10 mg orodispersible tablet
ebastine
1. What Ebastin ABECE is and what it is used for
Ebastin Abece is an antihistamine, which counteracts the effect of histamine. Histamine is a substance in the body’s tissues that are triggered when you are exposed to allergenic substances and which, among other things, triggers runny nose, nasal congestion, and sneezing as well as eye problems such as red, watery and itchy eyes. Insensitive individuals, histamine can also cause troublesome itching and skin rashes after mosquito bites.
Ebastin Abece is used for temporary allergic disorders such as red, watery, and itchy eyes as well as runny nose, nasal congestion, and sneezing. The allergic problems can be caused by, among other things, pollen, fur animals, mites, or dust. Ebastin Abece can also be used by people who are sensitive to mosquito bites, during temporary stays in mosquito-rich areas.
Ebastin contained in Ebastin Abece may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Ebastin ABECE
Do not use Ebastin ABECE
- if you are allergic to ebastine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
- Ebastin Abece can cause dry mouth. For long-term treatment, good oral hygiene is therefore important (teeth should be cleaned with fluoride toothpaste twice daily) to prevent the risk of caries.
- If you have a severe hepatic impairment, you should consult a doctor before starting treatment with Ebastin Abece.
Other medicines and Ebastin ABECE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ebastin Abece may affect or be affected by certain medicines that contain any of the following active substances:
- ketoconazole , itraconazole ( antifungal drugs),
- erythromycin ( antibiotics ),
- rifampicin (a medicine used to treat tuberculosis ).
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There is limited experience of use during pregnancy. Ask your doctor or pharmacist for advice before taking any medicine.
It is unknown whether ebastine passes into breast milk. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Some people may react with drowsiness and dizziness to this type of medicine.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Ebastin ABECE contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Ebastin ABECE
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose for adults and children over 12 years is 1 orodispersible tablet of 10 mg melted on the tongue once a day in connection with breakfast for a maximum of 14 days. For more severe allergic symptoms, the dose can be increased to 2 orodispersible tablets of 10 mg daily. Ebastin Abece should not be given to children under 12 years of age.
Patients with severe hepatic impairment should not take more than 1 orodispersible tablet of 10 mg per day.
If you want to use Ebastin Abece for longer than 14 days, you should contact a doctor to rule out a more serious cause of the problem.
The effect of Ebastin Abece comes within 1 hour and lasts for 24 hours after taking the dose. Fur animal allergy sufferers should take Ebastin Abece 1 hour before visiting a home with fur animals. In case of itching caused by mosquito bites, you get the best effect if Ebastin Abece is taken before you have been bitten by a mosquito. People who are extra sensitive to mosquito bites have the greatest effect. The effect on itching lasts less than 2 hours and therefore does not affect the latter phase of itching after mosquito bites.
User manual:
Ebastin Abece has a peelable foil. The symbol with an arrow, on the edge of the blister, shows the appropriate place to separate the foil from the underlying foil containing orodispersible tablets.
– Carefully pull off the back of an orodispersible tablet, as shown by the arrow
– Take the orodispersible tablet out of its pocket
The orodispersible tablet is then placed on the tongue, where it is immediately dissolved. Water or other liquid does not need to be used. The orodispersible tablets should be carefully removed from the blister with dry hands so that it is not crushed. The tablet should then be taken as soon as possible.
If you use more Ebastin ABECE then you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to use Ebastin ABECE
Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ebastine Abece and seek immediate emergency medical attention if you experience symptoms such as itching, rash, difficulty swallowing, difficulty breathing, low blood pressure, and swelling of the face, tongue, and throat. This may be a sign of a severe allergic reaction, which has been reported in rare cases.
The following side effects have also been reported:
Very common (may affect more than 1 user in 10):
- headache
Common (may affect up to 1 in 10 people):
- drowsiness
- dry mouth
Rare (may affect up to 1 in 1,000 people):
- nervousness
- insomnia
- dizziness
- reduced feel
- taste changes
- palpitation
- abnormal heart rhythm
- abdominal pain
- vomiting
- nausea
- digestive problems
- liver effects
- abnormal liver function tests
- hives
- rash
- dermatitis
- menstrual disorders
- fluid retention ( edema )
- fatigue
Has been reported (occurs in an unknown number of users):
- weight gain
- increased appetite
5. How to store Ebastin ABECE
Keep this medicine out of the sight and reach of children.
Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton after EXP. dat. and on the blister after EXP. The expiration date is the last day of the specified month.
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 to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is ebastine. 1 orodispersible tablet contains 10 mg of ebastine.
The other ingredients (excipients) are hypromellose (E464), povidone (E1201), poloxamer, gelatin, Carmello calcium, crospovidone, mannitol (E421), microcrystalline cellulose (E460), croscarmellose sodium (E468), silica (E468) natural silica (E468) flavors, gum arabic (E414), maltodextrin, sodium benzoate (E211) and butyl hydroxyanisole (E320), neotame (E961) and magnesium stearate (E470).
What the medicine looks like and the contents of the pack
White to off-white, round orodispersible tablets with beveled edges and a diameter of approximately 8.5 mm and a thickness of 2.2 mm and marked “10” on one side.
Pack sizes : 10, 15, 20 and 30 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Evolan Pharma AB
Box 120
182 12 Danderyd
Manufacturer
MEDREICH PLC
Warwick House
Plane Tree Crescent
Feltham, TW13 7 HF
UK
MEIJI PHARMA SPAIN SA
Avda de Madrid, 94
Alcala de Henares,
Madrid, 28802
Spain