Allegra Tablets 10 coated Allergy medicine

Dimensions: Height: 65 mm. Width: 126 mm. Depth: 22 mm.

Opella Healthcare Poland Sp. z o.o.

Carefully read the leaflet before using the drug, as it contains important information for the patient.
Always take this medication exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
- If there is no improvement after 5 days, or if the patient feels worse, contact your doctor.

Table of contents of the leaflet
1 What is Allegra drug and what is it used for?
2. important information before taking Allegra
3 How to use Allegra
4 Possible side effects
5. how to store Allegra
6. package contents and other information

1 What is the drug Allegra and for what purpose it is used.

Allegra contains fexofenadine hydrochloride, which is an antihistamine.
Allegra is used in adults and children 12 years of age and older to treat symptoms of hay fever (seasonal allergic rhinosinusitis), such as sneezing, itchy nose, runny or blocked nose, and itchy, red and watery eyes.

3 How to use Allegra medicine

Always take this medication exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The following instructions apply if your doctor has not advised you otherwise to take Allegra.
For adults and children aged 12 years and older
The recommended dose is 1 tablet (120 mg) once daily.
Tablets should be taken orally, before meals, with a drink of water.

If symptoms do not resolve after 5 days of starting the drug, contact your doctor.

Taking more than the recommended dose of Allegra.
If you take more than the recommended dose of the drug, contact your doctor immediately or go to the nearest hospital. Symptoms of drug overdose include dizziness, drowsiness, fatigue and dry mouth.

Omission of use of Allegra drug
Do not use a double dose to make up for a missed dose.
Take the next dose of the drug at the usual time.

If you have any further doubts about the use of this drug, ask your doctor or pharmacist.

5 How to store the drug Allegra

Store the drug out of sight and reach of children.

Do not use this medication after the expiration date on the cardboard box after "Expiration date (EXP):". Expiration date means the last day of the month stated.

Store at temperatures below 25°C.

Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines you no longer use. This treatment will help protect the environment.

4 Possible side effects

Like any drug, this medication may cause side effects, although they will not occur in everyone.

See your doctor immediately and stop taking Allegra if you experience swelling of the face, lips, tongue or throat and difficulty breathing. These may be symptoms of a severe allergic reaction.

Common side effects (occurring less frequently than in 1 in 10 but more frequently than in 1 in 100 patients): headache, drowsiness, nausea and dizziness.

Uncommon side effects (less common than 1 in 100 but more common than 1 in 1,000 patients): fatigue/somnolence.

Other side effects (frequency unknown) that may occur are: difficulty falling asleep (insomnia), sleep disturbances, nightmares/sprawling dreams, nervousness, accelerated or irregular heart rate, diarrhea, skin rash, pruritus, hives, severe allergic reactions that may cause swelling of the face, lips, tongue and throat, difficulty breathing, a feeling of tightness in the chest, sudden redness of the skin.

Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the responsible entity or the responsible entity's representative in Poland.
By reporting side effects, more information on the safety of the drug can be gathered.

6 Contents of the package and other information

What the drug Allegra contains
- The active substance of Allegra drug is fexofenadine hydrochloride. Each tablet contains 120 mg of fexofenadine hydrochloride.
- The other ingredients of the drug are:
Composition of the tablet core: croscarmellose sodium, gelatinized corn starch, microcrystalline cellulose, magnesium stearate.
Composition of the shell: hypromellose E-15, hypromellose E-5, povidone K30, titanium dioxide (E 171), colloidal silica anhydrous, macrogol 400, iron oxide red (E 172) and iron oxide yellow (E 172).

What Allegra drug looks like and what the packaging contains
Allegra tablets are peach-colored, capsule-shaped, measuring 6.1 mm x 15.8 mm and labeled "012" on one side and "e" on the other side.

Allegra tablets are packaged in blister packs and in a cardboard box.
The package contains 10 film-coated tablets.

Responsible party and manufacturer

Responsible party
Opella Healthcare Poland Sp. z o.o.
Bonifraterska street 17
00-203 Warsaw

Manufacturer
Sanofi Winthrop Industrie
30-36 avenue Gustave Eiffel
37100 Tours
France
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France

For more detailed information, contact the representative of the responsible party:
Opella Healthcare Poland Sp. z o.o.
17 Bonifraterska St.
00-203 Warsaw
Tel: +48 22 280 00 00

Date of the last leaflet update: April 2022

2 Important information before using Allegra

When not to use Allegra:
- if you are allergic to fexofenadine hydrochloride or any of the other ingredients of this drug (listed in section 6).

Warnings and precautions
Discuss with your doctor or pharmacist before taking Allegra.

When to take special care with Allegra drug:
- if the patient has renal or hepatic impairment,
- if the patient currently has or has had a history of cardiovascular disease, as this drug may cause accelerated or irregular heart rate,
- if the patient is elderly.

If any of the above apply to you, or if you have any doubts, you should consult your doctor or pharmacist before taking Allegra.

Allegra drug and other drugs
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as medications you plan to take.
Taking antacids, containing aluminum and magnesium may affect the effect of Allegra by reducing the amount of drug absorbed.
Therefore, it is recommended to maintain an interval of about 2 hours between taking the above-mentioned antacids and taking Allegra.

Allegra drug with food and drink
Allegra tablets should be taken before a meal, sipped with water.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a baby, you should consult your doctor or pharmacist before taking this drug.
Allegra drug should not be used during pregnancy unless absolutely necessary.
Allegra is not recommended for use during breastfeeding.

Driving and operating machinery
Allegra is unlikely to affect the ability to drive or operate machinery. This means that patients can drive and perform tasks that require concentration. However, before driving or operating mechanical devices, make sure that the drug does not cause drowsiness or dizziness. If such symptoms occur, do not drive or operate machinery.

Allegra contains sodium
The drug contains less than 1 mmol (23 mg) of sodium per tablet, that is, the drug is considered "sodium free."

Package insert: information for users
Allegra, 120 mg, film-coated tablets
Fexofenadini hydrochloridum