Mock up; BPZ Naproxen; size: 860 x 210 mm; colour: black; font: Helvetica; fontsize: 11Pt; Id.-Nr.: 1540100411G03_Mockup04

Package leaflet: Information for the user • inflammatory rheumatic diseases of soft tissues cholesterol levels, or if you smoke), discuss this reactions usually occur at the start of treatment (in Other medicines and Naproxen If any of the above apply to you, or if you are not sure, sugars, contact your doctor before taking this medicinal • Remove the syringe from the bottle. • painful swelling or inflammation after treatment with your doctor or pharmacist. the first month). If you develop a skin rash (including Tell your doctor or pharmacist if you are taking, have talk to your doctor or pharmacist before you take product. • Place the end of the syringe in the patient’s mouth musculoskeletal injuries Talk to your doctor or pharmacist before taking lesions of the mucous membranes such as mouth, recently taken or might take any other medicines. This Naproxen. May be harmful to the teeth. and gently press the plunger down to slowly and throat, nose, eyes, genitals) or any other signs of includes medicines that you buy without a prescription Naproxen 50mg/m - period pain Naproxen: Naproxen with food, drink and alcohol Sorbitol gently release the medicine. hypersensitivity, stop using Naproxen and contact your and herbal medicines. In particular, tell your doctor or The consumption of alcoholic drinks during treatment It can also be used in children from 2 years of age and • if you have asthma, allergies (like hayfever) or chronic One mL of Naproxen Oral Suspension contains 128.6mg • After use replace the bottle cap. Wash the syringe doctor immediately. pharmacist if you are taking: with Naproxen increases the risk of bleeding in the Oral Suspension adolescents with rheumatoid arthritis. obstructive airway disease or have had swelling of the sorbitol 70% solution – which is broken down in the body with water. Disassemble the two parts of the syringe face, lips, eyes or tongue in the past. General information • Other NSAIDs including salicylates (like acetylsalicylic gastrointestinal tract (stomach/intestine) and should to fructose (fruit sugar). If you have been told by your and allow to dry. Store out of the reach of children. Naproxen Pain relief and underlying illness acid) and COX-2 inhibitors therefore be avoided. 2. What you need to know before you take • if you have lumps in your nose (polyps) or you sneeze doctor that you have an intolerance to some sugars, Unless otherwise prescribed by your doctor, the For children from 2 years of age and adults If, during treatment with naproxen, you do not feel better, Naproxen a lot or have a runny, blocked, or itchy nose (rhinitis). • Aspirin/acetylsalicylic acid to prevent blood clots Pregnancy, breast-feeding and fertility contact your doctor before taking this medicinal product. recommended dose is: or if you should continue to have pain, fever, fatigue or Read all of this leaflet carefully before you start • Glucocorticoids (for swelling and inflammation), like If you are pregnant or breast-feeding, think you may be Sodium Do not take Naproxen: • if you have a feeling of weakness (perhaps because other signs of illness, please ask your doctor for advice. Adults up to 65 years of age taking this medicine because it contains important hydrocortisone, prednisolone and dexamethasone pregnant or are planning to have a baby, ask your doctor This medicinal product contains 0.4mmol (or 9.2mg) • if you are allergic to naproxen or any of the other of an illness) or you are an older person. This is because painkillers may mask possible warning The recommended dose range is 10–20mL of Naproxen information for you. for advice before taking this medicine. sodium per mL. To be taken into consideration by ingredients of this medicine (listed in section 6). • if you have problems with your kidneys or liver. signs of an underlying illness. • Medicine to stop your blood clotting, like warfarin, Oral Suspension (500mg to 1,000mg naproxen) per day. - Keep this leaflet. You may need to read it again. heparin or clopidogrel Pregnancy patients on a controlled sodium diet. A daily dose of 20mL of Naproxen Oral Suspension • if you have a history of asthma attacks, angioedema, • if you have problems with the way that your blood Headache from painkillers - If you have any further questions, ask your doctor or During the first 6 months of pregnancy, the use of Methyl-parahydroxybenzoate (1,000mg naproxen) should not be exceeded. skin reactions or acute rhinitis after taking clots. Prolonged, high-dose use of painkillers may cause • Phenytoin (used to treat epilepsy) pharmacist. Naproxen should be avoided unless explicitly instructed This medicinal product contains methyl- acetylsalicylic acid or any other NSAIDs. headaches that must not be treated by taking more • Sulfonamide medicines, like hydrochlorothiazide, Dosage should be individually adjusted to the clinical • if you are taking medicines such as corticosteroids, by a doctor. parahydroxybenzoate as preservative. May cause - This medicine has been prescribed for you only. Do painkillers. acetazolamide, indapamide and including condition. • if you have blood formation disturbances. anticoagulants, selective serotonin re-uptake Do not take Naproxen if you are in the last 3 months of allergic reactions (possibly delayed). not pass it on to others. It may harm them, even if sulphonamide antibiotics (for infections) Symptomatic treatment of painful swelling or their signs of illness are the same as yours. • if you have now an ulcer or bleeding in your stomach inhibitors (SSRIs), acetylsalicylic acid or NSAIDs Kidney damage from painkillers pregnancy because it may harm you or your baby. including COX-2 inhibitors. Habitual use of certain painkillers for a prolonged period • Oral medicines for the treatment of diabetes like inflammation after musculoskeletal injuries or gut. Do not take Naproxen after childbirth because it may 3. How to take Naproxen - If you get any side effects, talk to your doctor or of time may lead to permanent kidney damage with the glimepiride or glipizide The usual initial dose is 10mL of Naproxen Oral pharmacist. This includes any possible side effects • If you have a history of recurrent stomach/duodenal • if you have previously experienced stomach ulcer delay the process of the uterus shrinking back into its Suspension (500mg naproxen). If necessary, you can or bleeding. You will be asked to report any unusual risk of kidney failure. • An ‘ACE inhibitor’ or any other medicine for high blood Always take this medicine exactly as your doctor has not listed in this leaflet. See section 4. ulcers (peptic ulcers) or bleeding (at least two different normal shape and size. told you. Check with your doctor or pharmacist if you are take an additional dose of 5mL (250mg naproxen) every symptoms from your stomach to your doctor. If any of the above applies to you, or if you are not pressure like cilazapril, enalapril or propranolol episodes of confirmed ulcers or bleeding). Breast-feeding not sure. 6 to 8 hours. The daily dose should not exceed 20mL of What is in this leaflet sure, talk to your doctor or pharmacist before you 1. What Naproxen is and what it is used for • if you have previously experienced bleeding or • if you have an autoimmune condition, such as • An angiotensin-II receptor antagonist, like You should avoid taking Naproxen if you are breast- Naproxen Oral Suspension (1,000mg naproxen). ‘systemic lupus erythematosus’ (SLE, causes joint take Naproxen. candesartan, eprosartan or losartan Shake the bottle vigorously before use. Take Naproxen perforation in your stomach or gut while taking feeding since it may pass into human milk in small Oral Suspension with a sufficient amount of liquid. Symptomatic treatment of pain and inflammation in 2. What you need to know before you take Naproxen pain, skin rashes and fever) or mixed connective Laboratory test results NSAIDs. • A diuretic (water tablet) (for high blood pressure), like amounts. Naproxen starts to act earlier when taken on an empty rheumatoid arthritis, ankylosing spondylitis and acute 3. How to take Naproxen tissue disease and ulcerative colitis or Crohn’s If your doctor recommends monitoring of your blood • if you have severe kidney, liver or heart failure. furosemide or triamterene Fertility stomach. Patients with sensitive stomach are advised to attacks of osteoarthrosis and spondylarthrosis as well as disease (conditions causing inflammation of the counts, blood clotting and/or liver and kidney function 4. Possible side effects • if you have a brain bleed. • A ‘cardiac glycoside’ (for heart problems), like digoxin Naproxen may make it more difficult to become take Naproxen Oral Suspension during meals. in inflammatory rheumatic diseases of soft tissues bowel, bowel pain, diarrhoea, vomiting and weight and/or any other tests (e.g. determination of the blood The daily dose is usually 10–15mL of Naproxen Oral 5. How to store Naproxen • if you currently have any other form of acute bleeding. • A ‘quinolone antibiotic’ (for infections), like pregnant. You should inform your doctor if you are Naproxen – like all NSAIDs – should be taken at the loss). levels of certain medicines), it is essential that you Suspension (500–750mg naproxen). At the start of 6. Contents of the pack and other information ciprofloxacin or moxifloxacin planning to become pregnant or if you have problems lowest dose necessary for pain relief for the shortest • if you are in the last three months of pregnancy (see • if you have problems with vision or hearing. have these tests performed. This applies particularly to therapy, during phases of acute inflammation or when becoming pregnant. possible period of time. This precaution helps minimise “Pregnancy, breast-feeding and fertility”). patients with impaired liver function, heart failure, high • Certain medicines for mental health problems like switching from another high-dose NSAID to Naproxen 1. What Naproxen is and what it is used for • if you have had a major surgery shortly before starting Driving and using machines possible side effects. Warnings and precautions blood pressure or kidney damage. lithium or selective serotonin reuptake inhibitors Oral Suspension, the recommended dose is 15mL of treatment with Naproxen. Naproxen may make you tired, dizzy, have problems Naproxen Oral Suspension contains a medicine called Undesirable effects may be minimised by using the If you need to have an adrenal function test done, you (SSRIs) like fluoxetine or citalopram The pack contains a 8mL graduated oral syringe Naproxen Oral Suspension (750mg naproxen), taken • if you have heavy menstrual bleeding. with your eyesight or other central nervous disturbances naproxen. This is a ‘Non-Steroidal Anti-Inflammatory lowest effective dose for the shortest duration necessary must (temporarily) stop taking Naproxen at least 3 days • Probenecid and sulphinpyrazone (for gout) with graduations of 0.1mL which should be used to as two divided doses per day (10mL of Naproxen Oral • if you have a disorder of the biosynthesis of the red may occur. Talk to your doctor if any of these happen to Drug’ or NSAID. to control the symptoms. before the test to avoid interference with the test result. • Methotrexate (used to treat skin problems, arthritis or administer this medicine. Suspension in the morning and 5mL in the evening, or pigment that gives blood its colour (porphyria). you and do not drive or use any tools or machines. Naproxen is used in adults for the symptomatic Medicines such as Naproxen may be associated with Children and adolescents cancer) Using the oral syringe: vice versa) or as a single dose (either in the morning or Naproxen Oral Suspension contains sucrose, treatment of: a small increased risk of heart attack (“myocardial This medicine must be stopped immediately in case Naproxen is not recommended for use in children • Immerse the tip of the oral syringe in the medicine. in the evening). • Ciclosporin or tacrolimus (for skin problems or after sorbitol, sodium and methyl-parahydroxybenzoate infarction”) or stroke. Any risk is more likely with high of gastrointestinal bleeding or visual disturbances or under 2 years of age because there is no adequate • Whilst holding the syringe in place, gently pull the In individual cases, your doctor can increase the daily dose - pain and inflammation in: an organ transplant) Sucrose doses and prolonged treatment. Do not exceed the hearing impairment. experience. plunger up drawing the medicine to the correct mark to 20mL of Naproxen Oral Suspension (1,000mg naproxen). • rheumatoid arthritis, ankylosing spondylitis (pain • Zidovudine (used to treat AIDS and HIV infections) One mL of Naproxen Oral Suspension contains 300mg recommended dose or duration of treatment. There have been very rarely reports of severe skin on the syringe. The maintenance dose is 10mL of Naproxen Oral and stiffness in the neck and back), acute attacks of Naproxen is not recommended for use in any disorder • Mifepristone (used to end pregnancy or to bring on sugar (sucrose) which corresponds to a bread exchange reactions (including exfoliative dermatitis, Stevens- Suspension (500mg naproxen) per day, which may be osteoarthrosis and spondylarthrosis If you have heart problems, have ever had a stroke other than juvenile rheumatoid arthritis in children and labour if the baby has died) of approximately 0.03. This should be taken into account • When bubbles occur, release the medicine back or think that you may be at increased risk for these Johnson syndrome or toxic epidermal necrolysis) adolescents under 18 years of age. into the bottle and pull up the medicine again to the taken either in two divided doses (5mL in the morning • acute gout associated with the administration of NSAIDs. These • ‘Antacids’ (neutralise excess acid in the stomach) in patients with diabetes mellitus. If you have been told conditions (e.g.: high blood pressure, diabetes, elevated by your doctor that you have an intolerance to some correct mark on the syringe. and 5mL in the evening) or as a single dose (either in the morning or in the evening). to know before you take Naproxen”). • Swelling of the face or throat, difficulty swallowing • Stomach pain • Hair loss (usually temporary) necrolysis) This includes any possible side effects not listed in this Marketing Authorisation Holder and Manufacturer Symptomatic treatment of pain and inflammation in Patients with impaired kidney function • (Itchy) skin rash, redness, small blisters • Fullness • Inflammation of the skin caused by (sun)light (which • Kidney damage (renal papillary necrosis) (especially leaflet. You can also report side effects directly via the Infectopharm Arzneimittel und Consilium GmbH Yellow Card scheme at www.mhra.gov.uk/yellowcard. Von-Humboldt-Str. 1 acute gout Should your kidney function be impaired, your doctor Serious stomach and gut problems (may affect up to • Constipation or diarrhoea and minor blood loss in the may include blistering) during long-term therapy) By reporting side effects you can help provide more 64646 Heppenheim The usual initial dose is 15mL of Naproxen Oral may want to reduce your Naproxen dose. 1 in 10 people), signs include: gastrointestinal tract which, in exceptional cases, may • Muscle pain • Increased uric acid level in the blood Suspension (750mg naproxen); thereafter, take 5mL of information on the safety of this medicine. Germany Should your kidney function be severely impaired, you • Relatively severe abdominal (stomach) pain - cause anaemia • Muscle weakness Not known (frequency cannot be estimated from the Naproxen Oral Suspension (250mg naproxen) every Distributed by: must not take Naproxen (see section 2 “What you need especially if onset is sudden Common side effects (may affect up to 1 in 10 available data): 8 hours until the attack is over. During acute gout • Acute kidney failure 5. How to store Naproxen Thornton & Ross Ltd., Linthwaite, Huddersfield, to know before you take Naproxen”). • Bloody vomit or coffee grounds-like vomit people): • Increased potassium levels attacks, you may thus exceed the maximum daily dose • Impairment of kidney function (nephrotic syndrome) Store in the original package in order to protect from HD7 5QH, United Kingdom Duration of treatment • Bloody or black stools • Bleeding of the skin and mucous membranes • Decreased white blood cell counts (neutropenia). of 20mL (1,000mg naproxen) (for a short period of time). • Inflammation of the kidney(s) (interstitial nephritis) The duration of use is decided by the treating physician. • Depression light. Symptomatic treatment of period pain • Ulcers, perforations (holes) and bleeds in your • Swelling of the lens and optic nerve head This leaflet was last revised in June 2018 For rheumatic diseases, it may be necessary to take • Fever and chills, malaise After first opening, this medicine is stable for 3 months. The usual initial dose is 10mL of Naproxen Oral stomach or gut sometimes fatal particularly in elderly • Dream abnormalities • Corneal opacity Naproxen over a prolonged period. • Inflammation of the stomach lining Store in the original package in order to protect from Suspension (500mg naproxen); thereafter, you may take Heart attack, signs include: • Difficulty falling asleep or staying asleep (insomnia) • Inflammation of the optic nerve head light. The following information is intended for healthcare 5mL of Naproxen Oral Suspension (250mg naproxen) In period pain the treatment duration depends on the • Chest pain which may spread to your neck and • Gas • Headache • Pins and needles or numbness of your hands and feet professionals only: every 6–8 hours. A daily dose of 20mL of Naproxen respective symptomology. However, the treatment with shoulders and down your left arm Rare side effects (may affect up to 1 in 1,000 Keep this medicine out of the sight and reach of Naproxen should not exceed a few days. • Dizziness • Lung oedema children. Oral Suspension (1,000mg naproxen) should not be Liver problems (may affect up to 1 in 10,000 people), people): • Agitation In case of a naproxen overdose: exceeded. If you take more Naproxen than you should signs include: • Blistering skin conditions (epidermolysis bullosa-like • Inflammation of the pancreas (a large gland behind Do not use this medicine after the expiry date which is Symptoms of overdose Children from 2 years of age and adolescents for If you take more Naproxen than you should, talk to • Severe fatigue with loss of appetite, with or without • Irritability reactions) the stomach) stated on the label and on the carton after “EXP”. The Symptoms of overdose may include CNS disturbances the treatment of rheumatoid arthritis a doctor or go to a hospital straight away. Take the yellow colouration of the skin and the whites of the • Sleep disturbances Very rare side effects (may affect up to 1 in 10,000 • Erythema nodosum (a skin inflammation that involves expiry date refers to the last day of that month. including headache, dizziness or lightheadedness, and The recommended dose is 10mg naproxen/kg body medicine pack with you. eyes people): reddish painful bumps) Do not throw away any medicines via waste-water. • Tiredness epigastric pain and abdominal discomfort, indigestion, weight per day which corresponds to a daily dose of • Decreased red and/or white blood cell and/or blood Ask your pharmacist how to throw away medicines you For healthcare professionals: Information on how • Feeling or being sick, or pale coloured stools • Perception disorders and cognitive dysfunction • Lichen planus (a non-infectious, itchy rash that can nausea, vomiting, transient change in hepatic function, 0.2mL of Naproxen Oral Suspension per kilogram platelet counts (aplastic or haemolytic anaemia, no longer use. These measures will help protect the to manage poisoning with naproxen can be found at Impairment of sensory organs, e.g.: affect many areas of the body) hypoprothrombinaemia, renal dysfunction, metabolic of body weight, administered in two divided doses • Ringing noises in the ears thrombocytopenia, leukopenia, pancytopenia, environment. the end of this package leaflet. • Suddenly occurring visual disturbances (may affect • Systemic lupus erythematosus (SLE, an autoimmune acidosis, apnoea and disorientation. Naproxen can be (single dose 0.1mL of Naproxen Oral Suspension (5mg • Vertigo (dizziness) agranulocytosis). up to 1 in 10,000 people) or hearing impairment (may condition leading to an inflammatory process that can absorbed rapidly. High and early drug concentrations naproxen) per kilogram body weight). The daily dose If you forget to take Naproxen 6. Contents of the pack and other information affect up to 1 in 10 people) • Sweating • Seizures (fits) affect various parts of the body) in the blood should be expected. A few patients have for adolescents should not exceed 20mL (1,000mg Do not take a double dose to make up for a forgotten • Fluid deposits in the body (oedema), especially in • Nerve inflammation What Naproxen Oral Suspension contains experienced seizures, but it remained unclear whether naproxen). dose. Continue taking Naproxen as usual. Aseptic meningitis (may affect up to 1 in 10,000 • Pustular reaction patients with high blood pressure • The active substance is: naproxen these were caused by treatment with naproxen. If you have any further questions on the use of this people), signs include: • High blood pressure • Blood in the urine (haematuria) Naproxen is not recommended for use in children under Gastrointestinal bleeding may also occur. Hypertension, medicine, ask your doctor or pharmacist. • Severe headache - especially if onset is sudden • Thirst • Acceleration of the heart rate 1mL of Naproxen Oral Suspension contains 50mg 2 years of age (see section “warnings and precautions”, • Inflammation of certain parts of the kidneys naproxen. acute renal failure, respiratory depression and coma subsection “children and adolescents”). • Stiff neck, fever, feeling or being sick Uncommon side effects (may affect up to 1 in 100 • Pounding heart (glomerulonephritis) 4. Possible side effects people): • The other ingredients are: sucrose (sugar), saccharin may occur, but are rare. Anaphylactic reactions have • Confusion, sensitivity to bright light • Heart failure Special patient populations • Blood count changes • Female infertility sodium (E 954), sodium cyclamate (E 952), sodium been described after treatment with non-steroidal Elderly (over 65 years of age) Like all medicines, this medicine can cause side effects, Patients with autoimmune diseases (SLE, mixed • Inflammation of blood vessels • Oedema chloride, methyl-parahydroxybenzoate (E 218), anti-inflammatory drugs and may also occur following Careful monitoring by your doctor is necessary. In older although not everybody gets them. Medicines such as connective tissue diseases) are at increased risk for • Increased counts of certain types of white blood cells overdose. (eosinophilia) • Worsening of infection-related inflammation (e.g. Naproxen may interfere with laboratory test results; you potassium sorbate (E 202), tragacanth (E 413), citric patients it is particularly important to select the lowest Naproxen may be associated with a small increased risk developing meningitis. development of necrotising fasciitis, i.e. acute acid (E 330), sorbitol 70 % solution (E 420), water. Management of overdose • Asthma attacks (with and without drop in blood should therefore inform all of your doctors (if applicable) effective dose of Naproxen for the shortest possible of heart attack (‘myocardial infarction’) or stroke. Blood and lymphatic disorders (may affect up to 1 in inflammation and necrosis [death of tissue] of the fatty that you are taking Naproxen (see section 2 “What you Patients should be treated symptomatically. There is duration (see section 2 “What you need to know before pressure) What Naproxen Oral Suspension looks like and Important side effects to look out for: 10,000 people), signs include: tissue beneath the skin and muscles). need to know before you take Naproxen”). contents of the pack no specific antidote. Preventive measures to avoid you take Naproxen”). • Inflammation of the lungs (eosinophilic pneumonia) If you experience any of the following symptoms or • Flu-like symptoms, mouth sores, sore throat and • Anaphylactic or anaphylactoid systemic reactions Methyl-parahydroxybenzoate may cause hypersensitivity Naproxen Oral Suspension is a white to yellowish-white further absorption (e.g. administration of activated Patients with impaired liver function combinations of symptoms, please stop taking this nosebleeds • Symptoms in the lower abdomen (e.g. inflammation of reactions, including delayed reactions. oral suspension. charcoal) may be indicated in patients within four Patients with impaired liver function are at risk of over- medicine and contact a doctor straight away. You • Liver inflammation (hepatitis), liver damage especially hours after ingestion or because of a large overdose. Naproxen may cause the following side effects: the large bowel with bleeding or worsening of Crohn‘s Amber glass bottle with child-resistant screw closure dose when taking Naproxen. Therefore, the lowest dose may need urgent medical treatment: after long-term therapy Side effects in children and adolescents Forced diuresis, alkalinisation of urine, haemodialysis or Very common side effects (may affect more than 1 disease/ulcerative colitis) 8mL graduated oral syringe with graduations of 0.1mL of Naproxen that is still effective should be selected. • Hypersensitivity reactions such as skin rash, The frequency, type and severity of side effects in haemoperfusion are probably unsuitable because of the Severe allergic reactions (may affect up to 1 in 10,000 in 10 people): • Inflammation of the lining of the oral cavity (mouth) children and adolescents are similar to those in adults. Careful monitoring by your doctor is necessary. people), signs include: • Feeling sick erythema multiforme, in isolated cases manifesting Pack size: 100mL high protein binding of naproxen. • Injury to the food pipe as severe cutaneous adverse reactions (including Reporting of side effects Should your liver function be severely impaired, you • Shortness of breath • Being sick must not take Naproxen (see section 2 “What you need • Changes in liver function with transaminase elevation Stevens-Johnson syndrome or toxic epidermal If you get any side effects, talk to your doctor or pharmacist. • Large drop in blood pressure • Heartburn 1540100411G03