Sudafed Sinus Pressure & Pain Tablets Sudafed Sinus Pressure & Pain Tablets

• Not suitable for children under 12 years
• Do not use if allergic to ibuprofen, pseudoephedrine, aspirin, or other NSAIDs
• Consult a doctor if pregnant, breastfeeding, or have underlying health conditions
• May cause side effects such as nausea or dizziness
• Do not exceed the recommended dose
• Always read the label before use

Stop taking Sudafed Sinus Pressure & Pain 200mg/30mg Tablets and consult a doctor immediately if you experience: ¦ signs of intestinal bleeding such as: bright red faeces (stools/motions), black tarry stools, vomiting blood or dark particles that look like coffee grounds ¦ signs of a serious allergic reaction such as: severe skin rashes, peeling, flaking or blistering skin, facial swelling, swollen hands, feet or genitals, unexplained wheeziness, shortness of breath, easy bruising ¦ A severe skin reaction known as DRESS syndrome. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

Tell your doctor if you have any of the following side effects, they become worse or you notice any effects not listed. Common (may affect up to 1 in 10 people) ¦ indigestion, stomach discomfort or pain, nausea, vomiting, flatulence, diarrhoea, constipation, minor gastrointestinal blood loss in rare cases leading to anaemia ¦ insomnia, dry mouth

Uncommon (may affect up to 1 in 100 people) ¦ hypersensitivity reactions with nettle rash, itching and asthma attacks (with drop in blood pressure) ¦ central nervous disturbances such as headache, dizziness, difficulty in sleeping, agitation, irritability or tiredness ¦ visual disturbances ¦ stomach or intestinal ulcers, sometimes with bleeding and perforation, gastritis, swelling of the mouth lining with ulceration (ulcerative stomatitis), worsening of colitis and Crohn's disease ¦ various skin rashes

Rare (may affect up to 1 in 1,000 people) ¦ tinnitus (ringing in the ears) ¦ restlessness, tremor ¦ worsening of asthma or hypersensitivity reaction with shortness of breath ¦ kidney-tissue damage (papillary necrosis), increased uric acid concentrations in the blood

Very rare (may affect up to 1 in 10,000 people) ¦ worsening of infectious inflammations (e.g. necrotizing fasciitis), aseptic meningitis (stiffness of the neck, headache, nausea, vomiting, fever or disorientation) in patients with preexisting autoimmune diseases (Systemic Lupus Erythematosus (SLE), mixed connective tissue disease) ¦ problems in blood cell production (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis) that might make you bruise more easily or make you more susceptible to infections ¦ severe allergic reactions ¦ psychotic reactions and depression ¦ high blood pressure, irregular heartbeat, heart failure, heart attack ¦ rash, pruritus (itching skin), angioedema (difficulty in breathing, skin rash, swelling of the face, hands or feet) ¦ inflammation of the oesophagus (oesophagitis) and the pancreas (pancreatitis), intestinal diaphragm-like strictures ¦ liver dysfunction, liver damage, especially in long-term therapy, liver failure, acute liver inflammation (hepatitis) ¦ severe skin reactions including skin rash with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome), loss of hair (alopecia), severe skin infections and soft-tissue complications in a chicken pox infection (varicella zoster infection) ¦ increase in serum creatinine, oedemas (especially in patients with arterial hypertension or renal insufficiency), nephrotic syndrome, interstitial nephritis, acute renal insufficiency

Not known (frequency cannot be estimated from the available data) ¦ abnormal behaviour ¦ stroke, fits, headache ¦ chest pain, fast heartbeat, irregular heartbeat ¦ thirst, nausea, vomiting ¦ nettle rash, itching, excessive sweating ¦ euphoric mood, hallucination, nervousness, anxiety, ¦ sleepiness, ¦ reddening of the skin, blisters or rash ¦ pain, discomfort or difficulty passing urine, inability to pass urine ¦ high blood pressure ¦ Sudden onset of fever, reddening of the skin, or many small pustules (possible symptoms of Acute Generalized Exanthematous Pustulosis - AGEP) may occur within the first 2 days of treatment with Sudafed Sinus Pressure & Pain 200mg/30mg Tablets. See section 2.

Stop using Sudafed Sinus Pressure & Pain 200mg/30mg Tablets if you develop these symptoms and contact your doctor or seek medical attention immediately. Medicines such as Sudafed Sinus Pressure & Pain 200mg/30mg Tablets may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard The following details are applicable for Malta: ADR Reporting www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine

• Take one tablet every 6 hours as needed
• Do not exceed three tablets in 24 hours
• Swallow whole with water—do not chew or crush
• Do not take with other ibuprofen or decongestant products
• Consult a doctor if symptoms persist

The active substances are ibuprofen and pseudoephedrine hydrochloride. Each film-coated tablet contains 200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride

The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, croscarmellose sodium, maize starch, silica colloidal anhydrous, magnesium stearate. Tablet coat: hypromellose, macrogol 400, talc, titanium dioxide (E171), iron oxide yellow (E 172)

What Sudafed Sinus Pressure & Pain 200mg/30mg Tablets looks like and contents of the pack Sudafed Sinus Pressure & Pain 200mg/30mg Tablets are round, yellow film-coated tablets.