Naproxen 50mg/ml Oral Suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6).
• if you have a history of asthma attacks, angioedema, skin reactions or acute rhinitis after taking acetylsalicylic acid or any other NSAIDs.
• if you have blood formation disturbances.
• if you have now an ulcer or bleeding in your stomach or gut.
• if you have a history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least two different episodes of confirmed ulcers or bleeding).
• if you have previously experienced bleeding or perforation in your stomach or gut while taking NSAIDs.
• if you have severe kidney, liver or heart failure.
• if you have a brain bleed.
• if you currently have any other form of acute bleeding.
• if you are in the last three months of pregnancy (see “Pregnancy, breast-feeding and fertility”).

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control the symptoms.

Medicines such as Naproxen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, have ever had a stroke or think that you may be at increased risk for these conditions (e.g.: high blood pressure, diabetes, elevated cholesterol levels, or if you smoke), discuss this treatment with your doctor or pharmacist.

Talk to your doctor or pharmacist before taking Naproxen:

• if you have asthma, allergies (like hayfever) or chronic obstructive airway disease or have had swelling of the face, lips, eyes or tongue in the past.
• if you have lumps in your nose (polyps) or you sneeze a lot or have a runny, blocked, or itchy nose (rhinitis).
• if you have a feeling of weakness (perhaps because of an illness) or you are an older person.
• if you have problems with your kidneys or liver.
• if you have problems with the way that your blood clots.
• if you are taking medicines such as corticosteroids, anticoagulants, selective serotonin re-uptake inhibitors (SSRIs), acetylsalicylic acid or NSAIDs including COX-2 inhibitors.
• if you have previously experienced stomach ulcer or bleeding. You will be asked to report any unusual symptoms from your stomach to your doctor.
• if you have an autoimmune condition, such as ‘systemic lupus erythematosus’ (SLE, causes joint pain, skin rashes and fever) or mixed connective tissue disease and ulcerative colitis or Crohn’s disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss).
• if you have problems with vision or hearing.
• if you have had a major surgery shortly before starting treatment with Naproxen.
• if you have heavy menstrual bleeding.
• if you have a disorder of the biosynthesis of the red pigment that gives blood its colour (porphyria).

This medicine must be stopped immediately in case of gastrointestinal bleeding or visual disturbances or hearing impairment.

Serious skin reactions (including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)) have been reported in association with Naproxen Oral Suspension. Stop using Naproxen Oral Suspension and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Pain relief and underlying illness

If, during treatment with naproxen, you do not feel better, or if you should continue to have pain, fever, fatigue or other signs of illness, please ask your doctor for advice. This is because painkillers may mask possible warning signs of an underlying illness.

Headache from painkillers

Prolonged, high-dose use of painkillers may cause headaches that must not be treated by taking more painkillers.

Kidney damage from painkillers

Habitual use of certain painkillers for a prolonged period of time may lead to permanent kidney damage with the risk of kidney failure.

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before you take Naproxen.

Laboratory test results

If your doctor recommends monitoring of your blood counts, blood clotting and/or liver and kidney function and/or any other tests (e.g. determination of the blood levels of certain medicines), it is essential that you have these tests performed. This applies particularly to patients with impaired liver function, heart failure, high blood pressure or kidney damage.

If you need to have an adrenal function test done, you must (temporarily) stop taking Naproxen at least 3 days before the test to avoid interference with the test result.

Naproxen is not recommended for use in children under 2 years of age because there is no adequate experience.

Naproxen is not recommended for use in any disorder other than juvenile idiopathic arthritis in children and adolescents under 18 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. In particular, tell your doctor or pharmacist if you are taking:

• Other NSAIDs including salicylates (like acetylsalicylic acid) and COX-2 inhibitors
• Aspirin/acetylsalicylic acid to prevent blood clots
• Glucocorticoids (for swelling and inflammation), like hydrocortisone, prednisolone and dexamethasone
• Medicine to stop your blood clotting, like warfarin, heparin or clopidogrel
• Phenytoin (used to treat epilepsy)
• Sulfonamide medicines, like hydrochlorothiazide, acetazolamide, indapamide and including sulphonamide antibiotics (for infections)
• Oral medicines for the treatment of diabetes like glimepiride or glipizide
• An ‘ACE inhibitor’ or any other medicine for high blood pressure like cilazapril, enalapril or propranolol
• An angiotensin-II receptor antagonist, like candesartan, eprosartan or losartan
• A diuretic (water tablet) (for high blood pressure), like furosemide or triamterene
• A ‘cardiac glycoside’ (for heart problems), like digoxin
• A ‘quinolone antibiotic’ (for infections), like ciprofloxacin or moxifloxacin
• Certain medicines for mental health problems like lithium or selective serotonin reuptake inhibitors (SSRIs) like fluoxetine or citalopram
• Probenecid and sulphinpyrazone (for gout)
• Methotrexate (used to treat skin problems, arthritis or cancer)
• Ciclosporin or tacrolimus (for skin problems or after an organ transplant)
• Zidovudine (used to treat AIDS and HIV infections)
• Mifepristone (used to end pregnancy or to bring on labour if the baby has died)
• ‘Antacids’ (neutralise excess acid in the stomach)

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Naproxen.

The consumption of alcoholic drinks during treatment with Naproxen increases the risk of bleeding in the gastrointestinal tract (stomach/intestine) and should therefore be avoided.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Do not take Naproxen if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take Naproxen during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Naproxen can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Do not take Naproxen after childbirth because it may delay the process of the uterus shrinking back into its normal shape and size.

Breast-feeding

You should avoid taking Naproxen if you are breast-feeding since it may pass into human milk in small amounts.

Fertility

Naproxen may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Naproxen may make you tired, dizzy, have problems with your eyesight or other central nervous disturbances may occur. Talk to your doctor if any of these happen to you and do not drive or use any tools or machines.

Sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. One mL contains 300mg sucrose (sugar). This should be taken into account in patients with diabetes mellitus. May be harmful to the teeth.

Sorbitol

This medicine contains 90 mg sorbitol in each mL. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

Sodium

This medicine contains 9.2mg sodium (main component of cooking/table salt) in each mL. This is equivalent to 0.46 % of the recommended maximum daily dietary intake of sodium for an adult.

Methyl parahydroxybenzoate

This medicinal product contains methyl parahydroxybenzoate as preservative. May cause allergic reactions (possibly delayed).

The duration of use is decided by the treating physician.

For rheumatic diseases, it may be necessary to take Naproxen over a prolonged period.

In period pain the treatment duration depends on the respective symptomology. However, the treatment with Naproxen should not exceed a few days.

If you take more Naproxen than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

For healthcare professionals: Information on how to manage poisoning with naproxen can be found at the end of this package leaflet.

Do not take a double dose to make up for a forgotten dose. Continue taking Naproxen as usual.

Stop taking Naproxen Oral Suspension and immediately contact a doctor if you notice any of the following side effects:

Severe allergic reactions (may affect up to 1 in 10,000 people), signs include:

• Shortness of breath
• Large drop in blood pressure
• Swelling of the face or throat, difficulty swallowing
• (Itchy) skin rash, redness, small blisters

Serious skin reactions (frequency cannot be estimated from the available data), e.g.:

• Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS). See also section 2.
• A distinctive cutaneous allergic reaction known as fixed drug eruption, that usually recurs at the same site(s) on re-exposure to the medication and may look like round or oval patches of redness and swelling of the skin, blistering (hives), itching.

Serious stomach and gut problems (may affect up to 1 in 10 people), signs include:

• Relatively severe abdominal (stomach) pain - especially if onset is sudden
• Bloody vomit or coffee grounds-like vomit
• Bloody or black stools
• Ulcers, perforations (holes) and bleeds in your stomach or gut sometimes fatal particularly in elderly

Heart attack, signs include:

• Chest pain which may spread to your neck and shoulders and down your left arm

Liver problems (may affect up to 1 in 10,000 people), signs include:

• Severe fatigue with loss of appetite, with or without yellow colouration of the skin and the whites of the eyes
• Feeling or being sick, or pale coloured stools

Impairment of sensory organs, e.g.:

• Suddenly occurring visual disturbances (may affect up to 1 in 10,000 people) or hearing impairment (may affect up to 1 in 10 people)

Aseptic meningitis (may affect up to 1 in 10,000 people), signs include:

• Severe headache - especially if onset is sudden
• Stiff neck, fever, feeling or being sick
• Confusion, sensitivity to bright light

Patients with autoimmune diseases (SLE, mixed connective tissue diseases) are at increased risk for developing meningitis.

Blood and lymphatic disorders (may affect up to 1 in 10,000 people), signs include:

• Flu-like symptoms, mouth sores, sore throat and nosebleeds

Naproxen may cause the following side effects:

Very common side effects (may affect more than 1 in 10 people):

• Feeling sick
• Being sick
• Heartburn
• Stomach pain
• Fullness
• Constipation or diarrhoea and minor blood loss in the gastrointestinal tract which, in exceptional cases, may cause anaemia

Common side effects (may affect up to 1 in 10 people):

• Bleeding of the skin and mucous membranes
• Depression
• Dream abnormalities
• Difficulty falling asleep or staying asleep (insomnia)
• Headache
• Dizziness
• Agitation
• Irritability
• Sleep disturbances
• Tiredness
• Perception disorders and cognitive dysfunction
• Ringing noises in the ears
• Vertigo (dizziness)
• Sweating
• Fluid deposits in the body (oedema), especially in patients with high blood pressure
• Thirst

Uncommon side effects (may affect up to 1 in 100 people):

• Blood count changes
• Increased counts of certain types of white blood cells (eosinophilia)
• Asthma attacks (with and without drop in blood pressure)
• Inflammation of the lungs (eosinophilic pneumonia)
• Symptoms in the lower abdomen (e.g. inflammation of the large bowel with bleeding or worsening of Crohn‘s disease/ulcerative colitis)
• Inflammation of the lining of the oral cavity (mouth)
• Injury to the food pipe
• Changes in liver function with transaminase elevation
• Hair loss (usually temporary)
• Inflammation of the skin caused by (sun)light (which may include blistering)
• Muscle pain
• Muscle weakness
• Acute kidney failure
• Impairment of kidney function (nephrotic syndrome)
• Inflammation of the kidney(s) (interstitial nephritis)
• Fever and chills, malaise
• Inflammation of the stomach lining
• Gas

Rare side effects (may affect up to 1 in 1,000 people):

• Blistering skin conditions (epidermolysis bullosa-like reactions)

Very rare side effects (may affect up to 1 in 10,000 people):

• Decreased red and/or white blood cell and/or blood platelet counts (aplastic or haemolytic anaemia, thrombocytopenia, leukopenia, pancytopenia, agranulocytosis)
• Seizures (fits)
• Nerve inflammation
• High blood pressure
• Acceleration of the heart rate
• Pounding heart
• Heart failure
• Inflammation of blood vessels
• Worsening of infection-related inflammation (e.g. development of necrotising fasciitis, i.e. acute inflammation and necrosis [death of tissue] of the fatty tissue beneath the skin and muscles)
• Anaphylactic or anaphylactoid systemic reactions
• Liver inflammation (hepatitis), liver damage especially after long-term therapy
• Hypersensitivity reactions such as skin rash, erythema multiforme, in isolated cases manifesting as severe cutaneous adverse reactions (including Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Kidney damage (renal papillary necrosis) (especially during long-term therapy)
• Increased uric acid level in the blood

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

• Increased potassium levels
• Decreased white blood cell counts (neutropenia)
• Swelling of the lens and optic nerve head
• Corneal opacity
• Inflammation of the optic nerve head
• Pins and needles or numbness of your hands and feet
• Lung oedema
• Inflammation of the pancreas (a large gland behind the stomach)
• Erythema nodosum (a skin inflammation that involves reddish painful bumps)
• Lichen planus (a non-infectious, itchy rash that can affect many areas of the body)
• Systemic lupus erythematosus (SLE, an autoimmune condition leading to an inflammatory process that can affect various parts of the body)
• Pustular reaction
• Blood in the urine (haematuria)
• Inflammation of certain parts of the kidneys (glomerulonephritis)
• Female infertility
• Oedema

Naproxen may interfere with laboratory test results; you should therefore inform all of your doctors (if applicable) that you are taking Naproxen (see section 2 “What you need to know before you take Naproxen”).

The frequency, type and severity of side effects in children and adolescents are similar to those in adults.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is: naproxen
  1mL of Naproxen Oral Suspension contains 50mg naproxen.
• The other ingredients are: sucrose (sugar), saccharin sodium (E 954), sodium cyclamate (E 952), sodium chloride, methyl parahydroxybenzoate (E 218), potassium sorbate (E 202), tragacanth (E 413), citric acid (E 330), sorbitol 70 % solution (E 420), water.

Naproxen Oral Suspension is a white to yellowish-white oral suspension.

Amber glass bottle with child-resistant screw closure.

8mL graduated oral syringe with graduations of 0.1mL.

Pack size: 100mL

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