REACTINE 5 MG + 120 MG PROLONGED RELEASE TABLETS, 6 TABLETS IN PVC-ACLAR-AL BLISTER

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


What is it and what is it for?
REACTINE prolonged-release tablets contain two active ingredients: 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).

REACTINE is a medicine used to treat, for a short period of time, symptoms due to inflammation of the nasal mucosa of seasonal and/or perennial allergic origin such as nasal congestion and hypersecretion, itching of the nose and/or eyes, 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 substances or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other antihistamines, such as hydroxyzine, and piperazine derivatives such as levocetirizine, oxatomide;
• if you have very high blood pressure (severe hypertension) or hypertension not controlled by drugs;
• if you suffer from severe acute (sudden) or chronic (long-term) kidney disease or kidney failure;
• if you have serious problems with your heart vessels (severe coronary artery disease);
• if you have severe heart rhythm disorders (severe arrhythmia);
• if you suffer from increased pressure in the eye;
• if you have problems that cause difficulty urinating (urinary retention);
• if you have a rare, untreated tumor of the adrenal gland (pheochromocytoma);
• if you have previously had bleeding or a blood clot in the brain (stroke);
• if you are at high risk of developing a brain haemorrhage (haemorrhagic stroke);
• if the thyroid works too much and the problem is not under control (uncontrolled hyperthyroidism);
• if you are taking or have taken in 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:

• has thyroid problems;
• has problems that may cause difficulty urinating, for example an enlarged prostate or spinal cord injury;
• have kidney or liver problems;
• suffer from heart problems, such as heart rhythm disturbances (arrhythmia) or increased heart rate (tachycardia);
• suffers from high blood pressure;
• have epilepsy or are at risk of seizures;
• has diabetes;
• have previously suffered from bronchospasm (symptoms of which include difficulty breathing, coughing, wheezing and shortness of breath);
• suffer from blood clotting problems (hypercoagulation);
• is elderly, as he or she is more likely to develop adverse events from this medicine.

This medicine should be used under medical supervision if you suffer from cardiovascular problems such as myocardial infarction, coronary artery disease (a "hardening of the arteries" due to the accumulation of cholesterol and other fats on the walls of a coronary artery), high blood pressure, alterations in heart rhythm (tachycardia and arrhythmia).
Caution is required when using Reactine 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 narrow blood vessels (vasoconstrictors) and other medicines that may 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 eruption may occur within the first 2 days of treatment, with fever and numerous, small, mostly non-follicular pustules arising from a widespread edematous erythema, located primarily in the skin folds, trunk, and upper limbs.

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

Reduction of blood flow to the optic nerve may occur with REACTINE. If you experience sudden vision loss, stop taking REACTINE and contact your doctor or healthcare provider immediately. See section 4.

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 REACTINE 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 need to undergo surgery, tell your anaesthetist that you are taking Reactine.

Be careful
• If you need to perform skin tests to check if you have allergies, contact your doctor as it is necessary to stop treatment with REACTINE at least 3 days before performing these 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 see a doctor urgently if:
• known allergic reactions, which manifest themselves with the more or less sudden appearance of skin lesions, even serious ones, such as spots, blisters or peeling of the skin, accompanied by itching and/or swelling (angioedema) of the face, eyes, lips, throat with difficulty breathing, increased heart rate and sudden drop in blood pressure (anaphylactic shock).
• develops symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:
- severe headache with sudden onset
- nausea
- vomit
- confusion
- convulsions
- changes in vision

Tell your doctor if you notice:
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 in throat (palpitations);
• diarrhea;
• tiredness (asthenia), malaise;
• difficulty breathing (dyspnea);
• alterations in sensitivity (paraesthesia);
• anxiety, restlessness, agitation;
• itching, skin rashes.

Rare side effects (may affect up to 1 in 1,000 people)
• changes in heart rhythm, increased heart rate, high blood pressure, paleness;
• vomit;
• swelling (edema);
• alteration of liver functions: increase in transaminases, alkaline phosphatase, gamma GT or bilirubin;
• convulsions;
• hallucination, loss of contact with reality (psychotic disorder), aggression, confusion, depression, difficulty falling asleep (insomnia);
• dry skin, increased sweating, hives, weight gain;
• hypersensitivity reactions (including anaphylactic shock).

Very rare side effects (may affect up to 1 in 10,000 people)
• decrease in blood platelets (thrombocytopenia);
• ischemic colitis which manifests itself with abdominal pain and swelling, nausea, vomiting, bloody diarrhea and fever, abdominal discomfort;
• altered sense of taste (dysgeusia), fainting (syncope), tremor, involuntary muscle contractions that force some parts of the body to assume abnormal and often painful postures or movements (dystonia), movement disorders (dyskinesia), tics;
• urination with difficulty (dysuria) or during sleep (enuresis);
• skin reactions, such as spots on the skin that reappear in exactly the same place (fixed drug eruption);
• low blood pressure, circulatory collapse;
• vision disturbances such as problems focusing images (accommodation disorders), blurred vision, uncontrolled circular movements of the eye (oculogyric crisis), swollen eyes;
• cough;
• feeling nervous and unwell;
• 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 areas of redness and swelling (angioedema);
• Stroke;
• a widespread skin rash, which may be accompanied by fever and tiredness, characterised by numerous small pustules that may involve a large part of the skin surface (AGEP generalised exanthemal pustulosis)

Unknown side effects (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)

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

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.