ARTHROTEC 75 TABLETS - patient leaflet, side effects, dosage

Arthrotec® 75 Tablets

(diclofenac sodium/ misoprostol)

PATIENT INFORMATION LEAFLET

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.

Your medicine is available using the above name but will be referred to as Arthrotec throughout the leaflet.

What is in this leaflet

• 1. What Arthrotec is and what it is used for

• 2. What you need to know before you take Arthrotec

• 3. How to take Arthrotec

• 4. Possible side effects

• 5. How to store Arthrotec

• 6. 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 as aspirin (acetylsalicylic acid), misoprostol or another prostaglandin medicine, or any of the other ingredients in Arthrotec (see 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 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 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 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 antiinflammatory 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 must 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) or heart failure or palpitations (awareness of your heartbeat) – the occurrence is uncommon

• – Shortness of breath – the occurrence is uncommon

• – 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 – 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 – the occurrence is uncommon, or vomiting blood – this occurs 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

• – 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

• – Reduction in the number of blood platelets (increased chance of bleeding or bruising) – it is not known how often this occurs

• – Symptoms of meningitis (stiff neck, headache, nausea (feeling sick), vomiting, fever or loss of consciousness) – 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.

– 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

What Arthrotec 75 looks like and contents of the pack

Arthrotec 75 Tablets are available in blisters strips in packs of 30 or 60 tablets and are presented as white round tablets marked ‘SEARLE 1421’ on one side and a star logo on the reverse.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Arthrotec 75 Tablets are manufactured by Searle Division of Monsanto plc, Morpeth, Northumberland NE61 3YA. Procured from within the EU and Repackaged by Product Licence holder P.I.E. Pharma Ltd, 207 Kenton Road, Harrow, Middlesex HA3 0HD

POM Arthrotec 75 Tablets – PL 15361/0557

Leaflet revision and issue date (Ref.) 08.08.19[19]

Arthrotec® is a trademark of G. D. Searle LLC

Blind or partially sighted?

Is this leaflet hard to see or read? Call 020 8423 2111 to obtain the leaflet in a format suitable for you.

– Uncommon: may affect up to 1 in 100 people

• – Swelling of the mouth

• – Fluid build-up in the body that can cause swollen ankles and legs

• – 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

• – Loss of appetite

• – Menstrual disorders such as usually heavy or light bleeding, or delayed periods

• – Chills or fever

• – Drowsiness, tiredness, feeling shaky

• – Ringing in the ears

• – Depression and feeling anxious

• – Tingling or pricking (pins and needles)

• – Mouth ulcers and dry mouth

– 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

• – Vomiting blood

• – Worsening of ulcerative colitis (inflammation of lower intestine)

• – Damage to the gullet

• – Swelling of the tongue

• – Low blood pressure

• – Hair loss

• – Increased sensitivity to light

• – Nightmares

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

• – Severe liver disorders including liver failure

• - Not known: frequency cannot be estimated from the available data

• – Worsening of Crohn’s disease (inflammation of the intestines)

• – Kidney problems

• – Seizures

• – Inflamed blood vessels (can cause fever, aches, purple blotches)

• – Psychotic disorder (mental disorder that features loss of contact with reality)

• – Mood swings, irritability, memory problems, feeling confused

• – Difficulty seeing, changes in the way things taste

• – Inflammation

– 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 fetus) or other fetal material into the maternal blood stream, bleeding in the womb, miscarriage, death of the unborn baby, premature birth

• – 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

5. how to store arthrotec

Do not store above 25oC. Store in a dry place.

Do not take Arthrotec after the expiry date printed on the carton label or blister strip.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN. If your doctor tells you to stop taking this medicine, please take it back to your pharmacist for safe disposal. Only keep it if your doctor tells you to. If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. contents of the pack and other information

What Arthrotec 75 contains

Each Arthrotec 75 tablet contains the active ingredients:

75 milligrams diclofenac sodium and 200 micrograms misoprostol and also contains inactive ingredients lactose, microcrystalline cellulose, maize starch, povidone K-30, methylacrylic acid copolymer type C, sodium hydroxide, triethyl citrate, methylhydroxy­propylcellulo­se, crospovidone, magnesium stearate, hydrogenated castor oil, colloidal anhydrous silica and talc.