Skip to Content

NAPRATEC OP

Active substance(s): MISOPROSTOL / NAPROXEN

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Napratec OP



naproxen/misoprostol


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.

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.

In this leaflet







‘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.

Do not take Napratec if you:

• are pregnant or trying to become pregnant because it may

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

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

12/08/2013

Supplier No 20715481
Perigord No 206835
Barcode No N/A
Pages 1 of 22

Proof No 02
Component Leaflet
Colour Bar Positions N/A
Drawing No N/A
Laetus Code 5088

Dimensions 300 x 176 mm - Image Prints @ 100%
Notes N/A
Colours 02

Piramal
8.6pt
PAR-2013-0002591

PMS 533
15%

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)

11:43

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

Description NAPRATEC
Market United Kingdom

• 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.

Black

• 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.

You will find more about Napratec on the
back of this leaflet

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.

12/08/2013

Supplier No 20715481
Perigord No 206835
Barcode No N/A
Pages 2 of 22

Proof No 02
Component Leaflet
Colour Bar Positions N/A
Drawing No N/A
Laetus Code 5088

Dimensions 300 x 176 mm - Image Prints @ 100%
Notes N/A
Colours 02

Piramal
8.6pt
PAR-2013-0002591

PMS 533
15%

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 30ºC. 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.

11:43

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

Description NAPRATEC
Market United Kingdom

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.

Black

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

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide