Arthrotec 75 modified-release tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
DICLOFENAC SODIUM; Misoprostol
Available from:
PCO Manufacturing Ltd.
ATC code:
M01AB; M01AB55
INN (International Name):
DICLOFENAC SODIUM; Misoprostol
Dosage:
75/0.2 milligram(s)
Pharmaceutical form:
Modified-release tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Acetic acid derivatives and related substances; diclofenac, combinations
Authorization status:
Authorised
Authorization number:
PPA0465/114/002
Authorization date:
2004-03-31

Package leaflet: Information for the patient

Arthrotec

®

75 modified-release tablets

diclofenac sodium, misoprostol

Read all of this leaflet carefully before you start taking this medicine because it

contains important information for you.

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 only. Do not pass it on to others. It

may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Arthrotec is and what it is used for

What you need to know before you take Arthrotec

How to take Arthrotec

Possible side effects

How to store Arthrotec

Contents of the pack and other 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.

What you need to know 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

aspirin

(acetylsalicylic

acid),

misoprostol

another

prostaglandin medicine, or any of the other ingredients in Arthrotec (see section

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 established heart disease and/or cerebrovascular disease e.g. if you have

had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the

heart or brain or an operation to clear or bypass blockages

have or have had problems with your blood circulation (peripheral arterial

disease)

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.

are a woman of a childbearing age and you are not using an effective

contraceptive method to avoid becoming pregnant (see section on ‘Pregnancy’ for

further information)

Warnings and precautions

Talk to your doctor or pharmacist before taking Arthrotec

If you:

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 will want to monitor you regularly

are pregnant or plan to become pregnant (see section on “Pregnancy”). Due to

the risk to the foetus, your treatment with Arthrotec must be discontinued

immediately

are a woman of childbearing age (see also section on “Pregnancy”). It is

important to use effective contraception while you are taking this medicine

NSAID medicines such as Arthrotec can cause bleeding or ulceration. If this occurs,

treatment should be stopped. Use of Arthrotec with another NSAID other than aspirin

(e.g. ibuprofen) may also increase frequency of ulcers or bleeding in your stomach or

intestines.

Arthrotec may cause serious side effects, especially stomach and intestinal

complications, if you are using a corticosteroid (e.g. prednisone), an oral

anticoagulant, or a Selective Serotonin Re-uptake Inhibitor (e.g. sertraline) or if you

drink alcohol.

Make sure your doctor knows, before you are given Arthrotec If you:

smoke

have diabetes

have angina, blood clots, high blood pressure, raised cholesterol or raised

triglycerides

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.

Side effects may be minimised by using the lowest effective dose for the shortest

duration necessary.

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

regularly.

Other medicines and Arthrotec

Some medicines can affect the way other medicines work. Tell your doctor or

pharmacist if you are taking, have recently taken or might take any other

medicines, including:

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, e.g. aspirin)

Medicines used to treat anxiety and depression known as Selective Serotonin

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, fluconazole, miconazole and voriconazole (used to treat some

fungal infections)

Amiodarone (used to treat an abnormal heart beat)

Sulfinpyrazole (used to treat gout)

If you have taken a medicine called mifepristone (used to terminate pregnancy)

within the last 12 days. Arthrotec should not be taken within 8-12 days of taking

mifepristone.

Pregnancy, breast-feeding and fertility

Pregnancy

Do not take Arthrotec if you are pregnant, think you may be pregnant or trying to

become pregnant. You should tell your doctor if you are planning to become

pregnant. Due to the possible risk of damage to the foetus, you must make sure you

are not pregnant before starting treatment. Women who have not reached

menopause should use reliable contraception while they are taking Arthrotec.

Your doctor will make you aware of the risks if you do become pregnant while taking

Arthrotec as it may cause a miscarriage, premature birth, abnormal formation of the

foetus (birth defects). You should NEVER take this medicine if you are pregnant, as it

can also have severe consequences on your child, especially on the heart, lungs

and/or kidneys, including death. If you have received treatment with this medicine

during pregnancy, talk with your doctor. If you decide to continue with the pregnancy,

careful ultrasound scan monitoring of the pregnancy, with special attention to the

limbs and head must be carried out.

Breast-feeding

Ask your doctor or pharmacist for advice before taking this medicine if you are breast-

feeding. Do not use Arthrotec while you are breast-feeding.

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.

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 this medicine exactly as your doctor or pharmacist has told you. Check

with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet twice a day.

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.

Use in 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 a forgotten dose.

If you stop taking Arthrotec

Do not stop taking Arthrotec unless your doctor tells you to. If you have any further

questions on the use of this medicine ask your doctor or pharmacist.

4.

Possible side effects

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

them.

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.

If any of the following happen, stop taking Arthrotec and tell your doctor

immediately:

If you have

Weakness of or inability to move one side of body, slurred speech (stroke) or

chest pain (heart attack) – the occurrence is uncommon

Shortness of breath – the occurrence is uncommon

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

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

Heart failure, chest pain, palpitations (awareness of your heartbeat) – 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

Arthrotec can cause a decrease in a type of white blood cell (these help protect

the body from infection and disease) and lead to infections with symptoms like

chills, sudden fever, sore throat, or flu-like symptoms. Immediately contact your

doctor if any of these symptoms develop – it is not known how often this occurs.

Reduction in the number of blood platelets (increased chance of bleeding or

bruising) – it is not known how often this occurs

If you get any side effects, talk to your doctor or pharmacist. This includes any

possible side effects not listed in this leaflet

.

Very common: may affect more than 1 in 10 people

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: may affect up to 1 in 10 people

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

Inflammation of the digestive tract, including the intestines, such as nausea,

diarrhoea, abdominal pain

Abnormal formation of foetus

Uncommon: may affect up to 1 in 100 people

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)

Infection of the vagina (itching, burning, soreness, pain especially during

intercourse and/or urination)

Blurred vision

High blood pressure

Menstrual disorders such as usually heavy or light bleeding, or delayed

periods

Chills or fever

Rare: may affect up to 1 in 1,000 people

Inflammation of the liver (possible yellow discoloration of skin, headache,

fever, chills, general weakness)

Inflammation of the pancreas, which causes severe pain in the abdomen and

back

Inflammation of the lung such as coughing, increased sputum

Breast pain

Very rare: may affect up to 1 in 10,000 people

Severe liver disorders including liver failure

Nightmares

Not known: frequency cannot be estimated from the available data

Damage to the gullet

Worsening of ulcerative colitis or Crohn’s disease (inflammation of the

intestines)

Kidney or liver problems

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, drowsiness, tiredness

Difficulty seeing, ringing in the ears, changes in the way things taste

Increased sensitivity to light

Inflammation

Loss of appetite

Abnormal contractions of the womb, rupture in the womb, retained placenta

after giving birth, a life-threatening reaction in the mother due to the passage

of amniotic fluid (fluid covering the foetus) or other foetal material into the

maternal blood stream, bleeding in the womb, miscarriage, death of the

unborn baby, premature birth

Low blood pressure

Anaemia (low number of red blood cells) which can lead to pale skin and

cause weakness or breathlessness.

Painful menstrual/period cramps

Decreased fertility in females

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 HPRA Pharmacovigilance, Earlsfort Terrace, Dublin 2, Ireland;

Tel: +353 1 6764971; Fax: +353 1 6762517;

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety of this

medicine.

5.

How to store Arthrotec

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

Do not store above 25 °C

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

Do not use this medicine after the expiry date denoted by ‘EXP’ or ‘Scadenza’ on

the carton, label and blister foil. 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.

6.

Contents of the pack and other information

What Arthrotec contains

The active substances are diclofenac sodium and misoprostol.

One tablet contains 75mg diclofenac sodium and 200 micrograms misoprostol.

The other ingredients are: lactose, microcrystalline cellulose, maize starch, povidone

K-30, methacrylic acid copolymer type C, sodium hydroxide, triethyl citrate,

hypromellose, crospovidone, magnesium stearate, hydrogenated caster oil, colloidal

anhydrous silica and talc.

Each tablet consists of a gastro-resistant core containing diclofenac sodium

surrounded by an outer mantle containing misoprostol.

What Arthrotec looks like and contents of the pack

Arthrotec are white, round, biconvex tablets marked 'Searle’ and ‘1421' on one side

with four ‘A’s and ‘75’ on the other side or White, round, biconvex tablets, plain on

both sides.

Pack size: Arthrotec is available in blister packs of 30 or 60 tablets. Not all pack sizes

may be marketed.

Product procured from within the EU, repackaged and distributed by the

Parallel Product Authorisation Holder: PCO Manufacturing Ltd., Unit 10,

Ashbourne Business Park, Rath, Ashbourne, Co. Meath, Ireland.

Manufacturer

Piramal Healthcare UK Ltd. Morpeth, Northumberland NE61 3YA, United Kingdom or

NPIL Pharmaceuticals (UK) Ltd, Morpeth, Northumberland NE61 3YA, United

Kingdom or Piramal Pharma Solutions (Dutch) B.V. Level, 7e verdieping, Bargelaan

200, 2333 CW Leiden, Netherlands.

Parallel Product Authorisation Number

Arthrotec 75 PPA 465/114/2

Arthrotec is a registered trademark of G.D. SEARLE LLC

For any information about this medicine, please contact:

Pfizer Healthcare Ireland Limited, 9 Riverwalk, National Digital Park Citywest

Business Campus, Dublin 24, Ireland.

Telephone: 1800 633 363

This leaflet was last revised in June 2020.

Health Products Regulatory Authority

22 October 2019

CRN009758

Page 1 of 2

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Arthrotec 75 modified-release tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet consists of a gastro-resistant core containing 75 mg diclofenac sodium surrounded by an outer mantle containing

200 micrograms misoprostol

Excipient(s) with known effect:

Each tablet contains lactose

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Modified-release tablets

Product imported from UK (Artrotec):

White, round, biconvex tablets marked 'Searle' and '1421' on one side with four 'A's and '75' on the other side.

Product imported from Italy (Misofenac):

White, round, biconvex tablets, plain on both sides.

4 CLINICAL PARTICULARS

As per PA0822/112/002

5 PHARMACOLOGICAL PROPERTIES

As per PA0822/112/002

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose

Microcrystalline cellulose

Maize starch

Povidone K-30

Methacrylic Acid Copolymer Type C

Sodium Hydroxide

Triethyl Citrate

Hypromellose

Crospovidone

Magnesium stearate

Hydrogenated castor oil

Colloidal anhydrous silica.

Talc

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Health Products Regulatory Authority

22 October 2019

CRN009758

Page 2 of 2

The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in

the country of origin.

6.4 Special precautions for storage

Do not store above 25 °C.

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

6.5 Nature and contents of container

Blister pack containing 30 or 60 tablets.

Not all pack sizes may be marketed

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal

product and other handling of the product

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing Ltd.

Unit 10, Ashbourne Business Park

Rath

Ashbourne

Co. Meath

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/114/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 31

March 2004

Date of last authorisation: 31

March 2009

10 DATE OF REVISION OF THE TEXT

October 2019

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