Note. This product is not distributed or sold, and information is provided for information purposes only.
For more detailed information, contact your nearest pharmacy, pharmacist or your family doctor.

CIRRUS 5 mg / 120 mg prolonged-release tablets. It is used to suppress allergy symptoms, especially when cetirizine antiallergic properties are combined with pseudoephedrine exposure to reduce the swelling of the mucous membranes inside the nose.

CIRRUS 5 mg / 120 mg prolonged-release tablets

Cetirizine dihydrochloride, Pseudoephedrine Hydrochloride.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

- Keep this leaflet You may need to read it.

- If you have any further questions, ask your doctor or pharmacist.

- This medicine is only for you, so the others can not give. It may harm them (even if their symptoms are the same as yours).

- If you get side effects (even if it is not listed), ask your doctor or pharmacist. See. Chapter 4.

What is in this leaflet?

What is the Cirrus is and what it is used for
Before you use Cirrus
How to use Cirrus
Possible side effects
How to store CIRRUS
Contents of the pack and other information

What is the Cirrus is and what it is used for

Cirrus is a drug used to suppress allergy symptoms, especially when cetirizine antiallergic properties are combined with pseudoephedrine exposure to reduce the swelling of the mucous membranes inside the nose.

Cirrus suppressed seasonal allergic rhinitis (hay fever) or perennial allergic rhinitis (allergy to house dust) symptoms include nasal congestion, sneezing, runny nose, itchy eyes or nose.

Cirrus is intended for adults and adolescents (12 years and older).

Before you use Cirrus

CIRRUS Do not

- If you are allergic to cetirizine, ephedrine or any of the other ingredients of this medicine (listed in section 6), or other piperazine derivatives;

- If you have very high blood pressure;

- If you have coronary artery disease;

- If you have impaired kidney function;

- If your thyroid gland;

- If diagnosed with a tumor called pheochromocytoma;

- If you have severe heart rhythm disorder;

- If you have high eye pressure (inside the eye);

- If the difficulty in urination;

- If you have had a hemorrhagic stroke (brain haemorrhage) or are the risk factors for Cirrus vasoconstrictor effects in combination with other simultaneously administered drugs, such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine or any other medicines that lower mucosal a decongestant (such as phenylpropanolamine, phenylephrine, ephedrine, etc.), regardless of the conditions of use.

- If at the same time taking dihydroergotamine (impaired blood flow) or MAO inhibitors (a type of fruit from depression and parkinsonism) as well as 2 weeks after the last outage.

Warnings and Precautions

Check with your doctor or pharmacist before taking Cirrus.

- If you are over 65 years of age;

- If you have diabetes, hyperthyroidism (thyroid intensification), an increase in blood pressure, coronary heart disease or have a heart disorder (too fast or irregular heartbeat);

- If you have moderate renal or hepatic impairment;

- If your prostate is elevated or abnormal urination;

- If you are constantly taking alcohol or drugs that suppress the central nervous system;

- If you are taking medication that belongs to a group of medicines called Sympathomimetics (drugs that reduce swelling, appetite lowering drugs, stimulants, eg., Amphetamine);

- If you are at risk of increased bleeding, eg., For chronic inflammatory bowel disease;

- If you are taking medicines for depression (tricyclic antidepressants), cardiac glycosides, such as digoxin or digitoxin or antihypertensives;

- If you have high blood pressure and are taking non-steroidal anti-inflammatory drugs, your blood pressure may increase;

- Pseudoephedrine as central nervous system stimulants, the abusive;

- If you take other medicines, read the section "Other medicines and Cirrus.

Other medicines and Cirrus

If you are taking or have recently taken any other medicines, or because you are not sure, talk to your doctor or pharmacist.

- Concomitant use of these drugs: bromocriptine, cabergoline, lisuride, pergolide, dihydroergotamine, ergotamine, methylergometrine and other vasoconstricting medicines used by mouth or through the nose (phenylpropanolamine, ephedrine, phenylephrine, and others).

- Caution should be used in combination with sedatives (tranquillizers), theophylline (asthma medication), ritonavir (to treat HIV), certain antidepressants (MAO inhibitors, even if you do not take the last two weeks), and tricyclic antidepressants, blood pressure medicines (alpha blockers and beta-blockers, methyldopa, guanethidine, and reserpine), medications used to treat impaired circulation (dihydroergotamine), antibiotics containing linezolid, anti-heart (cardiac glycosides).

- Simultaneous administration of linezolid may result in increased blood pressure in patients with normal blood pressure.

- Some antacids and proton pump inhibitors can increase the impact of Cirrus, others may reduce it (kaolin).

- If you have to perform allergy skin test, tell your doctor that you are taking Cirrus. This medicine may distort the results.

Cirrus with food and drink

Cirrus can be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, you think you may be pregnant, or are planning to become pregnant before taking this medicine, talk to your doctor or pharmacist.

This medicine should not be used during pregnancy and lactation.

Driving and using machines

Cirrus usually does not cause drowsiness. However, in rare cases, Cirrus may reduce alertness. If you experience decreased alertness, fatigue and somnolence (sleepiness), drive a car or operate machinery.

Cirrus contains lactose.

This product contains lactose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicine.

How to use Cirrus

Always take this medicine exactly as directed by your doctor. If in doubt, ask your doctor or pharmacist.

Adults and children older than 12 years of age: one tablet twice a day (one tablet in the morning and one tablet in the evening).

Children under 12 years of age

Cirrus can not be younger than 12 years of age due to insufficient data on safety and efficacy.

Impaired renal or hepatic function

In patients with moderate renal or hepatic impairment, the dose should be reduced to 1 tablet per day.

Administration and duration of treatment

The tablets should be swallowed whole, unbroken, rather than chewed or unground, whole with a small amount of liquid.

The reduction of allergy symptoms pollen season treatment should continue for medicines containing only antiallergic material.

If symptoms do not improve within a week, contact your doctor again.

Drug should be used for no longer than 2-3 weeks and lasts longer than the symptoms.

If you take a large dose of Cirrus?

If you have taken a higher dose than needed, immediately contact your doctor, pharmacist or the nearest hospital emergency department.

A considerable overdose may cause the following symptoms: vomiting, dilated pupils (abnormally large), a heart rhythm disorder, high blood pressure, central nervous system depression (consciousness and sedation (sedation), difficulty breathing, loss of consciousness, cyanosis (skin emerald color due to lack of oxygen ), cardiovascular collapse (circulatory failure) or nervous system stimulation (insomnia, hallucinations, tremors, seizures), which can be fatal.

No specific antidote is known. Poisoning should be treated in the hospital.

Also read the section for medical or health care professionals.

If you forget to Cirrus

If you forget to take a tablet, take it as soon as you remember. However, another tablet should be taken 12 hours. interval.

Do not take more than 2 tablets in 24 hours.

If you stop taking Cirrus

Take this medicine only when you have allergy symptoms.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

This medicine, like all others, can cause side effects, although not everybody gets them.

The frequency of side effects listed below is defined as follows: very common (affects more than 1 user in 10); common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1000); rare (affects 1 to 10 users in 10,000); very rare (affects less than 1 user in 10, 000), not known (can not be estimated from the available data).

Common: palpitations, dry mouth, nausea, general weakness (asthenia), dizziness (vertigo), dizziness, sleepiness (somnolence), headache, fatigue, nervousness, insomnia.

Uncommon: agitation, anxiety.

Rare: cardiac arrhythmia, pallor, increased blood pressure, vomiting, liver function disorders (increase of certain enzymes), hypersensitivity (allergy), seizures, tremors, hallucinations, urinary disorder, dry skin, rash, increased sweating, urticaria.

Very rare: circulatory collapse (circulatory disorder), ischemic colitis (inflammation of the colon, which can cause abdominal pain, diarrhea with blood, urge to defecate and possible mucosal injury), taste perversion (dysgeusia), cerebrovascular accident (stroke), psychotic disorders of the mouth, nose and throat, skin color changes in certain areas.

Not known: accommodation disorders (difficulty focusing), blurred vision, pupil dilation, eye pain, visual disturbances, photophobia, dyspnea, erectile dysfunction.

Notification of side effects

If you experience side effects, including not listed, please tell your doctor or pharmacist. The side effects can also report directly by filling out the web site www.vvkt.lt the form by mail to the State Medicines Control Agency under the Lithuanian Ministry of Health, Žirmūnų g. 139A, LT 09120 Vilnius Tel: 8 800 73 568, fax 8 800 20131 or e-mail. Email NepageidaujamaR@vvkt.lt. When reporting side effects you can help us to get more information about the safety of the medicine.

How to store CIRRUS

Keep this medicine out of the sight and reach of children place.

This medicine does not require any special storage conditions.

On the carton and blister after EXP and EXP after the expiry date of this medicine. The expiry refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. How to dispose of unwanted medication, ask your pharmacist. These measures will help to protect the environment.

Contents of the pack and other information

Cirrus composition

- The active substance is cetirizine dihydrochloride and pseudoephedrine hydrochloride. Each prolonged-release tablet contains 5 mg of cetirizine dihydrochloride, and 120 mg of pseudoephedrine hydrochloride.

- The other ingredients are: Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, croscarmellose sodium; coating: Opadry Y-1-7000 consisting of hypromellose (E464), titanium dioxide (E 171), macrogol 400th

Cirrus appearance and contents of the pack

White or off-white, round, biconvex prolonged-release tablet.

Cirrus is available in a box containing 14 prolonged-release tablets, packed in blisters.

Marketing Authorisation Holder and Manufacturer

Holder:

UCB Pharma Oy Finland, Itsehallintokuja 6, FI-02600 Espoo, Finland

Brand:

Aesica Pharmaceuticals Srl

Via Praglia 15

I-10044 Pianezza (TO)

Italy

For any information about this medicine, please contact the Marketing Authorisation Holder.