Fexofenadine hydrochloride polpharma

Patient Information Leaflet

Fexofenadini Hydrochloridum Polpharma, 180 mg, film-coated tablets
Fexofenadini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Fexofenadini Hydrochloridum Polpharma is and what it is used for
2. What you need to know 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 Fexofenadini Hydrochloridum Polpharma is and what it is used for

Fexofenadini Hydrochloridum Polpharma contains fexofenadine hydrochloride, which is an antihistamine medicine.
It is used in adults and children aged 12 years and older 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 use Fexofenadini Hydrochloridum Polpharma

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

Warnings and precautions
Before starting treatment with Fexofenadini Hydrochloridum Polpharma, discuss this with your
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 to the patient or if the patient has any doubts, they should consult a doctor or pharmacist before taking Fexofenadini Hydrochloridum Polpharma.

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

Fexofenadini Hydrochloridum Polpharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines they plan to take.
Administration of antacids containing aluminium and magnesium may affect the action of Fexofenadini Hydrochloridum Polpharma by reducing the amount of the drug absorbed.
Therefore, it is recommended to maintain a 2-hour interval between taking the above-mentioned antacids and administration of Fexofenadini Hydrochloridum Polpharma.

Taking Fexofenadini Hydrochloridum Polpharma with food and drink
Take tablets before meals, 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.
Fexofenadini Hydrochloridum Polpharma should not be used during pregnancy unless absolutely necessary.
Do not use this medicine during breastfeeding.

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

3. How to use Fexofenadini Hydrochloridum Polpharma

This medicine should always be taken exactly as directed by the physician. If in doubt, consult
your doctor or pharmacist.
For adults and children over 12 years of age
The recommended dose is 1 tablet (180 mg) once daily.
The tablets should be taken orally before a meal, with water.
Taking more Fexofenadini Hydrochloridum Polpharma than recommended
If you take more than the recommended dose of this medicine, seek medical advice immediately or
go to the nearest hospital. Symptoms of overdose may 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 missed dose.
Take the next dose at the usual time according to the dosing schedule prescribed by your doctor.
Stopping Fexofenadini Hydrochloridum Polpharma treatment
If the patient plans to discontinue treatment with this medicine, they should inform their doctor beforehand.
If treatment with Fexofenadini Hydrochloridum Polpharma is stopped earlier than recommended, symptoms of the disease may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
You should seek immediate medical advice and stop taking Fexofenadini Hydrochloridum Polpharma 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 adverse reactions (frequency not known) which may occur include:
difficulty sleeping (insomnia), sleep disturbances, nightmares/vivid dreams, nervousness,
increased or irregular heart rate, 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.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Fexofenadini Hydrochloridum Polpharma

Keep the medicine out of 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 stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 coated tablet contains 180 mg of fexofenadine hydrochloride, equivalent to 168 mg of fexofenadine.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, maize starch, povidone K 30, magnesium stearate. The coating contains Opadry Yellow 03C52662: hypromellose 6 cP, titanium dioxide (E 171), polyethylene glycol 400, polyethylene glycol 4000, iron oxide yellow (E 172).

What Fexofenadini Hydrochloridum Polpharma looks like and contents of the pack
The 180 mg tablets are yellow, elongated, biconvex coated tablets, smooth on one side and with a central dividing line on the other side, measuring 17 mm x 8 mm.
The dividing line on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure equal dose division.
Fexofenadini Hydrochloridum Polpharma is available in packs containing 7, 10, 15, 20, 30, 50, 100 coated tablets.

Marketing Authorisation Holder and Importer
Marketing Authorisation 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 further information, please contact:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warszawa, tel. +48 (22) 543 60 00