Cirrus Duo

Package Leaflet: Information for the Patient

Cirrus Duo, 5 mg + 120 mg, prolonged-release tablets

Cetirizine dihydrochloride + Pseudoephedrine hydrochloride

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 this package leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or feel worse after 5 days, you should contact your doctor.

Table of Contents of the Package Leaflet

• 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 narrows the blood vessels in the nasal mucosa, reducing nasal congestion.
Cirrus Duo, prolonged-release tablets are 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 when both antiallergic and decongestant effects are desired.

2. Important information before taking Cirrus Duo

When not to take Cirrus Duo:

• if you are allergic to the active substances, ephedrine, piperazine, or any of the other ingredients of this medicine (listed in section 6),
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension,
• if you have severe acute (sudden) or chronic (long-term) kidney disease, or kidney failure / end-stage kidney failure,
• if you have uncontrolled hyperthyroidism,
• if you have severe heart rhythm disorders,
• if you have been diagnosed with a pheochromocytoma (a tumor of the adrenal gland),
• if you have been diagnosed with glaucoma or increased intraocular pressure,
• if you have urinary retention,
• if you have had a stroke,
• if you are at high risk of hemorrhagic stroke,
• if you are taking dihydroergotamine (a medicine used for migraine),
• if you are currently taking or have 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 taking Cirrus Duo, you should discuss it with your doctor or pharmacist.
You should be particularly careful when taking Cirrus Duo if:

• you have diabetes,
• you have hyperthyroidism,
• you have hypertension (high blood pressure), especially if you are also taking non-steroidal anti-inflammatory drugs (NSAIDs),
• you have coronary heart disease or heart rhythm disorders, such as tachycardia,
• you have moderate kidney or liver failure (see section 3),
• you are elderly,
• you are 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 alertness, digitalis glycosides, such as digoxin or digitoxin (see below "Cirrus Duo and other medicines"),
• you have benign prostatic hyperplasia or difficulty urinating,
• you have 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), as vasoconstriction and increased blood pressure increase the risk of hemorrhagic stroke,
• you have a risk of thrombophilia, e.g., in inflammatory bowel disease,
• you have conditions where anticholinergic effects are undesirable, especially in patients with risk factors for urinary retention (e.g., spinal cord injuries, prostatic hyperplasia, or urinary obstruction), as Cirrus Duo may increase the risk of urinary retention,

If you experience a fever with generalized redness of the skin and a pustular rash, you should stop taking Cirrus Duo and contact your doctor or seek medical attention immediately. See section 4.
During treatment with Cirrus Duo, you may experience sudden abdominal pain or rectal bleeding due to ischemic colitis (inflammation of the colon). If you experience such gastrointestinal symptoms, you should stop taking Cirrus Duo and seek medical attention immediately. See section 4.
There have been reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) in patients taking pseudoephedrine-containing medicines. PRES and RCVS are rare conditions that can be associated with decreased blood flow to the brain.
If you experience symptoms that may be indicative of PRES or RCVS, you should stop taking Cirrus Duo immediately and seek medical attention (symptoms, see section 4 "Possible side effects").
You should be cautious when taking Cirrus Duo if you have hypertension and are also taking non-steroidal anti-inflammatory drugs (NSAIDs), as both NSAIDs and pseudoephedrine can increase blood pressure.

Before taking Cirrus Duo, you should consult your doctor, even if the above warnings and precautions refer to a past situation.

Cirrus Duo 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 athletes taking pseudoephedrine, it should be noted that its use may result in a positive doping test.

Use of Cirrus Duo in patients with renal impairment

Caution should be exercised when using the medicine in patients with renal failure. In patients with moderate renal impairment, the dose of Cirrus Duo should be reduced to one tablet per day. In patients with end-stage renal failure, Cirrus Duo should not be used. You should consult your doctor before taking the medicine.

Use of Cirrus Duo in patients with hepatic impairment

Caution should be exercised when using the medicine in patients with liver failure. In patients with moderate liver impairment, the dose of Cirrus Duo should be reduced to one tablet per day.

Children and adolescents

The use of Cirrus Duo in children under 12 years of age is contraindicated (see above "When not to take 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 pseudoephedrine.
You should consult your doctor before taking the medicine.

Cirrus Duo and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Some medicines, when taken with Cirrus Duo, may cause side effects.
You should not take Cirrus Duo with the following medicines:

• monoamine oxidase inhibitors (MAOIs) used in depression. When taken with Cirrus Duo, they may cause increased blood pressure and even a hypertensive crisis. This side effect may occur within two weeks after stopping treatment with these medicines, so you should not take Cirrus Duo during treatment with MAOIs and for two weeks after their discontinuation.
• dihydroergotamine (a medicine used for migraine), see above "When not to take Cirrus Duo".

Before taking Cirrus Duo, you should consult your doctor if you 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 Duo may reduce the effectiveness of these medicines.
• digitalis glycosides, such as digoxin or digitoxin, used in the treatment of heart failure,
• medicines that impair central nervous system function, such as sedatives,
• antacids (medicines containing, e.g., aluminum or magnesium hydroxide) and proton pump inhibitors (medicines used for the treatment of ulcers, such as omeprazole). You should note that these medicines may increase the absorption of pseudoephedrine.
• halogenated anesthetics, such as halothane,
• kaolin (a medicine used for diarrhea) reduces the absorption of pseudoephedrine,
• theophylline (a medicine used for asthma),
• ritonavir (a medicine used for HIV infection).

You should be cautious when taking Cirrus Duo if you have hypertension and are also taking non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, paracetamol, ibuprofen, naproxen.
During treatment with Cirrus Duo, you may experience reduced blood flow in the optic nerve. If you experience sudden vision loss, you should stop taking Cirrus Duo and seek medical attention immediately. See section 4.

Use of Cirrus Duo with food and drink

Cirrus Duo can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking 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.
Studies in rats have not shown any effect on fertility. There are no data on the effect of Cirrus Duo on human fertility.

Driving and using machines

In studies, cetirizine at recommended doses did not have a significant effect on driving ability or psychomotor performance. Some patients experienced drowsiness. Cetirizine at higher-than-recommended doses may affect the central nervous system. Concomitant use of cetirizine with alcohol or other substances that impair central nervous system function may further reduce alertness and concentration. However, no negative effect of pseudoephedrine is expected.
Therefore, patients who drive vehicles, perform potentially hazardous activities, or operate machinery should be cautious, not exceed the recommended dose, and take into account their individual response to the medicine and the possibility of side effects. Patients should not drive if they experience drowsiness or dizziness.

Cirrus Duo contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Cirrus Duo

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
The recommended dose of Cirrus Duo for adults is one tablet twice a day (morning and evening) with food or on an empty stomach.
Cirrus Duo tablets should not be broken, chewed, or crushed. The medicine should be swallowed whole, with a sufficient amount of liquid.
Duration of treatment
If symptoms worsen or do not improve after 5 days, you should contact your doctor. The duration of treatment with Cirrus Duo should not exceed the duration of symptoms and should not be longer than 2 to 3 weeks. Your 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 Duo should be reduced by half (to 1 tablet per day).

Use in children and adolescents

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

Overdose of Cirrus Duo

In case of overdose (taking more than the recommended dose), you should seek medical attention immediately.
Symptoms of acute overdose of Cirrus Duo include: diarrhea, dizziness, fatigue, headache, malaise, mydriasis, urinary retention, tachycardia, arrhythmias, increased blood pressure, sedation, apnea, loss of consciousness, cyanosis, and cardiogenic shock. These symptoms can be life-threatening. Significant overdose of Cirrus Duo may cause toxic psychosis with hallucinations and delirium. 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. You should note that hemodialysis removes cetirizine and pseudoephedrine from the body only to a small extent.

Missed dose of Cirrus Duo

You should not take a double dose to make up for a missed dose.
After stopping treatment, you may experience itching (rarely).
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

• severe headache with sudden onset,
• nausea,
• vomiting,
• confusion,
• seizures,
• changes in vision.

Side effects that may occur: frequently (may affect up to 1 in 10 people):

• nervousness
• insomnia
• dizziness, headache
• drowsiness
• palpitations
• dry mouth
• nausea
• feeling weak

infrequently (may affect up to 1 in 100 people):

• anxiety
• agitation

rarely (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 transaminases, alkaline phosphatase, gamma-glutamyltransferase, increased bilirubin levels)
• dry skin, rash, increased sweating, urticaria
• painful or difficult urination

very rarely (may affect less than 1 in 1,000 people):

• psychotic disorders
• taste disorders
• cerebrovascular incidents (stroke)
• ischemic colitis (inflammation of the colon due to insufficient blood flow)
• drug 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 you experience any of these symptoms, you should inform your doctor immediately or go to the nearest hospital

frequency not known (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 (abnormal sensations in the skin), inability to sit still, calm down, or rest (psychomotor agitation), abnormal, prolonged muscle contractions (dystonia), involuntary movements (dyskinesia), amnesia, memory problems, fainting
• accommodation disorders (eye disorders), blurred vision, abnormal pupil dilation, eye pain, visual impairment, involuntary eye movements, abnormal light tolerance
• breathing difficulties (dyspnea)
• 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 you experience such symptoms, you should stop taking Cirrus Duo and seek medical attention immediately,
• itching
• palpitations, myocardial infarction, low blood pressure (hypotension)
• diarrhea, abdominal discomfort
• reduced blood flow in the optic nerve (ischemic optic neuropathy)
• urinary retention, incontinence
• joint pain, muscle pain
• edema, malaise

During treatment with cetirizine alone, there have been reports of rare cases of hepatitis.
In some patients, other side effects may occur during treatment with Cirrus Duo.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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. 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 Cirrus Duo

The medicine should be stored 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 month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should 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 Cirrus Duo contains

• The active substances of Cirrus Duo 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.
• The 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 white coating contains: hypromellose, titanium dioxide (E171), and macrogol 400.

What Cirrus Duo looks like and contents of the pack

Cirrus Duo is a white or almost white, round, biconvex tablet.
The pack contains 6 tablets.
PVC-Aclar/Rx160/Al blister pack in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

VEDIM Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Tel. + 48 22 696 99 20

Manufacturer:

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

Importer:

PHOENIX Pharma Polska Sp. z o.o.
ul. Rajdowa 9, Konotopa
05-850 Ożarów Mazowiecki
Date of last revision of the leaflet: March 2024