Ebastine Normon 20 mg orodispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ebastina Normon 20 mg orodispersible tablets EFG
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. See section 4.
Leaflet contents
- What Ebastina Normon is and what it is used for
- What you need to know before taking Ebastina Normon
- How to take Ebastina Normon
- Possible side effects
- How to store Ebastina Normon
- Contents of the pack and other information
1. What Ebastina Normon is and what it is used for
Ebastina Normon belongs to a group of medicines called antihistamines (antiallergic agents).
Ebastina Normon is indicated for the treatment of symptoms associated with 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 starting Ebastine Normon
Do not take Ebastine Normon
- If you are allergic to ebastine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Ebastine Normon.
This medicine should be used with caution:
- If your electrocardiogram (ECG) results are abnormal (prolongation of the QT interval).
- If you have high levels of potassium in your blood.
- If you suffer from severe liver disease (see section “How to take Ebastine Normon”).
- 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 Ebastine Normon 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
Ebastine Normon must not be administered to children under 12 years of age.
Taking Ebastine Normon 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 Ebastine Normon; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of them:
- Ebastine Normon may increase the effect of other medicines used to treat allergy (antihistamines).
- Ebastine Normon 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 changes in your electrocardiogram).
- The antihistaminic effect of Ebastine Normon 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
Ebastine Normon may interfere with the results of skin allergy tests; therefore, it is advisable not to perform these tests until 5–7 days after stopping treatment.
Taking Ebastine Normon with food and drinks
Orodispersible tablets can be taken with or without food. It is not necessary to take 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 Ebastine Normon. The doctor will decide whether or not treatment should be initiated.
Breastfeeding
It is unknown whether the medicine passes into breast milk; therefore, it should not be used during breastfeeding.
Driving and using machines
In humans, no effects on psychomotor function or 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, observe your response to the medication before driving or operating machinery.
Ebastine Normon contains glucose, benzyl alcohol, and sodium
This medicine contains glucose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.
May harm teeth.
This medicine contains 0.2 mg of benzyl alcohol in each tablet.
Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).
Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).
Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems ("gasping syndrome") in children.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".
3. How to take Ebastina Normon
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Your doctor will indicate the duration of your treatment with Ebastina Normon.
Dosage
Use in adults and children over 12 years of age: The usual recommended dose is 10 mg of ebastine once daily, although some individuals may require a dose of 20 mg once daily.
Use in patients with severe liver disease: The dose should not exceed 10 mg of ebastine per day. In this case, the 10 mg formulation is recommended.
Method of administration
Ebastina Normon tablets are for oral use and dissolve easily, so they must be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.
If you think that the effect of Ebastina Normon is too strong or too weak, inform your doctor or pharmacist.
If you take more Ebastina Normon than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20 (indicating the medicine and the amount ingested), or go to the nearest hospital. Take any remaining orodispersible tablets, the outer carton, and the complete packaging so that healthcare professionals can more 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 Ebastina Normon
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, this medicine can 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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish System of Pharmacovigilance 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 Ebastine Normon
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 packaging 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 empty containers and unused medicines at the SIGRE collection point at 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 Ebastine Normon
The active substance is ebastine. Each tablet contains 20 mg of ebastine.
The other components are: Pearlitol flash (containing mannitol, corn starch), microcrystalline cellulose (E-460), sodium carboxymethyl starch from potato (Type A), hydroxypropyl cellulose (E-463), macrogol 6000, colloidal silica, glycerol monostearate, tutti frutti flavour (containing glucose and benzyl alcohol), sodium saccharin (E-954) and magnesium stearate (E-572).
Appearance of the product and contents of the pack
Ebastine Normon is presented as white or almost white, round, flat tablets, packed in aluminum/aluminum-polyamide-PVC blisters. Each pack contains 20 tablets.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
Date of the most recent revision of this leaflet: May 2024
Detailed and up-to-date 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
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76307/P_76307.html