50 mg / 0.2 mg modified- release tablets
diclofenac sodium / misoprostol
Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.
– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
In this leaflet:
1. What Arthrotec is and what it is used for
2. What you need to know before you use Arthrotec
3. How to use Arthrotec
4. Possible side effects
5. How to store Arthrotec
6. Contents of the packaging and other information
1. What Arthrotec is and what it is used for
Arthrotec relieves pain and swelling in rheumatoid arthritis ( rheumatoid arthritis ) and joint wear and tear ( osteoarthritis ) and can also provide protection in patients who are at increased risk of irritation or ulcers in the stomach or intestines.
Arthrotec contains diclofenac and misoprostol. Diclofenac belongs to a group of medicines called non-steroidal anti-inflammatory drugs ( NSAIDs ).
NSAIDs relieve pain, but can also reduce the amount of naturally occurring substances, called prostaglandins, in the lining of the stomach .
This means that NSAIDs can cause stomach irritation or stomach ulcers. Arthrotec also contains misoprostol, which is very similar to these prostaglandins and can therefore help protect the stomach.
2. What you need to know before using Arthrotec
Do not take Arthrotec
- if you think you may be allergic to diclofenac sodium, acetylsalicylic acid, ibuprofen or any other NSAID, misoprostol or other prostaglandin-type medicines, or any of the other ingredients of Arthrotec (listed in section 6). Signs of a hypersensitivity reaction may include skin rash, swelling or itching of the skin, swelling of the face and mouth ( angioedema ), severe nasal congestion, asthma(difficulty breathing), chest pain, wheezing, or any other type of allergic reaction.
- if you currently have a stomach ulcer or perforation (hole) in your stomach or intestines
- if you currently have bleeding in your stomach, intestines, or brain
- if you are undergoing or have recently had a bypass operation on your coronary arteries
- if you have severe kidney or liver failure
- if you have known heart disease and/or disease of the blood vessels of the brain, e.g. heart attack, stroke, “mini-stroke” ( transient ischemic attack, TIA ). You may also have had constrictions in the blood vessels of the heart or brain, or have had surgery for such constrictions by clearing vessels one by one or via a bypass operation
- if you have or have had problems with blood circulation ( peripheral vascular disease)
- if you are pregnant or trying to conceive, as Arthrotec may cause miscarriage. Women of childbearing potential should have adequate contraception during treatment with Arthrotec
- if you are a woman of childbearing potential and do not use effective contraception to avoid pregnancy (read more in the section “Pregnancy”).
Warnings and cautions
Talk to your doctor or pharmacist before taking Arthrotec:
- if you have other health problems, such as liver or kidney disease.
- if you have previously had ulcers or bleeding in the stomach or intestines.
- if you easily get bleeding or bruising
- if you have intestinal inflammation (ulcerative colitis or Crohn’s disease )
- if you have or have had asthma or any allergic disease
- if you have an infection, as Arthrotec may mask a fever or other signs of infection
- if you are dehydrated
- if you are over 65 years old because doctors will want to check you regularly
- if you smoke
- if you have diabetes
- if you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides (blood fats)
- if you are pregnant or planning to become pregnant (see section “Pregnancy”). Due to the risk to the fetus, your treatment with Arthrotec must be stopped immediately.
- if you are a woman of childbearing potential (see also section “Pregnancy”). It is important that you use effective contraception while taking this medicine.
- if you have recently had surgery or are about to have surgery on your stomach or intestinal tract, as Arthrotec can sometimes impair wound healing in the intestines after surgery.
NSAIDs such as Arthrotec can cause bleeding or stomach ulcers. Treatment should be discontinued if this occurs. You have a particularly high risk of serious side effects in the stomach and intestines if you:
– while taking a corticosteroid (eg prednisone)
– at the same time taking a blood-thinning medicine orally,
– at the same time taking a selective serotonin reuptake inhibitor (eg sertraline )
– drink alcohol.
– use Arthrotec with acetylsalicylic acid or any other NSAID (eg ibuprofen ). You can then more easily get sores or bleeding in the stomach and intestines.
– is older
– have any cardiovascular disease
– if you have previously had or have ulcers or bleeding in the stomach or intestines
– be treated with higher doses of NSAIDs.
Medicines such as Arthrotec may have a small increased risk of heart attack or stroke. Such an increase in risk is more likely with the use of high doses and with long-term treatment. Do not exceed the recommended dose or treatment time.
Side effects can be minimized by treating with the lowest effective dose for the shortest possible time.
Like other NSAIDs (eg ibuprofen ), Arthrotec can cause high blood pressure, so your doctor may want to measure your blood pressure regularly.
Your doctor will want to examine you regularly if you have heart, liver, or kidney problems.
Other medicines and Arthrotec
Some medicines may affect the way some other medicines work. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, such as:
- Acetylsalicylic acid or other NSAIDs (eg ibuprofen )
- Medicines for osteoarthritis or rheumatoid arthritis belonging to the group cyclooxygenase-2 ( COX-2 ) inhibitors
- Diuretics (used for fluid retention in the body)
- Ciclosporin or tacrolimus (used to suppress the immune system, eg after transplants)
- Lithium (used to treat certain types of depression)
- Digoxin (a medicine for irregular heartbeat and/or heart failure )
- Warfarin or other blood-thinning medicines taken by mouth (reduces blood clotting, eg acetylsalicylic acid )
- Drugs for anxiety and depression belonging to the group of selective serotonin reuptake inhibitors ( SSRIs )
- Blood glucose control drugs are taken orally (for diabetes )
- Methotrexate (used to treat rheumatoid arthritis, psoriasis, and leukemia )
- Treatment with steroids (eg corticosteroids which are often used as anti-inflammatory drugs)
- Medicines for high blood pressure
- Antacids containing magnesium (used for heartburn, indigestion)
- Antibiotics quinolone (used against certain infectious s)
- Ketoconazole , fluconazole , miconazole and voriconazole (used against certain types of fungal infections)
- Amiodarone (used to treat abnormal heart rhythms)
- Sulfinpyrazone (used to treat gout )
If you have been taking mifepristone (to terminate a pregnancy) for the last 12 days. Arthrotec should not be used within 8-12 days after taking mifepristone.
Concomitant use of anti-inflammatory and analgesic drugs of the NSAID type can in rare cases cause an increase in certain blood levels, as well as fluid accumulation in the body (swelling in the ankles, legs, and/or hands). Concomitant use of other NSAIDs should be avoided as the risk of side effects increases.
Blood pressure-lowering drugs containing propranolol may, after repeated dosing of Arthrotec, lead to a moderate increase in the concentration of propranolol in the blood. Therefore, consult your doctor before concomitant use.
Pregnancy, breastfeeding, and fertility
Do not take Arthrotec if you are pregnant, think you may be pregnant, or are trying to become pregnant. Tell your doctor if you are planning to have a baby. Due to the possible risk of birth defects, you must make sure that you are not pregnant before starting treatment. Women who have not reached menopause must use a reliable contraceptive during treatment with Arthrotec.
Your doctor will inform you about the risks if you become pregnant while taking Arthrotec, as the medicine may cause miscarriage, premature birth, or abnormal fetal development (malformations). You should NEVER take this medicine if you are pregnant, as it can also have serious consequences for your baby, especially on the heart, lungs, and/or kidneys, including death. If you have been treated with this medicine during pregnancy, talk to your doctor. If you decide to complete the pregnancy, it should be followed up closely with ultrasound examinations with a special focus on the baby’s legs, arms, and head.
If you are breast-feeding, talk to your doctor or pharmacist before taking this medicine. Do not use Arthrotec if you are breast-feeding.
Arthrotec can cause temporary infertility. In women who are having difficulty conceiving or undergoing fertility testing, discontinuation of Arthrotec treatment should be considered.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Arthrotec can cause dizziness, fatigue, and visual disturbances.
If you feel dizzy or drowsy after taking Arthrotec, do not drive or use machines until these symptoms have subsided.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Arthrotec contains lactose
Arthrotec contains lactose (a sugar ). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Arthrotec
Always take this medicine exactly as your doctor or pharmacist has told you.
Ask your doctor or pharmacist if you are unsure.
The usual dose for adults is 1 tablet 2-3 times daily.
Arthrotec should be swallowed whole with water (not chewed) with, or immediately after, a meal.
Elderly patients and patients with liver or kidney disease
Your doctor may want to check you more closely. No dose adjustment is necessary.
Use for children
Arthrotec is for adults only and should not be used by children (under 18 years of age).
In case of overdose, the following symptoms may occur drowsiness, tremors, cramps, shortness of breath, abdominal pain, diarrhea, fever, palpitations, low blood pressure, or slow heartbeat.
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 tablet.
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 product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Arthrotec can cause side effects, although not everybody gets them.
Stop taking Arthrotec and contact a doctor immediately if any of the following occur:
- weakness or inability to move one side of the body, slurred speech ( stroke ), chest pain (heart attack), heart failure or palpitations (you feel your heartbeat) – Uncommon (may affect up to 1 in 100 people)
- shortness of breath – Uncommon (may affect up to 1 in 100 people)
- Arthrotec can cause a decrease in a type of white blood cell (which helps defend the body against infection and disease) which can lead to infection with symptoms such as chills, sudden fever, sore throat or flu-like symptoms – Uncommon (may occur in up to 1 in 100 users)
- severe abdominal pain or see any signs of bleeding or ulceration in the stomach or intestines, such as black or bloody stools – Uncommon (may affect up to 1 in 100 people), or bloody vomiting – Rare (may affect up to 1 in 1,000 people) )
- a severe allergic reaction with symptoms such as swelling of the face, tongue or throat, difficulty swallowing, wheezing or difficulty breathing, hives, drop in blood pressure ( angioedema, anaphylactic shock ) – Rare (may affect up to 1 in 1,000 people)
- jaundice (your skin or whites of the eyes look yellowish) – Rare (may affect up to 1 in 1,000 people)
- reduction in platelet count (increased risk of bleeding or bruising) – Uncommon(may affect up to 1 in 100 people)
- symptoms of meningitis (stiff neck, headache, nausea, vomiting, fever, or loss of consciousness) – occurs in an unknown number of users
- chest pain, which may be a sign of a potentially serious allergic reaction known as Kuoni’s syndrome – occurs in an unknown number of users
- a severe skin reaction such as rash, blistering, or peeling of the skin (DRESS, Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis ) – occurs in an unknown number of users.
Other side effects may occur
Very common (may affect more than 1 user in 10):
- Stomach pain, diarrhea, nausea, indigestion
Diarrhea is most common and in exceptional cases is of a serious nature. Taking Arthrotec with food reduces the risk of diarrhea. If you are taking antacids (for the acid stomach), you should avoid antacids that contain magnesium as they can worsen diarrhea.
The pharmacy staff can help you choose the appropriate antacid. If diarrhea continues and becomes severe, you should contact your doctor.
Common (may affect up to 1 in 10 people):
- Skin rash, itching
- Vomiting, flatulence, constipation, regurgitation, gastritis (indigestion, abdominal pain, vomiting)
- Inflammation of the esophagus
- Stomach or intestinal ulcers
- Headache, dizziness
- Difficulty sleeping
- Altered blood test results associated with liver function
- Inflammation of the gastrointestinal tract such as nausea, diarrhea, and abdominal pain
- Abnormal fetal development
Uncommon (may affect up to 1 in 100 people):
- Swelling and inflammation in the mouth
- Fluid retention in the body can cause swollen ankles and bones
- Abnormal or unexpected abdominal bleeding
- Decreased platelet count (may lead to increased risk of bleeding or bruising)
- Purple (purple skin spots)
- Hives (raised, itchy rash)
- Infection in the vagina ( itching, burning, soreness, pain particularly during intercourse and/or urination)
- High blood pressure
- Reduced appetite
- Menstrual disorders, such as heavy or minor bleeding or delayed menstruation
- Chills or fever
- Drowsiness, fatigue, tremors
- Ringing in the ears ( tinnitus )
- Bleeding from the stomach and intestines (gastrointestinal bleeding)
- Depression and anxiety
- Tingling or tingling
- Cold sores and dry mouth
Rare (may affect up to 1 in 1,000 people):
- Hepatitis (may lead to yellowing of the skin, headache, fever, chills, a general feeling of weakness)
- Inflammation of the pancreas, leading to severe pain in the abdomen and back
- Pain in the breasts
- Painful menstruation
- Vomiting containing blood
- Exacerbation of ulcerative colitis ( inflammation of the colon)
- Damage to the esophagus
- Swelling of the tongue
- Low blood pressure
- Hair loss
- The skin rash in the form of blisters (bullous skin rash)
- Increased light sensitivity
Very rare (may affect up to 1 in 10,000 people):
- Severe liver disease including liver failure
Has been reported (occurs in an unknown number of users):
- Exacerbation of Crohn’s disease (intestinal inflammation)
- Kidney problems
- Inflammation of the lungs such as cough increased mucus formation
- Tingling or numbness
- Inflamed blood vessels (may cause fever, aches, purple rash))
- Psychosis (a mental illness characterized by a lack of perception of reality)
- Mood swings
- , irritation, memory disorders, confusion
- Visual disturbances, taste changes
- Swelling of the face
- Abnormal contractions of the uterus, rupture of the uterine wall, retention of placenta after childbirth, a life-threatening reaction caused by amniotic fluid or other tissues passing from the pregnancy to the mother’s blood circulation, uterine bleeding, miscarriage, fetal death, premature birth
- Anemia (decreased number of red blood cells ) can lead to pale skin, feeling weak, and short of breath
- Decreased fertility in women
- Skin rash (Erythema multiforme, Henoch-Schönlein purpura, mucosal rash, vesicular rash)
- Altered blood test results associated with liver function (increased bilirubin )
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
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. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton after EXP. date. The expiration date is the last day of the specified month.
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. Contents of the packaging and other information
The active substances are diclofenac sodium and misoprostol.
One tablet contains 50 mg of diclofenac sodium and 0.2 mg of misoprostol.
The other ingredients are lactose monohydrate, microcrystalline cellulose, corn starch, povidone, magnesium stearate, methacrylic acid ethyl acrylate copolymer, sodium hydroxide, triethyl citrate hypromellose, crospovidone, colloidal anhydrous silica, hydrogenated talc castor oil.
What the medicine looks like and the contents of the pack
Arthrotec tablets are white to off-white, round, biconvex and marked with on one side and “SEARLE 1411” on the other side.
Blister: 20 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
191 90 Sollentuna
Tel: 08-550 520 00
Piramal Healthcare UK Limited
Piramal Pharma Solutions (Dutch) BV
Level, 7th floor