Allevia 120mg tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after taking Allevia.

1. What Allevia is and what it is used for
2. What you need to know before you take Allevia
3. How to take Allevia
4. Possible side effects
5. How to store Allevia
6. Contents of the pack and other information

• if you are allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6)

Talk to your doctor or pharmacist before taking Allevia if:

• you have problems with your liver or kidneys
• you have or ever had heart disease, since this kind of medicine may lead to a fast or irregular heart beat
• you are elderly

If any of these apply to you, or if you are not sure, tell your doctor before taking Allevia.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are taking apalutamide (a medicine to treat prostate cancer), as the effect of fexofenadine may be decreased.

Indigestion remedies containing aluminium and magnesium may affect the action of Allevia, by lowering the amount of medicinal product absorbed. It is recommended that you leave about 2 hours between the time that you take Allevia and your indigestion remedy.

Allevia should not be taken during pregnancy and whilst breast-feeding unless advised by a doctor.

Allevia is unlikely to affect your ability to drive or operate machinery. However, you should check that these tablets do not make you feel sleepy or dizzy before driving or operating machinery.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

The recommended dose is one tablet (120 mg) daily. Take the tablet with water before a meal.

This medicine starts to relieve your symptoms within 1 hour and lasts for 24 hours.

Allevia is not recommended for children under 12 years of age.

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

Do not take double dose to make up for a forgotten tablet. Take the next dose at the usual time.

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

The following undesirable effects have been reported in clinical trials, with an incidence similar to those observed in patients who did not receive the drug (placebo).

Common side effects (may affect up to 1 in 10 people):

• headache
• drowsiness
• feeling sick (nausea)
• dizziness.

Uncommon side effects (may affect up to 1 in 100 people):

• tiredness/sleepiness.

Additional side effects (frequency not known: cannot be estimated from the available data) 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 reactions which can cause swelling of the face, lips, tongue or throat, flushing, chest tightness, and difficulty breathing.
• blurred vision.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is fexofenadine hydrochloride. Each tablet contains 120 mg of fexofenadine hydrochloride.
• The other ingredients are:
  • Tablet core: microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, magnesium stearate.
  • Film coating: hypromellose, povidone K30, titanium dioxide (E171), colloidal anhydrous silica, macrogol 400, red iron oxide (E172) and yellow iron oxide (E172).

Allevia are peach coloured, capsule shaped tablets marked with “012” on one side and a scripted “e” on the other.

Allevia is presented in blister packs, available in pack sizes of 7, 10, 15, 20, 30 tablets. Not all pack sizes are marketed.

Marketing Authorisation Holder:

Manufacturers

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