Virlix Plus prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Virlix Plus 5 mg/120 mg prolonged-release tablets

cetirizine dihydrochloride, pseudoephedrine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use of this medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days of treatment.

Contents of the leaflet:

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

1. What Virlix Plus is and what it is used for

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

Virlix Plus is indicated for the treatment of nasal and ocular symptoms of seasonal allergic rhinitis when accompanied by nasal congestion in adults and adolescents aged 12 years and older.

You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

2. What you need to know before taking Virlix Plus

Do not take Virlix Plus:

• If you are allergic to the active substances, ephedrine, any piperazine, or any of the other components of this medicine (listed in section 6).
• If you have severe heart problems or serious irregularities in heart rhythm (severe arrhythmias).
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension not managed by your current medication.
• If you are being treated with migraine medications containing dihydroergotamine.
• If you have uncontrolled hyperthyroidism.
• If you are taking antidepressants (monoamine oxidase inhibitors).
• If you have end-stage kidney disease (patients with Glomerular Filtration Rate (GFR) below 15 ml/min).
• If you have severe acute (sudden) or chronic (long-term) kidney disease, or kidney failure.
• If you have difficulty urinating (urinary retention).
• If you have closed-angle glaucoma.
• If you have a history of, or are at high risk for, stroke.
• If you have a tumor of the adrenal medulla (called pheochromocytoma).
• If you are under 12 years of age, due to lack of studies in this patient group and because of the presence of pseudoephedrine.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Virlix Plus:

• If you have diabetes, hyperthyroidism, high blood pressure, rapid palpitations, irregular heart rhythm, heart problems (heart failure), liver problems, or if you are elderly.

• If you have kidney problems, a lower dose will be administered depending on the severity; your doctor will determine the appropriate dose.

• If you are taking sympathomimetic drugs (decongestants, appetite suppressants, stimulants), tricyclic antidepressants, or cardiac glycosides (see use with other medicines).

• If you consume alcohol or any other central nervous system depressants, as this may impair your ability to perform tasks.

• If you are taking vasoconstrictor medications (bromocriptine, pergolide, lisuride, cabergoline, ergotamine) or any other oral or nasal decongestants (phenylephrine, ephedrine).

• If you have hypertension and are being treated with non-steroidal anti-inflammatory drugs (NSAIDs).

• If you have blood clotting disorders.

• Skin allergy tests may yield false-negative results if you are taking Virlix Plus within the 3 days prior to testing; inform your doctor of this before testing.

• Virlix Plus may reduce blood flow to the optic nerve. If you experience sudden vision loss, stop taking Virlix Plus and contact your doctor or seek immediate medical attention. See section 4.

• Sudden abdominal pain or rectal bleeding may occur with Virlix Plus due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms occur, stop taking Virlix Plus and contact your doctor or seek immediate medical attention. See section 4. Cases of reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medications containing pseudoephedrine. PRES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using immediately and seek immediate medical help if you experience symptoms that could indicate PRES or RCVS (for symptoms, see section 4 "Possible side effects").

Children

Do not use this medicine in children under 12 years of age; it is contraindicated.

Use of Virlix Plus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Virlix Plus; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of them.

It is important to inform your doctor if you are taking or have recently taken any of the following medicines:

• Certain medicines used to treat depression (monoamine oxidase inhibitors).
• Certain medicines that lower blood pressure; antihypertensives (beta-adrenergic blockers).
• Some medicines used for stomach pain (antacids).
• Certain antihypertensives (methyldopa, guanethidine, or reserpine).
• Medicines used to treat heart problems (cardiac glycosides).
• Antibiotics containing linezolid.
• Certain medicines used in anesthesia (halogenated anesthetics).
• Certain sympathomimetic medicines (decongestants, appetite suppressants, stimulants).
• Certain vasoconstrictor medicines (bromocriptine, pergolide, lisuride, cabergoline, ergotamine).
• Non-steroidal anti-inflammatory drugs (NSAIDs).

Taking Virlix Plus with food, drinks, and alcohol

Virlix Plus should be swallowed whole with liquid and may be taken on an empty stomach or with food. Do not chew or break the tablet.

Alcohol consumption and fatty meals are not recommended, as they may impair your ability to perform tasks.

Pregnancy, breastfeeding, and fertility

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

This medicine is not recommended during pregnancy or breastfeeding, as it is excreted in breast milk.

Driving and using machines

There is no evidence that Virlix Plus, taken at the recommended dose, causes disturbances in attention, reaction ability, or driving skills.

However, patients who intend to drive, perform potentially hazardous activities, or operate machinery are advised not to exceed the recommended dose and should consider their individual response to Virlix Plus beforehand.

Important information about some of the components of Virlix Plus

Athletes should be informed that this medicine contains pseudoephedrine, which may lead to a positive doping test result.

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Due to its pseudoephedrine content, this medicine may be subject to abuse; therefore, treatment duration should not exceed 2 to 3 weeks.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially "sodium-free".

3. How to take Virlix Plus

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again. The recommended dose is:

• Adults and adolescents aged 12 years and older: 1 tablet twice daily (morning and evening). The maximum daily dose is 2 tablets.
• Patients over 60 years: patients over 60 years of age must not take this medicine.
• Patients with kidney or liver disease: patients with renal or hepatic impairment must not take this medicine.

The tablet should be swallowed whole with liquid and may be taken either on an empty stomach or with food. The tablet must not be split, chewed, or crushed.

If your condition worsens, or if symptoms persist after 7 days of treatment, you must consult a doctor.

Use in children

It is contraindicated in children under 12 years of age.

If you take more Virlix Plus than you should

If you have taken more Virlix Plus than you should, contact your doctor or pharmacist immediately.

A significant overdose may cause increased drowsiness, fatigue, symptoms of depression, and cardiac rhythm disturbances that may progress to unconsciousness or, conversely, stimulation with insomnia, hallucinations, tremors, and epileptic seizures.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 915 620 420.

If you forget to take Virlix Plus

Do not take a double dose to make up for missed doses. Continue taking your next dose at the usual time.

4. Possible adverse effects

Like all medicines, Virlix Plus may cause adverse effects, although not everyone experiences them.

Stop using Virlix Plus immediately and seek urgent medical attention if you experience symptoms that could be signs of reversible posterior encephalopathy syndrome (RPES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden, severe headache
• malaise
• vomiting
• confusion
• seizures
• changes in vision

The adverse effects reported with Virlix Plus, classified by frequency, are:

• Common (may affect up to 1 in 10 people): tachycardia (irregular heartbeat), dry mouth, nausea, fatigue, dizziness, vertigo, headache, somnolence, nervousness, and insomnia.
• Uncommon (may affect up to 1 in 100 people): anxiety and agitation.
• Rare (may affect up to 1 in 1,000 people): arrhythmia (irregular heartbeat), vomiting, hepatic function disorders (increased liver enzymes and bilirubin), hypersensitivity reactions (including anaphylactic shock), seizures, tremor, hallucinations, difficulty urinating, dry skin, pruritus, increased sweating, pallor, hypertension.
• Very rare (may affect up to 1 in 10,000 people): dysgeusia (altered sense of taste), stroke, psychiatric disorders, drug-related rash, angioneurotic edema (sudden development of red hives and wheals), and cardiovascular collapse.
• Frequency not known (cannot be estimated from available data): serious conditions affecting the blood vessels in the brain known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS), aggression, confusion, depression, involuntary and repetitive movements caused by contraction of one or more muscles (tics), exaggerated feeling of well-being (euphoria), suicidal thoughts, abnormal sensations in the skin (paresthesia), restlessness, prolonged abnormal muscle contractions (dystonia), involuntary movements (dyskinesia), memory loss (amnesia), memory problems, fainting (syncope), ischemic colitis (inflammatory disease of the colon), diarrhea, abdominal discomfort, difficulty breathing (dyspnea), visual accommodation disorder (ocular disorder), blurred vision, abnormal pupil dilation, eye pain, visual deterioration, abnormal intolerance to light perception, uncontrolled circular eye movements (oculogyric crisis), decreased blood flow to the optic nerve (ischemic optic neuropathy), urinary incontinence (enuresis), urinary retention (difficulty emptying the bladder), severe skin reactions characterized by fever and numerous small superficial pustules appearing in extensive red areas, pruritus, erectile dysfunction, palpitations, cardiac tissue injury leading to arrest or severe disruption of heartbeat rhythm due to blockage of the corresponding artery or arteries (myocardial infarction), low blood pressure (hypotension), joint pain (arthralgia), muscle pain (myalgia), swelling (edema), malaise.

Description of some adverse reactions:

Pruritus has been reported in some patients after discontinuation of treatment.

Discontinue the medication at the first signs of allergic reaction to treatment with Virlix Plus.

In post-marketing experience, isolated cases of hepatitis have been reported when cetirizine is administered alone.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Virlix Plus

No special storage conditions are required.

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

Do not use Virlix Plus after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Virlix Plus

• The active substances are cetirizine and pseudoephedrine. Each tablet contains 5 mg of cetirizine (as dihydrochloride) and 120 mg of pseudoephedrine (as hydrochloride).
• The other components are: hypromellose (E 464), microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, lactose, sodium croscarmellose, titanium dioxide (E 171), macrogol 400.

Nature of the product and pack contents

Virlix Plus is presented as prolonged-release film-coated tablets. The tablets are white, round, and biconvex.

Each pack contains 14 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LACER, S.A. – Boters, 5
08290 Cerdanyola del Vallès
Barcelona - Spain

Manufacturer:

Aesica Pharmaceuticals, S.r.l.
Via Praglia 15
I-10044 Pianezza (TO) - Italy

Date of the most recent review of this leaflet: April 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/