Pollofex 120 mg/180 mg Film-Coated Tablets

Pollofex tablets belong to a group of medicines called antihistamines.

Pollofex 120 is used to treat and relieve symptoms of seasonal allergic rhinitis (hay fever).

Pollofex 180 is used to treat and relieve symptoms of chronic idiopathic urticaria (chronic hives).

Do not take Pollofex:

• if you are hypersensitive (allergic) to fexofenadine hydrochloride or any of the other ingredients of Pollofex (listed in section 6).
• if you are pregnant or breastfeeding.

Pollofex should not be given to children under the age of 12 years old as the safety and efficacy has not been studied.

Warnings and precautions

Take special care with Pollofex:

• if you are elderly
• if you have liver problems
• if you have kidney problems
• if you have a history of heart disease or ongoing heart disease, Pollofex may cause additional side effects (see Side Effects).

Children and adolescents

Do not give Pollofex to children under the age of 12 years old because the safety and efficacy has not been studied.

Other medicines and Pollofex

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

The following medicines may increase the level of Pollofex in your blood:

• erythromycin (an antibiotic)
• ketoconazole (a medicine used to treat fungal infections).

The following medicine may lower the amount of Pollofex in your blood:

• antacids, as it may decrease the absorption of Pollofex from your gut. It is advisable to take Pollofex and antacids containing aluminium and magnesium hydroxide at least 2 hours apart.

No interaction between Biotech Fexofenadine and the medicine omeprazole was observed.

Pollofex with food and drink

You may get drowsy or sleepy if you drink alcohol when taking Pollofex.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine. Do not take Pollofex if you are pregnant or breastfeeding your baby.

Driving and using machines

Pollofex is unlikely to affect your ability to drive or operate machinery. A small number of individuals may experience sedation. The simultaneous intake of alcohol or medicines called central nervous system depressants may lead to drowsiness and sedation.

It is not always possible to predict to what extent Pollofex may interfere with your daily activities. You should ensure that you do not engage in driving a vehicle or operate machines until you are aware of the measure to which Pollofex affects you.

Pollofex contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Pollofex.

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

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

• Pollofex 120: The usual dose is one 120 mg tablet once a day.
• Pollofex 180: The usual dose is one 180 mg tablet once a day.

If you have decreased kidney function, the recommended starting dose is 60 mg once daily.

Take your tablet orally. Swallow your tablet with some water, do not chew the tablet.

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

If you take more Pollofex than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms of overdose may include dizziness, drowsiness or a dry mouth.

If you forget to take Pollofex

Do not take a double dose to make up for forgotten individual doses.

If you stop taking Pollofex

The symptoms of your allergy may return if you stop taking Pollofex.

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

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

• swelling of the hands, feet, ankles, face, lips and 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 Pollofex. You may need urgent medical attention or hospitalisation.

Tell your doctor, pharmacist or nurse if the following side effects become bothersome:

Frequent side effects:

• headache
• drowsiness
• dizziness
• nausea

Less frequent side effects:

• difficulty sleeping, sleeping disorders or nightmares and excessive dreaming
• nervousness
• sinusitis, cold or flu
• indigestion
• menstrual cramps
• tiredness

Frequency unknown:

• rapid heartbeat, heart skipping a beat or fluttering.

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 Pollofex.

Store all medicines out of reach of children. Store in the original pack at or below 25 ˚C. Protect from light. Keep the blisters in the carton until required for use.