Fexofenadine hidrohloride Cipla

Package Leaflet: Information for the User

Fexofenadine Hydrochloride Cipla, 180 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 package 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 experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Fexofenadine Hydrochloride Cipla and what is it used for
• 2. Important information before taking 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 is Fexofenadine Hydrochloride Cipla and what is it used for

Fexofenadine Hydrochloride Cipla contains fexofenadine hydrochloride, which is an antihistamine.
Fexofenadine Hydrochloride Cipla 180 mg is used in adults and adolescents aged 12 years and older to relieve symptoms of long-term skin allergies (chronic idiopathic urticaria), such as itching, swelling, and rash.

2. Important information before taking Fexofenadine Hydrochloride Cipla

When not to 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, you should discuss it with your doctor, pharmacist, or nurse.
In particular, you should tell your doctor, pharmacist, or nurse if:

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

Children and adolescents

Fexofenadine Hydrochloride Cipla 180 mg film-coated tablets are not recommended for use in children under 12 years of age.

Fexofenadine Hydrochloride Cipla and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Antacids containing aluminum or magnesium may affect the action of Fexofenadine Hydrochloride Cipla, reducing the amount of medicine absorbed.
A 2-hour interval should be maintained between taking Fexofenadine Hydrochloride Cipla and taking 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 necessary.
Fexofenadine Hydrochloride Cipla is not recommended during breastfeeding.

Driving and using machines

It is practically impossible for Fexofenadine Hydrochloride Cipla to affect the ability to drive or operate machinery. However, before driving or operating machinery, you should make sure that the medicine does not cause drowsiness or dizziness.

3. How to take Fexofenadine Hydrochloride Cipla

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

For adult patients and adolescents aged 12 years and older

The recommended dose is one tablet (180 mg) once daily.
Take the tablet before a meal, with water.
The medicine starts to relieve symptoms of the disease within 1 hour and its action lasts for 24 hours.

Use in children and adolescents

Fexofenadine Hydrochloride Cipla 180 mg film-coated tablets are not recommended for use in children under 12 years of age.

Taking more than the recommended dose of Fexofenadine Hydrochloride Cipla

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

Missing a dose of Fexofenadine Hydrochloride Cipla

Do not take a double dose to make up for a missed tablet.
Take the next dose at the usual time recommended by your doctor.

Stopping treatment with Fexofenadine Hydrochloride Cipla

Tell your doctor if you plan to stop taking Fexofenadine Hydrochloride Cipla before completing the prescribed treatment cycle.
If you stop taking Fexofenadine Hydrochloride Cipla before the planned date, symptoms may return.
If you have any further questions about the use of this medicine, 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 symptoms 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(frequency not known: frequency cannot be estimated from the available data), which may occur, include:

• 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, hot flushes, chest tightness, and difficulty breathing.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. Side effects can be reported directly to:
Department of Pharmacovigilance, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +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 stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
The batch number is stated on the packaging.
There are no special precautions for storage of the medicinal product.
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 Fexofenadine Hydrochloride Cipla contains

• The active substance is fexofenadine hydrochloride. Each film-coated tablet contains 180 mg of fexofenadine hydrochloride.
• The other ingredients are:
• Tablet core:microcrystalline cellulose, maize starch, sodium croscarmellose, povidone, magnesium stearate.
• Tablet coating:hypromellose, titanium dioxide (E171), Macrogol 400, Macrogol 4000, yellow iron oxide (E172).

What Fexofenadine Hydrochloride Cipla looks like and contents of the pack

Fexofenadine Hydrochloride Cipla 180 mg film-coated tablets are yellow, oval, biconvex, film-coated tablets with a score line on one side.
Dimensions: 17.00 x 8.00 mm
Blisters of PVC/PVDC/Aluminum in a cardboard box. 10, 15, 20, 30, 50, 100, or 200 tablets in a pack.
Not all pack sizes may be marketed.

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 package leaflet:31.03.2019