Ebastel Flas 10 mg oral lyophilisates
Spain
Table of Contents
Package Leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ebastel Flas 10 mg Oral Lyophilisates
Ebastine
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Contents of the leaflet:
- What Ebastel Flas is and what it is used for
- What you need to know before taking Ebastel Flas
- How to take Ebastel Flas
- Possible adverse effects
- How to store Ebastel Flas
- Contents of the pack and other information
1. What Ebastel Flas is and what it is used for
Ebastel Flas belongs to a group of medicines called antihistamines (antiallergic agents).
Ebastel Flas is indicated for the treatment of symptoms of allergic conditions such as seasonal or perennial allergic rhinitis, with or without allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, and sneezing), chronic urticaria, and allergic dermatitis.
2. What you need to know before taking Ebastel Flas
Do not take Ebastel Flas
- if you are allergic to ebastine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Ebastel Flas.
This medicine should be used with caution:
- if your electrocardiogram (ECG) results are abnormal (prolongation of the QT interval).
- if you have abnormal blood potassium levels.
- if you have severe liver disease (see section “How to take Ebastel Flas”).
- if you are being treated with a type of medicine used to treat fungal infections called azole antifungals, or with medicines used to treat certain infections called macrolide antibiotics (see section “Taking Ebastel Flas with other medicines”).
- if you are being treated with rifampicin, a medicine used to treat tuberculosis.
Do not use this medicine if you have an acute allergic emergency, as ebastine (the active substance in this medicine) takes 1 to 3 hours to take effect.
Children
Ebastel Flas must not be administered to children under 12 years of age.
Taking Ebastel Flas with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
The following medicines may interact with Ebastel Flas; in such cases it may be necessary to adjust the dose or discontinue one of the treatments:
- Ebastel Flas may enhance the effect of other medicines used to treat allergies (antihistamines).
- Ebastel Flas should be used with caution in patients taking medicines called ketoconazole and itraconazole, used to treat fungal infections, or with an antibiotic used to treat certain infections called erythromycin (as they may cause abnormalities in your electrocardiogram).
- The antihistaminic effect of Ebastel Flas may be reduced in patients taking a medicine called rifampicin, used to treat tuberculosis.
No interactions have been reported between ebastine and theophylline, warfarin, cimetidine, diazepam, or alcohol.
Interference with diagnostic tests
Ebastel Flas may interfere with skin allergy test results; therefore, it is recommended not to perform such tests until 5–7 days after stopping treatment.
Taking Ebastel Flas with food and drinks
The oral lyophilisate can be taken with or without food. It is not necessary to drink water or any other liquid.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
There is no experience in pregnant women; therefore, it is recommended to consult a doctor before taking Ebastel Flas. The doctor will decide whether or not to start treatment.
Breastfeeding
It is unknown whether the medicine passes into breast milk; therefore, Ebastel Flas should not be used during breastfeeding.
Driving and using machines
In men, no effects on psychomotor function, or on the ability to drive or operate machinery, have been observed at the recommended therapeutic doses. However, since somnolence and dizziness are listed among the adverse effects, you should assess your response to the medication before driving or operating machinery.
Ebastel Flas contains aspartame
This medicine contains 1 mg of aspartame per oral lyophilisate. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.
3. How to take Ebastel Flas
Follow exactly the administration instructions for Ebastel Flas provided by your doctor. If you have any doubts, consult your doctor or pharmacist again.
Remember to take your medication.
Your doctor will indicate the duration of your treatment with Ebastel Flas.
Dosage
Use in adults and children over 12 years of age: The recommended dose is 1 oral lyophilisate (10 mg of ebastine) once daily.
Use in patients with severe liver disease: The dose should not exceed 10 mg of ebastine per day (1 oral lyophilisate).
Method of administration
This medicine is for oral use.
- Do not remove the oral lyophilisate from its packaging until you are ready to take it.
- Do not push the lyophilisate out through the packaging. Just before taking the dose, with dry hands, open the blister pack by carefully lifting the foil from one blister at the point where it is unsealed (Figure 1).
- Pull the tab to unseal it (Figure 2).
- Carefully press the lyophilisate upwards (without touching it) (Figure 3).
- Carefully remove the lyophilisate (Figure 4).
- The dose should be taken immediately after opening the blister. Place the oral lyophilisate on the tongue, where it will dissolve rapidly, and swallow it with saliva. Do not take water or any other liquid.
Figure 1 Figure 2 Figure 3 Figure 4
If you think that the effect of Ebastel Flas is too strong or too weak, inform your doctor or pharmacist.
If you take more Ebastel Flas than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at 915 620 420 (indicating the medicine and the amount ingested), or go to the nearest hospital. Bring any remaining oral lyophilisates, the outer carton, and the full pack so that healthcare professionals can easily identify the medicine you have taken.
Treatment of poisoning with this medicine consists of gastric lavage and administration of appropriate medication.
If you forget to take Ebastel Flas
Do not take a double dose to make up for missed doses. Take the missed dose as soon as you remember, then continue with your regular schedule. However, if it is almost time for your next dose, do not take the missed dose and wait to take the next dose at the scheduled time.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Ebastel Flas may cause adverse effects, although not everyone experiences them.
The following adverse effects have been observed in clinical trials and post-marketing experience:
Very common (may affect more than 1 in 10 people):
- Headache
Common (may affect up to 1 in 10 people):
- Somnolence
- Dry mouth
Rare (may affect up to 1 in 1,000 people):
- Hypersensitivity reactions: allergic reactions (such as anaphylaxis and angioedema)
- Nervousness, insomnia
- Dizziness, decreased sensation of touch or sensitivity, decreased or altered taste
- Palpitations, tachycardia
- Abdominal pain, vomiting, nausea, digestive problems
- Liver inflammation (hepatitis), cholestasis, abnormal liver function tests (increased transaminases, gamma-GT, alkaline phosphatase, and bilirubin)
- Urticaria, skin rash, dermatitis
- Menstrual disorders
- Edema (swelling due to fluid accumulation), fatigue
Frequency not known (cannot be estimated from available data):
- Weight gain
- Increased appetite
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ebastel Flas
Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Ebastel Flas
- The active substance is ebastine. Each oral lyophilisate contains 10 mg of ebastine.
- The other components (excipients) are gelatin (E-441), mannitol (E-421), aspartame (E-951) and peppermint flavour.
Appearance of the product and contents of the pack
Ebastel Flas is presented as an oral lyophilisate. The lyophilisate is round and white. Each pack contains 20 oral lyophilisates.
Other presentations
Ebastel Forte Flas 20 mg Oral lyophilisates
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Almirall, S.A.
General Mitre, 151
08022 - Barcelona (Spain)
Manufacturer
Industrias Farmacéuticas Almirall, S.A.
Ctra. de Martorell, 41-61
08740 Sant Andreu de la Barca - Barcelona (Spain)
Date of the most recent revision of this leaflet: May 2019
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/Mod. P.03.1 (16/02/15)