle, and blister after "Exp". The expiry date refers to the last day of that month.
Blister:
This medicine does not require any special storage precautions.
Inform your pharmacist if you notice any changes in the appearance of the tablets.
Bottle:
This medicine does not require any specific storage temperature.
Keep the bottle tightly closed to protect from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What Desloratadina Actavis contains
- The active substance is desloratadine. Each film-coated tablet (tablet) contains 5 mg of desloratadine.
- The other components are: Tablet core: Microcrystalline cellulose, starch (pregelatinized), mannitol, talc, magnesium stearate. Tablet coating: Hypromellose 6 cP, titanium dioxide (E171), macrogol 6000, indigo carmine aluminium lake (E132).
Description of the appearance of Desloratadina Actavis and package contents
Film-coated blue, round tablets with a diameter of 6 mm, biconvex, marked with "LT" on one side.
Desloratadina Actavis 5 mg film-coated tablets are packaged 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 ingest the desiccant.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Actavis Group PTC ehf.
Dalshraun 1
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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203
България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373
Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400
Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 L-Irlanda
Tel: +44 2075407117
Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
Tel: +49 73140202 Tel: +31 8000228400
Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590
Ελλάδα Österreich
Specifar A.B.E.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070
España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300
France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550
Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524
Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390
Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911
Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900
Κύπρος Sverige
Specifar A.B.E.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000
Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.