Fexofenadine hydrochloride cipla

Package leaflet: Information for the user

Fexofenadine hydrochloride Cipla, 120 mg, film-coated tablets
Fexofenadine hydrochloride
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Fexofenadine hydrochloride Cipla is and what it is used for
2. What you need to know 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 medicine.
Fexofenadine hydrochloride Cipla 120 mg is used in adults and adolescents aged 12 years and older to relieve symptoms of hay fever (seasonal allergic rhinitis), such as sneezing, itchy, runny or blocked nose, and itchy, red, watery eyes.

2. Important information before taking Fexofenadine hydrochloride Cipla

When not to take Fexofenadine hydrochloride Cipla:

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

Warnings and precautions
Before starting to take Fexofenadine hydrochloride Cipla, discuss it with your
doctor, pharmacist, or nurse.
In particular, tell your doctor, pharmacist, or nurse if:

• the patient has liver or kidney function disorders;
• the patient has or has ever had heart disease, as this type of medicine may cause rapid or irregular heartbeat;
• the patient is elderly.

Children and adolescents
Fexofenadine hydrochloride Cipla 120 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 medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Antacids containing aluminium or magnesium may affect the action of Fexofenadine hydrochloride Cipla by reducing the amount of medicine absorbed.
It is recommended to maintain a 2-hour interval between taking Fexofenadine hydrochloride Cipla and taking an antacid.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Pregnant women should not take Fexofenadine hydrochloride Cipla unless clearly necessary.
Fexofenadine hydrochloride Cipla is not recommended during breastfeeding.
Driving and using machines
It is highly unlikely that Fexofenadine hydrochloride Cipla will affect the patient's ability to drive or
operate machinery. However, before driving or operating machinery, the patient should ensure
that this medicine does not cause drowsiness or dizziness.

3. How to take Fexofenadine hydrochloride Cipla

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
For adult patients and adolescents aged 12 years and older
The recommended dose is one tablet (120 mg) once daily.
The tablet should be taken before a meal, with water.
The medicine starts relieving 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 under 12 years of age.
Taking more Fexofenadine hydrochloride Cipla than recommended
If too many tablets have been taken, contact your doctor or the nearest hospital emergency department immediately.
Symptoms of overdose in adults include: dizziness, drowsiness, fatigue, and dry mouth.
If you miss a dose of Fexofenadine hydrochloride Cipla
Do not take a double dose to make up for the missed tablet.
Take the next dose at the usual time as prescribed by your doctor.
Stopping Fexofenadine hydrochloride Cipla
You should inform your doctor if you plan to stop taking Fexofenadine hydrochloride Cipla before completing the prescribed course of treatment.
If you stop taking Fexofenadine hydrochloride Cipla earlier than planned, symptoms may return.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If the patient experiences any of the following symptoms, contact a doctor immediately and
discontinue taking Fexofenadine hydrochloride Cipla:

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

Common adverse reactions (may occur in up to 1 in 10 patients):

• headache,
• drowsiness,
• nausea,
• dizziness.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• fatigue,
• drowsiness.

Other possible adverse reactions include:

• difficulty falling asleep (insomnia),
• sleep disturbances,
• nightmares,
• nervousness,
• fast or irregular heartbeat,
• diarrhoea,
• skin rash and itching,
• urticaria,
• severe allergic reactions which may cause swelling of the face, lips, tongue or throat, hot flushes, chest tightness, and difficulty breathing.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to 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 pack after
"EXP". The expiry date refers to the last day of the specified month.
The abbreviation "Lot" on the packaging indicates the batch number.
No special requirements for the storage conditions 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 in use. 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 coated tablet contains 120 mg of fexofenadine hydrochloride.
• The other ingredients are:
• Tablet core: microcrystalline cellulose, maize starch, sodium croscarmellose, povidone, magnesium stearate.
• Tablet 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-coloured, smooth, elongated, biconvex film-coated tablets, plain on both sides. Dimensions: 15.00 mm x 6.5 mm.
PVC/PVDC/Aluminium blisters in cardboard boxes. Pack sizes: 7, 10, 15, 20, 30, 50, 100 or 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
ul. Ostrzykowizna 14A
05-170 Zakroczym
Manufacturer/Importer
Cipla Europe NV
De Keyserlei 58-60, Box-19, 2018, Antwerp,
Belgium
S&D Pharma CZ, spol. s r.o.
Theodor 28, 273 08 Pchery (areal Pharmos a.s.)
Czech Republic
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
This medicinal product is authorised in the European Economic Area countries under the following names: