Cetirizine genoptim sph

Package leaflet: Information for the user

Cetirizine Genoptim SPH, 10 mg, film-coated tablets
Cetirizine dihydrochloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet. You may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Cetirizine Genoptim SPH is and what it is used for
2. What you need to know before taking Cetirizine Genoptim SPH
3. How to take Cetirizine Genoptim SPH
4. Possible side effects
5. How to store Cetirizine Genoptim SPH
6. Contents of the pack and other information

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

The active substance in Cetirizine Genoptim SPH is cetirizine dihydrochloride. Cetirizine Genoptim SPH is an antiallergic (antihistamine) medicine.
Cetirizine Genoptim SPH is indicated in adults and children aged 6 years and older:

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

If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before taking Cetirizine Genoptim SPH

When not to use 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 included in other medicines);
• if the patient has severe kidney disease.

Warnings and precautions
Before taking Cetirizine Genoptim SPH, talk to a doctor, pharmacist, or nurse if:

• the patient has impaired kidney function. A dose reduction may be necessary. The doctor will determine the appropriate dose.
• the patient has epilepsy or is at risk of seizures.
• the patient has urinary retention.

Cetirizine Genoptim SPH and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Due to the pharmacological 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 level after drinking one glass of wine). However, as with all antihistamines, it is advisable to avoid concomitant alcohol consumption.

Pregnancy and breastfeeding
As with other medicines, Cetirizine Genoptim SPH should be avoided in pregnant women. Accidental intake of the medicine during pregnancy is unlikely to have harmful effects on the fetus. Nevertheless, treatment should be discontinued.
Cetirizine Genoptim SPH should not be taken during breastfeeding, as cetirizine passes into human milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
This medicine does not cause drowsiness in most people. However, rare exceptions exist, and caution should be exercised when taking this medicine for the first time.
If this medicine causes drowsiness, the patient 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, consult a doctor,
pharmacist, or nurse.
The tablets should be swallowed with a glass of liquid.
Recommended dose:
Adults:
10 mg (1 tablet) once daily.
Use in children and adolescents
Children aged 6 to 12 years:
5 mg (half a tablet) twice daily.
Adolescents above 12 years of age:
10 mg (1 tablet) once daily.
Patients with moderate or severe renal impairment:
For patients with moderate renal impairment, a dose of 5 mg once daily is recommended.
If the patient feels that the effect of Cetirizine Genoptim SPH is too weak or too strong,
consult a doctor.
The tablet may be divided into equal doses.
Duration of treatment:
The duration of treatment depends on the type, duration, and cause of the patient's symptoms and is
determined by the treating physician.
Taking more than the recommended dose of Cetirizine Genoptim SPH
If the patient has taken more than the recommended dose of Cetirizine Genoptim SPH, or if a child
has accidentally ingested the medicine, contact a doctor or the nearest hospital emergency department
for advice.
After an overdose, the following adverse reactions may occur with increased intensity.
The following adverse reactions have been reported: confusion, diarrhoea, dizziness, fatigue, headache,
malaise, dilated pupils, itching, restlessness, sedation, somnolence, stupor, tachycardia, tremor, and difficulty in urination.
Missed dose of Cetirizine Genoptim SPH
Do not take a double dose to make up for a missed dose.
If there are any further questions regarding the use of this medicine, consult a
doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If a patient experiences first signs of hypersensitivity reactions, administration of Cetirizine Genoptim SPH must be discontinued immediately and medical advice should be sought without delay. Hypersensitivity symptoms may include: oral, facial and (or) throat swelling, breathing difficulties (chest tightness or wheezing), sudden drop in blood pressure followed by fainting or shock.

Common (may affect up to 1 in 10 people)

• fatigue, feeling drowsy, abdominal pain
• dry mouth, nausea, diarrhoea
• dizziness, headache
• somnolence
• sore throat (pharyngitis), nasal swelling and irritation (rhinitis)

Uncommon (may affect up to 1 in 100 people)

• diarrhoea
• feeling of weakness (asthenia), general malaise
• tingling in hands or feet (paraesthesia)
• anxiety
• itching, rash

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

• rapid heartbeat (tachycardia)
• oedema
• allergic reactions
• abnormal liver function
• convulsions
• aggression, confusion, depression, hearing sounds or seeing things that are not real (hallucinations), insomnia
• urticaria
• weight gain

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

• low platelet count, manifesting as increased tendency to bleeding and bruising (thrombocytopenia)
• difficulty focusing vision (accommodation disorders), blurred vision, eye rotation (episodic forced eye deviation with ocular rotation)
• fainting, tremors, taste disturbances, uncontrolled muscle contractions and body twisting, movement difficulties
• tics
• nocturnal enuresis, pain and (or) difficulty urinating
• skin swelling, especially facial swelling, persistent drug eruption, anaphylactic shock, involuntary and (or) jerky limb movements, neck and shoulder muscle spasms

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

• memory loss, memory disorders
• suicidal thoughts
• dizziness
• inability to urinate
• increased appetite

If any adverse reactions occur in a patient, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse.

Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Cetirizine Genoptim SPH

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Cetirizine Genoptim SPH contains

• The active substance in Cetirizine Genoptim SPH is cetirizine dihydrochloride. One coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: sodium croscarmellose, microcrystalline cellulose, colloidal anhydrous 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-shaped, rectangular film-coated tablets, embossed with the number "10" on one side and a division line on the other side.
The pack contains 7 or 10 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the following names:
Malta Cetirizine Fair-Med 10mg Film-coated tablets
Germany Cetirizin Fair-Med Healthcare 10 mg Filmtabletten
Poland Cetirizine Genoptim SPH
Portugal Cetirizina Fair-Med