Patient Information Leaflet

Comfortin
25 mg, coated tablets
Hydroxyzini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents:

What Comfortin is and what it is used for
What you need to know before taking Comfortin
How to take Comfortin
Possible side effects
How to store Comfortin
Contents of the pack and other information

1. What Comfortin is and what it is used for

The active substance in Comfortin is hydroxyzine, which has antihistaminic, sedative, and anxiolytic properties.
Indications

Symptomatic treatment of anxiety in adults.
Symptomatic treatment of pruritus (itching).
Premedication before surgical procedures.

2. Important information before using Comfortin

When not to use Comfortin

if the patient is allergic to hydroxyzine, cetirizine, other piperazine derivatives, aminophylline, ethylenediamine, or any of the other ingredients of this medicine (listed in section 6);
if the patient has porphyria (a disorder characterized by abnormal production of heme – a component of haemoglobin);
if the patient's ECG (electrocardiogram) shows heart rhythm disturbances known as QT interval prolongation;
if the patient has or has had cardiovascular disease or if the heart rate is very low;
if the patient has low levels of electrolytes in blood serum (e.g. low potassium or magnesium levels);
if the patient is taking certain medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section "Comfortin with other medicines");
if someone in the patient's family has died suddenly due to heart disease;
during breastfeeding and pregnancy.

Warnings and precautions
Before starting to use Comfortin, discuss this with your doctor or pharmacist.
Use of Comfortin may be associated with an increased risk of life-threatening heart rhythm
disturbances. Therefore, inform your doctor about any heart problems and about any other
medicines you are taking, including those available without a prescription.
If symptoms affecting the heart occur during treatment with Comfortin, such as rapid heartbeat
(palpitations), difficulty breathing, or loss of consciousness, contact your doctor immediately.
Treatment with hydroxyzine should be discontinued.
Special caution should be exercised when using Comfortin:

if the patient has an increased tendency to seizures (such cases have been reported more frequently in children than in adults);
if the patient has glaucoma, difficulty in urination from the urinary bladder, weakened gastrointestinal peristalsis, 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 upper limbs and walking; rarely, respiratory muscle weakness occurs), or dementia (reduced mental capacity);
if the patient is simultaneously taking other medicines that depress the central nervous system or medicines with anticholinergic properties (in such patients, dose adjustment may be necessary).

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

Comfortin with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
This includes medicines available without a prescription. Comfortin may affect the action of other medicines, and other medicines may affect the action of Comfortin.
Concomitant use of hydroxyzine with medicines that depress the central nervous system or with medicines exhibiting anticholinergic effects may require a lower dose, which should be individually adjusted according to the patient's response.
Hydroxyzine acts antagonistically to betahistine and cholinesterase inhibitors.
Concomitant administration of hydroxyzine with monoamine oxidase inhibitors (MAO inhibitors) should be avoided.
Hydroxyzine reduces the blood pressure increase caused by adrenaline and diminishes the anticonvulsant effect of phenytoin.
Since hydroxyzine is metabolized via alcohol dehydrogenase and CYP3A4/5, concomitant use of drugs inhibiting these enzymes may lead to increased plasma concentrations of hydroxyzine.
Concomitant administration of hydroxyzine and medicines capable of inducing heart rhythm disturbances may increase the risk of ECG changes – QT interval prolongation or occurrence of torsade de pointes-type arrhythmias.
Caution is advised when using hydroxyzine concomitantly with medicines causing bradycardia and hypokalaemia.
Do not take Comfortin if the patient is receiving medicines used to treat:

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

Comfortin and alcohol
Do not drink alcohol while taking Comfortin, as it intensifies the effect of this medicine.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Women of childbearing potential must use an appropriate contraceptive method to prevent pregnancy during treatment with hydroxyzine.
Use of Comfortin during pregnancy and breastfeeding is contraindicated.
If use of Comfortin is necessary, breastfeeding must be discontinued.
In newborns whose mothers received hydroxyzine during late pregnancy and/or during delivery, the following symptoms have been observed immediately or several hours after birth: tremors, muscle stiffness and/or weakness, breathing difficulties, and urinary retention (difficulty or inability to urinate).
Animal studies have not shown negative effects on fertility. Data on effects on human fertility are not available.

Driving and operating machinery
While taking Comfortin, do not drive, operate machinery, or use tools, as this medicine may impair reaction ability and concentration.

Comfortin contains lactose
One tablet contains 47.5 mg of monohydrate lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

3. How to use Comfortin

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Comfortin should be used at the lowest effective dose. The duration of treatment should be
as short as possible.
In adults and children with body weight above 40 kg, the maximum daily dose in all indications is 100 mg.
In elderly patients, the maximum daily dose is 50 mg.
In children with body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight/day.
For children under 6 years of age and older who are unable to swallow tablets, another formulation containing hydroxyzine is available – syrup, suitable for this age group.
This medicine is taken orally. The tablet may be divided into equal doses.
The usual dosing regimens are given 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 may be used.
Symptomatic treatment of pruritus (itching):
Treatment should be initiated with a dose of 25 mg at bedtime; if necessary, the dose may be increased to 25 mg 3 or 4 times daily.
Premedication before surgical procedures:
50 to 100 mg as a single dose.
Use in children and adolescents
Children (from 12 months of age) and adolescents
In children with body weight up to 40 kg, the maximum daily dose is 2 mg/kg body weight/day.
In children with body weight above 40 kg, the maximum daily dose is 100 mg.
Symptomatic treatment of pruritus:
1 mg/kg to 2 mg/kg body weight/day in divided doses.
Premedication before surgical procedures:
0.6 mg/kg body weight as a single dose.
The total daily dose should not exceed 2 mg/kg body weight/day.
Dosage adjustment
The doctor will individually adjust the dosage within the recommended dose range depending on the patient's response to treatment.
Elderly patients
The use of hydroxyzine in elderly patients is not recommended. If treatment is initiated, it is recommended to start with half the usual adult dose.
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 elimination of the drug metabolite cetirizine, the administered doses should be reduced.
Patients with hepatic impairment
In patients with hepatic impairment, a 33% reduction in the daily dose of the medicine is recommended.
Use of a higher than recommended dose of Comfortin
If a patient has taken or used more than the recommended dose of Comfortin, contact a doctor immediately, especially if this concerns a child.
In case of overdose, symptomatic treatment may be applied. ECG monitoring is required due to the risk of cardiac rhythm disturbances such as QT interval prolongation or torsade de pointes.
Symptoms of Comfortin overdose include: nausea, vomiting, rapid heartbeat (tachycardia), fever, drowsiness, disturbances of pupillary reflex, tremor, confusion or hallucinations, followed by decreased level of consciousness, reduced respiratory rate (respiratory depression), seizures, hypotension or cardiac arrhythmias, and progressively worsening coma and circulatory-respiratory collapse.
There is no specific antidote.
Missed dose of Comfortin
Do not take a double dose to make up for a missed dose.
Discontinuation of Comfortin
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment should be discontinued and medical advice should be sought immediately if the patient experiences
cardiac arrhythmias, such as rapid heartbeat (palpitations), difficulty breathing, or loss of
consciousness.

Very common (in more than 1 in 10 patients):
drowsiness.

Common (in up to 1 in 10 patients):
dry mouth,
fatigue,
headache,
drug-induced sedation (sedation).

Uncommon (in up to 1 in 100 patients):
nausea,
malaise,
fever,
dizziness,
insomnia,
tremor,
agitation,
confusion.

Rare (in up to 1 in 1,000 patients):
increased heart rate (tachycardia),
accommodation disorders, blurred vision,
constipation,
vomiting,
hypersensitivity reactions,
abnormal liver function test results,
seizures,
involuntary, uncoordinated movements of limbs and other body parts (dyskinesia),
disorientation,
hallucinations,
urinary retention,
itching, erythematous rash, maculopapular rash, urticaria, skin inflammation,
hypotension.

Very rare (occurring in fewer than 1 in 10,000 patients):
anaphylactic shock (caused by a severe systemic allergic reaction; symptoms include: shortness of breath, laryngeal and pharyngeal swelling, skin itching and redness, headache, sensation of "pressure", dizziness, profound weakness, up to and including loss of consciousness). Anaphylactic shock may be life-threatening in severe cases.
bronchospasm,
angioedema (skin lesions in the form of irregular patches, blisters, and swellings),
excessive sweating,
persistent drug-induced rash,
acute generalized exanthematous pustulosis (pustular rash on red skin, which may be accompanied by swelling and general symptoms such as fever),
erythema multiforme (skin rash which may lead to blister formation and resemble small bullseyes: a dark center surrounded by a lighter area and a dark ring around it),
Stevens-Johnson syndrome (widespread rash with blisters and skin peeling, occurring mainly around the mouth, eyes, nose, and genital organs).

Frequency not known (frequency cannot be estimated from available data):
changes in electrocardiogram (ECG findings showing QT interval prolongation or cardiac arrhythmias such as torsade de pointes), hepatitis, loss of consciousness (fainting), blistering skin changes [e.g.: toxic epidermal necrolysis (widespread rash with blisters and skin peeling, occurring mainly around the mouth, eyes, nose, and genital organs), pemphigoid (an autoimmune skin disease characterized by tense blisters located on erythematous-edematous lesions or on apparently normal skin)], weight gain.

Additionally, the following adverse reactions associated with cetirizine, the main metabolite of hydroxyzine, have been observed and may also occur after administration of hydroxyzine:
decreased platelet count (thrombocytopenia), aggression, depression, tics, dystonia (involuntary movements of various body parts), paresthesia, compulsive upward gaze with eye rotation, diarrhea, difficulty urinating, involuntary urination, fatigue and weakness (asthenia), edema, weight gain.

Other adverse reactions may occur in some individuals during treatment with Comfortin.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor, pharmacist, or nurse.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02 - 222 Warsaw,
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Comfortin

Keep the 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 (ED)". The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep the blisters in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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.
Other ingredients are: monohydrate lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, and the 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, elongated, biconvex, smooth, with a dividing line.
The tablet can be divided into equal doses.
One pack of the medicine contains 30 coated tablets.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel.: (22) 742 00 22
email: [email protected]