Cetrix

Patient Information Leaflet: User Information

Cetrix, 10 mg, Film-Coated Tablets

Cetirizine Dihydrochloride

Before Taking the Medication, Read the Entire Leaflet Carefully, as it Contains Important Information for the Patient.

The medication should always be used in accordance with the description contained in the leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept, so it can be read again if necessary.
• A doctor or pharmacist should be consulted if advice or additional information is needed.
• In the event of adverse reactions, the doctor or pharmacist should be informed. This also applies to possible adverse reactions not listed in the leaflet. See section 4.
• If symptoms worsen or do not improve after 3 days, a doctor should be consulted.

Table of Contents of the Leaflet:

• 1. What is Cetrix and what is it 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 is Cetrix and what is it used for

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

• to relieve symptoms from the nose and eyes, of seasonal and perennial allergic rhinitis.
• to relieve symptoms of chronic idiopathic urticaria (chronic hives).

2. Important information before taking Cetrix

When not to take Cetrix

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

Warnings and precautions

Before starting to take Cetrix, a doctor or pharmacist should be consulted if:

• the patient has kidney function disorders; the dose may need to be adjusted. The new dose of the medication will be determined by the doctor.
• the patient has problems with urination (e.g., spinal cord injury, prostate and bladder problems).
• the patient has epilepsy or is prone to seizures.
• the patient is to undergo skin allergy tests. The use of Cetrix should be discontinued 3 days before the tests.

Children

Cetrix should not be given to children under 6 years of age because the tablet formulation does not allow for appropriate dose adjustment.

Taking other medications with Cetrix

A doctor or pharmacist should be informed about all medications currently being taken, recently taken, or that may be taken.
Due to the profile of cetirizine, interactions with other medications are not expected.

Taking Cetrix with food and 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, which corresponds to 1 glass of wine) and cetirizine taken in usual doses. In sensitive patients, concomitant use of cetirizine with alcohol or other medications with a central nervous system depressant effect may enhance the effect of the medication on reaction and concentration, although cetirizine does not potentiate the effect of alcohol. As with other antihistamines, it is recommended to avoid concurrent consumption of alcohol.

Pregnancy and breastfeeding

In the event of pregnancy or breastfeeding, suspected pregnancy, or planning pregnancy, advice should be sought from a doctor or pharmacist before taking this medication.
Cetrix should be avoided in pregnant women. It is not considered that accidental use of the medication would cause any harmful effect on the fetus. Nevertheless, the medication should only be used if necessary, after consulting a doctor.
Cetrix should not be used during breastfeeding, as cetirizine passes into breast milk, unless a doctor recommends otherwise.

Driving and operating machinery

Clinical trials have not revealed any evidence of impaired attention, alertness, and ability to drive vehicles after taking Cetrix in the recommended dose.
Patients planning to drive vehicles, perform potentially hazardous activities, or operate machinery should not take doses higher than recommended. Patients should carefully observe their body's reaction to the medication.

3. How to take Cetrix

How and when to take Cetrix?

This medication should always be taken in accordance with the doctor's recommendations. If the patient has any doubts about taking the medication, they should consult a doctor or pharmacist.
The tablets should be swallowed with a glass of liquid.
The tablet can be divided into two equal doses.

Adults and adolescents over 12 years of age:

The recommended dose is: 10 mg (1 tablet) once a day.

Use in children aged 6 to 12 years:

The recommended dose is: 5 mg (half a tablet) twice a day.

Patients with moderate to severe kidney function disorders

In patients with moderate kidney function disorders, a dose of 5 mg once a day is recommended.
If it is felt that the effect of Cetrix is too strong or too weak, a doctor should be consulted.

Duration of treatment

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

Taking a higher dose of Cetrix than recommended

In the event of taking a higher dose of Cetrix than recommended, or if a child has taken the medication by accident, a doctor or the nearest hospital should be consulted immediately to obtain information on further action.
After taking a dose higher than recommended, the following adverse reactions may occur with increased intensity. The following adverse reactions have been reported: confusion, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, restlessness, sedation, somnolence, stupor, accelerated heart rate, tremor, difficulty urinating.

Missing a dose of Cetrix

A double dose should not be taken to make up for a missed dose.

Discontinuing Cetrix

In the event of any further doubts about taking the medication, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medications, Cetrix can cause side effects, although they may not occur in everyone.

Stop taking Cetrix and contact a doctor or go to the nearest emergency department immediately if any of the following symptoms occur:

such as:swelling of the lips, face, and (or) throat, difficulty breathing (tightness in the chest or wheezing), sudden drop in blood pressure with fainting or shock.
These symptoms may be signs of a very serious allergic reaction (angioedema) or anaphylactic shock. Such reactions are very rare (may occur in 1 in 10,000 patients).
Other side effects may occur:
Common (may occur in up to 1 in 10 patients):

• fatigue
• dry mouth, nausea, diarrhea
• dizziness, headache
• sleepiness (drowsiness)
• pharyngitis, rhinitis (swelling and irritation inside the nose)

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

• abdominal pain
• asthenia (extreme fatigue), malaise
• paresthesia (abnormal sensations)
• agitation
• pruritus, pruritic rash

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

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

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

• thrombocytopenia (decreased platelet count)
• accommodation disorders (vision disorders), blurred vision, eye rotation (uncontrolled rotational movements of the eyeball)
• syncope, tremor, taste disorders, dystonia (abnormal prolonged muscle contractions), dyskinesia (involuntary movements)
• tics (involuntary muscle contractions)
• urination disorders (nocturia, pain, and (or) difficulty urinating)
• drug rash

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

• increased appetite
• suicidal thoughts
• amnesia, memory impairment
• vertigo (feeling of spinning or movement)
• 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, a doctor or pharmacist should be informed. Side effects can be reported directly (see details below). By reporting side effects, more information can be collected on the safety of the medication.
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.

5. How to store Cetrix

The medication should be stored in a place inaccessible and invisible to children.
The medication should not be used after the expiration date stated on the carton and blister pack after the Expiration Date (EXP). The expiration date refers to the last day of the specified month.
Store at a temperature below 30°C.
The medication should not be used if there are visible signs of deterioration or if the tablets are damaged.
Medications should not be disposed of in the sewage system or household waste containers. A pharmacist should be asked what to do with unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Cetrix contains

• The active substance is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The medication also contains: microcrystalline cellulose, pregelatinized starch, sodium croscarmellose, colloidal silica, anhydrous, magnesium stearate, polydextrose, hypromellose, titanium dioxide (E 171), macrogol 4000.

What Cetrix looks like and what the pack contains

Appearance:
white, round, biconvex tablets with a dividing line on one side and the logo "5", with a diameter of 7 mm.
Pack sizes:
7 and 10 tablets in aluminum/aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Vitabalans Oy
Varastokatu 8
FI-13500 Hämeenlinna
FINLAND
Phone: +358 (3) 615600
Fax: +358 (3) 6183130

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

Cetimax (DK, FI, HU, NO, SE)
Cetrix (EE, LV, LT, PL)
Cetixin (CZ, DE, SI, SK)

Date of last revision of the leaflet: 2020-11-11