Nurofen Plus

Leaflet accompanying the packaging: information for the user

Nurofen Plus, 200 mg + 12.8 mg, coated tablets

Ibuprofen + Codeine phosphate

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 this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

Ibuprofen contained in Nurofen Plus belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs) that have the ability to reduce such discomfort as pain and fever. Codeine, the second active substance of Nurofen Plus, is a strong pain reliever. The combination of ibuprofen and codeine in Nurofen Plus provides a combined analgesic effect. The medicine is indicated for use in the following cases:

• short-term treatment of moderate acute pain (rheumatic and muscular pain, back pain, neuralgia, migraine, headache, toothache, painful menstruation) that does not subside after treatment with paracetamol, ibuprofen or acetylsalicylic acid.
• fever in the course of a cold or flu.

Codeine can be used in children aged 12 to 18 years for the treatment of moderate acute pain that does not subside after treatment with other pain relievers, such as paracetamol or ibuprofen used in monotherapy. This medicine contains codeine. Codeine belongs to a group of opioid pain relievers that relieve pain. It can be used in monotherapy or in combination with other pain relievers, such as paracetamol.

2. Important information before taking Nurofen Plus

When not to take Nurofen Plus

Nurofen Plus should not be taken by patients:

• if the patient is allergic to ibuprofen, codeine or any of the other ingredients of this medicine (listed in section 6) and to other non-steroidal anti-inflammatory drugs;
• in whom after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, allergic symptoms such as rhinitis, urticaria or bronchial asthma have occurred in the past;
• with active or past gastric and/or duodenal ulcer, perforation or bleeding, also those that occurred after taking non-steroidal anti-inflammatory drugs (two or more confirmed episodes of ulceration or bleeding);
• with severe liver, kidney or heart failure;
• in pregnant women;
• in breastfeeding women;
• with bleeding disorders;
• with respiratory disorders; with chronic constipation; being treated with monoamine oxidase inhibitors (MAO) or within 14 days of stopping treatment (see "Nurofen Plus and other medicines");
• if the patient is under 12 years old;
• for pain relief in children and adolescents (aged 0 to 18 years) after tonsillectomy or adenoidectomy in connection with obstructive sleep apnea syndrome;
• if it is known that the patient's metabolism of codeine to morphine is very rapid.

Warnings and precautions

Tolerance and dependence This medicine contains codeine, which is an opioid. Repeated use of opioids can lead to reduced efficacy of the medicine (the patient's body gets used to the medicine, which is called tolerance). Repeated use of Nurofen Plus may also lead to dependence, abuse and addiction, which can cause life-threatening overdose. If the patient takes Nurofen Plus for longer than the recommended time or in higher doses than recommended, the risk of these side effects may increase, as well as the risk of serious stomach or intestinal damage and low potassium levels in the blood, which can lead to death (see section 4). Dependence or addiction can cause the patient to lose control over the amount of medicine taken or the frequency of its use. The risk of dependence on Nurofen Plus may be higher in people who:

• have a history of substance abuse or addiction to prescription or illegal drugs ("addiction");
• are smokers;
• have had mood problems (depression, anxiety or personality disorders) or have been treated by a psychiatrist for other mental illnesses.

If the patient notices any of the following symptoms while taking Nurofen Plus, it may indicate dependence or addiction:

• need to take the medicine for a longer period than recommended by the doctor;
• need to take a higher dose than recommended;
• the patient feels that they need to continue taking the medicine, even if it does not relieve pain;
• the patient uses the medicine for reasons other than those for which it was prescribed, e.g. "to calm down" or "to sleep better";
• the patient has made repeated, unsuccessful attempts to stop or control the use of the medicine;
• after stopping the medicine, the patient feels unwell, and after taking it again, they feel better ("withdrawal symptoms");

and

• the patient experiences pain or increased sensitivity to pain (hyperalgesia) that does not subside after a higher dose of the medicine.

If the patient notices any of these symptoms, they should consult a doctor to discuss the best treatment option, including when to stop taking the medicine and how to do it safely (see section 3, Stopping Nurofen Plus). During the use of ibuprofen, symptoms of an allergic reaction to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema) and chest pain. If the patient notices any of these symptoms, they should stop taking Nurofen Plus immediately and seek medical attention immediately. Before starting Nurofen Plus, the patient should discuss with their doctor or pharmacist if they have:

• systemic lupus erythematosus and mixed connective tissue disease;
• allergic symptoms after taking acetylsalicylic acid;
• gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
• hypertension and/or heart disorders;
• kidney function disorders;
• hypokalemia (very low potassium levels in the blood);
• liver function disorders;
• bleeding disorders;
• active or past asthma or allergic symptoms in the past; after taking the medicine, bronchospasm may occur;
• concomitant use of other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids).
• infections - see below, section entitled "Infections".

Nurofen Plus may mask the symptoms of infection, such as fever and pain. Therefore, Nurofen Plus 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 is taking this medicine during an infection, and the symptoms of the infection persist or worsen, they should consult a doctor immediately. Skin reactions Serious skin reactions have been reported with the use of 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 of the symptoms associated with these serious skin reactions described in section 4, they should stop taking Nurofen Plus immediately and seek medical attention. Nurofen Plus belongs to a group of non-steroidal anti-inflammatory drugs that may adversely affect female fertility. This effect is temporary and disappears after the end of treatment. Caution should be exercised in patients with hypotension, increased intracranial pressure, asthma, reduced respiratory reserve, acute respiratory failure, chronic obstructive pulmonary disease, prostate enlargement, hypothyroidism, adrenal insufficiency, shock, head injuries, conditions with increased intracranial pressure, obstructive bowel diseases, acute abdominal conditions (e.g. peptic ulcer), after recent gastrointestinal surgery, with paralytic ileus, with gallstones, myasthenia, peptic ulcer or a history of seizures, as well as in patients with a history of drug or substance abuse and acute alcohol intoxication. Codeine is converted to morphine in the liver with the participation of an enzyme. Morphine is the substance that determines the action of codeine and relieves pain and cough. In some people, there is a variant of this enzyme, which can cause different effects. In some people, morphine is not produced or is produced in very small amounts, and therefore it will not have a sufficient analgesic or antitussive effect. In others, it is more likely that serious side effects will occur due to the very large amounts of morphine produced. If the patient experiences any of the following side effects, they should stop taking this medicine and seek medical attention immediately: slow or shallow breathing, disorientation, drowsiness, pupil constriction, nausea or vomiting, constipation, loss of appetite.

Respiratory disorders related to sleep

Nurofen Plus may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). The following symptoms may occur: pauses in breathing during sleep, waking up at night due to shortness of breath, difficulty maintaining sleep continuity or excessive daytime sleepiness. If the patient or another person observes these symptoms, they should consult a doctor. The doctor may consider reducing the dose. Hyperalgesia has been reported during the use of opioids, especially after long-term use and/or in high doses. Hyperalgesia may subside after reducing the opioid dose, stopping or changing to another opioid. If the patient experiences severe abdominal pain that may radiate to the back, nausea, vomiting or fever, they should consult a doctor, as these may be symptoms related to pancreatitis and biliary tract disorders.

Children and adolescents

Nurofen Plus should not be used in children under 12 years of age. Use in children and adolescents after surgical procedures Codeine should not be used to relieve pain in children and adolescents after tonsillectomy or adenoidectomy in connection with obstructive sleep apnea syndrome. Use in children with respiratory disorders Codeine is not recommended for use in children with respiratory disorders, as symptoms of morphine toxicity may worsen in these children. Adolescents over 12 years of age Codeine is not recommended for use in adolescents with respiratory function disorders for the treatment of cough and/or cold. In dehydrated patients - adolescents aged 12-18 years, there is a risk of kidney function disorders.

Nurofen Plus and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as about medicines they plan to take.

Avoid taking Nurofen Plus with the following medicines:

• acetylsalicylic acid;
• other non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors.

Nurofen Plus may affect the action of other medicines or other medicines may affect the action of Nurofen Plus. For example:

• anticoagulant medicines (i.e. blood thinners - preventing blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• diuretics;
• lithium and methotrexate;
• zydovudine;
• corticosteroids;
• monoamine oxidase inhibitors (MAO) taken within the last 14 days;
• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs). There have also been reports of serotonin syndrome during the concomitant use of serotonergic medicines, including triptans, selective serotonin and norepinephrine reuptake inhibitors, and tricyclic antidepressants with opioids at recommended doses;
• gabapentin or pregabalin used to treat epilepsy or nerve pain (neuropathic pain)
• cardiac glycosides;
• cyclosporine;
• mifepristone;
• tacrolimus;
• quinolone antibiotics;
• moclobemide;
• hydroxyzine;
• central nervous system depressants;
• abiraterone;
• anti-diarrheal and anti-peristaltic medicines;
• anticholinergic medicines;
• medicines that block nerve conduction;
• quinidine;
• mexiletine;
• metoclopramide, cisapride and domperidone;
• cimetidine;
• naloxone. Also, some other medicines may be affected by or have an effect on the treatment with Nurofen Plus. Therefore, before taking Nurofen Plus with other medicines, the patient should always consult a doctor or pharmacist.

Effect on laboratory test results

Nurofen Plus may affect the results of a number of laboratory tests, including amylase, lipase, bilirubin, alkaline phosphatase, lactate dehydrogenase, alanine aminotransferase and aspartate aminotransferase in serum. Nurofen Plus may affect gastric emptying tests and imaging tests of the biliary tract.

Nurofen Plus with alcohol

During treatment with Nurofen Plus, the patient should avoid consuming alcohol, as it increases the adverse effect of the medicine on psychophysical fitness.

Pregnancy, breastfeeding and fertility

Nurofen Plus is contraindicated during the entire pregnancy. Nurofen Plus is contraindicated during breastfeeding. Codeine and morphine pass into breast milk.

Driving and operating machinery

Nurofen Plus may impair mental functions and cause vision disturbances, drowsiness and dizziness. Rare side effects include seizures, hallucinations, blurred or double vision and orthostatic hypotension. Patients should be informed not to drive vehicles or operate machinery if they experience such side effects. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Nurofen Plus

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist. Adults and children over 12 years of age should take 1 to 2 tablets every 6 hours. The tablets should be swallowed with a drink. Do not take more than 6 tablets in 24 hours. The medicine should not be taken for more than 3 days. If the pain does not subside after 3 days, the patient should consult a doctor. The medicine is intended for oral administration only and for temporary use. If the symptoms persist or worsen, or if new symptoms occur, the patient should consult a doctor. The patient should use the smallest effective dose for the shortest duration necessary to relieve the symptoms. If the patient is taking this medicine during an infection, and the symptoms of the infection (such as fever and pain) persist or worsen, they should consult a doctor immediately (see section 2). Taking the medicine in the smallest effective dose for the shortest duration necessary to relieve the symptoms reduces the risk of side effects. In patients with gastrointestinal disorders, it is recommended to take the medicine during meals. If the patient has been prescribed Nurofen Plus, before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from taking Nurofen Plus, when and for how long to take it, when to consult a doctor and when to stop the medicine (see section 3, Stopping Nurofen Plus).

Use in children and adolescents

Nurofen Plus should not be used in children under 12 years of age due to the risk of serious respiratory disorders.

Taking a higher dose of Nurofen Plus than recommended

If the patient has taken a higher dose of Nurofen Plus than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to assess the potential risk to their health and to receive advice on what to do. 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 breathing problems have occurred.

Stopping Nurofen Plus

The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

The following side effects have been observed during short-term use of the medicine in doses available without a prescription. If the medicine is used for other indications and for a long time, other side effects may occur. Like all medicines, Nurofen Plus can cause side effects, although not everybody gets them. If the patient experiences any of the following symptoms, they should stop taking ibuprofen and seek medical attention immediately: Side effects are ranked according to frequency of occurrence using the following terms: Very common: occur in more than 1 in 10 treated patients. Common: occur in less than 1 in 10 but more than 1 in 100 patients. Uncommon: occur in less than 1 in 100 but more than 1 in 1,000 patients. Rare: occur in less than 1 in 1,000 but more than 1 in 10,000 patients. Very rare: occur in less than 1 in 10,000 patients and in individual cases. Frequency not known: frequency cannot be estimated from the available data. Uncommon:

• hypersensitivity with urticaria and itching;
• headache;
• abdominal pain, nausea and indigestion;
• skin rash.

Rare:

• diarrhea, bloating, constipation, vomiting, gastritis.

Very rare:

• blood system disorders;
• severe hypersensitivity reactions. Symptoms may include: facial, tongue or throat swelling, shortness of breath, tachycardia, blood pressure drop (anaphylaxis, angioedema or severe shock);
• aseptic meningitis;
• heart failure and edema;
• hypertension;
• peptic ulcers, perforation or bleeding from the gastrointestinal tract, melena or hematemesis, oral ulcers;
• worsening of ulcerative colitis and Crohn's disease;
• dry mouth;
• liver disorders;
• bullous reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis;
• acute kidney failure;
• decreased hemoglobin levels.

Frequency not known:

• decreased appetite;
• depression, hallucinations, confusion, dependence, mood changes, anxiety, nightmares, insomnia;
• dizziness, drowsiness, seizures, increased intracranial pressure, dyskinesia (uncoordinated and involuntary movements of the limbs or the whole body), agitation and tinnitus;
• blurred vision, double vision;
• dizziness;
• orthostatic hypotension;
• bradycardia (very slow heart rate), palpitations;
• respiratory tract reactivity, including asthma, bronchospasm, shortness of breath;
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• biliary colic;
• symptoms associated with pancreatitis (pancreatitis) and biliary tract disorders (a problem with the ileocecal valve called ileocecal valve dysfunction), e.g.: severe abdominal pain that may radiate to the back, nausea, vomiting or fever.
• sudden flushing of the face;
• muscle stiffness;
• renal colic, renal tubular acidosis, painful urination;
• hypothermia (body cooling), excessive sweating, irritability, fatigue, malaise.
• red, flat, target-like or circular patches on the torso, often with blisters in the center, exfoliative dermatitis, oral, pharyngeal, nasal, genital and eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome). Red, exfoliative rash with nodules under the skin and blisters, mainly in skin folds, on the torso and upper limbs, with concurrent fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking Nurofen Plus and seek medical attention immediately. See also section 2.

• photosensitivity.

Nurofen Plus may cause kidney damage and affect the proper removal of acids from the blood to the urine (renal tubular acidosis), especially when taking the medicine in doses higher than recommended or for a longer period. It may also cause very low potassium levels in the blood (see section 2). This is a very serious condition and will require immediate treatment. Symptoms include muscle weakness and dizziness.

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.: +48 22 49 21 301 Fax: +48 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, more information can be collected on the safety of the medicine.

5. How to store Nurofen Plus

Do not store above 25°C. The medicine should be stored out of sight and reach of children. The medicine should be stored in a safe place, out of reach of others. It can cause serious harm and be fatal if it is not intended for them. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment

6. Contents of the packaging and other information

What Nurofen Plus contains

• The active substances of the medicine are ibuprofen and codeine phosphate - 1 coated tablet contains 200 mg of ibuprofen and 12.8 mg of codeine phosphate.
• The excipients are: tablet core: microcrystalline cellulose, sodium carboxymethylcellulose, gelatinized starch, hypromellose. tablet coating: hypromellose, talc, Opaspray white M-1-7111B (titanium dioxide (E 171), hypromellose).

What Nurofen Plus looks like and contents of the pack

Tablets are available in packs of 12 or 24 coated tablets. Not all pack sizes may be marketed.

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 For more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder: Reckitt Benckiser (Poland) S.A. ul. Okunin 1 05-100 Nowy Dwór Mazowiecki Tel.: 801 88 88 07 Date of last revision of the leaflet:11/2024