Warnings or Restrictions
Skin reactions Serious skin reactions have been reported in association with Fenpaed Oral Suspension treatment. You should stop taking Fenpaed Oral Suspension 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 including a life-threatening widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals. These are known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS). See section 4. There is a risk of renal (kidney) impairment in dehydrated children. If you are taking Fenpaed Oral Suspension for longer than the recommended time or at higher than recommended doses you are at risk of serious harms. These include serious harms to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4). You should discuss your child’s treatment with your child’s doctor or pharmacist before giving Fenpaed Oral Suspension, if your child: • has high blood pressure, kidney or liver problems • has asthma or diabetes • has lupus or a mixed connective tissue disease • has a chronic inflammatory intestinal disease such as ulcerative colitis, Crohn's disease or gastrointestinal bleeding • has chickenpox • has an infection - please see heading “Infections” below. This product is intended for children aged between 3 months and 12 years. If you are an adult taking this product, all the above statements apply and so do the following additional warnings: • Do NOT take this product if you are taking aspirin at doses above 75 mg daily. If you are on low dose aspirin (up to 75 mg daily) speak to your doctor or pharmacist before you take this product. • Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack (‘myocardial infarction’) or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment. • Do not take if you are in the last three months of pregnancy. Speak to your doctor or pharmacist before taking if; • you are in the first six months of pregnancy • you are elderly • you are trying to get pregnant. Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that Ibuprofen, used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant • if you have 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’) • if you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker. Infections Fenpaed Oral Suspension may hide signs of infections such as fever and pain. It is therefore possible that Fenpaed Oral Suspension 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. The use of painkillers for a long period of time has been linked to headaches in some patients, a condition called medication overuse headache (MOH). Patients who have frequent or daily headaches despite (or because of) the regular use of pain killers should not be treated with increased doses of Fenpaed Oral Suspension. Tell your doctor if you have been having headaches while taking this medicine.
