Reactine

Package leaflet: Information for the patient

REACTINE 5 mg + 120 mg prolonged-release tablets

Cetirizine dihydrochloride; Pseudoephedrine hydrochloride
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after 7 days of treatment.

Contents of this leaflet:

1. What REACTINE is and what it is used for
2. What you need to know before taking REACTINE
3. How to take REACTINE
4. Possible side effects
5. How to store REACTINE
6. Contents of the pack and other information

1. What REACTINE is and what it is used for

REACTINE prolonged-release tablets contain two active substances: cetirizine
dihydrochloride, which is an antihistamine (blocks histamine, a substance released in the body
during an allergic or inflammatory reaction) and pseudoephedrine hydrochloride (a
vasoconstrictor that decongests the nasal mucosa).
REACTINE is a medicine used for the short-term treatment of symptoms caused by inflammation of the nasal mucosa due to seasonal and/or perennial allergic conditions, such as nasal congestion and hypersecretion, nasal and/or ocular itching, sneezing, and tearing.
This medicine is indicated for adults and children over 12 years of age.

2. What you need to know before taking REACTINE

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, or to piperazine derivatives such as levocetirizine, oxatomide;
• 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 suffer from very high blood pressure (severe hypertension) or have serious heart vessel problems (severe coronary disorders);
• if you have serious heart rhythm disorders (severe arrhythmia);
• if you have serious kidney problems (severe renal insufficiency);
• if you suffer from increased pressure in the eye;
• if you have conditions causing difficulty in urination (urinary retention);
• if you have a rare tumour of the adrenal gland, untreated (pheochromocytoma);
• if you previously had bleeding or blood clot in the brain (stroke);
• if you are at high risk of developing a haemorrhagic stroke (haemorrhagic stroke);
• if your thyroid is overactive and the condition is not controlled (uncontrolled hyperthyroidism);
• 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 conditions that may cause difficulty in urination, for example, enlarged prostate volume or spinal cord lesions;
• 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 previously suffered from bronchospasm (symptoms include: difficulty breathing, cough, wheezing, and shortness of breath);
• you suffer from blood clotting disorders (hypercoagulability);
• you are elderly, as you may have a higher risk of developing adverse reactions to this medicine.

This medicine should be used under medical supervision if you suffer from cardiovascular disorders such as myocardial infarction, coronary artery disease (a "hardening of the arteries" due to accumulation of cholesterol and other fats on the walls of a coronary artery), high blood pressure, or heart rhythm disturbances (tachycardia and arrhythmia).
Caution is required when using REACTINE if you are being treated with medicines that could predispose to haemorrhagic stroke, such as other nasal decongestants, medicines that constrict blood vessels (vasoconstrictors), and other medicines that could alter 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 widespread oedematous erythema, primarily located in skin folds, trunk, and upper limbs.
With REACTINE, sudden abdominal pain or rectal bleeding may occur due to inflammation of the colon (ischaemic colitis). If you experience these gastrointestinal symptoms or other signs and symptoms such as development of numerous small pustules with or without fever or erythema, stop treatment with REACTINE immediately 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 contact your doctor or a healthcare facility immediately. See section 4.
If you are scheduled for surgery, inform the anaesthetist that you are taking REACTINE.

Be careful

• If you need to undergo skin tests to check for allergies, contact your doctor, as treatment with REACTINE must be discontinued at least 3 days before such tests.
  Children Do not give this medicine to children under 12 years of age.

Other medicines and REACTINE
Do not use REACTINE if you are taking:

• medicines for depression known as monoamine oxidase inhibitors (MAOIs) or have taken them within the last 2 weeks, as this may cause an increase in blood pressure, even sudden (see "Do not use REACTINE").

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including:

• antihypertensive medicines used for high blood pressure, such as beta-blockers, methyldopa, guanethidine, reserpine;
• antidepressant medicines called tricyclic antidepressants;
• digitalis, a medicine used for heart conditions;
• other medicines that reduce nasal congestion;
• medicines that cause reduced appetite and weight loss (anorectics and amphetamines);
• antacids, medicines used to reduce stomach acidity;
• kaolin, a substance used as an excipient in many medicines;
• vasoconstrictors such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine;
• non-steroidal anti-inflammatory drugs (NSAIDs).

REACTINE and alcohol
It is preferable not to consume alcohol during treatment with REACTINE, as alcohol could interfere with your treatment and/or increase the risk of adverse effects, such as drowsiness.
Pregnancy and breastfeeding
Do not take REACTINE if you are pregnant or breastfeeding.
Driving and using machines
REACTINE may cause drowsiness. Make sure you do not experience this adverse effect before driving or using machinery.
REACTINE tablets contain lactose: If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per single tablet, i.e. it is essentially 'sodium-free'.
For those engaged in sports: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take REACTINE

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Check the table below to determine the correct dose to take.

• REACTINE is an oral medicine.
• Do not exceed the recommended doses.
• Take this medicine for the shortest possible time, until symptoms improve, and in any case not for longer than 7 days.
• Swallow the tablets with water, without dividing, chewing, or crushing them. You may take REACTINE during or apart from meals.

Children under 12 years of age
REACTINE must not be used in children under 12 years of age.
If you take more REACTINE than you should, you may experience: difficulty falling asleep,
increased heart rate or changes in heart rhythm, increased blood pressure, tremors, seizures,
sedation, shortness of breath, collapse.
If you take a large dose of REACTINE, contact your doctor immediately or go to the nearest hospital.
If you forget to take REACTINE
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking REACTINE and contact your doctor immediately if you notice:
allergic reactions, which may present as 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 breathing difficulties, increased heart rate and sudden drop in blood pressure (anaphylactic shock).
Tell your doctor if you notice any of the following while taking 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)

• sensation of pounding heartbeat (palpitations);
• diarrhoea;
• fatigue (asthenia), malaise;
• difficulty breathing (dyspnoea);
• disturbances in sensation (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, pallor;
• vomiting;
• swelling (oedema);
• liver function abnormalities: increased transaminases, alkaline phosphatase, gamma-GT or bilirubin;
• seizures;
• hallucinations, 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)

• decrease in blood platelets (thrombocytopenia);
• ischaemic colitis, presenting with abdominal pain and swelling, nausea, vomiting, bloody diarrhoea, fever, abdominal discomfort;
• taste disturbances (dysgeusia), fainting (syncope), tremor, involuntary muscle contractions causing abnormal and often painful postures or movements (dystonia), movement disorders (dyskinesia), tics;
• difficulty passing urine (dysuria) or during sleep (nocturnal enuresis);
• skin reactions, such as skin lesions recurring exactly in the same location (fixed drug eruption);
• low blood pressure, circulatory collapse;
• visual disturbances such as difficulty focusing (accommodation disorders), blurred vision, uncontrolled circular eye movements (oculogyric crisis), swollen eyes;
• cough;
• feeling of nervousness and malaise;
• visual hallucinations;
• severe skin eruptions characterized by fever and numerous small superficial pustules, surrounded by large red swollen areas (angioedema);
• stroke;
• widespread skin rash, which may be accompanied by fever and fatigue, characterized by numerous small pustules that may affect much of the skin surface (generalized pustular eruption AGEP).

Other side effects (frequency cannot be estimated from available data)

• memory loss (amnesia), memory impairment;

• behaviour aimed at self-harm (suicidal behaviour);

• difficulty urinating (urinary retention);

• increased appetite;

• dizziness;

• abnormal dilation of pupils, eye pain, visual impairment,
  abnormal intolerance to visual perception of light;

• erectile dysfunction;

• myocardial infarction;

• arthralgia (joint pain);

• itching after stopping treatment;

• behaviour characterized by enthusiasm and excitement;

• reduced blood flow to the optic nerve (ischaemic optic neuropathy).

Reporting of side effects
If you experience any side effect, 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 the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store REACTINE

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What REACTINE contains
The active substances are: cetirizine dihydrochloride; pseudoephedrine hydrochloride.
One tablet contains: 5 mg of cetirizine dihydrochloride and 120 mg of pseudoephedrine hydrochloride.
The other components are: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, lactose, sodium croscarmellose, Opadry Y-1-7000 white (Methocel E5, premium (hypromellose) (E 464), titanium dioxide (E 171), polyethylene glycol 400).

Description of the appearance of REACTINE and package contents
REACTINE is available in packages containing 6 or 14 tablets.

Marketing Authorization Holder
Johnson & Johnson S.p.A., Via Ardeatina km 23,500 - 00071 Santa Palomba - Pomezia ROMA

Manufacturer
Aesica Pharmaceuticals S.r.l. - Pianezza (TO).
Janssen – Cilag - Val De Reuil (France)

Patient Information Leaflet

REACTINE 5 mg + 120 mg prolonged-release tablets

Cetirizine dihydrochloride; Pseudoephedrine hydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What REACTINE is and what it is used for
2. What you need to know before taking REACTINE
3. How to take REACTINE
4. Possible side effects
5. How to store REACTINE
6. Contents of the pack and other information

1. What REACTINE is and what it is used for

REACTINE prolonged-release tablets contain two active substances: cetirizine
dihydrochloride, which is an antihistamine (blocks histamine, a substance released in the body
during an allergic or inflammatory reaction) and pseudoephedrine hydrochloride (a
vasoconstrictor that decongests the nasal mucosa).
REACTINE is a medicine used for the short-term treatment of symptoms due to inflammation of the nasal mucosa of seasonal and/or perennial allergic origin, such as nasal congestion and hypersecretion, nasal and/or ocular itching, sneezing and tearing.
This medicine is indicated for adults and children over 12 years of age.

2. What you should know before taking REACTINE

Do not use REACTINE:

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6);
• if you are allergic to other antihistamines, such as hydroxyzine, or to piperazine derivatives such as levocetirizine, oxatomide;
• 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 suffer from very high blood pressure (severe hypertension) or have serious heart vessel problems (severe coronary disorders);
• if you have serious heart rhythm disorders (severe arrhythmia);
• if you have serious kidney problems (severe renal failure);
• if you suffer from increased pressure in the eye;
• if you have conditions causing difficulty in urination (urinary retention);
• if you have a rare tumour of the adrenal gland, untreated (pheochromocytoma);
• if you previously had bleeding or a blood clot in the brain (stroke);
• if you are at high risk of developing brain haemorrhage (haemorrhagic stroke);
• if your thyroid gland is overactive and the condition is not under control (uncontrolled hyperthyroidism);
• 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 conditions that may cause difficulty in urination, for example, enlarged prostate volume or spinal cord injuries;
• you have kidney or liver problems;
• you suffer from heart problems, such as irregular heartbeat (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 previously suffered from bronchospasm (symptoms include: difficulty breathing, cough, wheezing and shortness of breath);
• you suffer from blood clotting disorders (hypercoagulability);
• you are elderly, as you are more likely to develop adverse reactions to 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 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 haemorrhagic stroke, such as other nasal decongestants, medicines that constrict blood vessels (vasoconstrictors), and other medicines that could alter 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, mainly localized in 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 you experience these gastrointestinal symptoms or other signs and symptoms such as development of numerous small pustules with or without fever or erythema, stop treatment with REACTINE immediately 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 contact your doctor or a healthcare facility immediately. See section 4.
If you are scheduled for surgery, inform your anaesthesiologist that you are taking REACTINE.
Be careful

• If you need to undergo skin tests to check for allergies, contact your doctor, as treatment with REACTINE must be discontinued at least 3 days before such tests.

Children
Do not give this medicine to children under 12 years of age.
Other medicines and REACTINE
Do not use REACTINE if you are taking:

• medicines for depression known as monoamine oxidase inhibitors (MAOIs) or have taken them within the last 2 weeks, as this may cause an increase in blood pressure, even sudden (see “Do not use REACTINE”).

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including:

• antihypertensive medicines used for high blood pressure, such as beta-blockers, methyldopa, guanethidine, reserpine;
• antidepressant medicines called tricyclic antidepressants;
• digitalis, a medicine used in heart diseases;
• other medicines that reduce nasal congestion;
• medicines that cause loss of appetite and weight reduction (anorectics and amphetamines);
• antacids, medicines used to reduce stomach acidity;
• kaolin, a substance used as an excipient in many medicines;
• vasoconstrictors such as bromocriptine, pergolide, lisuride, cabergoline, ergotamine;
• non-steroidal anti-inflammatory drugs (NSAIDs).

REACTINE and alcohol
It is advisable not to consume alcohol during treatment with REACTINE, as alcohol may interfere with your treatment and/or increase the risk of undesirable effects, such as drowsiness.
Pregnancy and breastfeeding
Do not take REACTINE if you are pregnant or breastfeeding.
Driving and using machines
REACTINE may cause drowsiness. Make sure you do not experience this adverse effect before driving or using machinery.
REACTINE tablets contain lactose:

• If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per single tablet, i.e. it is essentially ‘sodium-free’.
For those engaged in sports: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take REACTINE

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Check the table below to determine the correct dose to take.

• REACTINE is an oral medicine.
• Do not exceed the recommended doses.
• Take this medicine for the shortest possible time, until symptoms improve, and in any case not for longer than 7 days.
• Swallow the tablets with some water, without dividing, chewing, or crushing them. You may take REACTINE during or regardless of meals.

Children under 12 years of age
REACTINE must not be used in children under 12 years of age.
If you take more REACTINE than you should, you may notice: difficulty falling asleep,
increased heart rate or changes in heart rhythm, increased blood pressure, tremors,
seizures, sedation, shortness of breath, collapse.
If you take a high dose of REACTINE, inform your doctor immediately or go to the
nearest hospital.
If you forget to take REACTINE
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking REACTINE and contact your doctor immediately if you notice:

• allergic reactions, which may manifest as more or less sudden appearance of skin lesions, even severe, such as spots, blisters or peeling of the skin, accompanied by itching and/or swelling (angioedema) of the face, eyes, lips, throat with breathing difficulties, increased heart rate and sudden drop in blood pressure (anaphylactic shock).

Tell your doctor if during treatment with REACTINE 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)

• sensation of heart pounding (palpitations);
• diarrhoea;
• fatigue (asthenia), malaise;
• difficulty breathing (dyspnoea);
• disturbances in sensation (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, pallor;
• vomiting;
• swelling (oedema);
• liver function abnormalities: increased transaminases, alkaline phosphatase, gamma GT or bilirubin;
• seizures;
• hallucinations, loss of contact with reality (psychotic disorder), aggression, confusion, depression, difficulty falling asleep (insomnia);
• dryness of the skin, increased sweating, urticaria, 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);
• ischaemic colitis, presenting with abdominal pain and swelling, nausea, vomiting, diarrhoea with blood and fever, abdominal discomfort;
• taste disturbances (dysgeusia), fainting (syncope), tremor, involuntary muscle contractions causing parts of the body to assume abnormal and often painful postures or movements (dystonia), movement disorders (dyskinesia), tics;
• difficulty passing urine (dysuria) or during sleep (nocturnal enuresis);
• skin reactions, such as skin lesions recurring exactly in the same location (fixed drug eruption);
• low blood pressure, circulatory collapse;
• visual disturbances 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 skin eruptions characterised by fever and numerous small superficial pustules, surrounded by large swollen red areas (angioedema);
• stroke;
• widespread skin eruption, which may be accompanied by fever and fatigue, characterised by numerous small pustules that may affect much of the skin surface (generalised pustular eruption AGEP).

Other side effects (frequency cannot be estimated from available data)

• memory loss (amnesia), memory impairment;
• behaviour aimed at causing one's own death (suicidal behaviour);
• difficulty urinating (urinary retention);
• increased appetite;
• dizziness;
• abnormal dilation of pupils, eye pain, vision impairment, abnormal intolerance to visual light perception;
• erectile dysfunction;
• myocardial infarction;
• arthralgia (joint pain);
• itching after discontinuation of treatment;
• behaviour characterised by enthusiasm and excitement;
• reduced blood flow to the optic nerve (ischaemic optic neuropathy).

Reporting of side effects
If you experience any side effect, 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 the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store REACTINE

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What REACTINE contains
The active substances are: cetirizine dihydrochloride; pseudoephedrine hydrochloride.
One tablet contains: 5 mg of cetirizine dihydrochloride and 120 mg of pseudoephedrine hydrochloride.
The other components are: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, lactose, sodium croscarmellose, Opadry Y-1-7000 white (methocel E5, premium (hypromellose) (E 464), titanium dioxide (E 171), polyethylene glycol 400).
Description of the appearance of REACTINE and contents of the pack
REACTINE is available in packs of 6 and 14 tablets.
Marketing Authorization Holder
Johnson & Johnson S.p.A., Via Ardeatina km 23,500 - 00071 Santa Palomba - Pomezia ROMA
Manufacturer
Aesica Pharmaceuticals S.r.l. - Pianezza (TO).
Janssen – Cilag - Val De Reuil (France)