10 mg film-coated tablets 
Hydroxizinhydroklorid

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Atarax and what it is used for 
2. What you need to know before taking Atarax 
3. How to take Atarax 
4. Possible side effects 
5. How to store Atarax 
6. Contents of the pack and other ingredients information

1. What Atarax and what it is used for

Atarax suppresses certain functions in the brain without being addictive and blocks histamine, a substance found in the body’s tissues. In this way, it has an effect on anxiety, worry, itching, and hives.

Atarax is used for itching and hives. Atarax is also used for anxiety and worry in adults. 
With itching and hives, the effect is reached after about 1 hour and lasts at least 24 hours. In the case of anxiety and worry, the effect is noticeable after about 15 minutes and lasts for about 12 hours.

The hydroxyzine contained in Atarax may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Atarax

Do not take Atarax

  • if you are allergic to hydroxyzine or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to cetirizine, aminophylline, ethylenediamine, or piperazine derivatives (closely related to other medicines)
  • if you suffer from porphyria (a metabolic disease)
  • if your ECG ( electrocardiogram ) shows a type of heart problem called prolonged QT interval
  • if you have or have had cardiovascular disease or if you have a very slow heart rhythm
  • if you have low salt levels in your body (eg low levels of potassium or magnesium)
  • if you are taking certain medicines for heart rhythm problems or medicines that can affect your heart rhythm (see “Other medicines and Atarax”)
  • if someone in the family has died suddenly of heart problems
  • if you are pregnant or breast-feeding (see “Pregnancy and breast-feeding”)

Warnings and cautions

People with hepatic or renal impairment should consult their doctor before using Atarax.

Atarax should be used with caution in patients with an increased risk of seizures or risk factors for stroke. Atarax should also be used with caution in the elderly and in patients with glaucoma, urinary tract obstruction, slow bowel passage, severe muscle weakness ( myasthenia gravis ), or dementia.

Concomitant consumption of Atarax and alcohol should be avoided, as this combination may potentiate the effects of Atarax.

Dry mouth can be a side effect of Atarax. Therefore, good oral hygiene is important during treatment with Atarax.

Concomitant treatment with Atarax and medicines used to treat mental illness should be avoided.

If you are going to have an allergy test, ask your doctor if you should stop taking Atarax several days before the test. This medicine may affect the results of allergy tests.

Atarax can cause an increased risk of heart rhythm problems which can be life-threatening. Therefore, tell your doctor if you have any heart problems or if you are taking any other medicines, including medicines obtained without a prescription.

Contact your healthcare provider immediately if you experience heart problems such as palpitations, difficulty breathing, or unconsciousness while taking Atarax. Treatment with hydroxyzine should be discontinued.

Other medicines and Atarax

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Atarax can affect or be affected by other medicines.

Do not take Atarax if you are taking medicines to treat:

  • bacterial infections (eg antibiotics; erythromycin, moxifloxacin, levofloxacin)
  • fungal infections (eg pentamidine)
  • heart problems or high blood pressure (eg amiodarone, quinidine, disopyramide, sotalol)
  • psychosis (eg haloperidol )
  • depression (eg citalopram, escitalopram)
  • gastrointestinal disorders (eg prucalopride)
  • allergy
  • malaria (eg mefloquine, hydroxychloroquine)
  • cancer (eg toremifene, vandetanib)
  • drug abuse or severe pain ( methadone )

Atarax with food, drink, and alcohol

Concomitant consumption of Atarax and alcohol should be avoided as this combination may potentiate the effects of Atarax.

Pregnancy and breastfeeding

Atarax should not be used during pregnancy. 
The active substance in Atarax, hydroxyzine , is passed on to the fetus. There is a risk that the fetus is affected.

Atarax should not be used during breast-feeding. 
If treatment with Atarax is necessary during breast-feeding, breast-feeding should be discontinued. 
Atarax degradation products pass into breast milk.

Driving and using machines

Atarax may impair the ability to react and concentrate. You should be careful when driving and handling machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

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 medicine.

How to take Atarax

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for you.

Atarax should be used at the lowest effective dose and for the shortest possible treatment time. Do not change the dose without first talking to a doctor.

The tablets are also available in a strength of 25 mg.

In case of itching and hives:

The recommended dose for adults: 1-2 tablets of 25 mg in the evening.

The recommended dose for children 5-12 years: 1 tablet of 10 mg or 1 tablet of 25 mg in the evening.

For younger children, Atarax oral solution is recommended.

In the case of anxiety and worry:

The recommended dose for adults: 1-5 tablets of 10 mg 2-3 times daily or 1-2 tablets of 25 mg 2-3 times daily. But no more than 10 tablets of 10 mg or 4 tablets of 25 mg per day. See also “Maximum daily dose for all treatments” below.

The maximum daily dose for all treatments:

The maximum daily dose for adults and children weighing more than 40 kg is 100 mg per day.

The maximum daily dose for children weighing up to 40 kg is 2 mg/kg per day.

In elderly patients, it is recommended to start treatment with half the recommended dose due to prolonged effect. The maximum daily dose for the elderly is 50 mg per day.

Drug treatment of anxiety should only be a complement to another type of treatment.

If you forget to take Atarax

Do not take a double dose to make up for a forgotten tablet.

4. Possible side effects

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

Stop taking this medicine and contact your healthcare provider immediately if you get:

  • Heart rhythm problems such as palpitations, difficulty breathing, or unconsciousness. (Has been reported, occurs in an unknown number of users).
  • Angioedema – swelling of the face, lips, tongue, or throat; difficulty swallowing; hives and difficulty breathing. (Very rare side effect)
  • Stevens-Johnson syndrome – an extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals. (Very rare side effect)
  • Toxic epidermal necrolysis – a severe widespread skin lesion with skin detachment of the epidermis and superficial mucous membranes (Has been reported, occurs in an unknown number of users)

Other side effects that may occur:

Very common (may affect more than 1 user in 10): Drowsiness.

Common (may affect up to 1 in 10 people): Headache, drowsiness, dry mouth, fatigue.

Uncommon (may affect up to 1 in 100 people): Severe restlessness, confusion, dizziness, insomnia, tremors, nausea, malaise, fever.

Rare (may affect up to 1 in 1,000 people): Hypersensitivity, disorientation, hallucinations, seizures, dyskinesia (involuntary movements), accommodation disorders (difficulty focusing the eyes), blurred vision, low blood pressure, constipation, vomiting, altered liver values, itching, a rash with redness, spots or blemishes, hives, skin inflammation, obstructed urination and cardiac arrest.

Very rare (may affect up to 1 in 10,000 people): Anaphylactic shock (severe allergic reaction ), bronchospasm, increased sweating, fixed drug rash, acute generalized exanthematous pustulosis (scattered skin rash with purulent blisters), erythema multiforme (annular, red, often blistering rashes, often on hands and feet).

Has been reported (occurs in an unknown number of users): Decreased platelet count, hepatitis, aggression, depression, tics (recurrent involuntary muscle twitching), dystonia (abnormal prolonged muscle contractions), ant crawls, oculogyration (eyes have uncontrolled circulatory movements), diarrhea urinary excretion (bedwetting or difficulty urinating), asthenia (extreme weakness), edema, weight gain, fainting, pemphigoid (blisters on arms, legs, abdomen, and mucous membranes).

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 report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Atarax

Keep this medicine out of the sight and reach of children.

Used before the expiration date specified after the Expiration Date. on the carton and EXP on the print packaging. The expiration date is the last day of the specified month.

Store in the original package. Sensitive to light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance in Atarax is hydroxyzine hydrochloride 10 mg.
  • The other ingredients are lactose monohydrate 18.7 mg, titanium dioxide (dye E171), talc, corn starch, povidone, calcium stearate, eudragit E, macrogol 6000.

What the medicine looks like and the contents of the pack

The tablets are white, round.

Pack sizes: 25, 100 or 250 (only for dose dispensing) tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

UCB Nordic A / S

Edvard Thomsens Vej 14

2300 Copenhagen S

Denmark

tel 040-29 49 00

Manufacturer:

UCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium

Muhammad Nadeem

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