NUROFEN EXPRESS

Main information

  • Trade name:
  • NUROFEN EXPRESS
  • Dosage:
  • 400 Milligram
  • Pharmaceutical form:
  • Tablets
  • Prescription type:
  • Product not subject to medical prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NUROFEN EXPRESS
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • ibuprofen

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PPA0465/430/001
  • Authorization date:
  • 04-08-2017
  • Last update:
  • 12-12-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Ibuprofen (as sodium ibuprofen dihydrate)

Package Leaflet: Information for the User

Read all of this leaflet carefully because it contains important

information for you.

This medicine is available without prescription. However, you will still

need to take Nurofen Express Maximum Strength 400mg Tablets

carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice

You must contact a doctor if your symptoms worsen or do not

improve after 3 days.

If any of the side-effects gets serious, or if you notice any side-

effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Nurofen Express Maximum Strength 400mg Tablets are and

what are they used for

2. Before you take Nurofen Express Maximum Strength 400mg Tablets

3. How to take Nurofen Express Maximum Strength 400mg Tablets

4. Possible side-effects

5. How to store Nurofen Express Maximum Strength 400mg Tablets

6. Further Information

1.

What Nurofen Express Maximum Strength 400mg Tablets are

and what they are used for?

The active ingredient (which makes the medicine work) in Nurofen

Express Maximum Strength 400mg tablets is ibuprofen 400 mg (as

sodium ibuprofen dihydrate 512mg). Ibuprofen belongs to a group of

medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

These medicines work by changing how the body responds to pain,

swelling and high temperature.

Nurofen Express maximum Strength 400mg tablets are used for the

relief of fever and mild to moderate pain such as:

Headaches, period pain and dental pain

Muscle pain and backache

Symptoms of colds and flu, and high temperature (fever)

2.

Before you take Nurofen Express Maximum Strength 400mg

Tablets

Do not take these Tablets if you:

are allergic (hypersensitive) to ibuprofen or any of the other

ingredients (see Section 6; Further Information)

are allergic (hypersensitive) to aspirin or to other painkillers

have or ever had a stomach ulcer, perforation or bleeding in the

stomach

have ever had gastrointestinal bleeding in relation to NSAID

therapy

have severe liver or kidney problems

have severe heart failure

have difficulties breathing or have had a worsening of asthma, skin

rash, itchy runny nose, or facial swelling when previously taken

ibuprofen, aspirin or similar medicines

if you are taking other regular medication, other NSAID’s or pain

killers

if you have been told by your doctor that you an intolerance to

some sugars (e.g. fructose)

if you are pregnant or elderly

if you are under 12 years of age

Speak to your doctor or pharmacist before taking these tablets if

you

Have uncontrolled high blood pressure, any heart problems, any

disease of the arteries or blood vessels

Have high blood pressure, diabetes, high cholesterol, have a family

history of heart disease or stroke, or if you are a smoker

Are taking painkiller medication and find that you still have frequent

or daily headaches despite taking medication please speak to your

doctor

Have low blood pressure

Have or ever have had asthma

Have kidney, liver or bowel problems

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 or feet due to narroe or blocked

arteries), or any kind of stroke (including “mini-stroke” or transient

ischaemic attack “TIA”)

Have a history of gastrointestinal disease (such as ulcerative colitis,

crohn’s disease)

Have Systemic Lupus Erythematosus (SLE) – an illness which

affects your immune system. It causes joint pain, skin changes and

problems with other parts of your body

Have been told to limit the amount of sodium in your diet

Are elderly

Have chicken pox as it is advisable to avoid the use of Nurofen

Express maximum Strength 400mg tablets

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently

taken any other medicines. In particular, discuss with your doctor or

pharmacist if you are taking any of the following,

Aspirin or other NSAIDs (e.g. COX-2 inhibitors such as celecoxib or

etoricoxib)

Medicines that are anti-coagulants (i.e. thin blood/ prevent clotting

e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)

Medicines that reduce high blood pressure (ACE-inhibitors such as

captopril, beta-blockers such as atenolol medicines, angiotensin-II

receptor antagonists such as losartan)

Avoid taking this product with corticosteroid tablets, quinolone

antibiotics, aminoglycosides, mifepristone, probenecid, oral

hypoglycaemic agents or drugs that are prescribed to:

To stimulate your heart (e.g. glycosides) or to treat high blood

pressure

To help you passing water (diuretics)

Treat cancer, rheumatism or to temporarily suppress your immune

system (e.g. methotrexate, cyclosporine, tacrolimus)

For mania or depression (e.g. lithium, SSSRI’s)

For HIV treatment (e.g. zidovudine)

Some other medicines may also affect or be affected by the

treatment of Nurofen Express Maximum Strength 400mg Tablets.

You should therefore always seek the advice of your doctor of

pharmacist before you use Nurofen Express Maximum Strength

400mg Tablets with other medicines.

Other Warnings

Nurofen Express Maximum Strength 400mg Tablets belongs to a

group of medicines which may impair fertility in women. This is

reversible upon stopping the medicine. It is unlikely that using this

medicine occasionally will affect your chances of becoming

pregnant. However, talk to your doctor before taking ibuprofen if you

have problems becoming pregnant.

Anti-inflammatory/pain killer medicines like 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.

There is a risk of renal-impairment in dehydrated adolescents.

Pregnancy and breast-feeding

Do not take this medicine in the last 3 months of pregnancy. Avoid the

use of this medicine if you are in the first 6 months of pregnancy, unless

advised by your doctor.

Ibuprofen can pass in very small concentrations into the breast milk.

Speak to your doctor or pharmacist before taking this medicine if you are

breast-feeding.

Ibuprofen belongs to a group of medicines which may reduce fertility in

women. Fertility will go back to normal when you stop taking the

medicine (see Other Warnings).

Important information about some of the ingredients

Each tablet contains sodium. This should be taken into consideration for

people on a sodium controlled diet. Each tablet contains sucrose. If you

have been told by your doctor that you have an intolerance to some

sugars, contact your doctor before taking this product.

3.

How to take Nurofen Express maximum Strength 400mg

Tablets

This product is for short term use only. You should take the lowest dose

for the shortest time necessary to relieve your symptoms. If your

symptoms do not improve within 3 days consult your doctor.

Adults, the Elderly and children over 12 years old:

Take the tablets by mouth only with a glass of water.

Take ONLY 1 TABLET with a glass of water up to 3 times a day if

required. Leave at least 4 hours between doses and do not take

more than 3 tablets in 24 hours.

Do not give these tablets to children under 12 years.

This medicine is for short-term use only.

If in adolescents this medicinal product is required for more than 3 days,

or if symptoms worsen a doctor should be consulted.

If your symptoms persist of the pain worsens, or any new symptoms

occur, consult your doctor or pharmacist.

If you take more tablets than you should, you may feel drowsy or

nauseated. You should seek immediate medical advice in the event of

an over dose even if you feel well.

If you forget to take Nurofen Express Maximum Strength 400mg

Tablets: Simply refer to the direction above on how to take the medicine

and do not take more than is advised.

Possible Side Effects

Like all medicines, ibuprofen can cause side-effects, although not

everybody gets them. Side effects may be minimised by taking the

lowest dose for the shortest time necessary to relieve the symptoms.

Nurofen Express Maximum Strength 400mg Tablets are generally well

tolerated by most people. However side effects may occur.

STOP TAKING this medicine and seek immediate medical attention

if you develop:

signs of intestinal bleeding. Such as bright red faeces

(stools/motions), black tarry stool, vomiting blood or dark particles

that look like coffee granules. Intestinal bleeding may occur more

often in the elderly. In very rare cases this may be fatal.

Signs of serious allergic reaction such as:

Difficulties breathing or unexplained wheezing

Dizziness or faster heartbeat

Severe skin reaction (skin lesions, rashes, itchiness….)

Swelling of your tongue, face or throat

Stevens Johnson Syndrome (SJS) and Toxic Epidermal

Necrolysis may occur very rarely. Which is a hypersensitivity

reaction affecting the mucous membranes of the skin.

Signs of aseptic meningitis such as: stiff neck, headache,

dizziness, feeling sick, being sick, fever or consciousness. Patients

with auto-immune disorders (lupus, mixed connective tissue

disease) may be more likely to be affected.

Tell your doctor if you experience:

Fever, flu-like symptoms, sore throat, mouth ulcers, vomiting,

unexplained bleeding and bruising, severe exhaustion, nose or skin

bleeding. This may be a symptom of a blood or lymphatic disorder.

Skin reactions, such as redness, rashes, itchiness, or formation of

skin lesions. Worsening of asthma or bronchospasm

Hearing problems

Indigestion, stomach pain, constipation, diarrhoea, flatulence or if

you feel sick (vomiting). Peptic ulcers, exacerbation of colitis and

Crohn’s disease.

Chest pain, drop in blood pressure or fast irregular heart beat.

Liver and kidney problems associated with swelling, decreased

urine out put and very rarely failure associated with long term use.

Severe skin infections and soft tissue complications during chicken

pox (varicella) infection

Medicines such as Nurofen Express Maximum Strength 400mg Tablets

may be associated with a small increased risk of heart attack

(‘myocardial infarction’) or stroke. See section 2 Other Warnings.

If any of the side effects gets serious or you notice any side effect

not listed in this leaflet please contact your doctor or pharmacist.

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 HPRA Pharmacovigilance, Earlsfort

Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side

effects you can help provide more information on the safety of this

medicine.

5.

How to Store Nurofen Express Maximum Strength 400mg

Tablets

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF

CHILDREN

This medicinal product does not require any special storage precautions.

Do not use this medicine after the expiry date stated on the outer carton

and blister pack. The expiry date refers to the last day of that month.

Medicines should not be disposed of via waste water or household

waste. Ask your pharmacist how to dispose of medicines no longer

required. These measures will help protect the environment.

6.

Further Information

What Nurofen Express Maximum Strength 400mg Tablets contain:

The active ingredient is ibuprofen 400mg (as sodium ibuprofen

dihydrate). Other ingredients are: croscarmellose sodium (E468),

magnesium stearate (E572), xylitol (E967), sucrose, titanium dioxide

(E171), microcrystalline cellulose (E460), colloidal anhydrous silica

(E551), carmellose sodium (E466), talc (E553b), acacia spray dried

(E414), macrogol 6000 powder, red printing ink containing shellac, iron

oxide red (E172), ammonium hydroxide (E527) and simethicone.

What Nurofen Express Maximum Strength 400mg Tablets look like

and contents of the pack

The tablets are round in shape and white in colour with an identifying

logo in red on one side. Tablets are available in packs of 12 or 24. Not

all pack sizes may be marketed.

The name of this product in Lithuania is: Nurofen Forte Express 400 mg

dengtos tablets.

Manufacturer:

Reckitt Benckiser Healthcare International Ltd, Nottingham Site, Thane

Road, Nottingham, NG90 2DB, UK

Product procured from within the EU, repackaged and distributed

by the Parallel Product Authorisation Holder:

PCO Manufacturing, Unit 10, Ashbourne Business Park, Rath,

Ashbourne, Co. Meath

Parallel Product Authorisation Number: PPA 465/430/1

Nurofen is a registered trademark of Reckitt & Colman (Overseas)

Limited.

This leaflet was last approved by PCO Manufacturing in:

July 2017