Fexahist

Package Leaflet: Information for the User

Fexahist, 180 mg, Film-Coated Tablets

Fexofenadine Hydrochloride

Read All of This Leaflet Carefully Before Taking This Medicine.

• You should keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack:

• 1. What is Fexahist and What is it Used For
• 2. Before You Take Fexahist
• 3. How to Take Fexahist
• 4. Possible Side Effects
• 5. How to Store Fexahist
• 6. Contents of the Pack and Other Information

1. What is Fexahist and What is it Used For

Fexahist contains fexofenadine hydrochloride, which is an antihistamine.
Fexahist 180 mg is used in adults and adolescents aged 12 years and older to relieve the symptoms of long-standing allergic skin reactions (chronic idiopathic urticaria), such as itching, swelling, and rash.

2. Before You Take Fexahist

Do Not Take Fexahist

• if you are allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Before taking Fexahist, tell your doctor or pharmacist if:

• you have liver or kidney problems
• you have or have had heart problems, as this type of medicine may cause fast or irregular heartbeat
• you are elderly.

If any of these conditions apply to you, or if you are in doubt, tell your doctor before taking Fexahist.

Children and Adolescents

Fexahist 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 formulation for this age group.

Fexahist with Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and those you plan to take.
If you are taking apalutamide (a medicine used to treat prostate cancer), the effect of fexofenadine may be reduced.
It is especially important to talk to your doctor before taking fexofenadine if you are also taking any of the following medicines:

• an antibiotic used to treat certain bacterial infections (erythromycin)
• an antifungal medicine used to treat fungal infections (ketoconazole).

These medicines increase the amount of fexofenadine absorbed.
Antacids containing aluminum or magnesium may affect the action of Fexahist by reducing the amount of medicine absorbed.
A 2-hour interval between taking Fexahist and an antacid is recommended.

Pregnancy and Breast-Feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Fexahist if you are pregnant, unless your doctor advises you to do so.
Fexahist is not recommended during breast-feeding.

Driving and Using Machines

Fexahist is unlikely to affect your ability to drive or use machines. However, before driving or using machines, make sure that you are not affected by this medicine, as it may cause drowsiness or dizziness.

Fexahist Contains Lactose:

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Fexahist Contains Sodium:

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially 'sodium-free'.

3. How to Take Fexahist

Dosage

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Adults and Adolescents (12 Years and Older)

The recommended dose is one tablet (180 mg) daily.
Take the tablet before a meal, with water.
This medicine starts to relieve symptoms within 1 hour and its effect lasts for 24 hours.

If You Take More Fexahist Than You Should

If you have taken too many tablets, contact your doctor or pharmacist immediately or go to the nearest hospital casualty department. Symptoms of an overdose in adults include dizziness, drowsiness, fatigue, and dry mouth.

If You Forget to Take Fexahist

Do not take a double dose to make up for a forgotten dose.
Take the next dose at the usual time, as prescribed.

If You Stop Taking Fexahist

If you stop taking Fexahist, your symptoms may come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Fexahist can cause side effects, although not everybody gets them.

Stop Taking Fexahist and Seek Immediate Medical Attention If You Experience:

• swelling of the face, lips, tongue, or throat and difficulty breathing, which may be signs of a severe allergic reaction.

In clinical studies, the following side effects were reported; their frequency was similar to that seen in patients who did not take the medicine (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
• lethargy

Other Side Effects(frequency not known: cannot be estimated from the available data), which may include:

• insomnia
• sleep disorders
• nightmares
• nervousness
• blurred vision
• rapid or irregular heartbeat
• diarrhea
• skin rash and itching
• urticaria
• severe allergic reactions, which may include swelling of the face, lips, tongue, or throat, sudden redness of the skin, tightness in the chest, and difficulty breathing.

Reporting of Side Effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the 'Yellow Card Scheme' (www.mhra.gov.uk/yellowcard). By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Fexahist

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 carton and blister or bottle after EXP. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Fexahist Contains

The active substance is fexofenadine hydrochloride.
Each film-coated tablet contains 180 mg of fexofenadine hydrochloride, which corresponds to 168 mg of fexofenadine.
The other ingredients are:
Core:croscarmellose sodium, lactose, lactose monohydrate, maize starch, colloidal anhydrous silica, pregelatinised starch, stearic acid.
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 Looks Like and Contents of the Pack

Film-coated tablet
Peach-colored, capsule-shaped, biconvex, film-coated tablets with a score line on both sides, engraved with "FE" on one side and "180" on the other side.
Fexahist 180 mg film-coated tablets are available in blisters and HDPE bottles, in a cardboard box.

Pack Sizes:

Blisters:7, 15, 20, 30, 50, 60, and 100 film-coated tablets
HDPE Bottle:500 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
e-mail: [email protected]

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 Medicinal Product is Authorised in the Member States of the European Economic Area Under the Following Names:

France:
Fexofenadine Arrow 180 mg film-coated tablet
Germany:
Fexofenadine PUREN 180 mg film-coated tablets
Netherlands:
Fexofenadine HCl Aurobindo 180 mg, film-coated tablets
Poland:
Fexahist
Portugal:
Fexofenadine Generis

Date of Last Revision of the Leaflet: 11/2024