Ebastine Sandoz

Patient Information Leaflet

Ebastine Sandoz 10 mg orodispersible tablets, 20 mg orodispersible tablets

Equivalent medicine
Please read all of 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Ebastina Sandoz 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, Ebastina Sandoz is used to relieve symptoms of seasonal
and perennial allergic rhinitis (hay fever), including cases with allergic conjunctivitis.
In adults aged over 18 years, Ebastina Sandoz 10 mg is used to relieve itching and the development of
wheals (urticaria).

2. What you need to know before taking Ebastine Sandoz

Do not take Ebastine Sandoz

• 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 Ebastine Sandoz if:
you are already taking certain antibiotics or medicines used to treat fungal infections: see “Other medicines and Ebastine Sandoz” below;
you have severely impaired liver function (hepatic insufficiency).

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 Ebastine Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Ebastine Sandoz together with erythromycin (an antibiotic) or ketoconazole, itraconazole (active substances used to treat fungal infections) may lead to higher levels of ebastine in the blood. Concomitant administration of ebastine with rifampicin (an antituberculosis agent) may result in lower blood levels of ebastine and thus reduce its effects. The concomitant use of Ebastine Sandoz with clarithromycin or josamycin (antibiotics) is not recommended.

Ebastine Sandoz with food and drink
You may take Ebastine Sandoz regardless of meal times.

Pregnancy, breastfeeding and fertility
To date, human experience regarding safety for the fetus is limited. Therefore, you may take Ebastine Sandoz during pregnancy only if your doctor considers that the expected benefit outweighs any possible risks.
Do not take Ebastine Sandoz 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, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Most patients treated with Ebastine Sandoz can drive or perform other activities requiring good reaction ability. However, as with all medicines, you should assess your individual response after taking Ebastine Sandoz before driving or performing complex tasks, since some patients may experience drowsiness or dizziness.

Ebastine Sandoz contains lactose, aspartame and sodium
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
The 10 mg orodispersible tablets contain 2.5 mg of aspartame (E 951) and the 20 mg orodispersible tablets contain 5 mg of aspartame (E 951). Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet, i.e. essentially ‘sodium-free’.

3. How to take Ebastine Sandoz

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

In patients with impaired renal function, no dose adjustment is required.
In patients with mild to moderate hepatic impairment, no dose adjustment is required.
There is no experience with doses higher than 10 mg in patients with severe hepatic impairment; therefore, in these patients the dose must 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 within a few seconds: water or other liquids are not required.
Ebastine Sandoz may be taken regardless of meal times.
Your doctor will determine the duration of treatment.
If you take more Ebastine Sandoz than you should
There is no specific antidote for the active substance ebastine.
If you suspect an overdose with Ebastine Sandoz, inform your doctor. Depending on the severity of intoxication, your 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 Ebastine Sandoz
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 everybody gets them.
Stop taking Ebastine Sandoz and contact your doctor immediately or go to the nearest hospital if you experience any of the following:
severe allergic reaction causing itching and swelling of the face, tongue or throat, which may cause difficulty swallowing or breathing. Severe allergic reactions to Ebastine Sandoz are rare (may affect up to 1 in 1,000 people).

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

Rare side effects – may affect up to 1 in 1,000 people:
Nervousness, insomnia
Dizziness, decreased sense of touch, taste disturbances
Palpitations, increased heart rate
Abdominal pain, vomiting, nausea, indigestion
Inflammation of the liver (hepatitis), problems with bile elimination (cholestasis), changes in liver function tests
Skin rash, urticaria, skin inflammation
Menstrual disorders
Oedema (fluid accumulation in tissues), weakness (asthenia)

Frequency not known: frequency cannot be estimated from the available data
Weight increased
Appetite increased

Reporting of side effects
If you get any side effects, 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 https://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 Sandoz

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 and carton 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 you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Ebastina Sandoz Contains

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

Description of the Appearance of Ebastina Sandoz and Pack Sizes
Orodispersible Tablets 10 mg
White, biconvex, round tablets with a diameter of approximately 6.7 mm, marked with the letters 'E10' engraved on one side and smooth on the other side.
Orodispersible Tablets 20 mg
White, biconvex, round tablets with a diameter of approximately 9.2 mm, marked with the letters 'E20' engraved on one side and smooth on the other side.
The orodispersible tablets are packaged in blisters made of OPA/Al/PVC/Al and placed in a carton box.
Pack sizes:
Orodispersible Tablets 10 mg:
10, 20, 30, 40, 50, 90, 98 and 100 orodispersible tablets.
Orodispersible Tablets 20 mg:
10, 15, 20, 30, 40, 50, 98 and 100 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), 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
Lek Pharmaceuticals d.d.
Verovskova 57, SI-1526, Ljubljana, Slovenia

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Sweden: Ebastine Sandoz
Spain: Ebastina Sandoz 10 mg comprimidos bucodispersables EFG
Ebastina Sandoz 20 mg comprimidos bucodispersables EFG
Italy: Ebastina Sandoz
Belgium: Ebastine Sandoz 10 mg orodispergeerbare tabletten
Ebastine Sandoz 20 mg orodispergeerbare tabletten