PATIENT INFORMATION LEAFLET

Transcription

1 ALORES 2.5mg/5ml Syrup For oral use. PATIENT INFORMATION LEAFLET Active substance(s): Each 5 ml syrup (1 spoon) contains desloratadine 2.5 mg. Excipient(s): Propylene glycol, sorbitol 70%, citric acid monohydrate, sodium citrate, sodium benzoate, sodium edetate, sucrose, strawberry flavor, FDC yellow no: 6, sodium hydroxide and deionized water. Read this PATIENT INFORMATION LEAFLET carefully before you start using this medicine, because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. If you go to a doctor or hospital during the use of this medicine, inform your doctor about this Follow the instructions in this leaflet exactly. Do not use higher or lower doses than the dose which was recommended for you. What is in this leaflet: 1. What ALORES is and what it is used for 2. Before you use ALORES 3. How to use ALORES 4. Possible side effects 5. How to store ALORES 1. What ALORES is and what it is used for? ALORES is packaged in bottle of 150 ml. ALORES is an antiallergic drug that does not cause somnolence. It helps control your allergic reaction and its symptoms. ALORES relieves symptoms of allergic rhinitis such as sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes (for example hay fever or allergy to dust mites). ALORES can also be used to treat symptoms such as itching with urticaria and to eliminate symptoms such as rash and redness. The elimination of these symptoms lasts all day and helps you to continue your normal daily activities and sleep. 2. Before you use ALORES Do not use ALORES in the following conditions: If; - You are allergic (hypersensitive) to desloratadine, loratadine, or to any of the other ingredients of ALORES especially coloring substance E110 FDC yellow no:6. 1

2 ALORES is indicated for children 1-11 years old, adolescents (12 years of age and older), and adults, including the elderly. TAKE SPECIAL CARE WITH ALORES in the following conditions If; - you have poor kidney function. Please consult your doctor, even if these statements were applicable to you at any time in the past. Using ALORES with food and drink ALORES may be taken with or without a meal. Pregnancy: Ask your doctor or pharmacist for advice before using the medicine. If you are pregnant, do not use ALORES. If you notice that you are pregnant during treatment, please consult your doctor or pharmacist immediately. Breastfeeding: Ask your doctor or pharmacist for advice before using the medicine. If you are breastfeeding, do not use ALORES. Effects on ability to drive and use machines At the recommended doses, it is unlikely that ALORES will cause you to develop sleepiness or decrease your attention. However, ALORES may cause somnolence in some patients even if it is very rare. This can affect your ability to drive and use the machine. Important information about some of the ingredients of ALORES ALORES contains sucrose and sorbitol. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before using ALORES. ALORES contains FDC yellow no:6 coloring agent which may cause allergic reactions. This medicinal product contains less than 1 mmol (23 mg) sodium. No adverse effect associated with it is expected. Using with other medicines There are no known interactions of ALORES with other medicines. Please tell your doctor or pharmacist if you are taking or have recently taken any other prescription or nonprescription medicine. 3. How to use ALORES? Instructions for appropriate method and dose/frequency of administration: Children 1-5 years: take 2.5 ml (½ of a 5 ml spoonful) of syrup once a day. Children 6-11 years: take 5 ml (one 5 ml spoonful) of syrup once a day. Adults and adolescents (12 years of age and older): take 10 ml (two spoons of 5 ml) of syrup once a day. 2

3 You can take this medicine with or without food. Regarding the duration of treatment, your doctor will determine the type of allergic rhinitis and tell you how long you should use ALORES. If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your doctor will recommend 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 doctor may recommend 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 doctor. Route and method of administration: Swallow the dose of syrup, and then drink some water. You can take this medicine with or without food. Different age groups: Use in children: ALORES is used in children 1 year and older. Use in elderly: The efficacy and safety of ALORES has not been established in elderly patients. Special populations Liver failure: There is no data on patients with liver failure. Kidney failure: In severe kidney failure, ALORES should be used with caution. If you have the impression that the effect of ALORES is too strong or too weak, talk to your doctor or pharmacist. If you have used more ALORES than you should: Take ALORES only as it is prescribed for you. No serious problems are expected with accidental overdose. If you may have taken more ALORES than you should, talk to a doctor or pharmacist. If you forget to use ALORES Do not use a double dose to make up for a forgotten dose. If you forget to take your dose on time, take it as soon as possible. Continue to take it again at the recommended dose according to the subsequent normal intake time. If you stop using ALORES None. 3

4 4. Possible side effects Like all medicines, side effects can occur in people sensitive to the contents of ALORES. Side effects in adults are similar to placebo (a type of drug without therapeutic properties). However, common side effects in children less than 2 years old were diarrhea, fever and insomnia while in adults fatigue, dry mouth and headache were reported more often than with placebo. Side effects are classified as shown in the following categories Very common: may be seen at least 1 in 10 patients Common: may be seen less than one in 10 patients but more than one in 100 patients Uncommon: may be seen less than one in 100 patients but more than one in 1000 patients Rare: may be seen less than one in 1000 patients but more than one in patients Very rare: may be seen less than one in patients Unknown: it cannot be estimated from the available data. Common: fatigue Uncommon: dry mouth headache Very rare: allergic reactions (difficulties in breathing, wheezing, itching, urticaria (hives), rash) hallucinations stroke restlessness with increased body movement palpitations fast heartbeat abnormal liver function tests liver inflammation drowsiness excessively physical and mental state of hyperactivity stomach ache, nausea (feeling sick), vomiting diarrhea insomnia somnolence muscle pain bloating If you notice any side effects not mentioned in this leaflet inform your doctor or pharmacist. 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 via clicking Reporting of Drug Side Effects icon on the website or Turkish Pharmacovigilance Center (TUFAM) by calling the phone number for side 4

5 effects reporting line. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store ALORES? Keep in the original package and out of the reach and sight of children. Store in room temperature under 25 C. Use in accordance with expiry date. Do not use ALORES after the expiry date which is stated on the packaging. Do not use ALORES if you notice any damage to the product and/or package. Marketing Authorization Holder: Berko İlaç ve Kimya San.A.Ş. Yenişehir Mah. Özgür Sok. No: Ataşehir/İstanbul (Pbx) (Fax) Manufacturer: Berko İlaç ve Kimya San.A.Ş. Adil Mah. Yörükler Sok. No: 2 Sultanbeyli/ İstanbul (Pbx) (Fax) This patient information leaflet was approved on 04/01/2016 5