Package leaflet: information for the patient

Alermed, 10 mg, coated tablets
Cetirizini dihydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

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

Table of contents of the leaflet:

What Alermed is and what it is used for
Important information before taking Alermed
How to take Alermed
Possible side effects
How to store Alermed
Contents of the pack and other information

1. What Alermed is and what it is used for

The active substance in Alermed is cetirizine dihydrochloride.
Alermed is an antiallergic medicine.
Alermed 10 mg coated tablets are 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 Alermed

When not to use Alermed:

if the patient is allergic to cetyrizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6), hydroxyzine, or piperazine derivatives (active substances with a similar structure contained in other medicines);
if the patient has end-stage renal failure requiring dialysis (severe kidney failure requiring dialysis).

Warnings and precautions
Before starting treatment with Alermed, discuss it with your doctor or pharmacist.
If the patient has kidney impairment, consult a doctor before using this medicine;
a lower dose may be required. The doctor will determine the appropriate dose.
If the patient has difficulty urinating (e.g. due to spinal cord disorders, prostate problems,
or bladder disorders), medical advice should be sought.
If the patient has epilepsy or is at risk of seizures, consult a doctor.
No clinically significant interactions have been observed between alcohol (at a blood concentration of 0.5 per mille (g/l), equivalent to the concentration after drinking one glass of wine) and cetyrizine administered at recommended doses. However, there are no safety data available regarding the concomitant use of higher doses of cetyrizine and alcohol. Therefore, as with other antihistamine medicines, it is recommended to avoid taking Alermed together with alcohol.
If the patient has scheduled allergy testing, ask the doctor whether the patient should stop taking Alermed several days before the test. Alermed may affect the results of skin tests.
Children
This medicine should not be given to children under 6 years of age, as the tablet formulation does not allow for appropriate dose adjustment.
Alermed with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking Alermed with food and drink
Food does not affect the absorption of Alermed.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
The use of Alermed during pregnancy should be avoided. Accidental intake of the medicine by a pregnant woman is not expected to have harmful effects on the fetus. However, the medicine should only be used if necessary and after consultation with a doctor.
Cetirizine passes into breast milk. The risk of adverse effects in breastfed infants cannot be excluded. Therefore, Alermed should not be used during breastfeeding unless otherwise directed by a doctor.
Driving and operating machinery
Clinical studies have not shown any impairment of reaction ability, concentration, or driving skills after administration of Alermed at the recommended dose.
If the patient plans to drive, perform potentially hazardous activities, or operate machinery after taking Alermed, he or she should carefully observe how his or her body reacts to the medicine. Do not exceed the recommended dose.
Alermed contains lactose and lactitol
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Alermed

This medicine should always be used 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 2 equal doses.
Adults and adolescents over 12 years of age
The recommended dose is 10 mg (1 tablet) once daily.
Other formulations of this medicine may be more suitable for children. Consult a doctor or
pharmacist.
Use in children aged 6 to 12 years
The recommended dose is 5 mg twice daily (half a tablet twice daily). Other formulations of this medicine
may be more suitable for children. Consult a doctor or pharmacist.
Patients with renal function impairment
For patients with moderate renal impairment, a dose of 5 mg once daily is recommended.
If a patient has severe kidney disease, consult a doctor, who will adjust the dose accordingly.
If a child has kidney disease, consult a doctor, who will adjust the dose according to the child's needs.
If you feel that the effect of Alermed is too strong or too weak, consult a doctor.
Duration of treatment
The duration of treatment depends on the type, duration, and course of symptoms and is determined by
the doctor.
Taking more than the recommended dose of Alermed
If more than the recommended dose of Alermed has been taken, seek immediate medical advice. The doctor
will decide whether and what measures should be taken.
After an overdose, the following adverse reactions may occur with increased intensity:
disorientation, diarrhoea, dizziness, fatigue, headache, malaise, pupil dilation, itching, motor restlessness,
sedation, somnolence, stupor, increased heart rate, tremor, urinary retention (difficulty completely
emptying the bladder).
Missed dose of Alermed
Do not take a double dose to make up for a missed dose.
Stopping Alermed
In rare cases, itching (intense pruritus) and (or) urticaria may recur after discontinuation of Alermed.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions occur rarely or very rarely; however, you should discontinue
taking the medicine and immediately inform your doctor 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 of the medicine or may occur later.

Adverse reactions occurring frequently (may affect fewer than 1 in 10 patients):

drowsiness,
dizziness, headache,
pharyngitis (sore throat), rhinitis (nasal discharge, sensation of nasal congestion) (in children),
diarrhoea, nausea, dry mouth,
fatigue.

Adverse reactions occurring uncommonly (may affect fewer than 1 in
100 patients):

restlessness,
paraesthesia (sensory disturbances),
abdominal pain,
itching, rash,
asthenia (extreme tiredness), malaise.

Adverse reactions occurring rarely (may affect fewer than 1 in 1000
patients):

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

Adverse reactions occurring very rarely (may affect fewer than 1 in 10,000
patients):

thrombocytopenia (low platelet count),
tics (habitual spasms),
fainting, dyskinesia (involuntary movements), dystonia (abnormal, prolonged muscle contractions), tremor, taste disturbances,
blurred vision, accommodation disorders (impaired visual focus), nystagmus (involuntary, rhythmic eye movements),
angioedema (severe allergic reaction causing swelling of the face or throat), drug eruption (skin allergic reaction to a medicine),
urinary disorders (nocturia, pain and/or difficulty in passing urine).

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

increased appetite,
suicidal behaviour (recurring suicidal thoughts or interest in suicide), nightmares,
amnesia (loss of memory), memory impairment,
vertigo (sensation of spinning or loss of balance),
urinary retention (inability to completely empty the bladder),
itching (intense pruritus) and/or urticaria after stopping the medicine,
joint pain, muscle pain,
acute generalized exanthematous pustulosis (rash with pustules containing purulent discharge),
hepatitis.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. 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:
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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Alermed

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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Alermed contains

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

What Alermed looks like and contents of the pack
Alermed 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.
Alermed is packed in blisters made of PVC/Aluminium or PVC/PVDC/Aluminium, and then placed together with the patient leaflet into a cardboard box. The pack contains 20 or 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
LEK-AM Sp. z o.o.
ul. Ostrzykowizna 14A
05-170 Zakroczym
Tel.: +48 22 785 27 60