ALERZINA

Package leaflet: Information for the patient

Alerzina, 10 mg, film-coated tablets
Cetirizini dihydrochloridum
{logo of the responsible entity}
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

Table of contents of the leaflet:

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

1. What Alerzina is and what it is used for

The active substance in Alerzina is cetirizine dihydrochloride.
Alerzina is an antiallergic medicinal product.
Alerzina is indicated in adults and children aged 6 years and older:

• for relief of nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis,
• for relief of symptoms of urticaria.

2. Important information before using Alerzina

When not to use Alerzina:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6), hydroxyzine, or piperazine derivatives (active substances with a similar structure found in other medicines);
• if the patient has end-stage renal failure (severe kidney failure requiring dialysis);
• if the patient has hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

If any of the above conditions apply, Alerzina must not be used. The patient should inform their doctor and follow the doctor's advice.

Warnings and precautions

Before starting treatment with Alerzina, discuss the following with a doctor:

• if the patient has kidney impairment; a lower dose may be required. The doctor will determine the appropriate dosage;
• if the patient has difficulty urinating (e.g. due to spinal cord, prostate, or bladder problems);
• if the patient has epilepsy or is at risk of seizures.

Due to its antihistamine (antiallergic) effect, Alerzina may affect the results of skin tests. The medicine should be discontinued at least 3 days before such tests are performed.

Alerzina and alcohol

No clinically significant interactions have been observed between alcohol (at a blood concentration of 0.5 g/l, equivalent to the level after drinking one glass of wine) and ceterizine when used at recommended doses. However, there is no safety data available regarding concomitant use of higher doses of ceterizine and alcohol. Therefore, as with other antihistamine medicines, it is recommended to avoid taking ceterizine together with alcohol.

Children

This medicine should not be given to children under 6 years of age, as the tablet form does not allow for appropriate dose adjustment.

Alerzina and other medicines

Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.

Alerzina with food and drink

Food does not significantly affect the extent of ceterizine absorption.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

As with other medicines, the use of Alerzina in pregnant women should be avoided. Accidental use during pregnancy is not expected to have harmful effects on the fetus. However, the medicine should only be used if clearly necessary and after consultation with a doctor.

Alerzina should not be used during breastfeeding, as ceterizine passes into breast milk.

Driving and operating machinery

Clinical studies using ceterizine at the recommended dose have not shown a significant effect on the ability to drive, drowsiness, or psycho-motor performance.

If the patient intends to drive, perform potentially hazardous activities, or operate machinery after taking Alerzina, they should pay attention to their individual response to the medicine. The recommended dose should not be exceeded.

In sensitive individuals, concomitant use of ceterizine with alcohol or medicines with central nervous system depressant effects may increase the medicine's effect on reaction time and concentration.

Alerzina contains lactose

If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Alerzina

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The tablets should be swallowed with a glass of water.
The tablet may be divided into two equal doses.

Adults and adolescents aged 12 years and above
One tablet (10 mg) once daily.

Children aged 6 to 12 years
5 mg twice daily (half a tablet twice daily).

Patients with impaired kidney function
For patients with moderate renal impairment, a dose of 5 mg (half a tablet) once daily is recommended.
If a patient has severe kidney disease, consult a doctor, who will adjust the dose accordingly. Alerzina must not be used in patients with end-stage kidney disease requiring dialysis.
If a child has kidney disease, consult a doctor, who will adjust the dose according to the child's needs.

Elderly patients
If kidney function is normal, there is no need to reduce the dose.

Duration of treatment
Treatment with cetirizine without medical advice should not exceed 010 days. If there is no improvement after 3 days, or if symptoms worsen, consult a doctor.
If you feel the effect of Alerzina is too strong or too weak, consult your doctor.

Taking more Alerzina than recommended
If you take more Alerzina than recommended, contact a doctor immediately. The doctor will decide whether and what measures should be taken.
After taking a dose higher than the recommended daily dose, the adverse reactions listed below may occur with increased intensity. Reported adverse reactions include: disorientation, diarrhoea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness (especially motor restlessness), sedation, drowsiness, stupor, increased heart rate, tremor, and urinary retention.

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

Stopping Alerzina
In rare cases, itching (intense pruritus) and/or urticaria may recur after discontinuation of Alerzina.

If you have any further doubts concerning 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 will experience them.
The following adverse reactions are rare or very rare; however, you must stop taking the medicine and
contact your doctor immediately if any of the following occur:

• allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face and throat). These reactions may occur immediately after the first dose or may appear later.

Frequently occurring adverse reactions (may occur in less than 1 in 10 patients):

• drowsiness,
• dizziness, headache,
• sore throat, inflammation of the nasal mucosa (in children),
• diarrhoea, nausea, dry mouth,
• fatigue.

Uncommon adverse reactions (may occur in less than 1 in 100 patients):

• restlessness,
• paraesthesia (sensory disturbances),
• abdominal pain,
• itching, rash,
• extreme weakness, malaise.

Rare adverse reactions (may occur in less than 1 in 1000 patients):

• allergic reactions, sometimes severe (very rare),
• depression, hallucinations, aggressive behaviour, disorientation, insomnia,
• seizures,
• tachycardia (rapid heartbeat),
• abnormal liver function,
• urticaria,
• oedema,
• weight gain.

Very rare adverse reactions (may occur in less than 1 in 10,000 patients):

• thrombocytopenia (reduced number of blood platelets),
• tics (habitual spasms),
• fainting, dyskinesia (involuntary movements), dystonia (prolonged muscle contractions), tremor, taste disturbances,
• blurred vision, accommodation disorders (impaired visual focus), ocular rotation (uncontrolled, circular eye movements),
• angioedema (severe allergic reaction causing swelling of the face or throat), drug rash,
• urinary disorders (nocturnal enuresis, pain and/or difficulty in passing urine).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• increased appetite,
• suicidal attempts (recurrent suicidal thoughts or interest in suicide), nightmares,
• memory loss, memory disturbances,
• dizziness (sensation of spinning or loss of balance),
• urinary retention (inability to completely empty the bladder),
• itching (intense pruritus) and/or urticaria after discontinuation of the medicine,
• joint pain, muscle pain,
• acute generalized exanthematous pustulosis (rash with pustules),
• hepatitis.

If any of the adverse reactions listed above occur, inform your doctor. If the first signs of hypersensitivity
reactions appear, discontinue taking Alerzina. Your doctor will assess the severity of the symptoms and
decide whether further management is necessary.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. 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 Alerzina

Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
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 packaging and other information

What Alerzina contains

• The active substance in Alerzina is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine dihydrochloride.
• Other ingredients are: microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, crospovidone, talc, lactitol monohydrate, macrogol 3350, hypromellose, titanium dioxide (E171).

What Alerzina looks like and contents of the pack
Alerzina is a white, round, film-coated tablet with a smooth surface and a score line allowing the tablet to be divided into two equal parts.
Alerzina is packed in blisters made of PVC/Aluminum or PVC/PVDC/Aluminum, and then placed with the patient leaflet into a cardboard box. The pack contains 10 film-coated tablets.

Marketing Authorisation Holder
Silesian Pharma Sp. z o.o.
ul. Szopienicka 77
40-431 Katowice
tel: (32) 20 80 600

Manufacturer
Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
ul. Ostrzykowizna 14A
05-170 Zakroczym