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 this medicine.

1. What Histahive is and what they are used for
2. What you need to know before you take Histahive
3. How to take Histahive
4. Possible side effects
5. How to store Histahive
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 Histahive if you:

• have problems with your liver or kidneys
• have or ever had heart problems, as fexofenadine, like other antihistamines may cause your heart to beat faster (tachycardia) or you feel your heart beating (palpitations).
• are elderly.

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially important for the following medicines:

• Erythromycin (an antibiotic)
• Ketoconazole (a treatment for fungal infections)

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 Histahive, by lowering the amount of medicinal product absorbed.

It is recommended that you leave about 2 hours between the time that you take Histahive and your indigestion remedy.

Histahive should be taken before meals with water.

If you are pregnant or breastfeeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Histahive 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.

Histahive contains Allura Red AC Lake, which may cause allergic reactions.

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 (180mg) daily. Take your tablet with water before a meal. This medicine starts to relieve your symptoms within 1 hour and lasts for 24 hours.

If the symptoms of allergic skin reactions persist, or gets worse or other symptoms appear, you should stop the treatment and consult a doctor.

Do not exceed the stated dose. Do not give to adolescents below 12 years of age.

If you have accidentally taken more than this leaflet recommended, contact the nearest hospital emergency department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.

The most common signs of overdose are dizziness, drowsiness, fatigue and dry mouth.

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

Tell your doctor if you want to stop taking Histahive before you have finished your course of treatment. If you stop taking Histahive earlier than planned, your symptoms may return.

• swelling of the face, lips, tongue or throat and difficulty breathing

The following side effects have also been reported:

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.

Not known (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 reaction which can cause swelling of the face, lips, tongue or throat, flushing, chest tightness
• 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 website: 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 film-coated tablet contains 180mg of fexofenadine hydrochloride; equivalent to 168mg of fexofenadine.

The other ingredients (excipients) are:

Tablet core: powdered cellulose, mannitol (E421), maize starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.

Tablet coating: opadry pink film-coating mixture containing hypromellose (E464), titanium dioxide (E171), macrogol 400, allura red AC lake (FD&C Red #40) (E129), and iron oxide, black (E172)

Histahive Tablets are pink coloured, oval, tablets marked with “FXF” on one side and “180” on the other side.

Histahive Tablets are packed in blister strips packaged in cartons.

The cartons contain 7, 10, 14, 15, 20, 21, 28 or 30 Tablets. Not all packs may be marketed.