IBUPROFEN/PARACETAMOL 200/500 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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 have 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. 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.

What is in this leaflet

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

• 2. What you need to know before you take Ibuprofen/Para­cetamol

• 3. How to take Ibuprofen/Para­cetamol

• 4. Possible side effects

• 5. How to store Ibuprofen/Para­cetamol

• 6. Contents of the pack and other information

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 antiinflammatory 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 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.

Skin reactions

Serious skin reactions have been reported in association with Ibuprofen/Para­cetamol treatment. You should stop taking Ibuprofen/Para­cetamol 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.

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.

Do not take Ibuprofen/Paracetamol with

- 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 (ACEinhibitors 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.

{[Product name}] with food

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. Take special care if you are in the first 6 months of pregnancy.

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.

Only use the minimum effective dose for the shortest time necessary to relieve your symptoms. You should not take Ibuprofen/Para­cetamol for longer than 3 days. If your symptoms worsen or persist, consult your doctor.

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:

- 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)

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

• - A red, scaly widespread rash with bumps under the skin and blisters mainly localized

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: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- 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

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,

Greece

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in 04/2020