Cetrix

Cetrix, 10 mg, film-coated tablets
Cetirizini dichydrochloridum
Before using this medicine, read the entire leaflet carefully, as it contains
important information for the patient.
Always use the medicine exactly as described in this leaflet or as directed by a physician or pharmacist.

• Keep this leaflet for future reference.
• Consult a physician or pharmacist if you need advice or further information.
• If any adverse reactions occur, inform your physician or pharmacist. This includes possible adverse reactions not listed in this leaflet. See section 4.
• If symptoms worsen or do not improve within 3 days, contact your physician.

Leaflet contents:

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

1. What Cetrix is and what it is used for

Cetirizine dihydrochloride is the active substance in Cetrix.
Cetrix belongs to a group of medicines called systemic antihistamines, which have antiallergic effects.
Cetrix is used in adults and children aged 6 years and older:

• to relieve nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• to relieve symptoms of chronic urticaria (chronic idiopathic urticaria).

2. Information before using Cetrix

When not to use Cetrix

• if the patient is allergic to cetyrine dihydrochloride or any of the other ingredients of this medicine (listed in section 6.1)
• if the patient is allergic to hydroxyzine or piperazine derivatives (active substances with a similar structure contained in other medicines)
• if the patient has severe kidney disease

Warnings and precautions
Before starting treatment with Cetrix, consult a doctor or pharmacist if:

• the patient has impaired kidney function; dose adjustment may be necessary. The doctor will determine the new dose.
• the patient has difficulty urinating (e.g. spinal cord injury, prostate or bladder problems).
• the patient has epilepsy or a tendency to seizures.
• the patient is scheduled to undergo skin allergy tests. Treatment with Cetrix should be discontinued 3 days before the tests.

Children
Do not give this medicine to children under 6 years of age, as the tablet formulation does not allow for appropriate dose adjustment.
Taking other medicines with Cetrix
Inform your doctor or pharmacist about all medicines currently being taken, recently taken, or possibly to be taken.
Due to the profile of cetirizine, interactions with other medicines are not expected.
Taking Cetrix with food, drink and alcohol
The absorption of cetirizine is almost unaffected by food.
There is no evidence of interaction between alcohol (at a concentration of 0.5 per mille, equivalent to one glass of wine) and cetirizine administered at usual doses. In sensitive patients, concomitant use of cetirizine with alcohol or other medicines with central nervous system depressant effects may enhance the effect of the drug on reaction ability and concentration, even though cetirizine does not potentiate the effects of alcohol. As with other antihistamines, it is recommended to avoid consuming alcohol simultaneously.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Cetrix should be avoided during pregnancy. Accidental use of the medicine is not considered to cause any harmful effect on the fetus. Nevertheless, the medicine should be used only if necessary and only after consulting a doctor.
Cetrix should not be used during breastfeeding, as cetirizine passes into breast milk, unless otherwise advised by a doctor.
Driving and operating machinery
Clinical studies have not shown evidence of impaired attention, alertness, or ability to drive following administration of Cetrix at the recommended dose.
Patients planning to drive motor vehicles, perform potentially hazardous activities, or operate machinery should not use doses higher than recommended. Patients should carefully observe their body's response to the medicine.

3. How to use Cetrix

How and when to take Cetrix?
This medicine should always be taken as prescribed by a doctor. If the patient has any doubts about its use, they should consult a doctor or pharmacist.
Tablets should be swallowed with a glass of liquid.
The tablet may be divided into two equal doses.

Adults and adolescents over 12 years of age:
Recommended dose: 10 mg (1 tablet) once daily.

Use in children aged 6 to 12 years:
Recommended dose: 5 mg (half a tablet) twice daily.

Patients with moderate to severe kidney impairment
For patients with moderate kidney impairment, a dose of 5 mg once daily is recommended.
If the effect of Cetrix seems too strong or too weak, consult a doctor.

Duration of treatment
The duration of treatment depends on the type, duration, and cause of symptoms and is determined by the doctor.

Taking more than the recommended dose of Cetrix
If more than the recommended dose of Cetrix has been taken, or if a child has accidentally ingested the medicine, seek immediate advice from a doctor or the nearest hospital for further instructions.
After taking a higher-than-recommended dose, the adverse effects listed below may occur with increased intensity. Reported adverse effects include: confusion, diarrhoea, dizziness, fatigue, headache, malaise, pupil dilation, itching, restlessness, sedation, drowsiness, stupor, rapid heartbeat, tremor, and difficulty urinating.

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

Stopping Cetrix treatment
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.
You must stop taking Cetrix immediately and contact your doctor or go to the nearest emergency department
immediately if any of the following symptoms occur: swelling of the lips, face and (or) throat, difficulty breathing (chest tightness or wheezing), sudden drop in blood pressure with fainting or shock.
These symptoms may indicate a very serious allergic reaction (angioedema) or anaphylactic shock. Such reactions are very rare (may occur in 1 out of 10,000 patients).

Other adverse effects may also occur:

Common (may affect up to 1 in 10 patients):

• fatigue
• dry mouth, nausea, diarrhoea
• dizziness, headache
• drowsiness (sleepiness)
• sore throat, rhinitis (nasal mucosa inflammation – swelling and irritation inside the nose)

Uncommon (may affect up to 1 in 100 patients):

• abdominal pain
• asthenia (extreme exhaustion), malaise
• paraesthesia (abnormal sensations)
• restlessness
• itching, itchy rash

Rare (may affect up to 1 in 1,000 patients):

• tachycardia (abnormally fast heart rate)
• oedema (swelling)
• allergic reactions, sometimes severe (very rare)
• impaired liver function
• weight gain
• seizures
• aggression, confusion, depression, hallucinations, insomnia
• urticaria (hives)

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

• thrombocytopenia (reduced number of blood platelets)
• accommodation disorders (vision focusing problems), blurred vision, ocular nystagmus (involuntary rotational eye movements)
• fainting, tremor, taste disturbances, dystonia (abnormal prolonged muscle contractions), dyskinesia (involuntary movements)
• tics (involuntary muscle contractions)
• urinary disorders (bedwetting, pain and (or) difficulty urinating)
• drug rash

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

• increased appetite
• suicidal thoughts
• amnesia, memory impairment
• vertigo (sensation of spinning or movement)
• urinary retention (inability to completely empty the bladder)

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can also be reported directly (see details below). Reporting adverse effects helps provide more information on the safety of this medicine.

Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]

Adverse effects can also be reported to the marketing authorization holder.

5. How to store Cetrix

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Do not use the medicine if there are visible signs of deterioration or if the tablets are damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer in use. Proper disposal helps protect the environment.

6. Package contents and other information
What Cetrix contains

• The active substance is cetyryzine dihydrochloride. Each coated tablet contains 10 mg of cetyryzine dihydrochloride.
• Other ingredients: microcrystalline cellulose, pregelatinized starch, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, polydextrose, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Cetrix looks like and contents of the pack
Appearance:
white, round, convex tablets with a break line on one side and the logo “5”, 7 mm in diameter.
Pack sizes:
7 and 10 tablets in aluminium/aluminium blisters packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Vitabalans Oy
Varastokatu 8
FI-13500 Hämeenlinna
FINLAND
Tel: +358 (3) 615600
Fax: +358 (3) 6183130

This medicinal product is authorised in the European Economic Area countries under the following names:
Cetimax (DK, FI, HU, NO, SE)
Cetrix (EE, LV, LT, PL)
Cetixin (CZ, DE, SI, SK)