Cetip

Package Leaflet: Information for the User

Cetip, 10 mg, Film-Coated Tablets

Cetirizine Dihydrochloride

Read the package 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 package leaflet or as directed by a doctor, pharmacist, or nurse.

• Keep this package leaflet, you may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, including any not listed in the package leaflet, tell your doctor, pharmacist, or nurse.
• If after 2 days there is no improvement or you feel worse, you should contact a doctor.

Table of Contents of the Package Leaflet

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

1. What is Cetip and what is it used for

The active substance of Cetip is cetirizine dihydrochloride, which belongs to a group of medicines called antihistamines.

This medicine is used to treat adults and children aged 6 years and above with hay fever (seasonal allergic rhinitis), perennial allergic rhinitis (persistent allergic rhinitis), and urticaria (hives).

Cetip relieves the symptoms associated with these conditions, including itching, sneezing, runny or itchy nose, hives, and itchy or watery eyes.

If after 2 days there is no improvement or you feel worse, you should contact a doctor.

2. Important information before taking Cetip

When not to take Cetip:

• if you are allergic to cetirizine or any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney problems,
• if you have intolerance to some sugars (hereditary fructose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption),
• if you have problems with urination.

Warnings and precautions

Before taking Cetip, tell your doctor, pharmacist, or nurse.

• If you have epilepsy or are at risk of convulsions, you should ask your doctor for advice.
• If you have kidney problems.
• If you have risk factors for urinary retention (e.g., spinal cord injury, prostate enlargement), as cetirizine may increase the risk of urinary retention.

Cetip is not recommended for children under 6 years of age.

No interactions have been observed between alcohol (at a blood concentration of 0.5 mg/ml, corresponding to a blood alcohol level of about 0.5 per mille) and cetirizine used at the recommended dose. However, as with all antihistamines, it is recommended to avoid taking alcohol while taking this medicine.

Good oral hygiene is recommended during long-term treatment with this medicine, as there is an increased risk of tooth or gum infections.

Patients who are scheduled to undergo allergy testing should stop taking this medicine at least 3 days before the test.

Other medicines and Cetip

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, including those obtained without a prescription, herbal preparations, and dietary supplements available in pharmacies, supermarkets, or health food stores,

as these may interact with Cetip.

Examples of medicines that may affect cetirizine include:

• medicines that act on the central nervous system (antidepressants, anxiolytics, and sedatives),
• ritonavir (a medicine used to treat HIV infection).

Cetip with food, drink, and alcohol

Food does not affect the absorption of cetirizine.

• As with all antihistamines, you should avoid excessive alcohol consumption while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine if you are breastfeeding.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Cetip contains cetirizine dihydrochloride.

A full list of excipients is provided in section 6.

• This medicine may cause drowsiness; if affected, do not drive or operate machinery.
• If you are sensitive to the effects of this medicine, concurrent consumption of alcohol or other central nervous system depressants may increase the risk of sedation.

3. How to take Cetip

Always take this medicine exactly as described in the package leaflet or as directed by your doctor, pharmacist, or nurse. If you are unsure, consult your doctor, pharmacist, or nurse.

Do not take more than one tablet per day. If after a few days there is no improvement, consult your doctor.

• Do not exceed the recommended dose.
• Swallow the tablets with a glass of water.
• The tablets can be taken with or without food.

Recommended dose:

Use in children and adolescents

The tablet can be divided into equal doses.

• Adults and children aged 12 years and above:one tablet once daily.
• Children aged 6 to 12 years:5 mg (half a tablet) twice daily (half a tablet in the morning and half a tablet in the evening) or 10 mg (one tablet) once daily as directed by the doctor.
• Children with a body weight below 30 kg:5 mg (half a tablet) once daily.

Cetip should not be given to children under 6 years of age.

Patients with liver or kidney impairment:the recommended dose is 5 mg (half a tablet) once daily. Consult your doctor before taking this medicine.

Overdose of Cetip

If you accidentally take too many tablets, contact your doctor or the nearest hospital emergency department immediately, even if you feel fine.

Drowsiness or dizziness may occur; do not drive or operate machinery.

Take this medicine in its original packaging to show the doctor what you have taken.

Missed dose of Cetip

If you forget to take a tablet, take it as soon as you remember, provided that it is at least 24 hours before the next dose.

Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Cetip

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

If you notice any of the following symptoms of an allergic reaction, stop taking Cetip and contact a doctor immediately: difficulty breathing, swelling of the face, neck, tongue, or throat.

The doctor will assess the severity of these symptoms and decide on any further necessary action.

During post-marketing experience, the following side effects have been reported.

The frequency of these side effects is defined as follows:

common (affects less than 1 in 10 people but more than 1 in 100 people),

uncommon (affects less than 1 in 100 people but more than 1 in 1,000 people),

rare (affects less than 1 in 1,000 people but more than 1 in 10,000 people),

very rare (affects less than 1 in 10,000 people).

Common side effects

• Fatigue
• Dry mouth
• Nausea
• Diarrhea (in children only)
• Dizziness
• Headache
• Drowsiness
• Sore throat
• Nasal congestion
• Tiredness and drowsiness
• Abdominal pain
• Cold symptoms (in children only)

Uncommon side effects

• Extreme fatigue and weakness
• Feeling unwell or weak
• Abnormal skin sensations (paresthesia)
• Psychomotor hyperactivity
• Itching (pruritus)
• Rash
• Diarrhea

Rare side effects

• Fast heartbeat (tachycardia)
• Edema
• Allergic reactions, sometimes severe (very rare)
• Abnormal liver function tests (consult your doctor)
• Weight gain
• Seizures
• Movement disorders
• Aggression
• Disorientation
• Depression
• Hallucinations (seeing or hearing things that are not there)
• Sleep disturbances (insomnia)
• Abdominal pain
• Edema, redness, and itching of the skin (hives)
• Insomnia

Very rare side effects

• Low platelet count (thrombocytopenia)
• Visual disturbances (accommodation disorders)
• Blurred vision, difficulty focusing
• Uncontrolled eye movements (nystagmus)
• Sudden, unusual, and repetitive movements (tics)
• Urination disorders
• Edema
• Drug rash
• Unusual bleeding or bruising
• Taste disturbances
• Tremors, tics
• Involuntary movements of the limbs and (or) jerky movements of the limbs
• Fainting
• Recurring rash
• Nocturnal enuresis and (or) difficulty urinating

Side effects of unknown frequency

• Increased appetite
• Dizziness
• Urinary retention

There have also been reports of memory loss and (or) memory disturbances.

In very rare cases, suicidal thoughts have been reported. If you experience any of these side effects, stop taking the tablets and consult your doctor.

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Urzad Rejestracji Produktow Leczniczych, Wyrobów Medycznych i Produktow Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.

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

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cetip

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.

No special precautions for storage are necessary.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cetip contains

• The active substance is cetirizine dihydrochloride. Each film-coated tablet contains 10 mg of cetirizine dihydrochloride.
• The other ingredients are: tablet core: lactose monohydrate, maize starch, pregelatinized maize starch, talc, magnesium stearate; coating: hypromellose, titanium dioxide (E 171), talc, and macrogol 6000.

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.

What Cetip looks like and contents of the pack

• Cetip is a white or almost white, film-coated tablet, capsule-shaped with a score line on one side and engraved with "10" on the other.
• Cetip is available in blisters in a pack containing 10 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Milapharm Sp. z o.o.

pl. Gen. Józefa Hallera 5/14A

03-464 Warsaw

Phone: (+48) 699 711 147

Manufacturer:

Medicofarma S.A.

ul. Tarnobrzeska 13

26-613 Radom

PharmaS d.o.o.

Industrijska cesta 5

44317 Potok, Popovača

Croatia

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

DE:

Cetirizine Dihydrochloride IPCA 10 mg Film-Coated Tablets

PL:

Cetip

PT:

Zarec 10 mg Film-Coated Tablets

Date of last revision of the package leaflet: