Cetigran

Leaflet attached to the packaging: patient information

Cetigran, 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 the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Cetigran and what is it used for

The active substance of Cetigran is cetirizine dihydrochloride.
Cetigran is an antiallergic medicine.
Cetigran, 10 mg, coated tablets are indicated for adults, adolescents, and children aged 6 and above:

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

2. Important information before taking Cetigran

When not to take Cetigran:

• if the patient has severe kidney disease (severe renal impairment with creatinine clearance less than 10 ml/min);
• if the patient is 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, which are part of other medicines).

Warnings and precautions

Before taking Cetigran, the patient should discuss it with their doctor or pharmacist.
If the patient has kidney disease, they should consult their doctor before taking the medicine;
it may be necessary to use a lower dose. The doctor will determine the dose of the medicine.
If the patient has problems with urination (e.g., spinal cord or prostate problems, or bladder problems), they should consult their doctor.
If the patient has epilepsy or a risk of seizures, they should consult their doctor.
No significant clinical interactions have been observed between alcohol (at a concentration of 0.5 per mille (g/l) in the blood, corresponding to the concentration after drinking one glass of wine) and cetirizine at the recommended doses. However, there are no data on the safety of concomitant use of higher doses of cetirizine and alcohol. Therefore, as with other antihistamine medicines, it is recommended to avoid taking Cetigran with alcohol.
If the patient is scheduled to undergo allergy tests, they should ask their doctor if they should stop taking 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, as the tablet form does not allow for appropriate dose adjustment.

Cetigran and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Cetigran with food and drink

Food does not affect the absorption of Cetigran.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Cetigran 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 should only be used if necessary and after consulting a doctor.
Cetirizine passes into breast milk. Therefore, Cetigran should not be taken during breastfeeding, unless the doctor recommends otherwise.

Driving and using machines

Clinical studies have not shown any significant impairment of reaction time, and ability to drive or operate machinery after taking Cetigran at the recommended dose.
If the patient plans to drive or perform potentially hazardous activities after taking Cetigran, they should carefully observe their body's reaction to the medicine. They should not take more than the recommended dose of the medicine.

Cetigran contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Cetigran

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

Adults and adolescents over 12 years

The recommended dose is 10 mg (1 tablet) once daily.

Children from 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. The patient should consult their doctor or pharmacist.

Patients with renal impairment

In patients with moderate renal impairment, a dose of 5 mg once daily is recommended.
If the patient has severe kidney disease, they should consult their doctor, who will adjust the dose accordingly.
If a child has kidney disease, they should consult their doctor, who will adjust the dose according to the child's needs.
If the patient feels that the effect of Cetigran is too strong or too weak, they should consult their doctor.

Duration of treatment

The duration of treatment depends on the type, duration, and course of symptoms. The patient should consult their doctor or pharmacist.
Treatment with cetirizine without a doctor's recommendation should not last longer than 10 days.

Overdose of Cetigran

In case of overdose, the patient should consult their doctor.
The doctor will decide what measures 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, somnolence, stupor, accelerated heart rate, tremor, and urinary retention.

Missed dose of Cetigran

The patient should not take a double dose to make up for a missed dose.

Stopping Cetigran

In rare cases, itching (intense itching) and/or urticaria may recur after stopping Cetigran.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Cetigran can cause side effects, although not everybody gets them.

The following side effects are rare or very rare, but the patient should stop taking the medicine and immediately inform their doctor if they occur:

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

Common side effects(may occur in less than 1 in 10 people):

• drowsiness
• dizziness, headache
• pharyngitis, rhinitis (in children)
• diarrhea, nausea, dry mouth
• fatigue.

Uncommon side effects(may occur in less than 1 in 100 people):

• excitation
• paresthesia (sensory disturbances)
• abdominal pain
• itching, rash
• asthenia (extreme fatigue), malaise.

Rare side effects(may occur in less than 1 in 1,000 people):

• allergic reactions, sometimes severe (very rare)
• depression, hallucinations, aggressive behavior, disorientation, insomnia
• seizures
• tachycardia (rapid heart rate)
• abnormal liver function
• urticaria
• edema
• weight gain.

Very rare side effects(may occur in less than 1 in 10,000 people):

• thrombocytopenia (decreased platelet count)
• tics (habitual contractions)
• syncope, dyskinesia (involuntary movements), dystonia (prolonged muscle contractions), tremor, taste disturbances
• blurred vision, accommodation disorders (vision disorders), eye rotation (uncontrolled, circular movements of the eyeballs)
• angioedema (severe allergic reaction causing swelling of the face or throat), drug rash
• urinary disorders (nocturia, pain, and/or difficulty urinating).

Side effects of unknown frequency(frequency cannot be estimated from the available data):

• increased appetite
• suicidal attempts (recurring suicidal thoughts or interest in suicide)
• memory loss, memory disorders
• vertigo (feeling of spinning or loss of balance)
• urinary retention (inability to completely empty the bladder)

Reporting side effects
If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist, or nurse. 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:
Aleje Jerozolimskie 181 C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Cetigran

The medicine should be stored 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 month stated.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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.
• The other ingredients are: lactose monohydrate, corn starch, povidone, magnesium stearate. The ingredients of the Opadry II White coating are: lactose monohydrate, hypromellose, macrogol 3000, glycerol triacetate, titanium dioxide.

What Cetigran looks like and contents of the pack

Cetigran tablets are white, oval, biconvex, coated tablets with a dividing line.
The pack contains 10 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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

Date of last revision of the leaflet: