Fexofenadine Hydrochloride 120 Mg Film-Coated Tablets
PATIENT INFORMATION LEAFLET Fexofenadine Hydrochloride 120 mg & 180 mg Film-Coated Tablets
(Fexofenadine Hydrochloride)
The name of this medicine is Fexofenadine 120 mg & 180 mg Film-Coated Tablets which will be referred to as Fexofenadine Tablets throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your 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 the leaflet, please tell your doctor or pharmacist. (See section 4)
In this leaflet
1. What FexofenadineTablets are and what they are used for
2. Before you take Fexofenadine Tablets
3. How to take FexofenadineTablets
4. Possible side effects
5. How to store Fexofenadine Tablets
6. Further Information
1. WHAT FEXOFENADINE TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredient in your tablets is fexofenadine hydrochloride, which belongs to a group of medicines called antihistamines. It can be used to relieve the symptoms of
• 120mg: hay fever (seasonal allergic rhinitis), such as sneezing, itchy and runny nose and red, itchy and watery eyes
• 180mg: long term allergic skin reactions (chronic idiopathic urticaria) such as itching, swelling and rashes.
• FexofenadineTablets are not suitable for children under 12 years of age
2. BEFORE YOU TAKE FEXOFENADINE TABLETS Do not take Fexofenadine Tablets if you:
• have ever had a reaction to Fexofenadine or any of the other ingredients of the tablets (see section 6 for a full list of ingredients), or if you suspect that you are allergic to any of these ingredients.
Take special care with Fexofenadine Tablets
Before you take Fexofenadine Tablets you should tell your doctor if you:
• have problems with your liver or kidneys
• are elderly
• have heart problems, as fexofenadine like other antihistamines may cause your heart to beat faster (tachycardia) or you feel your heart beating (palpitations).
Taking other medicines
Please tell your doctor if you are taking or have recently taken any of the following medicines, as they may decrease or increase the effect of Fexofenadine Tablets and vice versa.
• Erythromycin (an antibiotic)
• Ketoconazole (a treatment for fungal infections)
• Antacids containing aluminium and magnesium
It is recommended that you leave about 2 hours between the time that you take Fexofenadine tablets and your antacids. It may still be alright for you to take Fexofenadine Tablets and your doctor will be able to decide what is suitable for you.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Fertility pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you might be pregnant, are planning to become pregnant or are breastfeeding.
Do not take Fexofenadine Tablets if you are pregnant, unless prescribed. Fexofenadine Tablets are not recommended during breast-feeding.
Driving and using machines
It is unlikely that Fexofenadine Tablets will affect your ability to drive or use machines. However, you should check that these tablets do not make you feel sleepy or dizzy before driving or operating machinery.
3. HOW TO TAKE FEXOFENADINE TABLETS_
Always take Fexofenadine Tablets exactly as your doctor has told you to do so. You should check with your doctor or pharmacist if you are not sure.
Dosage
Adults and children aged 12 years and over
The recommended dose is one tablet (120 mg or 180 mg) daily. Take your tablet with water before a meal.
Children aged under 12 years
Fexofenadine 120mg or 180mg is not suitable for children under 12 years.
If you take more Fexofenadine Tablets than you should
If you have accidentally taken more than the prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. The most
Product: Fexofenadine 120mg & 180mg Film-Coated Tablets Dimensions: 170 x 290 mm Item Code: AXP041FME Date: 18Aug15
Revison: Update To PIL Following PRAC Update
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common signs of overdose are dizziness, drowsiness, fatigue and dry mouth.
If you forget to take Fexofenadine Tablets
Simply leave out that dose and then take your next dose at the right time. Do not take a double dose or make up for a missed dose.
If you stop taking Fexofenadine Tablets
Tell your doctor if you want to stop taking Fexofenadine Tablets before you have finished your course of treatment. If you stop taking Fexofenadine Tablets earlier than planned, 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 Tablets can cause side effects, although not everybody gets them. If you get any of the following symptoms after taking these tablets you should contact your doctor or pharmacist immediately as these may be signs of a serious allergic reaction:
• Swelling of the face, lips, tongue or throat and difficulty breathing.
The following side effects have also been reported:
• Common (occurring in less than 1 in 10 but more than 1 in 100 patients):
- headache
- drowsiness
- feeling sick (nausea)
- dizziness.
• Uncommon (occurring in less than 1 in 100 but more than 1 in 1,000 patients):
- difficulty sleeping (insomnia) - tiredness or sleepiness
- fatigue - sleeping disorders
- bad dreams - nervousness
- fast or irregular heart beat - diarrhoea.
• Rare (occurring in less than 1 in 1,000 but more than 1 in 10,000 patients):
- skin rash and itching
- hives
• serious allergic reaction which can cause swelling of the face, lips tongue or throat and difficulty breathing.
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In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (can not be estimated from available data): hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis, insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria), tachycardia, palpitations, diarrhoea, rash, urticaria, pruritus
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via United Kingdom Yellow Card Scheme - Website: www.mhra.gov.uk/yellowcard
5. HOW TO STORE FEXOFENADINE TABLETS Keep out of the reach and sight of children.
Do not take this medicine after the expiry date (Exp.) stated on both blister and carton. The expiry date refers to the last day of that month. Store your tablets in the original package.
This medicinal product does not require any special temperature storage condition.
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 Tablets contain:
The active ingredient is Fexofenadine hydrochloride. Each Film-Coated tablet contains 120 mg or 180mg of Fexofenadine hydrochloride.
The other ingredients are:
Tablet core:
Microcrystalline Cellulose, Maize Starch, Magnesium Stearate, Croscarmellose Sodium, Povidone,
Film coating:
Hypromellose (E464), Macrogol (PEG 400), Macrogol (PEG 4000), Titanium Dioxide (E171), Iron Oxide Yellow (E172). The film coating on the 120mg Tablet also contains Iron Oxide Red (E172).
What Fexofenadine Tablets looks like and the contents of the pack:
Fexofenadine 120 mg Film-coated Tablets are peach coloured, oblong, biconvex, film coated tablets.
Fexofenadine 180 mg Film-coated Tablets are yellow coloured, oblong, biconvex, film coated
tablets, plain on one side and with a central breakline on the reverse side. The breakline allows division of the tablet.
Your medicine is available in PVC/PVDC foil blister packs of 7, 10, 15, 20, 30, 50, 100 or 500 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder:
Fannin (UK) Ltd, 42-46 Booth Drive, Park Farm South,Wellingborough, Northamptonshire, NN8 6GT, UK Manufacturer responsible for batch release:
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K
This information is available in alternative formats upon request.
This leaflet was last approved in Aug 2015 AXP041FME