Nurofen Ultima

Leaflet accompanying the packaging: information for the user

Nurofen Ultima

200 mg + 500 mg, coated tablets

Ibuprofen/Paracetamol

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Nurofen Ultima and what is it used for

This medicine contains two active substances (which make the medicine work). These are ibuprofen and paracetamol. Ibuprofen belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by reducing pain and swelling. Paracetamol is a pain reliever that works in a different way than ibuprofen, relieving pain.
Nurofen Ultima is used only in adults for short-term symptomatic treatment of mild to moderate pain associated with migraine, headache, back pain, menstrual pain, toothache, muscle pain, pain associated with colds and flu, and throat pain.
This medicine is particularly suitable for pain that cannot be relieved by ibuprofen or paracetamol alone.

2. Important information before taking Nurofen Ultima

When not to take Nurofen Ultima

• if the patient is allergic to ibuprofen, paracetamol, or any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking other products containing paracetamol.
• if the patient is taking any other pain relievers, such as ibuprofen, aspirin in high doses (above 75 mg per day), or other NSAIDs, including COX-2 inhibitors.
• if the patient is allergic to aspirin or other pain relievers from the NSAID group.
• if the patient currently has or has had ulcers or bleeding in the stomach or duodenum (small intestine).
• if the patient has blood clotting disorders.
• if the patient has heart, liver, or kidney failure.
• if the patient is in the last 3 months of pregnancy.
• in children under 18 years of age.

Warnings and precautions

Before starting to take Nurofen Ultima, you should discuss it with your doctor or pharmacist:

• in case of infection - see "Infections" below. in elderly patients.
• if the patient has asthma or has had asthma in the past.
• if the patient has kidney, heart, liver, or bowel disorders. If the patient has kidney or liver disorders, a lower dose or longer intervals between doses may be necessary.
• if the patient has a low body mass (less than 50 kg), is malnourished, or has alcoholic liver disease.
• if the patient has been diagnosed with a condition known as hemolytic anemia (low red blood cell count) or if the patient lacks a certain enzyme (a protein called glucose-6-phosphate dehydrogenase).
• if the patient has systemic lupus erythematosus (SLE) - an autoimmune disease affecting connective tissue, causing joint pain, skin changes, and disorders of some organs, or other mixed connective tissue disease.
• if the patient has gastrointestinal or chronic inflammatory bowel diseases (such as ulcerative colitis, Crohn's disease).
• in the first 6 months of pregnancy or during breastfeeding.
• if the patient plans to become pregnant.

Infections

This medicine may mask the symptoms of an infection, such as fever and pain. Therefore, this medicine may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine while an infection is present, and the symptoms of the infection persist or worsen, they should consult their doctor immediately.

Skin reactions

Severe skin reactions have occurred with ibuprofen, 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). If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should stop taking Nurofen Ultima and seek medical attention immediately.
Taking anti-inflammatory/pain relievers, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment.
Before taking this medicine, the patient should discuss their treatment with their doctor or pharmacist if:

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

While taking ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, swelling around the face and neck (angioedema), chest pain. If any of these symptoms are noticed, the patient should stop taking Nurofen Ultima and seek medical attention immediately.

Children and adolescents

This medicine is not intended for use in children and adolescents under 18 years of age.

Nurofen Ultima and other medicines:

Do not take Nurofen Ultima with:

• other products containing paracetamol
• other products containing NSAIDs, such as aspirin or ibuprofen.

Be careful, as some medicines may interact with this medicine, e.g.:

• oral corticosteroids
• antibiotics (e.g., chloramphenicol or quinolones)
• anti-emetics (e.g., metoclopramide, domperidone)
• blood-thinning medicines (e.g., warfarin, aspirin, ticlopidine)
• heart stimulants (e.g., glycosides)
• cholesterol-lowering medicines (e.g., cholestyramine)
• diuretics (which help remove excess water)
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).
• immunosuppressants (e.g., methotrexate, cyclosporine, tacrolimus)
• medicines used in mania or depression (e.g., lithium or SSRIs)
• mifepristone (a medicine used to terminate pregnancy)
• medicines used to treat HIV (e.g., zidovudine)
• flucloxacillin (an antibiotic), due to the risk of serious blood and fluid disorders (metabolic acidosis with increased anion gap), which must be treated immediately and which may occur especially in cases of severe kidney disorders, sepsis (when bacteria and their toxins circulate in the blood, causing damage to internal organs), malnutrition, chronic alcoholism, and when taking maximum daily doses of paracetamol.

Before taking Nurofen Ultima with other medicines, you should always consult your doctor or pharmacist.

Also, some other medicines may be affected by or have an effect on this medicine. Therefore, before taking this medicine with other medicines, you should always consult your doctor or pharmacist.

Nurofen Ultima with food and drink

To reduce the likelihood of side effects, this medicine should be taken with food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Do not take Nurofen Ultima in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Taking Nurofen Ultima may cause kidney and heart disorders in the unborn child. It may also affect the patient's and their child's tendency to bleed and may prolong or prolong labor.
Do not take Nurofen Ultima during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to become pregnant, the smallest dose should be used for the shortest possible time. Taking Nurofen Ultima for a period longer than a few days after the start of the 20th week of pregnancy may cause kidney disorders 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 longer-term treatment is necessary, the doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen and its metabolites may pass into breast milk in small amounts. The medicine can be taken during breastfeeding if it is used in the recommended dose and for the shortest possible time.

Female fertility

This medicine may cause difficulties in becoming pregnant. Ibuprofen belongs to a group of medicines that may have a negative effect on female fertility. This effect is reversible after stopping the medicine. The patient should inform their doctor if they plan to become pregnant or if they are having difficulty becoming pregnant.

Driving and using machines

This medicine may cause dizziness, impaired concentration, and drowsiness. If such side effects occur, the patient should not drive or operate machinery.

Nurofen Ultima contains sodium

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

3. How to take Nurofen Ultima

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
Do not take this medicine for longer than 3 days.
The medicine is for oral use, intended for short-term use only (no longer than 3 days).
If symptoms worsen or persist, or if the medicine needs to be taken for a longer period, you should consult your doctor.
Use the smallest effective dose for the shortest time necessary to relieve symptoms.
In case of infection, you should contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
To reduce the likelihood of side effects, you should take this medicine with food.
Recommended dose:

Adults

1 tablet with food and drink, up to 3 times a day. There should be at least a 6-hour interval between doses.
If symptoms are not relieved after taking one tablet, a maximum of two tablets can be taken up to three times a day. Do not take more than six tablets in 24 hours (which corresponds to 1200 mg of ibuprofen and 3000 mg of paracetamol per day).

Use in children and adolescents

Do not use in children and adolescents under 18 years of age.

Taking a higher dose of Nurofen Ultima than recommended

If the patient has taken a higher dose of Nurofen Ultima 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 in such a case.
Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and difficulty breathing may occur.
In case of overdose, you should seek medical attention immediately, even if the patient feels well, due to the risk of delayed, severe liver damage. In some patients, the risk of liver damage due to paracetamol overdose is increased. These include patients with liver disease, elderly patients, children, long-term users of antiepileptic drugs (such as carbamazepine, phenobarbital, phenytoin, and primidone), drugs used to treat tuberculosis (rifampicin and isoniazid), and St. John's Wort (a natural medicine used to treat depression). Patients who consume excessive amounts of alcohol, patients with eating disorders, patients with cystic fibrosis, patients infected with HIV, malnourished patients, and patients with significant weight loss are also at increased risk of liver damage.

Missing a dose of Nurofen Ultima

Do not take a double dose to make up for a missed dose. If the patient forgets to take a dose, they should take it as soon as they remember, and then take the next dose no sooner than 6 hours later.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
YOU SHOULD STOP TAKING the medicine and contact your doctor if you experience:

• heartburn, indigestion.
• symptoms of bleeding from the gastrointestinal tract (severe stomach pain, vomiting blood or coffee grounds, blood in the stool, black tarry stools).
• symptoms of meningitis, such as stiff neck, headache, nausea or vomiting, fever, or feeling disoriented.
• symptoms of a severe allergic reaction (swelling of the face, tongue, or throat, difficulty breathing, or worsening of asthma).
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, 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 bumps under the skin and blisters, usually on the folds of the skin, on the torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop taking this medicine and seek medical attention immediately. See also section 2.

Other possible side effects

Common (occurring in less than 1 in 10 people):

• stomach pain or discomfort, nausea or vomiting, diarrhea, indigestion.
• excessive sweating.
• swelling.
• elevated alanine aminotransferase, gamma-glutamyltransferase, and abnormal liver function test results with paracetamol. Increased creatinine and urea levels in the blood.

Uncommon (occurring in less than 1 in 100 people):

• headache and dizziness.
• gas and constipation, rash.
• skin rash, facial swelling, and itching.
• ulcer disease, exacerbation of ulcerative colitis and Crohn's disease, perforation or bleeding from the gastrointestinal tract, vomiting blood, gastric mucosal inflammation, and pancreatitis.
• decreased red blood cell count or increased platelet count (responsible for blood clotting).
• increased aspartate aminotransferase, increased alkaline phosphatase in the blood, increased creatine phosphokinase in the blood, decreased hemoglobin, and increased platelet count.

Rare (occurring in less than 1 in 1000 people):

• tingling, numbness, or itching (feeling of pins and needles in the skin).

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

• hematopoietic disorders, such as decreased blood cell count (manifested by sore throat, mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, bruising, and nosebleeds).
• severe allergic reactions.
• vision disorders, ringing in the ears, confusion.
• disorientation, depression, hallucinations.
• meningitis, optic neuritis, and drowsiness.
• respiratory system reactivity, including asthma, asthma exacerbation, bronchospasm, dyspnea
• fatigue, general malaise.
• severe skin reactions, such as blistering.
• high blood pressure, fluid retention
• liver function disorders (manifested by yellowing of the skin and whites of the eyes).
• kidney function disorders (manifested by increased or decreased urine output, swelling of the legs).
• heart function disorders (causing shortness of breath).

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

• severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell).
• red scaly rash with bumps under the skin and blisters, usually in the skin folds, on the torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop taking this medicine and seek medical attention immediately. See also section 2.
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.
• skin becomes sensitive to light.

Medicines like this one may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (see section 2).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nurofen Ultima

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging after: EXP.
The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nurofen Ultima contains

• The active substances are ibuprofen and paracetamol. Each coated tablet contains 200 mg of ibuprofen and 500 mg of paracetamol.
• The other ingredients are: croscarmellose sodium, microcrystalline cellulose, anhydrous colloidal silica (E 551), magnesium stearate, stearic acid. The tablet coating contains: polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), macrogol/PEG 4000 (E 1521), potassium aluminum silicate (E 555), polysorbate (E 433).

What Nurofen Ultima looks like and contents of the pack

Nurofen Ultima tablets are white to almost white, oval, and coated with a pearlescent coating with an embossed identification helix. The tablets are available in packs (blisters) of 6, 8, 10, 12, 16, 20, 24, 32 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Patient hotline: 22 211 26 92

Importer

RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
Netherlands

Date of last revision of the leaflet: