Fexxtab Film-Coated Tablets

FEXXTAB contains fexofenadine hydrochloride, which belongs to a group of medicines called antihistamines. FEXXTAB is used in adults and adolescents of 12 years and older to relieve the symptoms of:

• FEXXTAB 120: Hay fever (seasonal allergic rhinitis), such as sneezing, itchy, runny or blocked nose and red, itchy and watery eyes.
• FEXXTAB 180: Long term allergic skin reactions (chronic idiopathic urticaria) such as itching, swelling and rashes.

Do not take FEXXTAB:

• If you are hypersensitive (allergic) to fexofenadine hydrochloride or any of the other ingredients of FEXXTAB (listed in section 6).
• If you are pregnant or breastfeeding since the safety has not yet been established.

Warnings and precautions

Take special care with FEXXTAB and talk to your doctor:

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

If any of these apply to you, or you are not sure, please inform you doctor or pharmacist before taking FEXXTAB.

Children and adolescents

Do not give FEXXTAB to children under the age of 12 years because the safety and effectiveness of FEXXTAB in this age group has not been studied.

Do not share medicines prescribed for you with any other person. Always take FEXXTAB exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults and adolescents aged 12 years and over

The usual dose for adults and children aged 12 years and older is:

• For hay fever (seasonal allergic rhinitis): One 120 mg tablet daily.
• For long term allergic skin reactions (chronic idiopathic urticaria): One 180 mg tablet daily.

The tablets should be swallowed with liquid and should not be chewed. FEXXTAB should not be broken because the coating is intended to make sure that the medicines are released over a long period.

If you have the impression that the effect of FEXXTAB is too strong or too weak, tell your doctor or pharmacist.

If you take more FEXXTAB than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. The most common signs of overdose are dizziness, drowsiness and dry mouth.

If you forget to take FEXXTAB

If you have missed your dose by only a few hours, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take FEXXTAB at the next regularly scheduled time. Do not take a double dose of FEXXTAB to make up for forgotten individual doses.

If you stop taking FEXXTAB

Tell your doctor or pharmacist if you want to stop taking FEXXTAB before you have finished your course of treatment. If you stop taking FEXXTAB earlier than planned, your symptoms may return. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

FEXXTAB can have side effects. Not all side effects reported for FEXXTAB are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FEXXTAB, please consult your health care provider for advice.

If any of the following happens, stop taking FEXXTAB and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to FEXXTAB. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Changes in the way your heart beats, for example, if you notice it beating faster or irregular. This is a serious side effect. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Headache, drowsiness, dizziness,
• Nausea (feeling sick).

Less frequent side effects:

• Chest tightness, swelling, flushing,
• Tiredness, difficulty sleeping (insomnia), nervousness and sleep disorders or paranoia (nightmares/excessive dreaming),
• Skin rash and itching, hives.

Side effects with unknown frequency:

• Blurred vision
• Fast heart rate or a sensation that your heart is racing, pounding, fluttering or skipping a beat.
• Diarrhoea.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of FEXXTAB.

Store all medicines out of reach of children. Store at or below 30 ºC. Protect from light and moisture. Do not take after the expiry date stated on the package. Return all unused medicine to your pharmacist. Do not dispose of unused tablets in drains or sewerage systems (e.g., toilets).