Cirrus

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language.
Cirrus, 5 mg + 120 mg, prolonged-release tablets
Cetirizini dihydrochloridum + Pseudoephedrini hydrochloridum
Please read the following information carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Cirrus is and what it is 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 pack and other information

1. What Cirrus is and what it is used for

Cirrus contains two active substances: cetirizine dihydrochloride and pseudoephedrine hydrochloride. Cetirizine dihydrochloride is an antiallergic medicine, while pseudoephedrine hydrochloride constricts blood vessels in the nasal mucosa, thereby reducing nasal mucosal congestion.
Cirrus prolonged-release tablets are indicated for the treatment of symptoms of seasonal and perennial allergic rhinitis, such as nasal congestion (nasal mucosal congestion), sneezing, watery nasal discharge (rhinorrhea), and itching (pruritus) of the nose and conjunctiva. This medicine is intended for use when both the antiallergic effect of cetirizine dihydrochloride and the decongestant effect of pseudoephedrine hydrochloride on the nasal mucosa are desired.

2. Important information before using Cirrus

When not to use 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 arterial hypertension), uncontrolled hypertension with medication, or a severe form of ischemic 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 untreated hyperthyroidism,
• if the patient has severe cardiac arrhythmias,
• if the patient has been diagnosed with a pheochromocytoma (a tumor of the adrenal medulla),
• 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 belongs to a high-risk group for hemorrhagic stroke,

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• if the patient is taking dihydroergotamine (a medicine used to treat 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, discuss this with your doctor or pharmacist.
Exercise particular caution when using Cirrus if:

• the patient has diabetes,
• the patient has hyperthyroidism,
• the patient has arterial hypertension (high blood pressure), especially if also taking non-steroidal anti-inflammatory drugs (see below "Cirrus and other medicines"),
• the patient has ischemic heart disease or cardiac arrhythmias such as tachycardia,
• the patient has moderate renal or hepatic impairment (see section 3),
• the patient is elderly,
• the patient is taking sympathomimetic drugs (such as those reducing nasal mucosal congestion, appetite suppressants, psychostimulants, e.g. amphetamine and its derivatives), tricyclic antidepressants, antihypertensive drugs, alcohol, or drugs that depress the central nervous system and impair performance, cardiac glycosides such as digoxin or digitoxin (see below "Cirrus and other medicines"),
• the patient has benign prostatic hyperplasia or difficulty urinating,
• the patient has risk factors for hemorrhagic stroke (such as concomitant use of other vasoconstrictive drugs (e.g. bromocriptine, pergolide, lisuride, cabergoline, ergotamine) or any other decongestant drug reducing nasal congestion (e.g. phenylpropanolamine, phenylephrine, ephedrine) administered orally or nasally), because vasoconstriction and increased arterial pressure increase the risk of hemorrhagic stroke,
• the patient has risk factors for hypercoagulable states, e.g. in inflammatory bowel diseases,
• the patient has conditions in which anticholinergic effects are undesirable, especially in patients with risk factors for urinary retention (e.g. spinal cord injury, prostatic hyperplasia, benign prostatic hyperplasia, or bladder outlet obstruction), since Cirrus may increase the risk of urinary retention,

If the patient develops fever with generalized skin redness and vesicular rash,
discontinue Cirrus and contact a doctor or seek immediate medical help. See section 4.
During treatment with Cirrus, sudden abdominal pain or rectal bleeding due to
inflammatory condition of the large intestine (ischemic colitis) may occur. If such
gastrointestinal symptoms occur, discontinue Cirrus and immediately consult a
doctor or seek medical help. See section 4.
Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following use of medicines containing pseudoephedrine.
PRES and RCVS are rare conditions that may involve reduced blood flow to the brain.
If symptoms suggestive of PRES or RCVS occur, discontinue Cirrus immediately and seek immediate medical attention (symptoms, see section 4 "Possible adverse effects").
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Caution is advised in patients with hypertension who are also taking non-steroidal anti-inflammatory drugs (NSAIDs), since both NSAIDs and pseudoephedrine may increase blood pressure.
Before using Cirrus, consult a doctor, even if the above warnings refer to conditions that occurred in the past.
Cirrus may affect the results of skin allergy tests. Therefore, skin tests should be performed at least 3 days after discontinuation of the medicine.
Cases of pseudoephedrine abuse have been reported, similar to other substances with central nervous system stimulant effects.
When pseudoephedrine is used by professional athletes, it should be noted that its use may result in a positive anti-doping test result.
Use of Cirrus in patients with renal impairment
Exercise special caution when using the medicine in patients with renal impairment. In patients with moderate renal impairment, the dose of Cirrus should be reduced to one tablet per day. Cirrus should not be used in patients with end-stage renal failure. Consult a doctor before use.
Use of Cirrus in patients with hepatic impairment
Exercise special caution when using the medicine in patients with hepatic impairment. In patients with moderate hepatic impairment, the dose of Cirrus should be reduced to one tablet per day. Consult a doctor before use.
Children and adolescents
Use of Cirrus in children under 12 years of age is contraindicated (see above "When not to use Cirrus"), because 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, pseudoephedrine.
Cirrus and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use. Some medicines, when taken together with Cirrus, may cause adverse effects.
Do not use Cirrus with the following medicines:

• medicines known as monoamine oxidase inhibitors (MAOIs), used in depression. When taken concomitantly with Cirrus, increased blood pressure or even hypertensive crisis may occur. This adverse effect may occur within two weeks after discontinuation of such medicines; therefore, Cirrus should not be used during treatment with MAOIs or within two weeks after their discontinuation.
• dihydroergotamine (a medicine used in migraine), see above "When not to use Cirrus".

Consult a doctor before using Cirrus if the patient is taking any of the
following medicines:

• linezolid (an antibiotic),
• tricyclic antidepressants, such as imipramine, amitriptyline, doxepin,
• vasoconstrictive drugs, such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine,
• nasal decongestants acting on the nasal mucosa, such as phenylpropanolamine, phenylephrine, ephedrine,
• appetite suppressants, such as phentermine, mazindol,
• psychostimulant drugs, such as amphetamine and its derivatives,

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• antihypertensive drugs such as methyldopa, guanethidine, and reserpine, and drugs known as beta-adrenergic receptor blockers (e.g. atenolol, bisoprolol). Cirrus may reduce the effectiveness of these drugs.
• medicines known as cardiac glycosides, such as digoxin or digitoxin, used in the treatment of heart failure,
• drugs that depress the central nervous system, e.g. sedatives,
• antacids (medicines containing, for example, aluminum or magnesium hydroxide) and proton pump inhibitors (medicines used in peptic ulcer disease, such as omeprazole). Note that these medicines increase the absorption rate of pseudoephedrine.
• halogenated general anesthetics, such as halothane,
• kaolin (a medicine used in diarrhea) reduces the absorption rate of pseudoephedrine,
• theophylline (a medicine used, among others, in bronchial asthma),
• ritonavir (a medicine used in HIV infection).

Caution is advised in patients with hypertension who are also taking non-steroidal anti-inflammatory drugs (NSAIDs), e.g. acetylsalicylic acid, paracetamol, ibuprofen, naproxen.
During treatment with Cirrus, reduced blood flow in the optic nerve may occur. If sudden vision loss occurs, discontinue Cirrus and immediately contact a doctor or seek medical help. See section 4.
Use of Cirrus with food and drink
Cirrus can be taken during meals or between meals.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Cirrus should not be used during pregnancy.
Cirrus should not be used during breastfeeding, as cetirizine and pseudoephedrine pass into breast milk.
Animal studies in rats did not show effects on fertility. There are no data available on the effects of Cirrus on human fertility.
Driving and operating machinery
In clinical studies, cetirizine at recommended doses did not significantly affect the ability to drive or psychomotor performance. However, drowsiness was reported in some individuals participating in the studies. Cetirizine at doses higher than recommended may affect the central nervous system. Concurrent use of cetirizine with alcohol or other substances with CNS depressant effects may further impair reaction ability and concentration. However, no negative effect of pseudoephedrine has been reported or expected.
Therefore, patients who drive, perform potentially hazardous activities, or operate machinery are advised to exercise caution, not exceed the recommended dose, and consider their individual response to the medicine and the possibility of adverse 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 certain sugars, the patient should contact a doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
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3. How to use Cirrus

This medicine should always be used according to the instructions given by the doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose of Cirrus for adults is one tablet twice daily (in the morning and evening), taken during
meals or between meals.
Cirrus tablets must not be broken, crushed, chewed, or split. The tablet should be swallowed whole with an adequate amount of liquid.
Duration of treatment
The duration of treatment with Cirrus should not exceed the period during which symptoms are present and should not
last longer than 2 to 3 weeks. The doctor may recommend continuing treatment with cetyryzine alone.
Use in patients with moderate renal impairment or hepatic impairment
In patients with moderate renal impairment or hepatic impairment, the dose of Cirrus should be reduced by half (to 1 tablet daily).
Use in children and adolescents
Adolescents aged 12 to below 18 years: one tablet twice daily (in the morning and evening), taken during meals or between meals.
Children under 12 years of age: use of this medicine is contraindicated (see above "When not to use Cirrus" and "Children and adolescents").
If you feel that the effect of Cirrus is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Cirrus
If you take more than the recommended dose (overdose), seek immediate medical advice from a doctor or pharmacist.
Symptoms of acute overdose of Cirrus include: diarrhea, dizziness, fatigue, headache, malaise, pupil dilation, urinary retention,
increased heart rate, cardiac arrhythmias, elevated blood pressure, sedation, respiratory depression, loss of consciousness, cyanosis,
circulatory collapse, insomnia, hallucinations, tremors, and seizures. These symptoms may be life-threatening. A significant overdose of Cirrus may lead to toxic psychosis with delusions and hallucinations. In some patients, cardiac arrhythmias, circulatory collapse, seizures, coma, and respiratory failure may occur. These symptoms may result in death.
Treatment of overdose (symptomatic and supportive) should be carried out under hospital conditions. It should be noted that hemodialysis removes cetyryzine and pseudoephedrine from the body only to a limited extent.
Missed dose of Cirrus
Do not take a double dose to make up for a missed dose.
After discontinuation of the medicine, itching may occur (rarely).
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
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You should stop taking Cirrus immediately and seek medical help straight away if you experience symptoms indicating posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

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

Adverse effects reported:
Common (may occur in 1 to 10 out of 100 patients):

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

Uncommon (may occur in 1 to 10 out of 1,000 patients):

• anxiety
• restlessness

Rare (may occur in 1 to 10 out of 10,000 patients):

• hypersensitivity reactions (including anaphylactic shock)
• hallucinations
• seizures, tremor
• cardiac arrhythmias
• pallor
• high blood pressure
• vomiting
• liver function disorders (increased aminotransferase, alkaline phosphatase, gamma-glutamyl transferase activity, increased bilirubin concentration)
• dry skin, rash, increased sweating, urticaria
• painful or difficult urination

Very rare (may occur less frequently than in 1 out of 10,000 patients):

• psychotic disorders
• taste disturbances
• cerebrovascular incidents (stroke)
• colitis caused by insufficient blood flow (ischaemic colitis)
• drug rash
• circulatory collapse (sudden drop in arterial blood pressure, manifesting as severe weakness, skin pallor, excessive sweating, often with loss of consciousness)
• angioedema (swelling of the face, eyelids, mucous membranes, lips, tongue, and larynx, causing breathing and swallowing difficulties). If any of these symptoms occur, contact a doctor immediately or go to the nearest hospital.

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

• severe conditions affecting blood vessels in the brain, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

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• aggression, confusion, low mood (depression), involuntary movements (tics), euphoria, suicidal thoughts
• skin sensory disturbances (paraesthesia), inability to sit still or relax (psychomotor restlessness), abnormal prolonged muscle contractions (dystonia), involuntary movements (dyskinesia), memory loss (amnesia), memory problems, fainting
• accommodation disorders (eye disorders), blurred vision, unusual pupil dilation, eye pain, visual impairment, involuntary eye movements, abnormal light sensitivity
• breathing difficulties (dyspnoea)
• erectile dysfunction
• sudden fever, skin redness, 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, discontinue Cirrus and contact your doctor or seek immediate medical help
• itching
• palpitations, heart attack, low blood pressure (hypotension)
• diarrhoea, discomfort in the lower abdomen
• reduced blood flow in the optic nerve (ischaemic optic neuropathy)
• difficulty emptying the bladder (urinary retention), urination
• joint pain, muscle pain
• swelling, malaise

Cases of hepatitis have been reported with cetyryzine alone.
Other adverse effects may occur in some individuals during treatment with Cirrus.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Adverse effects can also be reported to the marketing authorisation holder. Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store the medicine Cirrus

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must 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 packaging and other information

What Cirrus contains
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• The active substances are: ceterizine dihydrochloride and pseudoephedrine hydrochloride. Each tablet contains 5 mg of ceterizine dihydrochloride in an immediate-release form and 120 mg of pseudoephedrine hydrochloride in a prolonged-release form.
• Other components: The immediate-release layer contains: monohydrate lactose, 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 white coating contains: hypromellose, titanium dioxide (E 171), and polyethylene glycol 400.

What Cirrus looks like and contents of the pack
Cirrus is a white or almost white, round, biconvex tablet.
The pack contains 14 tablets.
PVC/Al blister in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Lithuania, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing authorization number in Lithuania, country of export: LT/1/05/0180/001
Parallel import authorization number: 96/26
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