Allertec fexo

Patient Information Leaflet

ALLERTEC FEXO, 120 mg, film-coated tablets
Fexofenadini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4. If there is no improvement or if you feel worse after 5 days, you should contact your doctor.

Leaflet Contents:

1. What Allertec Fexo is and what it is 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. Contents of the pack and other information

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

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

2. Important information before using Allertec Fexo

When not to use 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 starting treatment with Allertec Fexo, consult a doctor or pharmacist:

• if the patient has kidney or liver function disorders,
• if the patient currently has or has previously had a cardiovascular disease, as this medicine may cause rapid or irregular heartbeat,
• if the patient is elderly. If any of the above situations apply or if the patient has any doubts, medical advice should be sought from a doctor or pharmacist before using Allertec Fexo.

Children and adolescents
Do not use this medicine in children under 12 years of age.

Allertec Fexo and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, 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.
Medicines that neutralize gastric acid and contain aluminium and magnesium may affect the action of Allertec Fexo by reducing the amount of the drug absorbed.
Therefore, it is recommended to maintain an interval of approximately 2 hours between taking the above-mentioned acid-neutralizing medicines and administration of Allertec Fexo.

Allertec Fexo with food and drink
Take tablets before a meal, with water.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Allertec Fexo should not be used during pregnancy unless absolutely necessary.
Do not use Allertec Fexo during breastfeeding.
Fertility
There is no data available on the effect of the medicine on fertility in men and women.

Driving and operating machinery
It is unlikely that Allertec Fexo will affect the ability to drive or operate machinery. This means that patients may drive vehicles and perform tasks requiring concentration. However, before driving or operating machinery, patients should ensure that the medicine does not cause drowsiness or dizziness. If such symptoms occur, driving or operating machinery should be avoided.

Allertec Fexo contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Allertec Fexo

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and children aged 12 years and older
The recommended dose is 1 tablet (120 mg) once daily.
The tablets should be taken orally, before a meal, with water.
Do not use this medicine for longer than 5 days without consulting a doctor.
Taking more medicine than recommended
If more medicine has been taken than recommended, seek immediate medical advice from a doctor or go to the nearest hospital. Symptoms of overdose may include dizziness, drowsiness, fatigue, and dry mouth.
Missed dose of Allertec Fexo
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time.
If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately contact a doctor and stop taking Allertec Fexo if you 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 patients):
headache, drowsiness, dizziness, nausea.
Uncommon (may affect up to 1 in 100 patients):
fatigue.
Other possible adverse reactions:
Frequency not known (cannot be estimated from the available data):
difficulty sleeping (insomnia), sleep disturbances, nightmares/vivid dreams, nervousness,
rapid or irregular heartbeat, diarrhoea, 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, blurred vision.
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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store ALLERTEC Fexo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the specified month.
No special storage instructions apply 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. Such measures help protect the environment.

6. Contents of the packaging and other information

What Allertec Fexo contains

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

What Allertec Fexo looks like and contents of the pack
The 120 mg tablets are elongated, biconvex, peach-coloured coated tablets, smooth on both sides, with dimensions of 15 mm x 6.6 mm.
Allertec Fexo is available in packs containing 7, 10 or 20 coated tablets.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Importer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
FARMAPROJECTS S.A.U.
Parc Cientific de Barcelona
C/Baldiri Reixac, 4/12 i 15
08028 Barcelona
Spain