DESLORATADINE CINFA 5 mg FILM-COATED TABLETS
How to use DESLORATADINE CINFA 5 mg FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
desloratadine cinfa 5 mg film-coated tablets EFG
Read this package leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this package leaflet, you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.
Contents of the package leaflet
- What is desloratadine cinfa and what is it used for
- What you need to know before you take desloratadine cinfa
- How to take desloratadine cinfa
- Possible side effects
- Storage of desloratadine cinfa
- Contents of the pack and further information
1. What is desloratadine cinfa and what is it used for
What is desloratadine cinfa
desloratadine cinfa contains desloratadine, which is an antihistamine.
How desloratadine cinfa works
Desloratadine is an anti-allergic medicine that does not cause drowsiness. It helps to control the allergic reaction and its symptoms.
When to use desloratadine cinfa
Desloratadine relieves the symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or house dust mite allergy) in adults and adolescents aged 12 years and older. These symptoms include sneezing, runny or itchy nose, itchy palate and itchy, red or watery eyes.
Desloratadine is also used to relieve the symptoms associated with urticaria (a skin disease caused by an allergy). These symptoms include itching and skin rashes.
The relief of these symptoms lasts a full day and helps you to continue your daily activities and normal sleep periods.
2. What you need to know before you take desloratadine cinfa
Do not take desloratadine cinfa
- If you are allergic to desloratadine, or to loratadine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before taking desloratadine cinfa.
- If you have impaired kidney function.
- If you have a personal or family history of seizures.
Children and adolescents
Do not give this medicine to children under 12 years of age.
Taking desloratadine cinfa with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are no known interactions of desloratadine with other medicines.
Taking desloratadine cinfa with food, drinks and alcohol
Desloratadine can be taken with or without food. Be careful when taking desloratadine with alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take desloratadine if you are pregnant or breastfeeding.
Fertility
There are no data available on male and female fertility.
Driving and using machines
At the recommended dose, it is not expected that this medicine will affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities that require a state of alertness, such as driving a car or using machines, until you have determined your own response to the medicine.
desloratadine cinfa contains sodium
This medicine contains 26 mg of sodium (a major component of cooking/table salt) in each tablet. This is equivalent to 1.3% of the maximum recommended daily intake of sodium for an adult.
3. How to take desloratadine cinfa
Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
Adults and adolescents from 12 years of age
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 have and how long you should take desloratadine.
If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment schedule that depends on the evaluation of your medical history.
If your allergic rhinitis is persistent (presence of symptoms for 4 or more days a week and for more than 4 weeks), your doctor may recommend long-term treatment.
For urticaria, the duration of treatment may vary from one patient to another and therefore you should follow your doctor's instructions.
If you take more desloratadine cinfa than you should
Take desloratadine only as your doctor has told you. An accidental overdose is not expected to cause serious problems. However, if you take more desloratadine than you should, tell your doctor, pharmacist or nurse immediately.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.
If you forget to take desloratadine cinfa
If you forget to take your dose at the right time, take it as soon as possible and then continue with your normal dosing schedule. Do not take a double dose to make up for forgotten doses.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the marketing of desloratadine, very rare cases of serious allergic reactions (difficulty breathing, wheezing, itching, rash and swelling) have been reported. If you experience any of these serious side effects, stop taking this medicine and seek medical attention immediately.
In clinical trials in adults, the side effects were approximately the same as with a tablet that does not contain active ingredients. However, fatigue, dry mouth and headache were reported more frequently than with a tablet that does not contain active ingredients. In adolescents, headache was the most commonly reported adverse reaction.
In clinical trials with desloratadine, the following side effects were reported:
Frequent (may affect up to 1 in 10 patients):
- fatigue
- dry mouth
- headache
Adults
During the marketing of desloratadine, the following side effects have been reported:
Very rare (may affect up to 1 in 10,000 patients):
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Frequency not known (cannot be estimated from the available data):
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Children
Frequency not known (cannot be estimated from the available data):
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Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of desloratadine cinfa
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 after EXP. The expiry date refers to the last day of the month shown.
This medicine does not require any special storage conditions.
Store in the original package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and further information
Composition of desloratadine cinfa
- The active substance is desloratadine. Each film-coated tablet contains 5 mg of desloratadine.
- The other ingredients of the tablet are:
Core: anhydrous sodium carbonate, microcrystalline cellulose (E-460i), corn starch, talc, sodium croscarmellose and magnesium stearate.
Coating: Opadry II White (polyvinyl alcohol, titanium dioxide (E-171), talc, polyethylene glycol, macrogol) and indigo carmine (E-132).
Appearance of the product and contents of the pack
desloratadine cinfa 5 mg film-coated tablets EFG are cylindrical, biconvex, film-coated tablets, blue in color and marked with the code “DL”.
They are presented in aluminum/aluminum blisters. Each pack contains 20 or 100 (clinical pack) film-coated tablets.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Date of last revision of this package leaflet:August 2022
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) www.aemps.gob.es/
You can access detailed and up-to-date information about this medicine by scanning the QR code included in the package leaflet and carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/75335/P_75335.html
QR code to: https://cima.aemps.es/cima/dochtml/p/75335/P_75335.html
- Country of registration
- Average pharmacy price6.63 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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