Cetirizine Medreg: detailed information

Package leaflet: Information for the patient

Cetirizina Medreg 10 mg film-coated tablets

cetirizine dihydrochloride
Equivalent medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Cetirizina Medreg is and what it is used for
What you need to know before taking Cetirizina Medreg
How to take Cetirizina Medreg
Possible side effects
How to store Cetirizina Medreg
Contents of the pack and other information

1. What Cetirizina Medreg is and what it is used for

The active substance of Cetirizina Medreg is cetirizine dihydrochloride, an antihistamine.
Antihistamines help relieve symptoms of certain allergies.
Cetirizina Medreg is indicated in adults, adolescents, and children aged 6 years and older:

for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
for the treatment of urticaria (chronic idiopathic urticaria).

2. What you need to know before taking Cetirizina Medreg

Do not take Cetirizina Medreg

if you are allergic to cetirizine hydrochloride or to any of the other ingredients of this medicine (listed in section 6); to hydroxyzine or to piperazine derivatives (active substances in other closely related medicines).
if you have severe kidney disease requiring dialysis.

Warnings and precautions
Talk to your doctor before taking Cetirizina Medreg:

If you have kidney impairment, consult your doctor; if necessary, you will be prescribed a lower dose. Your doctor will determine the new dose.
Consult your doctor if you have difficulty urinating (in conditions such as spinal cord injury or bladder or prostate problems).
If you are an epileptic patient or at risk of seizures, you should consult your doctor before starting treatment with Cetirizina Medreg.

If you need to undergo an allergy test, ask your doctor whether you should stop taking Cetirizina Medreg for a few days before the test. This medicine may alter the results of allergy testing.
Children
Do not give this medicine to children under 6 years of age, as the tablet formulation does not allow for the necessary dose adjustments.
Other medicines and Cetirizina Medreg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Cetirizina Medreg and alcohol
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5 g/l, equivalent to one glass of wine) and cetirizine used at recommended doses. However, there are no available data on safety when higher doses of cetirizine and alcohol are taken simultaneously. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizina Medreg together with alcohol.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Administration of Cetirizina Medreg should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not produce any harmful effects on the fetus. However, the medicine should only be taken if necessary and under medical advice.
Cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be excluded. Therefore, you should not take Cetirizina Medreg while breastfeeding unless you have consulted your doctor.
Driving and using machines
Clinical studies have not shown any impairment of attention, alertness, or ability to drive vehicles following cetirizine intake at the recommended dose.
You should carefully observe your response to the medicine after taking Cetirizina Medreg if you intend to drive, perform potentially hazardous activities, or operate machinery.
Cetirizina Medreg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Cetirizina Medreg

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The tablets should be taken, preferably with a glass of water. The tablet may
be divided into equal doses.
Adults and adolescents over 12 years of age:
The recommended dose is one tablet (10 mg) once daily.
Use in children aged 6–12 years:
The recommended dose is half a tablet (5 mg) twice daily (morning and evening).
Patients with renal impairment
If your child has kidney disease, contact your doctor, who may adjust the dose according to
the child's individual needs.
If you feel that the effect of cetirizine is too weak or too strong, inform your doctor.
Duration of treatment
The duration of treatment depends on the type, duration and course of your symptoms. If you have doubts,
consult your doctor or pharmacist.
If you take more Cetirizina Medreg than you should
If you think you have taken an excessive dose of Cetirizina Medreg, inform your doctor. The doctor will decide
which measures should be taken, if necessary.
After an overdose, the adverse effects described below may occur with increased intensity. Adverse events
reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise (feeling unwell), pupillary dilation,
itching, restlessness, sedation, somnolence, stupor, abnormal and rapid heart rate, tremors and urinary retention
(difficulty completely emptying the bladder).
If you forget to take Cetirizina Medreg
Do not take a double dose to make up for the forgotten dose.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects are rare or very rare; however, you must stop taking the medicine and
contact your doctor immediately if you notice any of the following:

Allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face or throat). These reactions may occur immediately after taking the medicine or later.

Common (may affect up to 1 in 10 people)

Drowsiness (need to sleep)
Dizziness, headache
Pharyngitis (sore throat), rhinitis (stuffy or runny nose) (in children)
Diarrhoea, nausea, dry mouth
Fatigue

Uncommon (may affect up to 1 in 100 people)

Agitation
Paresthesia (abnormal skin sensations)
Abdominal pain
Pruritus (itchy skin), skin rash
Asthenia (extreme tiredness), malaise (feeling unwell)

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

Allergic reactions, some severe (very rare)
Depression, hallucinations, aggression, confusion, insomnia
Seizures
Tachycardia (rapid heartbeat)
Abnormal liver function
Urticaria
Edema (swelling)
Weight gain

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

Thrombocytopenia (low platelet count in the blood)
Tic (habitual spasm)
Syncope (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes with uncontrollable circular movements)
Angioedema (severe allergic reaction causing swelling of the face or throat), drug-induced fixed eruption (allergic reaction to the medicine)
Abnormal urinary elimination (involuntary emptying of the bladder during sleep, pain and/or difficulty urinating)

Not known (frequency cannot be estimated from the available data)

Increased appetite
Suicidal ideation (recurring suicidal thoughts or concerns), nightmares
Amnesia (loss of memory), memory impairment
Vertigo (sensation of spinning or movement)
Urinary retention (inability to completely empty the bladder)
Pruritus (intense itching) and/or urticaria after stopping treatment
Arthralgia (joint pain), myalgia (muscle pain)
Generalized pustular eruption (skin rash with pus-filled blisters)
Hepatitis (inflammation of the liver)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cetirizina Medreg

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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 that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Cetirizina Medreg contains

The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
The other ingredients are:
Tablet core: monohydrate lactose; microcrystalline cellulose; anhydrous colloidal silica; magnesium stearate (E572)
Tablet coating: Opadry II OY GM 28900 white (hypromellose (E464), polydextrose, titanium dioxide (E171) and macrogol)

Description of the appearance of Cetirizina Medreg and package contents
Film-coated tablets, white to almost white, capsule-shaped, with a score line on one side of the tablet.
The tablet can be divided into equal doses.
The tablets are supplied in PVC/PVDC/aluminium blisters packed in cardboard cartons.
Pack sizes: 14, 15, 20, 28, 30, 40, 45, 50, 60, 70, 80, 90, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

Manufacturer:
SANECA PHARMACEUTICALS A.S.
Nitrianska 100
92027 Hlohovec
Slovakia

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Cetirizina Medreg
Poland: AlleMax
Czech Republic: Cetirizin Dr.Max
Romania: AlleMax 10 mg film-coated tablets
Slovakia: Cetirizin Dr.Max 10 mg

Patient information leaflet

Cetirizina Medreg 10 mg film-coated tablets

cetirizine dihydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any of the side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after 3 days.

Contents of this leaflet:

What Cetirizina Medreg is and what it is used for
What you need to know before taking Cetirizina Medreg
How to take Cetirizina Medreg
Possible side effects
How to store Cetirizina Medreg
Contents of the pack and other information

2. What Cetirizina Medreg is and what it is used for

for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
for the treatment of urticaria (chronic idiopathic urticaria).

Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 3 days.

4. What you need to know before taking Cetirizine Medreg

Do not take Cetirizine Medreg

if you are allergic to cetirizine dihydrochloride or to any of the other ingredients of this medicine (listed in section 6); to hydroxyzine or to piperazine derivatives (active substances in other closely related medicines).
if you have severe kidney disease requiring dialysis.

Warnings and precautions
Talk to your doctor before taking Cetirizine Medreg:

If you have kidney impairment, consult your doctor; if necessary, you will take a lower dose. Your doctor will determine the new dose.
Consult your doctor if you have problems with urination (in conditions such as spinal cord injury or bladder or prostate problems).
If you are a patient with epilepsy or at risk of seizures, you should consult your doctor before starting treatment with Cetirizine Medreg.

If you need to undergo an allergy test, ask your doctor whether you should stop taking Cetirizine Medreg for a few days before the test. This medicine may alter the results of the allergy test.
Children
Do not give this medicine to children under 6 years of age, as the tablet formulation does not allow for the necessary dose adjustments.
Other medicines and Cetirizine Medreg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Cetirizine Medreg and alcohol
No clinically significant interactions have been observed between alcohol (at blood levels of 0.5 g/l, corresponding to one glass of wine) and cetirizine when used at the recommended doses. However, there are no available data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with all antihistamines, it is recommended to avoid taking Cetirizine Medreg together with alcohol.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
The use of Cetirizine Medreg should be avoided during pregnancy. Accidental use of the medicine by a pregnant woman does not produce any harmful effects on the fetus. However, the medicine should be taken only if necessary and under medical advice.
Cetirizine passes into breast milk. A risk of adverse effects in breastfed infants cannot be excluded. Therefore, you should not take Cetirizine Medreg while breastfeeding unless you have consulted your doctor.
Driving and using machines
Clinical studies have not shown impairment of attention, alertness, or ability to drive vehicles after taking cetirizine at the recommended dose.
You should carefully observe your response to the medicine after taking Cetirizine Medreg if you intend to drive, engage in potentially hazardous activities, or operate machinery.
Cetirizine Medreg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

5. How to take Cetirizina Medreg

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The tablets should be taken, preferably with a glass of water. The tablet may be divided into equal doses.
Adults and adolescents over 12 years of age:
The recommended dose is one tablet (10 mg) once daily.
Use in children aged 6–12 years:
The recommended dose is half a tablet (5 mg) twice daily (morning and evening).
Patients with renal impairment
If your child suffers from kidney disease, contact your doctor, who may adjust the dose according to the child's needs.
If you feel that the effect of cetirizine is too weak or too strong, inform your doctor.
Duration of treatment
The duration of treatment depends on the type, duration and course of your symptoms. If you have any doubts, consult your doctor or pharmacist.
Do not use Cetirizina Medreg for more than 3 days without consulting your doctor.
If you take more Cetirizina Medreg than you should
If you think you have taken an overdose of Cetirizina Medreg, inform your doctor. The doctor will decide which measures should be taken, if necessary.
After an overdose, the following undesirable effects may occur with increased intensity. Adverse events reported include confusion, diarrhoea, dizziness, fatigue, headache, malaise (feeling unwell), pupillary dilation, itching, restlessness, sedation, somnolence, stupor, abnormal and rapid heart rate, tremors, and urinary retention (difficulty completely emptying the bladder).
If you forget to take Cetirizina Medreg
Do not take a double dose to make up for a forgotten dose.
If you have further questions about 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 will get them.
The following side effects are rare or very rare; however, you must stop taking the medicine and
contact your doctor immediately if you notice any of the following:

Allergic reactions, including severe reactions and angioedema (a severe allergic reaction causing swelling of the face or throat). These reactions may occur immediately after taking the medicine or may develop later.

Common (may affect up to 1 in 10 people)

Drowsiness (need to sleep)
Dizziness, headache
Pharyngitis (sore throat), rhinitis (stuffy or runny nose) (in children)
Diarrhoea, nausea, dry mouth
Fatigue

Uncommon (may affect up to 1 in 100 people)

Agitation
Paresthesia (abnormal skin sensation)
Abdominal pain
Pruritus (itchy skin), skin rash
Asthenia (extreme tiredness), malaise (feeling unwell)

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

Allergic reactions, some severe (very rare)
Depression, hallucinations, aggression, confusion, insomnia
Seizures
Tachycardia (rapid heartbeat)
Abnormal liver function
Urticaria
Edema (swelling)
Weight gain

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

Thrombocytopenia (low platelet count in the blood)
Tic (habitual spasm)
Syncope (fainting), dyskinesia (involuntary movements), dystonia (abnormal prolonged muscle contractions), tremor, dysgeusia (altered taste)
Blurred vision, accommodation disorder (difficulty focusing), oculogyric crisis (eyes with uncontrollable circular movements)
Angioedema (severe allergic reaction causing swelling of the face or throat), drug-induced fixed eruption (allergic reaction to the medicine)
Abnormal urination (involuntary emptying of the bladder during night sleep, pain and/or difficulty in urinating)

Not known (frequency cannot be estimated from the available data)

Increased appetite
Suicidal ideation (recurrent suicidal thoughts or concerns), nightmares
Amnesia (loss of memory), memory impairment
Vertigo (sensation of spinning or movement)
Urinary retention (inability to completely empty the bladder)
Pruritus (intense itching) and/or urticaria occurring after discontinuation of treatment
Arthralgia (joint pain), myalgia (muscle pain)
Generalized acute exanthematous pustulosis (skin eruption with pus-filled blisters)
Hepatitis (inflammation of the liver)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cetirizina Medreg

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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 that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cetirizina Medreg contains

The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
The other ingredients are:
Tablet core: monohydrate lactose; microcrystalline cellulose; anhydrous colloidal silica; magnesium stearate (E572)
Tablet coating: Opadry II OY GM 28900 white (hypromellose (E464), polydextrose, titanium dioxide (E171) and macrogol)

Description of the appearance of Cetirizina Medreg and pack sizes
Film-coated tablets, white to off-white in colour, capsule-shaped, with a score line on one side of the tablet. The tablet can be divided into equal doses.
The tablets are supplied in PVC/PVDC/aluminium blisters in cardboard cartons.
Pack sizes: 7, 10 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

Manufacturer:
SANECA PHARMACEUTICALS A.S.
Nitrianska 100
92027 Hlohovec
Slovakia

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