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PACKAGE LEAFLET: INFORMATION FOR THE USER

Napratec OP'"

Read all of this leaflet carefully before you start using this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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.

In this leaflet

1.    What Napratec OP is and what it is used for

2.    Before you take Napratec

3.    How to take Napratec

4.    Possible side effects

5.    How to store Napratec

6.    Further information

1. What Napratec OP is and what it is used for

•    Napratec OP (the OP stands for 'Original Pack') is a specially designed pack containing two different types of tablet which you take together. Your doctor will have prescribed Napratec because you need to take both the medicines in it.

•    One is called naproxen.The naproxen tablets belong to a group of medicines called 'Non-Steroidal Anti-inflammatory Drugs' or NSAIDs. They help to treat pain and inflammation

in your joints as a result of rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis (inflammation affecting the bones of the pelvis and spine). Naproxen relieves pain by reducing inflammation and swelling.

•    The other is called misoprostol (tradename 'Cytotec'). Cytotec is similar to a chemical substance called

'prostaglandin' which your body produces naturally. Prostaglandins are produced in the stomach and intestine and help to protect the lining. Cytotec belongs to a group of medicines known as 'anti-ulcer agents'.

•    The Cytotec tablets may help prevent you getting ulcers in your stomach or the part it empties into, called the duodenum. These ulcers could be caused by taking nonsteroidal anti inflammatory drugs (NSAIDs) like naproxen. The way NSAIDs work means they reduce the amount of prostaglandins in your stomach and intestine. This can cause indigestion and lead to ulcers forming. The Cytotec tablets will replace these prostaglandins and help to protect your stomach and intestine, so you can continue getting benefit from your naproxen.

2. Before you take Napratec

Napratec may not be suitable for everyone. Please read the

following list carefully to see if any of these apply to you.

Consult your doctor if you are not sure.

Do not take Napratec if you:

•    are pregnant or trying to become pregnant because it may cause a miscarriage (see Section 'Pregnancy' for further information)

•    are breast-feeding

•    have ever had an allergic reaction, blocked nose (rhinitis), swelling, skin rash or wheezing after taking naproxen or aspirin (acetylsalicylic acid) or any other medicine you have been given for painful conditions

•    have ever had an allergic reaction to Cytotec or any of the other ingredients in it, or other prostaglandin medicines in the past

•    have a stomach or duodenal ulcer or bleeding in your stomach

•    have severe heart failure (this is where the heart cannot pump properly)

•    have liver failure

•    have kidney failure

Take special care with Napratec

Tell your doctor if you have any of the following conditions

to help him or her decide if Napratec is suitable for you:

•    asthma or any other allergic condition (for example hay fever)

•    heart, liver or kidney disease

•    low or high blood pressure, or any disease of the blood vessels If you are taking Napratec for a long period of time, your doctor may need to do blood tests to assess your kidney and liver function and your blood cell counts.

If you are a younger woman who has not yet gone through the menopause, your doctor will have only prescribed Napratec if he is satisfied you are at high risk of developing ulcers from your NSAID medicine.

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

For elderly patients your doctor may want to monitor you more closely.

Taking other medicines

Taking any of the medicines listed below together with naproxen can increase the effects of these medicines:

•    Warfarin or other medicines that thin the blood

•    Sulphonamides (some types of antibiotic for treating infections)

•    Ciclosporin (may be used for severe rheumatoid arthritis)

•    Tacrolimus (an immunosuppressant medicine- used to lower your body's resistance after organ transplants)

•    Digoxin (for heart problems)

•    Probenecid (for treating gout)

•    Hydantoins or anti-coagulants

•    Zidovudine (a medicine used to treat HIV infection)

Taking any of the following medicines together with Napratec could alter their effects on you, or make any side effects worse:

•    Lithium (for treating certain types of mental illness e.g. mania or schizophrenia)

•    Diuretics ('water tablets')

•    Beta blockers (for high blood pressure)

•    Quinapril/Quinapril hydrochlorothiazide (to treat high blood pressure)

•    Methotrexate (a cancer treatment, sometimes given for rheumatoid arthritis and psoriasis)

•    Quinolone antibiotics (for treating infections)

•    Corticosteroids ('steroids')

•    Any other anti-inflammatory painkillers

•    Antacids containing magnesium (used to reduce acid in the stomach)

•    Medicines used to treat depression, anxiety and personality disorders known as selective serotonin reuptake inhibitors (SSRIs)

•    Anti-platelet agents (to prevent blood clots from forming) Tell your doctor if you have taken Mifepristone (a medicine used to terminate pregnancy) in the last 12 days.

Tell your doctor or hospital you are taking Napratec if you need to have any tests on your blood or urine. You may need to stop taking the tablets for a short time before having certain tests.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Napratec with food and drink

You should normally take one Naproxen tablet and one Cytotec tablet at the same time, twice a day with or after food.

Pregnancy

If you are a younger woman who has not yet gone through the menopause, your doctor will have only prescribed Napratec if he is satisfied you are at high risk of developing ulcers from your NSAID medicine. Your doctor will make you aware of the risks if you do become pregnant.

The misoprostol in Napratec can cause a miscarriage so it's very important to use reliable contraception while taking this medicine. If you want to try for a baby, tell your doctor as you will have to stop taking Napratec and use a different treatment. Napratec should not be taken in pregnancy.

Breast-feeding

Do not breast-feed while taking Napratec.

Driving and using machinery

Dizziness, drowsiness, fatigue, visual disturbances or headaches have been reported after taking Napratec. Be cautious when driving or operating machinery until you know how the medicine affects you.

REASON FOR REVISION:

variation already submitted Final mock up request for MHRA -approval is imminent so production PAR created.

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Important information about some of the ingredients of Napratec

The naproxen in Napratec contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. The Cytotec in Napratec contains hydrogenated castor oil which may cause stomach upset and diarrhoea.

3.    How to take Napratec

Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Napratec is suitable only for adults aged 18 years and over. You should normally take one naproxen tablet and one Cytotec tablet at the same time, twice a day with food.

Your tablets come in a blister. Each blister contains fourteen tablets (seven naproxen 500 mg Tablets and seven 200 mcg Cytotec Tablets). Two blisters contain one week's supply of tablets. The blister is divided into shaded linked pockets which indicate one dose. This will help you remember how to take them.

If you take more Napratec than you should

If you take too many tablets, contact your doctor or accident and emergency department straight away.

If you forget to take Napratec

If you forget to take either of the two tablets, take them as soon as you remember. But if it is almost time for your next tablet, do not take the tablet you have missed. Do NOT take more than one tablet of each in an eight-hour period.

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

4.    Possible Side Effects

Like all medicines, Napratec can cause side effects although not everybody gets them. As you are taking two medicines together there are a lot of side effects listed.

Most of these don't happen very often, are not serious and will often wear off after a while. If you are worried about any side effects, then talk to your doctor.

Stop taking the tablets and get emergency medical help immediately if you have any of the following symptoms which could represent a severe allergic reaction:

• Wheezing, difficulty breathing, feeling faint, swelling of the face, throat, tongue, hands and feet.

•    Intense itchy skin rash, reddening of the skin over your whole body, severe blistering and peeling of the skin, inflammation of mucous membranes.

•    Any other bad reaction to this medicine.

Also stop taking the tablets and seek immediate medical help if you suffer from any of the following at any time during your treatment:

Any sign of bleeding in the stomach or intestine, for example -

•    passing black tarry bowel movements

•    passing blood in your faeces (stools/motions)

•    vomiting any blood or dark particles that look like ground coffee If you have any of the following symptoms, stop taking the tablets and tell your doctor.

•    Fainting or feeling weak or dizzy.

•    Any severe, sharp pain in the stomach or other abnormal stomach symptoms.

•    Yellowing of your skin and the whites of your eyes (jaundice).

•    A constantly sore throat or high temperature.

•    Indigestion or heartburn.

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

The following side effects have also been reported with naproxen:

Effects on the stomach and intestines: feeling or being sick, diarrhoea, stomach discomfort, stomach ulcer, constipation. Inflammation of the bowel (colitis) has also been seen - the symptoms include cramp, bloating and diarrhoea. Effects on your skin and hair: itching, rashes, blistering or swelling of the skin, hives, hair loss or thinning, sensitivity of the skin to sunlight, or bruising.

Effects on the immune system: asthma, narrowing of the airways (bronchospasm), or shortness of breath, slow or interrupted breathing, especially at night.

Effects on the nervous system: headache, depression, confusion, hallucinations, dizziness, fatigue, drowsiness, feeling generally unwell, problems with vision (optic neuritis), problems sleeping, poor concentration, tingling and prickling feeling, poor memory or problems with speech.

Effects on the kidneys and liver: passing urine with blood in it, changes in kidney and liver function (this shows up in blood tests), sometimes leading to kidney failure and changes in quantity or frequency of urine production, liver problems (hepatitis) which can sometimes be fatal.

Effects on the blood: anaemia, problems with some types of blood cells called 'platelets', 'neutrophils' or 'granulocytes'. These problems can be picked up with blood tests.

Effects on the heart and circulation: Heart failure (problems with the pumping of the heart) and high blood pressure.

Effects on the reproductive system: Decreased fertility in females. There is also an increased risk of spontaneous abortion. Other effects: Balance problems, ringing in the ears or other hearing problems, mild swelling of the feet, ankles or hands. Very occasionally you may have problems with your sight (for example blurred vision).

You could also get inflammation of your blood vessels, a sore mouth, mouth ulcers or meningitis (symptoms which may include neck stiffness, dislike of bright lights and a rash). These problems are rare.

The following side effects have also been reported with Cytotec:

Effects on the stomach and intestines: wind, indigestion, abdominal pain, feeling or being sick. Diarrhoea is the most common problem and is occasionally severe. You have less chance of getting diarrhoea if you take Napratec with food. If you use an antacid (something to reduce acid in the stomach) you should avoid antacids with magnesium in them as these may make diarrhoea worse. Your pharmacist can help you choose a suitable antacid.

Effects on the reproductive system: Some women can get period problems including heavy bleeding or bleeding between periods. Some older women may have vaginal bleeding even though they have gone through the menopause.

Other effects: Skin rashes and dizziness can occur.

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

5. How to Store Napratec

Keep out of the reach and sight of children.

Do not use Napratec after the expiry date which is stated on the carton or blister strip.

Do not store above 30°C. Store in the original package. 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.

6. Further Information

What Napratec contains

The naproxen tablets contain 500 mg of the active substance. In addition to the active substance the other ingredients are lactose, maize starch, povidone, sodium starch glycolate, magnesium stearate, and the colours yellow lake CLF 3076 (E104 and E172).

The Cytotec tablets contain 200 micrograms (mcg) of the active substance, misoprostol. In addition to the active substance the other ingredients are: microcrystalline cellulose, sodium starch glycolate, hydrogenated castor oil, and hypromellose (E464).

What Napratec looks like and contents of the pack

Each Napratec combination pack contains eight blisters.

Each combination pack contains 56 naproxen tablets and 56 Cytotec tablets.

The naproxen and Cytotec tablets are packed in aluminium blisters. The naproxen tablets are yellow oblong tablets, engraved 'NXN500' with a breakline on one side and CP on the reverse. The Cytotec tablets are white/off white hexagonal tablets scored on both sides and engraved 'SEARLE 1461' on one side.

Marketing Authorisation Holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.

Manufacturer

Piramal Healthcare UK Limited, Whalton Road, Morpeth, Northumberland, NE61 3YA, UK.

Company Contact Address:

For further information on your medicine please contact Medical Information at the following address: Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Telephone: 01304 616161.

This leaflet was last revised in 08/2013.

Ref: NA 13_1 UK    20715481

REASON FOR REVISION:

variation already submitted Final mock up request for MHRA -approval is imminent so production PAR created.

N/A

02

Piramal

8.6pt

PAR-2013-0002591