Fexofenadini Hidrohloridum Polpharma

Package Leaflet: Information for the Patient

Fexofenadini Hydrochloridum Polpharma, 180 mg, Film-Coated Tablets

Fexofenadini hydrochloridum

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

• 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Fexofenadini Hydrochloridum Polpharma and what is it used for
• 2. Important information before taking Fexofenadini Hydrochloridum Polpharma
• 3. How to take Fexofenadini Hydrochloridum Polpharma
• 4. Possible side effects
• 5. How to store Fexofenadini Hydrochloridum Polpharma
• 6. Contents of the pack and other information

1. What is Fexofenadini Hydrochloridum Polpharma and what is it used for

Fexofenadini Hydrochloridum Polpharma contains fexofenadine hydrochloride, which is an antihistamine.
The medicine is used in adults and children over 12 years of age to treat symptoms of
chronic skin allergic reactions (chronic idiopathic urticaria) such as itching, swelling, and rash.

2. Important information before taking Fexofenadini Hydrochloridum Polpharma

When not to take Fexofenadini Hydrochloridum Polpharma

Warnings and precautions

Before taking Fexofenadini Hydrochloridum Polpharma, discuss it with your doctor or pharmacist:

Children and adolescents

Do not give this medicine to children under 12 years of age.

Fexofenadini Hydrochloridum Polpharma and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, including those obtained without a prescription.
Taking antacids containing aluminum and magnesium may affect the action of Fexofenadini Hydrochloridum Polpharma by reducing the amount of medicine absorbed.
Therefore, it is recommended to leave a 2-hour interval between taking these antacids and taking Fexofenadini Hydrochloridum Polpharma.

Taking Fexofenadini Hydrochloridum Polpharma with food and drink

Take the tablets before a meal, with a glass of water.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, 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 Fexofenadini Hydrochloridum Polpharma during pregnancy, unless it is clearly necessary.
Do not take this medicine while breastfeeding.

Driving and using machines

It is unlikely that Fexofenadini Hydrochloridum Polpharma will affect your ability to drive or use machines.
This means that patients can drive vehicles and perform tasks that require concentration. However, before driving or operating machinery, make sure that the medicine does not cause drowsiness or dizziness. If such symptoms occur, do not drive or operate machinery.

3. How to take Fexofenadini Hydrochloridum Polpharma

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
For adults and children over 12 years of age
The recommended dose is 1 tablet (180 mg) once daily.
Take the tablets by mouth, before a meal, with a glass of water.

Overdose of Fexofenadini Hydrochloridum Polpharma

If you take more than the recommended dose, contact your doctor or go to the nearest hospital immediately. Symptoms of overdose include dizziness, drowsiness, fatigue, and dry mouth.

Missing a dose of Fexofenadini Hydrochloridum Polpharma

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

Stopping treatment with Fexofenadini Hydrochloridum Polpharma

If you plan to stop treatment, tell your doctor first.
If you stop taking Fexofenadini Hydrochloridum Polpharma earlier than recommended, the symptoms of your disease may return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fexofenadini Hydrochloridum Polpharma can cause side effects, although not everybody gets them.
Stop taking Fexofenadini Hydrochloridum Polpharma and tell your doctor immediately 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 people):
headache, drowsiness, dizziness, nausea
Uncommon(may affect up to 1 in 100 people):
fatigue

Other side effects (frequency not known) that may occur include:

difficulty sleeping (insomnia), sleep disorders, nightmares/vivid dreams, nervousness, rapid or irregular heartbeat, diarrhea, skin rash, itching, urticaria, severe allergic reactions that may cause swelling of the face, lips, tongue, and throat, difficulty breathing, feeling of compression in the chest, sudden flushing of the skin.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fexofenadini Hydrochloridum Polpharma

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions 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. This will help protect the environment.

6. Contents of the pack and other information

What Fexofenadini Hydrochloridum Polpharma contains

• The active substance is fexofenadine hydrochloride. Each film-coated tablet contains 180 mg of fexofenadine hydrochloride, equivalent to 168 mg of fexofenadine.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, corn starch, povidone K 30, magnesium stearate. The coating contains Opadry Yellow 03C52662: hypromellose 6 cP, titanium dioxide (E 171), macrogol 400, macrogol 4000, yellow iron oxide (E 172).

What Fexofenadini Hydrochloridum Polpharma looks like and contents of the pack

The 180 mg tablets are yellow, film-coated, oblong, biconvex tablets, smooth on one side and with a score line in the middle on the other side, 17 mm x 8 mm in size.
The score line on the tablet is only to facilitate breaking and not to divide the tablet into equal doses.
Fexofenadini Hydrochloridum Polpharma is available in packs of 7, 10, 15, 20, 30, 50, 100 film-coated tablets.

Marketing authorization holder and importer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA SA, ul. Pelplińska 19, 83-200 Starogard Gdański

Importer

US Pharmacia Sp. z o.o., ul. Ziębicka 40, 50-507 Wrocław. For more detailed information, please contact: USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warszawa, tel. +48 (22) 543 60 00

Date of last revision of the leaflet: