Properties
What is it?
ALLERSET® TAKEN ORALLY • Active substance: Cetirizine dihydrochloride Each ml of syrup contains 1 mg of cetirizine dihydrochloride. • Excipients: Sorbitol solution (E420), Glycerin, Propylene glycol, Sodium saccharin, Banana flavor, Sodium acetate, Methylparahydroxybenzoate (E218), Propylparahydroxybenzoate (E216) and Deionized water. Please read the patient information leaflet carefully before using the medicine, as it contains important information for you. • Keep the patient information leaflet. You may need to read it again. • For additional questions, please consult your doctor or pharmacist. • This medicine has been prescribed for you personally; do not pass it on to others. • Before using this medicine, tell your doctor that you are using this medicine during your visit to the doctor or pharmacist. • Please follow the instructions. Do not use a dose higher or lower than recommended. In the patient information leaflet: 1. What is ALLERSET® and what is it used for? 2. Before you start using ALLERSET® 3. How to use ALLERSET®? 4. What are the possible side effects? 5. Storage of ALLERSET® 1. What is ALLERSET® and what is it used for? ALLERSET® is presented in a honey-colored bottle containing 200 ml of syrup, with a 5 ml plastic measuring spoon. It is a colorless, almost transparent solution. ALLERSET® syrup is a medicine used to treat allergic rhinitis and urticaria, which are long-lasting and have an unknown cause. ALLERSET® syrup in children aged 2 years and older and in adults: • is used to treat allergic rhinitis associated with the nose and eyes, and to treat the symptoms of chronic idiopathic urticaria (persistent hives of unknown cause) and itching. 2. Before you start using ALLERSET® ALLERSET® must not be used in the following cases: • If you are allergic to the active substance of ALLERSET® or any of the ingredients, hydroxyzine or piperazine derivatives. • If you have severe renal failure (renal failure with a creatinine clearance of less than 10 ml/min (creatinine clearance, used to monitor kidney function)), do not use this medicine. • If your doctor has told you that you have an intolerance to a specific type of sugar (you are sensitive to such sugars), you should contact your doctor before taking this medicinal product. Use ALLERSET® with caution in the following cases: • Be careful if you are taking ALLERSET® with alcohol. • If you have problems with urination (spinal problems or prostate or bladder problems), consult your doctor for advice. • If you need an allergy test, consult your doctor to determine whether you should stop treatment with ALLERSET® a few days before the test, as ALLERSET® may alter the results of allergy tests. If you have ever had these problems, even in the past, consult your doctor for advice. Use of ALLERSET® with food and drink ALLERSET® can be taken before or after meals. Pregnancy • Please consult your doctor or pharmacist before using this medicine. • Clinical data available on the use of cetirizine dihydrochloride in pregnant women are very limited. Although studies in animals have not shown harmful effects, the use of cetirizine dihydrochloride is recommended only when absolutely necessary. • If pregnancy is confirmed during treatment, be sure to inform your doctor or pharmacist. Lactation If you are breastfeeding, consult your doctor or pharmacist before taking this medicine. Since the active substance of ALLERSET® (cetirizine) passes into breast milk, it is not recommended to take ALLERSET® during breastfeeding. Use of the medicine while driving or operating machinery Cetirizine dihydrochloride at a recommended dose of 10 mg did not show any clinically significant effect on driving ability, sleep, and the vigilance test (a test sensitive to all variations during sleep that are responsible for behavior in a real work environment. It is used to determine the sedative/somnolent effect of the drug). Patients who plan to drive or perform potentially hazardous work should not exceed the recommended dose and their reaction to the drug should be taken into account. In such patients, the use of ALLERSET®, along with alcohol and central nervous system depressants, can lead to reduced alertness and behavioral disturbances. Important information about some excipients in ALLERSET® ALLERSET® syrup contains sorbitol. If your doctor has told you that you are sensitive to specific types of sugars, consult your doctor or pharmacist for advice. Methylparahydroxybenzoate (E218) and Propylparahydroxybenzoate (E216) contained in ALLERSET® syrup may cause allergic reactions (possibly delayed). Interactions with other medicines ALLERSET® has no known clinically significant interactions with other medicines. If you are taking or have recently taken any prescription or over-the-counter medicine, please inform your doctor or pharmacist. 3. How to use ALLERSET® Instructions for appropriate use and frequency of dosage: Children aged 2-6 years: 2.5 mg once a day (half a spoon) (2.5 mg/2.5 ml syrup). In this age group, the daily dose can be increased to 5 mg once a day (a full spoon) (5 mg/5 ml syrup) or 2.5 mg twice a day (every 12 hours) (half a spoon) (2.5 mg/2.5 ml syrup). Children aged 6-12 years: 5 mg once a day (a full spoon) (5 mg/5 ml syrup) or 10 mg (2 full spoons) (10 mg/10 ml syrup) depending on the severity of symptoms, or the daily dose is divided into two. Children aged 12 years and older and adults: 5 mg (a full spoon) (5 mg/5 ml syrup) or 10 mg (2 full spoons) (10 mg/10 ml syrup) depending on the severity of symptoms. Route and method of administration ALLERSET® is for oral use only. Different age groups Use in children: The use of ALLERSET® in children under 2 years of age is not recommended. Use in the elderly: If kidney function is normal, dose reduction is not necessary. Special conditions of use: Renal/hepatic insufficiency If you have renal and hepatic insufficiency, the dose will be adjusted by the doctor according to the severity of renal insufficiency. In children with renal insufficiency, the dose should be adjusted by the doctor based on kidney function and body weight. Patients with hepatic insufficiency only may take the regular prescribed dose. Dose adjustment is recommended in patients with both renal and hepatic insufficiency. If you are unsure whether ALLERSET® is too weak or too strong, consult your doctor or pharmacist. If you have taken more ALLERSET® than you should have. If you have taken more ALLERSET® than you should have, consult your doctor or pharmacist. If you forget to take ALLERSET® Continue taking the medicine as prescribed by your doctor. Do not double the dose to compensate for a missed dose. Effects that may occur after stopping treatment with ALLERSET® The duration of treatment with ALLERSET® depends on the course of the disease and clinical symptoms. 4. What are the possible side effects? Like all medicines, side effects can occur in patients who are sensitive to the components of ALLERSET®. If any of the following events occur, stop taking ALLERSET® and inform your doctor immediately and go to the emergency department of the nearest hospital: Thrombocytopenia (reduction in the number of platelets (cells that cause blood clotting)). Anaphylactic shock (immediate hypersensitivity reaction) Hypersensitivity Confusion Hallucinations (seeing/hearing things that are not really there) Convulsions (involuntary muscle contractions, seizures) Syncope (fainting) Tremor Accommodation disorder (disorder of visual adaptation) Visual disturbances (involuntary movement of the eyeball in any direction) Tachycardia (increased heart rate) Liver function disorders (increase in transaminases, alkaline phosphatase, gamma-glutamyl transferase, and bilirubin) Angioneurotic edema (swelling of the hands, feet, ankles, lips, or specifically difficulty swallowing or breathing due to swelling of the mouth or throat). All of the above are acute side effects. If you experience any of them, it means you have a severe allergy to ALLERSET®. You may need emergency medical attention or hospitalization. All these side effects are reported very rarely. If you experience any of the following side effects, you should inform your doctor: Fatigue Feeling of confusion Headache Dry mouth Somnolence (drowsiness) Rhinitis (cold) Pharyngitis (inflammation of the pharyngeal mucosa) Diarrhea Aggression (aggressiveness) Agitation (excessive irritability) Amnesia Memory impairment Insomnia Tic Taste disturbance Dyskinesia (difficulty with movement) Paresthesia (temporary loss of sensation, numbness/tingling sensation) Itching Rash Urticaria (hives) Drug eruption Dysuria (painful urination) Enuresis (urinary incontinence) Asthenia (weakness) Malaise Weight gain Abdominal pain Depression Edema Dystonia (involuntary muscle contractions, spasms or movements) Increased appetite Suicidal thoughts Dizziness due to loss of balance (vertigo) Urinary retention, difficulty urinating. These are considered mild side effects of ALLERSET®. If you experience any side effect not listed in this leaflet, please inform your doctor or pharmacist. Reporting of side effects If a side effect occurs, whether listed in the instructions or not, consult your doctor, pharmacist, or nurse. By reporting side effects, you contribute to providing more information about the safety profile of the medicine you are using. 5. Storage of ALLERSET® Store ALLERSET® out of reach of children, in its packaging. Store at room temperature up to 25°C. Shelf life Do not use after the expiry date indicated on the packaging. Dispensing category: Pharmaceutical product group II, dispensed with prescription N3.
