Fexahist Allergi

Package Leaflet: Information for the User

Fexahist Allergy, 120 mg, Film-Coated Tablets

Fexofenadine Hydrochloride

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

• This Medication Should Always be Used Exactly as Described in this Package Leaflet for the Patient or as Advised by a Doctor or Pharmacist. Keep this Package Leaflet, You May Need to Read it Again. If You Need Advice or Further Information, Consult a Pharmacist. If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4. If There is no Improvement or You Feel Worse After 7 Days, Consult a Doctor.

Table of Contents of the Package Leaflet:

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

1. What is Fexahist Allergy and What is it Used for

Fexahist Allergy Contains Fexofenadine Hydrochloride, Which is an Antihistamine.
Fexahist Allergy 120 mg is Used in Adults and Adolescents 12 Years of Age and Older to Relieve the Symptoms of Allergic Rhinitis (e.g., Hay Fever), Such as Sneezing, Nasal Itching, Runny or Stuffy Nose, and Itchy, Red, or Teary Eyes.
If There is no Improvement or You Feel Worse After 7 Days, Consult a Doctor.

2. Important Information Before Taking Fexahist Allergy

When Not to Take Fexahist Allergy

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

Warnings and Precautions

Before Taking Fexahist Allergy, Discuss with Your Doctor or Pharmacist if You Have:

• Liver or Kidney Problems
• Heart Disease, as this Type of Medication may Cause Fast or Irregular Heartbeat
• If You are an Elderly Patient.

If any of these Conditions Apply to You or if You are in Doubt, Inform Your Doctor Before Taking Fexahist Allergy.

Children and Adolescents

Fexahist Allergy is not Recommended for Children Under 12 Years of Age.
For Children Aged 6 to 11 Years: Fexofenadine Hydrochloride 30 mg Tablets are the Appropriate Form for this Age Group.

Fexahist Allergy and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Have Recently Taken, as well as any Medications You Plan to Take.
If You are Taking Apalutamide (a Medication Used to Treat Prostate Cancer), the Effect of Fexofenadine may be Reduced.
It is Especially Important to Consult Your Doctor Before Taking Fexofenadine if You are Also Taking any of the Following Medications:

• An Antibiotic Used to Treat Certain Bacterial Infections (Erythromycin)
• An Antifungal Medication Used to Treat Fungal Infections (Ketoconazole).

These Medications Increase the Amount of Fexofenadine Absorbed.
Antacids Containing Aluminum and Magnesium may Affect the Action of Fexahist Allergy, Reducing the Amount of Medication Absorbed.
A 2-Hour Interval is Recommended Between Taking Fexahist Allergy and an Antacid.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You may be Pregnant or are Planning to Have a Baby, Consult Your Doctor or Pharmacist Before Taking this Medication.
Do not Take Fexahist Allergy if You are Pregnant, Unless Your Doctor Recommends it.
Fexahist Allergy is not Recommended During Breastfeeding.

Driving and Using Machines

It is Unlikely that Fexahist Allergy will Affect Your Ability to Drive or Use Machines. However, Before Driving or Using Machines, Make Sure that this Medication does not Cause Drowsiness or Dizziness.

Fexahist Allergy Contains Lactose:

If You have been Diagnosed with an Intolerance to Some Sugars, Consult Your Doctor Before Taking this Medication.

Fexahist Allergy Contains Sodium:

This Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, Which Means it is Essentially Sodium-Free.

3. How to Take Fexahist Allergy

Dosage

Always Take this Medication Exactly as Described in this Package Leaflet for the Patient or as Advised by a Doctor or Pharmacist. If in Doubt, Consult a Doctor or Pharmacist.

Adults and Adolescents 12 Years of Age and Older

The Recommended Dose is 1 Tablet (120 mg) per Day.
Take the Tablet Before a Meal, with a Glass of Water.
This Medication Starts to Relieve Symptoms Within 1 Hour and its Effect Lasts for 24 Hours.

Taking More than the Recommended Dose of Fexahist Allergy

If You Have Taken Too Many Tablets, Contact a Doctor or Pharmacist or the Nearest Hospital Emergency Department Immediately. Symptoms of Overdose in Adults Include: Dizziness, Drowsiness, Fatigue, and Dry Mouth.

Missing a Dose of Fexahist Allergy

Do not Take a Double Dose to Make Up for a Missed Dose.
Take the Next Dose at the Usual Time, as Advised.

Stopping Fexahist Allergy

If You Stop Taking Fexahist Allergy, Symptoms may Return.
If You Have any Further Questions on the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Fexahist Allergy can Cause Side Effects, Although not Everybody Gets them.

Stop Taking Fexahist Allergy and Consult a Doctor Immediately if You Experience:

• Swelling of the Face, Lips, Tongue, or Throat, and Difficulty Breathing, Which may be Symptoms of a Severe Allergic Reaction.

In Clinical Trials, the Following Side Effects were Reported, with a Frequency Similar to that Observed in Patients who did not Receive the Medication (Placebo).
Common Side Effects(may Affect up to 1 in 10 People):

• Headache
• Drowsiness
• Nausea
• Dizziness

Uncommon Side Effects(may Affect up to 1 in 100 People):

• Fatigue
• Somnolence

Other Side Effects(Frequency not Known: Cannot be Estimated from the Available Data), Which may Include:

• Difficulty Sleeping (Insomnia)
• Sleep Disorders
• Nightmares
• Nervousness
• Blurred Vision
• Fast or Irregular Heartbeat
• Diarrhea
• Skin Rash and Itching
• Hives
• Severe Allergic Reactions, Which may Include Swelling of the Face, Lips, Tongue, or Throat, Sudden Redness of the Skin, Chest Tightness, and Difficulty Breathing.

Reporting Side Effects

If You Experience any Side Effects, Including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department for the Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Tel.: +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.
By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medication.

5. How to Store Fexahist Allergy

Keep this Medication out of the Sight and Reach of Children.
Do not Use this Medication After the Expiry Date Stated on the Carton and Blister After: EXP.
The Expiry Date Refers to the Last Day of the Month Stated.
No Special Precautions for Storage are Required.
Medications should not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications no Longer Required. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Fexahist Allergy Contains

The Active Substance is Fexofenadine Hydrochloride.
Each Film-Coated Tablet Contains 120 mg of Fexofenadine Hydrochloride, Which Corresponds to 112 mg of Fexofenadine.
The Other Ingredients are:
Tablet Core: Sodium Carboxymethylcellulose, Lactose, Lactose Monohydrate, Corn Starch, Silicon Dioxide, Povidone, Stearic Acid.
Tablet Coating: Red Iron Oxide (E 172), Yellow Iron Oxide (E 172), Hypromellose Type 2910 6 mPas (E 464), Macrogol 400 (E 1521), Titanium Dioxide (E 171).

What Fexahist Allergy Looks Like and Contents of the Package

Film-Coated Tablet
Peach-Colored, Capsule-Shaped, with a Score Line, Biconvex, with the Engraving "FE" on one Side and "120" on the Other Side.
Fexahist Allergy, 120 mg, Film-Coated Tablets are Available in Blisters of 7, 10, 15, and 20 Film-Coated Tablets, in a Cardboard Box.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: medicalinformation@aurovitas.pl

Manufacturer/Importer:

APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Generiques
26 Avenue Tony Garnier
69007 Lyon
France

This Medication is Authorized for Marketing in the Member States of the European Economic Area Under the Following Names:

France:
Fexofenadine Arrow 120 mg Film-Coated Tablet
Germany:
Fexofenadine PUREN 120 mg Film-Coated Tablets
Netherlands:
Fexofenadine HCl Aurobindo 120 mg, Film-Coated Tablets
Poland:
Fexahist Allergy
Portugal:
Fexofenadina Generis
Spain:
Riniwel 120 mg Film-Coated Tablets EFG

Date of the Last Revision of the Package Leaflet: 07/2025