Cirrus

Patient Information Leaflet

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

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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 (runny nose), and itching (pruritus) of the nose and conjunctivae. This 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 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 hypertension) or uncontrolled hypertension, 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 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 with other medicines",
• in children under 12 years of age.

Warnings and precautions
Before starting to use 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 hypertension (high blood pressure), especially if also taking non-steroidal anti-inflammatory drugs (see below "Cirrus with 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 nasal decongestants, 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 with 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 orally or nasally administered decongestant (e.g. phenylpropanolamine, phenylephrine, ephedrine)), because vasoconstriction and increased blood pressure increase the risk of hemorrhagic stroke,
• the patient has conditions predisposing to hypercoagulability, e.g. in inflammatory bowel diseases,
• the patient has conditions where anticholinergic effects are undesirable, especially in patients with risk factors for urinary retention (e.g. spinal cord injury, benign prostatic hyperplasia, or bladder outlet obstruction), since Cirrus may increase the risk of urinary retention. If the patient develops fever with generalized skin erythema and vesicular rash, discontinue Cirrus and contact a doctor or seek immediate medical help. See section 4.

During use of Cirrus, sudden abdominal pain or rectal bleeding may occur due to
inflammatory disease of the large intestine (ischemic colitis). If such gastrointestinal
symptoms occur, discontinue use of 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 after use of medicines containing pseudoephedrine.
PRES and RCVS are rare conditions that may be associated with reduced blood flow to the brain.
If symptoms that may indicate PRES or RCVS occur, discontinue use of Cirrus immediately and seek immediate medical help (symptoms, see section 4 "Possible side effects").
Exercise caution in patients with hypertension who are also taking non-steroidal anti-inflammatory drugs (NSAIDs), because 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 lead to 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Some medicines, if 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, a significant increase in blood pressure, even hypertensive crisis, may occur. This adverse effect may occur up to 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 for 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 medicines, such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine,
• nasal mucosal vasoconstrictors, 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, and beta-adrenergic blocking agents (e.g. atenolol, bisoprolol). Cirrus may reduce the effectiveness of these medicines.
• medicines known as cardiac glycosides, such as digoxin or digitoxin, used in the treatment of heart failure,
• medicines that depress the central nervous system, e.g. sedatives,
• medicines that neutralize gastric acid (medicines containing, e.g., aluminium or magnesium hydroxide) and proton pump inhibitors (medicines used in peptic ulcer disease, such as omeprazole). Note that these medicines increase the rate of pseudoephedrine absorption.
• halogenated general anesthetics, such as halothane,
• kaolin (a medicine used in diarrhea) reduces the rate of pseudoephedrine absorption,
• 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 use of Cirrus, reduced blood flow in the optic nerve may occur. If sudden vision loss occurs, discontinue use of 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 or between meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a 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 have not shown effects on fertility. There are no data on the effect of Cirrus on fertility in humans.
Driving and operating machinery
In clinical studies, cetirizine at recommended doses did not show significant effects on the ability to drive or psycho-motor performance. However, drowsiness was reported in some study participants. Cetirizine at doses higher than recommended may affect the central nervous system. Concomitant 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 of pseudoephedrine have been reported or are 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 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

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose of Cirrus for adults is one tablet twice daily (in the morning and evening),
taken during 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 ceterizine 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 per day).
Use in children and adolescents
Adolescents aged 12 to below 18 years: one tablet twice daily (in the morning and evening), taken during 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 the effect of Cirrus appears too strong or too weak, consult a doctor.
Taking more Cirrus than recommended
If more than the recommended dose of Cirrus has been taken (overdose), seek immediate medical advice from a doctor or pharmacist.
Symptoms of acute overdose of Cirrus include: diarrhoea, dizziness, fatigue, headache, malaise, pupil dilation, urinary retention, increased heart rate, cardiac arrhythmias, elevated blood pressure, sedation, respiratory depression, loss of consciousness, cyanosis (bluish skin discoloration), circulatory collapse, insomnia, hallucinations, tremor, 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 lead to death.
Treatment of overdose (symptomatic and supportive) should be carried out in a hospital setting. It should be noted that haemodialysis removes ceterizine 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 stopping the medicine, itching may occur (rare).
If you have any further questions about 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.
Treatment with Cirrus must be stopped immediately and medical help must be sought immediately
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 effects occurring:
Common (may occur in 1 to 10 out of 100 patients):

• nervousness
• insomnia
• dizziness, headache
• somnolence
• 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 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, a doctor must be informed immediately or the nearest hospital must be visited without delay.

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

• severe disorders affecting cerebral blood vessels, known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)
• aggression, confusion, depressed 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, treatment with Cirrus must be discontinued and a doctor must be contacted or medical help sought immediately
• 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 urinary bladder (urinary retention), micturition
• joint pain, muscle pain
• swelling, malaise

Cases of hepatitis have been reported during use of cetirizine 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 or pharmacist. Adverse effects can be reported directly to the Department for Monitoring 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 effects helps provide more information on the safety of this medicine.

5. How to store the medicine Cirrus

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

6. Contents of the packaging and other information

What Cirrus contains

• The active substances in this medicinal product are: cetirizine dihydrochloride and pseudoephedrine hydrochloride. Each tablet contains 5 mg of cetirizine dihydrochloride in an immediate-release layer and 120 mg of pseudoephedrine hydrochloride in an extended-release layer.
• Other components:
  The immediate-release layer contains: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.
  The extended-release layer contains: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
  The Opadry Y-1-7000 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 extended-release tablet.
The pack contains 14 extended-release tablets.
PVC/Aluminium blisters in a cardboard carton.
For further information about this medicinal product, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation 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 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 country of export: LT/1/05/0180/001
Parallel Import Authorisation Number: 117/25