Amertil Bio

Package Leaflet: Information for the User

Amertil Bio

10 mg, coated tablets

Cetirizine dihydrochloride

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

Always take this medicine 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 need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult your doctor.

Table of Contents of the Package Leaflet

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

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

The active substance of Amertil Bio is cetirizine dihydrochloride.
Amertil Bio is an antiallergic medicine.
Amertil Bio is indicated for 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 taking Amertil Bio

When not to take Amertil Bio

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

Warnings and precautions

Before taking Amertil Bio, discuss with your doctor:

• if the patient has kidney impairment. A lower dose may be necessary. The dose will be determined by the doctor;
• if the patient has problems with urination (e.g. spinal cord problems or prostate problems, or bladder problems);
• if the patient has epilepsy or is at risk of seizures.

No significant clinically relevant interactions (mutual interactions) have been observed between alcohol (at a concentration of 0.5 per mille (g/l) in the blood, corresponding to a concentration after drinking one glass of wine) and cetirizine taken at the recommended dose. However, there are no data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with other antihistamine drugs, it is recommended to avoid taking cetirizine with alcohol.
If the patient is scheduled to undergo skin allergy tests, they should ask their doctor if they should stop taking Amertil Bio a few days before the test. Amertil Bio may affect the results of skin allergy tests.

Children

Amertil Bio should not be given to children under 6 years of age. Consult a doctor who will determine the dose of cetirizine and the pharmaceutical form suitable for the child (e.g. oral drops or oral solution).

Amertil Bio and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Studies on cetirizine 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Amertil Bio 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 in agreement with the doctor.
Cetirizine passes into breast milk. Therefore, Amertil Bio should not be taken during breastfeeding.

Driving and using machines

Clinical studies have not shown any impairment of reaction and concentration and the ability to drive vehicles after taking cetirizine at the recommended dose.
Patients planning to drive vehicles, perform potentially hazardous activities, or operate machinery should pay attention to their body's reaction to the medicine. Do not take a higher dose than recommended.
Amertil Bio contains lactose.
If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Amertil Bio

Always take this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Swallow the tablets with a glass of liquid.
The tablet can be divided into two equal doses.

Adults and adolescents over 12 years of age

10 mg (1 tablet) once a day.

Children from 6 to 12 years of age

½ tablet (5 mg) twice a day.

Patients with renal impairment

In patients with moderate renal impairment, a dose of 5 mg once a day is recommended.
If the 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 treatment period should not exceed 10 days without consulting a doctor.

Overdose of Amertil Bio

In case of overdose, consult your doctor immediately. The doctor will decide what measures should be taken.
After an overdose, the following side effects may occur with increased intensity: disorientation, diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, sedation, somnolence, stupor, tachycardia, tremor, urinary retention.

Missed dose of Amertil Bio

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

Stopping treatment with Amertil Bio

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 immediately inform your doctor if you experience:

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

Common side effects(may affect up to 1 in 10 people):

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

Uncommon side effects(may affect up to 1 in 100 people):

• excitation
• paresthesia (sensory disturbances)
• abdominal pain
• pruritus, rash
• asthenia (extreme fatigue), malaise

Rare side effects(may affect up to 1 in 1,000 people):

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

Very rare side effects(may affect up to 1 in 10,000 people):

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

Frequency not known(frequency cannot be estimated from the available data):

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amertil Bio

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store 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 is the last day of the month stated.
The batch number and expiry date are stated on the outer packaging and blister.
The entry on the blister: the first part (embossed 6 digits) indicates the batch number, and the second part (6 consecutive digits) the expiry date.
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 package and other information

What Amertil Bio contains

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

What Amertil Bio looks like and contents of the package

Amertil Bio tablets are white, round, biconvex, coated tablets, with a notch on one side allowing the tablet to be divided into two equal doses. The surface of the coated tablets is smooth, without spots and cracks.
The package contains 7, 10, or 20 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization 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]

Date of last revision of the package leaflet: