Allemax

Package Leaflet: Information for the Patient

AlleMax, 10 mg, Film-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 leaflet, you may need to read it again.
• If you have any further questions, ask 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, you should contact your doctor.

Table of Contents of the Package Leaflet:

• 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 of AlleMax is cetirizine dihydrochloride, which is an antihistamine. Antihistamines help to reduce the symptoms of some allergies.

AlleMax is used in adults, adolescents, and children aged 6 years and above:

• to relieve symptoms of the nose and eyes, associated with seasonal and perennial allergic rhinitis,
• to relieve symptoms of chronic idiopathic urticaria (chronic hives).

Contact your doctor if after 3 days there is no improvement or you feel worse.

2. Important information before taking AlleMax

When not to take AlleMax

• if you are allergic to cetirizine dihydrochloride or any of the other ingredients of this medicine (listed in section 6), hydroxyzine or piperazine derivatives (active substances with a similar structure, contained in other medicines).
• if you have severe kidney disease requiring dialysis.

Warnings and precautions

Before taking AlleMax, discuss with your doctor or pharmacist:

• If you have kidney problems, consult your doctor, and if necessary, a lower dose may be prescribed. Your doctor will determine the new dose.
• If you have problems with urination (due to spinal cord injury or prostate enlargement or bladder problems), consult your doctor.
• If you have epilepsy or a risk of seizures, consult your doctor.

If an allergy test is planned, ask your doctor whether you should stop taking AlleMax a few days before the test. This medicine may affect the results of allergy tests.

Children

Do not give this medicine to children under 6 years of age, as the tablet form does not allow for appropriate dose adjustment.

AlleMax with 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.

AlleMax with alcohol

No clinically significant interactions have been observed between alcohol (at a concentration of 0.5 g/L, equivalent to one glass of wine) and cetirizine at the recommended doses. However, there are no data available on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking AlleMax with alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.

Avoid taking AlleMax during pregnancy. Accidental intake of the medicine by a pregnant woman should not have a harmful effect on the fetus. However, this medicine should only be used if necessary and after consulting a doctor.

Cetirizine passes into breast milk. In breastfed infants, the risk of side effects cannot be excluded. Therefore, do not take AlleMax during breastfeeding without consulting a doctor.

Driving and using machines

Clinical studies have not shown any impairment of reaction time, attention, or ability to drive after taking cetirizine at the recommended dose.

Be careful and watch for your body's reaction to AlleMax after taking it, and if you plan to drive, perform potentially hazardous activities, or operate machinery, do not take more than the recommended dose.

AlleMax contains lactose

AlleMax contains lactose; if you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take AlleMax

Always take this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Swallow the tablets with a glass of water. The tablet can be divided into equal doses.

Adults and adolescents over 12 years:

The recommended dose is one tablet (10 mg) once daily.

Children from 6 to 12 years:

The recommended dose is half a tablet (5 mg) twice daily (morning and evening).

Patients with renal impairment

If you or your child have kidney disease, consult your doctor, who may adjust the dose according to your needs or your 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 take AlleMax for more than 3 days without consulting your doctor.

Overdose of AlleMax

If you think you have taken more than the recommended dose of AlleMax, inform your doctor. Your doctor will decide what actions, if any, should be taken.

After an overdose, the following side effects may occur with increased intensity: disorientation, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, restlessness, sedation, sleepiness, stupor, increased heart rate, tremor, and urinary retention (difficulty emptying the bladder).

Missed dose of AlleMax

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

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

4. Possible side effects

Like all medicines, AlleMax 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 serious allergic reactions and angioedema (serious allergic reactions that may cause swelling of the face or throat).

These reactions may occur soon after the first intake of the medicine or may occur later.

Frequent(may affect up to 1 in 10 people)

• drowsiness;
• dizziness, headache;
• pharyngitis (sore throat), rhinitis (runny nose, stuffy nose) (in children);
• diarrhea, nausea, dry mouth;
• fatigue.

Infrequent(may affect up to 1 in 100 people)

• agitation;
• paresthesia (abnormal skin sensation);
• abdominal pain;
• pruritus (itching), rash;
• asthenia (extreme fatigue), malaise.

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

• allergic reactions, some severe (very rare);
• depression, hallucinations, aggression, confusion, insomnia;
• seizures;
• tachycardia (rapid heart rate);
• abnormal liver function;
• urticaria;
• edema (generalized swelling due to fluid retention);
• weight gain.

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

• thrombocytopenia (low platelet count);
• tics;
• syncope, dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, taste disturbances (altered taste);
• blurred vision, accommodation disorders (difficulty focusing), oculogyric crisis (involuntary, sustained eye deviation);
• angioedema (swelling of the skin, especially on the face), drug rash (allergic reaction to the medicine);
• abnormal urination (nocturnal enuresis, pain, and/or difficulty urinating).

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

• increased appetite;
• suicidal thoughts (recurring thoughts or preoccupation with suicide), nightmares;
• amnesia (memory loss), memory impairment;
• vertigo (feeling of spinning);
• urinary retention (inability to completely empty the bladder);
• pruritus (intense itching) and/or urticaria after withdrawal of the medicine;
• arthralgia (joint pain), myalgia (muscle pain);
• acute generalized exanthematous pustulosis (rash with pus-filled blisters);
• hepatitis.

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 Drug Safety Monitoring 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.

5. How to store AlleMax

Keep this medicine out of the sight and reach of children.

There are no special storage precautions for 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 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 AlleMax contains

• The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal 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 film-coated tablets in the shape of a capsule, with a dividing line on one side of the tablet.

The tablet can be divided into equal doses.

The tablets are packaged in PVC/PVDC/Aluminum blisters in a cardboard box.

Package sizes: 7 or 10 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:

Cetirizin Dr.Max

Poland:

AlleMax

Slovakia:

Cetirizin Dr.Max 10 mg

Date of last revision of the package leaflet: