ZIRTEC DECONG ANT 5 MG + 120 MG PROLONGED RELEASE TABLETS 6 TABLETS IN PVC-AL BLISTER

Name
Zirtec Decongestant Antihistamine 5 mg + 120 mg prolonged-release tablets
Cetirizine dihydrochloride + pseudoephedrine hydrochloride


What is it and what is it for?
Zirtec Decongestant Antihistamine prolonged-release tablets contain two active substances: cetirizine dihydrochloride, which is an antihistamine (blocks histamine, a substance released in the body when an allergic reaction or inflammation occurs) and pseudoephedrine hydrochloride (a vasoconstrictor that decongests the nasal mucosa).

Zirtec Decongestant Antihistamine is used to relieve the symptoms of acute inflammation of the nasal mucosa (acute rhinitis) such as stuffy nose, runny nose, itching of the nose and/or eyes and watery eyes.


What you need to know before taking the medicine
Do not take Zirtec Decongestant Antihistamine
• if you are allergic to cetirizine, pseudoephedrine, ephedrine, piperazines or any of the other ingredients of this medicine (listed in section 6);
• if you have very high blood pressure (severe hypertension) or hypertension not controlled by drugs or have serious problems with the coronary arteries that supply blood to the heart (severe coronary artery disease);
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure/severe kidney problems (severe renal failure);
• if the thyroid works too much and the problem is not under control (uncontrolled hyperthyroidism);
• if you have severe heart rhythm disorders (severe arrhythmia);
• if you have a tumor called pheochromocytoma;
• if you suffer from too high pressure inside the eye (high intraocular pressure or glaucoma);
• if you have problems urinating (urinary retention);
• if you have had a problem with the blood vessels in your brain called a stroke;
• if you are at risk of developing a brain haemorrhage (haemorrhagic stroke);
• if you are taking dihydroergotamine;
• if you are being treated with certain antidepressants called monoamine oxidase inhibitors (MAOIs) or have taken them within the last two weeks (see "Other medicines and Zirtec Decongestant Antihistamine");
• if you are pregnant;
• if you are breastfeeding;
• in children under 12 years of age.


Warnings and precautions
Take Zirtec Decongestant Antihistamine only for short-term treatments (see section 3).

Talk to your doctor or pharmacist before taking Zirtec Decongestant Antihistamine if:
• has diabetes;
• your thyroid is overactive (hyperthyroidism);
• has high blood pressure;
• has a heart that beats too fast (tachycardia) or beats irregularly (cardiac arrhythmia);
• suffers from heart problems because the coronary arteries that supply it do not supply sufficient blood (ischemic heart disease);
• has a medical condition in which the activity of the medicine may cause problems, in patients with a predisposition to urinary retention (e.g. spinal cord injury, prostatic hyperplasia, prostatic hypertrophy or bladder outflow obstruction) as Zirtec Decongestant Antihistamine may increase the risk of urinary retention;
• have liver and/or kidneys that do not work well (moderate liver or kidney failure);
• have an enlarged prostate (prostatic hypertrophy) or have problems urinating;
• is at risk of hypercoagulation as in inflammatory bowel disease;
• is over 65 years old.

Caution is required when using Zirtec Decongestant Antihistamine if you are being treated with medicines that may predispose you to the onset of haemorrhagic stroke, such as other nasal decongestant medicines; medicines that reduce the dilation of blood vessels (vasoconstrictors) and other medicines that may modify the effect of Zirtec Decongestant Antihistamine (see "Other medicines and Zirtec Decongestant Antihistamine").

Sudden abdominal pain or rectal bleeding may occur with Zirtec Decongestant Antihistamine due to inflammation of the colon (ischemic colitis). If you experience these gastrointestinal symptoms, stop using Zirtec Decongestant Antihistamine and contact your doctor or seek immediate medical attention. See section 4.

With Zirtec Decongestant Antihistamine, a reduction in blood flow to the optic nerve may occur. If you experience sudden vision loss, stop taking Zirtec Decongestant Antihistamine and contact your doctor or healthcare provider immediately (see section 4).

If fever and the appearance of numerous small blisters occur, stop treatment with Zirtec Decongestant Antihistamine and contact your doctor.

Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following the use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that can lead to reduced blood flow to the brain. Stop using Zirtec Decongestant Antihistamine immediately and seek immediate medical attention if you develop symptoms that could be signs of PRES or RCVS (see section 4 "Possible side effects" for symptoms).

If you are scheduled for an allergy test, tell your doctor because you must stop taking Zirtec Decongestant Antihistamine for a few days before the test. This medicine may alter the results of the allergy test.

Children
Do not give this medicine to children under 12 years of age.


Possible side effects
Like all medicines, Zirtec Decongestant Antihistamine can cause side effects, although not everybody gets them.

Stop taking Zirtec Decongestant Antihistamine immediately and contact your doctor urgently if you develop symptoms that could be signs of posterior reversible encephalopathy syndrome (PRES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:
• severe headache with sudden onset;
• nausea;
• vomit;
• confusion;
• convulsions;
• changes in vision.

You may notice the following side effects:

Common (may affect up to 1 in 10 people):
rapid heartbeat, dry mouth, nausea, weakness (asthenia), dizziness, drowsiness, headache, vertigo, nervousness, insomnia;

Uncommon (may affect up to 1 in 100 people):
agitation, anxiety;

Rare (may affect up to 1 in 1,000 people):
heart rhythm disturbances, hypersensitivity reactions (including anaphylactic shock), convulsions, tremor, hallucinations, paleness, high blood pressure, vomiting, impaired liver function, urinary disorders, dry skin, rash, excessive sweating, hives;

Very rare (may affect up to 1 in 10,000 people): fixed drug eruption, angioneurotic oedema (serious allergic reaction causing swelling of the face or throat), circulatory collapse, inflammation of the colon due to insufficient blood supply (ischemic colitis), cerebrovascular accident (stroke), psychosis, altered taste;

Not known (frequency cannot be estimated from the available data):
Serious conditions affecting the blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), aggression, confusion, depression, tics, behaviour characterised by enthusiasm and excitement (euphoria), suicidal ideation, paraesthesia, restlessness, involuntary muscle contractions that force parts of the body into abnormal and often painful postures or movements (dystonia), abnormal movements (dyskinesia), memory loss (amnesia), memory impairment, syncope, accommodation disorder (eye disorder), blurred vision and difficulty focusing, prolonged abnormal dilation of the pupils, eye pain, impaired vision, abnormal intolerance to the visual perception of light, reduced blood flow to the optic nerve (ischemic optic neuropathy), uncontrolled circular movements of the eyes (oculogyric crisis), palpitations, heart attack (myocardial infarction), low blood pressure blood, difficulty breathing (dyspnoea), diarrhoea, abdominal discomfort, involuntary loss of urine, difficulty urinating (urinary retention), erectile dysfunction, swelling due to fluid accumulation, feeling unwell, severe skin reactions characterised by fever and numerous small superficial pustules surrounded by large red areas, itching*, joint pain (arthralgia), muscle pain (myalgia).

Isolated cases of liver inflammation (hepatitis) have been reported when cetirizine is given alone.

*Itching may occur even after stopping the medicine.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.