Desloratadine Alter 5 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Desloratadine Alter 5 mg film-coated tablets EFG
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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because 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.
Contents of the leaflet
- What Desloratadine Alter is and what it is used for
- What you need to know before taking Desloratadine Alter
- How to take Desloratadine Alter
- Possible side effects
- How to store Desloratadine Alter
- Contents of the pack and other information
1. What Desloratadine Alter is and what it is used for
Desloratadine Alter is a non-sedating antihistamine medicine. It helps control allergic reactions and their symptoms.
Desloratadine Alter 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 12 years of age and older. These symptoms include sneezing, runny or itchy nose, itching of the palate, and itchy, red, or watery eyes.
Desloratadine 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 maintain normal sleep periods.
2. What you need to know before taking Desloratadine Alter
Do not take Desloratadine Alter
- 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 Alter:
- if you have impaired kidney function.
- if you or a family member has a history of seizures.
Children and adolescents
Do not give this medicine to children under 12 years of age.
Other medicines and Desloratadine Alter
There are no known interactions between Desloratadine Alter and other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Desloratadine Alter with food, drinks and alcohol
Desloratadine Alter can be taken regardless of meals.
Be cautious when taking Desloratadine Alter with alcohol.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. If you are pregnant or breastfeeding a baby, it is not recommended to take Desloratadine Alter.
There are no data available regarding male and female fertility.
Driving and using machines
At the recommended dose, Desloratadine Alter is not expected to affect your ability to drive or operate 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 Alter contains Sunset Yellow FCF
This medicine may cause allergic reactions because it contains Sunset Yellow FCF. It may cause asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Desloratadine Alter
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Adults and adolescents (12 years of age and older):
The recommended dose is one tablet once daily, with or without food.
Swallow the tablet whole with water.
Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis you have and how long you should take desloratadine.
If you have intermittent allergic rhinitis (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 you have persistent allergic rhinitis (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 Alter than you should
Take desloratadine only as your doctor has instructed. Accidental overdose is not expected to cause serious problems. However, if you take more desloratadine than prescribed, inform your doctor, pharmacist, or nurse immediately.
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Desloratadine Alter
If you forget to take your dose at the scheduled time, take it as soon as possible, and then continue with your usual dosing schedule. Do not take a double dose to make up for missed doses.
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 Alter can cause adverse effects, although not everyone experiences them. In adults, adverse effects were approximately the same as with a tablet containing no active ingredient. However, fatigue, dry mouth, and headache were reported more frequently than with a tablet containing no active ingredient. In adolescents, headache was the most frequently reported adverse reaction.
During the marketing of Desloratadina Alter, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, skin rash, and swelling) and skin rash have been reported. If you experience any of these serious adverse effects, stop taking this medicine immediately and consult your doctor.
In clinical trials with Desloratadina, the following adverse effects were reported as:
Frequent: the following may affect up to 1 in 10 people
- fatigue
- dry mouth
- headache
During the marketing of Desloratadina, the following adverse effects have been reported as:
Very rare: the following may affect up to 1 in 10,000 people
- serious allergic reactions
- skin rash
- strong or irregular heartbeats
- rapid heartbeats
- stomach pain
- nausea
- vomiting
- upset stomach
- diarrhea
- dizziness
- somnolence
- difficulty sleeping
- muscle pain
- hallucinations
- seizures
- agitation with increased body movement
- liver inflammation
- changes in liver function tests
Frequency 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 ultraviolet light from a sunbed
- changes in heartbeat rhythm
- abnormal behaviour
- aggression
- weight gain, increased appetite
- depressed mood
- dry eyes
Children
Frequency not known: frequency cannot be estimated from the available data
|
|
|
|
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
5. Storage of Desloratadine Alter
Keep out of the 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.
Store in the original packaging.
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. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Desloratadine Alter
- The active substance is desloratadine 5 mg.
- The other components of the tablet are: calcium hydrogen phosphate dihydrate, pregelatinized corn starch, corn starch, microcrystalline cellulose, talc, calcium stearate, and Opadry II blue (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, indigo carmine (E132), and sunset yellow FCF (E110)).
Appearance of the product and contents of the pack
Film-coated, round, biconvex blue tablets. Packaged in containers containing 20 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorios Alter, S.A.
C/Mateo Inurria, 30
28036 Madrid
Spain
Date of the most recent revision of this leaflet: October 2023
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/