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PACKAGE LEAFLET: INFORMATION FOR THE USER Apsifen-F Tablets 400 mg (Ibuprofen)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, or pharmacist or nurse has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 10 days.
1. What Aspifen-F Tablets are and what they are used for
2. What you need to know before you take Aspifen-F Tablets
3. How to take Aspifen-F Tablets
4. Possible side effects
5. How to store Aspifen-F Tablets
6. Contents of the pack and other information
1. What Aspifen-f Tablets are and what they are used for
Apsifen-F tablets contain 400 mg of the active ingredient ibuprofen BP. Ibuprofen belongs to a group of medicines called Non Steroidal Anti-Inflammatory Drugs (known as NSAIDs), which relieve pain and reduce inflammation in joints and soft tissues such as muscles and ligaments.
Ibuprofen tablets are used to:
• relieve mild to moderate pain e.g.:- post-operative pain, toothache, period pain and soft tissue injury (muscles and ligaments)
• relieve stiffness and pain in the back and other muscles
• reduce inflammation in different types of arthritis.
2. What you need to know before you take Aspifen-f Tablets Do NOT take Ibuprofen if you:
• are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• have or had an allergic reaction to aspirin or any other NSAID (you have ever had asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)
• have an increased tendency of bleeding
• are suffering from or have a history of repeated stomach ulcers or other gastric complaint
• are suffering from heart failure, which can cause shortness of breath or ankle swelling
• suffer from kidney or liver problems
• are in last 3 months of your pregnancy.
• have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue)
Do not take if you have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation.
There is a risk of renal impairment in dehydrated children and adolescents.
• are elderly
• are suffering from or have a history of bronchial asthma
• have a history of stomach or bowel problems
• have problems with your kidneys, heart or liver
• suffer from high blood pressure
• have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue).
• have a history of gastrointestinal disease
• are severely dehydrated
• have problems conceiving or are in the first 6 months of pregnancy
• are taking any non-steroidal anti-inflammatory medicine, including aspirin as this may result into increased tendency of ulceration or bleeding
• have ulcerated colitis or Crohn’s disease
If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:
• Pass blood in your faeces (stools/ motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds
STOP TAKING the medicine and tell your doctor if your experience:
• Indigestion or heartburn
• Abdominal pain (pains in your stomach) or other abdominal stomach symptoms
Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines of the following:
• any other pain-relieving medication, including aspirin
• an anticoagulant, e.g. warfarin to reduce the clotting of the blood
• a diuretic ('water tablet')
• medicines to treat high blood pressure , e.g. losartan, atenolol, captopril
• medicines for heart problems e.g. digoxin, digitoxin
• lithium, a drug used in the treatment of depression
• methotrexate, a treatment for leukaemia
• medicines known as immunosuppressants such as ciclosporin and tacrolimus dampen down your immune response)
• mifepristone in the last 8 - 12 days, used to end a pregnancy
• corticosteroids, (medicines to treat a variety of conditions such as allergies and imbalances), e.g. aldosterone, hydrocortisone or prednisolone
• quinolone antibiotics, e.g. ciprofloxacin, norfloxacin or levofloxacin
• zidovudine (an anti-viral drug)
• medicines known as selective serotonin reuptake inhibitors (SSRIs), used for the treatment of depression
• any other ibuprofen preparations, such as those you can buy without a prescription
• cholestyramine (a drug used to lower cholesterol)
• medicines known as sulphonylureas such as glibenclamide and glipizide (used to treat diabetes)
• voriconazole or fluconazole (types of anti-fungal drugs)
• Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen)
• aminoglycosides (a type of antibiotic).
Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines, including medicines obtained without a prescription.
The use of Ibuprofen whilst pregnant or breast feeding should be avoided.
Ibuprofen should not be used in the last 3 months of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.
Ibuprofen may make you feel dizzy or drowsy. Please do not drive or operate machinery if you experience this effect.
3. How to take Aspifen-f Tablets
Always take Ibuprofen exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist or nurse if you are not sure.
If you suffer from heart, liver or kidney problems your doctor may lower your dose and carry out regular tests. If you see another doctor or go into hospital, let the doctor or the staff knows what medicines you are taking.
The tablets should be swallowed preferably with a drink of water. Take with or after food.
The recommended dose is:
Maximum dose of 1200 mg per day in divided doses (200 mg-400 mg, up to three times a day as required. The maintenance dose will be determined on an individual basis (in the range 600 - 1200 mg per day).
Leave at least four hours between doses and do not take more than 1200 mg in any 24 hours.
To reduce the possibility of side effects if you are older, you should use the minimum dose for the shortest possible duration. Your doctor may monitor you for bleeding in the stomach.
General sales list
For oral administration and short -term use only.
Adults, the elderly and children over 12 years:
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.
For immediate release preparations: 200mg -400mg, up to three times a day as required.
For prolonged release preparations: 200 mg - 400mg up to twice a day is required.
Leave at least four hours between doses and do not take more than 1200 mg in any 24 hour period.
Do not give to children under 12 years except on the advice of a doctor.
• in children (age range: > 6 months to < 12 years) and/or in adolescents (age range: > 12 years to < 18 years):
If in children aged from 6 months and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
If you (or someone else) swallow a lot of the tablets all together or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause stomach pain, feeling sick, being sick, diarrhoea, ringing in the ears, headache, bleeding in the stomach or intestines.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one.
Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time. If you stop taking Ibuprofen
Do not stop taking your medicine without talking to your doctor first even if you feel better.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, Ibuprofen can cause side effects, although not everybody gets them.
If any of the following happen, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
• an allergic reaction swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)
• Stevens-Johnson syndrome (severe blisters and bleeding in the mucous membranes of the lips, eyes, mouth, nasal passage, and genitals) or severe headache, high temperature, stiffness of the neck, a skin reaction causing blistering and flaking of the skin, intolerance to light
• you pass blood in your faeces (stools/motions)
• you pass black tarry stools
• you vomit any blood or dark particles that look like coffee grounds.
• blood disorders such as low numbers of red or white blood cells, reduction in blood platelets (which may increase the risk of bleeding and bruising), neutropenia (which may cause fever or chills, sore throat, ulcers in your mouth or throat)
• heart problems causing symptoms such as shortness of breath when exercising or lying flat, wheezing and a cough, weight gain
These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.
The following side effects have been reported at the approximate frequencies shown:
Rare: may affect up to 1 in 1,000 people
• abdominal pain (pains in your stomach) or other abnormal stomach symptoms, indigestion, heartburn, feeling sick and/or being sick
• unexplained wheezing, shortness of breath, skin rash, itching or bruising
• yellowing of the eyes and/or skin
• severe sore throat with high fever
• blurred or disturbed vision, or seeing/hearing strange things
• fluid retention (e.g. swollen ankles)
Very rare: may affect up to 1 in 10,000 people
Very rarely Ibuprofen Tablets may cause aseptic meningitis (inflammation of the protective membrane surrounding the brain) especially in patients with an auto-immune disease e.g. Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease; symptoms may include stiff neck, headache, nausea, vomiting, fever, disorientation.
Other side effects (Frequency unknown)
Other side effects that have been reported while taking Ibuprofen:
• peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach
• pancreatitis (inflammation of the pancreas)
• flatulence (wind)
• inflammation or ulceration of the mouth e.g. mouth ulcers and cold sores (ulcerative stomatitis)
• high blood pressure
• kidney problems such as inflammation of the kidneys, kidney damage or kidney failure
• liver problems such as abnormal liver function test results, inflammation of the liver (hepatitis)
• breathlessness and wheezing in patients suffering from or with a previous history of asthma or allergic disease e.g. allergy to house dust mites, cats or dogs
• runny nose
• problems with the senses such as vision problems, inflammation of the optic nerve, pins-and-needles or numbness, ringing in the ears or impaired hearing
• headaches, hallucinations, depression, confusion, dizziness and vertigo (a feeling of dizziness or “spinning, drowsiness and a general feeling of being unwell, lethargy
• difficulty in sleeping, anxiety
Ibuprofen has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis.
Medicines such as ibuprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
You can minimize the risk of side effects by taking the least amount of tablets for the shortest amount of time necessary to control your symptoms.
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
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Aspifen-f Tablets
These tablets should be stored in a dry place, at or below 25° C, protected from light in the package or container supplied. Do not transfer them to another container.
Do not use Ibuprofen after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
• The active ingredient is ibuprofen.
• The other ingredients are maize starch, colloidal silicon dioxide, sodium starch glycollate and stearic acid. The tablet film coating contains hydroxypropylmethylcellulose (E464), talc and the colours erythrosine (E127) and titanium dioxide (E171)
• The Aspifen-F 400 mg tablets are Pink, biconvex film-coated tablets with APS on one side, plain on reverse
• The tablets are available in pack sizes of 7, 10, 14- tablets.
Not all pack sizes may be marketed.
The Marketing Authorisation holder and company responsible for manufacture is TEVA UK Limited, Eastbourne, BN22 9AG England.