Package Insert: Information for the User

Virlix Plus 5 mg/120 mg Extended-Release Tablets

cetirizine dihydrochloride, pseudoephedrine hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

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

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

2. What you need to know before starting to take Virlix Plus

3. How to take Virlix Plus

4. Possible adverse effects

5. Storage of Virlix Plus

6. Contents of the package and additional information

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 12 years of age and older.

Consult a doctor if symptoms worsen or do not improve after 7 days of treatment.

Do not take Virlix Plus:

• if you are allergic to the active ingredients, to ephedrine, to any piperazine or to any of the other components of this medication (listed in section 6).
• if you have severe heart problems, or serious irregularities of the heart rhythm (severe arrhythmias).
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension.
• if you have uncontrolled hyperthyroidism.
• if you are being treated with antidepressants (monoamine oxidase inhibitors).
• if you have end-stage kidney disease (patients with a Glomerular Filtration Rate (GFR) less than 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 angle-closure glaucoma.
• if you have a high risk of suffering a stroke.
• if you have a tumor in the adrenal gland (pheochromocytoma).
• if you are under 12 years old, as no studies have been conducted in this age group and due to 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 heart palpitations, irregular heart rhythms, heart problems (heart failure), liver problems, and in elderly people.
• if you have kidney problems, a smaller dose will be administered according to the severity of the kidney problems; the dose to be taken will be indicated by your doctor.
• if you are taking sympathomimetic medications (decongestants, appetite suppressants, stimulants), tricyclic antidepressants, or cardiac glycosides (see use of other medications).
• if you take alcohol or any other central nervous system depressant, as you may experience problems performing actions.
• if you are taking vasoconstrictor medications (bromocriptine, pergolide, lisuride, cabergoline, ergotamine) or any other oral or nasal decongestant (phenylephrine, ephedrine).
• if you have hypertension and are being treated with nonsteroidal anti-inflammatory drugs.
• if you have blood clotting problems.

• the skin allergy tests may give false-negative results if you are taking Virlix Plus during the 3 days prior to the tests, so inform your doctor of this circumstance before the tests are performed.
• 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 medical attention immediately. See section 4.
• Abdominal pain or rectal bleeding may occur with the use of Virlix Plus due to ischemic colitis. If these gastrointestinal symptoms appear, stop taking Virlix Plus, and contact your doctor or seek medical attention immediately. See section 4.Reversible posterior encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after the use of pseudoephedrine-containing medications. PRES and RCVS are rare diseases that may involve reduced blood flow to the brain. Stop using immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (see section 4 "Possible side effects").

Children

Do not use this medication in children under 12 years old, it is contraindicated.

Use of Virlix Plus with other medications

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

Certain medications may interact with Virlix Plus; in these cases, it may be necessary to change the dose or discontinue treatment with one of them.

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

-Some medications used to treat depression (monoamine oxidase inhibitors).

-Some medications that lower blood pressure; beta-blockers.

-Some medications used for stomach pain (antacids).

-Some hypotensive medications (methyldopa, guanethidine, or reserpine).

-Medications used to treat heart problems (cardiac glycosides).

-Antibiotics containing linezolid.

-Some anesthetics (halogenated anesthetics).

-Some sympathomimetic medications (decongestants, appetite suppressants, stimulants).

-Some vasoconstrictor medications (bromocriptine, pergolide, lisuride, cabergoline, ergotamine).

-Nonsteroidal anti-inflammatory drugs.

Taking Virlix Plus with food, drinks, and alcohol

Virlix Plus should be swallowed whole with the help of liquids and can be taken either on an empty stomach or with food. Do not chew or break.

It is not recommended to take alcohol or fatty foods as it may reduce your ability to perform actions.

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 not recommended during pregnancy or breastfeeding, as the medication is excreted in breast milk.

Driving and operating machinery

No evidence has been shown that Virlix Plus, taken at the recommended dose, produces alterations in attention, reaction time, and ability to drive.

However, it is recommended that patients who drive, perform potentially hazardous activities, or use machinery not exceed the recommended dose and consider their response to Virlix Plus beforehand.

Important information about some components of Virlix Plus

It is informed to athletes that this medication contains pseudoephedrine, which may result in a positive doping test.

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.

This medication, containing pseudoephedrine, may present abuse problems, so the treatment duration should not exceed 2 or 3 weeks.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The recommended dose is:

• Adults and adolescents 12 years of age and older:1 tablet 2 times a day (morning and night). The maximum daily dose is 2 tablets.
• Seniors 60 years of age and older:Patients 60 years of age and older should not take this medication.
• Patients with kidney or liver disease: Patients with kidney or liver insufficiency should not take this medication.

The tablet should be swallowed whole with the help of some liquid and can be taken both on an empty stomach and with food. The tablet should not be broken, chewed, or crushed.

If symptoms worsen, or if symptoms persist after 7 days of treatment, you should 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, consult your doctor or pharmacist immediately.

A significant overdose may cause increased drowsiness, feeling of fatigue, symptoms of depression, and irregular heart rhythm that can lead to unconsciousness or, on the contrary, stimulation with insomnia, hallucinations, tremors, and epileptic seizures.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 915 620 420.

If you forgot to take Virlix Plus

Do not take a double dose to compensate for the missed doses. Continue taking your regular dose when it is due.

Like all medications,Virlix Plus may cause side effects, although not everyone will experience them.

Stop using Virlix Plus immediately and seek urgent medical attention 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

The side effects described with Virlix Plus, classified by frequency, are:

• Frequent (may affect up to 1 in 10 people) are: tachycardia (irregular heart rhythm), dry mouth, nausea, fatigue, dizziness, vertigo, headache, drowsiness, nervousness, and insomnia.
• Infrequent (may affect up to 1 in 100 people): anxiety and agitation.
• Rare (may affect up to 1 in 1,000 people): arrhythmia (irregular heart rhythm), vomiting, liver function disorders (elevated liver enzymes and bilirubin), hypersensitivity reactions (including anaphylactic shock), seizures, tremor, hallucinations, difficulty urinating, dry skin, itching, increased sweating, pallor, hypertension.
• Very rare (may affect up to 1 in 10,000 people): dysgeusia (alteration of taste), cerebral hemorrhage, mental disorders, drug-related rash, angioneuritic edema (sudden development of red patches and hives), and cardiovascular collapse.
• Unknown frequency (cannot be estimated from available data): severe vascular disorders of the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS), aggression, confusion, depression,involuntary repetitive movement caused by muscle contraction(tic), excessive feeling of well-being (euphoric mood), suicidal thoughts, abnormal skin sensation (paresthesia), restlessness, abnormal prolonged 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 light intolerance,uncontrolled circular eye movements (ocular 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 pustules on extensive red areas, itching (pruritus), erectile dysfunction, palpitations,heart tissue damage that causes a stop or severe alteration of heart rhythm due to obstruction of the artery or arteries corresponding (myocardial infarction), low blood pressure (hypotension), joint pain (arthralgia), muscle pain (myalgia), swelling (edema), discomfort.

Description of some adverse reactions:

After treatment suspension, some patients have reported itching (pruritus).

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

During 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

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

Do not use Virlix Plus 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 disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Virlix Plus

• 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 are: hypromellose (E 464), microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, lactose, sodium croscarmellose, titanium dioxide (E 171), macrogol 400.

Appearance of the product and content of the packaging

Virlix Plus is presented in the form of prolonged-release coated tablets. They are white, round, and biconvex tablets.

Each package contains 14 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

LACER, S.A. – Boters, 5

08290 Cerdanyola del Vallès

Barcelona - Spain

Responsible for manufacturing:

Aesica Pharmaceuticals, S.r.l.

Via Praglia 15

I-10044 Pianezza (TO) - Italy

Last review date of this leaflet:April 2024

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