Ebastine Qualigen 10 mg film-coated tablets EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Ebastina Qualigen is and what it is used for
- 2. What you need to know before starting Ebastine Qualigen
- 3. How to take Ebastine Qualigen
- 4. Possible adverse effects
- 5. Storage of Ebastine Qualigen
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Ebastina Qualigen 10 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine.
- 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 and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Ebastina Qualigen is and what it is used for
- What you need to know before taking Ebastina Qualigen
- How to take Ebastina Qualigen
- Possible side effects
- How to store Ebastina Qualigen
- Contents of the pack and other information
1. What Ebastina Qualigen is and what it is used for
Ebastine, the active component of Ebastina Qualigen, belongs to a group of medicines known as antihistamines.
Ebastina Qualigen is indicated for the treatment of allergic conditions such as seasonal or perennial allergic rhinitis associated or not with allergic conjunctivitis (such as nasal discharge, nasal itching, eye itching, tearing, and sneezing), chronic urticaria, and allergic dermatitis.
2. What you need to know before starting Ebastine Qualigen
Do not take Ebastine Qualigen
- If you are allergic to ebastine or to any of the other ingredients of this medicine (listed in section 6).
- It should not be administered to children under 6 years of age, as its safety has not been established in this age group.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ebastine Qualigen:
- If you are experiencing an acute, urgent allergic reaction, as Ebastine Qualigen takes 1 to 3 hours to take effect.
- Ebastine Qualigen may interfere with the results of skin allergy tests; therefore, such tests should not be performed until 5–7 days after stopping treatment.
- It may enhance the effects of other antihistamines.
- In patients with mild or moderate hepatic impairment, dose adjustment is not necessary. In patients with severe hepatic impairment, the dose should not exceed 10 mg/day of ebastine.
Other medicines and Ebastine Qualigen
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to discontinue treatment or adjust the dose of one or more of them.
Ebastine may interact with erythromycin (an antibiotic) or ketoconazole (a medicine used to treat fungal infections).
Taking Ebastine Qualigen with food and drinks
The tablets can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
There is no experience in pregnant women; therefore, it is recommended to consult a doctor before taking this medicine.
It is unknown whether the medicine passes into breast milk.
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, monitor your response to the medication, as drowsiness has occurred in some cases at usual doses. If this occurs, refrain from driving and operating dangerous machinery.
Ebastine Qualigen contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free”.
3. How to take Ebastine Qualigen
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Your doctor will tell you how long to take Ebastine Qualigen. Do not stop treatment early, as your symptoms may worsen.
Remember to take your medicine.
The recommended dose for adults and children over 12 years of age is 1 tablet (10 mg) once daily.
Use in children
For children between 6 and 11 years of age, the usual recommended dose is half a tablet (5 mg) once daily.
Ebastine Qualigen tablets are for oral use. The tablets must be swallowed whole, without chewing, with a glass of liquid, preferably water.
If you think that the effect of Ebastine Qualigen is too strong or too weak, inform your doctor or pharmacist.
If you take more Ebastine Qualigen than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Ebastine Qualigen
If you miss a dose, wait and take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
If you stop treatment with Ebastine Qualigen
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Ebastina Qualigen may cause adverse effects, although not everyone experiences them.
In clinical studies, this medicine was well tolerated. Adverse reactions were mild or moderate, transient, and resolved spontaneously without specific treatment.
The adverse effects reported in adults and children over 12 years of age are as follows:
Frequent (may affect between 1 and 10 out of 100 patients):
- headache,
- somnolence,
- dry mouth.
Uncommon (may affect between 1 and 10 out of 1,000 patients):
- abdominal pain,
- digestive discomfort,
- nosebleed,
- rinitis,
- sinusitis,
- nausea,
- insomnia.
In children under 12 years of age, the adverse events reported are as follows:
Frequent (may affect between 1 and 10 out of 100 patients):
- headache,
- dry mouth,
- somnolence.
Uncommon (may affect between 1 and 10 out of 1,000 patients):
- increased appetite,
- diarrhea,
- skin rash,
- nervousness,
- affective imbalance,
- excessive mobility,
- taste disturbances,
- fatigue.
Frequency not known (cannot be estimated from available data):
- weight gain,
- increased appetite.
If you notice any adverse effects not listed in this leaflet, or if you experience any of the described adverse effects severely, inform your doctor or pharmacist.
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 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 Ebastine Qualigen
Keep out of the reach and sight of children.
No special storage conditions are required.
Do not use Ebastine Qualigen after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Return empty containers and any medicines no longer required to the SIGRE point at your usual pharmacy. If in doubt, please consult your pharmacist on how to dispose of containers and unwanted medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ebastina Qualigen
- The active substance is Ebastine. Each tablet contains 10 mg of ebastine.
- The other components are: microcrystalline cellulose (E-460i), stearoyl macrogol glyceride, sodium starch glycolate (from potato), magnesium stearate (E-572), purified water and Opadry White [hypromellose (E-464), polyethylene glycol (E-1521), titanium dioxide (E-171)].
Appearance of the product and contents of the pack
Ebastina Qualigen 10 mg tablets are oval, scored, and white.
Packs contain 20 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Neuraxpharm Spain, S.L.U.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona – Spain
Manufacturer:
Generis Farmacêutica, S.A.
Rua João de Deus nº 19, Venda Nova
2700-487 Amadora (Portugal)
Date of the most recent revision of this leaflet: May 2021
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