Cetririzinum Us Pharmacia

PATIENT LEAFLET: INFORMATION FOR THE USER

Cetirizinum US Pharmacia

10 mg, coated tablets

Cetirizine dihydrochloride

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional 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 leaflet:

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

1. WHAT IS CETIRIZINUM US PHARMACIA AND WHAT IS IT USED FOR

Cetirizine dihydrochloride is the active substance of Cetirizinum US Pharmacia. Cetirizinum US Pharmacia is an antiallergic medicine. Cetirizinum US Pharmacia is indicated for adults and children aged 6 years and older:

• for the relief of symptoms associated with seasonal and perennial allergic rhinitis.
• for the relief of symptoms of urticaria.

2. IMPORTANT INFORMATION BEFORE TAKING CETIRIZINUM US PHARMACIA

Pharmacia

When not to take Cetirizinum US Pharmacia

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

Warnings and precautions

Before taking Cetirizinum US Pharmacia, discuss it with your doctor or pharmacist.

• If you have kidney problems, consult your doctor before taking the medicine; a lower dose may be necessary. The dose will be determined by your doctor. Page 1 6
• If you have problems with urination (e.g. spinal cord problems or prostate problems, or bladder problems), consult your doctor.
• If you have epilepsy or a risk of seizures, consult your doctor.
• No significant effect of alcohol (blood concentration of 0.5 per mille (g/l), corresponding to the concentration after drinking one glass of wine) and cetirizine taken at the recommended dose has been observed. However, since there are no data on the safety of taking higher doses of cetirizine with alcohol, as with all antihistamines, it is recommended to avoid consuming alcohol with Cetirizinum US Pharmacia. If you are scheduled to undergo allergy testing, ask your doctor if you should stop taking Cetirizinum US Pharmacia a few days before the test. Cetirizinum US Pharmacia 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.

Cetirizinum US Pharmacia and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Taking Cetirizinum US Pharmacia with food and drink

Food does not affect the absorption of Cetirizinum US Pharmacia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor before taking this medicine. Cetirizinum US Pharmacia 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 may only be used if necessary and after consulting a doctor. Cetirizine passes into breast milk. The risk of side effects in breastfed infants cannot be excluded. Therefore, Cetirizinum US Pharmacia should not be taken during breastfeeding, unless your doctor advises otherwise.

Driving and using machines

Clinical studies have not shown any significant effect of Cetirizinum US Pharmacia at the recommended dose on the ability to drive or operate machinery. You should carefully observe your body's reaction to the medicine. Patients planning to drive, perform potentially hazardous activities, or operate machinery should pay attention to their body's reaction to the medicine and should not take higher doses than recommended.

Cetirizinum US Pharmacia tablets contain lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that the medicine is considered "sodium-free".

3. HOW TO TAKE CETIRIZINUM US PHARMACIA

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist. Page 2 6
Swallow the tablets with a glass of liquid. The tablets can be divided into halves.

Adults and adolescents over 12 years:

The recommended dose is 10 mg once daily, in the form of one tablet.

Use in children aged 6 to 12 years:

The recommended dose is 5 mg twice daily (half a tablet twice daily). Other forms of this medicine may be more suitable for children. Consult your doctor or pharmacist.

Patients with renal impairment

In patients with moderate renal impairment, the recommended dose is 5 mg once daily. Patients with severe renal impairment should consult their doctor or pharmacist, who may adjust the dose of the medicine accordingly. In the case of children with renal impairment, the parent should consult the doctor or pharmacist, who may adjust the dose of the medicine for the child. If you feel that the effect of the medicine 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.

Taking a higher dose of Cetirizinum US Pharmacia than recommended

In case of suspected overdose, the patient should inform the doctor, who will decide what actions to take. After an overdose, the following side effects may occur with increased intensity. The side effects listed below may occur with increased severity after an overdose. Reported side effects: disorientation, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, anxiety, especially restlessness, sedation, drowsiness, stupor, tremors, accelerated heart rate, urinary retention (difficulty in completely emptying the bladder).

Missing a dose of Cetirizinum US Pharmacia

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

Stopping treatment with Cetirizinum US Pharmacia

In rare cases, if you stop taking Cetirizinum US Pharmacia, itching and/or urticaria may return. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cetirizinum US Pharmacia can cause side effects, although not everybody gets them.

If you experience any of the following rare or very rare side effects, stop taking the medicine and consult your doctor immediately.

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• Allergic reaction, 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 of the medicine or may occur later. Frequent(may affect less than 1 in 10 people)

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

Uncommon(may affect less than 1 in 100 people)

• excitation
• paresthesia (sensory disturbances)
• abdominal pain
• itching (itching skin), rash
• weakness (extreme fatigue), malaise

Rare(may affect less than 1 in 1,000 people)

• allergic reactions, some severe (very rare)
• depression, hallucinations, aggression, disorientation, insomnia
• seizures
• tachycardia (rapid heart rate)
• liver function disorders
• urticaria (blisters)
• edema (swelling)
• weight gain

Very rare(may affect less than 1 in 10,000 people):

• thrombocytopenia (decreased platelet count)
• tics (habitual contractions)
• syncope, dyskinesia (involuntary movements), dystonia (prolonged muscle contractions), tremors, taste disorders (altered taste perception)
• blurred vision, accommodation disorders (vision disorders), dystonic eye rotation (uncontrolled circular eye movements)
• angioedema (severe allergic reaction causing swelling of the face or throat), fixed drug eruption (allergic reaction to medicines)
• urinary retention (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), nightmares
• memory loss, memory disorders
• vertigo (feeling of spinning or loss of balance)
• urinary retention (inability to completely empty the bladder)
• itching (intense itching) and/or urticaria after stopping treatment
• joint pain, muscle pain
• acute generalized exanthematous pustulosis (rash with blisters containing pus)
• hepatitis.

Reporting side effects

If you experience any side effects, including those not listed in the 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 Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz2.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 the medicine.

5. HOW TO STORE CETIRIZINUM US PHARMACIA

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

Do not use the medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month. There are no special precautions for storage.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Cetirizinum US Pharmacia contains

The active substance of the medicine is cetirizine dihydrochloride. Each coated tablet contains 10 mg of cetirizine dihydrochloride. The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, maize starch, colloidal anhydrous silica, magnesium stearate, talc; the composition of the Opadry white coating: hypromellose 15 cP, lactose monohydrate, titanium dioxide (E 171), macrogol 4000, and sodium citrate.

What Cetirizinum US Pharmacia looks like and contents of the pack

White, round, coated tablets with the inscription "A" on one side and a dividing line on the other side. The medicine is available in blisters containing 10 coated tablets, in a carton box.

Marketing authorization holder:

US Pharmacia Sp. z o.o., ul. Ziębicka 40, 50-507 Wrocław, Poland

Manufacturer/Importer:

Chanelle Medical Unlimited Company, Loughrea, Co. Galway, Ireland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

To obtain more detailed information, please contact:

USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warsaw

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Tel.: + (48) (22) 543 60 00
Date of last revision of the leaflet:August 2023
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