REACTINE*6CPR 5MG+120MG RP

REACTINE 5 mg + 120 mg prolonged-release tablets
Cetirizine dihydrochloride; Pseudoephedrine hydrochloride

What it is and what it is used for
REACTINE prolonged-release tablets contain two active ingredients: cetirizine dihydrochloride, which is an antihistamine (blocks histamine, a substance released in the body during an allergic reaction or inflammation), and pseudoephedrine hydrochloride (a vasoconstrictor that decongests the nasal mucosa).

REACTINE is a medicine used for the short-term treatment of symptoms caused by seasonal and/or perennial allergic inflammation of the nasal mucous membranes, such as nasal congestion and hypersecretion, nasal and/or eye itching, sneezing, and watery eyes.

This medicine is indicated for adults and children over 12 years of age.

What you need to know before taking the medicine
Do not use REACTINE:
• if you are allergic to the active ingredients or any of the other components of this medicine (listed in section 6);
• if you are allergic to other antihistamines, such as hydroxyzine, and piperazine derivatives like levocetirizine, oxatomide;
• if you have very high blood pressure (severe hypertension) or hypertension not controlled by medicines;
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if you have severe heart vessel problems (severe coronary disorders);
• if you have severe heart rhythm disturbances (severe arrhythmia);
• if you suffer from increased eye pressure;
• if you have problems that cause difficulty urinating (urinary retention);
• if you have a rare, untreated tumor of the adrenal gland (phaeochromocytoma);
• if you have previously had bleeding or a blood clot in the brain (stroke);
• if you are at high risk of developing a cerebral hemorrhage (hemorrhagic stroke);
• if your thyroid is overactive and the problem is not under control (uncontrolled hyperthyroidism);
• if you are taking or have taken within the last 2 weeks medicines for depression known as monoamine oxidase inhibitors (MAOIs) (see Other medicines and REACTINE);
• if you are taking dihydroergotamine;
• if you are pregnant or breastfeeding;
• in children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking REACTINE if:

• you have thyroid problems;
• you have problems that may cause difficulty urinating, for example, an enlarged prostate or spinal cord injuries;
• you have kidney or liver problems;
• you suffer from heart problems, such as rhythm disturbances (arrhythmia) or increased heart rate (tachycardia);
• you suffer from high blood pressure;
• you suffer from epilepsy or are at risk of seizures;
• you have diabetes;
• you have previously suffered from bronchospasm (symptoms include: difficulty breathing, coughing, wheezing during breathing, and shortness of breath);
• you suffer from blood clotting problems (hypercoagulation);
• you are elderly, as you have a higher probability of developing adverse events with this medicine.

This medicine should be used under medical supervision if you suffer from cardiovascular problems such as myocardial infarction, coronary artery disease (hardening of the arteries due to cholesterol and other fats accumulating on the walls of a coronary artery), high blood pressure, heart rhythm disturbances (tachycardia and arrhythmia).
Caution is required when using Reactine if you are being treated with medicines that could predispose to hemorrhagic stroke, such as other nasal decongestants, vasoconstrictors, and other medicines that could modify the effect of Reactine (see other medicines and Reactine);
Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) have been reported very rarely with products containing pseudoephedrine. This acute pustular rash can occur within the first 2 days of treatment, with fever and numerous small pustules, mostly non-follicular, arising from a very diffuse edematous erythema and mainly localized on skin folds, trunk and upper limbs.

With REACTINE, sudden abdominal pain or rectal bleeding may occur due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms or other signs and symptoms such as the formation of numerous small pustules with or without fever or erythema occur, immediately stop treatment with Reactine and contact your doctor or seek medical advice. See section 4.

With REACTINE, a reduction in blood flow to the optic nerve may occur. If sudden vision loss occurs, stop taking REACTINE and immediately contact your doctor or a healthcare facility. See section 4.

Cases of reversible posterior 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 supply to the brain. Immediately stop using REACTINE 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 need to undergo surgery, inform the anesthetist that you are taking Reactine.

Pay attention
• If you need to undergo skin tests to check for allergies, contact your doctor as it is necessary to stop therapy with REACTINE at least 3 days before performing such tests.

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

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking REACTINE and seek urgent medical attention if:
• you notice allergic reactions, which manifest with a more or less sudden appearance of skin lesions, even severe, such as spots, blisters or skin peeling, accompanied by itching and/or swelling (angioedema) of the face, eyes, lips, throat with difficulty breathing, increased heart rate and a sudden drop in blood pressure (anaphylactic shock).
• you develop symptoms that could be signs of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
- severe headache with sudden onset
- nausea
- vomiting
- confusion
- seizures
- changes in vision

Inform your doctor if you notice any of the following during treatment with REACTINE:
Common side effects (may affect up to 1 in 10 people)
• dry mouth, nausea, abdominal pain, inflammation of the throat (pharyngitis);
• weakness, dizziness, headache, drowsiness, nervousness.

Uncommon side effects (may affect up to 1 in 100 people)
• feeling of heart pounding (palpitations);
• diarrhea;
• exhaustion (asthenia), malaise;
• difficult breathing (dyspnoea);
• changes in sensation (paraesthesia);
• anxiety, restlessness, agitation;
• itching, skin rashes.

Rare side effects (may affect up to 1 in 1,000 people)
• heart rhythm disturbances, increased heart rate, high blood pressure, pallor;
• vomiting;
• swelling (oedema);
• altered liver function: increased transaminases, alkaline phosphatase, gamma GT or bilirubin;
• seizures;
• hallucination, loss of contact with reality (psychotic disorder), aggression, confusion, depression, difficulty falling asleep (insomnia);
• dry skin, increased sweating, urticaria, weight gain;
• hypersensitivity reactions (including anaphylactic shock).

Very rare side effects (may affect up to 1 in 10,000 people)
• decreased blood platelets (thrombocytopenia);
• ischemic colitis manifesting with abdominal pain and swelling, nausea, vomiting, diarrhoea with blood and fever, abdominal discomfort;
• altered taste (dysgeusia), fainting (syncope), tremor, involuntary muscle contractions that force some body parts to adopt abnormal and often painful postures or movements (dystonia), movement disorders (dyskinesia), tics;
• difficult urination (dysuria) or during sleep (enuresis);
• skin reactions, such as skin spots that reappear in exactly the same location (fixed drug eruption);
• low blood pressure, circulatory collapse;
• vision problems such as difficulty focusing images (accommodation disorders), blurred vision, uncontrolled circular eye movements (oculogyric crisis), swollen eyes;
• cough;
• feeling of nervousness and malaise;
• visual hallucination;
• severe headache, nausea, visual disturbances (See section 2 Warnings and precautions);
• liver damage (hepatitis);
• severe skin rashes characterized by fever and numerous small superficial pustules, surrounded by large reddened areas swelling (angioedema);
• Stroke;
• a widespread skin rash, which may be accompanied by fever and exhaustion, characterized by numerous small pustules that can affect most of the skin surface (acute generalized exanthematous pustulosis AGEP)

Side effects not known (frequency cannot be estimated from the available data)
• serious conditions affecting the cerebral blood vessels known as reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

Other side effects (frequency cannot be estimated from the available data)
• memory loss (amnesia), memory impairment;
• suicidal behavior;
• difficulty urinating (urinary retention);
• increased appetite;
• dizziness;
• abnormal dilation of the pupils, eye pain, vision impairment, abnormal intolerance to visual perception of light;
• erectile dysfunction;
• myocardial infarction;
• arthralgia (joint pain);
• itching after stopping treatment;
• behavior characterized by enthusiasm and excitement;
• reduced blood flow to the optic nerve (ischemic optic neuropathy).

Reporting of side effects
If you get any side effects, including those 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.