Fexofenadine hidrohloride Cipla

Package Leaflet: Information for the User

Fexofenadine Hydrochloride Cipla, 120 mg, Film-Coated Tablets

Fexofenadine Hydrochloride

Read the package leaflet carefully before taking the medicine, 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What Fexofenadine Hydrochloride Cipla is and what it is used for
• 2. Before you take Fexofenadine Hydrochloride Cipla
• 3. How to take Fexofenadine Hydrochloride Cipla
• 4. Possible side effects
• 5. How to store Fexofenadine Hydrochloride Cipla
• 6. Contents of the pack and other information

1. What Fexofenadine Hydrochloride Cipla is and what it is used for

Fexofenadine Hydrochloride Cipla contains fexofenadine hydrochloride, which is an antihistamine.
Fexofenadine Hydrochloride Cipla 120 mg is used in adults and adolescents aged 12 years and over to relieve the symptoms of hay fever (seasonal allergic rhinitis), such as sneezing, itchy, runny or blocked nose, and itchy, red or watery eyes.

2. Before you take Fexofenadine Hydrochloride Cipla

Do not take Fexofenadine Hydrochloride Cipla:

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

Warnings and precautions

Before taking Fexofenadine Hydrochloride Cipla, tell your doctor, pharmacist, or nurse:
if you have liver or kidney problems;
if you have or have had heart problems, as this type of medicine may cause fast or irregular heartbeat;
if you are elderly.

• if you have liver or kidney problems;
• if you have or have had heart problems, as this type of medicine may cause fast or irregular heartbeat;
• if you are elderly.

Children and adolescents

Fexofenadine Hydrochloride Cipla 120 mg film-coated tablets are not recommended for use in children below 12 years.

Fexofenadine Hydrochloride Cipla with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Antacids containing aluminum or magnesium may affect the action of Fexofenadine Hydrochloride Cipla by reducing the amount of medicine absorbed.
It is recommended to leave a 2-hour interval between taking Fexofenadine Hydrochloride Cipla and an antacid.

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.
Pregnant women should not take Fexofenadine Hydrochloride Cipla unless it is clearly necessary.
Fexofenadine Hydrochloride Cipla should not be taken during breastfeeding.

Driving and using machines

It is practically impossible for Fexofenadine Hydrochloride Cipla to affect your ability to drive or use machines. However, before driving or using machines, you should make sure that you are not affected by this medicine, as it may cause drowsiness or dizziness.

3. How to take Fexofenadine Hydrochloride Cipla

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

For adults and adolescents aged 12 years and over

The recommended dose is one tablet (120 mg) once daily.
Take the tablet before a meal, with water.
The medicine starts to relieve symptoms within 1 hour and its effect lasts for 24 hours.

Use in children and adolescents

Fexofenadine Hydrochloride Cipla 120 mg film-coated tablets are not recommended for use in children below 12 years.

If you take more Fexofenadine Hydrochloride Cipla than you should

If you have taken too many tablets, contact your doctor or the nearest hospital emergency department immediately.
Symptoms of overdose in adults are: dizziness, drowsiness, fatigue, and dry mouth.

If you forget to take Fexofenadine Hydrochloride Cipla

Do not take a double dose to make up for a forgotten tablet.
Take the next dose at the usual time, as prescribed by your doctor.

If you stop taking Fexofenadine Hydrochloride Cipla

Tell your doctor if you wish to stop taking Fexofenadine Hydrochloride Cipla before completing the prescribed treatment course.
If you stop taking Fexofenadine Hydrochloride Cipla before the planned end of treatment, your symptoms may return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fexofenadine Hydrochloride Cipla can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking Fexofenadine Hydrochloride Cipla and contact your doctor immediately:

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

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.

Other side effects that may occur:

• difficulty sleeping (insomnia),
• sleep disorders,
• nightmares,
• nervousness,
• fast or irregular heartbeat,
• diarrhea,
• skin rash and itching,
• hives,
• severe allergic reactions, which may cause swelling of the face, lips, tongue, or throat, flushing, tightness of the chest, and difficulty breathing.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the:
Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

• 02-222 Warsaw Tel.: + 48 22 49 21 301 Faks: + 48 22 49 21 309 e-mail: ndl@urpl.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 Fexofenadine Hydrochloride Cipla

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
Lot number on the packaging means batch number.
There are no special storage conditions for this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Fexofenadine Hydrochloride Cipla contains

• The active substance is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride.
• The other ingredients are:
• Core: microcrystalline cellulose, maize starch, sodium croscarmellose, povidone, magnesium stearate.
• Coating: hypromellose 6 cP, titanium dioxide (E171), macrogol 400, macrogol 4000, yellow iron oxide (E172), red iron oxide (E172).

What Fexofenadine Hydrochloride Cipla looks like and contents of the pack

Fexofenadine Hydrochloride Cipla 120 mg are peach-colored, oval, biconvex, film-coated tablets, smooth on both sides. Dimensions: 15.00 mm x 6.5 mm
PVC/PVDC/Aluminum blisters in a cardboard box. 7, 10, 15, 20, 30, 50, 100, or 200 tablets in a pack.
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

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

Date of last revision of the leaflet: 31.03.2019