Fenofex Tablets

Fenofex is an antihistamine which has an anti - allergy action. Fenofex 120 tablets are used to relieve symptoms like sneezing, itchy, runny nose, and itchy, red and watery eyes associated with hay fever (seasonal allergic rhinitis).

Fenofex 180 tablets are used to relieve symptoms such as swelling, itching and redness associated with an allergic skin condition known as chronic idiopathic urticaria.

Do not take Fenofex 120 or 180:

• If you are hypersensitive (allergic) to fexofenadine or any other ingredients of FENOFEX (listed in section 6). (An allergic reaction may include rash, itching, swelling of the lips or hands/feet or breathing difficulties).
• if you are pregnant or planning to become pregnant or are breast feeding.
• if you are a child under 12 years of age as safety and effectiveness of Fenofex 120 and 180 have not been established.

Warnings and precautions

Take special care with FENOFEX:

• If you are elderly or have problems with your kidneys and/ or liver.
• When you start taking Fenofex it may affect your ability to drive or use machinery.
• Fenofex tablets are not known to have sedative effects. However, a small number of patients may experience sedation.
• If you are taking alcohol or other medicines that cause sedation as you may experience sedation.
• You have ever had heart disease since this medicine may lead to fast or irregular heartbeat.

Other medicines and FENOFEX

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines). Care is needed if:

• You are taking erythromycin (an antibacterial, used for treating infections due to certain bacteria).
• You are taking ketoconazole (an antifungal, used for treating infections due to certain fungi).
• You are taking antacids containing aluminium hydroxide and magnesium hydroxide (used for treating indigestion). These products can reduce the absorption of fexofenadine. If it is essential that you take these products, it is recommended that you leave at least 2 hours between the time that you take Fenofex 120 or 180 tablets and your indigestion medicine.
• If you are taking medicines on a regular basis, including complementary or traditional medicines, the use of Fenofex 120 or 180 with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other health care professional for advice.

FENOFEX with food or drink

FENOFEX may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

Pregnancy: Do not take Fenofex if you are pregnant or planning to become pregnant.

Breastfeeding: If you are taking Fenofex you should not breastfeed your baby.

Driving and using machines

Fenofex causes dizziness and drowsiness which may affect your ability to drive or operate machinery.

Do not share medicines prescribed for you with any other person. Always take FENOFEX exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.

Adults and children aged 12 years and over:

• For the treatment of seasonal allergic rhinitis (hay fever) take one Fenofex 120 tablet once daily.
• For the treatment of chronic idiopathic urticaria take one Fenofex 180 tablet once daily.

Swallow the tablet whole with a glass of water.

Elderly and patients with liver or kidney disease

The starting dose for patients with liver disease or decreased kidney function is to take half a Fenofex 120 tablet once a day.

If you have the impression that the effect of Fenofex tablets is too strong or too weak, talk to your doctor or pharmacist.

If you have taken more FENOFEX than you should

You may feel dizziness, drowsiness and dry mouth. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Take this leaflet or some tablets with you so your doctor will know what you have taken.

If you forget to take FENOFEX

Take them as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses. To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

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

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

• Rashes, hives, itching, chest constriction, shortness of breath or swelling of the face, lips, tongue, hands/feet, fainting, high temperature. These are all very serious side effects. If you have them, you may have had a serious reaction to FENOFEX. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent:

• headache,
• dizziness,
• drowsiness,
• nausea.

Less frequent:

• sinus infections,
• viral infections such as cold or flu,
• hypersensitivity reactions with presentations such as tender red lumps under the skin, chest tightness, difficult or laboured breathing, flushing and severe allergic reactions,
• tiredness,
• insomnia,
• nervousness,
• sleep disorders or a nightmares/excessive dreaming (paroniria),
• dyspepsia,
• rash, urticaria and pruritis,
• dysmenorrhoea,
• fast or irregular heartbeat
• 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, pharmacist or nurse. 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 FENOFEX.

Store all medicines out of reach of children.

• Store at or below 25 °C, protected from moisture in the original carton.
• Protected from light/moisture.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems e.g. toilets.