Package leaflet: Information for the patient

[Product Name] 10 mg film-coated tablets [Product Name] 25 mg film-coated tablets 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 . 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 , 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. ) - 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. - 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 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. Physostigmine should not be used just to keep the patient awake. If cyclic have been coingested, use of physostigmine may precipitate seizures and intractable cardiac arrest. Also avoid physostigmine in patients with cardiac conduction defects.

If you forget to take [Product name] If you forget to take a dose, take it as soon as you remember, unless it is almost time to take the next dose. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Undesirable effects are mainly associated with CNS depressant or paradoxical CNS stimulant effects, with anticholinergic activity or hypersensitivity reactions.

If you get any of the following symptoms after taking [Product name], stop taking the medicine and seek immediate medical attention:

The following side effects were identified in clinical trials: - Sleepiness, headache, fatigue, dry mouth.

The following side effects were reported:

Common (may affect up to 1 in 10 people):  Sleepiness.

Uncommon (may affect up to 1 in 100 people):  Enhanced restlessness, confusion.  Dizziness, insomnia, tremor.  Nausea.  Malaise, fever.

Rare (may affect up to 1 in 1,000 people):  Hypersensitivity  Disorientation, hallucinations  Seizures, dyskinesia (involuntary movements)  Accommodation disorders (difficulty focusing eyes), blurred vision  High heart rhythm  Constipation, vomiting  Changes in liver values  Itching, rash with redness, spots or blemishes, hives, dermatitis  Difficulty urinating.

Very rare (may affect up to 1 in 10,000 people):  Hypotension  Bronchospasm  Stevens-Johnson syndrome (an extremely severe allergic reaction with rash usually in the form of blisters or ulcers in the mouth and eyes and other mucous membranes)  Erythema multiforme (ring-shaped, red, often blistering rash, usually on the hands and feet)  Acute generalized exanthematous pustulosis (widespread rash with blisters term)  Fixed drug eruption  Increased sweating

Not known (frequency cannot be estimated from the available data):  Stop taking the medicine and seek immediate medical attention if you experience any problems with the heart rhythm such as palpitations, trouble breathing or loss of consciousness.

Reporting of adverse events If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You may also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

[Poland] Departament Monitorowania Niepożądanych Działań Produktów Leczniczych Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych Al. Jerozolimskie 181C PL-02 222 Warszawa Tel.: + 48 22 49 21 301 Faks: + 48 22 49 21 309 e-mail: [email protected]

Or

[Portugal] INFARMED, I.P. Direção de Gestão do Risco de Medicamentos Parque da Saúde de Lisboa, Av. Brasil 53 1749-004 Lisboa Tel: +351 21 798 73 73 Linha do Medicamento: 800222444 (gratuita) Fax: + 351 21 798 73 97 Sítio da internet: http://extranet.infarmed.pt/page.seram.frontoffice.seramhomepage E-mail: [email protected]

Or

[Iceland] til Lyfjastofnunar, www.lyfjastofnun.is.

5. How to store [Product name]

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and carton after “EXP”. The expiry date refers to the last day of that month.

Store at temperatures below 25 °C. Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What [Product name] contains - The active substance is hydroxyzine hydrochloride. Each film-coated tablet contains 10 mg hydroxyzine hydrochloride. Each film-coated tablet contains 25 mg hydroxyzine hydrochloride. - The other ingredients are: Core: microcrystalline cellulose; lactose monohydrate; silica colloidal anhydrous; magnesium stearate. Film coating: hypromellose (E464); titanium dioxide (E171); macrogol 6000.

What [Product name] looks like and contents of the pack [Product name] 10 mg film-coated tablets: white, round, convex film-coated tablets with a diameter of about 6 mm. [Product name] 25 mg film-coated tablets: white, round, biconvex film-coated tablets, scored on one side with a diameter of about 8 mm.

The tablets are packed in PVC/PVDC/Alu blisters and HDPE containers with HDPE/LDPE cap.

10 mg: Blister: 25 and 100 tablets. HDPE containers: 25, 100 and 250 tablets. 25 mg: Blister: 25 and 100 tablets. HDPE containers: 25, 100 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder <[To be completed nationally]> Manufacturer Viminco A/S Lodshusvej 11 4230 Skælskør Denmark

S.C. SANTA S. A. Str. Carpatilor nr. 60, obiectiv nr. 47, 48, 58, 133, 156, Brasov, Jud. Brasov, cod 500269, Romania

This medicinal product is authorised in the Member States of the EEA under the following names:

<{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}>

This leaflet was last revised in MM/YYYY.