Package leaflet: Information for the user

Cetigran, 10 mg, film-coated tablets
Cetirizini dihydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
You must always use this medicine exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if you feel worse, contact your doctor.

Contents of the leaflet

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

1. What Cetigran is and what it is used for

The active substance in Cetigran is cetirizine dihydrochloride.
Cetigran is an antiallergy medicine.
Cetigran 10 mg film-coated tablets are indicated for adults, adolescents and children aged 6 years and older:

for the relief of nasal and ocular symptoms associated with seasonal and perennial allergic rhinitis,
for the relief of symptoms of chronic idiopathic urticaria (i.e. urticaria of unknown origin).

2. Important information before using Cetigran

When not to use Cetigran:

if the patient has severe kidney disease (severe renal insufficiency with creatinine clearance less than 10 ml/min);
if the patient is allergic to cetylpyridinium chloride 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).

Warnings and precautions
Before starting treatment with Cetigran, consult your doctor or pharmacist.
If the patient has renal insufficiency, consult a doctor before using the medicine;
a lower dose may be required. The doctor will determine the appropriate dose.
If the patient has problems with urination (e.g. due to spinal cord or prostate disorders, or
bladder problems), consult a doctor.
If the patient has epilepsy or a risk of seizures, consult a doctor.
No clinically significant interactions between alcohol (at a blood concentration of 0.5 per mille (g/l), corresponding to the level after drinking one glass of wine) and ceterizine administered at recommended doses have been observed. However, there is no safety data available regarding concomitant use of higher doses of ceterizine and alcohol. Therefore, as with other antihistamine medicines, it is recommended to avoid taking Cetigran together with alcohol.
If the patient has planned allergy testing, ask the doctor whether the patient should discontinue Cetigran a few days before the test. Cetigran 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.
Cetigran and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.
Cetigran with food and drink
Food does not affect the absorption of Cetigran.
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 before using this medicine.
Cetigran should be avoided in pregnant women. Accidental intake of the medicine during pregnancy is not expected to have harmful effects on the fetus. However, the medicine may be used only if necessary and after consultation with a doctor.
Cetirizine passes into breast milk. Therefore, Cetigran should not be used during breastfeeding, unless otherwise advised by a doctor.
Driving and operating machinery
Clinical studies have not shown any impairment of reaction ability, concentration, or ability to drive vehicles after administration of Cetigran at the recommended dose.
If the patient plans to drive, perform potentially hazardous activities, or operate machinery after taking Cetigran, he/she should carefully monitor his/her body's response to the medicine. Do not exceed the recommended dose of the medicine.
Cetigran contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.

3. How to use Cetigran

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be taken orally, with a glass of water. The tablet may be divided into equal doses.

Adults and adolescents aged over 12 years
The recommended dose is 10 mg (1 tablet) once daily.

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 doctor or pharmacist.

Patients with renal function impairment
In patients with moderate renal impairment, a dose of 5 mg once daily is recommended.
If a patient has severe kidney disease, consult a doctor, who will adjust the dose accordingly.
If a child has kidney disease, consult a doctor, who will adjust the dose according to the child's needs.

If you feel that the effect of Cetigran 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 a doctor or pharmacist.
Treatment with cetirizine without medical advice should not last longer than 10 days.

Taking more Cetigran than recommended
If you take more Cetigran than recommended, consult a doctor.
The doctor will decide whether and what measures should be taken.
After an overdose, the following adverse reactions described below may occur with increased intensity: disorientation, diarrhoea, dizziness, fatigue, headache, malaise, pupil dilation, itching, motor restlessness, sedation, somnolence, stupor, increased heart rate, tremor, and urinary retention.

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

Stopping Cetigran
In rare cases, itching (intense pruritus) and/or urticaria may recur after stopping Cetigran.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects are rare or very rare; however, treatment should be discontinued and
a doctor should be informed immediately if any of the following occur:

allergic reactions, including severe reactions and angioedema (a serious allergic reaction causing swelling of the face and throat). These reactions may occur immediately after the first dose or may appear later.

Common adverse effects (may affect fewer than 1 in 10 people):

drowsiness
dizziness, headache
sore throat, nasal mucosal inflammation (in children)
diarrhoea, nausea, dry mouth
fatigue.

Uncommon adverse effects (may affect fewer than 1 in 100 people):

restlessness
paresthesia (sensory disturbances)
abdominal pain
itching, rash
asthenia (extreme tiredness), malaise.

Rare adverse effects (may affect fewer than 1 in 1,000 people):

allergic reactions, sometimes severe (very rare)
depression, hallucinations, aggressive behaviour, disorientation, insomnia
seizures
tachycardia (rapid heartbeat)
liver function abnormalities
urticaria
swelling
weight gain.

Very rare adverse effects (may affect fewer than 1 in 10,000 people):

thrombocytopenia (reduced number of blood platelets)
tics (habitual spasms)
fainting, dyskinesia (involuntary movements), dystonia (prolonged muscle contractions), tremor, taste disturbances
blurred vision, accommodation disorders (impaired visual focus), nystagmus (uncontrolled, circular eye movements)
angioedema (serious allergic reaction causing swelling of the face or throat), drug eruption
urinary disorders (bedwetting, pain and/or difficulty passing urine).

Adverse effects with unknown frequency (frequency cannot be determined from available data):

increased appetite
suicidal behaviour (recurrent suicidal thoughts or interest in suicide)
memory loss, memory disturbances
vertigo (sensation of spinning or loss of balance)
urinary retention (inability to completely empty the bladder)

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects 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 181 C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Cetigran

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging 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. This will help protect the environment.

6. Contents of the pack and other information

What Cetigran contains

The active substance is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine dihydrochloride.
Other ingredients are: monohydrate lactose, corn starch, povidone, magnesium stearate. Film-coat (Opadry II White) composition: monohydrate lactose, hypromellose, macrogol 3000, glyceryl triacetate, titanium dioxide.

What Cetigran looks like and contents of the pack
Cetigran tablets are white, oval, biconvex coated tablets with a division line.
The pack contains 10 coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw
Manufacturer:
Grand Medical Poland Sp. z o.o.
Faradaya 2
03-233 Warsaw