SINUSVICKS 200mg/30mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sinusvicks 200 mg / 30 mg Film-Coated Tablets

ibuprofen and pseudoephedrine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow the instructions for administration of the 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 side effects, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or if it does not improve after 3 days in adolescents and 5 days in adults.

Contents of the Package Leaflet

1. What is Sinusvicks and what is it used for
2. What you need to know before you take Sinusvicks
3. How to take Sinusvicks
4. Possible side effects

5 Storage of Sinusvicks

1. Contents of the pack and further information

This medicine is called Sinusvicks 200 mg/30 mg film-coated tablets, but will be referred to as Sinusvicks in this leaflet.

1. What is Sinusvicks and what is it used for

Sinusvicks contains the active ingredients ibuprofen, which is a non-steroidal anti-inflammatory drug (NSAID), and pseudoephedrine, which is a nasal decongestant.

• Ibuprofen reduces pain, inflammation, and fever.
• Pseudoephedrine acts on the blood vessels in the nose, relieving nasal congestion.

Sinusvicks is indicated for the symptomatic relief of nasal congestion that occurs with headache, fever, or pain in the common cold and flu.

Sinusvicks is indicated in adults and adolescents over 15 years of age.

Use this medicine only if you have nasal congestion with pain or fever. Do not use this medicine if you have only one of these symptoms.

You should consult a doctor if it worsens or if it does not improve after 3 days in adolescents and 5 days in adults.

2. What you need to know before you take Sinusvicks

Do not take Sinusvicks:

• if you are allergic to ibuprofen, pseudoephedrine, or any of the other ingredients of this medicine (listed in section 6),
• if you are under 15 years of age,
• if you are pregnant or breastfeeding,
• if you have previously suffered an allergic reaction (such as wheezing, bronchospasm, asthma, nasal polyps, nasal secretion with itching, facial swelling, urticaria, or rash) when you have taken acetylsalicylic acid or other analgesics, other fever-reducing medications, or other anti-inflammatory medications,
• if you have (or have recurrent) stomach/duodenal ulcer or gastrointestinal bleeding (peptic ulcer) or have had previous episodes of stomach ulcers or bleeding.
• if you have previously suffered gastrointestinal bleeding related to the use of NSAIDs, if you have had other bleeding,
• if you have severe liver disease
• if you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure,
• if you have heart problems,
• if you have very high blood pressure (severe hypertension) or uncontrolled hypertension,
• if you have serious heart or circulation problems (coronary artery disease, heart disease, severe or uncontrolled hypertension, angina, tachycardia), hyperthyroidism, diabetes, pheochromocytoma (a tumor in the adrenal gland),
• if you have a history of heart attack (myocardial infarction),
• if you have had a stroke or have been told you are at risk of having a stroke,
• if you have a history of seizures,
• if you have blood disorders of unknown origin,
• if you have glaucoma (eye pressure),
• if you have difficulty urinating and/or prostate enlargement,
• if you have Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease (MCTD), a disease that affects the immune system and causes joint pain and skin changes,
• if you are taking:
• acetylsalicylic acid (more than 75 mg/day), other non-steroidal anti-inflammatory drugs (NSAIDs), or other analgesics,
• other nasal decongestants (phenylpropanolamine, phenylephrine, ephedrine, or methylphenidate) (see section 'Taking Sinusvicks with other medicines'),
• non-selective monoamine oxidase inhibitor medications (known as MAOIs, used to treat Parkinson's disease or depression), or if you have taken them in the last 2 weeks (see section 'Taking Sinusvicks with other medicines'),
• anticoagulant medications (oral anticoagulants, heparins, antiplatelet agents),
• corticosteroids,
• lithium (used for bipolar disorder or depression),
• selective serotonin reuptake inhibitors (SSRIs) (antidepressants),
• methotrexate, used at doses higher than 20 mg/week (immunosuppressive medication).

Warnings and precautions

Consult your doctor or pharmacist beforestarting to take Sinusvicks:

• if you have or have had asthma or allergic disease; risk of an asthma attack,
• if your doctor has informed you that you have a blood coagulation disorder,
• if you have mild or moderate high blood pressure and well-controlled heart failure and heart disease,

-if you have psychosis,

• if you have a history of gastrointestinal disorders (such as ulcerative colitis, Crohn's disease),
• if you have mild or moderate liver or kidney problems,
• if you are taking medications for migraine,
• if you have an infection; see the section "Infections" below.

Pain-relieving/anti-inflammatory medications like ibuprofen may be associated with a small increased risk of having a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.

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 may involve reduced blood flow to the brain. Stop using Sinusvicks immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (to learn about the symptoms, see section 4 "Possible side effects").

There have been reports of allergic reaction symptoms to this medicine, such as respiratory problems, facial swelling, and chest pain with ibuprofen. Stop taking Sinusvicks immediately and contact your doctor or seek emergency medical attention if you notice any of these symptoms.

Reduced blood flow to the optic nerve can occur with Sinusvicks. If you develop sudden vision loss, stop taking Sinusvicks and contact your doctor or seek immediate medical attention. See section 4.

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

Infections

Sinusvicks may hide the signs of an infection, such as fever and pain. Consequently, Sinusvicks may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

You should consult your doctor about your treatment before taking Sinusvicks if:

? You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").

? You have high blood pressure, diabetes, or high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Avoid consuming alcohol during treatment.

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives, facial swelling, asthma (wheezing), and shock. Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported. Severe skin reactions associated with Sinusvicks treatment have been reported. Stop taking Sinusvicks and see a doctor immediately if you develop any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

There is a risk of kidney problems in dehydrated adolescents.

Consult your doctor if it worsens or if the symptoms persist.

Children and adolescents

Sinusvicks is contraindicated in children and adolescents under 15 years of age.

Taking Sinusvicks with other medicines

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

Do not take Sinusvicks if you are taking:

• acetylsalicylic acid,
• other non-steroidal anti-inflammatory drugs (NSAIDs),
• other analgesics or fever-reducing medications,
• if you have been treated with monoamine oxidase inhibitors in the last 2 weeks (used to treat Parkinson's disease or depression),
• other vasoconstrictor agents used as nasal decongestants (e.g., phenylpropanolamine, phenylephrine, and ephedrine, administered orally and nasally),
• medications that prevent blood clotting, such as anticoagulants or antiplatelet agents (e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine),
• medications that may increase the risk of stomach ulcers or bleeding, such as steroids, antidepressants of the SSRI type (e.g., fluoxetine, paroxetine), or NSAIDs, including aspirin,
• lithium,
• methotrexate at high doses (more than 20 mg per week).

Sinusvicks may affect or be affected by other medicines. For example:

• anticoagulant medications (e.g., to treat circulation problems/prevent blood clotting, e.g., acetylsalicylic acid, warfarin, and ticlopidine),
• medications that lower high blood pressure (e.g., ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan, guanethidine, reserpine, and methyldopa),
• medications that may increase the risk of stomach ulcers or bleeding, such as steroids, selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine, paroxetine), or NSAIDs, including acetylsalicylic acid and selective cyclooxygenase-2 (COX-2) inhibitors,
• medications for heart rhythm disorders, angina, heart failure, or fluid retention (cardiac glycosides, quinidine) since Sinusvicks may reduce their effects or increase the risk of arrhythmias, hypertension, or worsen renal function,
• cyclosporin (an immunosuppressant) as it may increase the risk of renal function deterioration,
• medications for treating depression (lithium, tricyclic antidepressants) that may increase the risk of adverse reactions,
• concomitant use of phenytoin may increase the plasma levels of this active ingredient. If used correctly, no monitoring of phenytoin plasma levels is required, as a general rule (max. during 5 days).
• other decongestants or appetite-reducing medications as they may increase the risk of adverse effects,
• reversible inhibitors of monoamine oxidase A (RIMAs, used in the treatment of depression), linezolid (an antibiotic), and ergot alkaloids (used in the treatment of Parkinson's disease) may increase the risk of hypertension,
• probenecid or sulfinpyrazone may delay the excretion of ibuprofen,
• sulfonylureas (antidiabetics): although interactions with ibuprofen have not been described, it is recommended as a precaution when taken concomitantly to monitor blood glucose levels,
• diuretic medications (to increase urination),
• methotrexate at high doses (20 mg per week), as it may increase the effect of methotrexate,
• quinolone antibiotics due to the increased risk of seizures,
• tacrolimus and trimethoprim, corticosteroids,
• migraine medications,
• zidovudine (for HIV treatment),
• terpene derivatives, clobutinol, atropine-like substances, and local anesthetics may increase the risk of seizures,
• injectable heparin or preparations containing Ginkgo biloba as it increases the risk of bleeding.

Other medications may also affect or be affected by treatment with Sinusvicks. Therefore, you should always consult your doctor or pharmacist before using Sinusvicks with other medications.

Due to the administration of pseudoephedrine, acute hypertension may occur in the perioperative period. Therefore, discontinue treatment with Sinusvicks several days before surgery and inform your anesthesiologist.

Taking Sinusvicks with food and drinks

Swallow the tablets with water, preferably with a full stomach.

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 medicine.

Pregnancy:

Sinusvicks is contraindicated during pregnancy. The active ingredients, ibuprofen and pseudoephedrine, may cause serious problems in unborn babies. NSAIDs may cause kidney and heart problems in your baby. It may affect the mother's and baby's tendency to bleed and make labor longer than expected. From the 20th week of pregnancy, NSAIDs may cause kidney problems in the fetus, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.

Breastfeeding:

It has been shown that the active ingredients, ibuprofen and pseudoephedrine, are present in breastfed babies of women who have taken them.

Therefore, Sinusvicks should not be taken during breastfeeding.

Fertility:

Sinusvicks contains ibuprofen, which belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of treatment.

Driving and using machines

Sinusvicks has not shown effects on the ability to drive or use machines. However, dizziness and hallucinations may occur.

Sinusvicks contains sodium.Patients on low-sodium diets should be aware that this medicine contains 1.65 mg of sodium per tablet.

3. How to take Sinusvicks

Follow the administration instructions of the medicine contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Sinusvicks is for oral use only.

The recommended dose is:

Adults or adolescents from 15 years: 1 tablet every 4-6 hours as needed. If necessary, 2 tablets can be taken every 6-8 hours, as needed.

Do not take more than 6 tablets in 24 hours.

Swallow the tablets with water, preferably with a full stomach. Do not break or chew the tablets.

Sinusvicks should only be used if you have nasal congestion or headache and/or fever. If you only have one of these symptoms (either nasal congestion or headache and/or fever), ask your doctor or pharmacist for alternative medications.

In patients over 60 years, treatment should begin with the lowest possible dose due to a higher risk of bleeding, ulcer, or gastrointestinal perforation. If you belong to this age group, your doctor may recommend that you take gastroprotective medications along with Sinusvicks.

Consult your doctor if you have mild to moderate chronic kidney or liver disease, as it is necessary to adjust the dose to your condition.

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Use in children and adolescents

Contraindicated in children and adolescents under 15 years.

Duration of treatment

This medication is for short-term treatment. The lowest dose should be used for the shortest period that relieves symptoms.

Do not exceed 5 days of treatment in adults.

Do not exceed 3 days of treatment in adolescents (15-18 years).

If symptoms persist or worsen, you should consult your doctor.

If you take more Sinusvicks than you should

Consult your doctor immediately if you take or someone else accidentally takes more Sinusvicks than recommended. In case of overdose or accidental ingestion, go to a center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Sinusvicks

If you have taken more Sinusvicks than you should, or if a child has accidentally ingested the medication, always contact a doctor or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing problems have been reported.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

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

• severe headache of sudden onset
• discomfort
• vomiting
• confusion
• convulsions
• changes in vision

• if you have any of the following symptoms that may be signs of a severe allergic reaction:
  • difficulty breathing or swallowing
  • inflammation of the face, lips, tongue, or throat
  • itching of the skin and hives
  • skin reactions, including blisters under the skin
  • palpitations with low blood pressure
• if you have signs of intestinal bleeding such as
  • red stools (defecation), feeling of fainting, black tarry stools, stomach pain that does not improve, vomiting blood or dark particles that resemble coffee grounds

Other adverse effects:

Uncommon (may affect up to 1 in 100 people):

• headache, dizziness, difficulty sleeping, nervousness, irritability, or fatigue
• visual disturbances
• dry mouth, thirst
• stomach upset, gastrointestinal (stomach or intestine), nausea, vomiting, diarrhea, loss of appetite, dyspepsia (heartburn).

Rare (may affect up to 1 in 1,000 people):

• tinnitus (ringing in the ears)
• nervousness, tremors, anxiety, agitation, restlessness, insomnia
• worsening of asthma, wheezing
• allergic reaction with bronchospasm (difficulty breathing)
• abdominal pain (belly), flatulence (gas), constipation
• edema (inflammation), hypertension (high blood pressure), palpitations, heart failure, irregular heartbeats, rapid heart rate, chest pain, heart attack,

-

• kidney damage, elevated uric acid levels in the blood
• skin rash, hives (hives), itching, redness, excessive sweating

Very rare (may affect up to 1 in 10,000 people):

• stomach/duodenal ulcer (peptic ulcer), sometimes with bleeding or perforation (blood in vomit or stools), gastritis, mouth ulcers, worsening of colitis and Crohn's disease
• liver disorders, particularly in long-term therapy, liver failure, acute hepatitis
• infectious inflammation, symptoms of aseptic meningitis (headache, fever, neck stiffness, nausea, vomiting, or disorientation), especially in patients with existing autoimmune disorders (such as systemic lupus erythematosus, mixed connective tissue disease)
• blood disorders (anemia, leukopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis); The first signs are: fever, sore throat, superficial ulcers in the mouth, unexplained nosebleeds, and the appearance of bruises
• kidney failure and kidney disorders, increased serum creatinine,
• esophagitis (heartburn), pancreatitis; intestinal stenosis similar to a diaphragm
• red, non-raised, target-like or circular spots on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• psychotic reactions, depression

-

• hair loss, severe skin infections, soft tissue complications in chickenpox

Not known (frequency cannot be estimated from the available data):

• Severe diseases affecting the blood vessels of the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
• Reduced blood flow to the optic nerve that can cause vision loss or focusing problems (ischemic optic neuropathy).
• Dilated pupils (mydriasis)
• Increased blood sugar levels
• Drug reaction with eosinophilia and systemic symptoms. A severe skin reaction known as DRESS syndrome (by its English acronym) can occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell). Stop using this medication if you experience these symptoms and seek immediate medical attention.
• Sudden onset of fever, skin redness, or many small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP) that may occur within the first 2 days of treatment with Sinusvicks. See section 2.

Generalized red scaly rash, with bumps under the skin and blisters located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Sinusvicks if you experience these symptoms and seek medical attention immediately. See also section 2.

• Colon inflammation due to insufficient blood irrigation (ischemic colitis).
• Stroke
• Intestinal problems that can cause sudden pain or rectal bleeding
• Seizures.
• Difficulty urinating in men with prostate hypertrophy.
• Hallucinations, abnormal behavior.
• Skin becomes sensitive to light (photosensitivity reactions).
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome

Medications like Sinusvicks may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Medicines and Health Products Agency: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Sinusvicks

Keep out of sight and reach of children.

This medication does not require special storage conditions.

Do not use Sinusvicks after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Sinusvicks

• The active ingredients are ibuprofen (200 mg per tablet) and pseudoephedrine hydrochloride (30 mg per tablet, equivalent to 24.6 mg of pseudoephedrine base).

• The other components (excipients) are:

microcrystalline cellulose, pregelatinized starch (from corn), povidone K-30, anhydrous colloidal silica, stearic acid 95, sodium croscarmellose, sodium lauryl sulfate, partially hydrolyzed polyvinyl alcohol, talc (E553b), macrogol 3350, pigment based on MICA (mixture of potassium aluminum silicate (E555)-[mica], titanium dioxide (E171), polysorbate 80, hypromellose, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

(See section 2 for more information about sodium).

Appearance of the product and package contents

Sinusvicks are film-coated tablets of yellow color and oval shape (approximately 15.6 mm x 7.7 mm).

The tablets are packaged in blisters of 12, 20, or 24 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Vicks S.L.U.

Avda. de Bruselas, 24.

28108, Alcobendas. Madrid.

Spain

Local Representative

Procter & Gamble España, S.A.U.

Avda. de Bruselas, 24.

28108, Alcobendas. Madrid.

Spain

Manufacturer

Teva Czech Industries s.r.oOstravska 29, c.p. 305,74770 Opava-KomarovCzech Republic

or

Teva Operations Poland Sp. z.o.o. ul. Mogilska 80. 31-546, Krakow Poland

or

Merckle GmbhLudwig-Merckle-Strasse, 3Blaubeuren. Germany

or

P&G Health Austria GmbH & Co. OG

Hösslgasse 20

9800 Spittal an der Drau

Austria

This medication is authorized in the Member States of the European Economic Area with the following names:

Austria WICK DayMed Duo 200mg/30mg Filmtabletten

Germany WICK Duogripal 200mg/30mg Filmtabletten

Hungary Ibuprofen/Pszeudoefedrin – WICK 200mg/30mg Filmtabletta

Italy VICKS FLU ACTION 200mg+30mg compresse rivestite con film

Poland Vicks Nasivin Zatoki i Katar

Romania Ibuprofen/Pseudoefedrina Wick 200mg/30mg comprimate filmate

Spain Sinusvicks 200mg/30mg comprimidos recubiertos con película

Date of the last revision of this prospectus: March 2025

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