Ebastine Teva

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ebastina Teva 10 mg orodispersible tablets, 20 mg orodispersible tablets

ebastine
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 others, even if their symptoms are the same as yours, because it could 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 Ebastina Teva is and what it is used for
2. What you need to know before taking Ebastina Teva
3. How to take Ebastina Teva
4. Possible side effects
5. How to store Ebastina Teva
6. Contents of the pack and other information

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

2. What you need to know before taking Ebastine Teva

Do not take Ebastine Teva

• 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 Teva if:

• you have low levels of potassium in your blood;
• you have an abnormal heart rhythm (confirmed QTc interval prolongation on ECG), which may occur in certain types of heart disease;
• you are already taking certain antibiotics or medicines used to treat fungal infections: see "Other medicines and Ebastine Teva" below;
• you have severely impaired liver function (hepatic insufficiency).
• Ebastine Teva may cause dry mouth. During long-term treatment, it is therefore important to maintain good oral hygiene (teeth should be brushed twice daily) 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 Ebastine Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Ebastine Teva may affect or be affected by certain medicines containing the following active substances:

• ketoconazole, itraconazole (medicines used to treat fungal infections);
• erythromycin (an antibiotic);
• rifampicin (a medicine used to treat tuberculosis).

Ebastine Teva with food and drinks
You may take Ebastine Teva regardless of meal times.
Pregnancy, breastfeeding and fertility
Human data on fetal safety are limited. Therefore, you should take Ebastine Teva during pregnancy only if your doctor considers that the expected benefit outweighs the possible risks.
Do not take Ebastine Teva 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 a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Most patients treated with Ebastine Teva can drive or perform other activities requiring adequate reaction ability. However, as with all medicines, you should assess your individual response after taking Ebastine Teva before driving or performing complex tasks, since some patients may experience drowsiness or dizziness.
Ebastine Teva contains aspartame
Ebastine Teva 10 mg contains 2.5 mg of aspartame per tablet. Ebastine Teva 20 mg contains 5 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine due to the body's inability to properly metabolize it.
Ebastine Teva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking Ebastine Teva.
Ebastine Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Ebastina Teva

Take Ebastina Teva 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 older and adults | One tablet of Ebastina Teva 10 mg (10 mg of ebastine) daily | | Severe symptoms | | Two tablets of Ebastina Teva 10 mg or one tablet of Ebastina Teva 20 mg (20 mg of ebastine) once daily | | Urticaria | Adults over 18 years | One tablet of Ebastina Teva 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 higher than 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 Teva can be taken regardless of meal times.
Your doctor will determine the duration of treatment.

If you take more Ebastina Teva than you should
There is no specific antidote for the active substance ebastine.
If you suspect an overdose with Ebastina Teva, 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 48 hours, symptomatic treatment, and gastric lavage), if necessary.

If you forget to take Ebastina Teva
Do not take a double dose to make up for the forgotten dose.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Do not take Ebastine Teva and contact your doctor immediately or go to the nearest hospital if you
experience the following:

• Itching, hives, and swelling of the face, tongue or throat, which may cause difficulty in swallowing or breathing. This may indicate the onset of a hypersensitivity reaction to Ebastine Teva such as anaphylaxis and angioedema, which are rare side effects (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
Uncommon side effects: may affect up to 1 in 100 people
Nosebleed
Sore throat (pharyngitis)
Runny nose (rhinitis)
Rare side effects: may affect up to 1 in 1,000 people
Nervousness
Insomnia
Drowsiness
Dizziness
Decreased sense of touch
Taste disturbances
Palpitations (fast heartbeat, irregular heartbeat)
Rapid pulse
Abdominal pain
Vomiting
Nausea
Indigestion
Hepatitis (inflammation of the liver)
Cholestasis (impaired bile flow)
Abnormal liver function tests
Skin rash, redness with itching, widespread skin rash
Menstrual disorders
Oedema (fluid accumulation in tissues)
Weakness (asthenia)
Very rare side effects: may affect up to 1 in 10,000 people
Altered sense of touch
Eczema, skin inflammation
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, tell your doctor. 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 Teva

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

Description of the appearance of Ebastina Teva and package contents
Orodispersible tablet.
Ebastine 10 mg: white, biconvex, round tablets, with the inscription 'E10' engraved on one side, smooth on the other side.
Ebastine 20 mg: white, biconvex, round tablets, with the inscription 'E20' engraved on one side, 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.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milan, Italy

Manufacturers
Pharmachemie B.V.
Swensweg 5
P.O. Box 552
2003 RN Haarlem (The Netherlands)

Teva Pharmaceutical Works Private Limited Company
Pallagi út. 13
H-4042 Debrecen (Hungary)

TEVA Czech Industries s.r.o.
Ostravská 29, č.p. 305,
747 70 Opava
Komárov (Czech Republic)

Teva Pharma, S.L.U.
C/ C, n° 4, Poligono Industrial Malpica,
50016 Zaragoza (Spain)