40 mg / ml oral suspension
ibuprofen
What Nurofen Orange is and what it is used for
Ibuprofen belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs).
These drugs have analgesic and antipyretic properties. Nurofen Orange is used for temporary treatment of:
- Fever in colds
- Mild to moderate pain conditions, e.g. headache and toothache
Ibuprofen contained in Nurofen Orange may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
You must talk to a doctor if your child does not feel better or if your child feels worse after 3 days.
What you need to know before taking Nurofen Orange
Do not give Nurofen Orange to children who
- is allergic to ibuprofen or similar painkillers ( NSAIDs ) or any of the other ingredients of this medicine (listed in section 6).
- have previously had difficulty breathing, asthma , runny nose, swelling of the face and / or hands or hives after using acetylsalicylic acid or other similar painkillers ( NSAIDs ).
- have or have had stomach ulcers or bleeding in the gastrointestinal tract in connection with previous use of NSAIDs
- have or have had recurrent stomach ulcers / bleeding (two or more confirmed cases of ulcers or bleeding)
- have severe kidney or liver disease
- have severe heart failure
- have cerebral haemorrhage (cerbrovascular haemorrhage) or other ongoing haemorrhage
- have problems with the blood’s ability to coagulate ( coagulation ) because ibuprofen can increase the bleeding time
- has undiagnosed disorder of blood formation
- is severely dehydrated (caused by vomiting, diarrhea or insufficient fluid intake)
Adults: do not take the medicine during the last three months of pregnancy.
Warnings and cautions
Talk to your doctor or doctor before using Nurofen Orange about your child
- have certain hereditary hematopoietic disorders (eg acute intermittent porphyria )
- have coagulation disorders
- have connective tissue disease SLE (systemic lupus erythematosus) or mixed connective tissue disease
- have or have had an intestinal disease ( ulcerative colitis or Crohn’s disease ), as these conditions may worsen (see section 4 “Possible side effects”)
- have previously had or have high blood pressure and / or heart failure
- has impaired renal function
- have any liver disease. Long-term use of Nurofen Orange requires regular monitoring of liver values, kidney function and blood counts.
- Caution is advised if other medicines are taken at the same time as may increase the risk of stomach ulcers or bleeding, e.g. oral corticosteroids (predisolone), blood thinners ( warfarin ), SSRIs (for depression) or platelet inhibitors ( acetylsalicylic acid ).
- take other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), as concomitant use of different painkillers should be avoided (see section Using other medicines).
- side effects can be minimized by taking the lowest effective dose in the shortest possible time.
- habitual use of (several types of) painkillers lead to persistent severe kidney problems. The risk can increase with physical exertion in combination with salt loss and dehydration. Therefore, this should be avoided.
- Prolonged use of any painkiller for headaches can make it worse. If this situation is experienced, or suspected, medical advice should be obtained and treatment discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who often or daily have headaches despite (or due to) regular use of headache medications.
- have or have had asthma or allergic disease.then breathing difficulties may occur
- have hay fever, nasal polyps or COPD ( chronic obstructive pulmonary disease ) as there is an increased risk of allergic reactions. The allergic reactions can manifest themselves as asthma attacks (so-called drug asthma), Quincke’s edema or hives.
- for chickenpox, Nurofen Orange should not be used.
- has recently undergone major surgery when medical supervision is required.
- is dehydrated, as the risk of kidney problems is then increased in dehydrated children
- Gastrointestinal side effects such as bleeding, ulcers and perforation , which can be life-threatening have been reported with the use of NSAIDs . This has occurred regardless of treatment time, with or without warning symptoms or previous occurrence of severe gastrointestinal side effects. If bleeding or ulcers occur in the gastrointestinal tract, treatment should be stopped immediately. The risk of bleeding, ulcers or perforation in the gastrointestinal tract increases with high NSAIDs , in patients with a history of gastric ulcers , especially in more severe cases of bleeding or perforation(see section 2 “Do not give your child Nurofen Orange”) and in the elderly. These patients should start their treatment with the lowest possible dose . Combination therapy with gastric mucosal protective drugs (eg misoprostol or proton pump inhibitors) should be considered for these patients and also for people who also need low-dose acetylsalicylic acid or other drugs that are likely to increase the risk of gastrointestinal side effects .
Infection is
Nurofen can hide signs of infection such as fever and pain. Therefore, Nurofen may delay the appropriate treatment of infection and increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections associated with chickenpox. If you are taking this medicine while you have an infection and the symptoms of infection persist or worsen, you should contact your doctor.
- Contact your doctor if your child needs to use this medicine for more than 3 days, or if the symptoms worsen.
Skin reactions
Serious skin reactions have been reported with Nurofen Orange. You should immediately stop taking Nurofen Orange and seek medical attention if you develop any rash, mucous membrane ulcers, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.
Anti-inflammatory/analgesic drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when using high doses. Do not exceed the recommended dose or treatment time.
You should discuss your treatment with a doctor or pharmacist before taking Nurofen Orange on your child:
- have heart problems including heart failure , angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked blood vessels) or some form of stroke (including “mini-stroke”) or transient ischemic attack ( TIA )).
- have high blood pressure , diabetes , high cholesterol, a history of heart disease or stroke in the family or if you are a smoker.
Ask your doctor for advice before using Nurofen Orange if any of the above apply to your child.
Older
Elderly people have an increased risk of side effects, especially gastrointestinal side effects.
Patients who have previously had side effects in the gastrointestinal tract, especially the elderly, should contact a doctor immediately if abnormal gastrointestinal problems occur (especially bleeding in the gastrointestinal tract), especially if it occurs at the beginning of treatment.
Other medicines and Nurofen Orange
Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
Nurofen Orange may affect or be affected by certain other medicines. For example:
- anticoagulant drugs (ie blood thinners, eg acetylsalicylic acid , dicumarol, warfarin , ticlopidine).
- drugs that lower high blood pressure ( diuretics , ACE inhibitors eg captopril , beta blockers eg atenolol, angiotensin II receptor antagonists eg losartan ).
Some other medicines may also affect or be affected by treatment with Nurofen Orange.
Therefore, always consult a doctor before using Nurofen Orange with other medicines.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially true if you take:
| Other NSAIDs include COX-2 inhibitors | As these can increase the risk of side effects |
| Digoxin (for heart failure ) | Then the effect of digoxin may increase |
| Glucocorticoids ( cortisone or cortisone-like substances) | As these can increase the risk of ulcers and bleed in the stomach and intestines |
| Platelet inhibitors | Then the risk of bleeding may increase |
| Acetylsalicylic acid (low dose) | Then the blood-whitening effect can be impaired |
| Blood thinners (eg warfarin ) | Then the effect of these drugs may increase |
| Phenytoin (for epilepsy ) | Then the effect of phenytoin may increase |
| Selective serotonin reuptake inhibitors (for depression) | As these can increase the risk of bleeding in the stomach and intestines |
| Lithium (a drug for manic-depressive states and depression) | Then the effect of lithium can increase |
| Probenecid and sulfinpyrazone (for gout ) | Then the secretion of ibuprofen can be delayed |
| Medicines for high blood pressure and diuretics | Then ibuprofen may reduce their effect and possibly increase the risk of kidney damage |
| Potassium-sparing diuretics e.g. amiloride, potassium kanrenoate, spironolactone, triamterene. | Then hyperkalemia can occur |
| Methotrexate (a medicine used to treat cancer and rheumatism) | Then the effect of methotrexate may increase |
| Tacrolimus and cyclosporine (immunosuppressive drugs, lower the body’s immune system) | Then kidney damage can occur |
| Zidovudine (against HIV / AIDS) | When there is an increased risk of bleeding in the joints or bleeding that leads to swelling in HIV -positive hemophiliacs |
| Sulfonylureas (for diabetes ) | Then the blood sugar level can be affected |
| Quinolone antibiotics | Then the risk of seizures (seizures) increases |
| Voriconazole or fluconazole (CYP2C9 inhibitor) for fungal infections | As the effect of ibuprofen may increase Reducing the ibuprofen dose should be considered, especially when high dose ibuprofen is given with either voriconazole or fluconazole. |
| Baclofen | Baclofen toxicity may develop after ibuprofen |
| Ritonavir | Then plasma concentrations of NSAIDs may increase |
| Aminoglycoside is | Then the secretion of aminoglycosides can decrease |
Nurofen Orange with alcohol
Do not drink alcohol while using Nurofen Orange. Certain side effects, such as those affecting the gastrointestinal tract or central nervous system, are more likely to occur if alcohol is taken with Nurofen Orange.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use this medicine during the last 3 months of pregnancy. Avoid taking this medicine for the first 6 months of pregnancy unless your doctor tells you otherwise.
Breast-feeding
Only small amounts of ibuprofen and its degradation products are transferred to breast milk. Nurofen Orange can be used during breastfeeding at the recommended dose and for the shortest possible time.
Fertil eats
Nurofen Orange belongs to a group of drugs ( NSAIDs ), which can impair fertility in women. That effect disappears when the drug treatment is stopped.
Driving and using machines
Short-term treatment of this drug has no or negligible effect on the ability to drive and use machines.
Important information about some of the ingredients of Nurofen Orange
- Nurofen Orange contains liquid maltitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
- May have a mild laxative effect.
- Calorific value 2.3 kcal / g maltitol.
- This medicine contains less than 1 mmol sodium per unit dose, ie essentially ‘sodium-free’.
- This medicine contains only very low levels of gluten (from wheat starch) and is considered gluten free. It is very unlikely that it causes problems if you have gluten intolerance ( celiac disease ).
- A 5 ml dosage unit contains a maximum of 0.315 micrograms of gluten.
- If you are allergic to wheat (a disease other than gluten intolerance), do not use this medicine.
How to take Nurofen Orange
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The lowest effective dose should be used for the shortest possible time to relieve symptoms. Contact a doctor if you have an infection and the symptoms (such as fever and pain) persist or worsen (see section 2).
Contact a doctor before using Nurofen Orange:
- If the child is difficult to carry or has abdominal pain, neck stiffness, or back pain.
- If the child has severe problems with ears, throat or trachea.
Generally, in case of fever in children, you should contact a doctor in the following situations:
- If the child has not drunk any fluid or lost a large amount of fluid due to persistent vomiting or diarrhea.
- If the treatment has not had any effect on the pain or fever after the first 24 hours.
- If new symptoms occur or stomach pain / stomach upset worsens or lasts a long time.
The usual dose for temporary mild to moderate pain and fever in colds:
| Child’s weight (age) | Amount | The number of doses is per day * |
|---|---|---|
| 7-9 kg (6-11 months) | 1.25 ml (equivalent to 50 mg ibuprofen ) | 3-4 times |
| 10-15 kg (1-3 years) | 2.5 ml (equivalent to 100 mg ibuprofen ) | 3 times |
| 16-19 kg (4-5 years) | 3.75 ml (equivalent to 150 mg ibuprofen ) | 3 times |
| 20-29 kg (6-9 years) | 5 ml (equivalent to 200 mg ibuprofen ) | 3 times |
| 30-40 kg (10-12 years) | 7.5 ml (equivalent to 300 mg ibuprofen )(use the syringe twice:5 ml + 2.5 ml) | 3 times |
* The dose should be given approximately every 6 to 8 hours, corresponding to 20-30 mg/kg per day.
Not recommended for use in children under 6 months or under 7 kg.
Patients with sensitive stomachs are advised to take Nurofen Orange with a meal.
WARNING: Do not exceed the specified dose. Higher doses than those recommended can lead to serious risks.
Instructions for use for the dosing syringe
Ints through the mouth
- Shake the bottle well.
- Remove the cap from the bottle by pushing it down and turning it counterclockwise.
- Press the dosing syringe firmly into the bottle opening.
- To fill the dosing syringe, turn the bottle upside down. While holding the dosing syringe in place, carefully pull out the syringe plunger until the solution has reached the desired mark on the syringe.
- Turn the bottle back to an upright position and remove the syringe from the bottle opening by gently turning the syringe.
- Insert the tip of the dosing syringe into the baby’s mouth. Slowly push in the syringe plunger to obtain the solution. After use, put the cap on the bottle. Wash the dosing syringe in warm water and allow it to dry. Keep out of sight and reach of children.
Treatment time
This medicine is for short-term use only. Nurofen Orange should be used for a maximum of 3 consecutive days. If used for a long time or if the symptoms worsen, a doctor should be consulted.
If you use more Nurofen Orange than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Symptoms may include nausea, stomach pain, vomiting (with blood), bleeding from the gastrointestinal tract, headache, ringing in the ears, confusion and jerky involuntary eye movements, or, more rarely, diarrhea. In addition, at high doses, dizziness, blurred vision, low blood pressure, elation, disorientation, coma, increased potassium in the blood, prolonged bleeding time, acute renal failure, liver damage, respiratory depression, worsening of asthma in asthmatics, drowsiness, chest pain, palpitations, unconsciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, chills and difficulty breathing have been reported.
If you or your child have forgotten to take Nurofen Orange
Do not take a double dose to make up for a forgotten dose. If you miss a dose, take or give it as soon as you remember and then take the next dose according to the dosing interval above.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Nurofen Orelsin can cause side effects, although not everybody gets them. Side effects can be minimized by taking the lowest dose for the shortest possible time to relieve symptoms. Your child may have side effects. If this happens or you feel anxious, stop giving your child this medicine and contact a doctor as soon as possible. Elderly people who use this medicine have an increased risk of side effects.
STOP USING this medicine and seek immediate medical attention if your child gets the following :
- Signs of bleeding from the gastrointestinal tract; severe abdominal pain, black tar-like stools, bloody vomiting or with dark particles resembling coffee grounds.
- Signs of severe allergic reaction; worsening of asthma , unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, palpitations, drop in blood pressure which may lead to shock . This may occur as early as the first time you take this medicine. If any of these symptoms occur, consult a doctor immediately
- Severe skin reactions; rash that covers the whole body, flaking, blisters or skin flaking.
Tell your doctor if any of the following side effects occur, if they get worse or if you experience any of them that are not listed.
Common (may affect up to 1 in 10 users)
- Stomach and intestinal problems such as heartburn, abdominal pain, nausea, indigestion, diarrhea, vomiting, flatulence, constipation and small bleeding in the stomach and / or intestines which in rare cases can cause anemia .
Uncommon (may affect up to 1 in 100 people)
- Gastric ulcer , perforation or bleeding, inflammation of the oral mucosa with ulcers, worsening of ongoing gastrointestinal disease ( ulcerative colitis or Crohn’s disease ), gastritis .
- Disorders of the central nervous system such as headache, dizziness, insomnia, anxiety, irritability or fatigue.
- Visual disturbances.
- Skin rash of various kinds
- Hypersensitivity reaction with hives and itching
Rare (may affect 1 in 1000 users)
- Tinnitus .
- Increased urea concentration in the blood, pain in the back and / or abdomen, blood in the urine and fever can be signs of kidney damage (papillary necrosis )
- Increased uric acid concentration in the blood
- Decreased hemoglobin levels
Very rare (may affect 1 in 10,000 users)
- Inflammation of the esophagus and pancreas , narrowing of the intestine
- Heart failure , heart attack and swelling of the face and hands ( edema )
- Less than normal urine output and swelling (especially in patients with high blood pressure and impaired kidney function), swelling ( edema ) and cloudy urine ( nephrotic syndrome ), inflammatory kidney disease (interstitial nephritis) that can lead to acute renal failure . If any of the above symptoms occur, or in case of malaise, stop taking Nurofen Orange and contact a doctor immediately as this may be the first signs of kidney damage or kidney failure .
- Psychotic reactions and depression
- High blood pressure , inflammation of blood vessels
- Palpitation
- Impaired liver function, damage to the liver (first signs may be discoloration of the skin), especially with long-term use, liver failure, acute hepatitis ( hepatitis )
- Disorder of blood cell formation – the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms , severe fatigue, nose and skin bleeding, unexplained bruising. In these cases, treatment must be stopped immediately and a doctor consulted. All self-medication with painkillers or antipyretics (antipyretic drugs) must be stopped.
- Severe skin infections and soft tissue complications in chickenpox
- Deterioration of inflammation-related infections (eg necrotizing fasciitis) has been reported with the use of certain painkillers ( NSAIDs ). If signs of infection appear or get worse, a doctor must be consulted without delay to investigate whether treatment against infection / with antibiotics should be initiated.
- Symptoms of meningitis , such as neck stiffness, headache, nausea, vomiting, fever and confusion have been observed with ibuprofen . Patients with autoimmune diseases ( SLE , mixed connective tissue disease) may be at greater risk of being affected. Contact a doctor immediately if this happens.
- Severe skin side effects; rash with redness and blisters (eg Stevens Johnson syndrome, erythema multiforme, toxic epidermal necrolysis / Lyell syndrome), hair loss ( alopecia ).
Not known: (frequency can not be estimated from available data)
- Respiratory reactions such as asthma , bronchospasm or shortness of breath ( dyspnoea ).
- A severe skin reaction called DRESS syndrome can occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell ).
- Widespread red, scaly rash with bumps under the skin and blisters mainly in the folds of the skin, on the torso and arms together with fever at the beginning of the treatment ( acute generalized exanthematous pustulosis ). Stop using Nurofen Orange immediately if you develop these symptoms and seek medical attention immediately. See also section 2.
- The skin becomes light-sensitive
Drugs belonging to this group may carry a slightly increased risk of heart attack or stroke.
How to store Nurofen Orange
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
After the bottle has been opened, the shelf life is 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
Nurofen Orange, 40 mg / ml, oral suspension
- The active substance is ibuprofen . 1 ml oral suspension contains 40 mg ibuprofen .
- The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, saccharin sodium, polysorbate 80, domifene bromide, liquid maltitol, glycerol , xanthan gum, orange flavor (contains wheat starch), purified water.
What the medicine looks like and contents of the pack
Nurofen Orange, 40 mg/ml, the oral suspension is an off-white viscous orange-flavored suspension.
Each bottle contains either 30 ml, 50 ml, or 100 ml.
The pack contains a dosing syringe (holds 5 ml and is graduated with 1.25 ml, 2.5 ml, 3.75 ml, and 5 ml).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (Scandinavia) A / S
Vandtårnsvej 83A
2860 Söborg
Denmark
Manufacturer
RB NL Brands BV
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
Netherlands
This medicinal product is authorized under the European Economic Area under the names: