Package leaflet: Information for the user

Amertil
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, so that you can read it again if necessary.
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. The medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Amertil is and what it is used for

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

for the relief of nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis;
for the relief of symptoms of urticaria.

2. Important information before using Amertil

When not to use Amertil

if the patient has severe kidney disease (severe renal insufficiency with creatinine clearance less than 10 ml/min);
if the patient is allergic to cetylpyridinium dichloride hydrochloride or any of the other ingredients of this medicine (listed in section 6), to hydroxyzine, or to piperazine derivatives (active substances with similar structure included in other medicines).

Warnings and precautions
Before starting treatment with Amertil, consult your doctor:

if the patient has renal insufficiency. A lower dose may be necessary. The doctor will determine the appropriate dosage;
if the patient has problems with urination (e.g. due to spinal cord, prostate, or bladder issues);
if the patient suffers from epilepsy or is at risk of seizures.

No clinically significant interactions between alcohol
(at a blood concentration of 0.5 per mille (g/l), corresponding to the level after drinking one glass of wine)
and ceterizine administered at recommended doses have been observed. 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 Amertil together with alcohol.
If the patient has scheduled skin allergy tests, they should ask their doctor whether Amertil should be discontinued
a few days before the test. Amertil may affect the results of skin allergy tests.
Children
The use of coated tablets of Amertil is not recommended in children under 6 years of age,
because this pharmaceutical form does not allow appropriate dose adjustment. It is recommended to use
a pediatric formulation (e.g. oral drops or oral solution).
Amertil and 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.
Studies on ceterizine indicate that interactions with other medicines are not expected.
Amertil with food and drink
Food does not affect the absorption of Amertil.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child,
she should consult a doctor or pharmacist before using this medicine.
The use of Amertil should be avoided in pregnant women. Accidental intake of the medicine by a pregnant woman
is not expected to have harmful effects on the fetus. However, the medicine may be used only if necessary and under medical supervision.
Ceterizine passes into breast milk. Therefore, Amertil should not be used during breastfeeding.
Driving and operating machinery
Clinical studies have not shown impairment of reaction time, concentration, or ability to drive vehicles
after administration of ceterizine at the recommended dose.
If the patient plans to drive, perform potentially hazardous activities, or operate machinery after taking Amertil,
they should carefully observe their body's response to the medicine. Do not exceed the recommended dose.
Amertil contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, they should
consult their doctor before using this medicine.

3. How to use Amertil

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

Adults and adolescents over 12 years of age
10 mg (1 tablet) once daily

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

Patients with impaired kidney function
In patients with moderate kidney 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 severe kidney disease, consult a doctor, who will adjust the dose according to the child's needs.

If you feel that the effect of Amertil is too strong or too weak, consult your doctor.

Duration of treatment
The duration of treatment depends on the type, duration, and course of the disease, and is determined by
the doctor.

Taking more than the recommended dose of Amertil
If more Amertil than recommended has been taken, contact your doctor immediately.
The doctor will decide whether any action is needed.
After an overdose, the adverse reactions listed below may occur with increased intensity.
The following adverse reactions have been reported: disorientation, diarrhoea, dizziness, fatigue, headache, malaise, pupil dilation, itching, motor restlessness, sedation, drowsiness, stupor, rapid heartbeat, tremor, and urinary retention.

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

Stopping Amertil
If you have any further doubts regarding the use of this medicine, consult your 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 contact your doctor immediately if any of the following occur:

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

Adverse reactions occurring frequently (may affect up to 1 in 10 patients):

drowsiness
dizziness, headache
sore throat, rhinitis (in children)
diarrhoea, nausea, dry mouth
fatigue

Adverse reactions occurring not frequently (may affect up to 1 in 100 patients):

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

Adverse reactions occurring rarely (may affect up to 1 in 1,000 patients):

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

Adverse reactions occurring very rarely (may affect up to 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 (visual focus disturbances), ocular rotation (uncontrolled, circular eye movements)
angioedema (serious allergic reaction causing swelling of the face or throat), drug eruption
urinary disorders (bedwetting, pain and/or difficulty in passing urine)

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

increased appetite
suicidal behaviour (recurring suicidal thoughts or interest in suicide)
memory loss, memory disorders
vertigo (sensation of spinning or loss of balance)
urinary retention (inability to completely empty the bladder)

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms 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 Warszawa
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Amertil

Keep this medicine out of sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP):" and on the blister after "EXP:".
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 pack and other information

What Amertil contains

The active substance in Amertil is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine dihydrochloride.
Other ingredients are: monohydrate lactose, microcrystalline cellulose, pregelatinized starch, crospovidone (type A), magnesium stearate; coating ingredients: hypromellose, titanium dioxide (E 171), and macrogol 400.

What Amertil looks like and contents of the pack
White, round, biconvex coated tablets with a score line on one side to facilitate division.
The pack contains 20, 30 or 60 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel. +48 61 66 51 500
fax: +48 61 66 51 505
[email protected]