Health:- Fever, Moderate Pain, ( Ibuprofen + Paracetamol )

Main use	Active ingredient	Manufacturer
Mild to moderate pain	Ibuprofen 200mg, paracetamol 500mg	Cipla, Mankind, Ranbaxy, etc

How does it work?

Nuromol tablets contain two active ingredients, ibuprofen and paracetamol, which are simple painkilling medicines used to relieve mild to moderate pain and fever. (NB. Both paracetamol and ibuprofen are also available without brand names, ie asgeneric medicines.)

Ibuprofen is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). It works by blocking the action of a substance in the body called cyclo-oxygenase (COX). Cyclo-oxygenase is involved in the production of various chemicals in the body, some of which are known as prostaglandins. Prostaglandins are produced in response to injury and certain diseases and conditions, and cause pain, swelling and inflammation. NSAIDs block the production of these prostaglandins and are therefore effective at reducing inflammation and pain.

Ibuprofen also reduces fever by reducing the production of prostaglandins. Fever is associated with an increase in prostaglandins in the brain, and these prostaglandins cause the body temperature to increase. By reducing prostaglandins in the brain, ibuprofen lowers body temperature and hence reduces fever.

Despite its widespread use for over 100 years, we still don't fully understand how paracetamol works to relieve pain and reduce fever. However, it is now thought that it works by reducing the production of prostaglandins in the brain and spinal cord.

It is thought paracetamol reduces fever by affecting an area of the brain that regulates our body temperature (the hypothalamic heat-regulating centre).

What is it used for?

• Short-term treatment relief of mild to moderate pain, such as headache,migraine, toothache, sore throat, muscular and rheumatic pain, non-serious arthritis, backache (lumbago), strains and sprains and period pain.
• Cold and flu symptoms.
• Fever.

This combination product can be used if you want a painkiller stronger than paracetamol or ibuprofen taken on its own.

How do I take it?

• Adults over 18 years can take one tablet with water up to three times a day. Leave at least six hours between doses.
• If one tablet does not relieve your symptoms, you can take a maximum of two tablets up to three times a day.
• The tablets should preferably be taken with food to minimise any side effects on your gut.

Warning!

• Do not exceed the dose recommended in the leaflet supplied with this medicine. No more than two tablets together and no more than six tablets in 24 hours.
• The minimum effective dose should be used for the shortest time necessary to relieve your symptoms. If symptoms persist despite treatment, seek medical advice from your doctor or pharmacist.
• Do not take this medicine for longer than three days without consulting your doctor.
• Taking a painkiller for headaches too often or for too long can actually make the headaches worse.
• Do not take this medicine with any other products that contain paracetamol or ibuprofen. Many over-the-counter painkillers and cold and flu remedies contain paracetamol or ibuprofen. It is important to check the ingredients of any medicines you buy without a prescription before taking them in combination with this medicine. Seek further advice from your pharmacist.
• An overdose of paracetamol is dangerous and capable of causing serious damage to the liver and kidneys. You should never exceed the dose stated in the information leaflet supplied with this medicine. Immediate medical advice should be sought in the event of an overdose with this medicine, even if you feel well, because of the risk of delayed, serious liver damage.
• Ibuprofen is generally well-tolerated and most people do not experience any side effects. The most common side effects are related to stomach irritation and include abdominal pain, indigestion and nausea. These can mainly be avoided by taking the ibuprofen with food. Rarely, serious side effects such as ulceration or bleeding in the stomach or intestines may occur. These are more likely with high doses and in elderly people. If you experience any sign of bleeding from the stomach or bowels after taking this medicine, for example vomiting blood and/or passing black/tarry/bloodstained stools, you should stop taking this medicine and consult your doctor immediately.
• Very rarely, NSAIDS may cause serious blistering or peeling skin reactions (eg Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis). For this reason, you should stop taking this medicine and consult your doctor if you get a skin rash or sores inside your mouth while taking this medicine.

Use with caution in

• Elderly people.
• History of disorders affecting the stomach or intestines.
• Inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
• Decreased kidney function.
• Decreased liver function.
• Heart failure.
• High blood pressure (hypertension).
• People taking anticoagulant medicines.
• History of asthma.
• History of allergies.
• Diseases affecting connective tissue, eg systemic lupus erythematosus.

Not to be used in

• People in whom aspirin or other NSAIDs, eg diclofenac, cause allergic reactions such as asthma attacks, itchy rash (urticaria), nasal inflammation (rhinitis) or swelling of the lips, tongue and throat (angioedema).
• Active peptic ulcer or a history of this.
• People who have ever experienced bleeding or perforation of the gut as a result of previous treatment with an NSAID.
• Severe heart failure.
• Severe kidney failure.
• Severe liver failure.
• People with blood clotting problems.
• People taking other NSAIDs, including COX-2 inhibitors (see end of factsheet for more details).
• People taking other medicines that contain paracetamol or ibuprofen.
• Children under 18 years of age.
• Third trimester of pregnancy.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• This medicine should not be used during pregnancy unless considered essential by your doctor. This is particularly important in the first and third trimesters. It should not be used in the third trimester because it may delay labour, increase the length of labour and cause complications in the newborn baby. Some evidence suggests that NSAIDs should also be avoided by women attempting to conceive, as they may temporarily reduce female fertility during treatment and may also increase the risk of miscarriage or malformations. Seek medical advice from your doctor.
• Small amounts of this medicine may pass into breast milk, however there are no known harmful effects when it is used by breastfeeding mothers.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Disturbances of the gut such as nausea, vomiting, abdominal pain, indigestion, diarrhoea.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Headache.
• Dizziness.
• Flatulence .
• Constipation.
• Skin reactions such as itching, hive-like rash.
• Swelling of the lips, tongue and throat (angioedema).
• Stomach or duodenal ulcer.
• Bleeding from the stomach or intestine.

Very rare (affect less than 1 in 10,000 people)

• Severe allergic reactions such as severe skin rashes, swelling of the lips, tongue and throat (angioedema) or narrowing of the airways (bronchospasm or asthma attacks).
• Sensation of spinning (vertigo).
• Ringing or other noise in the ears (tinnitus).
• Visual disturbances.
• Confusion.
• Depression.
• Excessive sweating.
• Kidney, liver or blood disorders.
• Retention of water in the body tissues (fluid retention), resulting in swelling (oedema).
• Increased blood pressure (hypertension).
• Heart failure.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start taking this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

You should not take this medicine if you are taking painkilling doses of aspirin(above 75mg per day) or any other oral NSAID, (eg naproxen, diclofenac, ibuprofen) as this increases the risk of side effects on the stomach and intestines. People taking selective inhibitors of COX-2 such as celecoxib or etoricoxib should not take this medicine for the same reason.

There may be an increased risk of ulceration or bleeding in the gut if this medicine is taken with corticosteroids such as prednisolone.

There may also be an increased risk of bleeding in the gut if this medicine is taken with the following medicines:

• anti-blood-clotting (anticoagulant) medicines such as warfarin
• antiplatelet medicines to reduce the risk of blood clots or 'thin the blood', eg low-dose aspirin, dipydridamole, clopidogrel
• dabigatran
• erlotinib
• SSRI antidepressants, eg fluoxetine, paroxetine, citalopram
• venlafaxine.

There may be an increased risk of side effects on the kidneys if ibuprofen is taken in combination with any of the following medicines:

• ACE inhibitors, eg enalapril
• ciclosporin
• diuretics, eg furosemide
• tacrolimus.

Ibuprofen may reduce the removal of the following medicines from the body and so may increase the blood levels and risk of side effects of these medicines:

• digoxin
• lithium
• methotrexate.

Ibuprofen may oppose the blood pressure lowering effects of certain medicines to treat high blood pressure, such as the following:

• amlodipine
• ACE inhibitors such as captopril
• beta-blockers such as atenolol.

If ibuprofen is used in combination with quinolone antibiotics, such as ciprofloxacinor norfloxacin there may be an increased risk of seizures (fits). This may occur in people with or without a previous history of epilepsy or convulsions.

Cholestyramine reduces the absorption of paracetamol from the gut. It should not be taken within an hour of taking this medicine or the effect of the paracetamol will be reduced.

Metoclopramide and domperidone may increase the absorption of paracetamol from the gut.

Long-term or regular use of paracetamol may increase the anti-blood-clotting effect of warfarin and other anticoagulant medicines, leading to an increased risk of bleeding. Regular monitoring of blood clotting times should be performed if paracetamol is used regularly with these medicines. This effect does not occur with occasional pain-killing doses.

You should not take other medicines that contain paracetamol in combination with this medicine, as this can easily result in exceeding the maximum recommended daily dose of paracetamol. Many cold and flu remedies and over-the-counter painkillers contain paracetamol, so be sure to check the ingredients of any other medicines before taking them with this one.

Other medicines containing the same active ingredients

There are currently no other medicines available in the UK that contain both ibuprofen and paracetamol as the active ingredients.

However, both ibuprofen and paracetamol are available separately, as branded products and without a brand name, ie as generic medicines.