1. What this product is and what it is used for What Loreta is Loreta is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms. Loreta 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 1 year of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes. Loreta 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. 2. What you need to know before you use this product Do not take Loreta - If you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of this medicine (listed in section 6) or to loratadine. Take Special Care with Loreta Talk to your doctor, pharmacist or nurse before taking Loreta: - If you have poor kidney function. - If you have medical or familial history of seizures. Use in children and adolescents Do not give this medicine to children less than 1 years of age. Using other medicines There are no known interactions of Loreta with other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Taking Loreta with food and drink Loreta may be taken with or without a meal. Pregnancy, breast-feeding and fertility Pregnancy Category C. 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 Loreta is not recommended if you are pregnant or nursing a baby. Fertility There is no data available 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 medicinal product. Loreta syrup contains sorbitol. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. 3. How to use this product. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Children 1 through to 5 years of age: 2.5ml (as marked on spoon) of Loreta syrup once a day. Children 6 through 11 years of age: The recommended dose is 5 ml (one 5 ml spoonful) of Loreta syrup once a day. Adults and adolescents 12 years of age and over: The recommended dose is 10 ml (two 5 ml spoonfuls) of Loreta syrup once a day. This medicine is for oral use. Swallow the dose of oral solution and then drink some water. You can take this medicine with or without food. 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 Loreta. 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 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 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 Loreta than you should Take Loreta only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Loreta than you were told to, tell your doctor, pharmacist or nurse immediately. If you forget to take Loreta 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 have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. During the marketing of Loreta, 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 were about the same as with a dummy solution or tablet. However, fatigue, dry mouth and headache were reported more often than with a dummy tablet. In clinical studies with Loreta, the following side effects were reported as: Children Common in children less than 2 years of age: the following may affect up to 1 in 10 children ● Diarrhoea ● Fever ● Insomnia Common: the following may affect up to 1 in 10 people ● Fatigue ● Dry mouth ● Headache During the marketing of Loreta, the following side effects were reported as: Very rare: the following may affect up to 1 in 10,000 people ● Severe allergic reactions ● Rash ● Pounding or irregular heartbeat ● Fast heartbeat ● Stomach ache ● Feeling sick (nausea) ● Vomiting ● Upset stomach ● Diarrhoea ● Dizziness ● Drowsiness ● Inability to sleep ● Muscle pain ● Hallucinations ● Seizures ● Restlessness with increased body movement ● Liver inflammation ● Abnormal liver function tests Not known: frequency cannot be estimated from the available data Adults: · Unusual weakness, · Yellowing of the skin and/or eyes · 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 · Change in the way the heart beats. Children · Slow heartbeat, · Change in the way the heart beats. If any of the side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet. Tell your doctor or pharmacist. 5. How to store this product ● Keep out of the reach and sight of children. ● Do not use Loreta after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. ● This medicine will be expired after 30 days from the first opening. ● Do not freeze. Store in the original package. ● Do not use this medicine if you notice any change in the appearance of the syrup. ● Store below 30°C. ● Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment