Fexofast 120 mg

Package leaflet: Information for the patient

Fexofast 120 mg, 120 mg, film-coated tablets
Fexofast 180 mg, 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. 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 someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Fexofast 120 mg and Fexofast 180 mg are and what they are used for
2. Important information before taking Fexofast 120 mg or Fexofast 180 mg
3. How to take Fexofast 120 mg or Fexofast 180 mg
4. Possible side effects
5. How to store Fexofast 120 mg and Fexofast 180 mg
6. Contents of the pack and other information

1. What Fexofast 120 mg and Fexofast 180 mg are and what they are used for

The active substance in this medicine, fexofenadine hydrochloride, belongs to a group of medicines called antihistamines.

Fexofast 120 mg tablets are indicated for use in adults and adolescents aged 12 years and older to relieve symptoms such as sneezing, itchy nose, runny nose or blocked nose, and itchy, watery and red eyes, which are usually associated with hay fever (seasonal allergic rhinitis).

Fexofast 180 mg tablets are indicated for use in adults and adolescents aged 12 years and older to relieve symptoms such as redness, swelling and itching of the skin associated with a chronic allergic skin condition called chronic idiopathic urticaria.

2. Important information before taking Fexofast 120 mg or Fexofast 180 mg

When not to take Fexofast 120 mg or Fexofast 180 mg

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

Warnings and precautions
Before taking Fexofast 120 mg or Fexofast 180 mg, talk to your doctor or pharmacist.
Exercise particular caution:

• if you are elderly,
• if you have kidney or liver problems,
• if you have heart problems now or have ever had them, because these medicines may cause rapid or irregular heartbeat.

If any of the above apply to you, or if you are unsure, speak to your doctor before taking Fexofast 120 mg or Fexofast 180 mg.

Fexofast 120 mg or Fexofast 180 mg and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking antacids containing aluminium or magnesium, it is recommended to leave an interval of about 2 hours between taking this medicine and taking Fexofast 120 mg or Fexofast 180 mg. Antacids may reduce the amount of Fexofast 120 mg or Fexofast 180 mg absorbed and thus affect its action.
If you take fexofenadine together with erythromycin or ketoconazole, or with a single dose of lopinavir with ritonavir, the plasma concentration of fexofenadine may increase. This may lead to an increased risk of side effects.

Pregnancy and breastfeeding
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.

Pregnancy
Fexofast 120 mg and Fexofast 180 mg should only be used during pregnancy if your doctor considers it absolutely necessary.

Breastfeeding
Fexofast 120 mg and Fexofast 180 mg are not recommended for use in women who are breastfeeding.

Driving and using machines
It is unlikely that Fexofast 120 mg or Fexofast 180 mg will affect your ability to drive or use machines. However, before driving or operating machinery, make sure that the medicine does not cause drowsiness or dizziness.

The medicine contains less than 1 mmol (23 mg) of sodium per Fexofast 120 mg or Fexofast 180 mg film-coated tablet, i.e. it is considered to be "sodium-free".

3. How to use Fexofast 120 mg or Fexofast 180 mg

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
Recommended dose
For adults and children aged 12 years and older
Fexofast 120 mg, tablets
The usual dose is one tablet (120 mg) once daily.
Fexofast 180 mg, tablets
The usual dose is one tablet (180 mg) once daily.
Method of administration
The tablets should be taken before a meal, with water.
Taking more than the recommended dose of Fexofast 120 mg or Fexofast 180 mg
If more than the recommended dose of Fexofast 120 mg or Fexofast 180 mg has been taken, contact
a doctor immediately or go immediately to the emergency room of the nearest hospital.
Symptoms of overdose in adults include: dizziness, drowsiness, fatigue, and dry mouth.
Missing a dose of Fexofast 120 mg or Fexofast 180 mg
Do not take a double dose to make up for a missed dose. Take the next dose as usual.
Stopping treatment with Fexofast 120 mg or Fexofast 180 mg
Consult your doctor if you plan to discontinue treatment with Fexofast 120 mg or Fexofast 180 mg.
If treatment is stopped earlier than recommended by the doctor, symptoms of the disease may return.
If you have any further doubts 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 everyone will experience them.
If symptoms of a severe allergic reaction occur (swelling of the face, lips, tongue or throat, and
difficulty breathing), the medicine must be discontinued immediately and medical advice must be sought without delay.
The frequency of the possible adverse reactions listed below is defined as follows:

• common (occur in 1 to 10 people out of 100);
• uncommon (occur in 1 to 10 people out of 1,000);
• unknown (frequency cannot be estimated from the available data).

Common:
headache, drowsiness, nausea, dizziness.
Uncommon:
feeling of fatigue/somnolence.
Unknown:
difficulty sleeping (insomnia), sleep disturbances, nightmares/vivid dreams, nervousness,
irregular or rapid heartbeat, diarrhoea, skin rash and itching, urticaria, severe
allergic reactions (with symptoms such as: swelling of the face, lips, tongue or throat, sudden
reddening of the skin, chest tightness, and difficulty breathing).

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 of 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fexofast 120 mg and Fexofast 180 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Fexofast 120 mg contains

• The active substance is fexofenadine hydrochloride. Each tablet contains 120 mg of fexofenadine hydrochloride, equivalent to 112 mg of fexofenadine.
• Other ingredients are: tablet core: microcrystalline cellulose, sodium croscarmellose, maize starch, povidone, magnesium stearate; coating (Opadry 03C54667 Pink): hypromellose 6 cP (E 464), titanium dioxide (E 171), polyethylene glycol 400, polyethylene glycol 4000, yellow iron oxide (E 172), red iron oxide (E 172).

What Fexofast 180 mg contains

• The active substance is fexofenadine hydrochloride. Each tablet contains 180 mg of fexofenadine hydrochloride, equivalent to 168 mg of fexofenadine.
• Other ingredients are: tablet core: microcrystalline cellulose, sodium croscarmellose, maize starch, povidone, magnesium stearate; coating (Opadry 03C52662 Yellow): hypromellose 6 cP (E 464), titanium dioxide (E 171), polyethylene glycol 400, polyethylene glycol 4000, yellow iron oxide (E 172).

What Fexofast 120 mg looks like and contents of the pack
Fexofast 120 mg are peach-coloured, elongated, coated tablets, smooth on both sides.

What Fexofast 180 mg looks like and contents of the pack
Fexofast 180 mg are yellow, elongated, coated tablets, smooth on one side and with a central dividing line on the other side.

The pack of Fexofast 120 mg and Fexofast 180 mg may contain 7, 10, 20, or 30 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
PHARMALAB POLAND Sp. z o.o.
ul. Siemianowicka 84
41-902 Bytom
Poland

Manufacturer
Chanelle Medical Unlimited Company
Loughrea, Co. Galway
Ireland