Ebastine Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

EBASTINE DOC 10 mg orodispersible tablets, 20 mg orodispersible tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. (See section 4.)

Contents of this leaflet:
1. What EBASTINE DOC is and what it is used for
2. What you need to know before taking EBASTINE DOC
3. How to take EBASTINE DOC
4. Possible side effects
5. How to store EBASTINE DOC
6. Contents of the pack and other information

1. What EBASTINE DOC is and what it is used for
Ebastine is an antihistamine that helps relieve allergic symptoms such as sneezing, runny nose,
watery eyes and itchy skin rashes.
In adults and children aged 12 years and older, EBASTINE DOC is used to relieve symptoms of seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis, including cases associated with allergic conjunctivitis.
In adults aged over 18 years, EBASTINE DOC 10 mg is used to relieve itching and wheal formation in urticaria.

2. What you need to know before taking EBASTINA DOC

Do not take EBASTINA DOC

• 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 before taking EBASTINA DOC:

• if you have low potassium levels in the blood;
• if you are already taking certain antibiotics or medicines used to treat fungal infections: see section “Other medicines and EBASTINA DOC” below;
• if you have severely impaired liver function (hepatic insufficiency).

EBASTINA DOC may cause dry mouth. Therefore, during long-term treatment, good oral hygiene is important (teeth should be brushed twice daily with fluoride toothpaste) to reduce the risk of dental caries.
Children and adolescents
This medicine should only be used in children aged 12 years and older. Do not give this medicine to children under 12 years of age, as safety and efficacy have not been established in this age group.
Other medicines and EBASTINA DOC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of EBASTINA DOC with erythromycin (an antibiotic) or ketoconazole, itraconazole (active substances used to treat fungal infections) may lead to increased blood levels of ebastine. Concomitant administration of ebastine with rifampicin (an antituberculosis agent) may result in low blood levels of ebastine and therefore reduced effects. Concomitant use of EBASTINA DOC with clarithromycin or josamycin (antibiotics) is not recommended.
EBASTINA DOC with food and drinks
You may take EBASTINA DOC regardless of meal times.
Pregnancy, breastfeeding and fertility
Currently, there are limited human data on fetal safety. Therefore, you should take EBASTINA DOC during pregnancy only if your doctor considers that the expected benefit outweighs the possible risks.
Do not take EBASTINA DOC if you are breastfeeding, as it is not known whether the active substance passes into breast milk.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Most patients treated with EBASTINA DOC can drive and perform other activities requiring adequate reaction ability. However, as with all medicines, you should assess your individual response after taking EBASTINA DOC before driving or performing complex tasks, since some patients may experience drowsiness or dizziness.
EBASTINA DOC contains aspartame
EBASTINA DOC 10 mg contains 2.5 mg per tablet. EBASTINA DOC 20 mg contains 5 mg per tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
EBASTINA DOC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
EBASTINA DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take EBASTINA DOC

Take EBASTINA DOC exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Indication Age Dose
Allergic rhinitis Children aged 12 years and One tablet of EBASTINA DOC 10 mg (10 mg
over, and adults of ebastine) once daily
In case of severe symptoms Two tablets of EBASTINA DOC 10 mg or one
tablet of EBASTINA DOC 20 mg (20 mg of
ebastine) once daily
Urticaria Adults over 18 years One tablet of EBASTINA DOC 10 mg (10 mg
of ebastine) once daily
In patients with impaired renal function, no dose adjustment is necessary.
In patients with mild to moderate hepatic impairment, no dose adjustment is necessary.
In patients with severe hepatic impairment, there is no experience with doses exceeding 10 mg;
therefore, in these patients, the dose should not exceed 10 mg.
Do not push the tablet out of its compartment to avoid breaking it.
Each blister contains tablets separated into compartments by perforations. Detach one compartment
along the dotted lines (figure 1).

Carefully remove the protective film, starting from the corner indicated by the arrow (figures 2 and
3).

With dry hands, remove the tablet from the strip.
Place the tablet on the tongue, where it will dissolve: no water or other liquids are needed.
EBASTINA DOC may be taken regardless of meal times.
Your doctor will determine the duration of treatment.
If you take more EBASTINA DOC than you should
There is no specific antidote for the active substance ebastine.
If you suspect an overdose with EBASTINA DOC, inform your doctor. Depending on the severity
of intoxication, the doctor will take appropriate measures (monitoring of vital functions,
including ECG monitoring for at least 24 hours, symptomatic treatment and gastric lavage),
if necessary.
If you forget to take EBASTINA DOC
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking EBASTINE DOC and contact your doctor immediately or go to the nearest hospital if you experience the following condition:
severe allergic reaction causing swelling of the face, tongue or throat, which may cause
difficulty swallowing or breathing.

Other side effects include:

Very common side effects (may affect more than 1 in 10 people):
headache

Common side effects (may affect up to 1 in 10 people):
drowsiness
dry mouth

Uncommon side effects (may affect up to 1 in 100 people):
sore throat (pharyngitis), runny nose (rhinitis), nosebleeds

Rare side effects (may affect up to 1 in 1,000 people):
nervousness, insomnia
altered sense of touch, reduced sense of touch
altered sense of taste
dizziness
palpitations, rapid heartbeat
abdominal pain, nausea, indigestion
vomiting
abnormal liver function tests
liver inflammation
problems with bile excretion causing itching, yellowing of the skin and eyes
rash, hives, skin inflammation
menstrual disorders
oedema (fluid accumulation in tissues)
weakness (asthenia)

Very rare side effects (may affect up to 1 in 10,000 people):
widespread rash, eczema
painful menstruation

Frequency not known: frequency cannot be estimated from the available data
weight increased
appetite increased

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EBASTINE DOC

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 blister pack and the outer box after 'EXP'. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What EBASTINA DOC contains
The active substance is ebastine.
EBASTINA DOC 10 mg: each orodispersible tablet contains 10 mg of ebastine.
EBASTINA DOC 20 mg: each orodispersible tablet contains 20 mg of ebastine.
The other ingredients are microcrystalline cellulose, monohydrate lactose, maize starch,
sodium croscarmellose, aspartame (E951), mint flavour, anhydrous colloidal silica and
magnesium stearate.

Description of the appearance of EBASTINA DOC and contents of the pack
Orodispersible tablet
Ebastine 10 mg: white, biconvex, round tablets, with the imprint 'E10' on one side and smooth on the other side.
Ebastine 20 mg: white, biconvex, round tablets, with the imprint 'E20' on one side and smooth on the other side.

Available in pack sizes of:
10 mg: 10, 20, 30, 40, 50, 90, 98 and 100 orodispersible tablets.
20 mg: 10, 15, 20, 30, 40, 50, 98 and 100 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l.
Via Turati, 40
20121 Milan
Italy

Manufacturers:
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary
Teva Pharma, S.L.U.
C/C, n° 4, Poligono Industrial Malpica,
50016 Zaragoza
Spain

This medicinal product is authorised in the European Economic Area countries under the
following names:
Sweden: Ebateva
Spain: Ebastina ratiopharm
Italy: EBASTINA DOC