Patient leaflet - Ibuprofen/paracetamol 200/500 mg film-coated tablets

1. What Ibuprofen/Paracetamol is and what it is used for

Ibuprofen/Paracetamol contains two active ingredients (which make the medicine work). These are ibuprofen and paracetamol.

Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by reducing pain, reducing swelling and lowering high temperatures.

Paracetamol is an analgesic which works in a different way from ibuprofen to relieve pain and fever. This product is especially suitable for pain which requires stronger analgesia than ibuprofen or paracetamol alone.

Ibuprofen/Paracetamol is used for the temporary relief of mild to moderate pain associated with migraine, headache, backache, period pain, dental pain, rheumatic and muscular pain, pain of non-serious arthritis, cold and flu symptoms, sore throat and fever.

Ibuprofen/Paracetamol is used in adults aged 18 years and older.

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 Ibuprofen/Paracetamol

Do not take Ibuprofen/Paracetamol if you

are already taking any other paracetamol-containing medicine
are taking any other pain relieving medicines including ibuprofen, high dose acetylsalicylic acid/ aspirin (above 75 mg per day), or other non-steroidal anti-inflammatory drugs (NSAIDs) including cyclo-oxygenase-2 (COX-2) specific inhibitors. If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take Ibuprofen/Paracetamol.
are allergic to ibuprofen, paracetamol or any of the other ingredients of this medicine (listed in section 6)
are allergic to acetylsalicylic acid/ aspirin or other NSAID painkillers
have or ever had an ulcer or bleeding in your stomach or duodenum (small bowel)
have blood clotting (coagulation) disorder
suffer from heart, liver or kidney failure
are in the last 3 months of pregnancy

Warnings and precautions

Talk to your doctor or pharmacist before taking Ibuprofen/Paracetamol if you

are elderly
have asthma or have suffered from asthma
have kidney, heart, liver or bowel problems
have an infection – please see heading “Infections” below
have Systemic Lupus Erythematosus (SLE) – a condition of the immune system affecting connective tissue resulting in joint pain, skin changes and disorder of other organs or other mixed connective tissue disease
have gastrointestinal disorders or chronic inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease
are in the first 6 months of pregnancy or are breast-feeding
are planning to become pregnant

Anti-inflammatory/pain-killer medicines such as 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.

If you are taking < Ibuprofen/Paracetamol > 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).

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema), chest pain have been reported with ibuprofen. Stop immediately Ibuprofen/Paracetamol and contact immediately your doctor or medical emergencies if you notice any of these signs.

During treatment with Ibuprofen/Paracetamol, tell your doctor straight away if:

If you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).

Infections

Ibuprofen/ Paracetamol may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen/ Paracetamol 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.

Skin reactions

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with Ibuprofen/Paracetamol treatment. Stop using Ibuprofen/Paracetamol and seek medical attention immediately if you you notice any of the symptoms related to these serious skin reactions described in section 4.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen/Paracetamol 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 of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”)
have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Other medicines and Ibuprofen/Paracetamol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Please inform your doctor or pharmacist if you are taking:

-flucloxacillin (antiobitic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

Do not take Ibuprofen/Paracetamol with

other paracetamol containing medicines
other NSAID-containing medicines such as acetylsalicylic acid/ aspirin, ibuprofen.

Special care is required as some medicines may interact with Ibuprofen/Paracetamol, for example:

corticosteroid tablets
antibiotics (e.g. chloramphenicol or quinolones)
anti-sickness medicines (e.g. metoclopramide, domperidone)
heart stimulants (e.g. glycosides)
medicines for high cholesterol (e.g. cholestyramine)
diuretics (to help you pass water)
medicines to suppress the immune system (e.g. methotrexate, ciclosporine, tacrolimus)
medicines for mania or depression (e.g. lithium or SSRIs)
mifepristone (for pregnancy termination)
HIV medicines (e.g. zidovudine).

Ibuprofen/Paracetamol may affect or be affected by some other medicines.

For example:

medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. acetylsalicylic acid/ aspirin, 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 Ibuprofen/Paracetamol. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen/Paracetamol with other medicines.

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To reduce the likelihood of side effects, take Ibuprofen/Paracetamol with food.

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. Do not take Ibuprofen/Paracetamol if you are in the last 3 months of your pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take Ibuprofen/Paracetamol during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Ibuprofen/Paracetamol can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.Ibuprofen/Paracetamol may make it more difficult to become pregnant.

Ibuprofen: Ibuprofen belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that if you only take ibuprofen occasionally it will affect your chances of becoming pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Paracetamol: If necessary, Ibuprofen/Paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible. Contact your doctor or pharmacist if the pain and/or fever are not reduced or if you need to take the medicine more often.

Driving and using machines

Ibuprofen/Paracetamol may cause dizziness, impaired concentration and drowsiness.

If you are affected, do not drive and do not use any tools or machines.

3. How to take Ibuprofen/Paracetamol

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

Adults: The recommended dose is 1 tablet with water and food, up to 3 times a day.

Leave at least 6 hours between doses.

If one tablet does not control symptoms, then a maximum of 2 tablets may be taken up to three times a day.

Do not take more than six tablets in any 24 hour period (equivalent to 1200 mg ibuprofen and 3000 mg paracetamol a day).

Use in children and adolescents

Not for use by children and adolescents under 18 years.

For oral use and for short term use only.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. You should not take Ibuprofen/Paracetamol for longer than 3 days. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

If you take more Ibuprofen/Paracetamol than you should

If you have taken more Ibuprofen/Paracetamol than you should, or if children have taken Ibuprofen/Paracetamol by accident, always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.

The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling and breathing problems have been reported.

Talk to a 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 Ibuprofen/Paracetamol

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember it and then take the next dose at least 6 hours later.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP TAKING the medicine and tell your doctor if you experience:

heartburn, indigestion
signs of intestinal bleeding (severe stomach pain, vomiting blood or liquid with what looks like coffee granules, blood in the stools/motions, black tarry stools)
signs of inflammation of the brain lining such as: stiff neck, headache, feeling or being sick, fever or feeling disorientated
signs of a severe allergic reaction (swelling of the face, tongue or throat, difficult breathing, worsening of asthma)
severe skin reaction known as DRESS syndrome (frequency not known). Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

Other possible side effects

Common (may affect up to 1 in 10 people)

stomach pain or discomfort, feeling or being sick, diarrhoea
higher levels of liver enzymes (shown in blood tests)
-

Uncommon (may affect up to 1 in 100 people)

headache and dizziness, wind and constipation, skin rashes, swelling of the face
reduction in red blood cells number or increase in platelets (blood clotting cells) number

Very rare (may affect up to 1 in 10,000 people)

reduction in blood cells (causing sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding, bruising and nose bleeds)
visual disturbances, ringing in the ears, spinning sensation
confusion, depression, hallucinations
fatigue, generally feeling unwell
severe skin reactions such as blistering
high blood pressure, water retention
liver problems (causing yellowing of the skin and whites of the eyes)
kidney problems (causing increased or decreased urination, swelling of the legs)
heart failure (causing breathlessness, swelling)

<Ibuprofen/Paracetamol>, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

Not known (frequency cannot be estimated from the available data)

reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalized exanthematous pustulosis).
A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).

Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medicines such as Ibuprofen/Paracetamol may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke (see section 2).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuprofen/Paracetamol

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Ibuprofen/Paracetamol contains

The active substances are ibuprofen and paracetamol. Each film-coated tablet contains 200 mg of ibuprofen and 500 mg of paracetamol.

The other ingredients are: Tablet core: maize starch, crospovidone (Type A) (E1202), silica, colloidal anhydrous (E551), povidone K-30 (E1201), starch, pregelatinized (maize), talc (E553b), stearic acid (50).

Film-coating: poly(vinyl alcohol) (E1203), talc (E553b), macrogol 3350 (E1521), titanium dioxide (E171).

What Ibuprofen/Paracetamol looks like and contents of the pack

Ibuprofen/Paracetamol film-coated tablets are white to off-white, oval shaped, film-coated tablets with dimensions of 19.7 mm x 9.2 mm.

They are available in blisters in cartons of 16 or 20 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

PharOS-Pharmaceutical Oriented Services Ltd

Lesvou str. (end), Thesi Loggos, Industrial Zone,

144 52 Metamorfossi Attikis,

Greece

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. Box 3012 Larisa Industrial Area

41004 Larisa,