Cirrus duo

Patient Information Leaflet

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What is Cirrus Duo and what is it used for

Cirrus Duo 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 Duo 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 (runny nose), and itching (pruritus) of the nose and conjunctiva. The medicine is intended for use when both the antiallergic effect of cetirizine dihydrochloride and the nasal decongestant effect of pseudoephedrine hydrochloride are desired.

2. Important information before using the medicine Cirrus Duo

When not to use the medicine Cirrus Duo:

• if the patient is allergic to the active substances, ephedrine, piperazine or its derivatives, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has very high blood pressure (severe hypertension) or arterial hypertension that cannot be controlled 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 uncontrolled hyperthyroidism,
• if the patient has severe cardiac arrhythmias,
• 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 belongs to a high-risk group for 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 Duo and other medicines",
• in children under 12 years of age.

Warnings and precautions
Before starting to use the medicine Cirrus Duo, discuss this with your doctor or pharmacist.
Exercise particular caution when using Cirrus Duo 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 Duo 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 medicines (such as those reducing nasal mucosal congestion, reducing appetite, or psychostimulants, e.g. amphetamine and its derivatives), tricyclic antidepressants, antihypertensive medicines, alcohol, or medicines that depress central nervous system function and impair performance, cardiac glycosides such as digoxin or digitoxin (see below "Cirrus Duo 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 medicines (e.g. bromocriptine, pergolide, lisuride, cabergoline, ergotamine) or any other decongestant medicine reducing nasal congestion (e.g. phenylpropanolamine, phenylephrine, ephedrine) administered orally or intranasally), as vasoconstriction and increased blood 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, particularly in patients with risk factors for urinary retention (e.g. spinal cord injury, prostatic injury, benign prostatic hyperplasia, or bladder outlet obstruction), as Cirrus Duo may increase the risk of urinary retention.

If the patient develops fever with generalized skin erythema and vesicular rash,
discontinue use of Cirrus Duo and contact a doctor or seek immediate medical
assistance. See section 4.
During treatment with Cirrus Duo, sudden abdominal pain or rectal bleeding due to
inflammatory disease of the large intestine (ischemic colitis) may occur. If such
gastrointestinal symptoms occur, discontinue use of Cirrus Duo 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 after use of medicines
containing pseudoephedrine.
PRES and RCVS are rare conditions that may involve reduced blood flow to the brain.
If symptoms occur that may indicate PRES or RCVS, immediately discontinue use of
Cirrus Duo and seek immediate medical help (symptoms, see section 4 "Possible
undesirable effects").
Exercise caution in patients with hypertension who are also taking non-steroidal
anti-inflammatory drugs (NSAIDs), as both NSAIDs and pseudoephedrine may increase
blood pressure.
Before using Cirrus Duo, consult a doctor, even if the above warnings relate to a
condition that occurred in the past.
Cirrus Duo 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
stimulating the central nervous system.
When pseudoephedrine is used by professional athletes, it should be noted that its
use may result in a positive anti-doping test.

Use of Cirrus Duo in patients with renal impairment
Exercise particular caution when using the medicine in patients with renal impairment.
In patients with moderate renal impairment, the dose of Cirrus Duo should be reduced
to one tablet per day. Cirrus Duo should not be used in patients with end-stage renal
failure. Consult a doctor before use.

Use of Cirrus Duo in patients with hepatic impairment
Exercise particular caution when using the medicine in patients with hepatic
impairment. In patients with moderate hepatic impairment, the dose of Cirrus Duo
should be reduced to one tablet per day. Consult a doctor before use.

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

Cirrus Duo and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken,
as well as any medicines planned for use. Some medicines, if taken together with
Cirrus Duo, may cause undesirable effects.
Do not use Cirrus Duo with the following medicines:

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

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

• linezolid (an antibiotic),
• tricyclic antidepressants, such as imipramine, amitriptyline, doxepin,
• vasoconstrictive medicines, such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine,
• medicines constricting nasal mucosal blood vessels, such as phenylpropanolamine, phenylephrine, ephedrine,
• appetite-reducing medicines, such as phentermine, mazindol,
• psychostimulant medicines, such as amphetamine and its derivatives,
• blood pressure-lowering medicines, such as methyldopa, guanethidine, and reserpine, and medicines known as beta-adrenergic receptor blockers (e.g. atenolol, bisoprolol). Cirrus Duo may reduce the effectiveness of these medicines.
• medicines called cardiac glycosides, such as digoxin or digitoxin, used in heart failure treatment,
• medicines depressing central nervous system function, e.g. sedatives,
• medicines neutralizing gastric acid (medicines containing, e.g. aluminium or magnesium hydroxide) and proton pump inhibitors (medicines used for 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 for diarrhea) reduces the absorption rate of pseudoephedrine,
• theophylline (a medicine used, among others, in bronchial asthma),
• ritonavir (a medicine used in HIV infection).

Exercise caution 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 Duo, reduced blood flow in the optic nerve may occur.
If sudden vision loss occurs, discontinue use of Cirrus Duo and immediately contact a
doctor or seek medical help. See section 4.

Use of Cirrus Duo with food and drink
Cirrus Duo may be taken during or between meals.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to
have a child, she should consult a doctor or pharmacist before using this medicine.
Cirrus Duo should not be used during pregnancy.
Cirrus Duo should not be used during breastfeeding, as cetirizine and pseudoephedrine
pass into breast milk.
Animal studies in rats have not shown effects on fertility. There are no data on the
effect of Cirrus Duo on human fertility.

Driving and operating machinery
In clinical studies, cetirizine at recommended doses did not show significant effects on
the ability to drive or psychomotor performance. However, drowsiness occurred 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 that depress the central nervous system may further impair reaction
ability and concentration. However, no adverse effects or no expected adverse effects
have been reported or anticipated with pseudoephedrine.
Therefore, patients who drive, perform potentially hazardous activities, or operate
machinery should exercise caution, avoid exceeding 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 Duo contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the
patient should consult 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".

3. How to use Cirrus Duo

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose of Cirrus Duo for adults is one tablet twice daily (in the morning and evening),
taken with or between meals.
Cirrus Duo 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 Duo should not exceed the period during which symptoms
persist and should not last longer than 2 to 3 weeks. The doctor may recommend continuing
treatment with cetirizine alone.
Use in patients with moderate renal impairment or hepatic impairment
In patients with moderate renal impairment or hepatic impairment, the dose of Cirrus Duo 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
with or between meals.
Children under 12 years of age: use of this medicine is contraindicated (see above "When not to use
Cirrus Duo" and "Children and adolescents").
If you feel that the effect of Cirrus Duo is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Cirrus Duo
In case of overdose (taking more than the recommended dose), seek immediate medical attention
from a doctor or pharmacist.
Symptoms of acute overdose of Cirrus Duo include: diarrhea, dizziness, fatigue, headache, malaise,
dilated pupils, urinary retention, increased heart rate, cardiac arrhythmias, elevated blood pressure,
sedation, respiratory depression, loss of consciousness, cyanosis, circulatory collapse, insomnia,
hallucinations, tremor, and seizures. These symptoms may be life-threatening. A significant overdose
of Cirrus Duo may lead to toxic psychosis with delusions and hallucinations. Some patients may
experience cardiac arrhythmias, circulatory collapse, seizures, coma, and respiratory failure. These
symptoms may result in death.
Treatment of overdose (symptomatic and supportive) should be conducted in a hospital setting. It
should be noted that hemodialysis removes cetirizine and pseudoephedrine from the body only to
a limited extent.
Missed dose of Cirrus Duo
Do not take a double dose to make up for a missed dose.
After discontinuation of the medicine, itching (rare) may occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must stop taking Cirrus Duo immediately and seek urgent medical help
if symptoms indicating posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS) occur. These include:

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

Adverse reactions 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
• agitation

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 activity of aminotransferases, alkaline phosphatase, gamma-glutamyltransferase, increased bilirubin concentration)
• dry skin, rash, increased sweating, urticaria
• painful or difficult urination.

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

• psychotic disorders
• taste disturbances
• cerebrovascular incidents (stroke)
• inflammation of the large intestine due to reduced blood flow (ischaemic colitis)
• drug eruption
• 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, a doctor must be notified immediately or the nearest hospital must be contacted without delay.

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)
• aggression, confusion, depressed mood (depression), involuntary movements (tics), euphoria, suicidal thoughts
• disturbances in skin sensation (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 Duo. See section 2. If such symptoms occur, treatment with Cirrus Duo must be discontinued and a doctor must be contacted or immediate medical help sought
• 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), micturition
• joint pain, muscle pain
• swelling, malaise.

Cases of hepatitis have been reported during treatment with cetirizine alone.
Other adverse reactions may occur in some individuals during treatment with Cirrus Duo.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can
be reported directly to the Department for Monitoring of Adverse Drug Reactions,
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 Cirrus Duo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Cirrus Duo contains

• The active substances are: cetyryzyny dichlorowodorek and pseudoefedryny chlorowodorku. Each tablet contains 5 mg of cetyryzyny dichlorowodorku in an immediate-release form and 120 mg of pseudoefedryny chlorowodorku in a prolonged-release form.
• Other components:
  • Immediate-release layer contains: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
  • Prolonged-release layer contains: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
  • Opadry Y-1-7000 coating contains: hypromellose, titanium dioxide (E 171), and macrogol 400.

What Cirrus Duo looks like and contents of the pack
Cirrus Duo is a white or almost white, round, biconvex prolonged-release tablet.
The pack contains 6 prolonged-release tablets.
PVC/Aluminum blisters in a cardboard box.
For further detailed information about the medicinal product, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Lithuania, the exporting country:
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 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Lithuania, the exporting country: LT/1/05/0180/001
Parallel Import Authorisation Number: 316/25