Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

NORMULEN TABLETS

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Ref: LTT65/210313/1/F

®

Normulen Tablets
(diclofenac sodium/misoprostol)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Normulen Tablets however throughout this leaflet it
will be reffered to as Normulen.
In this leaflet:
1 What Normulen is and what it is used for
2 Before you take Normulen
3 How to take Normulen
4 Possible side effects
5 How to store Normulen
6 Further information

1

What Normulen is and what it is used for

Normulen helps to relieve the pain and swelling of rheumatoid arthritis and
osteoarthritis, and may help to protect patients at risk of irritation or
ulceration of the stomach or intestines.
Normulen contains diclofenac and misoprostol. Diclofenac belongs to a
group of medicinal products called Non-Steroidal Anti-Inflammatory drugs
(NSAIDs).
Although NSAIDs relieve the pain, they can reduce the amount of natural
protective substances called prostaglandins in the stomach lining.
This means that NSAIDs can lead to stomach upsets or stomach ulcers.
Normulen also contains misoprostol which is very similar to these
prostaglandins and may help protect your stomach.

2

Before you take Normulen

Do not take Normulen
If you:
* have had an allergic reaction such as a skin rash, swelling or itchiness of
the skin, severe nasal congestion, asthma or wheezing after taking
diclofenac or other NSAIDs such as aspirin (acetylsalicylic acid),
misoprostol or another prostaglandin medicine, or any of the other
ingredients in Normulen (see Further Information section 6)
* currently have an ulcer or perforation (hole) in your stomach or intestines
* currently suffer from bleeding in your stomach, intestines or brain
* are undergoing or you have just had coronary artery bypass graft (CABG)
surgery
* have severe kidney or liver failure
* have severe heart failure
* are pregnant, or trying to become pregnant, because it may cause a
miscarriage. Women who have not reached the menopause should use
reliable contraception while they are taking Normulen.
Take special care with Normulen
Check with your doctor if any of the following applies to you:
If you:
* have any heart problems, previous stroke or think you might be at risk of
these conditions (for example if you have high blood pressure, problems
with your blood circulation, diabetes, high cholesterol or are a smoker) you
should discuss your treatment with your doctor or pharmacist
* have other health problems such as a disease of the liver or kidneys.
Do not take Normulen if you have severe kidney or liver failure
* previously had an ulcer or bleeding in your stomach or intestines.
Do not take Normulen if you currently have an ulcer or bleeding in your
stomach or intestines
* bleed or bruise easily
* have inflammation of the intestines (ulcerative colitis or Crohn’s disease)
* have, or have ever had asthma or an allergic disease
* have an infection, as Normulen may mask a fever or other signs of
infection
* are dehydrated
* are over the age of 65 as your doctor may want to keep a regular check
on you.

Taking other medicines
Some medicines can affect the way other medicines work. Please tell your
doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription:
* Aspirin (acetylsalicylic acid) or other NSAIDs (e.g. ibuprofen)
* Medicines used to treat osteoarthritis or rheumatoid arthritis known as
cyclo-oxygenase-2 (COX-2) inhibitors
* Diuretics (used to treat excess fluid in the body)
* Ciclosporin or tacrolimus (used for immune system suppression e.g. after
transplants)
* Lithium (used to treat some types of depression)
* Digoxin (a medicine for an irregular heart beat and/or heart failure)
* Warfarin or other oral anticoagulants (blood-thinning agents that reduce
blood clotting)
* Medicines used to treat anxiety and depression known as Serotonin
Selective Re-uptake Inhibitors (SSRIs)
* Medicines used to control your blood sugar (oral hypoglycaemics for
diabetes)
* Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
* Steroid medications (e.g. corticosteroids, which are often used as
anti-inflammatory medicines)
* Medicines for high blood pressure (anti-hypertensives)
* Magnesium containing antacids (used to treat heartburn, indigestion)
* Quinolone antibiotics (used to treat some infections)
* Ketoconazole (used to treat some fungal infections)
* If you have taken a medicine called mifepristone (used to terminate
pregnancy) within the last 12 days. Normulen 50 should not be taken
within 8-12 days of taking mifepristone.
Pregnancy and breast-feeding
Do not use Normulen if you are pregnant or trying to become pregnant.
Women who have not reached the menopause should use reliable
contraception while they are taking Normulen.
Do not use Normulen while you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel dizzy or drowsy after taking Normulen, do not drive and do not
use any tools or machines until these effects have worn off.
Important information about some ingredients of Normulen
Lactose or Sugar intolerance
Normulen contains lactose (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 Normulen.

3

How to take Normulen

Always take Normulen exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Take one tablet two or three times a day, or as directed by your doctor.
Normulen should be swallowed whole with a drink of water (not chewed),
taken during or after mealtimes.
In the elderly and patients with liver or kidney disorders, your doctor
may want to monitor you more closely. No change in dose is needed.
Children: Normulen is for adults only, it is not for use in children (under 18
years).
If you take more Normulen than you should
You should not take more tablets than your doctor tells you to. If you take too
many tablets contact your doctor, pharmacist or hospital as soon as
possible, and take your medicine with you.
If you forget to take Normulen
If you forget to take a tablet, take it as soon as you remember. Do not take a
double dose to make up for forgotten doses.
If you stop taking Normulen
Do not stop taking Normulen 50 unless your doctor tells you to. If you have
any questions on the use of this product ask your doctor or pharmacist.

4

Possible side effects

NSAID medicines such as Normulen can cause bleeding or ulceration. If this
occurs, treatment should be stopped.

Like all medicines, Normulen can have side effects, although not everybody
gets them.

Medicines such as Normulen 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 are worried about side effects, ask your doctor. It is important that you
know what can happen, so that you can take action if Normulen does have a
side effect. Normulen sometimes causes side effects but these usually go
away during treatment as your body gets used to the medicine.

As with other NSAIDs (e.g. ibuprofen) Normulen may lead to an increase in
blood pressure, and so your doctor may ask to monitor your blood pressure
on a regular basis.

If any of the following happen, stop taking Normulen and tell your
doctor immediately:
If you have
* severe stomach pain or any sign of bleeding or rupture in the stomach or
intestines, such as passing black or bloodstained stools, or vomiting blood
- this occurs very rarely

If you have heart, liver or kidney problems, your doctor will want to monitor
you regularly

Ref: LTT65/210313/1/B

®

Normulen Tablets
(diclofenac sodium/misoprostol)
Patient Information Leaflet (continued)
* a serious skin reaction such as rash, blistering or peeling of the skin
*
*

(Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal
necrolysis) – this occurs very rarely
a serious allergic reaction such as skin rash, swelling of the face,
wheezing or difficulty breathing (anaphylactic shock) – this occurs rarely
jaundice (your skin or the whites of your eyes look yellow) – this occurs
rarely

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

* Very common side effects

(affecting more than 1 in every 10):
* Stomach ache, diarrhoea, nausea (feeling sick), indigestion
Diarrhoea is the most common problem and is occasionally severe. You
have less chance of getting diarrhoea if you take Normulen 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. If this diarrhoea
continues and is severe tell your doctor.
* Common side effects
(affecting less than 1 person in every 10, but more than 1 in every 100):
* Rash, itching
* Vomiting, wind, constipation, burping, gastritis (indigestion, stomach
ache, vomiting)
* Ulcers in the stomach or intestines
* Headache, dizziness
* Difficulty sleeping
* Changes in blood tests relating to the liver
* Uncommon side-effects
(affecting less than 1 person in every 100, but more than 1 in every 1000):
* Swelling of the mouth
* Abnormal or unexpected bleeding from the vagina, menstrual
disturbances
* Reduction in the number of blood platelets (increased chance of
bleeding or bruising)
* Purpura (purple spots on the skin)
* Urticaria (raised itchy rash)
* Rare side-effects
(affecting less than 1 person in every 1,000, but more than 1 in every
10,000):
* Inflammation of the liver (possible yellow discoloration of skin,
headache, fever, chills, general weakness)
* Very rare side effects
(affecting less than 1 person in every 10,000 patients):
* Severe liver disorders including liver failure
* Additional side effects experienced in actual use
(post-marketing experience, frequency unknown):
* Heart failure, chest pain, palpitations (awareness of your heartbeat)
* Damage to the gullet
* Worsening of ulcerative colitis or Crohn’s disease (inflammation of the
intestines)
* Kidney or liver problems
* Shortness of breath
* Seizures
* Allergic reaction, (including asthma, breathing problems, itching, hair
loss, inflamed blood vessels (can cause fever, aches, purple blotches))
* Symptoms of meningitis (stiff neck, headache, nausea (feeling sick),
vomiting, fever or loss of consciousness)
* Fluid build-up in the body that can cause swollen ankles and legs
* Vomiting blood
* Psychotic reactions (mental disorder that features loss of contact with
reality)
* Swelling of the tongue, mouth ulcers, dry mouth
* Depression, feeling anxious, mood swings, irritability, memory problems,
feeling confused, feeling shaky, nightmares, drowsiness, tiredness
* Difficulty seeing, impaired or blurred vision, ringing in the ears, changes
in the way things taste
* Chills, fever, increased sensitivity to light, inflammation
* Loss of appetite
* Abnormal contractions of the womb, rupture in the womb, retained
placenta after giving birth, clotting in the amniotic fluid (fluid covering the
foetus), bleeding in the womb, miscarriage, death of the unborn baby,
birth defects, premature birth
* Low blood pressure, high blood pressure
* Reduction in the number of white blood cells (these help protect the
body from infection and disease)
* Anaemia (low number of red blood cells) which can lead to pale skin
and cause weakness or breathlessness.
Medicines such as Normulen may be associated with a small increased risk
of heart attack or stroke.
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.

5

How to store Normulen

Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package. Store in a dry place.
Do not use Normulen after the expiry date printed on the blister and carton.
The expiry date refers to the last day of that month.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist on how to dispose of medicines no longer required.
These measures will help protect the environment.

6

Further Information

What Normulen contains
The active substances are diclofenac sodium and misoprostol.
Each modified-release tablet contains 50 milligrams diclofenac sodium and
200 micrograms misoprostal.
The other ingredients are:
Lactose, microcrystalline cellulose, maize starch, povidone, magnesium
stearate, cellulose acetate phthalate, diethyl phthalate,
methylhydroxypropylcellulose, crospovidone, hydrogenated castor oil and
colloidal anhydrous silica.
What Normulen looks like and contents of the pack
Normulen is available as white, round, biconvex tablets. The tablets are
packed in blister strips and supplied in boxes of 40 or 60 tablets.
Manufacturer and licence holder
This medicine is manufactured by NPIL Pharmaceuticals (UK) Limited,
Whalton Road, Morpeth, Nothumberland, NE61 3YA, UK and is procured
from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
Repackaged by Lexon (UK) Ltd, B98 0RE.
If you have any questions or are not sure about anything , ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to help you.
Normulen is a registered trademark of Searle Iberica, S.A..

POM

PL: 33723/0065

Revision date: 21/03/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: LTT65/210313/2/F

®

Arthrotec 50 Modified-Release Tablets
(diclofenac sodium/misoprostol)
Patient Information Leaflet
Read all of this leaflet carefully before you start taking 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Arthrotec 50 Modified-Release Tablets however
throughout this leaflet it will be reffered to as Arthrotec.
In this leaflet:
1 What Arthrotec is and what it is used for
2 Before you take Arthrotec
3 How to take Arthrotec
4 Possible side effects
5 How to store Arthrotec
6 Further information

1

What Arthrotec is and what it is used for

Arthrotec helps to relieve the pain and swelling of rheumatoid arthritis and
osteoarthritis, and may help to protect patients at risk of irritation or
ulceration of the stomach or intestines.
Arthrotec contains diclofenac and misoprostol. Diclofenac belongs to a group
of medicinal products called Non-Steroidal Anti-Inflammatory drugs
(NSAIDs).
Although NSAIDs relieve the pain, they can reduce the amount of natural
protective substances called prostaglandins in the stomach lining.
This means that NSAIDs can lead to stomach upsets or stomach ulcers.
Arthrotec also contains misoprostol which is very similar to these
prostaglandins and may help protect your stomach.

2

Before you take Arthrotec

Do not take Arthrotec
If you:
* have had an allergic reaction such as a skin rash, swelling or itchiness of
the skin, severe nasal congestion, asthma or wheezing after taking
diclofenac or other NSAIDs such as aspirin (acetylsalicylic acid),
misoprostol or another prostaglandin medicine, or any of the other
ingredients in Arthrotec (see Further Information section 6)
* currently have an ulcer or perforation (hole) in your stomach or intestines
* currently suffer from bleeding in your stomach, intestines or brain
* are undergoing or you have just had coronary artery bypass graft (CABG)
surgery
* have severe kidney or liver failure
* have severe heart failure
* are pregnant, or trying to become pregnant, because it may cause a
miscarriage. Women who have not reached the menopause should use
reliable contraception while they are taking Arthrotec.
Take special care with Arthrotec
Check with your doctor if any of the following applies to you:
If you:
* have any heart problems, previous stroke or think you might be at risk of
these conditions (for example if you have high blood pressure, problems
with your blood circulation, diabetes, high cholesterol or are a smoker)
your should discuss your treatment with your doctor or pharmacist
* have other health problems such as a disease of the liver or kidneys.
Do not take Arthrotec if you have severe kidney or liver failure
* previously had an ulcer or bleeding in your stomach or intestines.
Do not take Arthrotec if you currently have an ulcer or bleeding in your
stomach or intestines
* bleed or bruise easily
* have inflammation of the intestines (ulcerative colitis or Crohn’s disease)
* have, or have ever had asthma or an allergic disease
* have an infection, as Arthrotec may mask a fever or other signs of
infection
* are dehydrated
* are over the age of 65 as your doctor may want to keep a regular check
on you.

Taking other medicines
Some medicines can affect the way other medicines work. Please tell your
doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription:
* Aspirin (acetylsalicylic acid) or other NSAIDs (e.g. ibuprofen)
* Medicines used to treat osteoarthritis or rheumatoid arthritis known as
cyclo-oxygenase-2 (COX-2) inhibitors
* Diuretics (used to treat excess fluid in the body)
* Ciclosporin or tacrolimus (used for immune system suppression e.g. after
transplants)
* Lithium (used to treat some types of depression)
* Digoxin (a medicine for an irregular heart beat and/or heart failure)
* Warfarin or other oral anticoagulants (blood-thinning agents that reduce
blood clotting)
* Medicines used to treat anxiety and depression known as Serotonin
Selective Re-uptake Inhibitors (SSRIs)
* Medicines used to control your blood sugar (oral hypoglycaemics for
diabetes)
* Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
* Steroid medications (e.g. corticosteroids, which are often used as
anti-inflammatory medicines)
* Medicines for high blood pressure (anti-hypertensives)
* Magnesium containing antacids (used to treat heartburn, indigestion)
* Quinolone antibiotics (used to treat some infections)
* Ketoconazole (used to treat some fungal infections)
* If you have taken a medicine called mifepristone (used to terminate
pregnancy) within the last 12 days. Arthrotec 50 should not be taken
within 8-12 days of taking mifepristone.
Pregnancy and breast-feeding
Do not use Arthrotec if you are pregnant or trying to become pregnant.
Women who have not reached the menopause should use reliable
contraception while they are taking Arthrotec.
Do not use Arthrotec while you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel dizzy or drowsy after taking Arthrotec, do not drive and do not use
any tools or machines until these effects have worn off.
Important information about some ingredients of Arthrotec
Lactose or Sugar intolerance
Arthrotec contains lactose (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 Arthrotec.

3

How to take Arthrotec

Always take Arthrotec exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Take one tablet two or three times a day, or as directed by your doctor.
Arthrotec should be swallowed whole with a drink of water (not chewed),
taken during or after mealtimes.
In the elderly and patients with liver or kidney disorders, your doctor
may want to monitor you more closely. No change in dose is needed.
Children: Arthrotec is for adults only, it is not for use in children (under 18
years).
If you take more Arthrotec than you should
You should not take more tablets than your doctor tells you to. If you take too
many tablets contact your doctor, pharmacist or hospital as soon as
possible, and take your medicine with you.
If you forget to take Arthrotec
If you forget to take a tablet, take it as soon as you remember. Do not take a
double dose to make up for forgotten doses.
If you stop taking Arthrotec
Do not stop taking Arthrotec 50 unless your doctor tells you to. If you have
any questions on the use of this product ask your doctor or pharmacist.

4

Possible side effects

NSAID medicines such as Arthrotec can cause bleeding or ulceration. If this
occurs, treatment should be stopped.

Like all medicines, Arthrotec can have side effects, although not everybody
gets them.

Medicines such as Arthrotec 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 are worried about side effects, ask your doctor. It is important that you
know what can happen, so that you can take action if Arthrotec does have a
side effect. Arthrotec sometimes causes side effects but these usually go
away during treatment as your body gets used to the medicine.

As with other NSAIDs (e.g. ibuprofen) Arthrotec may lead to an increase in
blood pressure, and so your doctor may ask to monitor your blood pressure
on a regular basis.

If any of the following happen, stop taking Arthrotec and tell your
doctor immediately:
If you have
* severe stomach pain or any sign of bleeding or rupture in the stomach or
intestines, such as passing black or bloodstained stools, or vomiting blood
– this occurs very rarely

If you have heart, liver or kidney problems, your doctor will want to monitor
you regularly.

Ref: LTT65/210313/B/2

®

Arthrotec 50 Modified-Release Tablets
(diclofenac sodium/misoprostol)
Patient Information Leaflet (continued)
* a serious skin reaction such as rash, blistering or peeling of the skin
*
*

(Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal
necrolysis) – this occurs very rarely
a serious allergic reaction such as skin rash, swelling of the face,
wheezing or difficulty breathing (anaphylactic shock) – this occurs rarely
jaundice (your skin or the whites of your eyes look yellow) – this occurs
rarely

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

* Very common side effects

(affecting more than 1 in every 10):
* Stomach ache, diarrhoea, nausea (feeling sick), indigestion
Diarrhoea is the most common problem and is occasionally severe. You
have less chance of getting diarrhoea if you take Arthrotec 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. If this diarrhoea
continues and is severe tell your doctor.
* Common side effects
(affecting less than 1 person in every 10, but more than 1 in every 100):
* Rash, itching
* Vomiting, wind, constipation, burping, gastritis (indigestion, stomach
ache, vomiting)
* Ulcers in the stomach or intestines
* Headache, dizziness
* Difficulty sleeping
* Changes in blood tests relating to the liver
* Uncommon side-effects
(affecting less than 1 person in every 100, but more than 1 in every 1000):
* Swelling of the mouth
* Abnormal or unexpected bleeding from the vagina, menstrual
disturbances
* Reduction in the number of blood platelets (increased chance of
bleeding or bruising)
* Purpura (purple spots on the skin)
* Urticaria (raised itchy rash)
* Rare side-effects
(affecting less than 1 person in every 1,000, but more than 1 in every
10,000):
* Inflammation of the liver (possible yellow discoloration of skin,
headache, fever, chills, general weakness)
* Very rare side effects
(affecting less than 1 person in every 10,000 patients):
* Severe liver disorders including liver failure
* Additional side effects experienced in actual use
(post-marketing experience, frequency unknown):
* Heart failure, chest pain, palpitations (awareness of your heartbeat)
* Damage to the gullet
* Worsening of ulcerative colitis or Crohn’s disease (inflammation of the
intestines)
* Kidney or liver problems
* Shortness of breath
* Seizures
* Allergic reaction, (including asthma, breathing problems, itching, hair
loss, inflamed blood vessels (can cause fever, aches, purple blotches))
* Symptoms of meningitis (stiff neck, headache, nausea (feeling sick),
vomiting, fever or loss of consciousness)
* Fluid build-up in the body that can cause swollen ankles and legs
* Vomiting blood
* Psychotic reactions (mental disorder that features loss of contact with
reality)
* Swelling of the tongue, mouth ulcers, dry mouth
* Depression, feeling anxious, mood swings, irritability, memory problems,
feeling confused, feeling shaky, nightmares, drowsiness, tiredness
* Difficulty seeing, impaired or blurred vision, ringing in the ears, changes
in the way things taste
* Chills, fever, increased sensitivity to light, inflammation
* Loss of appetite
* Abnormal contractions of the womb, rupture in the womb, retained
placenta after giving birth, clotting in the amniotic fluid (fluid covering the
foetus), bleeding in the womb, miscarriage, death of the unborn baby,
birth defects, premature birth
* Low blood pressure, high blood pressure
* Reduction in the number of white blood cells (these help protect the
body from infection and disease)
* Anaemia (low number of red blood cells) which can lead to pale skin
and cause weakness or breathlessness.
Medicines such as Arthrotec may be associated with a small increased risk
of heart attack or stroke.
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.

5

How to store Arthrotec

Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package. Store in a dry place.
Do not use Arthrotec after the expiry date printed on the blister and carton.
The expiry date refers to the last day of that month.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist on how to dispose of medicines no longer required.
These measures will help protect the environment.

6

Further Information

What Arthrotec contains
The active substances are diclofenac sodium and misoprostol.
Each modified-release tablet contains 50 milligrams diclofenac sodium and
200 micrograms misoprostal.
The other ingredients are:
Lactose, microcrystalline cellulose, maize starch, povidone, magnesium
stearate, cellulose acetate phthalate, diethyl phthalate,
methylhydroxypropylcellulose, crospovidone, hydrogenated castor oil and
colloidal anhydrous silica.
What Arthrotec looks like and contents of the pack
Arthrotec is available as white, round, biconvex tablets. The tablets are
packed in blister strips and supplied in boxes of 40 or 60 tablets.
Manufacturer and licence holder
This medicine is manufactured by NPIL Pharmaceuticals (UK) Limited,
Whalton Road, Morpeth, Nothumberland, NE61 3YA, UK and is procured
from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
Lexon (UK) Ltd, B98 0RE
If you have any questions or are not sure about anything , ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to help you.
Arthrotec is a registered trademark of G.D. Searle LLC.

POM

PL: 33723/0065

Revision date: 21/03/13

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

+ Expand Transcript

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