Active ingredients: Pseudoephedrine (pseudoephedrine hydrochloride), Cetirizine (cetirizine dihydrochloride)
REACTINE 5 mg + 120 mg prolonged-release tablets
Why is Reactine used? What is it for?
WHAT IS IT
REACTINE 5 mg + 120 mg prolonged-release tablets Rapidly reduces congestion, discharge, nasal itching, sneezing and tearing. It is composed of Cetirizine dihydrochloride, an effective antihistamine active in the treatment of many allergic manifestations and of Pseudoephedrine hydrochloride which is a decongestant of the upper respiratory tract.
WHY IT IS USED
Reactine is used in the short-term symptomatic treatment of seasonal and / or perennial allergic rhinitis with nasal congestion and hypersecretion, nasal and / or ocular itching, sneezing and tearing.
Contraindications When Reactine should not be used
Reactine is contraindicated in case of hypersensitivity to the active substance, to any of the excipients, to hydroxyzine or to piperazine derivatives.
It must also not be used in patients with severe hypertension, severe coronary artery disease, and in those patients who are being treated or have been treated within the previous two weeks with monoamine oxidase inhibitors (antidepressant drugs), in patients with glaucoma (increased intraocular pressure ) and with urinary retention.
In patients with severe renal insufficiency with creatinine clearance less than 10 ml / min.
It is advisable to consult your doctor even in cases where these disorders have occurred in the past.
In children under the age of 12.
During pregnancy and breastfeeding (see What to do during pregnancy and breastfeeding).
Precautions for use What you need to know before taking Reactine
Reactine should be used with caution in diabetics and in subjects with hyperthyroidism, hypertension, tachycardia, arrhythmia, prostatic hypertrophy, hepatic or renal insufficiency.
Consult your doctor to determine the dose in the elderly due to their greater sensitivity to antihistamines and pseudoephedrine.
Caution should also be exercised in subjects being treated with sympathomimetics (decongestants, anorectics, psychostimulants such as amphetamines), tricyclic antidepressants and digitalis.
Medicinal product containing lactose therefore not suitable in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. At therapeutic doses of cetirizine, no clinically significant interactions with alcohol have been demonstrated (for a level of blood alcohol of 0.5 g / l) However, caution is advised if you drink alcohol at the same time.
Use caution in patients with predisposing factors for urinary retention (e.g. spinal cord injury, prostatic hyperplasia), as cetirizine may increase the risk of urinary retention.
Caution is advised in epileptic patients and in patients at risk of seizures. Allergy skin tests are inhibited by antihistamines therefore a wash-out period (3 days) is required before performing them.
Interactions Which drugs or foods can modify the effect of Reactine
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Due to the pharmacokinetic, pharmacodynamic and tolerability profile of cetirizine, no interactions are expected with this antihistamine. In fact, neither pharmacodynamic nor significant pharmacokinetic interactions have been reported in drug-drug interaction studies carried out, in particular, with pseudoephedrine or theophylline (400 mg / day).
Do not use Reactine if you are on therapy with monoamine oxidase inhibitors (antidepressants), β-blockers, digitalis and with antihypertensives such as methyldopa, guanethidine and reserpine.
The extent of absorption of cetirizine is not reduced by food, although the rate of absorption is decreased.
Antacids increase the absorption of pseudoephedrine while it is reduced by the simultaneous intake of kaolin.
Warnings It is important to know that:
When it can be used only after consulting your doctor
It is advisable to consult the doctor even in cases in which these disorders have occurred in the past For those who carry out sports activities: the use of the drug without therapeutic need constitutes doping and can in any case determine positive anti-doping tests.
See Precautions for use.
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Reactine should not be used during pregnancy. Both cetirizine and pseudoephedrine are excreted with breast milk so Reactine should not be taken during breastfeeding.
Its use should also be avoided if you suspect a pregnancy or wish to plan a maternity leave.
Effects on ability to drive and use machines
Cetirizine at the recommended doses does not affect cognitive and motor functions; no effect on these abilities has been demonstrated with pseudoephedrine. However, it is recommended not to exceed the recommended doses when driving or operating potentially dangerous machines.Objective measurements of ability to drive, sleep latency and assembly line performance have not shown any clinically relevant effects of cetirizine at a dose of 10 mg.
Patients intending to drive, engage in potentially hazardous activities or operate machinery should not exceed the 10 mg dose of cetirizine and consider their response to the medicine.
In sensitive patients, concomitant use with alcohol or other CNS depressants could cause further reductions in alertness and impaired performance.
Important information about some of the ingredients
In case of ascertained intolerance to sugars, contact your doctor before taking the medicine.
Dose, Method and Time of Administration How to use Reactine: Posology
How many
Adults and children from 12 years: one tablet 2 times a day, in the morning and in the evening, to be taken without chewing, during or between meals.
The dose should be halved (1 tablet per day) in patients with renal and / or hepatic insufficiency.
In the case of diabetic patients and in subjects with hyperthyroidism, hypertension, tachycardia, arrhythmia, hepatic insufficiency, as well as in elderly subjects, it is necessary to consult a doctor.
Warning: do not exceed the indicated doses without medical advice.
When and for how long
Do not use for periods longer than the duration of acute symptoms and in any case not to exceed 2-3 weeks.
Once an improvement in nasal disorders has been achieved, treatment can be continued, if required, with cetirizine alone.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Like
Take the tablets without chewing them, during or between meals.
Overdose What to do if you have taken too much Reactine
In case of overdose, the following can be observed: tachycardia, arrhythmias, hypertension, depressive or stimulating effects on the central nervous system (sedation, difficulty breathing, collapse, insomnia, hallucinations, tremors, convulsions). Treatment, which should preferably take place in a hospital setting, should be symptomatic. A gastric lavage is recommended. There are no known antidotes.
In case of accidental ingestion / intake of an excessive dose of Reactine, notify your doctor immediately or go to the nearest hospital. If you have any questions about the use of Reactine, contact your doctor or pharmacist.
Side Effects What are the side effects of Reactine
Like all medicines, Reactine can cause side effects, although not everybody gets them.
Undesirable effects observed and reported during treatment with Reactine are reported according to the MedDRA system organ class.
Frequencies are defined as follows:
Very common (≥ 1/10)
Common (≥ 1/100,
Uncommon (≥ 1 / 1,000 to
Rare (≥ 1 / 10,000,
Very rare (
Not known (frequency cannot be estimated from the available data)
Disorders of the blood and lymphatic system:
Very rare: thrombocytopenia
Cardiac disorders:
Uncommon: palpitations
Rare: arrhythmia, tachycardia
Gastrointestinal disorders:
Common: dry mouth, nausea
Uncommon: diarrhea, abdominal pain
Rare: vomiting
Very rare: ischemic colitis
General disorders and administration site conditions:
Common: weakness, fatigue
Uncommon: asthenia, malaise
Rare: edema
Respiratory disorders:
Common: pharyngitis, rhinitis (in children)
Uncommon: breathing difficulties
Hepatobiliary disorders:
Rare: abnormal liver function (increased transaminases, alkaline phosphatase, γ-GT, bilirubin)
Immune system disorders:
Rare: hypersensitivity
Very rare: anaphylactic shock
Nervous system disorders:
Common: vertigo, dizziness, headache, somnolence
Uncommon: paraesthesia
Rare: convulsions
Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia
Not known: amnesia, memory impairment
Psychiatric disorders:
Common: nervousness
Uncommon: anxiety, restlessness, agitation
Rare: hallucination, psychotic manifestations, aggression, confusion, depression, insomnia
Very rare: tics
Not known: suicidal behavior
Renal and urinary disorders:
Very rare: dysuria, enuresis
Not known: urinary retention
Skin and subcutaneous tissue disorders:
Uncommon: pruritus, skin rash
Rare: dry skin, increased sweating, hives
Very rare: FDE (Fixed Drug Eruption), angioneurotic edema, skin reactions
Vascular disorders:
Rare: pallor, hypertension
Very rare: circulatory collapse, hypotension.
Metabolism and nutrition disorders:
Not known: increased appetite
Eye disorders:
Very rare: accommodation disturbances, blurred vision, oculogyration
Ear and labyrinth disorders:
Not known: dizziness
Diagnostic tests:
Rare: weight gain
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on safety of this medicine.
Expiry and Retention
EXPIRY: see the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
This medicine does not require any special storage conditions
Keep this medicine out of the reach and sight of children.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
COMPOSITION
1 tablet contains:
First layer:
Active ingredient: Pseudoephedrine hydrochloride 120 mg (equal to Pseudoephedrine 98.316 mg). Excipients: Hypromellose, Microcrystalline cellulose, Silica, colloidal anhydrous, Magnesium stearate.
Second layer:
Active ingredient: Cetirizine dihydrochloride 5 mg (equal to Cetirizine 4.21 mg).
Excipients: Lactose, microcrystalline cellulose, crosscaramel sodium, colloidal anhydrous silica, magnesium stearate.
Excipients of the coating:
Opadry Y- 1- 7000 white (Methocel E5 Premium (Hypromellose) (E 464) Titanium dioxide (E 171) Macrogol 400).
HOW IT LOOKS
Reactine comes in the form of prolonged-release tablets, white in color and circular biconvex, for oral use.
The contents of the box are 14 tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
REACTINE 5 MG + 120 MG PROLONGED RELEASE TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
• cetirizine dihydrochloride 5 mg.
• pseudoephedrine hydrochloride 120 mg.
For excipients, see 6.1.
03.0 PHARMACEUTICAL FORM
Prolonged-release, white, circular biconvex tablets for oral use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Reactine is indicated for the short-term symptomatic treatment of seasonal and / or perennial allergic rhinitis with nasal congestion and hypersecretion, nasal and / or ocular itching, sneezing and tearing.
04.2 Posology and method of administration
Adults and children from 12 years: one tablet twice a day, in the morning and in the evening, to be taken without chewing, during or between meals.
The duration of treatment should not exceed periods exceeding the duration of the acute symptoms and in any case should not be continued beyond 2-3 weeks. Once an improvement in nasal disorders has been achieved, treatment can be continued, if required, with cetirizine alone. The dose should be halved in patients with renal insufficiency or hepatic insufficiency.
04.3 Contraindications
Reactine is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients or to other closely related substances from a chemical point of view.
It is also contraindicated in patients with severe hypertension, severe coronary artery disease, and in those patients who are being treated or have been treated within the previous two weeks with monoamine oxidase inhibitors, in patients with increased intraocular pressure and urinary retention. In children under the age of 12. Pregnancy and lactation (see 4.6).
04.4 Special warnings and appropriate precautions for use
Reactine should be used with caution in diabetics and in subjects with hyperthyroidism, hypertension, tachycardia, arrhythmia, prostatic hypertrophy, hepatic or renal insufficiency, as well as in elderly subjects.
Caution also in subjects being treated with sympathomimetics (decongestants, anorectics, psychostimulants such as amphetamines), tricyclic antidepressants and digitalis.
Cases of abuse have been observed with pseudoephedrine as well as with other central stimulants.
Medicinal product containing lactose therefore not suitable for subjects with lactase deficiency, galactosemia or glucose / galactose malabsorption syndrome.
04.5 Interactions with other medicinal products and other forms of interaction
No interactions have been documented for cetirizine.
The activity of sympathomimetic amines such as pseudoephedrine contained in this drug is increased by the simultaneous administration of monoamine oxidase inhibitors and β-blockers. Due to the long duration of action of monoamine oxidase inhibitors, the activity of sympathomimetic amines can be observed even after 15 days from the suspension of administration.
Sympathomimetic amines reduce the antihypertensive effects of methyldopa, guanethidine and reserpine.
The administration of pseudoephedrine to digitized patients increases the ectopic activity of the myocardium.
Antacids increase the absorption of pseudoephedrine while it is reduced by the simultaneous intake of kaolin.
Since allergy tests are inhibited by antihistamines it is necessary to allow an adequate wash-out period after administration before practicing them.
04.6 Pregnancy and lactation
Reactine is contraindicated in pregnancy. Both cetirizine and pseudoephedrine are excreted with breast milk so Reactine should not be taken during breastfeeding.
04.7 Effects on ability to drive and use machines
Cetirizine at the recommended doses does not affect cognitive and motor functions; no effect on these abilities has been demonstrated with pseudoephedrine. However, it is advisable not to exceed the recommended doses when driving or using potentially dangerous machines.
04.8 Undesirable effects
Undesirable effects observed and reported during treatment with Reactine are reported by system organ class with the frequencies indicated:
• very common: (≥ 1/10)
• common: (≥ 1/100 a
• uncommon: (≥ 1/1000 a
• rare: (≥ 1 / 10,000 y
• very rare: (
Cardiac pathologies
Common: tachycardia.
Uncommon: palpitations.
Rare: arrhythmia.
Gastrointestinal disorders
Common: dry mouth, nausea.
Rare: vomiting.
Very rare: ischemic colitis.
General disorders and administration site conditions
Common: asthenia, weakness.
Respiratory pathologies
Uncommon: breathing difficulties.
Hepatobiliary disorders
Rare: liver function disorders (increased transaminases, alkaline phosphatase, gamma-GT, bilirubin).
Disorders of the immune system
Rare: hypersensitivity.
Nervous system disorders
Common: vertigo, dizziness, headache, somnolence.
Rare: convulsions, tremors.
Very rare: dysgeusia.
Psychiatric disorders
Common: nervousness, insomnia.
Uncommon: anxiety, restlessness.
Rare: hallucinations, psychotic manifestations.
Renal and urinary disorders
Rare: dysuria.
Skin and subcutaneous tissue disorders
Rare: dry skin, rash, increased sweating, hives.
Very rare: FDE Fixed Drug Eruption, angioneurotic edema, skin reactions.
Vascular pathologies
Rare: pallor, hypertension.
Very rare: circulatory collapse, hypotension.
Report any undesirable effect not described in the package leaflet to your doctor or pharmacist.
04.9 Overdose
In case of overdose, the following can be observed: tachycardia, arrhythmias, hypertension, depressive or stimulating effects on the S.N.C. (sedation, apnea, collapse, insomnia, hallucinations, tremors, convulsions). These effects can be fatal. Treatment, which should preferably take place in a hospital setting, should be symptomatic. A gastric lavage is recommended. There are no known antidotes. It is important to avoid the use of sympathomimetics. Hypertension can be controlled with α-blockers, possible tachycardia with β-blockers, convulsions with diazepam iv.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: nasal decongestants for its systemic - sympathomimetics in combination. Pharmacotherapeutic group: ATC: R01BA52.
Reactine works quickly resulting in a rapid improvement in symptoms.
The pharmacodynamic effects of Reactine are due to the sum of the effects of its components: cetirizine, a powerful antihistamine with antiallergic properties, inhibits the early histamine-related phase of the allergic reaction, the migration of certain types of inflammatory cells and the release of mediators associated with the delayed allergic response. At the nasal provocation test it is able to inhibit the reactions induced by histamine and pollen.
Pseudoephedrine is a sympathomimetic active per os with predominantly α-mimetic activity and less pronounced β activity which is expressed with a vasoconstriction which has decongestant effects on the nasal mucosa.
05.2 Pharmacokinetic properties
Cetirizine is rapidly absorbed following oral administration. In fasting mode, the maximum peak is observed 1 hour after administration, in a full stomach after 3 hours. Cetirizine is not metabolised and is mainly excreted via the urine. The half-life of cetirizine is approximately 9 hours and increases in subjects with renal insufficiency. Cetirizine is bound to plasma proteins by 93%.
Pseudoephedrine, thanks to its slow release formulation, gives a maximum peak after 8 hours from the intake not modified by the simultaneous intake of food. The steady-state is obtained in 6 days after the administration of a dose every 12 hours. half-life is 15 hours, elimination is predominantly urinary and in unchanged form. The excretion increases when the urinary pH decreases. Conversely, the alkalinization of the urine reduces its elimination.
The therapeutic effects of Recatine on symptoms generally begin to manifest in about 30 minutes, peaking within 1 hour.
05.3 Preclinical safety data
Administration of a single oral dose of cetirizine + pseudoephedrine (1:24) of 75-640 mg / kg depending on the animal species used (monkey, rat) proved to be the maximum tolerated dose. The same applies to chronic (6 months) administration of 30-60 mg / kg / day (rat) and 40 mg / kg / day (monkey), respectively 8 and 11 times the recommended dose in humans.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Excipients of the first layer:
Hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
Excipients of the second layer:
Lactose, microcrystalline cellulose, crosscaramel sodium, colloidal anhydrous silica, magnesium stearate.
Excipients of the coating:
Opadry® Y-1-7000 white (Methocel® E5 Premium (Hypromellose) (E 464), Titanium Dioxide (E 171) Macrogol 400).
06.2 Incompatibility
They are not known.
06.3 Period of validity
3 years in intact packaging.
WARNING: do not use the medicine after the expiry date indicated on the package.
06.4 Special precautions for storage
No special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
Blister of 14 tablets.
06.6 Instructions for use and handling
No special instructions
The unused product and the waste derived from this medicine must be disposed of in accordance with the legal requirements.
07.0 MARKETING AUTHORIZATION HOLDER
Johnson & Johnson SpA Via Ardeatina km 23,500 - 00040 Santa Palomba - Pomezia ROME
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 032800031
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
April 22, 1999
10.0 DATE OF REVISION OF THE TEXT
July 2011