Cetirizine Genoptim Sph

Leaflet attached to the packaging: Information for the user

Cetirizine Genoptim SPH, 10 mg, film-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, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, you should 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, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Cetirizine Genoptim SPH and what is it used for
• 2. Important information before taking Cetirizine Genoptim SPH
• 3. How to take Cetirizine Genoptim SPH
• 4. Possible side effects
• 5. How to store Cetirizine Genoptim SPH
• 6. Package contents and other information

1. What is Cetirizine Genoptim SPH and what is it used for

The active substance of Cetirizine Genoptim SPH is cetirizine dihydrochloride. Cetirizine Genoptim SPH is an antiallergic (antihistamine) medicine.
Cetirizine Genoptim SPH is indicated for adults and children aged 6 years and above

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

If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Cetirizine Genoptim SPH

When not to take Cetirizine Genoptim SPH

• if the patient is allergic to cetirizine or any of the other ingredients of this medicine (listed in section 6);
• 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 taking Cetirizine Genoptim SPH, the patient should talk to their doctor, pharmacist, or nurse if:

• the patient has kidney problems. The dose may need to be reduced. The doctor will determine the new dose.
• the patient has epilepsy or a risk of seizures.
• the patient has urinary retention.

Cetirizine Genoptim SPH and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Due to the profile of cetirizine, no interactions with other medicines are expected.

Cetirizine Genoptim SPH with food, drink, and alcohol

Cetirizine Genoptim SPH can be taken with or without food.
There is no evidence of interactions between cetirizine at the recommended dose and alcohol (at a blood concentration of 0.5 per mille, equivalent to the concentration after drinking one glass of wine). However, as with all antihistamines, it is recommended to avoid consuming alcohol at the same time.

Pregnancy and breastfeeding

As with other medicines, Cetirizine Genoptim SPH 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 be discontinued.
Cetirizine Genoptim SPH should not be taken during breastfeeding, as cetirizine passes into human milk.
If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

In most people, this medicine does not cause drowsiness. However, there are rare exceptions, and caution should be exercised when taking this medicine for the first time.
If this medicine causes drowsiness in the patient, they should not drive or operate machinery.

3. How to take Cetirizine Genoptim SPH

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, the patient should consult their doctor, pharmacist, or nurse.
The tablets should be swallowed with a glass of liquid.
The recommended dose of the medicine is:

Adults:

10 mg (1 tablet) once a day.

Use in children and adolescents

Children aged 6 to 12 years:

5 mg (half a tablet) twice a day.

Adolescents over 12 years of age:

10 mg (1 tablet) once a day.

Patients with moderate or severe kidney problems:

Patients with moderate kidney problems are recommended to take 5 mg once a day.
If the patient feels that the effect of Cetirizine Genoptim SPH is too weak or too strong, they should consult their doctor.
The tablet can be divided into equal doses.

Duration of treatment:

The duration of treatment depends on the type, duration, and cause of the symptoms in the patient and is determined by the attending physician.

Taking a higher dose of Cetirizine Genoptim SPH than recommended

If the patient has taken a higher dose of Cetirizine Genoptim SPH than recommended, or if a child has accidentally taken the medicine, they should contact their doctor or the nearest hospital emergency department for advice.
After an overdose, the following side effects may occur with increased intensity.
The following side effects have been reported: confusion, diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, itching, restlessness, sedation, drowsiness, stupor, rapid heartbeat, tremors, and difficulty urinating.

Missing a dose of Cetirizine Genoptim SPH

A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences the first symptoms of an allergic reaction, they should stop taking Cetirizine Genoptim SPH and immediately consult their doctor. Symptoms of an allergic reaction may include: swelling of the mouth, face, and (or) throat, difficulty breathing (tightness in the chest or wheezing), a sudden drop in blood pressure with subsequent fainting or shock.
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• diarrhea
• weakness (asthenia), general malaise
• tingling of hands or feet (paresthesia)
• restlessness
• itching, rash

Rare (may affect up to 1 in 1,000 people)

• rapid heartbeat (tachycardia)
• edema
• allergic reactions
• abnormal liver function
• seizures
• aggression, confusion, depression, hearing sounds or seeing things that do not exist (hallucinations), insomnia
• urticaria
• weight gain

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

• low platelet count, which may cause increased bleeding and bruising (thrombocytopenia)
• difficulty focusing (accommodation disorders), blurred vision, eye rotation (forced gaze with eye rotation)
• fainting, tremors, taste disorders, uncontrolled muscle contractions and twisting of the body, difficulty walking
• tics
• bedwetting, pain and (or) difficulty urinating
• skin edema, especially facial edema, persistent drug rash, anaphylactic shock, involuntary and (or) jerky movements of the limbs, muscle contractions of the neck and shoulders

Frequency not known (frequency cannot be estimated from the available data)
memory loss, memory disorders
suicidal thoughts
dizziness
difficulty urinating
increased appetite
If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse.

Reporting side effects

If side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Cetirizine Genoptim SPH

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Cetirizine Genoptim SPH contains

• The active substance of Cetirizine Genoptim SPH is cetirizine dihydrochloride. One film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: croscarmellose sodium, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, hypromellose 6cP, and titanium dioxide (E171).

What Cetirizine Genoptim SPH looks like and contents of the pack

White or almost white, oval, rectangular film-coated tablets with the number "10" embossed on one side and a score line on the other side.
The pack contains 7 or 10 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

PharmSol Europe Limited
Victoria Centre Unit 2
Lower Ground Floor Valletta Road
Mosta, MST 9012 Malta

Manufacturer

Fairmed Healthcare GmbH
Maria-Goeppert-Straße 3
23562 Lübeck
Germany

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

Countries:

Malta
Cetirizine Fair-Med 10mg Film-coated tablets
Germany
Cetirizin Fair-Med Healthcare 10 mg Filmtabletten
Poland
Cetirizine Genoptim SPH
Portugal
Cetirizina Fair-Med

Date of last revision of the leaflet: