Nurofen express tabs

Patient Information Leaflet

Nurofen Express Tabs, 200 mg, coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine must always be used 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 consult your pharmacist.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

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

Nurofen Express Tabs contains 200 mg of ibuprofen in the form of ibuprofen sodium dihydrate.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic and anti-inflammatory properties.
This medicine is intended for use in the following conditions:

• Mild to moderate pain of various origins:
  • Headache, including tension headache and migraine;
  • Toothache;
  • Neuralgia;
  • Muscular, joint and bone pain;
  • Pain associated with influenza and common cold.
• Fever of various causes (e.g. due to influenza, cold or other infectious diseases)
• Painful menstruation

2. Important information before taking Nurofen Express Tabs

When not to use Nurofen Express Tabs
Do not take Nurofen Express Tabs:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• in patients who have 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 a history of peptic ulceration or perforation of the stomach and/or duodenum (two or more confirmed episodes of ulceration or bleeding);
• in patients with gastrointestinal perforation or bleeding in the past associated with previous NSAID treatment;
• in patients with severe hepatic insufficiency, severe renal insufficiency or severe heart failure;
• in pregnant women during the last three months of pregnancy;
• in patients with bleeding disorders.

Warnings and precautions
Important information before taking Nurofen Express 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 Tabs immediately and contact a doctor or emergency medical services without delay.
Exercise special caution when taking Nurofen Express Tabs:
Serious skin reactions, including 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 any of the symptoms associated with severe skin reactions described in section 4 occur, discontinue Nurofen Express Tabs immediately and seek medical help.
Before starting Nurofen Express Tabs, discuss with a doctor if the patient has previously had:

• systemic lupus erythematosus or mixed connective tissue disease;
• allergic reactions after taking acetylsalicylic acid;
• gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• hypertension and/or heart dysfunction;
• renal function disorders;
• hepatic function disorders;
• blood 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 medications (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids);
• if the patient needs to restrict dietary sodium intake.
• infection – see below, section titled "Infections".

Avoid concomitant use of Nurofen Express Tabs with NSAIDs, including selective cyclooxygenase-2 inhibitors.
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. Discontinue the medicine immediately if gastrointestinal bleeding or ulceration occurs. Patients with gastrointestinal disorders, particularly elderly patients, should report any unusual gastrointestinal symptoms (especially bleeding) to their doctor, particularly during the initial treatment period.
Prolonged, concurrent use of various analgesics may lead to kidney damage with risk of renal failure (analgesic nephropathy).
Exercise special caution (the patient should consult a doctor or pharmacist) before using Nurofen Express Tabs in patients with hypertension and/or heart failure with fluid retention, or a history of hypertension and edema associated with NSAID use.
Taking 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.
If symptoms persist or worsen despite treatment, or new symptoms appear after 3 days, consult a doctor.
Before using Nurofen Express Tabs, discuss treatment with a doctor or pharmacist if:

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

Infections
Nurofen Express Tabs may mask symptoms of infection such as fever and pain. Therefore, Nurofen Express 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 varicella.
If the patient takes this medicine during an existing infection and infection symptoms persist or worsen, consult a doctor immediately.

Skin reactions
Rare but serious skin reactions, some of which have been fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported with NSAIDs. The highest risk of these severe reactions occurs early in treatment, usually within the first month of use.
Discontinue the medicine at the first signs of skin rash, mucosal lesions, or other hypersensitivity symptoms.

Medicines in this group (non-steroidal anti-inflammatory drugs) may adversely affect fertility in women. This effect is reversible and resolves upon discontinuation of treatment. If difficulty conceiving occurs, consult a doctor before taking ibuprofen.

Use in elderly patients
Elderly patients have an increased risk of adverse effects associated with ibuprofen use compared to younger patients. The frequency and severity of adverse effects can be reduced by using the lowest effective dose for the shortest possible duration.
Consult a doctor even if the above warnings relate to conditions experienced in the past.

Children and adolescents
This medicine is not indicated for children under 12 years of age.
In dehydrated adolescents aged 12–18 years, there is a risk of impaired renal function.

Nurofen Express Tabs and other medicines
Avoid using Nurofen Express Tabs if taking other NSAIDs (including cyclooxygenase-2 inhibitors such as celecoxib or etoricoxib), other analgesics, or acetylsalicylic acid (at analgesic doses).
Inform the doctor about all medicines currently taken, including those available without a prescription.
Nurofen Express Tabs may affect the action of other medicines or other medicines may affect the action of Nurofen Express Tabs. For example:

• anticoagulant medicines (i.e. blood thinners/preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan).

In particular, inform the doctor before taking ibuprofen if any of the following medicines are being used:

• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs);
• cardiac glycosides;
• lithium and methotrexate;
• cyclosporine;
• mifepristone;
• tacrolimus;
• zidovudine;
• quinolone antibiotics;
• diuretics;
• corticosteroids (such as prednisolone or dexamethasone).

Other medicines may also interact with or be affected by treatment with Nurofen Express Tabs. Therefore, always consult a doctor or pharmacist before using Nurofen Express 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 have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Consult a doctor before taking any medicine. Do not take Nurofen Express Tabs during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. Use of Nurofen Express 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 Tabs during the first 6 months of pregnancy unless clearly necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, use the lowest dose for the shortest possible time. Taking Nurofen Express Tabs for longer than a few days beyond week 20 of pregnancy may cause kidney problems in the unborn child and lead to reduced amniotic fluid levels (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If longer-term treatment is required, the doctor may recommend additional monitoring tests.

Breastfeeding
Ibuprofen may pass into breast milk in small amounts. No adverse effects in breastfed infants have been reported; therefore, interruption of breastfeeding is not necessary during short-term use of low doses.
Consult a doctor before taking any medicine.

Effects on fertility
See section "Warnings and precautions".

Driving and operating machinery
There is no data available on the effect of Nurofen Express Tabs on the ability to drive, operate machinery or on psychomotor performance when used at the recommended doses and duration.

Nurofen Express Tabs contains sucrose and sodium
Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Sodium
The medicine contains 25.72 mg of sodium (main component of table salt) per tablet. This corresponds to 1.29% of the maximum recommended daily dietary sodium intake for adults. This should be taken into account in patients whose total sodium intake must be significantly restricted.

3. How to use Nurofen Express Tabs

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine is intended for short-term use only.
The medicine is intended for oral use only in adults, elderly patients, and adolescents aged over 12 years.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Nurofen Express Tabs tablets should be taken as directed by a doctor. In case of doubt, contact your doctor again.
The usual dosage is as follows:
Adults, elderly patients, and adolescents over 12 years of age: Initial dose – 1 to 2 tablets, then if needed, 1 to 2 tablets every four hours. Swallow the tablets with water.
Do not take more than 6 tablets in 24 hours. At least a four-hour interval must be maintained between doses.
Elderly patients: Elderly patients have an increased risk of adverse effects. This risk can be minimized by using the lowest effective dose for the shortest possible duration.
Warning:
Do not exceed the recommended dose!
In case of overdose, contact a doctor immediately.
If the effect of the medicine seems too strong or too weak, contact your doctor.
If symptoms persist or worsen, or if new symptoms occur, contact your doctor.
Use the lowest possible dose for the shortest possible time. This reduces the risk of adverse effects.
Do not take this medicine for more than 3 days without medical advice.
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 Tabs
Cases of overdose are rare. However, if a patient takes more than the recommended dose of Nurofen Express Tabs or if a child accidentally ingests 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, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. Other possible symptoms include upper abdominal pain or, less commonly, diarrhoea, gastrointestinal bleeding, very rarely agitation or coma, metabolic acidosis (excess acid in the blood), prolonged blood clotting time (so-called prothrombin time/INR), probably due to impaired function of circulating coagulation factors, acute kidney failure or liver damage, and in patients with asthma, worsening of symptoms. Additionally, low blood pressure and slowed breathing may occur.
There is no specific antidote. Treatment is symptomatic and supportive, aimed at maintaining vital functions until the drug is eliminated from the body. The doctor will monitor heart function and vital signs, if stable. The doctor may consider administering activated charcoal orally within 1 hour of overdose. In case of frequent or prolonged seizures, the doctor may administer intravenous diazepam or lorazepam. In patients with asthma, the doctor will administer bronchodilators.
Missed dose of Nurofen Express 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 effects

Like all medicines, Nurofen Express Tabs can cause adverse effects, although not everyone will experience them.
The adverse effects listed below have been observed during short-term use of ibuprofen at over-the-counter doses. When ibuprofen is used for other indications or for prolonged periods, additional adverse effects may occur.
Adverse effects are listed according to frequency of occurrence.

Not common (occur in less than 1 in 100, but no more than 1 in 1,000 patients):

• Dyspepsia, abdominal pain, nausea, headache, urticaria and itching.

Rare (occur in less than 1 in 1,000, but no more than 1 in 10,000 patients):

• Diarrhoea, flatulence, constipation, vomiting, gastritis;
• Psychotic disorders, depression, tinnitus;
• Dizziness, insomnia, restlessness, irritability and fatigue, oedema.

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

• Melena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease;
• Decreased urine output, renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention);
• Liver function disorders, particularly during long-term use;
• Blood morphology abnormalities (anaemia, leukopenia – reduced number of white blood cells, thrombocytopenia – reduced number of platelets, pancytopenia – haematological disorder characterised by deficiency of all normal blood cells: red cells, white cells and platelets, agranulocytosis – absence of a certain type of white blood cells – granulocytes). Initial symptoms include fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding (e.g. bruising, petechiae, purpura, epistaxis);
• Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis;
• Facial, tongue and laryngeal swelling, dyspnoea;
• Tachycardia – increased heart rate, hypotension – sudden drop in blood pressure, shock;
• Aseptic meningitis;
• Heart failure, hypertension, oedema;
• Exacerbation of asthma and bronchospasm.

Frequency not known (frequency cannot be estimated from available data):

• Hyper-reactivity of the airways, including asthma;
• Skin becomes sensitive to light.

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

• Red, flat, target-like or circular skin lesions on the trunk, often with blisters in the centre, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin reactions 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, predominantly located in skin folds, trunk and upper limbs, accompanied by fever occurring at the beginning of treatment (acute generalised exanthematous pustulosis).
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Edema, hypertension and heart failure have been reported in association with high-dose NSAID therapy. Use of medicines such as Nurofen Express Tabs may be associated with a small increased risk of myocardial infarction (heart attack) or stroke.

Other adverse effects may occur in some individuals during treatment. If any of the above effects, or other effects not listed in this leaflet, are observed, the medicine should be discontinued and a doctor should be consulted.

Reporting of adverse effects

If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.

By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store Nurofen Express Tabs

No special storage conditions are required.
Keep the medicine out of the sight and reach of children.
Do not use Nurofen Express Tabs after the expiry date stated on the cardboard box and blister
after: EXP.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nurofen Express Tabs contains

• The active substance is ibuprofen – one coated tablet contains 200 mg of ibuprofen in the form of 256 mg of ibuprofen sodium dihydrate.
• Other ingredients (excipients) are: sodium croscarmellose, xylitol, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium carmellose, talc, spray-dried arabic gum, sucrose, titanium dioxide (E 171), macrogol 6000, printing ink Opacode S-1-277001 (shellac, iron oxide black (E 172), propylene glycol).

What Nurofen Express Tabs looks like and contents of the pack
White, round, biconvex coated tablets with an imprint. Tablets are available in packs containing
2, 4, 6, 10, 12, 24 or 48 coated tablets. Not all pack sizes may be marketed.
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,
Netherlands
For further information on this medicinal product, please contact the Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100
Nowy Dwór Mazowiecki
Tel.: (22) 211 26 92