Allegra

Package Leaflet: Information for the User

Allegra, 120 mg, Film-Coated Tablets

Fexofenadine Hydrochloride
((responsible entity logo))

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Directed by a Doctor or Pharmacist.

• This Package Leaflet Should be Kept in Case it Needs to be Read Again.
• If Advice or Additional Information is Needed, a Pharmacist Should be Consulted.
• If the Patient Experiences any Undesirable Effects, Including any Possible Undesirable Effects not Listed in the Package Leaflet, the Doctor or Pharmacist Should be Informed. See Section 4.
• If There is no Improvement or the Patient Feels Worse After 5 Days, a Doctor Should be Consulted.

Package Leaflet Contents

• 1. What Allegra is and What it is Used for
• 2. Important Information Before Taking Allegra
• 3. How to Take Allegra
• 4. Possible Side Effects
• 5. How to Store Allegra
• 6. Package Contents and Other Information

1. What Allegra is and What it is Used for

Allegra Contains Fexofenadine Hydrochloride, which is an Antihistamine.
Allegra is Used in Adults and Adolescents Aged 12 Years and Older for the Relief of Symptoms of Allergic Rhinitis (e.g., Hay Fever), such as: Sneezing, Nasal Itching, Runny Nose or Nasal Congestion, and Itching, Redness, and Tearfulness of the Eyes.

2. Important Information Before Taking Allegra

When Not to Take Allegra:

• If the Patient is Allergic to Fexofenadine Hydrochloride or any of the Other Ingredients of this Medication (Listed in Section 6).

Warnings and Precautions

Before Taking Allegra, the Doctor or Pharmacist Should be Consulted.
When Special Caution is Required When Taking Allegra:

• If the Patient has Kidney or Liver Impairment,
• If the Patient Currently has or has had Cardiovascular Disease in the Past, as this Medication may Cause Rapid or Irregular Heartbeat,
• If the Patient is Elderly.

If any of these Cases Apply to the Patient or if the Patient has any Doubts, Before Taking Allegra, the Doctor or Pharmacist Should be Consulted.

Allegra and Other Medications

The Doctor or Pharmacist Should be Informed of all Medications the Patient is Currently Taking or has Recently Taken, as well as any Medications the Patient Plans to Take.
If the Patient is Taking Apalutamide (a Medication Used to Treat Prostate Cancer), the Effectiveness of Fexofenadine may be Reduced.
Taking Antacids Containing Aluminum and Magnesium may Affect the Action of Allegra by Reducing the Amount of Medication Absorbed.
Therefore, it is Recommended to Maintain an Interval of Approximately 2 Hours Between Taking these Antacids and Taking Allegra.

Allegra with Food and Drink

Allegra Tablets Should be Taken Before a Meal, with a Glass of Water.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant, or Plans to have a Child, the Doctor or Pharmacist Should be Consulted Before Taking this Medication.
Allegra Should not be Taken During Pregnancy, unless it is Absolutely Necessary.
It is not Recommended to Take Allegra During Breastfeeding.

Driving and Operating Machinery

It is Unlikely that Allegra will Affect the Ability to Drive or Operate Machinery.
This Means that Patients can Drive Vehicles and Perform Tasks that Require Concentration.
However, Before Driving or Operating Machinery, it Should be Ensured that the Medication does not Cause Drowsiness or Dizziness.
If such Symptoms Occur, the Patient Should not Drive or Operate Machinery.

Allegra Contains Sodium

The Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, which Means the Medication is Considered "Sodium-Free".

3. How to Take Allegra

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Directed by a Doctor or Pharmacist.
In Case of Doubt, the Doctor or Pharmacist Should be Consulted.
The Following Instructions Apply if the Doctor has not Recommended a Different Method of Taking Allegra.
For Adults and Adolescents Aged 12 Years and Older
The Recommended Dose is 1 Tablet (120 mg) Once a Day.
Tablets Should be Taken Orally, Before a Meal, with a Glass of Water.
If Symptoms do not Improve After 5 Days of Taking the Medication, a Doctor Should be Consulted.

Taking a Higher Dose of Allegra than Recommended

In Case of an Overdose, a Doctor or the Nearest Hospital Should be Consulted Immediately.
Symptoms of Overdose Include: Dizziness, Drowsiness, Fatigue, and Dry Mouth.

Missing a Dose of Allegra

A Double Dose Should not be Taken to Make up for a Missed Dose.
The Next Dose Should be Taken at the Usual Time.
In Case of Further Doubts About Taking this Medication, the Doctor or Pharmacist Should be Consulted.

4. Possible Side Effects

Like all Medications, Allegra can Cause Side Effects, although not Everybody gets them.
A Doctor Should be Consulted Immediately and the Use of Allegra Stopped if the Patient Experiences Swelling of the Face, Lips, Tongue, or Throat, and Difficulty Breathing.
These may be Symptoms of a Severe Allergic Reaction.
Common Side Effects (Occurring in Less than 1 in 10 but more than 1 in 100 Patients): Headache, Drowsiness, Nausea, and Dizziness.
Uncommon Side Effects (Occurring in Less than 1 in 100 but more than 1 in 1000 Patients): Fatigue/Drowsiness.
Other Side Effects (Frequency not Known - Frequency cannot be Estimated from Available Data) that may Occur Include: Difficulty Sleeping (Insomnia), Sleep Disturbances, Vivid Dreams/Nightmares, Nervousness, Blurred Vision, Rapid or Irregular Heartbeat, Diarrhea, Skin Rash, Itching, Urticaria, Severe Allergic Reactions which may Cause Swelling of the Face, Lips, Tongue, and Throat, Difficulty Breathing, Feeling of Tightness in the Chest, Sudden Redness of the Skin.

Reporting Side Effects

If any Side Effects Occur, Including any Side Effects not Listed in the Package Leaflet, the Doctor, Pharmacist, or Nurse Should be Informed.
Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side Effects can also be Reported to the Marketing Authorization Holder or its Representative in Poland.
Reporting Side Effects will Help to Gather more Information on the Safety of this Medication.

5. How to Store Allegra

The Medication Should be Stored out of Sight and Reach of Children.
This Medication Should not be Taken After the Expiration Date Stated on the Carton after "Expiration Date (EXP):".
The Expiration Date Refers to the Last Day of the Specified Month.
Store in a Temperature Below 25°C.
Medications Should not be Disposed of via Wastewater or Household Waste.
A Pharmacist Should be Asked how to Dispose of Medications that are no Longer Needed.
This will Help Protect the Environment.

6. Package Contents and Other Information

What Allegra Contains

• The Active Substance of Allegra is Fexofenadine Hydrochloride.
  Each Tablet Contains 120 mg of Fexofenadine Hydrochloride.
• The Other Ingredients of the Medication are: Core Tablet Ingredients:Sodium Carboxymethylcellulose, Maize Starch, Microcrystalline Cellulose, Magnesium Stearate.Coating Ingredients:Hypromellose E-15, Hypromellose E-5, Povidone K30, Titanium Dioxide (E 171), Colloidal Anhydrous Silica, Macrogol 400, Red Iron Oxide (E 172), and Yellow Iron Oxide (E 172).

What Allegra Looks Like and What the Package Contains

Allegra Tablets are Peach-Colored, Capsule-Shaped, 6.1 mm x 15.8 mm in Size, and are Marked "012" on one Side and "e" on the Other Side.
Allegra Tablets are Packaged in Blisters and a Carton.
The Package Contains 10, 15, or 20 Film-Coated Tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Manufacturer
Sanofi Winthrop Industrie
30-36 avenue Gustave Eiffel
37100 Tours
France
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France
To Obtain more Detailed Information, the Representative of the Marketing Authorization Holder Should be Contacted:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Phone: +48 22 280 00 00
Date of Last Update of the Package Leaflet:May 2025