Allertec Fexo

Leaflet attached to the packaging: patient information

ALLERTEC FEXO, 120 mg, film-coated tablets

Fexofenadine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a doctor or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4. If there is no improvement after 5 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Allertec Fexo and what is it used for
• 2. Important information before taking Allertec Fexo
• 3. How to take Allertec Fexo
• 4. Possible side effects
• 5. How to store Allertec Fexo
• 6. Package contents and other information

1. What is Allertec Fexo and what is it used for

Allertec Fexo contains fexofenadine hydrochloride, which is an antihistamine.
The medicine is used in adults and children aged 12 years and older to treat symptoms of hay fever (seasonal allergic rhinitis), such as: sneezing, runny or itchy nose, and itchy, red or watery eyes.

2. Important information before taking Allertec Fexo

When not to take Allertec Fexo

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

Warnings and precautions

Before taking Allertec Fexo, the patient should discuss it with their doctor or pharmacist:

• if the patient has kidney or liver problems,
• if the patient currently has or has had cardiovascular disease, as this medicine may cause fast or irregular heart rhythm,
• if the patient is elderly. If any of these cases apply to the patient or if they have any doubts, they should consult their doctor or pharmacist before taking Allertec Fexo.

Children and adolescents

The medicine should not be taken by children under 12 years of age.

Allertec Fexo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those obtained without a prescription.
If the patient is taking apalutamide (a medicine used to treat prostate cancer), the effect of fexofenadine may be reduced.
Taking antacids that contain aluminum and magnesium may affect the action of Allertec Fexo by reducing the amount of medicine absorbed.
Therefore, it is recommended to maintain an interval of about 2 hours between taking the above-mentioned antacids and taking Allertec Fexo.

Taking Allertec Fexo with food and drink

Tablets should be taken before a meal, with a glass of water.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Allertec Fexo should not be taken during pregnancy unless it is absolutely necessary.
The medicine should not be taken during breastfeeding.
Fertility
There is no data on the effect of the medicine on fertility in men and women.

Driving and using machines

It is unlikely that Allertec Fexo will affect the ability to drive or use machines.
This means that patients can drive and perform tasks that require concentration. However, before driving or using machines, they should make sure that the medicine does not cause drowsiness or dizziness. If such symptoms occur, the patient should not drive or use machines.

Allertec Fexo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Allertec Fexo

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Adults and children 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.

Do not take the medicine for more than 5 days without consulting a doctor.

Taking a higher dose of Allertec Fexo than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or go to the nearest hospital. Symptoms of overdose include: dizziness, drowsiness, fatigue, and dry mouth.

Missing a dose of Allertec Fexo

The patient should not take a double dose to make up for a missed dose.
The next dose should be taken at the usual time.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should immediately consult a doctor and stop taking Allertec Fexo if they experience swelling of the face, lips, tongue, or throat, and difficulty breathing. These may be symptoms of a severe allergic reaction.
Common(may affect up to 1 in 10 people):
headache, drowsiness, dizziness, nausea.
Uncommon(may affect up to 1 in 100 people):
fatigue.

Other side effects that may occur:

Frequency not known(cannot be estimated from the available data)
difficulty sleeping (insomnia), sleep disorders, vivid dreams/nightmares, nervousness, fast or irregular heart rhythm, diarrhea, skin rash, itching, hives, severe allergic reactions that may cause swelling of the face, lips, tongue, and throat, difficulty breathing, feeling of tightness in the chest, sudden flushing of the skin, blurred vision.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Allertec Fexo

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging and blister after the EXP label. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Allertec Fexo contains

• The active substance of the medicine is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride, which corresponds to 112 mg of fexofenadine.
• The other ingredients of the medicine are: microcrystalline cellulose, sodium croscarmellose, corn starch, povidone K 30, magnesium stearate. The Opadry Pink 03C54667 coating contains: hypromellose 6 cP, titanium dioxide (E 171), macrogol 400, macrogol 4000, yellow iron oxide (E 172), red iron oxide (E 172).

What Allertec Fexo looks like and what the package contains

The 120 mg tablets are oblong, biconvex, film-coated, pink, smooth on both sides, 15 mm x 6.6 mm in size.
Allertec Fexo is available in packs of 7, 10, or 20 film-coated tablets.

Marketing authorization holder and importer

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Importer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Farmaprojects S.A.U.
Parc Cientific de Barcelona
C/Baldiri Reixac, 4/12 i 15
08028 Barcelona
Spain

Date of last revision of the leaflet: