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Sudafed Sinus Pressure & Pain Tablets

SKU : OTCSUDSINP12-CH PIP-Code : 3570637 EAN : 3574660605945
Sudafed Sinus Pressure & Pain Tablets are for the short-term symptomatic treatment of nasal congestion in head colds together with headache and/or fever, in adults and adolescents aged 15 years and older.
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SKU
OTCSUDSINP12-CH
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Description

Sudafed Sinus Pressure & Pain Tablets

Sudafed Sinus Pressure & Pain Tablets are for the short-term symptomatic treatment of nasal congestion in head colds together with headache and/or fever, in adults and adolescents aged 15 years and older. They contain two actuve ingredients:
  • Ibuprofen: a non-steroidal anti-inflammatory drug (NSAID) that provides relief by reducing pain and high temperature.
  • Pseudoephedrine hydrochloride: a vasoconstrictor which act on the blood vessels in the nose to relieve nasal congestion.

Directions

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This medicine is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. You must talk to a doctor if symptoms worsen, or if this medicine is required for more than 4 days (adults) or 3 days (adolescents).

The tablets are for oral use. They should be swallowed whole and without chewing with a large glass of water, preferably during meals.

Adults and adolescents aged 15 years and older:
  • 1 tablet every 6 hours, if necessary.
  • For more severe symptoms, take 2 tablets every 6 hours, if necessary.
  • Never exceed the maximum daily dose of 6 tablets per day (equivalent to 1200mg ibuprofen and 180mg pseudoephedrine hydrochloride).

Ingredients

  • Active Ingredients: ibuprofen 200mg and pseudoephedrine hydrochloride 30mg.
  • Other Ingredients: 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 (E172).

Cautions

  • If you develop a feverish generalised erythema associated with pustules, stop taking Sudafed Sinus Pressure & Pain Tablets and contact your doctor or seek medical attention immediately.
  • Undesirable effects may be minimised by using the minimum effective dose for the shortest period of time. The elderly are at increased risk of side effects.
  • The use with concomitant NSAIDs, including cyclo-oxygenase (COX)-2 specific inhibitors, increases risk of adverse reactions and should be avoided. Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
  • Do not take this product for anything other than its intended use and never take more than the recommended amount. Do not take for longer than the recommended length of treatment (4 days in adults or 3 days in adolescents).
  • Increased doses of pseudoephedrine can be toxic and continuous use may lead to taking more Sudafed Sinus Pressure & Pain Tablets than the recommended dose to get the desired effect, increasing the risk of overdosing. If you suddenly stop treatment, depression may occur.
  • Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.
  • Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of treatment: the onset of the reaction occurring in the majority of cases within the first month of treatment. Sudafed Sinus Pressure & Pain Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
  • Pseudoephedrine has the potential to interfere with some diagnostic blood tests. You should tell your doctor that you are taking this medicine if you have a blood test.
  • Sudafed Sinus Pressure & Pain Tablets must not be given to children below 15 years.
  • There is a risk of renal impairment in dehydrated adolescents.
  • Athletes: Pseudoephedrine hydrochloride can lead to positive results in doping tests.
  • Some other medicines may also affect or be affected by the treatment of Sudafed Sinus Pressure & Pain Tablets. Always seek the advice of a doctor before you use Sudafed Sinus Pressure & Pain 200mg/30mg Tablets with other medicines.
  • Being given pseudoephedrine may cause a sudden increase in blood pressure around the time of your surgery. Discontinue treatment with Sudafed Sinus Pressure & Pain Tablets several days before surgery and inform your anaesthetist.
  • You should avoid alcohol intake during treatment with Sudafed Sinus Pressure & Pain Tablets.
  • If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Avoid the use of this medicine in the first 6 months of pregnancy unless your doctor advises otherwise. Sudafed Sinus Pressure & Pain Tablets should not be taken during the third trimester of pregnancy. Do not take this medicine if you are breastfeeding, as it may harm your baby.
  • Ibuprofen belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible upon stopping the medicine.
  • Sudafed Sinus Pressure & Pain Tablets could cause dizziness, hallucinations, unusual headache and visual or hearing disturbances and therefore might temporarily affect your ability to drive and use machines. If you experience any of these symptoms you should avoid driving or using machines.
Do not take Sudafed Sinus Pressure & Pain Tablets if you:
  • Are allergic to ibuprofen or pseudoephedrine hydrochloride or to any of the other ingredients of this medicine.
  • Are younger than 15 years.
  • Are in the third trimester of pregnancy (6 months or more pregnant).
  • Are breastfeeding
  • Have had an allergic reaction or shortness of breath, asthma, skin rash, itchy runny nose or facial swelling when previously taking acetylsalicylic or other NSAIDs.
  • Have an active or history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least two different episodes of confirmed ulcers or bleeding).
  • Have a history of gastro-intestinal bleeding or perforation related to previous NSAID treatment.
  • Have severe liver or kidney failure.
  • Have severe heart failure.
  • Have severe heart or circulation problems (heart disease, high blood pressure, angina, fast heart rate), an overactive thyroid gland, diabetes, pheochromocytoma (a tumour of the adrenal gland).
  • Have a history of heart attack (myocardial infarction)
  • Have had a stroke or have previously been told you are at risk of having a stroke.
  • Have a history of seizures (fits)
  • Have unexplained disorders in the formation of blood components.
  • Have increased pressure in the eye (closed-angle glaucoma).
  • Have difficulty in urinating related to prostate problems.
  • Have been diagnosed with Systemic Lupus Erythematosus (SLE), an illness affecting the immune system causing joint pain, skin changes and other problems.
  • Are taking:
    • Other nasal decongestants (vasoconstrictor drugs) administered orally or nasally (e.g. phenylpropanolamine, phenylephrine, ephedrine, xylometazoline or oxymetazoline).
    • Methylphenidate, a medicine for ADHD (attention deficit hyperactivity disorder).
    • Medicines for depression like non-selective Monoamine Oxidase Inhibitors (known as MAOIs e.g. iproniazid) or have taken them in the last 14 days.
Talk to your doctor or pharmacist before taking Sudafed Sinus Pressure & Pain Tablets if you:
  • Have asthma; use of this medicinal product can cause an asthma attack.
  • Have a history of gastro-intestinal disorders (such as hiatus hernia, gastro-intestinal bleeding, peptic or duodenal ulcer).
  • Have or have ever had gastro-intestinal disease (ulcerative colitis or Crohn's disease).
  • Have high blood pressure diabetes, high cholesterol, have a family history of heart disease or stroke or if you are a smoker.
  • Have liver or kidney problems.
  • Have diabetes because of potential diabetic nephropathy.
  • Have overactive thyroid gland (hyperthyroidism) or psychosis.
  • Have a blood clotting disorder.
  • Are pregnant or breastfeeding.
  • Have had heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including 'mini-stroke' or transient ischaemic attack "TIA").
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Sudafed Sinus Pressure & Pain Tablets may affect or be affected by some other medicines. For example:
  • Anti-coagulants (i.e. thin blood/prevent clotting e.g. acetylsalicylic acid, warfarin, ticlopidine).
  • Medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan).
Sudafed Sinus Pressure & Pain Tablets must not be used in combination with:
  • Other vasoconstrictor agents used as nasal decongestants, whether administered orally or nasally (e.g. phenylpropanolamine, phenylephrine and ephedrine).
  • A medicine for ADHD (attention deficit hyperactivity disorder) called methylphenidate.
  • Medicines for depression like non-selective Monoamine Oxidase Inhibitors (MAOIs, such as iproniazid). Also do not take this medicine if you have taken them within the last 14 days.
  • In particular tell your doctor or pharmacist if you are taking:
  • Other nonsteroidal anti-inflammatory drugs (NSAIDs) including high dose acetylsalicylic acid and cyclo-oxygenase (COX)-2 selective inhibitors.
  • Medicines to treat heart arrhythmias (cardiac glycosides, e.g. digoxin).
  • Medicine to treat epilepsy (e.g. phenytoin).
  • Glucocorticoids, which are used for many conditions such as pain, swelling, allergy, asthma, rheumatism and skin problems.
  • Injectable heparin.
  • Some medicines for depression (e.g. lithium, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase A inhibitors (MAOIs)).
  • Medicines for the temporary suppression of your immune system e.g. methotrexate (for arthritis, psoriasis and some cancers), ciclosporin or tacrolimus (given after transplant surgery).
  • Antidiabetic medicines (sulphonylureas).
  • Medicines used to treat infections (e.g. quinolone antibiotics, trimethoprim).
  • Medicines to help you pass water (water tablets e.g. potassium sparing diuretics).
  • Medicines for gout (e.g. probenecid and sulfinpyrazones).
  • Any anti migraine medicinal products (including ergot alkaloid derivatives medicinal products).
  • Medicine for treating HIV/AIDS (zidovudine).
  • Preparations containing Ginkgo biloba.

Patient Information

Always read the product information. Click on the link below to view the Patient Information Leaflet. Requires Adobe Reader – if you cannot open the file, please
click here to download.

Patient Information Leaflet

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