Fexofast 180 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.
• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 medicine, fexofenadine hydrochloride, belongs to a group of antihistamine medicines.
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 itchy 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 medicine (listed in section 6).

Warnings and precautions

Before taking Fexofast 120 mg or Fexofast 180 mg, you should discuss this with your doctor or pharmacist.
Particular care should be taken:

• if you are elderly,
• if you have kidney or liver problems,
• if you have or have had heart problems, as these medicines may cause fast or irregular heartbeats.

If any of the above apply to you, or if you are not sure, consult your doctor before taking Fexofast 120 mg or Fexofast 180 mg.

Fexofast 120 mg or Fexofast 180 mg with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take.
If you are taking medicines for stomach ulcers or heartburn that contain aluminum or magnesium, it is recommended that you leave a 2-hour gap between taking this medicine and taking Fexofast 120 mg or Fexofast 180 mg. Stomach ulcer medicines may reduce the amount of Fexofast 120 mg or Fexofast 180 mg absorbed and affect its action.
If you take fexofenadine with erythromycin or ketoconazole, or with a single dose of lopinavir in combination with ritonavir, the level of fexofenadine in your blood may increase. 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 medicine.
Pregnancy
Fexofast 120 mg and Fexofast 180 mg can be used during pregnancy only if your doctor considers it essential.
Breastfeeding
Fexofast 120 mg and Fexofast 180 mg are not recommended for use in breastfeeding women.

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 you are not affected by dizziness or drowsiness.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially sodium-free.

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

This medicine should always be taken exactly as your doctor has instructed. If you are not sure, ask your doctor or pharmacist.
Recommended dose
For adults and children aged 12 years and over
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 have taken more than the recommended dose of Fexofast 120 mg or Fexofast 180 mg, contact your doctor or go to the nearest hospital 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 forgotten 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 soon, your symptoms may come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 medicine and seek medical attention immediately.
The frequency of possible side effects is defined as follows:

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

Common:

headache, drowsiness, nausea, dizziness.

Uncommon:

feeling tired or sleepy.

Not known:

difficulty sleeping (insomnia), sleep disorders, nightmares/vivid dreams, nervousness, irregular or fast 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, tightness in the chest, and difficulty breathing).

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported 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 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 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 Fexofast 120 mg contains

• The active substance is fexofenadine hydrochloride. Each tablet contains 120 mg of fexofenadine hydrochloride, equivalent to 112 mg of fexofenadine.
• The 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), 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, equivalent to 168 mg of fexofenadine.
• The 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), 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 pack 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: