Allemax

Patient Information Leaflet

AlleMax, 10 mg, coated tablets
Cetirizini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if symptoms worsen, contact your doctor.

Table of Contents:

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

1. What AlleMax is and what it is used for

The active substance in AlleMax is cetirizine dihydrochloride, which is an antihistamine. Antihistamines help reduce symptoms of certain allergies.
AlleMax is used in adults, adolescents, and children aged 6 years and older:

• to relieve nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis,
• to relieve symptoms of chronic urticaria (chronic idiopathic urticaria).

Please contact your doctor if there is no improvement after 3 days or if symptoms worsen.

2. Important information before using AlleMax

When not to use AlleMax

• if the patient is allergic to cetylryzine dihydrochloride or any of the other ingredients of this medicine (listed in section 6), hydroxyzine, or piperazine derivatives (active substances with similar structure included in other medicines).
• if the patient has severe kidney disease requiring dialysis.

Warnings and precautions
Before starting treatment with AlleMax, discuss this with a doctor or pharmacist:

• If the patient has kidney impairment, consult a doctor, who may decide to prescribe a lower dose. The new dose will be determined by the doctor.
• If the patient has problems with urination (due to spinal cord injury, benign prostatic hyperplasia, or bladder disorders), consult a doctor.
• If the patient has epilepsy or is at risk of seizures, consult a doctor.

If an allergy test is planned, ask the doctor whether treatment with AlleMax should be discontinued a few days before the test. This medicine may affect the results of allergy tests.
Children
This medicine should not be given to children under 6 years of age, because the tablet form does not allow appropriate dose adjustment.
Interaction of AlleMax with other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to use.
AlleMax and alcohol
Clinically significant interactions between alcohol (at a concentration of 0.5 g/L, equivalent to one glass of wine) and cetirizine administered at recommended doses have not been observed. However, safety data are not available when higher doses of cetirizine and alcohol are used simultaneously. Therefore, as with all antihistamines, it is recommended to avoid taking AlleMax with alcohol.
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 a doctor or pharmacist before using this medicine.
The use of AlleMax 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, this medicine should only be used when clearly necessary and after consultation with a doctor.
Cetirizine passes into breast milk. Adverse effects in breastfed infants cannot be excluded. Therefore, AlleMax should not be used during breastfeeding without medical advice.
Driving and operating machinery
Clinical studies have not shown impairment of reaction time, concentration, or ability to drive vehicles after administration of cetirizine at the recommended dose.
Patients should carefully observe their body's response to AlleMax after taking it. If the patient plans to drive, perform potentially dangerous activities, or operate machinery, the dose should not exceed the recommended dose.
AlleMax contains lactose
AlleMax 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 take AlleMax

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The tablets should be swallowed whole, preferably with a glass of water. The tablet may be divided into equal doses.
Adults and adolescents aged above 12 years:
The recommended dose is one tablet (10 mg) once daily.
Children aged 6 to 12 years:
The recommended dose is half a tablet (5 mg) twice daily (morning and evening).
Patients with renal function impairment
If the patient or the patient's child suffers from kidney disease, consult a doctor, who may adjust the dose according to the patient's or child's needs.
If you feel that the effect of cetirizine is too strong or too weak, consult your doctor.
Duration of treatment
The duration of treatment depends on the type, duration, and course of symptoms. Consult your doctor for advice.
Do not use AlleMax for longer than 3 days without consulting a doctor.
Taking more AlleMax than recommended
If the patient suspects having taken more than the recommended amount of AlleMax, inform your doctor immediately. The doctor will decide what actions, if any, need to be taken.
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, psychomotor agitation, calming, somnolence, stupor, increased heart rate, tremor, and urinary retention (difficulty completely emptying the bladder).
If you forget to take AlleMax
Do not take a double dose to make up for a missed dose.
If you have any further questions about 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 everyone will experience them.
The following adverse reactions occur rarely or very rarely; however, you should stop taking the medicine and immediately inform your doctor if any of the following occur:

• allergic reactions, including severe allergic reactions and angioedema (serious allergic reactions which may cause swelling of the face or throat).

These reactions may occur shortly after the first dose of the medicine or may occur later.
Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

• restlessness;
• paraesthesia (abnormal sensation of the skin);
• abdominal pain;
• itching (skin pruritus), rash;
• asthenia (extreme fatigue), malaise.

Rare (may affect up to 1 in 1,000 patients)

• allergic reactions, some severe (very rarely);
• depression, hallucinations, aggression, confusion, insomnia;
• seizures;
• tachycardia (abnormally fast heartbeat);
• abnormal liver function;
• urticaria;
• oedema (generalised swelling due to water retention);
• weight gain.

Very rare (may affect up to 1 in 10,000 patients)

• thrombocytopenia (low platelet count);
• tics;
• fainting, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, taste disturbances (altered taste);
• blurred vision, accommodation disorders (difficulty focusing vision), oculogyric crisis (involuntary upward gaze with rotation of the eyeballs, uncontrolled circular eye movements);
• angioedema (skin swelling, especially in the facial area), drug rash (allergic reaction to the medicine);
• urinary disorders (nocturnal enuresis, pain and/or difficulty in passing urine).

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

• increased appetite;
• suicidal thoughts (recurring thoughts or preoccupation with suicide), nightmares;
• amnesia (loss of memory), memory impairment;
• vertigo (sensation of spinning);
• urinary retention (inability to completely empty the bladder);
• pruritus (intense itching) and/or urticaria after discontinuation of the medicine;
• joint pain, muscle pain;
• acute generalised exanthematous pustulosis (rash with pustules);
• 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 at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the marketing authorisation holder.

5. How to store AlleMax

Keep this medicine out of sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the carton and 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 required. Such measures help protect the environment.

6. Contents of the pack and other information

What AlleMax contains

• The active substance is cetirizine dihydrochloride. Each coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are:
  Tablet core: monohydrate lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate (E 572).
  Tablet coating: Opadry II OY GM 289000 white (hypromellose (E 464), polydextrose, titanium dioxide (E 171) and macrogol).

What AlleMax looks like and contents of the pack
White or almost white, capsule-shaped coated tablets with a scored line on one side of the tablet.
The tablet can be divided into equal doses.
The tablets are packed in blisters made of PVC/PVDC/Aluminium and placed in a cardboard box.
Pack sizes: 7 or 10 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Dr. Max Pharma s.r.o.
Na Florenci 2116/15, Nové Město
110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

Manufacturer/Importer:
Saneca Pharmaceuticals a.s.
Nitrianska 100
92027 Hlohovec
Slovakia

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Cetirizin Dr.Max
Poland: AlleMax
Slovakia: Cetirizin Dr.Max 10 mg