Panacombo Dual Action Pain Relief 200mg/500mg film-coated tablets

1. What is this medicine and what is it used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

• are already taking any other paracetamol containing products
• are taking any other pain-relieving products including ibuprofen, high dose aspirin (above 75 mg per day), or other non-steroidal anti-inflammatory drugs (NSAIDs) including cyclo- oxygenase-2 (COX-2) specific inhibitors
• are allergic to ibuprofen, paracetamol or any other ingredients in this medicine
• are allergic to aspirin or other NSAID painkillers
• have or ever had an ulcer or bleeding in your stomach or duodenum (small bowel)
• have a blood clotting (coagulation) disorder
• suffer from heart, liver or kidney failure
• are in the last 3 months of pregnancy
• are under 18 years old.

Talk with your doctor or pharmacist before taking this medicine 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 breastfeeding
• are planning to become pregnant
• have an infection - please see heading “Infections” below.

During treatment with this medicine, tell your doctor straight away 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).

This medicine may hide signs of infections such as fever and pain. It is therefore possible that this medicine 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.

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

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 take this medicine if you have not tried using either ibuprofen or paracetamol individually to relieve your pain. See section 3.

You should discuss your treatment with your doctor or pharmacist before taking this medicine 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.

Do not exceed the recommended dose or duration of treatment.

• Do not take this medicine with: other paracetamol containing products
• other NSAID containing products such as aspirin, ibuprofen.

Do not take if you are taking more than 75 mg of aspirin a day. If you are on low-dose aspirin (up to 75 mg daily) speak to your doctor or pharmacist before you take this medicine.

• Some other medicines may also affect or be affected by the treatment of this medicine. You should therefore always seek the advice of your doctor or pharmacist before you use this medicine with other medicines. For example:
• corticosteroid tablets
• antibiotics (e.g. chloramphenicol or quinolones)
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality called metabolic acidosis) that must have urgent treatment (see section 2)
• anti sickness medicines (e.g. metoclopramide, domperidone)
• anti-coagulant medicines (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• heart stimulants (e.g. glycosides)
• medicines for high cholesterol (e.g. cholestyramine)
• diuretics (to help you pass water)
• medicines to reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
• 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)

If you are taking this medicine 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).

This medicine, 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.

To reduce the likelihood of side effects, take this medicine with food.

Ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine if you are in the last 3 months of 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 this medicine 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, this medicine 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. Do not take if you are breastfeeding. Talk to your doctor or pharmacist if you are in the first 6 months of pregnancy.

This medicine may make it more difficult to become pregnant. Ibuprofen belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. You should inform your doctor if you are planning to become pregnant or have problems becoming pregnant.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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

Symptoms of overdose 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.

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.

• 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)
• signs of hypersensitivity and skin reactions such as 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)
• high blood pressure, water retention
• liver problems (causing yellowing of the skin and white of eyes)
• kidney problems (causing increased or decreased urination, swelling of the legs)
• heart failure (causing breathlessness, swelling)
• 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)
• a red, scaly widespread rash with bumps under the skin and blisters mainly localised on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis) (frequency not known) See also section 2.
• skin becomes sensitive to light (frequency not known).

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)
• change in kidney function (shown in blood tests)
• excessive sweating.

Uncommon may affect up to 1 in 100 people:

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

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 nosebleeds. Stop taking this medicine and contact a doctor at once if this occurs)
• visual disturbances, ringing in the ears, spinning sensation
• confusion, depression, hallucinations
• fatigue, generally feeling unwell
• mouth ulcer
• inflammation of the pancreas
• worsening of ulcerative colitis and Crohn’s disease
• ‘pins and needles’ e.g. pricking, tingling, burning or numbing sensation
• inflammation of the optic nerve, sensitivity to light

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

• chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome
• a serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2)

Medicines such as this may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. (see section 2).

Like all medicines, this medicine can cause side-effects, although not everybody gets them. Tell your doctor or pharmacist if you notice any of the following:

• Liver, kidney problems or difficulty urinating This medicine, 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.

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 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.

• The active substance are ibuprofen and paracetamol. Each film-coated tablet contains ibuprofen 200 mg and paracetamol 500 mg.
• The other ingredients are croscarmellose sodium; hydroxypropylcellulose; microcrystalline cellulose; silica, colloidal anhydrous; stearic acid; magnesium stearate.
  Film-coating: polyvinyl alcohol, calcium carbonate (E170), carmellose sodium, microcrystalline cellulose, stearic acid.

This medicine is in the form of white or almost white film-coated oval tablets. Size of the film-coated tablet - length: 18.9-19.4 mm, width: 8.9-9.3 mm.

This medicine is packed in child-resistant Aluminium and PVC/PVDC blisters containing 10, 16 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

Trade Marks are owned by or licensed to the Haleon group of companies.