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HYDROXYZINE HYDROCHLORIDE 25MG FILM-COATED TABLETS

Active substance(s): HYDROXYZINE HYDROCHLORIDE

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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 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
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.

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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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

- 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.
Other possible side effects of Hydroxyzine 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 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
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 the 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 waste water 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 25mg film-coated tablets is available in
28, 30 and 84 film-coated tablets in blisters (Not all pack sizes may
be marketed).

Marketing Authorization Holder & Manufacturer
Medreich PLC
Warwick House
Plane Tree Crescent
Feltham, TW13 7HF
United-Kingdom
Manufacturer
Rottendorf Pharma
ZI N°2 Prouvy - Rouvignies
1, rue de Nungesser
59121 Prouvy
France
This leaflet was last revised in 09/2016
0192/O/PIL/001/I
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POM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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