Cirrus

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Cirrus

5 mg + 120 mg, prolonged-release tablets

Cetirizine dihydrochloride + Pseudoephedrine hydrochloride

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Cirrus and what is it used for

Cirrus contains two active substances: cetirizine dihydrochloride and pseudoephedrine hydrochloride. Cetirizine dihydrochloride is an antiallergic medicine, while pseudoephedrine hydrochloride narrows the blood vessels in the nasal mucosa, reducing nasal congestion.
Cirrus, prolonged-release tablets, is indicated for the treatment of symptoms of seasonal and perennial allergic rhinitis, such as nasal congestion, sneezing, runny nose, and itching of the nose and eyes. The medicine is intended for use in cases where both the antiallergic effect of cetirizine dihydrochloride and the decongestant effect of pseudoephedrine hydrochloride are desired.

2. Important information before taking Cirrus

When not to take Cirrus:

• if the patient is allergic to the active substances, ephedrine, piperazine, or its derivatives, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has very high blood pressure (severe hypertension) or uncontrolled hypertension, or severe coronary heart disease,
• if the patient has severe acute (sudden) or chronic (long-term) kidney disease, or renal failure / end-stage renal failure,
• if the patient has uncontrolled hyperthyroidism,
• if the patient has severe heart rhythm disorders,
• if the patient has been diagnosed with a pheochromocytoma,
• if the patient has glaucoma or increased intraocular pressure,
• if the patient has urinary retention,
• if the patient has had a stroke,
• if the patient is at high risk of hemorrhagic stroke,
• if the patient is taking dihydroergotamine (a medicine used for migraine),
• if the patient is currently taking or has taken within the last two weeks monoamine oxidase inhibitors (MAOIs), see below "Cirrus and other medicines",
• in children under 12 years of age.

Warnings and precautions

Before starting treatment with Cirrus, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when taking Cirrus if:

• the patient has diabetes,
• the patient has hyperthyroidism,
• the patient has hypertension (high blood pressure), especially if they are also taking non-steroidal anti-inflammatory drugs (see below "Cirrus and other medicines"),
• the patient has coronary heart disease or heart rhythm disorders, such as tachycardia,
• the patient has moderate renal or hepatic impairment (see section 3),
• the patient is elderly,
• the patient is taking sympathomimetic medicines (such as decongestants, appetite suppressants, psychostimulants, e.g., amphetamine and its derivatives), tricyclic antidepressants, antihypertensive medicines, alcohol, or medicines that impair central nervous system function and reduce performance, cardiac glycosides such as digoxin or digitoxin (see below "Cirrus and other medicines"),
• the patient has prostatic hyperplasia or difficulty urinating,
• the patient has risk factors for hemorrhagic stroke (such as concomitant use of other vasoconstrictor medicines (e.g., bromocriptine, pergolide, lisuride, cabergoline, ergotamine) or any other decongestant medicine (e.g., phenylpropanolamine, phenylephrine, ephedrine) administered orally or intranasally), as vasoconstriction and increased blood pressure increase the risk of hemorrhagic stroke,
• the patient has a risk of hypercoagulable states, e.g., in inflammatory bowel disease,
• the patient has conditions where anticholinergic effects are undesirable, particularly in patients with risk factors for urinary retention (e.g., spinal cord injuries, prostatic hyperplasia, or urinary obstruction), as Cirrus may increase the risk of urinary retention. If the patient experiences fever with generalized redness of the skin and pustular rash, they should stop taking Cirrus and consult their doctor or seek medical attention immediately. See section 4.

During treatment with Cirrus, sudden abdominal pain or rectal bleeding may occur due to ischemic colitis. If such gastrointestinal symptoms occur, the patient should stop taking Cirrus and seek medical attention immediately. See section 4.
After taking pseudoephedrine-containing medicines, cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported.
PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain.
If symptoms that may be indicative of PRES or RCVS occur, the patient should immediately stop taking Cirrus and seek medical attention (symptoms, see section 4 "Possible side effects").
Caution should be exercised in patients with hypertension who are taking non-steroidal anti-inflammatory drugs (NSAIDs) concomitantly, as both NSAIDs and pseudoephedrine may increase blood pressure.

Before taking Cirrus, the patient should consult their doctor, even if the above warnings refer to a past situation.

Cirrus may affect the results of skin allergy tests. Therefore, skin tests should be performed after a 3-day washout period from the medicine.
There have been reports of pseudoephedrine abuse, similar to other centrally acting stimulants.
In the case of pseudoephedrine use by professional athletes, it should be remembered that its use may result in a positive doping test result.

Use of Cirrus in patients with renal impairment

Particular caution should be exercised when using the medicine in patients with renal failure. In patients with moderate renal impairment, the dose of Cirrus should be reduced to one tablet per day. In patients with end-stage renal failure, Cirrus should not be used. Before taking the medicine, the patient should consult their doctor.

Use of Cirrus in patients with hepatic impairment

Particular caution should be exercised when using the medicine in patients with hepatic failure. In patients with moderate hepatic impairment, the dose of Cirrus should be reduced to one tablet per day. Before taking the medicine, the patient should consult their doctor.

Children and adolescents

The use of Cirrus in children under 12 years of age is contraindicated (see above "When not to take Cirrus"), as the combination of active substances in Cirrus has not been studied in this age group and due to the presence of one of the active substances, i.e., pseudoephedrine.

Cirrus and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Some medicines, when taken with Cirrus, may cause side effects.
Cirrus should not be taken with the following medicines:

• monoamine oxidase inhibitors (MAOIs) used in depression. When taken concomitantly with Cirrus, an increase in blood pressure may occur, and a hypertensive crisis is possible. The occurrence of this side effect is possible within two weeks after discontinuation of such medicines, so Cirrus should not be taken during treatment with MAOIs and within two weeks after their discontinuation.
• dihydroergotamine (a medicine used for migraine), see above "When not to take Cirrus".

Before taking Cirrus, the patient should consult their doctor if they are taking any of the following medicines:

• linezolid (an antibiotic),
• tricyclic antidepressants, such as imipramine, amitriptyline, doxepin,
• vasoconstrictor medicines, such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine,
• nasal decongestants, such as phenylpropanolamine, phenylephrine, ephedrine,
• appetite suppressants, such as phentermine, mazindol,
• psychostimulants, such as amphetamine and its derivatives,
• antihypertensive medicines, such as methyldopa, guanethidine, and reserpine, as well as beta-adrenergic blocking agents (e.g., atenolol, bisoprolol). Cirrus may reduce the effect of these medicines.
• cardiac glycosides, such as digoxin or digitoxin, used in the treatment of heart failure,
• central nervous system depressants, such as sedatives,
• antacids (medicines containing, e.g., aluminum or magnesium hydroxide) and proton pump inhibitors (medicines used to treat ulcers, such as omeprazole). It should be remembered that these medicines increase the absorption rate of pseudoephedrine.
• halogenated general anesthetics, such as halothane,
• kaolin (a medicine used for diarrhea) reduces the absorption rate of pseudoephedrine,
• theophylline (a medicine used, among others, for asthma),
• ritonavir (a medicine used for HIV infection).

Caution should be exercised when taking Cirrus in patients with hypertension who are also taking non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, paracetamol, ibuprofen, naproxen.
During treatment with Cirrus, a decrease in blood flow in the optic nerve may occur. If sudden vision loss occurs, the patient should stop taking Cirrus and seek medical attention immediately. See section 4.

Use of Cirrus with food and drink

Cirrus can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Cirrus should not be taken during pregnancy.
Cirrus should not be taken during breastfeeding, as cetirizine and pseudoephedrine pass into breast milk.
Studies in rats have not shown an effect on fertility. There are no data on the effect of Cirrus on human fertility.

Driving and using machines

In studies, cetirizine has not been shown to have a significant effect on driving ability or psychophysical performance at recommended doses. In some patients, drowsiness has occurred. Cetirizine at higher-than-recommended doses may affect the central nervous system. Concomitant use of cetirizine with alcohol or other substances that have a depressant effect on the central nervous system may further impair the ability to react and concentrate. However, no negative effect of pseudoephedrine is expected.
Therefore, patients who drive vehicles, perform potentially hazardous activities, or operate machinery should exercise caution, not exceed the recommended dose, and consider their individual response to the medicine and the possibility of side effects. Patients should not drive if they experience drowsiness or dizziness.

Cirrus contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Cirrus

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The recommended dose of Cirrus for adults is one tablet twice a day (morning and evening) with food or on an empty stomach.
Cirrus tablets should not be broken, chewed, or crushed. The medicine should be swallowed whole, with a sufficient amount of liquid.
Duration of treatment
The treatment period with Cirrus should not exceed the duration of symptoms and should not be longer than 2 to 3 weeks. The doctor may recommend continued treatment with cetirizine alone.

Use in patients with moderate renal or hepatic impairment

In patients with moderate renal or hepatic impairment, the dose of Cirrus should be reduced by half (to 1 tablet per day).

Use in children and adolescents

Adolescents aged 12 to less than 18 years: one tablet twice a day (morning and evening), with food or on an empty stomach.
Children under 12 years of age: the use of Cirrus is contraindicated (see above "When not to take Cirrus" and "Children and adolescents").
If the patient feels that the effect of Cirrus is too strong or too weak, they should consult their doctor.

Overdose of Cirrus

In case of overdose (taking more than the recommended dose), the patient should immediately consult their doctor or pharmacist.
Symptoms of acute overdose of Cirrus include: diarrhea, dizziness, fatigue, headache, malaise, dilated pupils, urinary retention, increased heart rate, arrhythmias, increased blood pressure, sedation, apnea, loss of consciousness, cyanosis, and cardiogenic shock, insomnia, hallucinations, tremors, seizures. These symptoms can be life-threatening. Significant overdose of Cirrus may cause toxic psychosis with hallucinations. In some patients, arrhythmias, cardiogenic shock, seizures, coma, and respiratory failure may occur. These symptoms can lead to death.
Treatment of overdose (symptomatic and supportive) should be carried out in a hospital setting. It should be remembered that hemodialysis removes cetirizine and pseudoephedrine from the body only to a small extent.

Missed dose of Cirrus

A double dose should not be taken to make up for a missed dose.
After stopping treatment with Cirrus, itching (rarely) may occur.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Cirrus can cause side effects, although not everybody gets them.
The patient should immediately stop taking Cirrus and seek medical attention if symptoms indicative of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:

• severe headache with sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures,
• visual disturbances.

Frequent side effects (may affect up to 1 in 10 people):

• nervousness
• insomnia
• dizziness, headache
• drowsiness
• increased heart rate
• dryness of the oral mucosa
• nausea
• feeling of weakness

Uncommon side effects (may affect up to 1 in 100 people):

• restlessness
• excitement

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

• hypersensitivity reactions (including anaphylactic shock)
• hallucinations
• seizures, tremors
• arrhythmias
• pallor
• high blood pressure
• vomiting
• liver function disorders (increased activity of aminotransferases, alkaline phosphatase, gamma-glutamyltransferase, increased bilirubin levels)
• dry skin, rash, increased sweating, urticaria
• painful or difficult urination

Very rare side effects (may affect less than 1 in 1,000 people):

• psychotic disorders
• taste disorders
• cerebrovascular incidents (stroke)
• ischemic colitis
• pustular rash
• cardiogenic shock (sudden decrease in blood pressure, severe weakness, pallor, increased sweating, often with loss of consciousness)
• angioedema (swelling of the face, eyelids, mucous membranes, lips, tongue, and larynx, causing difficulty breathing and swallowing). If any of these symptoms occur, the patient should immediately inform their doctor or go to the nearest hospital.

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

• severe vascular disorders affecting the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
• aggression, confusion, depressed mood (depression), involuntary movements (tics), euphoria, suicidal thoughts
• paresthesia, inability to sit still, calm down, or rest (psychomotor restlessness), abnormal, prolonged muscle contractions (dystonia), involuntary movements (dyskinesia), memory loss (amnesia), memory problems, fainting
• accommodation disorders, blurred vision, abnormal pupil dilation, eye pain, decreased vision, involuntary eye movements, abnormal light tolerance
• breathing difficulties (dyspnea)
• erectile dysfunction
• sudden fever, redness of the skin, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) may occur within the first 2 days of taking Cirrus. See section 2. If such symptoms occur, the patient should stop taking Cirrus and consult their doctor or seek medical attention immediately.
• pruritus
• palpitations, myocardial infarction, low blood pressure (hypotension)
• diarrhea, abdominal discomfort
• decreased blood flow in the optic nerve (ischemic optic neuropathy)
• urinary retention, incontinence
• arthralgia, myalgia
• edema, malaise

During treatment with cetirizine alone, isolated cases of hepatitis have been reported.
In some patients, other side effects may occur during treatment with Cirrus.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Cirrus

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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. Contents of the packaging and other information

What Cirrus contains

• The active substances of Cirrus are cetirizine dihydrochloride and pseudoephedrine hydrochloride. Each tablet contains 5 mg of cetirizine dihydrochloride in the form of immediate release and 120 mg of pseudoephedrine hydrochloride in the form of prolonged release.
• Other ingredients are: The immediate-release layer contains: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate. The prolonged-release layer contains: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. The Opadry Y-1-7000 coating contains: hypromellose, titanium dioxide (E 171), and macrogol 400.
• 400.

What Cirrus looks like and contents of the packaging

Cirrus is a white or almost white, round, biconvex prolonged-release tablet.
The packaging contains 14 prolonged-release tablets.
PVC/Aluminum blisters in a cardboard box.
For more detailed information on the medicine, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, the country of export:

UCB Pharma Oy Finland
Bertel Jungin aukio 5
02600 Espoo
Finland

Manufacturer:

Aesica Pharmaceuticals S.r.l.
Via Praglia 15
I-10044 Pianezza (TO)
Italy

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa
Lithuanian, export country marketing authorization number: LT/1/05/0180/001

Parallel import authorization number: 117/25

Date of leaflet approval: 27.03.2025

[Information about the trademark]