Sinusvicks 200 mg/30 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sinusvicks 200 mg / 30 mg film-coated tablets

ibuprofen and 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 administration contained in this leaflet or those 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 3 days in adolescents and 5 days in adults.

Contents of the leaflet

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

Sinusvicks contains the active substances 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 to relieve nasal congestion.

Sinusvicks is indicated for the symptomatic relief of nasal congestion associated with headache, fever, and/or pain in the common cold and influenza.

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

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

Consult a doctor if symptoms worsen or do not improve after 3 days in adolescents or 5 days in adults.

2. What you need to know before taking 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 experienced an allergic reaction (such as wheezing, bronchospasm, asthma, nasal polyps, itchy nasal discharge, facial swelling, hives, or rash) after taking acetylsalicylic acid or other painkillers, fever-reducing medicines, or other anti-inflammatory drugs,
• if you currently have (or have recurrent) stomach/duodenal or gastrointestinal ulcers (peptic ulcer) or bleeding, or have previously had two or more episodes of confirmed gastric ulceration or bleeding,
• if you have previously experienced gastrointestinal bleeding related to taking NSAIDs, or any other bleeding,
• if you have severe liver disease,
• if you have severe, acute (sudden) or chronic (long-term) kidney disease, 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 circulatory problems (coronary artery disease, heart disease, severe or poorly controlled hypertension, angina, tachycardia), overactive thyroid gland (hyperthyroidism), diabetes, or pheochromocytoma (a tumor of 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 stroke,
• if you have a history of seizures,
• if you have blood disorders of unknown origin,
• if you have glaucoma (increased eye pressure),
• if you have difficulty urinating and/or an enlarged prostate,
• if you have systemic lupus erythematosus (SLE), or mixed connective tissue disease (MCTD), conditions affecting the immune system causing 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 painkillers,
• other nasal decongestants (phenylpropanolamine, phenylephrine, ephedrine, or methylphenidate) (see section ‘Taking sinusvicks with other medicines’),
• non-selective monoamine oxidase inhibitors (known as MAOIs, used to treat Parkinson’s disease or depression), or if you have taken them within the last 2 weeks (see section ‘Taking sinusvicks with other medicines’),
• anticoagulant medicines (oral anticoagulants, heparins, antiplatelet agents),
• corticosteroids,
• lithium (used for bipolar disorder or depression),
• selective serotonin reuptake inhibitors (SSRIs) (antidepressants),
• methotrexate, when used at doses exceeding 20 mg/week (an immunosuppressive drug).

Warnings and precautions

Consult your doctor or pharmacist before starting 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 clotting disorder,
• if you have mild or moderately controlled high blood pressure, heart failure, or 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 medicines for migraine,
• if you have an infection; see the section "Infections" below.

Painkillers/anti-inflammatory medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

Cases of reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine. RPES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using sinusvicks immediately and seek urgent medical attention if you experience symptoms that could indicate RPES or RCVS (for symptoms, see section 4 "Possible side effects").

Allergic reactions to this medicine have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain with ibuprofen. Stop taking sinusvicks immediately and contact your doctor or emergency services right away if you notice any of these symptoms.

Reduced blood flow to the optic nerve may occur with sinusvicks. If you experience 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 sinusvicks due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms occur, stop taking sinusvicks and contact your doctor or seek immediate medical attention. See section 4.

Infections

Sinusvicks may mask signs of infection such as fever and pain. Therefore, sinusvicks may delay appropriate treatment of infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin infections related to chickenpox. If you take this medicine while having an infection and symptoms 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 have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked 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 alcohol consumption 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. Serious 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. Serious skin reactions associated with sinusvicks treatment have been reported. Stop taking sinusvicks and see a doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a serious skin reaction. See section 4.

There is a risk of kidney problems in dehydrated adolescents.

Consult your doctor if your condition worsens or 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 need to take any other medicines.

Do not take sinusvicks if you are taking:

• acetylsalicylic acid,
• other non-steroidal anti-inflammatory drugs (NSAIDs),
• other painkillers or fever-reducing medicines,
• if you have been treated with monoamine oxidase inhibitors within 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 or nasally),
• medicines that prevent blood clotting, such as anticoagulants or antiplatelet agents (e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine),
• medicines that may increase the risk of stomach ulcers or bleeding, e.g., corticosteroids, 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 medicines (e.g., to treat circulation problems/prevent clotting, e.g., acetylsalicylic acid, warfarin, and ticlopidine),
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan, guanethidine, reserpine, and methyldopa),
• medicines that may increase the risk of stomach ulcers or bleeding such as corticosteroids, selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine, paroxetine), or NSAIDs, including acetylsalicylic acid and selective COX-2 inhibitors,
• medicines for cardiac arrhythmias, angina, heart failure, or fluid retention (cardiac glycosides, quinidine), as sinusvicks may reduce their effectiveness or increase the risk of arrhythmias, hypertension, or worsen kidney function,
• cyclosporine (an immunosuppressant), which may increase the risk of impaired kidney function,
• medicines for depression (lithium, tricyclic antidepressants), which may increase the risk of adverse reactions,
• concomitant use of phenytoin may increase plasma levels of this active ingredient. If used correctly, plasma level monitoring of phenytoin is generally not required (maximum for 5 days),
• other decongestants or appetite suppressants, which may increase the risk of adverse effects,
• reversible inhibitors of monoamine oxidase A (RIMAs, used to treat depression), linezolid (an antibiotic), and ergot alkaloids (used to treat Parkinson’s disease) may increase the risk of high blood pressure,
• probenecid or sulfinpyrazone may delay ibuprofen excretion,
• sulfonylureas (antidiabetic agents): although interactions with ibuprofen have not been described, blood glucose monitoring is recommended as a precaution when taken concomitantly,
• medicines to increase urination (diuretics),
• high-dose methotrexate (20 mg per week), as the effect of methotrexate may be increased,
• quinolone antibiotics due to increased risk of seizures,
• tacrolimus and trimethoprim, corticosteroids,
• migraine medicines,
• zidovudine (for treating HIV),
• terpene derivatives, clobutinol, atropine-like substances, and local anesthetics may increase the risk of seizures,
• injectable heparin or preparations containing Gingko biloba, as they increase the risk of bleeding.

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

Due to the administration of pseudoephedrine, acute hypertension may occur during the perioperative period. Therefore, discontinue sinusvicks treatment several days before surgery and inform your anesthetist.

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. They may affect the bleeding tendency in both mother and baby and may delay or prolong labor. From 20 weeks of pregnancy, NSAIDs may cause kidney problems in the fetus, leading 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 infants breastfed by women who have taken them.

Therefore, sinusvicks must 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 exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Sinusvicks is for oral use only.

Recommended dose:

Adults or adolescents aged 15 years and older: 1 tablet every 4–6 hours as needed. If necessary, 2 tablets every 6–8 hours as needed.

Do not exceed 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 have only one of these symptoms (either nasal congestion or headache and/or fever), ask your doctor or pharmacist about alternative medicines.

In patients over 60 years of age, treatment should start with the lowest possible dose due to an increased risk of gastrointestinal bleeding, ulceration, or perforation. If you belong to this age group, your doctor may recommend taking gastrointestinal protective medicines alongside Sinusvicks.

Consult your doctor if you have chronic mild to moderate kidney or liver disease, as the dose may need to be adjusted according to your condition.

Use the lowest effective dose for the shortest duration 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 of age.

Duration of treatment

This medicine is intended for short-term treatment only. The lowest effective dose should be used for the shortest duration needed to relieve 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, consult your doctor.

If you take more Sinusvicks than you should

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

If you forget to take Sinusvicks

If you have taken more Sinusvicks than recommended, or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital to assess the risk and obtain advice on necessary measures.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, chills, and breathing difficulties have been reported.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

If you experience any of the following symptoms that could indicate a serious allergic reaction:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• skin itching and hives
• skin reactions, including blisters under the skin
• palpitations with low blood pressure

If you have signs of gastrointestinal bleeding such as:

• bright red stools (bowel movements), feeling faint, black tarry stools, stomach pain that does not improve, vomiting blood or dark particles resembling 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 discomfort, gastrointestinal disturbances (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, flatulence (gas), constipation

• edema (swelling), hypertension (high blood pressure), palpitations, heart failure, irregular heartbeat, rapid heart rate, chest pain, heart attack

• kidney injury, elevated blood uric acid levels

• skin rash, urticaria (hives), itching, redness, excessive sweating

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

• gastric/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 with long-term therapy, liver failure, acute hepatitis

• infectious inflammations, 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, leucopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis); early signs include: fever, sore throat, superficial mouth ulcers, unexplained nosebleeds, and appearance of bruises

• renal failure and kidney disorders, increased serum creatinine

• esophagitis (heartburn), pancreatitis; intestinal diaphragm-like stenosis

• red, non-elevated, target-like or circular skin lesions on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may 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 associated with chickenpox

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

• Serious diseases affecting blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
• Reduced blood flow to the optic nerve, which may cause vision loss or difficulty focusing (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 (Drug Reaction with Eosinophilia and Systemic Symptoms) may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell). Stop using this medicine if you experience these symptoms and seek immediate medical attention.
• Sudden onset of fever, skin redness, or numerous small pustules (possible symptoms of acute generalized exanthematous pustulosis - AGEP), which 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 mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Sinusvicks if you experience these symptoms and seek immediate medical attention. See also section 2.

• Inflammation of the colon due to insufficient blood supply (ischemic colitis).
• Stroke
• Intestinal problems that may cause sudden pain or rectal bleeding
• Seizures
• Difficulty urinating in men with prostate enlargement
• Hallucinations, abnormal behavior
• Skin becomes sensitive to light (photosensitivity reactions)
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

Medicines 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 adverse effect, talk to your doctor, pharmacist, or nurse, 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 Medicines: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of sinusvicks

Keep out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use sinusvicks after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sinusvicks

• The active substances 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, mica-based pigment (a mixture of potassium aluminium 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 medicinal product and contents of the pack

Sinusvicks are yellow, film-coated, oval tablets (approximately 15.6 mm x 7.7 mm).

The tablets are packed in blisters containing 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.o.
Ostravska 29, c.p. 305, 74770 Opava-Komarov
Czech Republic

or

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

or

Merckle GmbH
Ludwig-Merckle-Strasse, 3
Blaubeuren, Germany

or

P&G Health Austria GmbH & Co. OG
Hösslgasse 20
9800 Spittal an der Drau
Austria

This medicinal product is authorized in the European Economic Area member states under 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 most recent revision of this leaflet: March 2025

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