Fexofenadine Hydrochloride 120 Mg Film-Coated Tablets
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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 is and what it is used for
2. Before you take Fexofenadine hydrochloride
3. How to take Fexofenadine hydrochloride
4. Possible side effects
5. How to store Fexofenadine hydrochloride
6. Further information
1. WHAT FEXOFENADINE HYDROCHLORIDE IS AND WHAT IT IS 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
Do not take Fexofenadine hydrochloride:
- if you are allergic (hypersensitive) to fexofenadine hydrochloride or any of the other ingredients of Fexofenadine hydrochloride.
This medicine is not recommended for children under 12 years of age.
Take special care with Fexofenadine hydrochloride:
- if you are elderly.
- 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. The remedy may lower the amount of drug absorbed and the action of Fexofenadine hydrochloride may be effected.
If you are taking fexofenadine together with erythromycin or ketoconazole, or with a single dose of lopinavir and ritonavir combination, the level of fexofenadine in your plasma may increase. It is possible that the side effects 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 with food and drink
Fexofenadine hydrochloride should be taken with water.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy: Take Fexofenadine hydrochloride during pregnancy only if your doctor considers it to be strictly necessary.
Breast-feeding: It is not recommended to take Fexofenadine hydrochloride if you are breast-feeding. Driving and using machines
It is unlikely that Fexofenadine hydrochloride will affect your ability to drive or use machines. However, there may be rare exceptions, so please ensure that you are alert before driving or performing tasks demanding your full attention.
3. HOW TO TAKE FEXOFENADINE HYDROCHLORIDE
Always take Fexofenadine hydrochloride 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 once daily for adults and children 12 years and older.
Fexofenadine hydrochloride 180 mg Tablets: For relief of symptoms of chronic idiopathic urticaria (allergic skin condition):
The usual dose is one tablet once daily for adults and children 12 years and older.
Take the tablets with water.
If you think the effects of Fexofenadine hydrochloride are too strong or too weak, please consult your doctor or pharmacist.
If you take more Fexofenadine hydrochloride than you should
Contact your doctor, emergency room or pharmacist if you have taken more Fexofenadine hydrochloride 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
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.
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4. POSSIBLE SIDE EFFECTS
Like all medicines, Fexofenadine hydrochloride can cause side effects although not everybody gets them.
The side effects described below have been experienced by people taking fexofenadine and they are listed as either common, uncommon or rare.
Common (experienced by between 1 in 10 and 1 in 100 people): headache, drowsiness, nausea, dry mouth and dizziness.
Uncommon (experienced by between 1 in 100 and 1 in 1,000 people): feeling tired.
Other side effects include diarrhoea, difficulty sleeping, nervousness, sleep disturbances, bad dreams, allergic skin reactions such as eczema, hives and itching, unexpected swelling (oedema), chest tightness, shortness of breath and flushing. Also, the heart may beat more quickly or irregularly. Seek medical advice if symptoms of anaphylactic reactions (for example swelling or difficulty breathing) or serious skin reactions occur.
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
Keep out of reach and sight of children. Do not use Fexofenadine hydrochloride tablets after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
This medicinal product does not require any 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 contains
The active substance is fexofenadine hydrochloride.
Each Fexofenadine hydrochloride 120 mg tablet contains 120 mg of fexofenadine hydrochloride equivalent to 112 mg of fexofenadine. The other ingredients are microcrystalline cellulose, croscarmellose sodium, maize starch, povidone, magnesium stearate. The tablet coat contains hypromellose (E464), 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 equivalent to 168 mg of fexofenadine. The other ingredients are microcrystalline cellulose, croscarmellose sodium, maize starch, povidone, magnesium stearate. The tablet coat contains hypromellose (E464), titanium dioxide (E171), macrogol 400, macrogol 4000 and iron oxide yellow (E172).
What Fexofenadine hydrochloride looks like and contents of the pack
Fexofenadine hydrochloride 120 mg tablets are peach coloured, oblong, film-coated tablets, plain on
both sides.
Fexofenadine hydrochloride 180 mg tablets are yellow coloured, oblong, film coated tablets, plain on one side with a central break-line on the other.
Fexofenadine hydrochloride tablets come in packs of 2, 7, 10, 15, 20, 30, 50, 100 or 200 tablets; not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Chanelle Medical, Loughrea, Co Galway, Ireland.
Distributed in UK by: Chanelle Medical UK Ltd
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Denmark |
Histafast 120 mg, filmovertrukne tabletter Histafast 180 mg, filmovertrukne tabletter |
|
France |
Fexofenadine BIOGARAN 120 mg, comprime pellicule Fexofenadine BIOGARAN 180 mg, comprime pellicule |
|
Italy |
Fixodin 120 mg compresse film-rivestite Fixodin 180 mg compresse film-rivestite |
|
Poland |
Fexofast 120 mg Fexofast 180 mg |
|
Portugal |
Fexocare 120 mg Fexocare 180 mg |
|
Spain |
FEXOFENADINA IFC 120 mg comprimidos recubiertos con pelicula FEXOFENADINA IFC 180 mg comprimidos recubiertos con pelicula |
|
United Kingdom |
Fexofenadine hydrochloride 120 mg film-coated tablets Fexofenadine hydrochloride 180 mg film-coated tablets |
This leaflet was last approved in 03/2011
CO
LB3891
