Hydroxyzine Hydrochloride 25 mg Film-coated tablet

• 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.

1. What Hydroxyzine hydrochloride is and what it is used for
2. What you need to know before you take Hydroxyzine hydrochloride
3. How to take Hydroxyzine hydrochloride
4. Possible side effects
5. How to store Hydroxyzine hydrochloride
6. Contents of the pack and other information

• if you are allergic (hypersensitive) to Hydroxyzine hydrochloride, cetirizine, other piperazine derivatives, aminophylline or ethylenediamine,or any of the ingredients of Hydroxyzine hydrochloride (see Section 6 Further information)
• 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 Hydroxyzine hydrochloride”)
• 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 you have porphyria (a disease which causes stomach pain, constipation, changes in the colour of urine, skin rashes and disturbed behaviour)
• if you are pregnant, trying to become pregnant or breast-feeding.

Hydroxyzine hydrochloride 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. If you have hereditary galactose intolerance, Lactose deficiency or glucose-galactose malabsorption you should not take this medicine.

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

Hydroxyzine hydrochloride 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 hydrochloride, seek immediate medical attention if you experience heart problems such as palpitations, trouble breathing, loss of consciousness.

Treatment with Hydroxyzine hydrochloride should be stopped

Before you take Hydroxyzine hydrochloride tell your doctor if you suffer with:

• kidney disease or are on dialysis
• liver disease. Hydroxyzine hydrochloride is not suitable for patients with severe liver disease or liver failure
• 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 hydrochloride may affect the results of some tests for allergy or asthma.

Always tell your doctor or nurse that you have been given Hydroxyzine hydrochloride recently.

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without prescription. Hydroxyzine hydrochloride can affect or be affected by other medicinal products.

Hydroxyzine hydrochloride may affect the results of some tests for allergy or asthma.

Do not take Hydroxyzine hydrochloride 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)

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 Ménière’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

You should not take alcohol with Hydroxyzine hydrochloride because the sedative effects of the alcohol may be increased.

Do not take Hydroxyzine hydrochloride if you are pregnant , trying to become pregnant or breast-feeding. If you become pregnant whilst taking Hydroxyzine hydrochloride tell your doctor immediately.

Ask your doctor or pharmacist for advice before taking any medicine

Hydroxyzine hydrochloride may make you drowsy and make you feel less alert than usual for the first few days after you start taking it. If you are affected do not drive or operate machinery until this effect has worn off.

Hydroxyzine hydrochloride 10mg and 25mg film-coated tablets contain 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.

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

For treating itching in children

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

Children aged 6 months to 6 years:

5mg to 15mg daily taken throughout the day, the doctor may change this depending on the child’s weight

Children over 6 years:

15mg to 25mg daily which your doctor may increase up to 50mg - 100mg daily, taken throughout the day. The doctor may change this depending on the child’s weight.

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

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

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

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

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

If you have used or taken too much Hydroxyzine hydrochloride, immediately contact your doctor or the nearest 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 heart beat, 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 hydrochloride can cause considerable sedation that requires treatment.

If any other medicines or substances have been taken at the same time as Hydroxyzine hydrochloride tell the medical staff carrying out the treatment of the overdose.

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. Then go on as before.

• symptoms of a severe allergic reaction such as;
  • swelling of the face, tongue or throat
    • difficulties in swallowing
  • hives and difficulties in breathing
• severe reactions that can include blistering of the skin, eyes, mouth and genitals
• tremor (shakiness) or convulsions (fits)
• if you experience any problems with the heart rhythm such as palpitations, trouble breathing or loss of consciousness.

• drowsiness, sedation, coma, slurred speech, slowing of thought processes and movements, involuntary movements, dizziness, faintness, headache, inability to concentrate, sleep disturbances, bitter taste in mouth
• confusion, hallucinations, disorientation, unusual mood changes
• bloodshot eyes, blurred vision and difficulty in focusing
• faster or pounding heart beat
• low blood pressure, flushing
• dryness of the nose, mouth or throat, wheezing
• liver problems (symptoms include jaundice)
• difficulty or pain when passing water, blood in urine
• tiredness, general feeling of being unwell, fever, chills, muscle pain, chest tightness, achy joints
• porphyria (a rare illness which affects the metabolism), anorexia
• blood disorders
• skin rashes, swelling, itching, hives, eczema, increased sweating, hair loss, tingling, prickling, numbing of skin, pus-filled skin sores
• prolonged penile erection, impotence, early menstruation
• hearing, balance or coordination problems
• digestive system or stomach problems, feeling or being sick, diarrhoea, constipation

Not known (frequency cannot be estimated from the available data):

• Weight increased

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow card scheme, www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store”. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient in this medicine is hydroxyzine hydrochloride.

The other ingredients are: Lactose monohydrate, Calcium phosphate, Pregelatinised starch, Sodium lauryl sulphate, Colloidal anhydrous silica, Magnesium stearate, Opadry white Y-1-7000

Hydroxyzine hydrochloride 10mg tablets are white to off white, circular approx 5.50mm, biconvex film coated tablets and plain on both sides.

Hydroxyzine hydrochloride 25mg tablets are white to off white, circular approx 8.00mm, biconvex film coated tablets with ‘Score Notch’ on one side and plain on other side.

They are supplied in blister pack. Pack size: 14, 25, 28,56, 84 and 100 tablets.

Not all pack sizes may be marketed.