Package Insert: Information for the User

Reactine Cetirizina/Pseudoefedrina 5 mg / 120 mg Extended-Release Tablets

Cetirizine dihydrochloride/Pseudoephedrine hydrochloride

Read this package insert carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those given by your doctor or pharmacist

- Keep this package insert, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

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

1. What is Reactine Cetirizina/Pseudoefedrina and what it is used for.

2. What you need to know before starting to take Reactine Cetirizina/Pseudoefedrina.

3. How to take Reactine Cetirizina/Pseudoefedrina.

4. Possible side effects.

5. Storage of Reactine Cetirizina/Pseudoefedrina.

6. Contents of the package and additional information.

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

Reactine Cetirizina/Pseudoefedrinais indicated for the relief of nasal and ocular symptoms of seasonal allergic rhinitis when accompanied by nasal congestion, in adults and adolescents 12 years of age and older.

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

Do not take REACTINE Cetirizina/Pseudoefedrina if

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

Warnings and precautions

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

If you are taking other medicines that contain nasal decongestants, do not take this medicine.

Cases of reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after the use of pseudoephedrine-containing medicines. RPLS and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using Reactine immediately and seek medical attention immediately if you experience symptoms that may be signs of RPLS or RCVS (see section 4 "Possible side effects").

If small pustules, mainly non-follicular, that may or may not be accompanied by fever and a disseminated erythematous edematous rash, mainly located on the skin folds, trunk, and upper limbs, especially in the first 2 days of treatment, form. You may be suffering from acute generalized pustular psoriasis, which should be medically monitored.

Abdominal pain or rectal bleeding may occur with the use of Reactine, due to ischemic colitis. If these gastrointestinal symptoms appear, stop taking Reactine and contact your doctor or seek medical attention immediately. See section 4.

In controlled-release tablets using the OROS technology: Patients with intestinal obstruction or narrowing should consult a doctor before using it. Rarely, these types of tablets 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 medicine, you notice or are diagnosed with high blood pressure, rapid or strong heartbeats (tachycardia), palpitations, or 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 medical attention immediately. See section 4.

You should discontinue treatment at least 24 hours before surgery.

If you are to undergo an allergy test, discontinue treatment 2 days before the test and inform your doctor.

Pseudoephedrine, the active ingredient in this medicine, can cause dependence if taken in large quantities, which can be harmful.

You should avoid consuming alcohol during treatment with this medicine.

The simultaneous use of cocaine with this medicine may increase cardiovascular effects and the risk of adverse effects.

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

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

Interaction with analytical tests

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

Warning to athletes

It is not recommended to take Reactine Cetirizina/Pseudoefedrina (which contains pseudoephedrine and is a prolonged-release tablet) by athletes, especially if there is a possibility that they will be subjected to a doping control in the next 6 hours.

Use in children

Do not use this medicine in children under 12 years old.

Taking Reactine Cetirizina/Pseudoefedrina with other medicines:

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

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

• Urinary acidifiers (ammonium chloride)
• Urinary alkalinizers (sodium bicarbonate, citrates) as they may make pseudoephedrine eliminate more slowly and increase its effect and toxicity
• Inhalation anesthetics as they may increase the risk of heart problems
• Antidepressants (tricyclics and MAOIs) as they may cause an increase in blood pressure or hypertensive crisis: headache, high fever, and increased blood pressure (See "Do not take REACTINE Cetirizina/Pseudoefedrina")
• Medicines to lower blood pressure or to promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids such as reserpine, metildopa, guanetidina) as they may cause a decrease or a sudden increase in blood pressure
• Oral anticoagulants such as acenocoumarol as they may decrease the action of acenocoumarol
• Dihydroergotamine (ergotamine derivative for headache treatment) as it may cause a severe increase in blood pressure
• Stimulants of the nervous system (amphetamine, xanthines) as they may cause nervousness, irritability, insomnia, or possibly seizures or arrhythmias
• Digitalis glycosides (used for the heart) as they may cause arrhythmias
• Thyroid hormones (used for thyroid diseases) as they may increase the effects of both hormones and pseudoephedrine
• Levodopa and selegiline (used for Parkinson's disease) as they may cause a severe increase in blood pressure, high fever, and headache
• Linezolid (used as an antibacterial) as it may cause an increase in blood pressure
• Nitrates (used for angina pectoris) as they may reduce the effects of nitrates
• Procarbazine (used to treat cancer) as it may cause a severe increase in blood pressure, high fever, and headache
• Ritonavir (anti-retroviral) as it increases the amount of cetirizine in the blood and causes its elimination to be slower
• Asthma medications containing theophylline
• Antacids and kaolin.

Taking Reactine Cetirizina/Pseudoefedrina with food and drinks:

This medicine can be taken with or without food.

You should avoid consuming alcoholic beverages during treatment with this medicine.

Pregnancy, breastfeeding, and fertility

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

This medicine is contraindicated during pregnancy and lactation.

Driving and operating machinery

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

Reactine Cetirizina/Pseudoefedrina contains lactose

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

Follow exactly the administration instructions for Reactine Cetirizina/Pseudoefedrina contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

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

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

Administration form

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 taken a few hours before bedtime to minimize the risk of insomnia.

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

Use in children

This medication is contraindicated in children under 12 years.

If you take moreReactine Cetirizina/Pseudoefedrinathan you should

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

The symptoms of an overdose of Reactine Cetirizina/Pseudoefedrina are: confusion, diarrhea, nausea, vomiting, dizziness, fatigue, headache, discomfort, dilated pupil (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, arrhythmias, myocardial infarction, intestinal infarction, cerebral hemorrhage, urinary difficulty, sedation, altered respiration during sleep, unconsciousness, cardiovascular collapse, hallucinations, and epileptic seizures. In children, a hyperactivity and sleeplessness syndrome may appear.

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

If you forget to takeReactine Cetirizina/Pseudoefedrina:

If you forget to take Reactine Cetirizina/Pseudoefedrina and symptoms continue, do not take a double dose to compensate for the missed dose.

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

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

Like all medicines, REACTINE Cetirizina/Pseudoefedrina may cause side effects, although not everyone will experience them.

Unknown frequency: cannot be estimated from available data: severe blood vessel disorders in the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS).

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

• Sudden onset of severe headache

• Malaise

• Vomiting

• Confusion

• Seizures

• Changes in vision

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

Very rare side effects (may affect up to 1 in 10,000 people): Allergy, Anxiety, Aggression, Euphoria, Hallucinations, Visual hallucinations, Agitation, Cerebrovascular accident, Dysgeusia (alteration of the sense of taste), Dyskinesia (abnormal and involuntary movements), Dystonia (trouble with rigidity or tremors), Memory impairment, Headache, Paresthesia or numbness of the extremities, Restlessness, Loss of consciousness, Tremor, Eye pain and swelling, Photophobia, Blurred vision, Arrhythmia, Palpitations, Tachycardia, Myocardial infarction, Abdominal discomfort, Diarrhea, Vomiting, Ischemic colitis, Abnormal liver function (elevated transaminases, alkaline phosphatase, -γGT, and bilirubin), Acute generalized pustular psoriasis (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 use of the drug), Arthritis, Angioedema (swelling under the skin), Itching, Urticaria, Tachycardia, Difficulty breathing, Urinary retention, Difficulty or pain urinating, Involuntary urination, Itching after treatment cessation, Erectile dysfunction, Increased blood pressure, Reversible posterior leukoencephalopathy syndrome, Reversible cerebral vasoconstriction syndrome, Hepatitis.

Unknown frequency:Visual accommodation disorder, Pupil dilation, Ocular deterioration

During the period of marketing of cetirizine and pseudoephedrine, the following side effects have occurred with an estimated frequency established by clinical or epidemiological studies:

Unknown frequency: Aggression, Euphoria, Hallucination, Visual hallucinations, Agitation, Cerebrovascular accident, Dysgeusia (alteration of the sense of taste), Dyskinesia (abnormal and involuntary movements), Dystonia (trouble with rigidity or tremors), Memory impairment, Paresthesia and numbness of the extremities, Tremor, Restlessness, Loss of consciousness, Eye pain, Visual accommodation disorder, Pupil dilation, Ocular deterioration, Photophobia, Blurred vision, Arrhythmia, Myocardial infarction, Abdominal discomfort, Vomiting, Ischemic colitis, Abnormal liver function, Acute generalized pustular psoriasis (severe skin reactions characterized by fever and numerous small superficial pustules appearing in extensive areas of redness), Angioedema (swelling under the skin), Eruption, Itching, Urticaria, Fixed drug eruption (skin and/or mucous membrane lesions after use of the drug), Arthritis, Urinary retention, Difficulty or pain urinating, Involuntary urination, Abnormal sensations, Itching after treatment cessation, Erectile dysfunction, Reversible posterior leukoencephalopathy 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, Malaise, Increased blood pressure

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

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

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

Reporting ofside effects

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

Keep this medication out of the sight and reach of children.

This medication does not require special conditions for conservation.

Do not useReactine Cetirizina/Pseudoefedrina after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the Sigre point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Reactine Cetirizina/Pseudoefedrina:

The active principles 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 content of the packaging:

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

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization :

JNTL Consumer Health (Spain), S.L.

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

28033-Madrid

Spain

Responsible for manufacturing:

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

Last review date of this leaflet: June 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es