Package leaflet: Information for the user

Fexahist, 180 mg, film-coated tablets
Fexofenadini hydrochloridum
Please read the entire leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary. If you have any doubts, consult your doctor or pharmacist. This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same. If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Fexahist is and what it is used for
What you need to know before taking Fexahist
How to take Fexahist
Possible side effects
How to store Fexahist
Contents of the pack and other information

1. What Fexahist is and what it is used for

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

2. Important information before using Fexahist

When not to use Fexahist

if the patient is allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Fexahist, consult your doctor or pharmacist if:

the patient has liver or kidney function disorders
the patient has or has had heart disease in the past, as this type of medicine may cause rapid or irregular heartbeat
the patient is elderly.

If any of the above situations apply to the patient or if the patient has any doubts, they should
inform their doctor before starting treatment with Fexahist.
Children and adolescents
Fexahist is not recommended for children under 12 years of age.
For children aged 6 to 11 years: fexofenadine hydrochloride in 30 mg tablets is the appropriate
formulation and dosage for this patient group.
Fexahist and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is 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 the patient is 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.
Indigestion medicines containing aluminium and magnesium may affect the action of Fexahist by reducing the amount of medicine absorbed.
It is recommended to leave approximately a 2-hour interval between taking Fexahist and taking an indigestion medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Fexahist should not be used if the patient is pregnant unless advised by a doctor.
Fexahist is not recommended during breastfeeding.
Driving and operating machinery
It is unlikely that Fexahist will affect the ability to drive or operate machinery. However, before driving or operating machinery, ensure that this medicine does not cause drowsiness or dizziness.
Fexahist contains lactose:
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.
Fexahist contains sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Fexahist

Dosage
This medicine should always be used as directed by a physician. If in doubt, consult a
doctor or pharmacist.
Adults and adolescents aged 12 years and older
The recommended dose is 1 tablet (180 mg) per day.
The tablet should be taken before a meal, with water.
This medicine starts relieving symptoms within 1 hour, and the effect lasts for 24 hours.
Taking more Fexahist than recommended
If too many tablets are taken, contact a doctor or pharmacist or the nearest hospital emergency department immediately. Symptoms of overdose in adults may include dizziness, drowsiness, fatigue, and dry mouth.
Missing a dose of Fexahist
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time, as recommended.
Stopping Fexahist
If treatment with Fexahist is stopped, symptoms may return.
If there are any further doubts regarding the use of this medicine, consult a
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should immediately contact a doctor and stop taking Fexahist if any of the following occur:

swelling of the face, lips, tongue or throat, and breathing difficulties – these may be symptoms of a severe allergic reaction.

The following adverse reactions have been reported in clinical trials, with frequencies similar to those observed in patients who did not receive the active drug (placebo).
Common adverse reactions (may occur in up to 1 in 10 people):

headache
drowsiness
nausea
dizziness

Uncommon adverse reactions (may occur in up to 1 in 100 people):

fatigue
somnolence

Other adverse reactions (frequency unknown: cannot be estimated from available data) which may occur include:

difficulty sleeping (insomnia)
sleep disturbances
nightmares
nervousness
blurred vision
rapid or irregular heartbeat
diarrhoea
skin rash and itching
urticaria
severe allergic reactions which may include swelling of the face, lips, tongue or throat, sudden redness of the skin, chest tightness and breathing difficulties.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Fexahist

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, or bottle after:
EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Fexahist contains
The active substance is fexofenadine hydrochloride.
Each coated tablet contains 180 mg of fexofenadine hydrochloride, equivalent to 168 mg of
fexofenadine.
The other ingredients are:
Tablet core: sodium croscarmellose, lactose, monohydrate lactose, maize starch,
anhydrous colloidal silica, pregelatinized starch, stearic acid.
Tablet coating: iron oxide red (E 172), iron oxide yellow (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
Coated tablet
Peach-coloured, capsule-shaped, biconvex coated tablets with bevelled edges, embossed with the code "FE" on one side and "180" on the other.
Fexahist 180 mg, coated tablets, is available in blisters and HDPE bottles, packed in a cardboard box.
Pack sizes:
Blister: 7, 15, 20, 30, 50, 60 and 100 coated tablets
HDPE bottle: 500 coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa Street 13D, unit 27
01-909 Warsaw
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 European Economic Area under the following names:
France: Fexofenadine Arrow 180 mg comprimé pelliculé
Germany: Fexofenadin PUREN 180 mg Filmtabletten
Netherlands: Fexofenadine HCl Aurobindo 180 mg, filmomhulde tabletten
Poland: Fexahist
Portugal: Fexofenadina Generis