Informations for option: Naproxen 500mg Tablets, show other option

Select option:

1. Naproxen 500mg Tablets
2. Naproxen 500mg Tablets

Document: document 0 change

• document 0
• document 1
• document 2
• document 3
• document 4
• document 5
• document 6
• document 7
• document 8

---

Module 1 Administrative

1.3.1 Labeling

Athlone Pharmaceuticals Limited

Naproxen 250mg & 500mg Tablets

1.3.1    PATIENT INFORMATION LEAFLET

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking this medicine. o Keep this leaflet. You may need to read it again. o If you have any further questions, ask your doctor or pharmacist.

o This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

o If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Naproxen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines help relieve pain and joint inflammation.

Naproxen Tablets can be used to treat: o arthritis o gout

o ankylosing spondylitis (causing pain and stiffness in the back) o muscle, joint and tendon pain caused by injury (e.g. strains and sprains) o period pain

o juvenile rheumatoid arthritis in children over 5 years of age

DO NOT take Naproxen Tablets if you:

o are allergic to naproxen or any other ingredients contained in these tablets (see section 6, Further information)

o have suffered any allergic reactions or if you have had wheezing (asthma), hay fever, itchiness or skin rash (urticaria) after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin or ibuprofen

o have now or have ever had a stomach ulcer, or bleeding of the stomach or intestine o have had bleeding or perforation in your stomach while taking other NSAIDs o have severe problems with your kidneys, liver or heart o are in the last three months of pregnancy

Take special care with Naproxen Tablets if you:

o are already taking another non-steroidal anti-inflammatory drug (NSAID), such as aspirin or ibuprofen

o suffer bleeding in the stomach or gut while taking naproxen. If you have black, tarry stools or notice specks like coffee grounds when you vomit while taking this medicine, you must stop taking it and tell your doctor at once.

o have other stomach or bowel problems such as colitis or Crohn’s disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss) o are elderly - you may be more likely to suffer side effects and your doctor may prescribe a lower dose along with a protective agent (e.g. a proton pump inhibitor) o suffer from asthma, hay fever or allergies (swelling of face, lips, eyes or tongue) as these tablets can cause breathing difficulties o suffer from nasal polyps (growths inside the nose)

o suffer from any blood clotting disorders or are taking medicines which may increase the risk of bleeding (for example, warfarin, aspirin, serotonin reuptake inhibitors) o take steroid medication and it is reduced/stopped during naproxen treatment - you should be observed for signs of side effects or worsening of your condition o have heart problems or high blood pressure - you may be at greater risk of developing swelling in feet or hands

o have kidney problems or are taking diuretics. Your doctor may wish to check your kidney function before and during treatment and/or use a lower dose than normal o have liver problems, including alcohol-related disease

o have lupus (an autoimmune condition that causes joint pain, skin rashes and fever) o are attempting to become pregnant

o have an intolerance to some sugars as this medicine contains lactose Tell your doctor if any of the above applies to you.

SPECIAL WARNING:

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, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, or herbal remedies or any of the following: o hydantoins such as phenytoin (to treat epilepsy)

o anticoagulants such as warfarin and heparin and antiplatelet agents such as clopidogrel (to thin your blood)

o sulphonamide and quinolone antibiotics, e.g. ciprofloxacin o sulphonylureas such as gliclazide (anti-diabetic drugs)

o medicines used for heart problems: diuretics (water tablets), e.g. furosemide and drospirenone;

cardiac glycosides, e.g. digoxin; ACE inhibitors, e.g. ramipril o probenecid (for gout)

o lithium and serotonin reuptake inhibitors (SSRIs), such as fluoxetine (to treat depression) o other NSAIDs or pain killers such as aspirin, ibuprofen, diclofenac or paracetamol o mifepristone (used to end pregnancy) o erlotinib (used to treat certain types of cancer)

o ciclosporin or tacrolimus (for preventing organ transplant rejection) o methotrexate (used to treat psoriasis, arthritis and some cancers) o corticosteroids (for swelling or inflammation), e.g. hydrocortisone o penicillamine (for arthritis) o baclofen (used to treat muscle tightness) o pentoxyifylline (used to treat poor blood circulation) o zidovudine (for the treatment of AIDs)

Effects on laboratory tests

You should tell your doctor if you are having certain hormone tests or certain cancer diagnostic tests as these tablets can interfere with the results.

Pregnancy and breast-feeding

Do not take Naproxen Tablets if you are in the last three months of pregnancy, as it can harm your baby. You must tell your doctor if you are pregnant, or if you think you may be pregnant. Your doctor will decide whether you should take this medicine. If you are breast-feeding you should not take this medicine. As with other NSAIDs, naproxen may make it more difficult to become pregnant as it may reduce fertility. You should inform your doctor if you are attempting to become pregnant or if you have problems becoming pregnant

Driving and using machines

If you are affected by dizziness, tiredness, abnormal vision or depression when taking Naproxen Tablets you should not drive or operate machinery.

Important information about some of the ingredients of Naproxen Tablets

Naproxen Tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

These tablets should be taken with a glass of water, with or after food.

Always take Naproxen Tablets exactly as your doctor has told you to. The number of tablets you should take will depend on the type of pain you have.

Read the following section carefully. If you are not sure ask your doctor or pharmacist.

While you are taking this medicine your doctor will want to see you to check you are on the right dose for you and look for any side effects. This is particularly important if you are elderly.

Dosage

Adults:

The usual dose is prescribed below:

■    For arthritis and ankylosing spondylitis:

Take between 500mg to 1000mg. The dose can be taken all at once or split into two separate doses given 12 hours apart.

■    For muscle, joint or tendon pain and for period pain:

Take 500mg at the start and then take 250mg every 6 to 8 hours as needed. Do not take more than 1250mg a day after the first day.

■    For gout:

Take 750mg and then 250mg every eight hours.

Children over 5 years with rheumatoid arthritis:

■ The usual dose is 10mg/kg of body weight per day, split into 2 doses and given 12 hours apart.

Elderly people and people with liver or kidney problems:

Your doctor will usually prescribe a lower dose than for other adults.

If you take more of your medicine than you should

If you take too many tablets, or someone accidentally takes your medicine, contact your doctor or pharmacist or nearest hospital straight away.

If you forget to take your medicine:

If you forget to take your medicine, take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

Like most other medicines, Naproxen Tablets may cause side effects in some people.

Medicines such as naproxen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

STOP taking Naproxen Tablets and tell your doctor immediately if you experience any of the following side effects:

o Bleeding from the stomach - seen as vomit which has blood in it or bits that look like coffee grounds or black, tarry stools

o Inflammation, ulcers or holes forming in your stomach or gut. Signs include upset stomach, stomach pain, fever, feeling or being sick.

o Problems with your pancreas. Signs include severe stomach pain which spreads to your back. o Worsening of ulcerative colitis or Crohn’s disease, seen as pain, diarrhoea, vomiting and weight loss.

o Allergic reactions - signs may include sudden swelling of your throat, face, hands or feet o Difficulty breathing, tightness in your chest, skin rashes, itching, damage to blood vessels causing reddening of skin

o Severe blistering or peeling of the skin

o Jaundice (yellowing of the skin and whites of the eyes), hepatitis (life-threatening) o Kidney problems - signs may include painful urination or blood in the urine

If you notice any of the following side effects, tell your doctor as soon as possible:

•    Indigestion, feeling or being sick, constipation, diarrhoea, stomach upset

■    Headache, drowsiness, dizziness, convulsions

■    Pins and needles

■    Unusual bruising or bleeding, anaemia (may make you look pale and feel tired), lowered immunity resulting in sore throats or mouth ulcers (due to changes in numbers of blood cells)

■    Eyesight problems or eye pain - if you notice this you may need to have an eye examination

■    Ringing in your ears, vertigo

•    Hyperkalaemia (high blood potassium)

•    Heart problems - may result in breathlessness, trouble breathing, tiredness, swelling of the feet and hands, high blood pressure, palpitations

•    Asthma, coughing

•    Sleeping difficulties, depression, hallucinations

•    Confusion, difficulty concentrating, forgetfulness

•    Meningitis (symptoms may include stiff neck, vomiting and fever) - especially in patients suffering from lupus, an auto-immune disease

•    Hair loss

•    Sweating

•    Feeling thirsty

•    Increased skin sensitivity to the sun

•    Muscle weakness

•    Female infertility

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Do not use the tablets after the expiry date shown on the label or carton.

KEEP ALL MEDICINES OUT THE OF REACH AND SIGHT OF CHILDREN.

Store this medicine below 25^oC in a dry place and protect from light.

Keep the tablets in the original container. 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.

What your medicine contains

Each tablet contains the active ingredient naproxen. The tablets also contain the inactive ingredients lactose, maize starch, povidone, sodium starch glycollate, magnesium stearate and quinoline yellow (E104).

What your medicine looks like and contents of the pack

Naproxen 250mg Tablets are yellow, flat, circular bevel-edged uncoated tablets marked with ‘SP/N250’ on one side and are available in packs of 60, 100 and 250 tablets.

Naproxen 500mg Tablets are yellow, capsule-shaped uncoated tablets marked with ‘SP/N500’ on one side and are available in packs of 60, 100 and 250 tablets.

Marketing Authorisation Holder and Manufacturer:

The marketing authorisation holder is:

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland

Distributor

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

This product is manufactured by:

Sussex Pharmaceuticals Limited, Charlwoods Road, East Grinsted, West Sussex, RH19 2HL, U.K.

Naproxen 250mg Tablets: PL 30464/0003 Naproxen 500mg Tablets: PL 30464/0004

This leaflet was last revised in January 2013.