Nurofen express forte tabs

Package leaflet: Information for the user

Nurofen Express Forte Tabs, 400 mg, coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your symptoms do not improve or worsen, consult your doctor.

Table of contents

1. What Nurofen Express Forte Tabs is and what it is used for
2. Important information before taking Nurofen Express Forte Tabs
3. How to take Nurofen Express Forte Tabs
4. Possible side effects
5. How to store Nurofen Express Forte Tabs
6. Contents of the pack and other information

1. What Nurofen Express Forte Tabs is and what it is used for

Nurofen Express Forte Tabs contains ibuprofen in the form of ibuprofen lysinate. Lysine increases
the solubility of ibuprofen, thereby enabling faster absorption. The medicine starts to work
approximately 35 minutes after taking the tablet.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs),
which have the ability to reduce pain, swelling and fever associated with inflammation.
This medicine is intended for use in the following conditions:

• Acute migraine headache with or without aura,
• Tension-type headache,
• Painful conditions (e.g. back pain, toothache, muscle pain, joint pain, painful menstruation, neuralgia),
• Pain associated with colds and influenza.

2. Information before using Nurofen Express Forte Tabs

When not to use Nurofen Express Forte Tabs

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever previously experienced hypersensitivity reactions (e.g. urticaria, rhinitis, angioedema or bronchial asthma) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• in patients with active or recurrent peptic ulceration or gastrointestinal bleeding (two or more distinct episodes of confirmed ulceration or bleeding);
• with a history of gastrointestinal perforation or bleeding associated with previous NSAID therapy;
• in severe hepatic insufficiency, severe renal insufficiency or severe heart failure;
• during the last 3 months of pregnancy;
• in bleeding disorders.

Warnings and precautions
Important information before taking Nurofen Express Forte Tabs:
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported.
If any of these symptoms occur, discontinue Nurofen Express Forte Tabs immediately and seek immediate medical advice or emergency medical assistance.
Special caution is required when using Nurofen Express Forte Tabs:
Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with ibuprofen use. If the patient develops any symptoms related to severe skin reactions described in section 4, Nurofen Express Forte Tabs must be discontinued immediately and medical help sought.
Before starting Nurofen Express Forte Tabs, consult a doctor or pharmacist if the patient has:

• systemic lupus erythematosus or mixed connective tissue disease;

• gastrointestinal disorders (e.g. ulcerative colitis, Crohn's disease);

• hypertension and/or heart dysfunction;

• renal impairment;

• hepatic impairment;

• coagulation disorders;

• active or past history of bronchial asthma or allergic reactions; bronchospasm may occur after taking the medicine;

• conditions requiring concomitant use of other medicines (especially anticoagulants, diuretics, cardiac drugs, corticosteroids).

• infection – see section titled “Infections” below.

Concomitant use of Nurofen Express Forte Tabs with NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, should be avoided.
There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and may occur without warning symptoms; they may also occur in patients who have experienced warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with gastrointestinal disorders, especially elderly patients, should report any unusual gastrointestinal symptoms (particularly bleeding) to their doctor, especially during the initial treatment period.
Long-term, concomitant use of various analgesic drugs may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Use of anti-inflammatory and analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Nurofen Express Forte Tabs, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart disease such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has hypertension, diabetes, high cholesterol, a family history of heart disease or stroke, or if the patient smokes.

Infections
Nurofen Express Forte Tabs may mask symptoms of infection such as fever and pain. Therefore, Nurofen Express Forte Tabs may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If the patient takes this medicine during an existing infection and symptoms of infection persist or worsen, immediate medical advice should be sought.
Medicines in this class (non-steroidal anti-inflammatory drugs) may adversely affect fertility in women. This effect is reversible and resolves upon discontinuation of treatment.
Talk to your doctor, even if the above warnings relate to conditions occurring in the past.

Children and adolescents
In dehydrated adolescents aged 12–18 years, there is a risk of impaired kidney function.

Use in elderly patients
Elderly patients are more susceptible to adverse effects than younger individuals.

Nurofen Express Forte Tabs and other medicines
Avoid concomitant use of Nurofen Express Forte Tabs with acetylsalicylic acid unless the doctor has specifically prescribed low-dose aspirin (not exceeding 75 mg daily), and with other NSAIDs, including selective COX-2 inhibitors. Avoid simultaneous use of two or more NSAIDs due to the possible increased risk of adverse effects.
Inform your doctor about all medicines currently used, recently used, or planned for use, including over-the-counter medicines.
Nurofen Express Forte Tabs may affect the action of other medicines or other medicines may affect the action of Nurofen Express Forte Tabs. For example:

• anticoagulants (i.e. blood thinners/preventing clot formation, such as aspirin (acetylsalicylic acid), warfarin, ticlopidine);
• antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan);
• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs);
• cardiac glycosides;
• lithium and methotrexate;
• cyclosporine;
• mifepristone;
• tacrolimus;
• zidovudine;
• quinolone antibiotics;
• corticosteroids;
• probenecid or sulfinpyrazone;
• antidiabetic medicines.

Other medicines may also interact with or be affected by treatment with Nurofen Express Forte Tabs. Therefore, always consult a doctor or pharmacist before using Nurofen Express Forte Tabs with other medicines.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not take Nurofen Express Forte Tabs during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of Nurofen Express Forte Tabs may cause kidney and heart problems in the unborn child. It may also affect bleeding tendency in both mother and child and may delay or prolong labour. Do not take Nurofen Express Forte Tabs during the first 6 months of pregnancy unless clearly necessary and advised by a doctor. If treatment is required during this period or when trying to conceive, use the lowest effective dose for the shortest possible duration. Taking Nurofen Express Forte Tabs for longer than a few days beyond the 20th week of pregnancy may cause kidney problems in the unborn child and lead to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart.
If prolonged treatment beyond a few days is necessary, the doctor may recommend additional monitoring tests.

Breastfeeding
Ibuprofen may pass into breast milk in small amounts. There are no known cases of adverse effects in breastfed infants; therefore, there is no need to interrupt breastfeeding during short-term use at recommended doses.

Effect on fertility
See section “Warnings and precautions”.

Driving and operating machinery
Nurofen Express Forte Tabs has no influence on the ability to drive or operate machinery when used as directed.

Nurofen Express Forte Tabs contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Nurofen Express Forte Tabs

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If, during an infection, symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
This medicine should not be given to children under 12 years of age.
Adults, elderly and adolescents over 12 years of age: initial dose of 1 tablet, then if needed, 1 tablet every 4 hours. Do not exceed 3 tablets in 24 hours. At least a four-hour interval must be maintained between consecutive doses.
Elderly patients: elderly individuals have a higher risk of adverse effects. This risk can be minimised by using the lowest effective dose for the shortest possible duration.
This medicine is for oral use. Tablets should be swallowed whole with an adequate amount of liquid. Do not chew the tablets.
If fever and pain symptoms do not improve or worsen despite taking the medicine, contact your doctor.
For adolescents aged 12–18 years, consult a doctor if treatment is required for more than 3 days or if symptoms worsen.
Taking more than the recommended dose of Nurofen Express Forte Tabs
If a patient has taken more than the recommended dose of Nurofen Express Forte Tabs, or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital for assessment of potential health risks and advice on necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion and nystagmus. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold and breathing difficulties may occur. Upper abdominal pain or, less commonly, diarrhoea, tinnitus, gastrointestinal bleeding, restlessness, coma, prolonged blood clotting time (so-called prothrombin time/INR), probably due to impaired function of circulating coagulation factors, acute kidney failure or liver damage may also occur. In patients with asthma, worsening of symptoms may occur. Additionally, low blood pressure and slowed breathing may occur.
Missed dose of Nurofen Express Forte Tabs
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions listed below have been observed during short-term use of ibuprofen for the treatment of mild to moderate fever and pain at over-the-counter doses. Other adverse reactions may occur when ibuprofen is used for other indications or with long-term use.
Adverse reactions are listed according to frequency using the following categories:
Not common: occur in less than 1 in 100 but more than 1 in 1000 patients.

• abdominal pain, nausea and dyspepsia;
• headache;
• hypersensitivity with urticaria and itching;
• various skin rashes.

Rare: occur in less than 1 in 1000 but more than 1 in 10,000 patients.

• diarrhoea, flatulence, constipation, vomiting.

Very rare: occur in less than 1 in 10,000 patients.

• blood disorders;
• severe allergic reactions, including facial, tongue and throat swelling, breathlessness, tachycardia (increased heart rate), hypotension (sudden, severe allergic reaction, angioedema or anaphylactic shock);
• aseptic meningitis;
• gastrointestinal ulcers, perforation or bleeding, tarry stools and bloody vomit;
• oral ulceration and gastritis;
• liver disorders;
• severe skin reactions such as blistering reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis;
• acute kidney failure;
• decreased haemoglobin concentration.

Frequency not known: frequency cannot be estimated from available data.

• heart failure and oedema;
• hypertension;
• respiratory tract hyperreactivity, including asthma, bronchospasm, breathlessness;
• kidney failure;
• heart failure and oedema;
• hypertension;
• respiratory tract reactivity, including asthma, bronchospasm, breathlessness;
• exacerbation of colitis and Crohn's disease;
• skin becomes light-sensitive.

If any of the following symptoms occur in a patient, ibuprofen should be discontinued immediately and medical help sought:

• red, flat, target-like or circular spots on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever and enlarged lymph nodes (DRESS syndrome).
• red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis).
• chest pain, which may indicate a potentially serious allergic reaction called Kounis syndrome.

In isolated cases, peptic ulceration of the stomach and/or duodenum, gastrointestinal bleeding, sometimes with fatal outcome, particularly in elderly patients, and perforation may occur.
In patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms typical of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever and disorientation have been reported during ibuprofen treatment.
Taking medicines such as Nurofen Express Forte Tabs may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Nurofen Express Forte Tabs

Keep this medicine out of the sight and reach of children.
Store below 25 °C.
Do not use Nurofen Express Forte Tabs after the expiry date stated on the carton and blister pack after: EXP. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Nurofen Express Forte Tabs contains

• The active substance is Ibuprofen – 1 tablet contains 400 mg of ibuprofen in the form of ibuprofen lysine (684 mg).
• Other ingredients of the core: povidone, sodium carboxymethyl starch Type A, magnesium stearate; coating ingredients: hypromellose, talc, Opaspray White M-1-7111B (hypromellose, titanium dioxide E 171); ink ingredients: Opacode S-1-277001 (shellac, iron oxide black (E 172), propylene glycol).

What Nurofen Express Forte Tabs looks like and contents of the pack

The medicine is contained in a cardboard box containing:
12 coated tablets in 1 blister, or
24 coated tablets in 2 blisters, or
48 coated tablets in 4 blisters.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Importer
RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
The Netherlands

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
tel: (22) 211 26 92