Properties
What is it?
PARLAZIN® (Cetirizine) Oral Drops 10 mg/ml Read the package leaflet carefully before you start taking this medicine, as it contains important information for you - Keep this package leaflet. You may need to read it again - If you have any further questions, ask your doctor or pharmacist - If you get any side effects, including any possible side effects not listed in this leaflet (see section 4), talk to your doctor or pharmacist This package leaflet contains the following information: 1. What PARLAZIN® drops are and what they are used for 2. What you need to know before taking PARLAZIN® drops 3. How to take PARLAZIN® drops 4. Possible side effects 5. How to store PARLAZIN® drops 6. Expiry date 7. How to dispense from the pharmacy 8. Package contents and other information 1. What PARLAZIN® drops are and what they are used for Cetirizine dihydrochloride is the active substance in PARLAZIN®. PARLAZIN® is an anti-allergic medicine. PARLAZIN® drops are used to treat the following allergic conditions in adults and children from 1 year of age: - Symptoms of watery eyes and runny nose in allergic seasonal and perennial rhinitis (hay fever) - Itchy allergic skin conditions - Symptoms of chronic urticaria (chronic idiopathic urticaria) Consult your doctor for advice if your condition improves or worsens. See blog: What is Parlazin and how does it help our body? 2. What you need to know before taking PARLAZIN® drops Do not take PARLAZIN® drops: - If you are allergic to cetirizine (the active substance of the medicine), hydroxyzine or piperazine (substances similar to those in other medicines) or any of the other ingredients of this medicine listed in section 8. - If you have severe kidney disease (severe renal insufficiency with a creatinine clearance of less than 10 ml/min). Precautions for medical use Before starting to take PARLAZIN® drops, consult your doctor or pharmacist. If you have any of the following conditions, consult your doctor before taking this medicine: - If you have kidney disease - If you are prone to urinary retention (e.g., due to spinal cord injury, bladder disease or enlarged prostate) - If you have epilepsy or are at increased risk of seizures No significant interactions have been observed between alcohol (blood alcohol level of 0.5%, equivalent to one glass of wine) and the normally recommended doses of cetirizine. Nevertheless, as with other antihistamines, it is recommended to avoid consuming alcoholic beverages. As with other antihistamines, you should stop taking this medicine at least 3 days before performing planned allergic skin tests to avoid false negative results. Children and adolescents under 18 years of age PARLAZIN® drops are intended for children over 1 year of age. This medicine should not be used in children under 1 year of age, as the efficacy and safety of cetirizine in children under 1 year of age have not been established. Other medicines and PARLAZIN® drops Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or plan to take. Based on the profile of cetirizine, interactions with other medicines are not expected. Taking PARLAZIN® drops with food, drink and alcohol Food does not significantly affect the absorption of cetirizine. No significant interactions between cetirizine and alcohol (at a blood level of 0.5%, equivalent to one glass of wine) have been observed. Nevertheless, as with other antihistamines, avoid consuming alcohol while taking PARLAZIN®. Fertility, pregnancy and breastfeeding Pregnancy If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. As with other antihistamines, the use of PARLAZIN® is not recommended during pregnancy. Accidental intake of PARLAZIN® during pregnancy does not have an adverse effect on the fetus; however, this medicine should only be used during pregnancy in cases of extreme necessity, on the recommendation of a doctor. Breastfeeding Cetirizine is excreted in breast milk. Therefore, PARLAZIN® should not be taken during lactation unless recommended by your doctor. If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to have a baby, ask your doctor for advice before taking any medicine. Effects on ability to drive and use machines Clinical studies have not shown any deterioration in concentration or impairment of driving ability after taking cetirizine at recommended doses. If you plan to drive or operate machinery that requires full concentration, do not exceed the recommended dose of the medicine. Observe your reaction to this medicine. If you find that you are sensitive to the medicine, it is possible that its use in combination with alcohol and other central nervous system depressants may have an additional effect on attention and reaction time. PARLAZIN® drops contain parahydroxybenzoates as excipients, which may cause delayed allergic reactions. 3. How to take PARLAZIN® drops Always take PARLAZIN® drops exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. Dosage regimen Adults: 10 mg, i.e., 20 drops once a day Children and adolescents: Children and adolescents from 12 years of age: 10 mg, i.e., 20 drops once a day Children 6-12 years: 5 mg, i.e., 10 drops twice a day. Children 2-6 years: 2.5 mg, i.e., 5 drops twice a day. The recommended dose is 2 x 2.5 mg (2 x 5 drops) per day. Children 1-2 years of age: 2.5 mg, i.e., 5 drops twice a day. Patients with moderate to severe renal impairment: If you have kidney disease, consult your doctor. Your doctor will adjust the dose of the medicine. Duration of treatment: The duration of treatment depends on the type, duration and nature of your symptoms. If you take more PARLAZIN® drops than you should If you take more than the prescribed dose, consult your doctor. Your doctor will decide what measures (if any) should be taken. Overdose may lead to the undesirable effects listed below, but with greater intensity. The following undesirable effects have been reported: confusion, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, nervousness, sedation, somnolence, stupor, increased heart rate, tremor, urinary retention. If you forget to take PARLAZIN® drops If you miss a dose, take it as soon as you remember. However, if it is already time for the next dose, do not take the missed dose; take your usual dose. Do not take a double dose of PARLAZIN® to make up for a missed dose. This will not compensate for the missed dose but will increase the risk of overdose. If you stop taking PARLAZIN® drops Consult your doctor about further treatment. Method of administration The drops are taken orally. If you have any further questions about the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. If any of the following side effects occur, stop taking the medicine and contact your doctor immediately: - Severe allergic reaction causing swelling of the face or throat (angioedema) - Severe systemic reaction (anaphylactic shock) - Suicidal thoughts (thoughts of suicide or obsessive thoughts related to suicide) - Memory loss (amnesia), memory impairment - Inability to empty the bladder (urinary retention) - Fainting - Seizures Frequent side effects (affecting 1 to 10 out of 100 patients): - Somnolence (drowsiness) - Dizziness, headache - Runny nose, pharyngitis (sore throat) - Diarrhea (in children), nausea, dry mouth - Fatigue Uncommon side effects (affecting 1 to 10 out of 1,000 patients): - Agitation - Paresthesia (abnormal sensation on the skin) - Abdominal pain, diarrhea - Itching, rash - Asthenia (marked weakness), general feeling of discomfort Rare side effects (affecting 1 to 10 out of 10,000 patients): - Allergic reactions - Depression, hallucinations, aggression, confusion, insomnia - Seizures - Tachycardia (increased heart rate) - Changes in liver function - Urticaria (hives) - Swelling - Weight gain Very rare side effects (affecting less than 1 out of 10,000 patients): - Thrombocytopenia (reduced number of blood platelets) - Severe allergic reactions with swelling of the face or throat (angioedema), severe systemic reaction (anaphylactic shock), fixed drug eruption (rash that appears in the same place) - Tics (sudden, abnormal, repetitive muscle movements), tremor - Fainting - Taste disturbance - Blurred vision, accommodation disorder (inability to focus on images with the eye), oculogyric symptoms (involuntary, circular eye movements) - Urinary disorders (nocturnal enuresis, painful or difficult urination) Frequency not known (cannot be estimated from available data): - Increased appetite - Suicidal thoughts (thoughts of or related to suicide, obsessive thoughts) - Memory loss, memory impairment - Vertigo (dizziness accompanied by a sensation of spinning) - Urinary retention (inability to completely empty the bladder) Reporting of side effects If you get any side effects, including any possible side effects not listed in this leaflet, talk to your doctor or pharmacist. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store PARLAZIN® drops Store at a temperature not exceeding 25°C, protected from light and out of reach of children! 6. Expiry date The expiry date is indicated on the packaging. Do not use the medicine after the expiry date indicated on the packaging. The expiry date is the last day of the month indicated. After opening the bottle, the medicine can be used for 4 weeks. Do not use this medicine if you notice signs of deterioration in quality. Medicines should not be disposed of in household waste or running water. If you need to dispose of the medicine in the trash, consult your pharmacist. These measures will help prevent environmental pollution. 7. How to dispense from the pharmacy Available without a prescription. 8. Package contents and other information What PARLAZIN® drops contain Active substance: 10 mg cetirizine dihydrochloride per milliliter of solution. Excipients: Glycerol 85%, propylene glycol, sodium saccharin, sodium acetate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glacial acetic acid, purified water. Appearance and contents of PARLAZIN® drops Appearance: A clear, sweet liquid without sediment, with a slight characteristic odor of acetic acid. Packaging: A 20 ml brown glass bottle with a dropper and a PP cap with an inner PE layer, with a special child-resistant closure and first-opening control. One bottle is placed in a cardboard box with the package leaflet. Dispensing: Pharmaceutical product group - II, dispensed with prescription form №3
