Desloratadine Aurobindo Italia
ItalyTable of Contents
Patient Information Leaflet: Information for the patient
Desloratadine Aurobindo Italia 5 mg film-coated tablets
Generic medicine
Please read this 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 or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Desloratadine Aurobindo Italia is and what it is used for
- What you need to know before taking Desloratadine Aurobindo Italia
- How to take Desloratadine Aurobindo Italia
- Possible side effects
- How to store Desloratadine Aurobindo Italia
- Contents of the pack and other information
1. What Desloratadina Aurobindo Italia is and what it is used for
What Desloratadina Aurobindo Italia is
Desloratadine belongs to the class of antihistamines.
How Desloratadina Aurobindo Italia works
Desloratadina Aurobindo Italia is an antiallergic medicine that does not cause drowsiness. It helps control your allergic reaction and its symptoms.
When Desloratadina Aurobindo Italia should be used
Desloratadina Aurobindo Italia relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by 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 palate, and itchy, red or watery eyes.
Desloratadina Aurobindo Italia is also used to relieve symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives (wheals).
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 Aurobindo Italia
Do not take Desloratadine Aurobindo Italia
- if you are allergic 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 Aurobindo Italia:
- 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 Aurobindo Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No interactions of Desloratadine Aurobindo Italia with other medicines are known.
Desloratadine Aurobindo Italia with food, drinks and alcohol
Desloratadine Aurobindo Italia can be taken with or without food.
Use caution when taking Desloratadine Aurobindo Italia with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, the use of Desloratadine Aurobindo Italia is not recommended.
Fertility
There are no data available regarding male/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 carry out activities requiring mental alertness, such as driving a vehicle or operating machinery, until you have assessed your response to the medicine.
3. How to take Desloratadina Aurobindo Italia
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 Desloratadina Aurobindo Italia.
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 you must
follow your doctor's instructions.
If you take more Desloratadina Aurobindo Italia than you should
Take Desloratadina Aurobindo Italia only as prescribed. No serious problems are expected following accidental overdose. However, if you take more Desloratadina Aurobindo Italia than prescribed, contact your doctor, pharmacist, or nurse immediately.
If you forget to take Desloratadina Aurobindo Italia
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 taking Desloratadina Aurobindo Italia
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 everybody will experience them.
Very rare cases of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling) have been reported during the marketing of Desloratadina Aurobindo Italia. If you experience any of these serious side effects, stop taking the medicine and seek immediate medical attention.
In clinical studies in adults, side effects with Desloratadina Aurobindo Italia were similar to those observed with a placebo tablet (a tablet without active ingredient). However, fatigue, dry mouth, and headache were reported more frequently compared to the placebo tablet. In adolescents, headache was the most commonly reported side effect.
The following side effects have been reported in clinical studies with Desloratadina Aurobindo Italia:
Common: may affect from 1 to 10 people
- fatigue
- dry mouth
- headache
Adults
During the marketing of Desloratadina Aurobindo Italia, the following side effects have been reported:
Very rare: may affect up to 1 in 10,000 people
- severe allergic reactions;
- skin rash;
- strong or irregular heartbeat;
- rapid heartbeat;
- stomach ache;
- feeling unwell (nausea);
- vomiting;
- stomach discomfort;
- diarrhoea;
- dizziness;
- drowsiness;
- difficulty sleeping;
- muscle pain;
- hallucinations;
- seizures;
- liver inflammation;
- changes in liver function tests;
- restlessness with increased body movements.
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;
- abnormal behaviour;
- aggression;
- changes in heartbeat rhythm;
- .
Children
Not known: frequency cannot be estimated from the available data
- slow heartbeat;
- abnormal behaviour;
- aggression;
- changes in heartbeat rhythm;
- .
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website: “www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa”.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Desloratadina Aurobindo Italia
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label, the carton, and the blister pack after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect from moisture.
Blister packs: Do not store above 30°C.
HDPE bottle: This medicine does not require any special storage temperature conditions. After first opening of the bottle, the tablets must be used within 18 months.
Do not use this medicine if you notice any change in the appearance of the tablet.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.
6. Package contents and other information
What Desloratadina Aurobindo Italia contains
- The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
- The other components are: Tablet core: microcrystalline cellulose (Grade-102), pregelatinized starch (corn starch), colloidal anhydrous silica, and magnesium stearate. Tablet coating: hypromellose 2910 (6 cp), titanium dioxide (E171), microcrystalline cellulose, stearic acid, and indigo carmine aluminium lake (E132).
Description of the appearance of Desloratadina Aurobindo Italia and package contents
Film-coated tablets.
Desloratadina Aurobindo Italia 5 mg film-coated tablets:
Blue, round, biconvex, film-coated tablets, marked with “D” on one side and “5” on the other side.
The film-coated tablets are available in blister packs and in HDPE bottles.
Pack sizes:
Blister packs: 20, 28, 30, 50, 90 and 100 tablets,
HDPE bottles: 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA), Italy
Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, 3000 BBG, Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora, Portugal
This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium: Desloratadine AB 5 mg filmomhulde tabletten
Czech Republic: Desloratadin Aurovitas
Germany: Desloratadin PUREN 5 mg Filmtabletten
Italy: Desloratadina Aurobindo Italia
Netherlands: Desloratadine Aurobindo 5 mg, filmomhulde tabletten
Poland: Desloratadine Aurovitas
Portugal: Desloratadina Aurobindo
Romania: Desloratadină Aurobindo 5 mg comprimate filmate
Spain: Desloratadina Aurovitas 5 mg comprimidos recubiertos con película EFG