Package leaflet: Information for the user

Hydroxyzine hydrochloride 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.

•    The name of this medicine is Hydroxyzine hydrochloride 25 mg film-coated tablets but it will be referred to as Hydroxyzine tablets throughout this leaflet.

What is in this leaflet

1.    What Hydroxyzine tablet is and what it is used for

2.    What you need to know before you take Hydroxyzine tablets

3.    How to take Hydroxyzine tablets

4.    Possible side effects

5.    How to store Hydroxyzine tablets

6.    Contents of the pack and other information

1.    What Hydroxyzine tablet is and what it is used for

Hydroxyzine tablet belongs to the group of medicines called sedating antihistamines. It is thought to work by inhibiting some activity in the brain.

Hydroxyzine tablets are used to treat:

•    Anxiety in adults

•    Itching (pruritus) caused by allergic reactions in adults and children over 6 years of age.

2.    What you need to know before you take Hydroxyzine tablets

Hydroxyzine tablets 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 Hydroxyzine tablets, seek immediate medical attention if you experience heart problems such as palpitations, trouble breathing, loss of consciousness. Treatment with hydroxyzine should be stopped.

Do not take Hydroxyzine tablet if:

•    You are allergic to hydroxyzine hydrochloride or any of the other ingredients of Hydroxyzine tablets (listed in section 6)

•    You are allergic to cetirizine, other piperazine derivatives, aminophylline or ethylenediamine

•    You are pregnant or breastfeeding

•    You have a condition called porphyria (A blood disease that can cause stomach pain, vomiting and mental disturbances such as depression)

•    Your ECG (electrocardiogram) shows a heart rhythm problem called “QT interval prolongation”

•    You have or had a cardiovascular disease or if your heart rate is very low

•    You have low salt levels in your body (e.g. low level of potassium or of magnesium)

•    You are taking certain medicines for heart rhythm problems or medicines that may affect the heart rhythm (see “Other medicines and Hydroxyzine Tablets”)

•    If anyone in your close family has died suddenly of heart problems

•    If you are an asthmatic who has suffered a bad reaction to an antihistamine in the past

If any of the above applies to you talk to your doctor or pharmacist. Warnings and precautions

While taking this medicine, seek immediate medical attention if you experience heart problems such as palpitations, trouble breathing, loss of consciousness. Treatment with hydroxyzine should be stopped.

Before you take this medicine tell your doctor if you suffer with:

•    kidney disease or are on dialysis

•    liver disease. Hydroxyzine is not suitable for patients with severe liver disease or liver failure

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•    glaucoma (increased pressure in the eye)

•    difficulty passing water e.g. due to an enlarged prostate

•    digestive system or stomach problems

•    myasthenia gravis (a muscle weakness disorder)

•    dementia

•    seizure disorders including epilepsy (fits)

•    breathing problems

•    bladder outflow obstruction

•    hyperthyroidism (often referred to as an “overactive thyroid”)

•    high blood pressure (hypertension)

Your doctor may adjust your dose if you are elderly.

Hydroxyzine may affect the results of some tests for allergy or asthma. Always tell your doctor or nurse that you have been given hydroxyzine recently.

If the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Hydroxyzine.

Taking other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Hydroxyzine tablets if you are taking medicine 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).

Tell your doctor that you are taking Hydroxyzine tablets if you are going to have allergy testing or a chest medical examination (for asthma) in the next 5 days. Hydroxyzine tablets can affect the test results.

It is also important that you tell your doctor if you are taking any of the following medicines:

•    adrenaline or epinephrine

•    barbiturates (for sleeping disorders and epilepsy)

•    cimetidine (for ulcers and heartburn)

•    antiemetics (drugs effective against vomiting and nausea)

•    betahistine (used to treat a condition called Meniere’s disease)

•    anaesthetics

•    muscle relaxants

•    opioids (medicines for relieving severe pain) anticholinergic medicines, these include some medicines used for irritable bowel syndrome, asthma or incontinence

•    aminophylline (for breathing problems)

•    benzylpenicillin salts and chloramphenicol sodium succinate (antibiotics)

•    doxorubicin hydrochloride (a chemotherapy drug)

•    antidepressants, including monoamine oxidase inhibitors (MAOIs) (such as isocarboxazid or moclobemide), and tricyclics (such as amitriptyline) medicines to treat anxiety

•    medicines that help you sleep

•    benzodiazepines

•    anticholinesterase medicines (such as edrophonium and neostigmine)

•    antimuscarinic medicines (such as atropine)

•    antiepileptic medicines

•    other antihistamines

Taking with food and drink

You should not take alcohol with this medicine because the sedative effects of the alcohol may be increased.

Pregnancy and breastfeeding

Do not take Hydroxyzine tablets if you are pregnant, trying to become pregnant or breastfeeding.

Driving and using machines

Do not drive or operate machines if you take Hydroxyzine tablets. Hydroxyzine tablets may affect your ability to react and concentrate.

Hydroxyzine tablet contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This section is continued overleaf —►

3.    How to take Hydroxyzine tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Important: Your doctor will choose the dose that is right for you. Your dose and when to take it will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist

Important:

You may also need to break the tablets in half along the line down the middle. Your doctor or pharmacist will tell you how to do this. Hydroxyzine tablets 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.

Adults: For anxiety:

The dose is 50mg to 100mg daily, taken throughout the day.

For pruritis (itchiness of the skin):

The starting dose is 25mg at night, your doctor may increase the dose up to 25mg three or four times daily Children and adolescents

In children up to 40 kg, the maximum daily dose is 2 mg/kg/day In children over 40kg in weight, the maximum daily dose is 100mg per day.

For children over 6 years of age, starting at 15-25mg and increasing to 50-100mg daily in divided doses adjusted according to the child's weight.

Other presentations of hydroxyzine are available for doses that cannot be achieved with this product

The elderly

In the elderly, the maximum daily dose is 50 mg per day

•    The usual starting dose is 25 mg (1 tablet) a day

•    Your doctor will tell you how and when to take your tablets.

For patients with liver disease

Your doctor will reduce your dose by about one third if you have liver disease.

Hydroxyzine is not suitable for patients with severe liver disease or liver failure.

For patients with kidney disease

Your doctor will reduce your dose by about half if you have kidney disease.

If you take more Hydroxyzine tablets than you should Other side-effects include:

If you have used or taken too much Hydroxyzine tablets, immediately contact or attend your nearest hospital accident and 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 of an overdose can vary and may include:

•    slowing of your thoughts, slurred speech and experiencing restless, involuntary or slow movements

•    dry mouth, problems with your vision, fast or pounding heartbeat, difficulty passing water and constipation

•    slowing down of your central nervous system, which can slow your breathing and heart rate, cause you to feel drowsy or become unconscious. Or, you may experience stimulation of your central nervous system, with feelings of excitement, fits, shaking and hallucinations.

Hydroxyzine can cause considerable sedation that requires treatment.

If you forget to take Hydroxyzine tablets

If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose. Do not take a double dose to make up for a missed dose. Simply take your next dose as planned.

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

4.    Possible side effects

Like all medicines, Hydroxyzine tablets can cause side effects, although not everybody gets them.

Stop taking Hydroxyzine tablets and seek immediate medical help if you have any of the following symptoms:

• Symptoms of a severe allergic reaction such as;

- Swelling of the face, tongue or throat

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