Properties
- Form
- khsnari
- Dosage mg
- 0.5მგ/
- Pack
- 1
What is it?
Instructions for use Sophalor® 0.5 mg/ml oral solution Sophalor® 0.5 mg/ml oral solution desloratadine Read this leaflet carefully before you start taking this medicine, as it contains important information for you. * Keep this leaflet. You may need to read it again. * If you have any further questions, ask your doctor, pharmacist, or nurse. * This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. * If you experience any side effects, tell your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What this leaflet contains: 1. What Sophalor is and what it is used for 2. What you need to know before you start taking Sophalor 3. How to take Sophalor 4. Possible side effects 5. How to store Sophalor 6. What Sophalor contains and other information. 1. What Sophalor is and what it is used for What Sophalor is Sophalor contains desloratadine, which is an antihistamine. How Sophalor works Sophalor - oral solution is a non-drowsy allergy medicine. It helps control the symptoms of allergic reactions and their symptoms. What Sophalor is used for Sophalor oral solution relieves the symptoms of allergic rhinitis (inflammation of the airways caused by allergies, such as hay fever or allergy to house dust) in adults, adolescents, and children aged 1 year and older. These symptoms include sneezing, itching and runny nose, itchy palate, itchy, red or watery eyes. Sophalor oral solution is also used to relieve the symptoms of urticaria (a skin condition caused by allergies), including itching and hives. Relief from these symptoms lasts throughout the day and helps you resume your normal daily activities and sleep. 2. What you need to know before you start taking Sophalor Do not take Sophalor * if you are allergic to desloratadine or any of the other ingredients of this medicine (listed in section 6), or to loratadine. Warnings and precautions Talk to your doctor, pharmacist, or nurse before taking Sophalor: * if you have impaired kidney function. Children and adolescents Do not give this medicine to children under 1 year of age. Other medicines and Sophalor Interactions between Sophalor and other medicines are unknown. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Taking Sophalor with food and drink Sophalor can be taken with or without food. Be cautious when taking Sophalor and alcohol. Pregnancy, breast-feeding 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; it is not recommended to use Sophalor if you are pregnant or breast-feeding. Fertility There is no data on fertility in men/women. Driving and using machines Your ability to drive and use machines is not expected to be affected when taking this medicine at the recommended dose. Although most people do not experience drowsiness, it is not recommended to perform activities that require concentration, such as driving and operating machinery, until you know how the medicine affects you. Sophalor contains sorbitol If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3. How to take Sophalor Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. Children: Children aged 1 to 5 years: The recommended dose is 2.5 ml of oral solution once daily. Children aged 6 to 11 years: The recommended dose is 5 ml of oral solution once daily. Use the oral syringe provided in the packaging to measure the recommended amount of oral solution. Adults and adolescents aged 12 years and over The recommended dose is 10 ml of oral solution once daily. Use the measuring cup or oral syringe provided in the packaging to measure the recommended amount of oral solution. This medicine is for oral use. After taking the oral solution dose, drink a small amount of water. You can take the medicine independently of meals. Duration of treatment – your doctor will determine the type of allergic rhinitis you have and, based on this, how long you should take Sophalor. If you have intermittent allergic rhinitis (symptoms present for less than 4 days a week or for less than 4 weeks), your doctor will recommend a treatment regimen based on the course of your illness. If you have persistent allergic rhinitis (symptoms present for more than 4 days a week or for more than 4 weeks), your doctor will recommend longer treatment. Different patients with urticaria may require different durations of treatment, so it is important to follow your doctor's recommendation. If you take more Sophalor than you should Take Sophalor only as prescribed. Accidental overdose is not expected to cause serious problems. However, if you do take more Sophalor than prescribed, seek advice from your doctor, pharmacist, or nurse immediately. If you forget to take Sophalor If you forget to take a dose of Sophalor, take it as soon as you remember, then continue taking it according to your prescribed schedule. Do not take a double dose to make up for a missed 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 post-marketing surveillance of desloratadine, there have been very rare reports of severe allergic reactions (difficulty breathing, wheezing, itching, hives, and swelling). If you notice any of these severe side effects, stop taking this medicine immediately and seek emergency medical help. In clinical trials in children and adults, side effects were practically the same as with placebo in most cases, whether taken as a solution or tablet. However, in children under 2 years of age, diarrhea, fever, and insomnia were more common compared to placebo, while in adults – fatigue, dry mouth, and headache. The following side effects were known during clinical trials with desloratadine: Children Common (in children under 2 years of age): may affect up to 1 in 10 children Diarrhea, fever, insomnia Adults Common: the following side effects may affect up to 1 in 10 people Fatigue, dry mouth, headache During post-marketing surveillance of desloratadine, the following side effects have been reported: Adults Very rare: the following events may affect up to 1 in 10,000 people * Severe allergic reactions * Increased heart rate * Vomiting, dizziness * Muscle pain * Increased motor activity * Rash * Abdominal pain * Indigestion * Drowsiness * Hallucinations * Liver inflammation * Palpitations or irregular heartbeat * Nausea * Diarrhea * Insomnia * Convulsions * Abnormal liver function tests. Frequency not known: cannot be estimated from the available data. * Unusual weakness * Yellowing of the skin and/or eyes * Photosensitivity – increased skin sensitivity to sunlight, even in weak sunlight, and increased sensitivity to ultraviolet (UV) radiation used in tanning beds. * Changes in heart rhythm * Abnormal behavior * Aggression Children Frequency not known: cannot be estimated from the available data. * Slowing of heart rate, changes in heart rhythm * Abnormal behavior * Aggression Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the National Agency for State Regulation of Medical Activities of the Ministry of Labour, Health and Social Affairs of Georgia. Address: Georgia, Tbilisi 0119, A. Tsereteli Ave. 144 By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store Sophalor Keep out of reach of children. Do not use this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month. Expiry date: 2 (two) years after first opening the bottle Expiry date: 3 (three) months. Store in the original packaging to protect from light. This medicine does not require any special storage temperature conditions. Do not take this medicine if you notice any change in the appearance of the oral solution. Do not dispose of medicines down the drain or into household waste containers. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. What Sophalor contains and other information. What Sophalor contains Active substance: desloratadine. Each milliliter of oral solution contains 0.5 mg of desloratadine. * Other ingredients of the oral solution: sorbitol, liquid (non-crystallizing) (E420), propylene glycol, sucralose (E 955), hypromellose 2910 (15 mPa.s), sodium citrate dihydrate, cherry flavor (D-limonene, benzaldehyde, alpha-terpineol, 2-phenylethanol, triacetin, propylene glycol), citric acid monohydrate, disodium edetate, and purified water. * Dispensing regime: Pharmaceutical product group III, available without prescription. Description and contents of Sophalor packaging Sophalor is a clear, colorless liquid with a cherry flavor. 120 ml of Sophalor is contained in dark brown glass (Type III) bottles of 125 ml capacity, with a child-resistant cap with a tamper-evident ring and a low-density polyethylene stopper. The packaging is supplied with a measuring cup with special graduations (graduations of 2.5 ml, 5 ml, 10 ml, 15 ml and 20 ml, or 2.5 ml, 3 ml, 7.5 ml, 10 ml, 12.5 ml, 15 ml and 20 ml) and a measuring syringe for oral use (graduations of 0.5 ml, 1 ml, 1.5 ml, 2 ml, 2.5 ml, 3 ml, 3.5 ml, 4 ml, 4.5 ml and 5 ml). Marketing Authorisation Holder: Sopharma AD, Iliensko Shose 16, 1220 Sofia, Bulgaria. Date of last revision of the leaflet: October 2017.
