Dazit® Film-Coated Tablets

DAZIT ® TABLETS contains a medicine called desloratadine. The active substance of DAZIT ® TABLETS belongs to the group of medicines called antihistamines. DAZIT ® TABLETS are indicated for the relief of symptoms associated with seasonal allergic rhinitis (sneezing, rhinorrhoea and itching of the eyes, nose and throat). DAZIT® TABLETS may also be used to relieve the symptoms associated with chronic idiopathic urticaria (itching, redness and number and size of hives).

Do not take DAZIT® TABLETS:

• If you are hypersensitive (allergic) to desloratadine or any of the ingredients (listed in section 6).
• If you are hypersensitive (allergic) to other medicines similar to DAZIT® TABLETS antihistamines for example loratadine.

Warnings and precautions

Take special care with DAZIT® TABLETS:

• If you have severe liver or kidney disease as the dosage you should take may need to be adjusted.
• If you suffer from the following diseases: - emphysema (shortness of breath, with a cough): - prostate problems; - narrow angle glaucoma (high pressure in the eye); - heart problems; - medical or family history of seizures

Inform your doctor before undergoing skin allergy test since DAZIT® TABLETS may interfere with the result of the test. DAZIT® TABLETS should be discontinued at least 48 hours before undergoing this test. The use of DAZIT® TABLETS has been associated with the risk of weight gain. Safety and efficacy of DAZIT® TABLETS have not been established for treatment periods in excess of 4 weeks.

Children and adolescents

Do not give this medicine to children under 12 years of age.

Other medicines and DAZIT® TABLETS

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Certain medicine can influence the mechanism of action of DAZIT® TABLETS and vice versa Medicines known to influence the effect of DAZIT ® TABLETS are medicines used for the treatment of:

• heartburn (such as cimetidine),
• anti-fungal (such as ketoconazole),
• antibiotic (such as erythromycin, azithromycin and clarithromycin),
• anti-depressant (such as fluoxetine) treatment.

Pregnancy, breastfeeding and fertility

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. Safety and efficacy in pregnancy and lactation has not been established. The use of DAZIT® TABLETS during pregnancy and breastfeeding is therefore not recommended.

Driving and using machines

DAZIT® TABLETS lack significant sedative effects. However some people may suffer sedation and blurred vision. Test your response before driving or performing complicated tasks.

Always take DAZIT® TABLETS exactly as your doctor or pharmacist has instructed you. Check with your doctor or pharmacist if you are not sure. The usual dose for adults older than 12 years of age: One tablet orally, once daily. Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take DAZIT® TABLETS. If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks) your physician will recommend you for a treatment schedule that will depend on the evaluation of the history of your disease. If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment. For chronic idiopathic urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.

If you take more DAZIT® TABLETS than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. The symptoms reported for overdosage in adults and children: are headache, sleepiness and rapid heart rate.

If you forget to take DAZIT® TABLETS

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for the forgotten individual doses. Continue to take the next tablet at the usual time.

If you stop taking DAZIT® TABLETS

Do not stop taking DAZIT® TABLETS unless your doctor tells you to do so. If you have further questions on the use of DAZIT® TABLETS, ask your doctor or pharmacist.

DAZIT® TABLETS can have side effects. Not all side effects reported for DAZIT® TABLETS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving DAZIT® TABLETS, please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happens, stop taking DAZIT® TABLETS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Puffiness or swelling of the hands, feet, ankles, face, lips or tongue, mouth or throat, which may cause difficulty in swallowing or breathing, tightness in chest and wheezing, shortness of breath. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DAZIT® TABLETS. 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:

• Less frequent: Changes in the way your heart beats, for example, if you notice it beating faster. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent: Headache.
• Frequent: Pharyngitis (body aches or pain, congestion, cough, hoarseness, runny nose).
• Frequent: Dry mouth.

Side-effects that require medical attention only if they become bothersome are the following:

• Frequent: Headache and pharyngitis (body aches or pain, congestion, cough, hoarseness, runny nose).
• Less frequent: Dizziness;
• Less frequent: Dry mouth;
• Less frequent: Difficult or painful menstruation;
• Less frequent: Acid or sour stomach;
• Less frequent: Unusual tiredness or weakness;
• Less frequent: Muscle aching or cramping;
• Less frequent: Nausea and vomiting;
• Less frequent: Blurred vision;
• Less frequent: Confusion;
• Less frequent: Nightmares;
• Less frequent: Sleepiness or drowsiness;
• Less frequent: Difficulty in sleeping;
• Less frequent: Seizures (epileptic fits);
• Less frequent: Agitation or increased feeling of restlessness (psychomotor hyperactivity);
• Less frequent: Diarrhoea;
• Less frequent: Stomach pain;
• Less frequent: Abnormal liver function tests;
• Less frequent: Rash or itchy skin;
• Less frequent: Hair loss;
• Less frequent: Extreme sensitivity to light and sunlight.

Frequency unknown: Yellowing of the skin and/or eyes (jaundice); Abnormal physical weakness or lack of energy (asthenia); Weight gain due to increased appetite. If you get side effects, talk to your doctor 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 DAZIT® TABLETS.

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Protect from light and moisture.
• Keep container tightly closed.
• Store in the original container
• Keep the container in the outer carton.
• Do not use after the expiry date stated on the label / carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).