Alezhina

Package Leaflet: Information for the Patient

Alerzina, 10 mg, Film-Coated Tablets

Cetirizine Dihydrochloride

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

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.
• If after 10 days there is no improvement or you feel worse, you should contact your doctor.

Contents of the Package Leaflet:

• 1. What is Alerzina and what is it 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 is Alerzina and what is it used for

The active substance of Alerzina is cetirizine dihydrochloride.
Alerzina is an antiallergic medicine.
Alerzina is indicated for the treatment of:

• chronic allergic rhinitis,
• seasonal allergic rhinitis (hay fever),
• allergic conjunctivitis,
• chronic idiopathic urticaria.

2. Important information before taking Alerzina

When not to take Alerzina:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6) or to hydroxyzine and piperazine derivatives (active substances with a similar structure, contained in other medicines);
• if you have severe kidney disease (severe renal insufficiency with creatinine clearance less than 10 ml/min);
• if you have hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome.

If any of these conditions apply, do not take Alerzina.
Tell your doctor and follow his advice.

Warnings and precautions

Before taking Alerzina, discuss with your doctor:

• if you have kidney disease; a lower dose may be necessary. The dose will be determined by your doctor;
• if you have problems with urination (e.g. spinal cord injury or prostate problems, or bladder problems);
• if you have epilepsy or a risk of seizures.

Due to its antihistamine effect, Alerzina may affect the results of skin tests.
They should be performed after a 3-day interval following the discontinuation of the medicine.
No clinically significant interactions have been observed between alcohol (at a concentration of 0.5 g/l in the blood, corresponding to the concentration after drinking one glass of wine) and cetirizine, administered at the recommended doses. However, as with other antihistamines, it is recommended to avoid taking cetirizine with alcohol.

Alerzina and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the medicines you plan to take.
Due to the profile of cetirizine, interactions with other medicines are not expected.

Alerzina with food and drink

Food does not affect the absorption of cetirizine to a significant extent.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
As with other medicines, Alerzina should be avoided in pregnant women.
Accidental intake of the medicine by a pregnant woman should not have a harmful effect on the fetus.
However, the medicine should only be used if necessary and after consulting a doctor.
Alerzina should not be taken during breastfeeding, as cetirizine passes into breast milk.

Driving and using machines

Clinical studies with cetirizine at the recommended dose have not shown an effect on the ability to drive vehicles, drowsiness, and psychomotor performance.
If you plan to drive a vehicle, perform potentially hazardous activities, or operate machinery after taking Alerzina, you should pay attention to your body's reaction to the medicine. Do not exceed the recommended dose.
In sensitive patients, concomitant use of cetirizine with alcohol or medicines with a sedating effect on the central nervous system may enhance the effect of the medicine on reaction time and concentration.

Alerzina contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Alerzina

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist.
In case of doubt, consult your doctor or pharmacist.
The tablets should be swallowed with a glass of water.

Adults and adolescents over 12 years of age

One tablet (10 mg) once daily.

Children from 6 to 12 years of age

5 mg twice daily (half a tablet twice daily).

Patients with renal impairment

In patients with moderate renal impairment, a dose of 5 mg (half a tablet) once daily is recommended.
If you have severe kidney disease, consult your doctor, who will adjust the dose accordingly.

Elderly patients

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

Duration of treatment

Treatment with cetirizine without medical supervision should not exceed 10 days.
If you feel that the effect of Alerzina is too strong or too weak, consult your doctor.

Overdose of Alerzina

In case of overdose, consult your doctor immediately. The doctor will decide what measures should be taken.
After taking a higher dose than the recommended daily dose, the following side effects may occur with increased intensity: disorientation, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, especially motor restlessness, sedation, drowsiness, stupor, accelerated heart rate, tremor, urinary retention.

Missed dose of Alerzina

Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The following side effects are rare or very rare, but you should stop taking the medicine and inform your doctor immediately if you experience:

• allergic reactions, including severe reactions and angioedema (a severe allergic reaction that causes swelling of the face and throat). These reactions may occur immediately after the first administration of the medicine or may occur later.

To assess the frequency of the following side effects, the following criteria were used:
Common (affect 1 to 10 in 100 patients)
Uncommon (affect 1 to 10 in 1,000 patients)
Rare (affect 1 to 10 in 10,000 patients)
Very rare (affect less than 1 in 10,000 patients)
Unknown (frequency cannot be estimated from available data).

Common side effects:

• drowsiness,
• dizziness, headache,
• pharyngitis, rhinitis (in children),
• diarrhea, nausea, dry mouth,
• fatigue.

Uncommon side effects:

• excitation,
• paresthesia (sensory disturbances),
• abdominal pain,
• itching, rash,
• very strong weakness, malaise.

Rare side effects:

• allergic reactions, sometimes severe (very rare),
• depression, hallucinations, aggressive behavior, disorientation, insomnia,
• seizures,
• tachycardia (rapid heart rate),
• abnormal liver function,
• urticaria,
• edema,
• weight gain.

Very rare side effects:

• thrombocytopenia (decreased platelet count),
• tics (habitual contractions),
• fainting, dyskinesia (involuntary movements), dystonia (prolonged muscle contractions), tremor, taste disturbances,
• blurred vision, accommodation disorders (vision sharpness disorders), eye rotation (uncontrolled, circular eye movements),
• angioedema (severe allergic reaction causing swelling of the face or throat), drug rash,
• urination disorders (nocturia, pain and/or difficulty urinating).

Side effects of unknown frequency:

• increased appetite,
• suicidal attempts (recurring suicidal thoughts or interest in suicide),
• memory loss, memory disturbances,
• vertigo (feeling of spinning or loss of balance),
• urinary retention (inability to completely empty the bladder).

If you experience any of the above side effects, inform your doctor. If you experience the first symptoms of hypersensitivity, stop taking Alerzina. Your doctor will then assess the severity of the symptoms and

decide whether further action is necessary.

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, inform your doctor or pharmacist. 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
Al. Jerozolimskie 181C
02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Alerzina

Store in a temperature below 25°C.
Keep the medicine out of the 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 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 pack and other information

What Alerzina contains

• The active substance of Alerzina is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: microcrystalline cellulose, anhydrous colloidal 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, with a score line that allows the tablet to be divided into two halves.
Alerzina is packaged in a PVC/Aluminium or PVC/PVDC/Aluminium blister pack, and then, together with the package leaflet, in a cardboard box. The pack contains 10 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder

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

Manufacturer

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

Date of last revision of the package leaflet: