Dazit ® 2,5 mg/5 ml Syrup

What DAZIT ® SYRUP is DAZIT ® SYRUP contains desloratadine which is an antihistamine

How DAZIT ® SYRUP works DAZIT ® SYRUP is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.

When DAZIT ® SYRUP should be used DAZIT ® SYRUP relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults, adolescents and children 2 year of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes. DAZIT ® SYRUP is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives. Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.

Do not take DAZIT ® SYRUP: If you are allergic to desloratadine, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Take special care with DAZIT ® SYRUP: if you have poor kidney function if you have medical or familial history of fits (seizures) if you have fructose/glucose/sucrose intolerance

Safety of this medicine has not been reported beyond 4 to 6 weeks. Do check with your doctor if you have to take this medicine for longer duration.

Children and adolescents

Do not give this medicine to children less than 2 years of age.

Other medicines and DAZIT ® SYRUP

Always tell your healthcare professional if you are taking any other medicine. (This Includes complementary or traditional medicine). There are no known interactions of DAZIT ® SYRUP with other medicines.

DAZIT ® SYRUP with food

DAZIT ® SYRUP may be taken with or without food.

DAZIT® SYRUP with alcohol

Use caution when taking DAZIT ® SYRUP with alcohol.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Taking DAZIT ® SYRUP is not recommended if you are pregnant or nursing a baby. There is no data reported on male/female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicine.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Use in children

Children 2 to 5 years of age: The recommended dose is 2,5 mL (½ of a 5 mL spoonful) of oral solution once a day.

Children 6 to 11 years of age: The recommended dose is 5 mL (one 5 mL spoonful) of oral solution once a day.

Use in adults and adolescents 12 years of age and over: The recommended dose is 10 mL (two 5 mL spoonful) of oral solution once a day. In case an oral measuring syringe is provided with the medicine, you can alternatively use it to take the appropriate amount of the medicine dose.

Method of administration

This medicine is for oral use. You can take this medicine with or without food.

If you take more DAZIT ® SYRUP than you should

Take DAZIT ® SYRUP only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more DAZIT ® SYRUP than you were told to, tell your doctor, pharmacist or nurse immediately.

If you forget to take DAZIT ® SYRUP

If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking DAZIT ® SYRUP

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the marketing of desloratadine, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away. In clinical studies in most children and adults, side effects reported with desloratadine were about the same as reported with a dummy solution or tablet. However, common side effects reported in children less than 2 years of age were diarrhoea, fever and insomnia while in adults, fatigue, dry mouth and headache were reported more often than with a dummy tablet.

If any of the following happens, stop taking DAZIT® SYRUP and tell your doctor immediately or go to the casualty department at your nearest hospital: Severe allergic reactions (anaphylaxis, angioedema): Swelling of the face, mouth, tongue, throat, hands, or feet, and/or a raised itchy rash (hives), trouble swallowing or breathing (dyspnoea). These are all very serious side-effects. If you have them, you may have had a serious allergic reaction to DAZIT® SYRUP. 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: Irregular heart beat (QT prolongation) Liver inflammation (Hepatitis): The symptoms of hepatitis are nausea (feeling sick) or vomiting (being sick), loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine Fits (seizures)

These are all serious side-effects. You may need urgent medical attention. Other side-effects: Tell your doctor if you notice any of the following: Frequent side effects: Headache Difficulty in sleeping (Insomnia); Frequent in children less than 2 years Dry mouth Loose stool (diarrhoea); Frequent in children less than 2 years Tiredness (fatigue) Fever (frequent in children less than 2 years) Less frequent side effects: Seeing or hearing things that are not there (Hallucinations) Dizziness, Sleepiness (somnolence) Difficulty in sleeping (insomnia) Excessive mobility and impulsivity preventing normal functioning (psychomotor hyperactivity) Fast heart beats (tachycardia) Palpitations Abdominal (belly) pain, Feeling unwell (nausea) Vomiting Indigestion (dyspepsia) Loose motions (diarrhea) Abnormal liver function tests Muscle pain (myalgia) Itching (pruritus) Rash Hives (urticaria) Side effects with frequency unknown: Increased appetite Abnormal behaviour, aggression Yellowing of the skin and/or eyes (jaundice) Increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium (photosensitivity) Unusual weakness (asthenia) Weight increased If you notice any other 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 DAZIT® Syrup.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Store at or below 30 °C. Protect from light 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).