COMFORTIN 25 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Comfortin
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the Package Leaflet:
3. What Comfortin is and what it is used for
   1. Indications for Use
4. Important Information Before Taking Comfortin
   1. When Not to Take Comfortin
   2. Warnings and Precautions
   3. Comfortin and Other Medicines
   4. Comfortin with Alcohol
   5. Pregnancy, Breastfeeding, and Fertility
   6. Driving and Using Machines
   7. Comfortin Contains Lactose
5. How to Take Comfortin
   1. Comfortin Should be Taken in the Smallest Effective Dose. The Treatment Duration Should be as Short as Possible.
   2. Use in Adults
   3. Use in Children and Adolescents
   4. Children (from 12 months) and Adolescents
   5. Dose Adjustment
   6. Elderly Patients
   7. Patients with Moderate or Severe Renal Impairment
   8. Patients with Hepatic Impairment
   9. Overdose of Comfortin
   10. Missed Dose of Comfortin
   11. Stopping Comfortin Treatment
6. Possible Side Effects
   1. Reporting Side Effects
7. How to Store Comfortin
8. Contents of the Pack and Other Information
   1. What Comfortin Contains
   2. What Comfortin Looks Like and Contents of the Pack
   3. Marketing Authorization Holder and Manufacturer
   4. Medicine Information
   5. Date of Last Revision of the Leaflet:

Package Leaflet: Information for the Patient

Comfortin

25 mg, coated tablets
Hydroxyzine hydrochloride

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

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

Contents of the Package Leaflet:

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

1. What Comfortin is and what it is used for

The active substance of Comfortin is hydroxyzine, which has antihistamine, sedative, and anxiolytic effects.

Indications for Use

• Symptomatic treatment of anxiety in adults.
• Symptomatic treatment of itching.
• Pre-medication before surgical procedures.

2. Important Information Before Taking Comfortin

When Not to Take Comfortin

• ;
• during breastfeeding and pregnancy.

Warnings and Precautions

Before starting Comfortin, discuss it with your doctor or pharmacist.
Taking Comfortin may be associated with an increased risk of heart rhythm disturbances, which can be life-threatening. Therefore, tell your doctor about any heart problems and about taking any other medicines, including those available without a prescription.
If you experience heart symptoms such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness while taking Comfortin, seek medical attention immediately. You should stop taking hydroxyzine.
You should be particularly cautious when taking Comfortin:

myasthenia gravis(a disease characterized by muscle weakness and fatigue after repeated effort; initial symptoms include: drooping eyelids, double vision, nasal voice, difficulty chewing and swallowing, difficulty lifting arms and walking; rarely, respiratory muscle weakness occurs); or dementia (reduced mental performance);

Comfortin tablets should be discontinued at least 5 days before performing allergy tests or the so-called methacholine bronchial provocation test to avoid the influence of the medicine on the test results.
Use in women of childbearing age - see "Pregnancy, breastfeeding, and fertility".

Comfortin and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
This includes medicines available without a prescription.
Comfortin may affect the action of other medicines. Other medicines may affect the action of Comfortin.
Taking hydroxyzine with medicines that depress the central nervous system or have anticholinergic effects may require the use of a lower dose, which should be adjusted individually according to the patient's response.
Hydroxyzine acts antagonistically to betahistine and cholinesterase inhibitors.
Avoid concurrent administration of hydroxyzine with monoamine oxidase inhibitors (MAOIs).
Hydroxyzine limits the increase in blood pressure caused by adrenaline and reduces the anticonvulsant effect of phenytoin.
Since hydroxyzine is metabolized by alcohol dehydrogenase and CYP3A4/5, concurrent use of medicines that inhibit the action of these enzymes may lead to increased hydroxyzine levels in the blood.
Concomitant administration of hydroxyzine and medicines that may cause heart rhythm disturbances may increase the risk of changes in the ECG recording - QT interval prolongation or heart rhythm disturbances of the torsade de pointestype.
Caution should be exercised when using Comfortin with medicines that cause bradycardia and hypokalemia.
Do not take Comfortin 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);
• gastrointestinal diseases (e.g., prucalopride);
• allergies;
• malaria (e.g., mefloquine, hydroxychloroquine);
• cancer (e.g., toremifene, vandetanib);
• drug addiction or severe pain (methadone).

Comfortin with Alcohol

Do not drink alcohol while taking Comfortin, as it enhances the effect of the medicine.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Women of childbearing age must use appropriate contraception to prevent pregnancy during hydroxyzine treatment.
Taking Comfortin during pregnancy and breastfeeding is contraindicated.
If Comfortin is necessary, breastfeeding should be discontinued.
In newborns whose mothers received hydroxyzine during late pregnancy and/or during delivery, the following symptoms have been observed directly or a few hours after birth: tremors, stiffness, and/or muscle weakness, breathing problems, and urinary retention.
Animal studies have not shown a negative effect on fertility. Data on the effect on human fertility are not available.

Driving and Using Machines

Do not drive, operate machinery, or use tools while taking Comfortin, as the medicine may impair your reaction and concentration abilities.

Comfortin Contains Lactose

One Comfortin tablet contains 47.5 mg of lactose monohydrate. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to Take Comfortin

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

Comfortin Should be Taken in the Smallest Effective Dose. The Treatment Duration Should be as Short as Possible.

In adults and children over 40 kg, the maximum daily dose for all indications is 100 mg.
In the elderly, the maximum daily dose is 50 mg.
In children up to 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
For children under 6 years of age and older children who cannot swallow tablets, another form of hydroxyzine is available - a syrup suitable for this age group.
The medicine is taken orally. The tablet can be divided into equal doses.
Usual dosing is described below.

Use in Adults

Symptomatic treatment of anxiety:
50 mg per day, in 2 or 3 divided doses. In severe cases, up to 100 mg per day can be used.
Symptomatic treatment of itching:
Treatment should start with a dose of 25 mg before bedtime, and if necessary, the dose can be increased to 25 mg 3 or 4 times a day.
Pre-medication before surgical procedures:
50 to 100 mg as a single dose.

Use in Children and Adolescents

Children (from 12 months) and Adolescents

In children up to 40 kg, the maximum daily dose is 2 mg/kg body weight per day.
In children over 40 kg, the maximum daily dose is 100 mg.
Symptomatic treatment of itching:
1 mg/kg body weight per day to 2 mg/kg body weight per day in divided doses.
Pre-medication before surgical procedures:
0.6 mg/kg body weight as a single dose.
The cumulative daily dose should not exceed 2 mg/kg body weight per day.

Dose Adjustment

Your doctor will adjust the dose individually, within the recommended dose range, depending on your response to treatment.

Elderly Patients

Hydroxyzine is not recommended for use in the elderly. If treatment is decided, it is recommended to start with half the recommended dose for adults.
In elderly patients, the maximum daily dose is 50 mg.

Patients with Moderate or Severe Renal Impairment

In patients with moderate or severe renal impairment, due to reduced excretion of the medicine's metabolite, cetirizine, the doses used should be reduced.

Patients with Hepatic Impairment

In patients with hepatic impairment, it is recommended to reduce the daily dose of the medicine by 33%.

Overdose of Comfortin

If you have taken or used more than the recommended dose of Comfortin, contact your doctor immediately, especially if it concerns a child.
In case of overdose, symptomatic treatment can be used. ECG monitoring is recommended due to the possibility of heart rhythm disturbances, such as QT interval prolongation or torsade de pointes.
Overdose symptoms of Comfortin include: nausea, vomiting, rapid heartbeat (tachycardia), fever, drowsiness, pupillary reflex disturbances, tremors, confusion, or hallucinations, followed by decreased consciousness, reduced breathing frequency (respiratory depression), seizures, hypotension, or heart rhythm disturbances, and deepening coma and cardiopulmonary collapse.
There is no specific antidote.

Missed Dose of Comfortin

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

Stopping Comfortin Treatment

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Comfortin can cause side effects, although not everybody gets them.
Stop taking the medicine and seek medical attention immediately if you experience heart rhythm disturbances, such as rapid heartbeat (palpitations), difficulty breathing, or loss of consciousness.
Very Common(affects more than 1 in 10 people):
drowsiness.
Common(affects up to 1 in 10 people):
dry mouth,
fatigue,
headache,
sedation.
Uncommon(affects up to 1 in 100 people):
nausea,
malaise,
fever,
dizziness,
insomnia,
tremors,
agitation,
confusion.
Rare(affects up to 1 in 1,000 people):
rapid heartbeat (tachycardia),
accommodation disorders, blurred vision,
constipation,
vomiting,
allergic reactions,
abnormal liver function test results,
seizures,
involuntary, uncoordinated movements of limbs and other body parts (dyskinesia),
disorientation,
hallucinations,
urinary retention,
itching, rash, urticaria, skin inflammation.
Very Rare(affects less than 1 in 10,000 people):
anaphylactic shock (a severe, life-threatening allergic reaction, symptoms include: shortness of breath, swelling of the throat and larynx, skin itching and redness, headache, feeling of "pressure", dizziness, significant weakness, up to loss of consciousness). Anaphylactic shock can be life-threatening in severe cases.
bronchospasm,
angioedema (skin lesions in the form of irregular spots, blisters, and swellings),
increased sweating,
fixed drug eruption,
acute generalized exanthematous pustulosis (pustular rash on reddened skin, which may be accompanied by swelling and general symptoms, e.g., fever),
erythema multiforme (skin rash that can cause blistering and looks like small targets: a dark spot surrounded by a lighter area and a dark ring around it),
Stevens-Johnson syndrome (widespread rash with blisters and peeling skin, mainly in the mouth, eyes, nose, and genital areas).
Frequency Not Known(frequency cannot be estimated from the available data):
changes in the ECG recording (QT interval prolongation or heart rhythm disturbances of the torsade de pointestype), liver inflammation, loss of consciousness (syncope), bladder changes [e.g., toxic epidermal necrolysis (widespread rash with blisters and peeling skin, mainly in the mouth, eyes, nose, and genital areas), pemphigoid (an autoimmune skin disease characterized by well-tensioned blisters, located in the area of erythematous-edematous lesions and in apparently unchanged skin)], weight gain.
Additionally, the following side effects have been observed with cetirizine, the main metabolite of hydroxyzine, which may also occur after taking hydroxyzine:
reduced platelet count (thrombocytopenia), aggression, depression, tics, dystonia (involuntary movements of different body parts), paresthesia, episodes of forced gaze with eye rotation, diarrhea, difficulty urinating, involuntary urination, fatigue, and weakness (asthenia), edema, weight gain.
Some people may experience other side effects while taking Comfortin.
If any of the side effects get worse or if you experience any side effects not listed in this leaflet, please tell your doctor, pharmacist, or nurse.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to Store Comfortin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry Date (Tw)". The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Store blisters in the outer packaging to protect from light.
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 Pack and Other Information

What Comfortin Contains

• The active substance is hydroxyzine hydrochloride. One coated tablet contains 25 mg of hydroxyzine hydrochloride.
• The other excipients are: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, and coating (containing hypromellose, polydextrose (E 1200), titanium dioxide (E 171), talc, maltodextrin, and medium-chain triglycerides).

What Comfortin Looks Like and Contents of the Pack

Coated tablets: white, oblong, biconvex, smooth, with a dividing line.
The tablet can be divided into equal doses.
One pack of Comfortin contains 30 coated tablets.

Marketing Authorization Holder and Manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine Information

phone: (22) 742 00 22
email: [email protected]

Date of Last Revision of the Leaflet: