Ebastine Mylan Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ebastine Mylan Pharma 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 others, 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, tell your doctor or pharmacist. (See section 4.)

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

1. What Ebastine Mylan Pharma 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 Mylan Pharma is used to relieve symptoms of seasonal (hay fever) and perennial allergic rhinitis, including cases with allergic conjunctivitis.
In adults aged over 18 years, Ebastine Mylan Pharma 10 mg is used to relieve itching and hives in urticaria.

2. What you need to know before taking Ebastine Mylan Pharma

Do not take Ebastine Mylan Pharma

• 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 Mylan Pharma:

• if you have low levels of potassium in your blood;
• if you are already taking certain antibiotics or medicines used to treat fungal infections: see section “Other medicines and Ebastine Mylan Pharma” below;
• if 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 Mylan Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of Ebastine Mylan Pharma 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 reduced blood levels of ebastine and therefore reduced effectiveness. Concomitant use of Ebastine Mylan Pharma with clarithromycin or josamycin (antibiotics) is not recommended.

Ebastine Mylan Pharma with food and drink
You can take Ebastine Mylan Pharma regardless of meal times.

Pregnancy, breastfeeding and fertility
Currently, there are limited human data available on fetal safety. Therefore, you should take Ebastine Mylan Pharma during pregnancy only if your doctor considers that the expected benefit outweighs any possible risk.
Do not take Ebastine Mylan Pharma if you are breastfeeding, as it is unknown whether the active substance passes into breast milk.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

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

Ebastine Mylan Pharma contains

• lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking Ebastine Mylan Pharma;

• aspartame (E951), a source of phenylalanine, which may be harmful if you have phenylketonuria.

3. How to take Ebastina Mylan Pharma

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:

| Indication | Age | Dose | |------------|-----|------| | Allergic rhinitis | Children aged 12 years and older, and adults | One tablet of Ebastina Mylan Pharma 10 mg (10 mg of ebastine) once daily | | Severe symptoms | | Two tablets of Ebastina Mylan Pharma 10 mg or one tablet of Ebastina Mylan Pharma 20 mg (20 mg of ebastine) once daily | | Urticaria | Adults over 18 years | One tablet of Ebastina Mylan Pharma 10 mg (10 mg of ebastine) once daily |

In patients with impaired renal function, no dose adjustment is required.

In patients with mild to moderate hepatic impairment, no dose adjustment is required.

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 within a few seconds: no water or other liquids are needed.

Ebastina Mylan Pharma may be taken regardless of meal times.

Your doctor will determine the duration of treatment.

If you take more Ebastina Mylan Pharma than you should

There is no specific antidote for the active substance ebastine.

If you suspect an overdose with Ebastina Mylan Pharma, 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 Ebastina Mylan Pharma

Do not take a double dose to make up for the forgotten 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 Ebastina Mylan Pharma and contact your doctor immediately or go to the nearest hospital if the following occurs:

• Severe allergic reaction causing swelling of the face, tongue or throat, which may cause difficulty in 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), nasal discharge (rhinitis), nosebleeds
Rare side effects may affect up to 1 in 1,000 people:
Nervousness, insomnia
Altered sense of touch, decreased sense of touch
Taste disturbances
Palpitations, rapid pulse
Abdominal pain, nausea, indigestion
Vomiting
Abnormal liver function tests
Liver inflammation
Problems with bile excretion causing itching, yellowing of the skin and eyes
Skin rash, hives, skin inflammation
Menstrual disorders
Edema (fluid accumulation in tissues), weakness (asthenia)
Dizziness
Very rare side effects may affect up to 1 in 10,000 people:
Widespread skin rash, eczema
Painful menstruation
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 the website www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ebastine Mylan Pharma

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 the
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 medicines via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help
protect the environment.

6. Package contents and other information

What Ebastina Mylan Pharma contains
The active substance is ebastine. Each orodispersible tablet contains 10 mg of
ebastine. Each orodispersible tablet contains 20 mg of ebastine.
The other ingredients are microcrystalline cellulose, lactose monohydrate, maize starch,
sodium croscarmellose, aspartame (E951), mint flavour, anhydrous colloidal silica and
magnesium stearate.
Description of the appearance of Ebastina Mylan Pharma and contents of the pack
Orodispersible tablet
Ebastine 10 mg: white, biconvex, round tablets, engraved with the code ‘E10’ on one side and smooth on the other.
Ebastine 20 mg: white, biconvex, round tablets, engraved with the code ‘E20’ on one side and smooth on the other.
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
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano, 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