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HYDROXYZINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS

Active substance(s): HYDROXYZINE HYDROCHLORIDE

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24 mm

Hydroxyzine Hydrochloride 10 mg Film-coated tablets
Hydroxyzine Hydrochloride 25 mg Film-coated tablets
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 this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

1. What this medicine is and what it is used for
Hydroxyzine hydrochloride belongs to a group of medicines called
sedating antihistamines. It is used in adults and children over 6 years
to reduce itching caused by urticaria (nettle rash) and dermatitis
(eczema).
Hydroxyzine is also used to treat anxiety in adults.

2. What you need to know before you take this medicine

loss of consciousness. Treatment with hydroxyzine should be stopped.

Do not take this medicine
• if you are allergic (hypersensitive) to hydroxyzine hydrochloride,
cetirizine, other piperazine derivatives, aminophylline or
ethylenediamine, or any of the ingredients of this medicine (see
Section 6)
• 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 “Taking other
medicines”)
• 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.

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)

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

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

Warnings and precautions
This medicine 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.

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

While taking this medicine, seek immediate medical attention if you
experience heart problems such as palpitations, trouble breathing,

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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.

Do not take this medicine 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

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 breast-feeding
Do not take this medicine if you are pregnant, trying to become pregnant
or breast-feeding. If you become pregnant whilst taking this medicine
tell your doctor immediately.
Do not take this medicine if you are breast-feeding.
Stop breast-feeding if treatment with this medicine is necessary.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Hydroxyzine 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.
This medicine contains lactose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicine.

3. How to take this medicine
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Hydroxyzine should be used at the lowest effective dose and the
treatment period should be as short as possible.
For treating itching in adults
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
This product is not recommended for children under 6 years of age.

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Package leaflet: Information for the patient

24 mm

For treating anxiety in adults
The dose is 50 mg to 100 mg daily, taken throughout the day.

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.

• Symptoms of a severe allergic reaction such as:
- Swelling of the face, tongue or throat
- Difficulties in swallowing
- Hives and difficulties in breathing
• Severe skin reactions that can include blistering of the skin
• Tremor (shakiness) or convulsions (fits)
• if you experience any problems with the heart rhythm such as
palpitations, trouble breathing or loss of consciousness.

Route and method of administration
For oral use. The tablets should be swallowed with a sufficient amount
of water. The tablets can be taken with or without food. The tablets are
not intended for breaking into two halves.
For a dose below 10 mg other appropriate strengths and dosage
forms containing hydroxyzine should be used.

If you stop taking this medicine
Do not stop taking this medicine unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

If you take more of this medicine than you should
If you have used or taken too much hydroxyzine, 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.

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

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
• blurred vision and difficulty in focussing
• 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
• tiredness, general feeling of being unwell, fever, chills, muscle pain,
chest tightness
• 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

If you get any of the following symptoms after taking
hydroxyzine, stop taking the medicine and seek immediate
medical attention:

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also

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

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Hydroxyzine can cause considerable sedation that requires treatment.
If any other medicines or substances have been taken at the same time
as Hydroxyzine tell the medical staff carrying out the treatment of the
overdose.
If you forget to take this medicine
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 the forgotten dose. Take your next tablet at the usual time.

4. Possible side effects

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 this medicine
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage
conditions.
• Do not use this medicine after the expiry date which is stated on the
label after EXP. The expiry date refers to the last day of that month.
• 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.

Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
United Kingdom, HP4 1EG
Telephone:
0044 (0) 1442 200922
Fax:
0044 (0) 1442 873717
Email:
info@bristol-labs.co.uk
Hydroxyzine Hydrochloride 10 mg Film-coated tablets;
PL 17907/0528
Hydroxyzine Hydrochloride 25 mg Film-coated tablets;
PL 17907/0529
This leaflet was last revised in March 2016

6. Contents of the pack and other information
What this medicine contains
• The active substance is hydroxyzine hydrochloride. Each film-coated
tablet contains 10 mg or 25 mg of hydroxyzine hydrochloride.
• The other ingredients in tablet core are lactose monohydrate,
calcium phosphate, pregelatinised starch, sodium laurylsulfate,
colloidal anhydrous silica, magnesium stearate. The tablet coat
contains titanium dioxide (E171), hydroxypropyl methylcellulose,
macrogol 400.
What this medicine looks like and contents of the pack
• 10 mg: White to off-white, circular, biconvex film coated tablets
debossed with ‘C’ on one side and ‘31’ on other side.
• 25 mg: White to off white, circular, biconvex film coated tablets
debossed with ‘C’ on one side and ‘30’ on other side..
• This medicine is available in blister packs of 28’s, 25’s, 84’s or 100
tablets. Not all pack sizes may be marketed.

To request a copy of this leaflet in Braille, large print or audio format,
please contact the licence holder at the address (or telephone, fax,
email) above.

V4 10-03-16 D0

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In children up to 40 kg in weight, other appropriate strengths and
dosage forms containing hydroxyzine should be administered.
Children over 6 years:
15 mg to 25 mg daily which your doctor may increase up to 50 mg 100 mg daily, taken throughout the day. The doctor may change this
depending on the child’s weight.

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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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