Nurofen Express Forte Tabs

Leaflet accompanying the packaging: information for the user

Nurofen Express Forte Tabs, 400 mg, coated tablets

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist,
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Nurofen Express Forte Tabs and what is it 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 packaging and other information

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

Nurofen Express Forte Tabs contains ibuprofen in the form of ibuprofen lysinate. Lysine increases the solubility of ibuprofen, allowing it to be absorbed more quickly. The medicine starts working about 35 minutes after taking the tablet.
Ibuprofen belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs) that have the ability to reduce symptoms such as pain, swelling, and fever caused by inflammation.
The medicine is intended for use in the following cases:

• acute phase of migraine with or without aura,
• tension headache,
• painful conditions (e.g., back pain, toothache, muscle pain, joint pain, painful menstruation, neuralgia),
• pains associated with colds and flu.

2. Important information before taking Nurofen Express Forte Tabs

When not to take 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 had an allergic reaction to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., hives, rhinitis, angioedema, or bronchial asthma);
• in patients with active or recurrent peptic ulcer or bleeding (two or more distinct episodes of confirmed ulceration or bleeding);
• with perforation or bleeding from the gastrointestinal tract in the past, associated with previous NSAID treatment;
• with severe liver failure, severe kidney failure, or severe heart failure;
• in the last 3 months of pregnancy;
• with a bleeding disorder.

Warnings and precautions

Important information before taking Nurofen Express Forte Tabs:
During treatment with ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling of the face and neck (angioedema), and chest pain.
If any of these symptoms are noticed, the patient should immediately stop taking Nurofen Express Forte Tabs and seek medical attention or call emergency services.
During treatment with Nurofen Express Forte Tabs, the patient should be particularly careful:
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with ibuprofen. If the patient experiences any symptoms associated with severe skin reactions as described in section 4, they should immediately stop taking Nurofen Express Forte Tabs and seek medical attention.
Before starting treatment with Nurofen Express Forte Tabs, the patient should discuss it with their doctor or pharmacist if they have:

• systemic lupus erythematosus and mixed connective tissue disease;
• a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease);
• hypertension and/or heart failure;
• kidney problems;
• liver problems;
• blood clotting disorders;
• active or a history of bronchial asthma or allergic reactions; taking the medicine may cause bronchospasm;
• diseases for which the patient is taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).
• infections - see below, section "Infections".

The patient should avoid taking Nurofen Express Forte Tabs at the same time as other NSAIDs, including selective cyclooxygenase-2 inhibitors.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning signs; these complications can also occur in patients with warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be stopped immediately. Patients with gastrointestinal diseases, especially the elderly, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, especially during the initial treatment period.
Concomitant, long-term use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).
Taking anti-inflammatory and painkillers, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The patient should not exceed the recommended dose and duration of treatment.
Before taking Nurofen Express Forte Tabs, the patient should discuss their treatment with their doctor or pharmacist if they have:

• heart disease, such as heart failure, angina pectoris (chest pain), if they have had a heart attack, coronary artery bypass grafting, or if they have peripheral artery disease (poor blood circulation in the legs due to narrowed or blocked arteries) or if they have had a stroke (including a mini-stroke or transient ischemic attack - TIA).
• high blood pressure, diabetes, high cholesterol levels, if there is a history of heart disease or stroke in their family, or if they smoke.

Infections
Nurofen Express Forte Tabs may mask the symptoms of an infection, such as fever and pain. As a result, Nurofen Express Forte Tabs may delay the use of appropriate infection treatment and lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should immediately consult their doctor.
Medicines in this group (non-steroidal anti-inflammatory drugs) may adversely affect fertility in women. This effect is temporary and reverses after treatment is stopped.
The patient should talk to their doctor, even if the above warnings refer to past situations.

Children and adolescents

In dehydrated adolescents aged 12-18, there is a risk of kidney function disorders.

Use in the elderly

Elderly people are more likely to experience side effects than younger people.

Nurofen Express Forte Tabs and other medicines

The patient should avoid taking Nurofen Express Forte Tabs at the same time as acetylsalicylic acid, unless their doctor has recommended taking low doses (no more than 75 mg per day) and other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors. The patient should avoid taking two or more NSAIDs at the same time due to the possible increased risk of side effects.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
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:

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

Some other medicines may also be affected or have an effect on treatment with Nurofen Express Forte Tabs. Therefore, before taking Nurofen Express Forte Tabs with other medicines, the patient should always consult their doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should 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. Taking Nurofen Express Forte Tabs may cause kidney and heart problems in the unborn child. It may also affect the patient's and their child's tendency to bleed and may prolong or delay delivery. The patient should not take Nurofen Express Forte Tabs during the first 6 months of pregnancy unless it is clearly necessary and recommended by their doctor. If treatment is necessary during this period or when trying to conceive, the patient should use the smallest dose for the shortest possible time. Taking Nurofen Express Forte Tabs for more than a few days after the start of the 20th week of pregnancy may cause kidney problems in the unborn child and lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is necessary for more than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts. There are no known cases of side effects in breastfed infants, so there is no need to stop breastfeeding during short-term use of the medicine in recommended doses.
Fertility
See "Warnings and precautions".

Driving and using machines

Nurofen Express Forte Tabs does not affect the ability to drive or use machines if taken as directed.

Nurofen Express Forte Tabs contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Nurofen Express Forte Tabs

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The patient should use the smallest effective dose for the shortest possible time. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult their doctor (see section 2).
The medicine should not be given to children under 12 years of age.
Adults, elderly, and adolescents over 12 years:initial dose 1 tablet, then if necessary, 1 tablet every 4 hours. The patient should not exceed 3 tablets in 24 hours. The patient should maintain at least a 4-hour interval between doses.
Elderly patients:in elderly patients, there is a greater risk of side effects. These can be minimized by using the smallest effective doses for the shortest possible time.
The medicine is for oral use. The tablets should be swallowed with a sufficient amount of liquid. The tablets should not be chewed.
If, despite taking the medicine, fever and painful symptoms do not subside or worsen, the patient should contact their doctor.
In adolescents aged 12-18, the patient should consult their doctor if the medicine needs to be taken for more than 3 days or if symptoms worsen.

Taking a higher dose of Nurofen Express Forte Tabs than recommended

If the patient has taken a higher dose of Nurofen Express Forte Tabs than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, and confusion. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties may occur. Abdominal pain or, less frequently, diarrhea, tinnitus, gastrointestinal bleeding, excitement, coma, prolonged bleeding time (prothrombin time/INR) probably due to impaired function of circulating clotting factors, acute kidney failure, or liver damage may also occur. In patients with asthma, worsening of symptoms may occur. Additionally, low blood pressure and slow breathing may occur.

Missing a dose of Nurofen Express Forte Tabs

The patient should not take a double dose to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Nurofen Express Forte Tabs can cause side effects, although not everybody gets them.
During short-term use of ibuprofen for the treatment of fever and pain of mild to moderate intensity in doses available without a prescription, the following side effects have been observed. When ibuprofen is used for other indications and for a long time, other side effects may occur.
Side effects are ranked according to frequency of occurrence using the following terms:
Uncommon: occurs in less than 1 in 100 but more than 1 in 1,000 patients.

• stomach pain, nausea, and indigestion;
• headache;
• hypersensitivity with hives and itching;
• various skin rashes.

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

• diarrhea, bloating, constipation, vomiting.

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

• blood disorders;
• severe allergic reactions, including face, tongue, and throat swelling, difficulty breathing, tachycardia (rapid heart rate), low blood pressure (sudden, severe allergic reaction, angioedema, or severe shock);
• aseptic meningitis;
• peptic ulcers, perforation, or bleeding, black stools, and bloody vomiting;
• mouth ulcers and gastritis;
• liver disorders;
• severe skin reactions, such as blistering, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis;
• acute kidney failure;
• decreased hemoglobin levels.

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

• heart failure and edema;
• high blood pressure;
• respiratory tract hyperreactivity, including asthma, bronchospasm, dyspnea;
• kidney failure;
• heart failure and edema;
• high blood pressure;
• respiratory tract hyperreactivity, including asthma, bronchospasm, dyspnea;
• worsening of ulcerative colitis and Crohn's disease;
• skin becomes sensitive to light.

If the patient experiences any of the following symptoms, they should immediately stop taking ibuprofen and seek medical attention:

• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. 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 swollen lymph nodes (DRESS syndrome).
• red, peeling rash with bumps under the skin and blisters, mainly in skin folds, on the torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis).
• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

In individual cases, gastric and duodenal ulceration and (or) bleeding may occur, sometimes with fatal outcomes, especially in the elderly, as well as perforation.
In patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) during ibuprofen treatment, single cases of symptoms of aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever, disorientation, have been reported.
Taking medicines like Nurofen Express Forte Tabs may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
If any of the side effects worsen or any side effects not mentioned in this leaflet occur, the patient should inform their doctor or pharmacist.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Nurofen Express Forte Tabs

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use Nurofen Express Forte Tabs after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Nurofen Express Forte Tabs contains

• The active substance of the medicine is ibuprofen - 1 tablet contains 400 mg of ibuprofen in the form of ibuprofen lysinate (684 mg).
• The medicine also contains core ingredients: povidone, sodium carboxymethylcellulose 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 in a cardboard box containing:
12 coated tablets in 1 blister pack, or
24 coated tablets in 2 blister packs, or
48 coated tablets in 4 blister packs.

Marketing authorization holder and importer

Marketing authorization 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,
Netherlands
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
tel: (22) 211 26 92

Date of last revision of the leaflet: