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Package Leaflet: Information for the Patient [Product Name] 10 Mg Film Package leaflet: Information for the patient [Product Name] 10 mg film-coated tablets [Product Name] 25 mg film-coated tablets Hydroxyzine hydrochloride Read all of this leaflet carefully before you start taking 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, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. What [Product name] is and what it is used for Hydroxyzine belongs to the group of medicines called sedating antihistamines. It is thought to work by supressing some functions in the brain without being habit forming. [Product name] is used to treat: • Anxiety in adults • Itching (pruritus) caused by allergic reactions in adults and children 2. What you need to know before you take [Product name] Do not take [Product name]: • If you are allergic to hydroxyzine or any other ingredients of this medicine (listed in section 6) • If you are allergic to cetirizine, aminophylline, ethylene diamine or piperazine derivatives (closely related substance of other medicines) • If you suffer from porphyria (a metabolic disease) • If your ECG (electrocardiogram) shows a heart rhythm problem called “QT interval prolongation” • If you have or had a cardiovascular disease or if your heart rate is very low • If you have low salt levels in your body (e.g. low level of potassium or of magnesium) • If you are taking certain medicines for heart rhythm problems or medicines that may affect the heart rhythm (see “Other medicines and [Product name]”) • If anyone in your close family has died suddenly of heart problems • If you are pregnant or breast-feeding (see “Pregnancy, and breast-feeding”). Warning and precautions Talk to your doctor before taking [Product name] if: • You have an increased risk of getting fits (convulsions) • You have an increase in pressure in the eye (glaucoma) • You have obstructions in the urinary system • You have slow intestinal function • You have a severe muscle weakness (myasthenia gravis) • You have mental disorders (dementia) • You have heart problems. [Product name] may be associated with an increased risk of heart rhythm disorder which may be life threatening. Therefore, tell your doctor if you have any heart problems or are taking any other medicines, including medicines obtained without prescription. While taking [Product name], seek immediate medical attention if you experience heart problems such as palpitations, trouble breathing, loss of consciousness. Treatment with hydroxyzine should be stopped. A dose adjustment should be considered: • If you are taking medicines used in mental illness or drugs that affect the heart rhythm (see “Other medicines and [Product name]”), • In elderly patients, • If you have kidney disease, • If you have problems with your liver. Hydroxyzine should be used with caution in patients with risk factors for stroke. You should avoid drinking alcohol when you are taking [Product name] (see ‘[Product name] with food, drink and alcohol”). If you are undergoing allergy testing, treatment with [Product name] should be discontinued at least 5 days before the testing. If you suffer from any of the above conditions, consult your doctor or pharmacist about whether you may take hydroxyzine. Other medicines and [Product name] Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines obtained without prescription. [Product name] can affect or be affected by other medicinal products. Do not take [Product name] you are taking medicines to treat: - bacterial infections (e.g. the antibiotics erythromycin, moxifloxacin, levofloxacin) - fungal infections (e.g. pentamidine) - heart problems or high blood pressure (e.g. amiodarone, quinidine, disopyramide, sotalol) - psychoses (e.g. haloperidol) - depression (e.g. citalopram, escitalopram) - gastro-intestinal disorders (e.g. prucalopride) - allergy - malaria (e.g. mefloquine) - cancer (e.g. toremifene, vandetanib) - drug abuse or severe pain (methadone) It is also important that you tell your doctor if you are taking any of the following medicines: - Betahistine used to treat Meniere’s disease (problems with balance and hearing) - Anticholinergic medicines for the treatment of irritable bowel syndrome - Monoamine oxidase inhibitors used for the treatment of depression - Adrenaline used to treat severe allergic reactions. - Cimetidine used for the treatment of stomach problems. This may increase the level of Hydroxyzine in your blood. - Phenytoin used for the treatment of fits (convulsions). [Product name] may also interact with medicines which are metabolised by the liver. [Product name] with food, drink and alcohol The intake of alcohol together with [Product name] should be avoided, as this combination may enhance the sedative effects of [Product name]. Pregnancy and breast-feeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, [Product name] should not be used. Pregnancy Hydroxyzine crosses the placental barrier leading to higher foetal than maternal concentrations. To date, no relevant epidemiological data are available relating to exposure to hydroxyzine during pregnancy. In neonates whose mothers received [Product name] during late pregnancy and/or labour, the following events were observed immediately or a few hours after birth: hypotonia, movement disorders including extrapyramidal disorders, clonic movements, CNS depression, neonatal hypoxic conditions or urinary retention. Therefore, hydroxyzine is contraindicated during pregnancy. Breast-feeding [Product name] should not be used during breastfeeding. If treatment with [Product name] is necessary, breast-feeding should be discontinued. Driving and using machines [Product name] can impair reaction and concentration. You should be careful when driving or operating machinery. [Product name] contains lactose Lactose is a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 3. How to take [Product name] Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. [Product name] should be used at the lowest effective dose and the treatment period should be as short as possible. In adults and children over 40 kg in weight, the maximum daily dose is 100 mg per day in all indications. Symptomatic treatment of anxiety and concern: The usual adult dose: 50 mg a day in 2-3 divided doses. In severe cases, your doctor may increase this to a maximum of 100 mg per day. For itching: The usual adult dose: initial treatment of 1 tablet of 25 mg in the evening. Your doctor may increase the dose, if necessary by 25 mg, 3 to 4 times daily. Elderly In elderly patients it is recommended to start treatment with half the recommended dose due to the prolonged effect. In the elderly, the maximum daily dose is 50 mg per day. Renal impairment For patients with moderate or severe renal impairment, a dose reduction is recommended due to decreased excretion of its metabolite cetirizine. Hepatic impairment The total daily dose should be reduced by 33% in patients with hepatic impairment. Use in children Do not administer tablets in children under the age of 12 years or weighing less than 30 kg. In children up to 40 kg, the maximum daily dose is 2 mg/kg/day. In children over 40 kg in weight, the maximum daily dose is 100 mg/day. [Product name] 25 mg film-coated tablets: The tablet can be divided into equal doses. If you take more [Product name] than you should If you have used or taken too much [Product name], immediately contact [PT] Centro de Informação Antivenenos (808 250 143), [PL and IS] your doctor or hospital emergency department, in particular if a child has taken too much. In the event of overdose, symptomatic treatment could be implemented. An ECG monitoring could be undertaken, because of the possibility of a heart rhythm problem such as QT interval prolongation or Torsade de Pointes. Symptoms observed following a large hydroxyzine hydrochloride overdose has been mainly associated with CNS depression or paradoxical CNS stimulation. Symptoms include nausea, vomiting, tachycardia, pyrexia, sleepiness, impaired pupillary reflex, tremor, disorientation and hallucinations. These effects may be followed by depressed level of consciousness, respiratory depression, seizures or hypotension. Detailed coma and cardiorespiratory collapse may occur. Airway, breathing and circulatory status must be closely monitored with continuous ECG recording and an adequate oxygen supply should be available. Cardiac and blood pressure monitoring should be maintained until the patient is free of symptoms for 24 hours. Patients with altered mental status should be checked for simultaneous intake of other drugs or alcohol and should be given oxygen, naloxone, glucose, and thiamine if deemed necessary. Norepinephrine or metaraminol should be used if vasopressor is needed. Epinephrine should not be used. Syrup of ipecac should not be administered in symptomatic patients or those who could rapidly become obtunded, comatose or convulsing, as this could lead to aspiration pneumonitis. Gastric lavage with prior endotracheal intubation may be performed if a clinically significant ingestion has occurred. It is doubtful that hemodialysis or hemoperfusion would be of any value. There is no specific antidote. Literature data indicate that, in the presence of severe, life-threatening, intractable anticholinergic effects unresponsive to other agents, a therapeutic trial dose of physostigmine may be useful.
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