FEXOFENADINE CIPLA 180 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Fexofenadine Cipla 180 mg Film-Coated Tablets EFG

Fexofenadine Hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fexofenadine Cipla 180 mg and what is it used for
2. What you need to know before taking Fexofenadine Cipla
3. How to take Fexofenadine Cipla 180 mg
4. Possible side effects

5. Storage of Fexofenadine Cipla 180 mg

1. Package Contents and Additional Information

1. What is Fexofenadine Cipla 180 mg and what is it used for

Fexofenadine Cipla 180 mg contains fexofenadine hydrochloride, which is an antihistamine.

Fexofenadine Cipla 180 mg is used in adults and adolescents 12 years of age and older for the relief of symptoms associated with chronic allergic skin reactions (chronic idiopathic urticaria), such as itching, inflammation, and hives.

2. What you need to know before taking Fexofenadine Cipla 180 mg

Do not take Fexofenadine Cipla:

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

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before taking Fexofenadine Cipla if:

• You have liver or kidney problems.
• You have or have had a heart condition, as this type of medication may cause an irregular or faster heartbeat.
• You are an elderly patient.

Children and Adolescents

Fexofenadine Cipla 180 mg film-coated tablets are not recommended for children or adolescents under 12 years of age.

Taking Fexofenadine Cipla with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

If you are taking apalutamide (a medication for prostate cancer), as the effect of fexofenadine may be reduced.

Indigestion products containing aluminum and magnesium may alter the action of Fexofenadine Cipla by reducing the amount of medication absorbed.

It is recommended to leave a 2-hour interval between taking Fexofenadine Cipla and the indigestion product.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not take Fexofenadine Cipla if you are pregnant unless it is absolutely necessary.

Fexofenadine Cipla is not recommended during breastfeeding.

Driving and Using Machines

Fexofenadine Cipla is unlikely to affect your ability to drive or use machines. However, make sure these tablets do not make you feel drowsy or dizzy before driving or operating machinery.

Fexofenadine Cipla contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet, which is essentially "sodium-free".

3. How to take Fexofenadine Cipla 180 mg

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults and Adolescents 12 years and older

The recommended dose is one tablet (180 mg) per day.

Take the tablet with water before a meal.

This medication starts to relieve your symptoms within 1 hour and lasts 24 hours.

Use in Children and Adolescents

Fexofenadine is not recommended for children or adolescents under 12 years of age.

If you take more Fexofenadine Cipla than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of an overdose in adults are dizziness, drowsiness, fatigue, and dry mouth.

If you forget to take Fexofenadine Cipla

Do not take a double dose to make up for forgotten doses.

Take the next dose at the scheduled time as prescribed by your doctor.

If you stop taking Fexofenadine Cipla

Consult your doctor if you want to stop taking fexofenadine before completing the treatment cycle.

If you stop taking fexofenadine before it is due, your symptoms may recur.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Consult your doctor immediately and stop taking Fexofenadine Cipla if you experience:

• Facial swelling, lips, tongue, or throat, and difficulty breathing, as these may be signs of a severe allergic reaction.

The following side effects have also been reported:

Common side effects(may affect up to 1 in 10 people):

• Headache
• Drowsiness
• Nausea
• Dizziness

Uncommon side effects(may affect up to 1 in 100 people)

• Fatigue
• Drowsiness

Frequency not known(cannot be estimated from the available data)

• Difficulty sleeping (insomnia)
• Sleep disorders
• Nightmares
• Nervousness
• Fast or irregular heartbeat
• Diarrhea
• Hives and itching
• Rash
• Severe allergic reactions that can cause facial swelling, lips, tongue, or throat, flushing, chest tightness, and difficulty breathing
• Blurred vision

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fexofenadine Cipla 180 mg

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the label/box/blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fexofenadine Cipla 180 mg

• The active ingredient is fexofenadine hydrochloride. Each film-coated tablet contains 180 mg of fexofenadine hydrochloride.
• The other ingredients are:
• • Core of the tablet: microcrystalline cellulose, cornstarch, sodium croscarmellose, povidone, and magnesium stearate.
  • Coating: hypromellose, titanium dioxide (E 171), macrogol, and yellow iron oxide (E 172).

Appearance of the Product and Package Contents

Fexofenadine Cipla 180 mg are film-coated tablets, yellow, oblong, smooth on one side and scored on the other. Dimensions 17.00 mm x 8.00 mm.

They are packaged in PVC/PVDC/Al blisters in cardboard boxes containing 10, 15, 20, 30, 50, 100, and 200 (as 10x20) tablets per package.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Cipla Europe NV, De Keyserlei 58-60, Box-19, 2018, Antwerp, Belgium

Manufacturer:

Cipla Europe NV,

De Keyserlei 58-60, Box-19, 2018, Antwerp, Belgium

or

S&D Pharma CZ, spol.s r.o,

Theodor 28, Pchery (Pharmos a.s. facility), 27308, Czech Republic

Local Representative: Cipla Europe NV, Spanish branch. C/Guzmán el Bueno, 133 Edif Britannia-28003- Madrid

This medication is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this package leaflet:02/2023