REACTINE CETIRIZINE/PSEUDOEPHEDRINE 5mg/120mg PROLONGED-RELEASE TABLETS

Introduction

Leaflet: Information for the User

Reactine Cetirizine/Pseudoephedrine 5 mg / 120 mg prolonged-release tablets

Cetirizine dihydrochloride / Pseudoephedrine hydrochloride

Read the entire leaflet carefully before starting to take this medication because it contains important information for you.

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet.
• You should consult your doctor if your symptoms worsen or do not improve after 7 days of treatment.

Contents of the Leaflet

1. What Reactine Cetirizine/Pseudoephedrine is and what it is used for.
2. What you need to know before taking Reactine Cetirizine/Pseudoephedrine.
3. How to take Reactine Cetirizine/Pseudoephedrine.
4. Possible side effects.
5. Storage of Reactine Cetirizine/Pseudoephedrine.
6. Package contents and additional information.

1. What Reactine Cetirizine/Pseudoephedrine is and what it is used for

It is a medication that acts as an antiallergic and nasal decongestant.

Reactine Cetirizine/Pseudoephedrine is indicated for the relief of nasal and ocular symptoms of seasonal allergic rhinitis when accompanied by nasal congestion, in adults and adolescents over 12 years of age.

You should consult your doctor if your symptoms worsen or do not improve after 7 days of treatment.

2. What you need to know before taking Reactine Cetirizine/Pseudoephedrine

Do not takeREACTINE Cetirizine/Pseudoephedrine if:

• You are allergic (hypersensitive) to pseudoephedrine, cetirizine, antihistamines, other nasal decongestants, or any of the other components of this medication (listed in section 6).
• You are a child under 12 years of age.
• You have or have had difficulty urinating and/or urinary retention.
• You have prostate hypertrophy.
• You have kidney disease that requires dialysis.
• You suffer from severe hypertension or any heart or blood vessel disease, or have had a cerebral hemorrhage.
• You have very high blood pressure (severe hypertension) or uncontrolled hypertension.
• You have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure.
• You have narrow-angle glaucoma.
• You have hyperthyroidism.
• You are taking or have taken in the last 2 weeks monoamine oxidase inhibitor (MAOI) type antidepressants.
• You are pregnant or breastfeeding.

Warnings and precautions

• You should consult your doctor before taking this medication if you have:
• • Diabetes; patients with diabetes should not take pseudoephedrine unless indicated by a doctor.
  • Acute asthma attacks.
  • High blood pressure (hypertension), heart or blood vessel disease.
  • Thyroid disease.
  • High eye pressure (ocular hypertension).
  • Epilepsy or risk of seizures.
  • Severe liver disease with reduced function.
  • Moderate or severe kidney disease with reduced function.
  • You are over 60 years old.
  • Stomach ulcer or intestinal or bladder obstruction.
  • You have had bronchospasm.
  • Difficulty urinating due to prostate enlargement.

If you are taking other medications that contain nasal decongestants, you should not take this medication.

There have been reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) after the use of medications containing pseudoephedrine. PRES and RCVS are rare diseases that can involve reduced blood flow to the brain. Stop using Reactine immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (see section 4 "Possible side effects").

If small, mostly non-follicular pustules form, which may or may not be accompanied by fever and a disseminated edematous erythema, mainly localized to skin folds, trunk, and upper limbs, especially in the first 2 days of treatment, you may have acute generalized exanthematous pustulosis, which should be medically monitored.

Sudden abdominal pain or rectal bleeding may occur with the use of Reactine due to colon inflammation (ischemic colitis). If these gastrointestinal symptoms appear, stop taking Reactine and contact your doctor or seek immediate medical attention. See section 4.

In controlled-release tablets using OROS technology: Patients with intestinal obstruction or narrowing should consult a doctor before using it. Rarely, tablets of this type can cause intestinal obstruction (blockage), usually in people with severe intestinal narrowing (esophagus, stomach, intestine).

You should interrupt treatment and consult your doctor if, during treatment with this medication, you notice or are diagnosed with high blood pressure (hypertension), rapid or strong heartbeats (tachycardia), palpitations, or alteration of heart rhythm (arrhythmias), nausea, or headache.

With Reactine, blood flow to the optic nerve may be reduced. If you experience sudden vision loss, stop taking Reactine and contact your doctor or seek immediate medical attention. See section 4.

Treatment should be suspended at least 24 hours before surgery.

If you are going to have an allergy test, you should suspend treatment 2 days before the test and inform your doctor.

Pseudoephedrine, the active ingredient in this medication, can be habit-forming if taken in large quantities, so it can be harmful.

You should avoid consuming alcohol during treatment with this medication.

The simultaneous use of cocaine with this medication can increase cardiovascular effects and the risk of side effects.

Small balls may appear in the stool that are remnants of the medication, but this is not harmful and does not affect the efficacy of the medication.

If symptoms persist or worsen, or if new symptoms appear, patients should interrupt treatment and consult their doctor.

Interaction with analytical tests

If you are going to have any analytical tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Warning to athletes

It is not advisable to take Reactine Cetirizine/Pseudoephedrine (since it contains pseudoephedrine and is a prolonged-release tablet) in athletes, especially if there is a possibility of undergoing a banned substance control in the next 6 hours.

Use in children

Do not use this medication in children under 12 years of age.

Taking Reactine Cetirizine/Pseudoephedrine with other medications:

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

In particular, inform them if you are using any of the following medications, as it may be necessary to modify the dose or interrupt treatment of one of them:

• Urinary acidifiers (ammonium chloride).
• Urinary alkalizers (sodium bicarbonate, citrates), as they may cause pseudoephedrine to be eliminated more slowly and increase its effect and toxicity.
• Inhaled anesthetics, as they may increase the risk of heart problems.
• Antidepressants (tricyclic and monoamine oxidase inhibitors) as they may cause an increase in blood pressure or hypertensive crisis: headache, very high fever, and increased blood pressure (see section "Do not take REACTINE Cetirizine/Pseudoephedrine").
• Certain medications to lower blood pressure or promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids like reserpine, methyldopa, guanethidine), as they may cause a decrease or sudden increase in blood pressure.
• Oral anticoagulants like acenocoumarol, as they may decrease the effect of acenocoumarol.
• Dihydroergotamine (ergotamine derivative for headache treatment), as it may cause a severe increase in blood pressure.
• Nervous system stimulants (amphetamines, xanthines), as they may cause nervousness, irritability, insomnia, or possibly convulsions or alteration of heart rhythm (arrhythmias).
• Digitalis glycosides (used for heart conditions), as they may cause alterations in heart rhythm.
• Thyroid hormones (used for thyroid diseases), as they may increase the effects of both hormones and pseudoephedrine.
• Levodopa and selegiline (used for Parkinson's treatment), as they may cause a severe increase in blood pressure, very high fever, and headache.
• Linezolid (used as an antibacterial), as it may cause an increase in blood pressure.
• Nitrates (used for angina pectoris treatment), as they may reduce the effects of nitrates.
• Procarbazine (used to treat cancer), as it may cause a severe increase in blood pressure, very high fever, and headache.
• Ritonavir (antiretroviral), as it increases the amount of cetirizine in the blood and causes its elimination to be slower.
• Medications for asthma treatment that contain theophylline.
• Antacids and kaolin.

Taking Reactine Cetirizine/Pseudoephedrine with food and drinks:

This medication can be taken with or without food.

Alcohol consumption should be avoided during treatment with this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication is contraindicated during pregnancy and breastfeeding.

Driving and using machines

It is not expected that treatment with this medication at the recommended doses will cause a decrease in reaction capacity or drowsiness, dizziness, or vertigo, but if it does, do not drive or operate hazardous machinery.

Reactine Cetirizine/Pseudoephedrine contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

3. How to take Reactine Cetirizine/Pseudoephedrine

Follow the administration instructions of Reactine Cetirizine/Pseudoephedrine contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and adolescents over 12 years of age: 1 tablet 2 times a day, morning and evening. The maximum daily dose is 2 tablets.
• Patient over 60 years: patients over 60 years should not take this medication without consulting their doctor.

• Patient with kidney or liver disease: patients with kidney or liver insufficiency should not take this medication without consulting their doctor.

Method of administration

This medication is taken orally.

The tablet should be taken whole, not divided, chewed, or dissolved. It should be swallowed with some liquid, preferably water. It can be taken with or without food.

If the medication is taken at night, it should be done a few hours before bedtime to minimize the possibility of insomnia.

If symptoms worsen or persist after 7 days of treatment, you should consult a doctor.

Use in children

This medication is contraindicated in children under 12 years of age.

If you take more Reactine Cetirizine/Pseudoephedrine than you should:

If you have taken more Reactine Cetirizine/Pseudoephedrine than you should, consult your doctor or pharmacist immediately.

The symptoms of overdose of Reactine Cetirizine/Pseudoephedrine are: confusion, diarrhea, nausea, vomiting, dizziness, fatigue, headache, discomfort, pupil dilation (mydriasis), skin irritation (pruritus), sedation, drowsiness, stupor, tachycardia, bradycardia, psychosis, rapid breathing, excitement, nervousness, irritability, restlessness, agitation, anxiety, insomnia, tremors, convulsions, muscle damage, palpitations, increased blood pressure, alteration of heart rhythm (arrhythmias), heart attack, intestinal infarction, cerebral hemorrhage, difficulty urinating, sedation, alteration of breathing during sleep, loss of consciousness, cardiovascular collapse, hallucinations, and epileptic seizures. In children, a picture of hyperactivity and lack of sleep may appear.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone: 91.5620420), indicating the medication and the amount ingested.

If you forget to take Reactine Cetirizine/Pseudoephedrine:

If you forget to take Reactine Cetirizine/Pseudoephedrine and your symptoms continue, do not take a double dose to make up for the forgotten dose.

If necessary, take it again as indicated in section 3. How to take Reactine Cetirizine/Pseudoephedrine.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, REACTINE Cetirizine/Pseudoephedrine may cause adverse effects, although not all people suffer from them.

Unknown frequency: cannot be estimated from available data: serious diseases affecting the blood vessels of the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).

Stop using Reactine immediately and seek urgent medical attention if you experience symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden severe headache
• discomfort
• vomiting
• confusion
• seizures
• changes in vision

Rare adverse effects (may affect 1 in 10,000 people): Anaphylactic shock.

Very rare adverse effects (may affect up to 1 in 10,000 people): Allergy, Anxiety, Aggression, Euphoria, Hallucinations, Visual hallucinations, Agitation, Stroke, Dysgeusia (alteration of taste), Dyskinesia (abnormal and involuntary movements), Dystonia (disorders such as rigidity or tremors), Memory impairment, Headache, Paresthesia or numbness of the limbs, Restlessness, Loss of consciousness, Tremor, Eye pain and swelling, Photophobia, Blurred vision, Arrhythmia, Palpitations, Tachycardia, Myocardial infarction, Abdominal discomfort, Diarrhea, Vomiting, Ischemic colitis (inflammation of the colon due to insufficient blood irrigation), Abnormal liver function (increased transaminases, alkaline phosphatase, -γGT and bilirubin), Acute generalized exanthematous pustulosis (severe skin reactions characterized by fever and numerous small superficial pustules, appearing in extensive areas of redness), Fixed drug eruption (skin and/or mucous membrane lesions after drug use), Arthritis, Angioedema (swelling under the skin), Itching, Urticaria, Cough, Difficulty breathing, Urinary retention, Difficulty or pain when urinating, Involuntary urination, Itching after treatment cessation, Erectile dysfunction, Increased blood pressure, Posterior reversible encephalopathy syndrome, Reversible cerebral vasoconstriction syndrome, Hepatitis.

Adverse effects of unknown frequency: visual accommodation disorder, pupil dilation, eye impairment

During the marketing period of cetirizine and pseudoephedrine, the following adverse effects have occurred, whose frequency has been established by estimated frequency of clinical or epidemiological trials:

Unknown frequency: Aggression, Euphoria, Hallucination, Visual hallucinations, Agitation, Stroke, Dysgeusia (alteration of taste), Dyskinesia (abnormal and involuntary movements), Dystonia (disorders such as rigidity or tremors), Memory impairment, Paresthesia and numbness of the limbs, Tremor, Restlessness, Loss of consciousness, Eye pain, Visual accommodation disorder, Pupil dilation, Eye impairment or swelling, Photophobia, Blurred vision, Arrhythmia, Myocardial infarction, Abdominal discomfort, Vomiting, Ischemic colitis, Abnormal liver function, Acute generalized exanthematous pustulosis (severe skin reactions characterized by fever and numerous small superficial pustules, appearing in extensive areas of redness), Angioedema (swelling under the skin), Rash, Itching, Urticaria, Fixed drug eruption (skin and/or mucous membrane lesions after drug use), Arthritis, Urinary retention, Difficulty or pain when urinating, Involuntary urination, Abnormal sensations, Itching after treatment cessation, Erectile dysfunction, Posterior reversible encephalopathy syndrome, Reversible cerebral vasoconstriction syndrome, Hepatitis.

Rare (may affect 1 in 10,000 people): Anaphylactic shock

Uncommon (may affect 1 in 1,000 people): Allergy, Anxiety, Palpitations, Tachycardia, Difficulty breathing, Cough, Diarrhea, Itching, Urticaria, Discomfort, Increased blood pressure

Very common (may affect 1 in 10 people): Headache

In case of seizures or hallucinations, stop taking this medication immediately.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting ofadverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaram.es

5. Storage of Reactine Cetirizine/Pseudoephedrine

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use Reactine Cetirizine/Pseudoephedrine after the expiration date stated on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the Sigre collection point. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Reactine Cetirizine/Pseudoephedrine:

The active ingredients are cetirizine and pseudoephedrine. Each tablet contains 5 mg of cetirizine (as dihydrochloride) and 120 mg of pseudoephedrine (as hydrochloride).

The other components (excipients) are: microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, magnesium stearate, hypromellose (E-464), sodium croscarmellose, titanium dioxide (E-171), and polyethylene glycol 400.

Appearance of the product and package contents:

Reactine Cetirizine/Pseudoephedrine is presented in the form of white, round, and biconvex prolonged-release tablets. Each package contains 14 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-Madrid

Spain

Manufacturer:

AESICA PHARMACEUTICALS, S.R.L.

Via Praglia, 15

I.10044 Pianezza, Italy

JNTL Consumer Health (France) S.A.S.

Domaine de Maigremont

27100 Val de Reuil

France

Date of the last revision of this prospectus: June 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es