Paracetamol/Ibuprofen 500mg/150mg Film-Coated Tablets
Actavis Logo
Package leaflet: Information for the patient Paracetamol/Ibuprofen 500mg/150mg Film-coated Tablets
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, 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, 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 3 days.
- The full name of this medicine is Paracetamol/Ibuprofen 500mg/150mg Film-coated Tablets but within the leaflet it will be referred to as Paracetamol/Ibuprofen Tablets.
What is in this leaflet
1. What Paracetamol/Ibuprofen Tablets is and what it is used for
2. What you need to know before you take Paracetamol/Ibuprofen Tablets
3. How to take Paracetamol/Ibuprofen Tablets
4. Possible side effects
5. How to store Paracetamol/Ibuprofen Tablets 6. Contents of the pack and other information
1. What Paracetamol/Ibuprofen Tablets is and what it is used for
Paracetamol/Ibuprofen Tablets contains both paracetamol and ibuprofen.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (or NSAIDs). It relieves pain and reduces inflammation (swelling, redness or soreness) and reduces fever. Paracetamol is an analgesic which relieves pain and reduces fever.
Paracetamol/Ibuprofen Tablets is used for temporary relief of acute pain such as headache (not migraine), backache, dental pain, muscular pain and sore throat. Paracetamol/Ibuprofen Tablets is also used for fever.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
2. What you need to know before you take Paracetamol/Ibuprofen Tablets Do not take Paracetamol/Ibuprofen Tablets:
• if you are allergic to paracetamol and/ or ibuprofen or any of the other ingredients of this medicine (listed in section 6)
• if you have or have had any gastrointestinal bleeding which can be shown as bleeding from the back passage, black sticky stools or bloody diarrhoea
• you have a peptic ulcer (i.e. stomach or duodenal ulcer), a recent history of one, or have had peptic ulcers before
• if you have had asthma, hives, or allergic-type reactions after taking acetylsalicylic acid (aspirin)(above 75mg per day) or other non-steroidal anti-inflammatory drugs (NSAIDs)
• if you regularly drink large quantities of alcohol
• if you have severe kidney or liver failure
• if you have severe heart failure
• if you have bleeding in the brain or other active bleeding
• if you have problems with blood formation and an increased tendency to bleed
• during the last three months of pregnancy.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Paracetamol/Ibuprofen Tablets
• you have liver disease or kidney disease or if you are dehydrated
• you are taking other painkilling medicine, including paracetamol and non-steroidal antiinflammatory drugs (NSAIDs) and acetylsalicylic acid (aspirin) as this may increase the risk of serious side-effects
• you are elderly (over 65 years old), since there is an increased risk of side effects
• you currently have chicken pox
• you have porphyria
• you have or have had other medical conditions including:
- heart disease or high blood pressure
- heartburn, indigestion, stomach ulcer or any other stomach problems
- severe skin reactions such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrosis (TEN)
- asthma
- tendency to bleed or other blood problems
- bowel or intestinal problems such as ulcerative colitis or Crohn’s disease
- heart failure, swelling of ankles or feet
- autoimmune disease such as systemic lupus erythematosus (SLE).
Prolonged or frequent use of pain relieving medication can cause headaches which should not be treated by increasing the dose. If this happens, stop taking the medication and consult your doctor.
Never take more of Paracetamol/Ibuprofen Tablets than recommended. A higher dose does not increase pain relief; instead it can cause serious liver damage. The symptoms of liver damage occur first after a few days. It is therefore very important that you contact your doctor as soon as possible if you have taken more Paracetamol/Ibuprofen Tablets than recommended in this leaflet.
Do not use Paracetamol/Ibuprofen Tablets without a doctor’s prescription if you have alcohol problems or liver damage and do not use Paracetamol/Ibuprofen Tablets together with alcohol. The intoxicating effect of alcohol does not increase by taking Paracetamol/Ibuprofen Tablets.
Tell your doctor that you are using Paracetamol/Ibuprofen Tablets if your doctor orders a urine test, since this medicine can cause an incorrect test response in some tests.
Like other fever reducing medicines Paracetamol/Ibuprofen Tablets can mask signs of infection.
Children and adolescents
Paracetamol/Ibuprofen Tablets should not be used in children and adolescents under 18 years. Other medicines and Paracetamol/Ibuprofen Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Paracetamol/Ibuprofen Tablets can affect or be affected by treatment with certain medicines, including:
• medicines used to thin the blood or prevent blood clots (e.g. warfarin, ticlopidine or clopidogrel)
• medicines to treat epilepsy or fits (e.g. phenytoin, phenobarbital, carbamazepine)
• chloramphenicol, an antibiotic used to treat ear and eye infections
• probenecid, a medicine used to treat gout
• zidovudine a medicine used to treat HIV (the virus that causes AIDS)
• medicines used to treat tuberculosis such as isoniazid and rifampicin
• acetylsalicylic acid (aspirin), salicylates or other NSAID medicines
• medicines to treat high blood pressure (e.g. ACE inhibitors or angiotensin receptor antagonists)
• medicines to treat heart conditions (e.g. digoxin or beta blockers)
• mifepristone, a medicine used for medical termination of a pregnancy
• diuretics, also called fluid tablets
• medicines used to treat mania or depression (e.g. lithium or SSRIs)
• methotrexate, a medicine used to treat arthritis and some types of cancer
• corticosteroids, such as prednisone, cortisone
• anti sickness medicines (e.g. metoclopramide and domperidone)
• medicines for high cholesterol (e.g. Cholestyramine)
• tacrolimus or ciclosporin, immunosuppressive drugs used after organ transplant
• sulphonylureas: medicines used to treat diabetes
• a type of antibiotic known as aminoglycosides
• antifungal medicines such as voriconazole or fluconazole.
Your doctor and pharmacist will have more information about these medicines and how to act.
Do not use different types of pain-relieving medicines at the same time unless directed by a doctor (see also section “Warnings and precautions”).
Paracetamol/Ibuprofen Tablets with alcohol
Do not use Paracetamol/Ibuprofen Tablets without a doctor’s prescription if you have alcohol problems or a liver damage and do not use Paracetamol/Ibuprofen Tablets together with alcohol.
The intoxicating effect of alcohol does not increase by taking Paracetamol/Ibuprofen Tablets .
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.
Pregnant women should not use Paracetamol/Ibuprofen Tablets during the three final months of the pregnancy.
Use of Paracetamol/Ibuprofen Tablets should be avoided by women who are planning a pregnancy or are pregnant. Treatment at any time in pregnancy should only take place if clearly necessary and as directed by a doctor.
Paracetamol/Ibuprofen Tablets may be used during breast-feeding if used for short term treatment at the recommended dose.
The use of Paracetamol/Ibuprofen Tablets may affect fertility. The use of ibuprofen is not recommended while attempting to conceive or during investigation of infertility.
Driving and using machines
Paracetamol/Ibuprofen Tablets may cause dizziness, drowsiness, fatigue and visual disturbances in some people. This should be taken into consideration on occasions when high alertness is required, e.g. driving. Be careful driving or operating machines until you know how Paracetamol/Ibuprofen Tablets affects you.
Paracetamol/Ibuprofen Tablets contains Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
3. How to take Paracetamol/Ibuprofen Tablets
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Paracetamol/Ibuprofen Tablets is for short term use only
The lowest effective dose should be used for the shortest possible duration.
Higher doses than recommended may lead to serious risks.
Adults: The recommended dose is 1 to 2 tablets taken every 6 hours, as required.
Do not take more than 8 tablets in a 24 hours period.
Take Paracetamol/Ibuprofen Tablets with or without food with a full glass of water.
The score-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Elderly: There is no indication that the dosage needs to be modified in the elderly, but if you are elderly you may be more prone to serious side effects, especially bleeding and perforation in the digestive tract.
Liver or kidney problems: If you have liver or kidney problems, your dose may need to be reduced or the time between doses increased, so ask your doctor for advice.
If you take more Paracetamol/Ibuprofen Tablets than you should
• Talk to your doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage.
If you forget to take Paracetamol/Ibuprofen Tablets
If it is almost time for your next dose, skip the dose missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking you tablets as you would normally. Do not take a double dose to make up for the dose that you missed.
If you are not sure whether to skip the dose, talk to your doctor or pharmacist.
Always leave at least 6 hours between doses
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, talk to your doctor or pharmacist.
If any of these serious side effects happen, stop taking Paracetamol/Ibuprofen Tablets and tell your doctor immediately or go to the emergency room at your nearest hospital:
Uncommon (may affect up to 1 in 100 people):
• vomiting blood or material that looks like coffee grounds. Bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea. These can all be signs of intestinal bleeding
• swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing. Sudden or severe itching (pruritus), skin rash, hives (urticaria). These can all be signs of a severe allergic reaction
• fever, generally feeling unwell, nausea, stomach ache, headache and stiff neck. These can be signs of inflammation of the brain lining.
Very Rare (may affect up to 1 in 10,000 people):
• asthma, wheezing, shortness of breath.
Very rare cases of serious skin reactions have been reported.
Other side effects:
Common (may affect up to 1 in 10 people):
• changes in liver or kidney function (established by blood tests)
• ringing in the ears (tinnitus)
• nausea or vomiting
• heartburn or stomach pain
• cramps, bloating, flatulence, stomach discomfort, constipation or diarrhoea
• skin rashes, itching, swelling of the lips, eyes, hands or feet
• vertigo
• fatigue, agitation, irritability, nervousness
• headache, dizziness
• fluid retention and swelling, which usually responds to stopping the treatment.
Uncommon (may affect up to 1 in 100 people):
• peptic ulcer, gastrointestinal bleeding, abdominal pain (gastritis)
• inflammation of the lips and mouth (stomatitis)
• worsening of existing ulcerative colitis or Crohn’s disease
• inflammation of the pancreas (pancreatitis)
• difficulty urinating
• changes in the numbers of red or white blood cells or other changes to blood composition or acidity (established by blood tests)
• breast enlargement (in males)
• abnormally low blood sugar (hypoglycaemia)
• change in mood, for example depression, confusion, emotional instability, insomnia, sleepiness
• signs of anaemia, such as tiredness, headaches, being short of breath, and looking pale
• signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers
• bleeding or bruising more easily than normal, reddish or purplish blotches under the skin
• allergic reactions
• eye problems such as blurred vision, changes in colour vision or blind spots
• fast or slow heart rate
• skin reactions and sensitivity to light
• kidney problems causing increased or decreased urination, swelling of the legs, blood in the urine or pain in the side of the abdomen
• hair loss.
Rare (may affect up to 1 in 1,000 people):
• tingling of the hands and feet
• abnormal dreams, hallucinations.
Very Rare (may affect up to 1 in 10,000 people):
• movement problems such as inability to keep still or inability to start and control movement
• anxiety and restlessness
• uncontrolled shaking or convulsions (fits)
• intestinal blockage
• flesh-eating infection, unusual weight gain, swelling of ankles or legs
• symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal.
• excessive sweating
• fast or irregular heartbeats, also called palpitations
• heart failure, heart attack, high blood pressure or low blood pressure
• kidney failure
• liver problems and yellowing of the skin and /or eyes, also called jaundice 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 Website: 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 Paracetamol/Ibuprofen Tablets
Keep this medicine out of the sight and reach of children and adolescents.
O
Store below 30 C.
Store in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP: ’. 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 protect the environment.
6. Contents of the pack and other information
What Paracetamol/Ibuprofen Tablets contains
• The active substances are paracetamol and ibuprofen. Each film-coated tablet contains 500 mg of paracetamol and 150 mg of ibuprofen.
• The other ingredients are: maize starch, pre-gelatinised maize starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc. Tablet coating: HPMC 2910/Hypromellose 15cP (E464), Lactose monohydrate, Titanium dioxide (E171), Macrogol/PEG-4000, Sodium citrate-dihydrate (E331).
What Paracetamol/Ibuprofen Tablets look like and contents of the pack
Paracetamol/Ibuprofen Tablets Film-coated Tablets are white, capsule shaped, film-coated tablets, 19mm in length, with score-line on one side and plain on the other side.
They come in blister packs containing 8, 10, 12, 16, 20, 24, 30, 32 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str
Dupnitsa
2600
Bulgaria
This leaflet was last revised in September 2015.
If you would like a leaflet with larger text, please contact
01271 385257.
Logo Actavis
Pil Spec no