HYDROXYZINUM 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Hydroxyzinum Adamed, 10 mg, film-coated tablets
3. Hydroxyzinum Adamed, 25 mg, film-coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
4. What is Hydroxyzinum Adamed and what is it used for
5. Important information before taking Hydroxyzinum Adamed
   1. When not to take Hydroxyzinum Adamed:
   2. Warnings and precautions
   3. Children
   4. Hydroxyzinum Adamed and other medicines
   5. Hydroxyzinum Adamed with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Hydroxyzinum Adamed contains lactose
   9. Hydroxyzinum Adamed contains sodium
6. How to take Hydroxyzinum Adamed
   1. Recommended dose:
   2. Elderly patients
   3. Patients with renal impairment
   4. Patients with hepatic impairment
   5. Use in children and adolescents
   6. Method of administration
   7. Overdose of Hydroxyzinum Adamed
   8. Missed dose of Hydroxyzinum Adamed
7. Possible side effects
   1. Stop taking the medicine and seek medical attention immediately if you experience:
   2. Reporting side effects
8. How to store Hydroxyzinum Adamed
9. Contents of the package and other information
   1. What Hydroxyzinum Adamed contains
   2. What Hydroxyzinum Adamed looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Package Leaflet: Information for the User

Hydroxyzinum Adamed, 10 mg, film-coated tablets

Hydroxyzinum Adamed, 25 mg, film-coated tablets

Hydroxyzine hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Hydroxyzinum Adamed and what is it used for
• 2. Important information before taking Hydroxyzinum Adamed
• 3. How to take Hydroxyzinum Adamed
• 4. Possible side effects
• 5. How to store Hydroxyzinum Adamed
• 6. Contents of the package and other information

1. What is Hydroxyzinum Adamed and what is it used for

Hydroxyzinum Adamed inhibits certain brain functions without causing dependence and blocks histamine, a substance found in body tissues. It is effective in treating anxiety and itching.

Hydroxyzinum Adamed is used to treat:

• anxiety in adults
• itching in adults, adolescents, and children over 6 years of age.

In the case of anxiety, the effect is noticeable after about 30-45 minutes.

In the case of itching, the effect is achieved after about 1 hour.

2. Important information before taking Hydroxyzinum Adamed

When not to take Hydroxyzinum Adamed:

Warnings and precautions

Before starting treatment with Hydroxyzinum Adamed, discuss it with your doctor or pharmacist:

Taking Hydroxyzinum Adamed may be associated with an increased risk of heart rhythm disorders, which can be life-threatening. Therefore, inform your doctor about any heart problems and about taking any other medicines, including those available without a prescription.

If you experience any heart symptoms, such as rapid heartbeat (palpitations), breathing difficulties, loss of consciousness, seek medical attention immediately. You should also stop taking Hydroxyzinum Adamed.

A side effect of Hydroxyzinum Adamed may be dry mouth. Therefore, it is essential to maintain good oral hygiene while taking Hydroxyzinum Adamed.

If you are undergoing allergy tests, you should stop taking Hydroxyzinum Adamed at least 5 days before the tests. Consult your doctor for advice.

Caution should be exercised in elderly patients. The treatment duration should be as short as possible.

Children

Hydroxyzinum Adamed is not recommended for children under 6 years of age due to possible difficulties in swallowing tablets.

The medicine should not be used in children under 12 months of age, as it has not been studied in this age group.

Younger children are more prone to experiencing side effects from the central nervous system, such as seizures.

Hydroxyzinum Adamed and other medicines

Inform your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those available without a prescription. Hydroxyzinum Adamed may affect the action of other medicines, and other medicines may affect the action of Hydroxyzinum Adamed.

Do not take Hydroxyzinum Adamed if you are taking medicines used to treat:

• bacterial infections (e.g., antibiotics such as erythromycin, moxifloxacin, levofloxacin),
• fungal infections (e.g., pentamidine),
• heart disease or high blood pressure (e.g., amiodarone, quinidine, disopyramide, sotalol),
• psychoses (e.g., haloperidol),
• depression (e.g., citalopram, escitalopram),
• stomach and intestine diseases (e.g., prucalopride),
• allergies,
• malaria (e.g., mefloquine),
• cancer (e.g., toremifene, vandetanib),
• drug addiction or severe pain (methadone).

Also, inform your doctor if you are taking:

• betahistine used to treat Meniere's disease (balance and hearing disorders),
• phenytoin used to treat seizure disorders (epilepsy),
• adrenaline used to treat severe allergic reactions,
• medicines used to treat anxiety or sleep disorders,
• anticholinergic medicines used, for example, to treat irritable bowel syndrome (gastrointestinal disease) or asthma,
• cimetidine used to treat stomach disorders. It may increase the level of Hydroxyzinum Adamed in the blood,
• monoamine oxidase inhibitors used to treat depression and Parkinson's disease,
• thiazide diuretics (used, for example, to treat high blood pressure). They may increase the risk of heart rhythm disorders.

Hydroxyzinum Adamed with food, drink, and alcohol

Avoid taking Hydroxyzinum Adamed with alcohol, as this combination may enhance the effect of Hydroxyzinum Adamed and increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Do not take Hydroxyzinum Adamed during pregnancy.

Hydroxyzine, the active substance of Hydroxyzinum Adamed, passes into the fetus. There is a risk of fetal harm.

In newborns of mothers who took Hydroxyzinum Adamed in late pregnancy and/or during delivery, the following symptoms may occur immediately or a few hours after birth: trembling, stiffness, and/or weakness, breathing difficulties, and urinary retention (urinary hesitation/retention).

Do not take Hydroxyzinum Adamed during breastfeeding.

If treatment with Hydroxyzinum Adamed is necessary, breastfeeding should be stopped, as hydroxyzine passes into breast milk.

Driving and using machines

Hydroxyzinum Adamed may impair your ability to drive and use machines.

The medicine may cause drowsiness, decreased attention, and reduced reaction ability. The occurrence of these side effects is more likely at the beginning of treatment or after increasing the dose. Do not drive or operate machines if you experience any of these symptoms.

Hydroxyzinum Adamed contains lactose

The tablets of Hydroxyzinum Adamed contain lactose. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Hydroxyzinum Adamed contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Hydroxyzinum Adamed

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The dose is determined by your doctor, who will adjust it individually for you.

Hydroxyzinum Adamed should be taken in the smallest effective dose. The treatment duration should be as short as possible.

The 25 mg tablet can be divided into two equal doses.

Recommended dose:

Itching:

Adults:

Initial dose is 25 mg in the evening, about an hour before bedtime. If necessary, up to 25 mg can be taken 3 to 4 times a day. The maximum daily dose for adults is 100 mg.

Children over 6 years of age:

1-2 mg/kg body weight per day in several doses.

In children over 40 kg, the maximum daily dose is 100 mg.

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

Anxiety:

Adults:

50 mg per day, divided into 3 doses: half a tablet (12.5 mg), half a tablet (12.5 mg), and 1 tablet (25 mg). In severe cases, up to 100 mg per day can be taken. The maximum daily dose for adults is 100 mg.

In the treatment of anxiety, this medicine should only be used as adjunctive therapy. Do not change the dose without consulting your doctor first.

Elderly patients

Due to the prolonged effect, it is recommended to start treatment with half the recommended dose in elderly patients. The maximum daily dose is 50 mg.

Patients with renal impairment

In patients with moderate or severe renal impairment, the dose should be reduced.

Patients with hepatic impairment

In patients with reduced liver function, the daily dose should be reduced.

Use in children and adolescents

In adolescents and children over 6 years of age, Hydroxyzinum Adamed is intended only for the treatment of itching.

If a child has difficulty swallowing tablets, other hydroxyzine-containing medicines may be more suitable. Consult your doctor.

Method of administration

Tablets should be swallowed with a sufficient amount of water. Tablets can be taken with or without food.

Overdose of Hydroxyzinum Adamed

If you have taken more than the recommended dose of Hydroxyzinum Adamed, contact your doctor immediately, especially if it concerns a child. In case of overdose, symptomatic treatment can be applied. ECG monitoring is recommended due to the possibility of heart rhythm disorders, such as QT interval prolongation or torsades de pointes.

Missed dose of Hydroxyzinum Adamed

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

4. Possible side effects

Like all medicines, Hydroxyzinum Adamed can cause side effects, although not everybody gets them.

Stop taking the medicine and seek medical attention immediately if you experience:

• any heart rhythm disorders, such as rapid heartbeat (palpitations), breathing difficulties, loss of consciousness (frequency not known, cannot be estimated from the available data),
• swelling of the face, lips, tongue, and/or throat, which may cause difficulty in breathing or swallowing (angioedema) (very rare side effects, which may occur in less than 1 in 10,000 people),
• generalized rash with blisters (acute generalized exanthematous pustulosis), red rash in a ring shape, often with blisters, mainly on the hands and feet (erythema multiforme), inflammation of the mucous membranes and skin, combined with high fever (Stevens-Johnson syndrome) (very rare side effects, which may occur in less than 1 in 10,000 people),
• intensive peeling and separation of the skin (toxic epidermal necrolysis) (frequency not known, cannot be estimated from the available data).

Other possible side effects:

Very common side effects (may affect more than 1 in 10 people):

• drowsiness.

Common side effects (may affect up to 1 in 10 people):

• headache,
• calmness,
• dry mouth,
• fatigue.

Uncommon side effects (may affect up to 1 in 100 people):

• excitement,
• confusion,
• dizziness,
• insomnia,
• tremors,
• nausea,
• fever.

Rare side effects (may affect up to 1 in 1,000 people):

• allergic reactions (hypersensitivity),
• disorientation, hallucinations (seeing things that do not exist),
• seizures (epilepsy), movement disorders (dyskinesias),
• accommodation disorders (difficulty focusing the eyes), blurred vision,
• low blood pressure,
• constipation,
• vomiting,
• changes in liver enzyme activity (aminotransferases, alkaline phosphatase, bilirubin, and glutamyl),
• itching, skin rash with redness, spots, or discoloration, skin inflammation,
• urinary retention,
• cardiac arrest, effect on heart rhythm, irregular heart rhythm.

Very rare side effects (may affect less than 1 in 10,000 people):

• anaphylactic shock (severe allergic reaction),
• bronchospasm (bronchial constriction),
• excessive sweating.

Frequency not known (frequency cannot be estimated from the available data):

• decreased platelet count (thrombocytopenia),
• aggression,
• depression,
• repeated, involuntary muscle contractions (tics),
• abnormal, prolonged muscle contractions (dystonia),
• feeling of tingling, numbness, or prickling (paresthesia),
• fainting,
• uncontrolled, circular eye movements (forced upward gaze with eye rotation),
• irregular heart rhythm and related changes in the electrocardiogram (QT interval prolongation, torsades de pointes),
• diarrhea,
• hepatitis,
• pemphigoid (blisters on hands, feet, abdomen, and mucous membranes),
• bedwetting or difficulty urinating (abnormal urination),
• extreme weakness (asthenia),
• tissue swelling due to fluid retention (edema),
• weight gain.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hydroxyzinum Adamed

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

Blister:

No special storage temperature instructions.

HDPE bottle:

No special storage temperature instructions.

Store in the original package to protect from moisture.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month stated.

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

6. Contents of the package and other information

What Hydroxyzinum Adamed contains

• The active substance is 10 mg and 25 mg of hydroxyzine hydrochloride.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, talc, magnesium stearate, hypromellose 5 cPs, macrogol 400, titanium dioxide (E 171).

What Hydroxyzinum Adamed looks like and contents of the pack

10 mg: White or almost white, round, biconvex film-coated tablets.

25 mg: White or almost white, capsule-shaped, biconvex film-coated tablets with a dividing line on both sides. The tablet can be divided into two equal doses.

Blister packs:

10 mg: 25, 30, 84, 100, and 250 tablets.

25 mg: 20, 25, 28, 30, 50, 60, 100, and 250 tablets.

Child-resistant closure bottles:

10 mg: 25, 30, 84, and 100 tablets.

25 mg: 20, 25, 28, 30, 50, 60, and 100 tablets.

Polypropylene bottles:

250 tablets. Packaging for dosing by medical personnel.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

tel.: +48 22 732 77 00

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the package leaflet:10.2024