Product Details

Product Information of Sudafed Sinus Pressure And Pain

Do not take Sudafed Sinus Pressure & Pain 200mg/30mg Tablets if you:

■ are allergic to ibuprofen or pseudoephedrine hydrochloride or to any of the other ingredients of this medicine (listed in section 6) ■ are younger than 15 years ■ are in the third trimester of pregnancy (6 months or more pregnant) ■ are breast-feeding ■ have had an allergic reaction or shortness of breath, asthma, skin rash, itchy runny nose or facial swelling when previously taking acetylsalicylic acid 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 Warnings and precautions Talk to your doctor or pharmacist before taking Sudafed Sinus Pressure & Pain 200mg/30mg 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 ■ if you are pregnant or breastfeeding ■ have an infection – please see heading “Infections” below ■ 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”). Infections This medicine may hide signs of infections such as fever and pain. It is therefore possible that this medicine may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay. Sudden abdominal pain or rectal bleeding may occur with this medicine, due to inflammation of the colon (ischaemic colitis). If you develop these gastro-intestinal symptoms, stop taking Sudafed Sinus Pressure & Pain 200mg/30mg Tablets and contact your doctor or seek medical attention immediately. See section 4. If you develop a feverish generalised erythema associated with pustules, stop taking Sudafed Sinus Pressure & Pain 200mg/30mg Tablets and contact your doctor or seek medical attention immediately. See section 4. 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 (see section “Other medicines and Sudafed Sinus Pressure & Pain 200mg/30mg Tablets” below) 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 200 mg/30 mg 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 have been reported in association with Sudafed Sinus Pressure & Pain 200 mg/30 mg Tablets treatment. You should stop taking this medicine and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4. Reduction of blood flow to your optic nerve may occur with this medicine. If you develop sudden loss of vision, stop taking this medicine and contact your doctor or seek medical attention immediately. See section 4. Interference with blood test result 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. Children and adolescents Sudafed Sinus Pressure & Pain 200mg/30mg 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. Other medicines and Sudafed Sinus Pressure & Pain 200mg/30mg Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Sudafed Sinus Pressure & Pain 200mg/30mg 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). Some other medicines may also affect or be affected by the treatment of Sudafed Sinus Pressure & Pain 200mg/30mg Tablets. Always seek the advice of a doctor before you use Sudafed Sinus Pressure & Pain 200mg/30mg Tablets with other medicines. Sudafed Sinus Pressure & Pain 200mg/30mg 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 Being given pseudoephedrine may cause a sudden increase in blood pressure around the time of your surgery. Discontinue treatment with Sudafed Sinus Pressure & Pain 200mg/30mg Tablets several days before surgery and inform your anaesthetist. Sudafed Sinus Pressure & Pain 200mg/30mg Tablets with alcohol You should avoid alcohol intake during the treatment. Pregnancy, breast-feeding and fertility 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. Pregnancy Avoid the use of this medicine in the first 6 months of pregnancy unless your doctor advises otherwise. Do not take Sudafed Sinus Pressure & Pain 200mg/30mg Tablets during the third trimester of pregnancy. Breast-feeding Do not take this medicine if you are breastfeeding, as it may harm your baby. Fertility Ibuprofen belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible upon stopping the medicine. Driving and using machines Sudafed Sinus Pressure & Pain 200mg/30mg 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. Sudafed Sinus Pressure & Pain 200 mg/30 mg tablets contains sodium This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say “sodium free”