AMERTIL BIO

Package leaflet: Information for the user

Amertil Bio
10 mg, coated tablets
Cetirizini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your 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 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.

Contents of the leaflet

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

1. What Amertil Bio is and what it is used for

The active substance in Amertil Bio is cetirizine dihydrochloride.
Amertil Bio is an antiallergic medicine.
Amertil Bio 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 Amertil Bio

When not to use Amertil Bio

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

Warnings and precautions
Before starting treatment with Amertil Bio, 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 or prostate disorders, or bladder problems);
• if the patient has epilepsy or is at risk of seizures.

No clinically significant interactions (mutual effects) have been observed 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. However, there are 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.
If the patient has planned skin allergy tests, they should ask the doctor whether Amertil Bio
should be discontinued a few days before the test. Amertil Bio may affect the results of skin allergy tests.
Children
Amertil Bio is not recommended for use in children under 6 years of age. Please consult a
doctor, who will determine the appropriate dose of ceterizine and suitable pharmaceutical form for the child
(e.g. oral drops or oral solution).
Amertil Bio 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 the patient plans to take.
Studies on ceterizine indicate that interactions with other medicines are not expected.
Amertil Bio with food and drink
Food does not affect the absorption of Amertil Bio.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child,
she should consult her doctor or pharmacist before using this medicine.
Amertil Bio 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 Bio should not be used during
breastfeeding.
Driving and operating machinery
Clinical studies have not shown any impairment of reaction ability, concentration, or ability
to drive vehicles after administration of ceterizine at the recommended dose.
Patients planning to drive, perform potentially hazardous activities, or operate machinery should
pay attention to their individual response to the medicine. Doses higher than recommended should not be used.
Amertil Bio contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before using this medicine.

3. How to use Amertil Bio

This medicine should always be taken exactly as described in the 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 liquid.
The tablet may be divided into two equal doses.

Adults and adolescents aged over 12 years
10 mg (1 tablet) once daily.

Children aged 6 to 12 years
½ tablet (5 mg) 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 Bio 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.
When starting treatment with cetirizine, the duration of use should not exceed 10 days without consulting a doctor.

Taking more Amertil Bio than recommended
If you take more Amertil Bio than recommended, contact your doctor immediately. The doctor will decide whether and what measures should be taken.
After an overdose, the following adverse effects may occur with increased intensity: confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupil dilation, itching, motor restlessness, sedation, somnolence, stupor, increased heart rate, tremor, and urinary retention.

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

Stopping Amertil Bio
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 everybody will experience them.
The following adverse reactions are rare or very rare; however, you must discontinue taking the medicine and immediately inform your doctor 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 that are common (may affect up to 1 in 10 patients):

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

Adverse reactions that are uncommon (may affect up to 1 in 100 patients):

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

Adverse reactions that are rare (may affect up to 1 in 1,000 patients):

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

Adverse reactions that are very rare (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 (nocturnal enuresis, pain and/or difficulty in urination)

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

• increased appetite
• suicidal behaviour (recurrent suicidal thoughts or interest in suicide)
• memory loss, memory disturbances
• dizziness (sensation of spinning or loss of balance)
• urinary retention (inability to completely empty the bladder)

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 of Adverse Drug Reactions at 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Amertil Bio

Keep the 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.
Batch number and expiry date are printed on the outer packaging and on the blister.
Blister marking: the first part (embossed 6 digits) indicates the batch number, while the second part (6 following digits) indicates the expiry date.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Amertil Bio contains

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

What Amertil Bio looks like and contents of the pack
Amertil Bio tablets are white, round, biconvex coated tablets with a score line on one side allowing the tablet to be divided into two equal doses. The surface of the coated tablets is smooth, without spots or chipping.
The pack contains 7, 10 or 20 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
e-mail: [email protected]