Patient leaflet - Hydroxyzine Hydrochloride 25 mg film-coated tablets

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

Hydroxyzine tablet belongs to the group of medicines called antihistamines (used to treat allergic reactions)

Hydroxyzine tablets are used in adults and children to treat:

Anxiety in adults
Itching caused by urticaria (nettle rash) and
dermatitis (eczema).

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

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
Your ECG (electrocardiogram) shows a heart
rhythm problem called “QT interval prolonga-tion”
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 sudden-
ly 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 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, Lapp lactase deficiency or glucose-galactose malabsorption you should not take this medicine.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 other medicines, including medicines obtained without prescription. 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
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.

Other medicines and Hydroxyzine Tablets 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 Tablets can affect or be affected by other medicinal products. 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
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 amitrip-tyline) medicines to treat anxiety
medicines that help you sleep
benzodiazepines
anticholinesterase medicines (such as edropho-
nium 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 breastfeed-ing. If you become pregnant whilst taking Hydroxyzine tablets tell your doctor immediately. The following symptoms may occur in new-born babies of mothers that have used Hydroxyzine Tablets during late pregnancy and/or labour, they were observed immediately or only a few hours after birth: shaking, muscle stiffness and/ or weakness, breathing problems and urinary retention (withholding/retaining urine). Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Hydroxyzine Tablets 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 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.

3. How to take Hydroxyzine tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharma-cist 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

130mm

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.

The recommended dose is:

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 50 mg to 100 mg daily, taken through-out the day.

For pruritis (itchiness of the skin):

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

Children and adolescents

For treating itching in children

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

Children aged 6 months to 6 years:

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

Children over 6 years:

Starting at 15-25 mg and increasing to 50-100 mg 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.

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

If you have used or taken too much Hydroxyzine tablets, immediately contact your doctor or the 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 monitor-ing 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 stimula-tion of your central nervous system, with feelings of excitement, fits, shaking and hallucinations.

Hydroxyzine can cause considerable sedation that requires treatment.

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

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. Do not worry. Like all medicines, Hydroxyzine Tablets can cause side effects, although not everyone gets them. Hydroxyzine Tablets can cause the following side effects in some people: 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;
o Swelling of the face, tongue or throat
o Difficulties in swallowing
o 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.

Other possible side effects of Hydroxyzine with frequency ‘Not Known’ include:

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 heartbeat
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 metabo-lism), 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
Weight increased

Reporting of side effects

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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How To store Hydroxyzine tablets

Keep this medicine out of sight and reach of children.

Do not use Hydroxyzine tablets after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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 Hydroxyzine tablets contain

The active substance is hydroxyzine hydrochloride.
Each film-coated tablet contains 25 mg hydroxyzine hydrochloride.
The other ingredients are lactose anhydrous, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol. What Hydroxyzine tablets look like and contents of the pack

Hydroxyzine hydrochloride 25 mg film-coated tablet is off-white to white, oblong, biconvex film-coated tablets with score line on both sides. Hydroxyzine hydrochloride 25 mg film-coated tablets is available in 28, 30 and 84 film-coated tablets in blisters (Not all pack sizes may be marketed).

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