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

Fexofenadine Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. 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 those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Fexofast 120 mg and Fexofast 180 mg and what is it 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 is Fexofast 120 mg and Fexofast 180 mg and what is it used for

The active substance of the medication, fexofenadine hydrochloride, belongs to the group of antihistamine medications.
Fexofast 120 mg, film-coated tablets are indicated for use in adults and adolescents aged 12 years and older, for the relief of symptoms such as: sneezing, nasal itching, runny or stuffy nose, and itchy, watery or red eyes, which are typically associated with hay fever (seasonal allergic rhinitis).
Fexofast 180 mg, film-coated tablets are indicated for use in adults and adolescents aged 12 years and older, for the relief of symptoms such as: redness, swelling, itching, which occur in association with an allergic skin condition, known as 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 medication (listed in section 6).

Warnings and precautions

Before taking Fexofast 120 mg or Fexofast 180 mg, discuss it with your doctor or pharmacist.
Particular caution is advised:

• if you are elderly,
• if you have kidney or liver problems,
• if you have or have had heart problems, as these medications may cause rapid or irregular heartbeat.

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

Fexofast 120 mg or Fexofast 180 mg and other medications

Tell your doctor or pharmacist about all medications you are taking, or have recently taken, and about any medications you plan to take.
If you are taking medications for stomach problems containing aluminum or magnesium, it is recommended to leave a 2-hour interval between taking this medication and taking Fexofast 120 mg or Fexofast 180 mg. Stomach medications may reduce the amount of Fexofast 120 mg or Fexofast 180 mg absorbed, and thus affect its action.
If you take fexofenadine with erythromycin or ketoconazole, or with a single dose of lopinavir in combination with ritonavir, the concentration of fexofenadine in the blood may increase. It is possible that this may increase the 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 medication.
Pregnancy
Fexofast 120 mg and Fexofast 180 mg can be used during pregnancy only if your doctor considers it absolutely necessary.
Breastfeeding
It is not recommended to take Fexofast 120 mg and Fexofast 180 mg if you 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 using machines, make sure that the medication does not cause drowsiness or dizziness.
The medication contains less than 1 mmol (23 mg) of sodium per film-coated tablet of Fexofast 120 mg or Fexofast 180 mg, which means that it is essentially 'sodium-free'.

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

Always take this medication exactly as your doctor has told you. If you are in doubt, consult your doctor or pharmacist.
Recommended dose
For adults and children aged 12 years and older
Fexofast 120 mg, film-coated tablets
The usual dose is one tablet (120 mg) once daily.
Fexofast 180 mg, film-coated tablets
The usual dose is one tablet (180 mg) once daily.
Method of administration
Tablets should be taken before a meal, with water.

Overdose of Fexofast 120 mg or Fexofast 180 mg

If you take more than the recommended dose of Fexofast 120 mg or Fexofast 180 mg, contact your doctor or go to the emergency room immediately.
Symptoms of overdose in adults include: dizziness, drowsiness, fatigue, and dry mouth.

Missed 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 stop taking Fexofast 120 mg or Fexofast 180 mg. If you stop treatment too quickly, your symptoms may return.
In case of any further doubts about the use of this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Fexofast 120 mg or Fexofast 180 mg can cause side effects, although not everybody gets them.
If you experience symptoms of a severe allergic reaction (swelling of the face, lips, tongue, or throat, and difficulty breathing), stop taking the medication and seek medical attention immediately.
The frequency of possible side effects listed below is defined as follows:

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

Common:

headaches, drowsiness, nausea, dizziness.

Uncommon:

feeling of fatigue/drowsiness.

Unknown:

difficulty sleeping (insomnia), sleep disorders, nightmares/vivid dreams, nervousness, irregular or rapid heartbeat, diarrhea, skin rash and itching, urticaria, severe allergic reactions (with symptoms such as: swelling of the face, lips, tongue, or throat, sudden redness of the skin, chest tightness, and difficulty breathing).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported 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, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

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

Keep the medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This 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, which corresponds to 112 mg of fexofenadine.
• The other ingredients are: tablet core: microcrystalline cellulose, sodium croscarmellose, corn starch, povidone, magnesium stearate; coating (Opadry 03C54667 Pink): hypromellose 6 cP (E 464), titanium dioxide (E 171), macrogol 400, macrogol 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, which corresponds to 168 mg of fexofenadine.
• The other ingredients are: tablet core: microcrystalline cellulose, sodium croscarmellose, corn starch, povidone, magnesium stearate; coating (Opadry 03C52662 Yellow): hypromellose 6 cP (E 464), titanium dioxide (E 171), macrogol 400, macrogol 4000, yellow iron oxide (E 172).

What Fexofast 120 mg looks like and contents of the pack

Fexofast 120 mg are peach-colored, oblong, film-coated tablets, smooth on both sides.

What Fexofast 180 mg looks like and contents of the pack

Fexofast 180 mg are yellow, oblong, film-coated tablets, smooth on one side, with a score line in the middle of the other side.
The packaging of Fexofast 120 mg and Fexofast 180 mg may contain 7, 10, 20, 30 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Owlpharma - Consulting Lda.
IPN Incubadora, Rua Pedro Nunes
3030-199 Coimbra
Portugal

Manufacturer

Chanelle Medical Unlimited Company
Loughrea, Co. Galway
Ireland

Date of last revision of the leaflet: