Description

Nasivin Sinus and Runny Nose is a medication used to relieve symptoms associated with colds and flu, such as pain, fever, and nasal congestion. Available in coated tablets, it contains two active ingredients with complementary effects. Ibuprofen has analgesic, anti-inflammatory, and antipyretic properties, while pseudoephedrine reduces swelling in the nasal mucosa, making breathing easier. The medication is intended for use in adolescents over 15 years of age and adults.

Composition

The active substances of the drug are ibuprofen and pseudoephedrine hydrochloride.

One film-coated tablet contains: 200 mg of ibuprofen and 30 mg of pseudoephedrine hydrochloride, equivalent to 24.6 mg of pseudoephedrine.

Excipients: Microcrystalline cellulose; Pregelatinized maize starch; Povidone K-30; Colloidal anhydrous silica; Stearic acid; Croscarmellose sodium; Sodium laurilsulfate. Tablet coating: Opadry Yellow: Hypromellose; Titanium dioxide (E 171); Macrogol 400; Iron oxide yellow (E 172); Polysorbate 80; Iron oxide red (E 172); Iron oxide black (E 172); Opadry fx Silver: Polyvinyl alcohol partially hydrolyzed; Talc; Macrogol 3350; Color “MICA-Based Pearlescent Pigment” (Mixture of: potassium aluminum silicate (E 555) and titanium dioxide (E 171)); Polysorbate 80.

Dosage

Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you have any further questions, ask your doctor or pharmacist.

The drug is administered entirely orally, after a meal.

The recommended dosage of Nasivin Sinus and Runny Nose for adults and adolescents over 15 years of age is 1 coated tablet every 4 to 6 hours. For severe symptoms, 2 tablets may be taken every 6 to 8 hours. The maximum daily dose is 6 tablets.

If there is no improvement or the condition worsens after 3 days in adolescents and after 5 days in adults, contact your doctor.

Action

Nasivin Sinus and Runny Nose contains two active ingredients and has a multifaceted effect. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), provides analgesic and antipyretic effects, and reduces inflammation. Pseudoephedrine helps with nasal congestion by reducing nasal congestion.

Indications

Nasivin Sinus and Runny Nose is used for nasal congestion with headaches, among other symptoms, and fever, such as those associated with colds or flu. This medication should be used for nasal congestion and pain or fever. Do not take if only one of these symptoms is present.

Contraindications

Do not use Nasivin Sinus and Runny Nose: if you are allergic to ibuprofen, pseudoephedrine or any of the other ingredients of this medicine; if you have ever had allergic reactions (such as wheezing, worsening of asthma, itchy runny nose, facial swelling or hives) after taking aspirin or other painkillers, fever reducers or anti-inflammatory drugs; if you have a stomach ulcer or have had stomach ulcers in the past; if you have had perforation or bleeding related to NSAIDs in the past; if you have severe kidney, liver or heart failure; if you have severe heart or circulation problems (heart disease, high blood pressure, angina, fast heartbeat), overactive thyroid gland, diabetes, pheochromocytoma (a tumor of the adrenal gland); if you have had a heart attack, have uncontrolled high blood pressure, seizures, stroke or are at risk of stroke; if you have unexplained blood disorders, glaucoma (an eye pressure disorder), difficulty urinating due to prostate problems; if you have systemic lupus erythematosus, a disease that affects the immune system, for example, causing joint pain and skin lesions.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP TAKING this medicine IMMEDIATELY and contact your doctor immediately: if you notice symptoms suggesting posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include: sudden onset of severe headache, nausea, vomiting, confusion, seizures, changes in vision; if you notice any of the following, which may be signs of a serious allergic reaction: difficulty breathing or swallowing, swelling of the face, lips, tongue or throat, severe itching of the skin with hives, severe skin reactions including blisters under the skin, fast heartbeat with low blood pressure; if you notice signs of intestinal bleeding: bright red stools, feeling weak, bloody or black tarry stools, stomach pain that does not go away, vomiting blood or dark particles that look like coffee grounds.

Other side effects:

Uncommon (may affect up to 1 in 100 people): headache, dizziness, difficulty sleeping, feeling agitated, irritable or tired; visual disturbances; dry mouth, thirst; gastrointestinal discomfort, nausea, vomiting, diarrhea, loss of appetite, indigestion (heartburn).

Rare (may affect up to 1 in 1,000 people): tinnitus (ringing in the ears); nervousness, tremor, anxiety, agitation, restlessness, insomnia; worsening of asthma, wheezing; allergic reaction with bronchospasm (shortness of breath); abdominal pain, flatulence, constipation; swelling, hypertension (high blood pressure), palpitations, heart failure, irregular heartbeat, fast pulse, chest pain, heart attack; kidney tissue damage, increased blood urea; rash, 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 especially in long-term treatment, liver failure, acute hepatitis; infectious inflammation, symptoms of aseptic meningitis (headache, fever, stiff neck, 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). First symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained nosebleeds and bruising - severe allergic reactions (symptoms may include facial swelling, angioedema, shortness of breath, bronchospasm, rapid heart rate, drop in blood pressure, anaphylactic shock) - psychotic reactions, depression - renal failure or other renal disorders, increased serum creatinine - inflammation of the esophagus (heartburn), pancreatitis, narrowing resembling the intestinal diaphragm - red, non-raised, target-like or circular spots on the trunk, often with central blisters, peeling skin, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis): hair loss, severe skin infections, soft tissue complications of chickenpox.

Not known (frequency cannot be estimated from the available data): serious conditions affecting the 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 loss of vision or problems concentrating (ischemic optic neuropathy); dilated pupils; increased blood sugar levels; drug reaction with eosinophilia and systemic symptoms: A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell). If these symptoms occur, stop taking this medicine and seek immediate medical attention. a red, scaly rash with bumps under the skin and blisters, mostly in the skin folds, on the trunk and upper limbs, with a fever at the beginning of treatment (acute generalised exanthematous pustulosis, AGEP). If these symptoms occur, stop taking Nasivin Sinus and Katar and seek medical help immediately; inflammation of the large intestine caused by insufficient blood supply (ischemic colitis); stroke; bowel disorders that can cause sudden pain or bleeding from the rectum; seizures; difficulty urinating in men with an enlarged prostate; hallucinations, abnormal behaviour; the skin becomes sensitive to light (photosensitivity reactions); chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medications such as Nasivin Sinus and Katar may be associated with a small increased risk of heart attack or stroke.

Warnings and precautions

Before taking Nasivin Sinus and Runny Nose, talk to your doctor or pharmacist: if you have asthma due to the risk of an asthma attack; if you have a blood clotting disorder; if you are taking blood-thinning medicines, e.g. warfarin, low-dose aspirin; if you are taking medicines that may increase the risk of stomach ulcers or bleeding, e.g. steroids, selective serotonin reuptake inhibitor (SSRI) antidepressants (e.g. fluoxetine, paroxetine) or NSAIDs, including aspirin; if you have psychosis or diabetes; if you have a history of gastrointestinal disease (e.g. ulcerative colitis or Crohn's disease); if you have kidney or liver problems; if you are taking antimigraine medicines.

Anti-inflammatory/painkiller medications such as Nasivin Sinus and Katar may be associated with a small increased risk of heart attack or stroke, particularly at high doses. Any risk increases with higher doses and long-term treatment. Do not exceed the recommended dose and duration of treatment.
While taking Nasivin Sinus and Runny Nose, you may experience sudden abdominal pain or rectal bleeding due to inflammation of the large intestine (ischemic colitis). If you experience these digestive symptoms, stop taking Nasivin Sinus and Runny Nose and Runny Nose and seek medical advice or attention immediately.

You should avoid drinking alcohol while taking this medicine.

There is a risk of kidney problems in adolescents who are dehydrated.

Use of other medications

Please tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take, including medicines obtained without a prescription.

Nasivin Sinus and Catarrh may interact with: acetylsalicylic acid, other non-steroidal painkillers and antipyretics, monoamine oxidase inhibitors (MAOIs), if used within the last 14 days, other nasal vasoconstrictors (e.g. phenylephrine or ephedrine), blood thinners, steroids, SSRI antidepressants (e.g. paroxetine, fluoxetine), NSAIDs, ACE inhibitors, beta-blockers, angiotensin II receptor antagonists, cardiac glycosides, cyclosporine, lithium, TCAs, phentytin, probenecid, sulfinpyrazone, sulfonylurea, diuretics, methotrexate, quinolone antibiotics, cyclosporine, tacrolimus, trimethoprim, antimigraine drugs, zidovudine, heparin.

Taking the medicine with food and drink

You should not drink alcohol while taking this medicine.

The tablets should be swallowed whole, after a meal.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Nasivin Sinus and Runny Nose should not be used during pregnancy or breastfeeding. The active ingredients, ibuprofen and pseudoephedrine, may cause serious problems in unborn children. These substances have been shown to pass through breast milk to breastfed infants.

Impact on fertility

Nasivin Sinus and Runny Nose contains ibuprofen, which belongs to a group of medications (NSAIDs) that may impair female fertility. This effect is reversible upon discontinuation of the medication.

Use of the drug in children and adolescents

Do not use in children under 15 years of age.