Atarax Tablets

Read all of this leaflet carefully before you start taking this medicine

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

The information in this leaflet has been divided into the following sections:

1. What Atarax is and what it is taken for
2. Check before you take Atarax
3. How to take Atarax
4. Possible side effects
5. How to store Atarax
6. Further information

Do not take Atarax

• if you are allergic (hypersensitive) to hydroxyzine hydrochloride, cetirizine, other piperazine derivatives, aminophylline or ethylenediamine, or any of the ingredients of Atarax (see Section 6 Further information)
• 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.

Atarax 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, Lapp lactase 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 Atarax.

Take special care with Atarax

Before you take Atarax tell your doctor if you suffer with:

• kidney disease or are on dialysis
• liver disease. Atarax 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
• any heart problems
• 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.

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

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

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines as they may interfere with Atarax or Atarax may increase the effects of these 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)
• some antibiotics (benzylpenicillin salts and chloramphenicol sodium succinate)
• the chemotherapy drug doxorubicin hydrochloride
• 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
• medicines to treat psychosis
• anticholinesterase medicines (such as edrophonium and neostigmine)
• antimuscarinic medicines (such as atropine)
• antiepileptic medicines
• other antihistamines

Please tell your doctor or pharmacist if you are taking or have recently taken/used any other medicines, including medicines obtained without a prescription.

Taking with food and drink

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

Pregnancy and breast-feeding

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Atarax 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.

Important information about some of the ingredients of Atarax

Atarax 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.

Atarax 10mg film-coated tablets contain Sunset yellow (E110), which may cause allergic reactions.

For treating itching in adults

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

The dose of Atarax depends on the age of the child:

Children aged 6 months to 6 years:

5mg to 15mg daily which your doctor may increase up to 50mg daily, taken throughout the day.

Children over 6 years:

15mg to 25mg daily which your doctor may increase up to 50mg -100mg daily, taken throughout the day.

For treating anxiety in adults

The dose is 50mg to 100mg four times a day.

For patients with liver disease

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

Atarax 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

Your doctor may reduce your dose if you are elderly.

What to do if you take more Atarax than you should

You probably need not worry if you have taken an extra dose of Atarax by mistake, but if you, or someone else have taken a large overdose you should tell your doctor or contact the nearest accident and emergency department immediately. Show any leftover medicines or the empty packet to the doctor.

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.

Atarax can cause considerable sedation that requires treatment.

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

If you forget to take Atarax

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.

If you get any of the following symptoms after taking Atarax, contact a doctor or go to the nearest hospital straight away as you may need urgent medical attention:

• 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)

What is in Atarax?

The active ingredient in this medicine is hydroxyzine hydrochloride.

The other ingredients are:

Calcium phosphate, lactose, magnesium stearate, maize starch, silicon dioxide and sodium lauryl sulphate.

The 10mg film-coated tablet coating contains Opadry® II Orange 85G23730. This is a mixture of Poly(vinyl alcohol), Talc, Macrogol 3350, Sunset yellow (E110), Titanium dioxide (E171), Iron oxide yellow (E172), Quinoline yellow (E104), Lecithin (E322).

The 25mg film-coated tablet coating contains Opadry® II Green 85G21674. This is a mixture of Poly(vinyl alcohol), Talc, Macrogol 3350, Quinoline yellow (E104), Titanium dioxide (E171), Brilliant blue (E133), Indigo carmine (E132), Lecithin (E322).

What Atarax looks like and contents of the pack

Atarax 10mg film-coated tablets are coloured orange imprinted with 'AX' on one side.

Atarax 25mg film-coated tablets are coloured green imprinted with 'AX' on one side.

Atarax film-coated tablets are supplied in blister packs contained in a carton. The Atarax 10mg film-coated tablet pack contains 84 film-coated tablets and the Atarax 25mg film-coated tablet pack contains 28 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The product licence holder is:

Atarax is manufactured by:

The information in this leaflet applies only to Atarax. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.