Cetririzine us pharmacia

Cetirizinum US Pharmacia
10 mg, coated tablets
Cetirizini dihydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

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

Leaflet contents:

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

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

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

• for relief of nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis;
• for relief of symptoms of urticaria.

2. IMPORTANT INFORMATION BEFORE TAKING CETIRIZINUM US PHARMACIA
When not to use Cetirizinum US Pharmacia

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

Warnings and precautions
Before starting treatment with Cetirizinum US Pharmacia, discuss it with your doctor or pharmacist.

• If the patient has renal impairment, consult a doctor before using the medicine; a lower dose may be required. The doctor will determine the appropriate dose. Page 1 of 6
• If the patient has difficulty urinating (e.g. due to spinal cord or prostate problems, or bladder disorders), consult a doctor.
• If the patient has epilepsy or is at risk of seizures, consult a doctor.
• No significant interaction between alcohol (blood concentration of 0.5 per mille (g/l), equivalent to one glass of wine) and cetirizine at recommended doses has been observed. However, as there are no data on the safety of using higher doses of cetirizine with alcohol, and as with all antihistamines, it is recommended to avoid concomitant consumption of alcohol with Cetirizinum US Pharmacia. If the patient is scheduled for allergy testing, ask the doctor whether the patient should discontinue Cetirizinum US Pharmacia a few days before the test. Cetirizinum US Pharmacia may affect the results of allergy tests.

Children
This medicine should not be given to children under 6 years of age, as the tablet formulation does not allow for appropriate dose adjustment.
Cetirizinum US Pharmacia and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Taking Cetirizinum US Pharmacia with food and drink
Food does not affect the absorption of Cetirizinum US Pharmacia.
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 her doctor before using this medicine.
Use of Cetirizinum US Pharmacia in pregnant women should be avoided.
Accidental intake of the medicine by a pregnant woman is not expected to have harmful effects on the fetus. However, the medicine should only be used if necessary and after consultation with a doctor.
Cetirizine passes into breast milk. The risk of adverse effects in breastfed infants cannot be excluded. Therefore, Cetirizinum US Pharmacia should not be used during breastfeeding unless otherwise advised by a doctor.
Driving and operating machinery
Clinical studies have not shown any effect of Cetirizinum US Pharmacia at the recommended dose on the ability to drive, drowsiness, or psycho-motor performance. The patient should carefully observe their body's response 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 exceed the recommended dose.
Cetirizinum US Pharmacia coated tablets contain lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. the medicine is considered "sodium-free".

3. HOW TO USE THE MEDICINAL PRODUCT Cetirizinum US Pharmacia

This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
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The tablets should be swallowed with a glass of liquid.
The tablets may be divided into halves.
Adults and adolescents aged 12 years and above:
The recommended dose is 10 mg once daily, as one tablet.
Use in children aged 6 to 12 years:
The recommended dose is 5 mg twice daily (half a tablet twice daily).
Other formulations of this medicine may be more suitable for children. Consult a physician or
pharmacist.
Patients with renal function impairment
For patients with moderate renal impairment, the recommended dose is 5 mg once daily.
Patients with severe renal impairment should contact a physician or pharmacist, who may adjust the
dose accordingly.
In children with renal impairment, parents should contact a physician or pharmacist, who may adjust
the dose according to the child's needs.
If the effect of the medicine appears too strong or too weak, consult a physician.
Duration of treatment
The duration of treatment depends on the type, duration, and course of the disease and is determined
by the physician.
Use of a higher than recommended dose of Cetirizinum US Pharmacia
If an overdose is suspected, the patient should inform a physician, who will decide whether and what
actions should be taken.
Following an overdose, the following adverse effects may occur with increased intensity.
The undesirable effects described below may occur with increased severity after an overdose.
Reported adverse effects: disorientation, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis
(pupil dilation), pruritus (itching), restlessness, particularly motor restlessness, sedation, somnolence
(drowsiness), stupor, tremor, tachycardia (rapid heartbeat), urinary retention (difficulty completely
emptying the urinary bladder).
Missed dose of Cetirizinum US Pharmacia
Do not take a double dose to make up for a missed dose.
Discontinuation of Cetirizinum US Pharmacia
In rare cases, if the patient stops taking Cetirizinum US Pharmacia, itching and/or urticaria may recur.
If you have any further questions concerning the use of this medicine, consult a physician or
pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Cetirizinum US Pharmacia may cause adverse reactions, although they do not occur in
everyone.
If any of the following rare or very rare adverse reactions occur,
you should stop taking the medicine and contact your doctor immediately.
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• Allergic reaction, including severe reactions and angioedema (serious allergic reaction causing swelling of the face and throat).

These reactions may occur immediately after the first dose of the medicine, or may occur later.
Common (may affect less than 1 in 10 people)

• Drowsiness (sleepiness)
• Dizziness, headache
• Sore throat, pharyngitis (sore throat), rhinitis (runny, stuffy nose) (in children)
• Diarrhea, nausea, dry mouth
• Fatigue

Uncommon (may affect less than 1 in 100 people)

• Restlessness
• Paresthesia (sensory disturbances)
• Abdominal pain
• Itching (pruritus), rash
• Weakness (extreme tiredness), 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 heartbeat)
• Liver function abnormalities
• Urticaria (hives)
• Edema (swelling)
• Weight gain

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

• Thrombocytopenia (decreased number of platelets)
• Tics (habitual spasms)
• Fainting, dyskinesia (involuntary movements), dystonia (prolonged muscle contractions), tremors, taste disturbances (altered taste sensation)
• Blurred vision, accommodation disorders (visual focusing problems), oculogyric dystonia (involuntary, sustained eye deviation)
• Angioedema (serious allergic reaction causing swelling of the face or throat), fixed drug eruption (allergic skin reaction to medication)
• Urinary disorders (nocturia, pain and/or difficulty passing urine)

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

• Increased appetite
• Suicidal ideation (recurrent thoughts of suicide or interest in suicide), nightmares
• Memory loss, memory impairment
• Dizziness (sensation of spinning or loss of balance)
• Urinary retention (inability to completely empty the bladder)
• Itching (intense pruritus) and/or urticaria after discontinuation of treatment
• Joint pain, muscle pain
• Acute generalized exanthematous pustulosis (rash with pustules containing pus)
• Hepatitis

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
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directly to the Department of Monitoring of Adverse Drug Reactions, 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://smz2.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE THE MEDICINAL PRODUCT Cetirizinum US Pharmacia

Keep this medicinal product out of sight and reach of children.
Do not use the medicinal product after the expiry date stated on the blister and the cardboard box.
The expiry date refers to the last day of the specified month.
No special storage conditions required.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

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

What Cetirizinum US Pharmacia looks like and contents of the pack
White, round, film-coated tablets with the mark “A” on one side and a break line on the other.
The medicine is available in blisters containing 10 film-coated tablets, packed in a cardboard box.

Marketing Authorisation 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 authorised for sale in the European Economic Area countries under the following names:

For more detailed information, please contact:
USP Zdrowie Sp. z o.o.
Poleczki 35 St.,
02-822 Warsaw
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Tel.: + (48) (22) 543 60 00
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