Naproxennatrium Banner 220 mg capsules, zacht

1. What is and what it is used for

<Invented name> contains naproxen which is an anti-inflammatory and pain-relieving medicine. It belongs to a group of medicines named NSAID (non-steroidal anti-inflammatory drugs).

<Invented name> is used in adults and children from 12 years of age for short term treatment of pain, such as headache, dental pain, muscular pain, low back pain and for pain and fever associated with flu and cold, pain and fever after vaccination and period pain.

2. What you need to know before you take

Do not take <Invented Name>:

• if you are allergic to naproxen or naproxen sodium, or to any of the other ingredients of this medicine (listed in section 6).
• if you ever had an allergic reaction such as asthma, runny nose or itching, when using aspirin, ibuprofen or other analgesic and anti-inflammatory drugs (NSAIDs)
• if you have a stomach or intestinal ulcer, inflammation of the stomach mucosa, or stomach pain.
• if you have an internal bleeding (e.g. stomach, intestine or brain haemorrhage)
• if you have a tendency to bleed or if you are treated with anticoagulants (medicines that thin your blood)
• if you have severe kidney problems.
• if you have severe liver problems.
• if you have severe heart failure.
• If you are in the last three months of pregnancy.

Warnings and precautions

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see gastro-intestinal and cardiovascular risks below).

Talk to your doctor or pharmacist before taking <Invented Name>:

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• if pain or fever symptoms persist, recur regularly or worsen, even if these symptoms are mild
• if gastrointestinal problems (such as stomach pain or heartburn) occur during the use of this medicinal product
• if you have high blood pressure or heart diseases
• if you have an infection
• if you are elderly
• if you suffer from liver problems
• If you suffer from kidney problems.

If you have heart problems, previous stroke or think that you might be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss this with your doctor or pharmacist before you take this medicine.

Medicines such as <Invented Name> 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 (10 days).

If you have stomach problems or have had stomach problems you should not use <Invented Name>, unless prescribed by a doctor.

Patients with bleeding disorders should take this medicine only under the supervision of a doctor.

Consult your doctor if any of the above warnings applies to you, or has applied in the past.

Other medicines and <Invented Name>

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without prescription.

Do not take <Invented Name> in combination with the following medicines: <Invented Name> can enhance the effect of:

• certain anti-coagulants (medicines that thin the blood)
• certain oral anti-diabetes medicines
• certain antibiotics
• certain medicines to treat epilepsy (hydantoins), like phenytoin
• certain sulfonamide medicines, like sulfadoxine
• certain narcotics, like thiopental

<Invented Name> can decrease the effect of certain medicines to treat high blood pressure (beta blockers and diuretics).

<Invented Name> can delay the excretion of lithium preparations (used to treat nervous disorders).

<Invented name> increases the risk of side effects when using:

• methotrexate (used to treat rheumatism)
• ACE inhibitors (used to treat for instance high blood pressure)
• cyclosporine (used to treat autoimmune diseases)
• other analgesic and anti-inflammatory medicines

When using <Invented Name> at the same time with probenecid (used to treat gout), the elimination of naproxen can be delayed.

Pregnancy, breast-feeding and fertility

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

Pregnancy

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You should not take <Invented Name> in the first 6 months of pregnancy unless clearly necessary and must not take <Invented Name> in the last 3 months of pregnancy or during labour. Ask your doctor or pharmacist for advice before taking this medicine.

Breast-feeding

Naproxen, the active ingredient of <Invented Name>, passes into breast milk. Therefore, <Invented Name> should not be used during breast-feeding.

Fertility

This product belongs to a group of medicines (NSAIDs) which might impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that this medicine, used occasionally, will affect your chances of becoming pregnant however, talk to your doctor before using it if you have problems becoming pregnant.

Driving and using machines

It is unlikely that taking <Invented Name> in the recommended doses will affect your ability to drive or use machines.

<Invented Name> contains sorbitol

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these capsules.

<Invented Name> contains lecithin originating from soya oil

If you are allergic to peanut or soya, do not use this medicinal product.

3. How to take

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and children from 12 years of age and above:

Do not take more than 2 capsules in 24 hours. In general, it is sufficient to take 1 capsule every 8 to 12 hours.

The capsules should be taken with plenty of water or milk, preferably immediately after meals.

Do not use <Invented Name> longer than 5 days for the treatment of pain, and not longer than 3 days for the treatment of fever without consulting a doctor.

Patients with kidney problems

If you have mild kidney problems, you should use the lowest effective dose and your doctor should monitor your kidney function. If you have moderate kidney problems, the use of naproxen should be avoided. Naproxen must not be used if you have severe kidney problems.

Patients with liver problems

If you have problems with the way your liver works, you should use <Invented Name> with caution. <Invented Name> should be avoided if you have severe liver problems or cirrhotic liver disease.

If you take more <Invented Name> than you should

If you take more <Invented Name> than you should, immediately contact your doctor or pharmacist. Show the package or the leaflet to your doctor or pharmacist.

Symptoms of overdose may include: nausea, vomiting, stomach pain, drowsiness, dizziness disorientation, diarrhoea, bleeding of the gastrointestinal tract, high levels of sodium in the blood (hypernatremia), convulsions (rarely) and acidification of the blood (metabolic acidosis).

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If you forget to take <Invented Name>

In that case you can take a normal dose as soon as you remember. Do not take a double dose to make up for a forgotten capsule.

If you stop taking <Invented Name>

If you suddenly stop taking <Invented Name>, it is possible that the symptoms, for which you started taking this medicine, have not disappeared yet or will return.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects which may occur are:

Very common (affects more than 1 user in 10)

• Nausea
• Discomfort in the abdomen
• Constipation

Common (affects 1 to 10 users in 100)

• Headache
• Visual disturbances
• Ringing or buzzing in the ears (tinnitus)
• Swollen ankles and feet (oedema)
• Heart problems
• Vomiting
• Rash

Uncommon (affects 1 to 10 users in 1,000)

• Inability to concentrate
• Trouble sleeping (insomnia)
• Inability to concentrate or remember things (cognitive dysfunction)
• Gastrointestinal bleeding and / or perforations
• Reactions due to exposure to light

Rare (affects 1 to 10 users in 10,000)

• Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anemia)
• Allergic reactions to naproxen and naproxen sodium preparations. Allergic reactions usually occur in patients with known allergy to aspirin, other NSAIDs and to <Invented Name>. However, they can also occur in patients without previous experience with this allergy.
• High levels of potassium in the blood (hyperkalaemia)
• Problems with hearing
• Inflammation of the blood vessels (vasculitis)
• Inflammation of the lung (eosinophilic pneumonitis)
• Mouth ulcers
• Life-threatening inflammation of the liver (fatal hepatitis)
• Hair loss (alopecia)
• Reactions due to exposure to light such as inflammation of the skin and blistering eruptions (porphyria cutanea tarda or epidermolysis bullosa-like reactions)

Very rare (affects less than 1 user in 100,000)

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• A reduction in the number of white blood cells (granulocytopenia)
• Decreased platelet count (thrombocytopenia)
• Convulsions
• Non-infectious inflammation of the membranes of the brain (aseptic meningitis)
• A small increased risk of heart attack (myocardial infarction or stroke). Any risk is more likely with high doses and prolonged treatment.
• Stevens-Johnson syndrome (blistering of hands and feet)
• Redness of the skin (erythema multiforme)
• Blood in urine (haematuria)
• Kidney disorders including glomerular or interstitial nephritis (inflammation of the kidney), renal papillary necrosis (death of part of the tissue of your kidneys) and nephrotic syndrome (protein in the urine)

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

• Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (aplastic anemia)
• Gout
• Dizziness (vertigo)
• High blood pressure
• Non-peptic gastrointestinal ulceration, peptic ulceration
• Inflammation of the colon (colitis)
• Swelling of the neck and face (angioedema)
• Peeling skin (epidermal necrolysis)
• Kidney failure
• Impaired female fertility
• Mildly swollen ankles and feet (mild peripheral oedema)

Reporting of side effects

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 <[To be completed nationally]>. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Do not refrigerate.

Store in the original package in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What <Invented Name> contains

• The active substance is naproxen sodium. One capsule contains 220 mg naproxen sodium.
• The other ingredients (excipients) are Macrogol, Lactic acid, Propylene glycol, Povidone, Gelatin, Sorbitol, Glycerol, Purified water, Patent blue V (E131). The printing ink WB white NS-78-18011 contains Titanium dioxide (E171), Hypromellose and Purified water.

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What <Invented Name> looks like and contents of the pack

• <Invented Name> is a blue transparent, oblong soft gelatin capsule with printing in white ink.
• <Invented Name> is supplied in a PVDC/PE/PVC//Alu or Aclar/PVC//Alu blister. Each pack contains 3, 10, 12 or 24 capsules. Not all pack sizes may be marketed.

Houder van de vergunning voor het in de handel brengen en fabrikant

Banner Pharmacaps Europe B.V. De Posthoornstraat 7

5048 AS Tilburg Nederland

In het register ingeschreven onder:

RVG 112620

This medicinal product is authorised in the Member States of the EEA under the following names:

NL Naproxennatrium Banner 220 mg capsules, zacht SE Naproxen Banner 200 mg Kapseln, mjuk

Deze bijsluiter is voor het laatst goedgekeurd in november 2013.

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