Amertil

Package Leaflet: Information for the User

Amertil

10 mg, coated tablets

Cetirizine dihydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Amertil and what is it used for

The active substance of Amertil is cetirizine dihydrochloride.
Amertil is an antiallergic medicine.
Amertil is indicated for adults and children aged 6 years and above:

• for relief of symptoms of the nose and eyes, associated with seasonal and perennial allergic rhinitis;
• for relief of symptoms of urticaria.

2. Important information before taking Amertil

When not to take Amertil

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

Warnings and precautions

Before taking Amertil, 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 problems or prostate problems, or bladder problems);
• if you have epilepsy or are at risk of seizures.

No significant clinically relevant interactions (mutual effects) 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 administered at the recommended doses. However, there are no data on the safety
of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with other antihistamine medicines, it is recommended to avoid taking Amertil with alcohol.
If you are scheduled to undergo skin allergy tests, you should ask your doctor whether you should stop taking Amertil a few days before the test. Amertil may affect the results of skin allergy tests.

Children

Amertil coated tablets are not recommended for children under 6 years of age, as this pharmaceutical form does not allow for appropriate dose adjustment. It is recommended to use a pharmaceutical form intended for children (e.g., oral drops or oral solution).

Amertil and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Studies with cetirizine 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 you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Amertil 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 your doctor.
Cetirizine passes into breast milk. Therefore, you should not take Amertil during breastfeeding.

Driving and using machines

Clinical studies have not shown any impairment of reaction time, and ability to drive or operate machinery after administration of cetirizine at the recommended dose.
If you plan to drive a vehicle, perform potentially hazardous activities, or operate machinery after taking Amertil, you should carefully observe your body's reaction to the medicine. Do not take a higher dose than recommended.

Amertil contains lactose.

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Amertil

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask 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

10 mg (1 tablet) once daily

Children from 6 to 12 years

5 mg twice daily (half a tablet twice daily)

Patients with renal impairment

In patients with moderate renal impairment, a dose of 5 mg once daily is recommended.
If you have severe kidney disease, consult your doctor, who will adjust the dose accordingly.
If your child has severe kidney disease, consult your doctor, who will adjust the dose according to your 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 your doctor.

Overdose of Amertil

If you have taken more than the recommended dose of Amertil, contact your doctor immediately. Your doctor will decide what measures to take.
After an overdose, the following side effects may occur with increased intensity: disorientation, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, restlessness, sedation, somnolence, stupor, increased heart rate, tremor, and urinary retention.

Missed dose of Amertil

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

Stopping Amertil treatment

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

4. Possible side effects

Like all medicines, Amertil 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 tell 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. 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):
• agitation
• 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 heart rate)
• abnormal liver function
• urticaria
• edema
• weight gain Very rare side effects(may affect up to 1 in 10,000 people):
• thrombocytopenia (reduced platelet count)
• tics (involuntary muscle contractions)
• syncope, dyskinesia (involuntary movements), dystonia (prolonged muscle contractions), tremor, taste disturbances
• blurred vision, accommodation disorders (vision disorders), eye rotation (uncontrolled, circular eye movements)
• 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 disturbances
• 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 any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
e-mail: ndl@urpl.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amertil

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original package to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton after "EXP:" and on the blister after "EXP:".
The expiry date refers to the last day of the month.
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 Amertil contains

• The active substance of Amertil is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, crospovidone (type A), magnesium stearate; coating: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 breaking.
The pack contains 20, 30, or 60 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
faks: +48 61 66 51 505
biofarm@biofarm.pl

Date of last revision of the leaflet: