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Document: leaflet MAH GENERIC_PL 04569-0821 change

• leaflet ACTAVIS_PL 13931-0039
• leaflet MAH BRAND_PLPI 20636-2541
• leaflet MAH GENERIC_PL 04569-0821
• leaflet MAH GENERIC_PL 13931-0039
• leaflet MAH GENERIC_PL 20417-0041
• leaflet MAH GENERIC_PL 36390-0053

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PACKAGE LEAFLET: INFORMATION FOR THE USER

FEXOFENADINE HYDROCHLORIDE 120 mg FILM-COATED TABLETS FEXOFENADINE HYDROCHLORIDE 180 mg FILM-COATED TABLETS

(Fexofenadine hydrochloride)

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Fexofenadine Hydrochloride Tablets are and what they are used for

2.    Before you take Fexofenadine Hydrochloride Tablets

3.    How to take Fexofenadine Hydrochloride Tablets

4.    Possible side effects

5.    How to store Fexofenadine Hydrochloride Tablets

6.    Further information

1.    WHAT FEXOFENADINE HYDROCHLORIDE TABLETS ARE AND WHAT THEY ARE USED FOR

Fexofenadine hydrochloride, the active ingredient in your medicine, belongs to the group of medicines known as antihistamines.

Fexofenadine Hydrochloride 120 mg Tablets are approved for the relief of symptoms such as sneezing, running nose and nose itch, eye itch, tearing and flushing, which typically occur in connection with hay fever (allergic rhinitis).

Fexofenadine Hydrochloride 180 mg Tablets are approved for the relief of symptoms such as flushing, oedema and itching, which occur in connection with the allergic skin condition called chronic idiopathic urticaria (CIU).

2.    BEFORE YOU TAKE FEXOFENADINE HYDROCHLORIDE TABLETS Do not take Fexofenadine Hydrochloride Tablets:

•    if you are allergic (hypersensitive) to fexofenadine hydrochloride or any of the other ingredients of Fexofenadine Hydrochloride Tablets.

Take special care with Fexofenadine Hydrochloride Tablets:

•    if you are elderly.

•    if you have ever had heart problems.

•    if you have kidney or liver problems.

Ask your doctor for advice before taking this medicine.

Taking other medicines

If you are taking a remedy against an upset stomach containing aluminium or magnesium, it is recommended that you leave about 2 hours between the time that you take your remedy and Fexofenadine Hydrochloride Tablets. The remedy may lower the amount of drug absorbed and the action of Fexofenadine Hydrochloride Tablets may be effected.

If you are taking Fexofenadine Hydrochloride Tablets together with erythromycin (an antibiotic) or ketoconazole (an antifungal medicine), the level of fexofenadine in your plasma may increase.

Allergy tests: If you are taking an allergy test this medicine must be discontinued three days before the test.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Fexofenadine Hydrochloride Tablets with food and drink

Fexofenadine Hydrochloride Tablets should be taken with water before a meal.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy: You must only take Fexofenadine Hydrochloride Tablets according to your doctor's instructions.

Breast-feeding: If you are breast-feeding, you must try to avoid taking Fexofenadine Hydrochloride Tablets. Please ask your doctor.

Driving and using machines

Trials have shown that Fexofenadine Hydrochloride Tablets do not cause drowsiness, and your ability to drive should therefore not be affected while you are on treatment with Fexofenadine Hydrochloride Tablets. However, there may be rare exceptions, so please ensure that you are alert before driving and performing tasks demanding your full attention.

3.    HOW TO TAKE FEXOFENADINE HYDROCHLORIDE TABLETS

Always take Fexofenadine Hydrochloride Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Fexofenadine Hydrochloride 120 mg Tablets: For relief of symptoms of hay fever (allergic rhinitis).

The usual dose is one tablet daily for adults and children 12 years or older.

Fexofenadine Hydrochloride 180 mg Tablets: For relief of symptoms of chronic idiopathic urticaria (allergic skin condition).

The usual dose is one tablet daily for adults and children 12 years or older.

Use in children

Children under 12 years of age should not take Nefoxef 120 mg/180 mg film-coated tablets.

For children 6 to 11 years of age: Other forms of this medicine may be more suitable; ask your doctor or pharmacist.

Take the tablets orally with water before a meal.

If you think the effects of Fexofenadine Hydrochloride Tablets are too strong or too weak, please consult your doctor or pharmacist.

If you take more Fexofenadine Hydrochloride Tablets than you should

Contact your doctor, emergency room or pharmacist if you have taken more Fexofenadine Hydrochloride Tablets than stated in this leaflet or more than your doctor has prescribed. Symptoms of overdose include dizziness, feeling drowsy, feeling tired and a dry mouth.

If you forget to take Fexofenadine Hydrochloride Tablets

If you forget to take a dose, take it as soon as you remember it unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

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 Tablets can cause side effects although not everybody gets them. The side effects described below have been experienced by people taking Fexofenadine Hydrochloride Tablets

Tell your doctor immediately and stop taking Nefoxef if you experience swelling of the face, lips tongue or throat and difficulty breathing, as these may be signs of a serious allergic reaction.

Common (experienced by between 1 in 10 and 1 in 100 patients):

•    headache

•    drowsiness

•    nausea

•    dizziness

Uncommon (experienced by between 1 in 100 and 1 in 1,000 patients):

•    feeling tired or sleepy.

Additional side effects (frequency unknown) which may occur are:

difficulty sleeping (insomnia), sleeping disorders, bad dreams, nervousness, fast or irregular heart beat, diarrhoea, skin rash and itching, hives, serious allergic reaction which can cause swelling of the face, lips, tongue or throat, flushing, chest tightness and difficulty breathing.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE FEXOFENADINE HYDROCHLORIDE TABLETS

Keep out of reach and sight of children. Do not use Fexofenadine Hydrochloride Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. This medicinal product does not require special storage conditions.

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 to protect the environment.

6.    FURTHER INFORMATION

What Fexofenadine Hydrochloride Tablets contain

The active substance is fexofenadine hydrochloride.

Each Fexofenadine Hydrochloride 120 mg Tablet contains 120 mg of fexofenadine hydrochloride, which is equivalent to 112 mg of fexofenadine. The other ingredients are microcrystalline cellulose, croscarmellose sodium, maize starch, povidone K30, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, macrogol 4000, iron oxide yellow (E172) and iron oxide red (E172).

Each Fexofenadine Hydrochloride 180 mg Tablet contains 180 mg of fexofenadine hydrochloride, which is equivalent to 168 mg of fexofenadine. The other ingredients are microcrystalline cellulose, croscarmellose sodium, maize starch, povidone K30, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400, macrogol 4000 and iron oxide yellow (E172).

What Fexofenadine Hydrochloride Tablets look like and contents of the pack

Fexofenadine Hydrochloride 120 mg Tablets are peach coloured, oblong, biconvex and film-coated tablets; plain on both sides. Fexofenadine Hydrochloride 180 mg Tablets are yellow coloured, oblong, biconvex and film-coated tablets; plain on one side with a score line on the other.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Fexofenadine Hydrochloride Tablets come in packs of 7, 10, 15, 20, 30, 50, 100, 200 or 250 tablets; not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mylan Potters Bar

Hertfordshire, EN6 1 TL United Kingdom

Manufacturer(s):

Chanelle Medical IDA Industrial Estate Loughrea, Co. Galway Ireland

Generics [UK] Limited Potters Bar

Hertfordshire, EN6 1 TL United Kingdom

Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

This leaflet was last approved in 11/2015

v1/May 2015