Prospect: information for the patient

Fexofenadine Cipla 120 mg film-coated tablets EFG

Fexofenadine hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.
If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Fexofenadine Cipla 120 mg and for what it is used

2. What you need to know before starting to take Fexofenadine Cipla

3. How to take Fexofenadine Cipla 120 mg

4. Possible adverse effects

5. Storage of Fexofenadine Cipla 120 mg

6. Contents of the package and additional information

Fexofenadina Cipla 120 mg contains fexofenadine hydrochloride, which is an antihistamine.

Fexofenadina Cipla 120 mg is used in adults and adolescents 12 years of age or older for the reliefdelosesymptomaticalalergiaalpolenical(riniticalérgicalestasonal)comonestornados,gote,picoryblockagenment,picorybruising,picorylagrimentation.

Do not take Fexofenadina Cipla:

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Fexofenadina Cipla if::

• You have problems with liver or kidney function.
• 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

Fexofenadina Cipla 120 mg film-coated tablets are not recommended for children or adolescents under 12 years of age.

Taking Fexofenadina Cipla with other medications

Inform your doctor or pharmacist if you are using, have used recently 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.

Antacids containing aluminium and magnesium may alter the action of Fexofenadina Cipla, reducing the amount of the drug absorbed.

It is recommended to leave a 2-hour interval between taking Fexofenadina Cipla and the antacid.

Pregnancy and breastfeeding

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

Do not take Fexofenadina Cipla if you are pregnant unless absolutely necessary.

Fexofenadina Cipla is not recommended during breastfeeding.

Driving and operating machinery

Fexofenadina Cipla 120 mg tablets are unlikely to affect your ability to drive or operate machinery. However, ensure that these tablets do not make you feel drowsy or dizzy before driving or operating machinery.

Fexofenadina Cipla contains sodium

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

Follow exactly the administration instructions for this medication 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 (120 mg) per day.

Take the tablet with water before a meal.

This medication begins to relieve your symptoms in 1 hour and lasts 24 hours.

Use in children and adolescents

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

If you take more Fexofenadina 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 forgot to take Fexofenadina Cipla

Do not take a double dose to compensate for the missed dose.

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

If you interrupt treatment with Fexofenadina Cipla

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

If you stop taking fexofenadina before the scheduled time, your symptoms may reappear.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

Facial, lip, tongue, or throat inflammation and difficulty breathing, as they may be signs of a severe allergic reaction.

The following adverse effects have also been reported:

Frequent Adverse Effects(may affect up to 1 in 10 people):

• Headache
• Drowsiness
• Nausea
• Dizziness

Less Frequent(may affect up to 1 in 100 people)

• Fatigue
• Drowsiness

Unknown Frequency (cannot be estimated from available data):

• Difficulty sleeping (insomnia)
• Sleep disorders
• Nightmares
• Anxiety
• Irregular or rapid heartbeats
• Diarrhea
• Urticaria and itching
• Rash
• Severe allergic reactions that may cause facial, lip, tongue, or throat swelling, flushing, chest tightness, and difficulty breathing
• Blurred vision

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use website:www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe label/box/blisterafter CAD. The expiration date is the last day of the month indicated.

Thismedicineshould not berequiredespeciallydesconservación.

Medicines should not be thrown into the drains or trash. Ask yourpharmacisthow to dispose ofthepackaging and of themedicinesthat you no longerneed. In this way, you will help protect the environment.

Composition of Fexofenadine Cipla 120 mg

• The active ingredient is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride.
• The other components are:
• • Core tablet: microcrystalline cellulose, maize starch, sodium croscarmellose, povidone, and magnesium stearate.
  • Film coating: hypromellose, titanium dioxide (E 171), macrogol, yellow iron oxide (E 172), and red iron oxide (E 172).

Appearance of the product and contents of the package

Fexofenadine Cipla 120 mg are film-coated tablets, orange in color, oblong, biconvex, and smooth on both sides. Dimensions 15.00 mm x 6.5 mm.

It is packaged in PVC/PVDC/Al blisters in cartons containing 7, 10, 15, 20, 30, 50, 100, and 200 (as 10x20) tablets per package.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

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

Responsible 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. installation), 27308 Czech Republic

Local Representative: Cipla Europe NV subsidiary in Spain.

C/Guzmán el Bueno, 133 Edif Britannia-28003- Madrid

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of thisleaflet:02/2023