ARTROTEC 50 mg /200 Mcg Coated Tablet

Зміст інструкції

1. Artrotec 75 modified-release tablets
   1. What you need to know before taking Artrotec
   2. How to take Artrotec
   3. Possible side effects
   4. How to store Artrotec
   5. Contents of the pack and other information
2. Artrotec 50 mg + 200 mcg tablets
   1. What is Artrotec and what is it used for
   2. Cosa deve sapere prima di prendere Artrotec
   3. How to take Artrotec
   4. Possible side effects
   5. How to store Artrotec
   6. Contents of the pack and other information

Artrotec 75 modified-release tablets

diclofenac sodium, misoprostol

Read this leaflet carefully before you start to take this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Artrotec is and what it is used for

2. What you need to know before you take Artrotec

3. How to take Artrotec

4. Possible side effects

5. How to store Artrotec

6. Contents of the pack and other information

1. What Artrotec is and what it is used for

Artrotec is used for the symptomatic treatment of rheumatoid arthritisand osteoarthritis,and may be
useful in protecting patients at risk of irritation or ulceration of the stomach or intestine.
Artrotec contains diclofenac and misoprostol. Diclofenac belongs to a class of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs).
Although NSAIDs relieve pain, they reduce the production of natural protective substances called
prostaglandins which are found in the lining of the stomach.
This means that NSAIDs can cause problems with the stomach or stomach ulcers. Artrotec
also contains misoprostol which is very similar to prostaglandins and can help to protect the
stomach.

2. What you need to know before taking Artrotec

Do not take Artrotec if:

• you think you are allergic to diclofenac sodium, to aspirin (acetylsalicylic acid), to ibuprofen or to any other NSAID, to misoprostol or to any other medicine containing prostaglandins, or to any of the excipients of Artrotec (see section 6). Signs of a hypersensitivity reaction include skin rash, swelling or itching of the skin, swelling of the face and mouth (angioedema), severe nasal congestion, asthma (breathing problems), chest pain, wheezing or any other allergic-type reaction
• you currently have a stomach or intestinal ulcer or perforation
• you currently have bleeding in the stomach, intestine or brain
• you are about to undergo or have undergone surgery for coronary artery bypass grafting (CABG)
• you have severe liver or kidney failure
• you have established heart and/or cerebrovascular disease for example if you have had a heart attack, a stroke or a mini-stroke (TIA) or blockages of the blood vessels of the heart or brain or if you have undergone surgery to remove or bypass these blockages
• you have had or have problems with blood circulation (peripheral arterial disease)
• you are pregnant, or if you are planning a pregnancy, because the drug can cause an abortion. Women who have not reached menopause must use suitable contraceptive measures during the period in which they take Artrotec
• you are a woman of childbearing potential and are not using effective contraceptive methods to avoid pregnancy (see section “Pregnancy” for further information).

Warnings and precautions
Talk to your doctor or pharmacist before taking Artrotec
If you:

• have other health problems such as liver or kidney disease. Do not takeArtrotec if you have severe kidney or liver failure
• have had a stomach or intestinal ulcer or bleeding in the past. Do not takeArtrotec if you currently have a stomach or intestinal ulcer or bleeding
• are easily prone to bleeding or bruising
• have inflammation of the intestine (ulcerative colitis or Crohn's disease)
• have or have ever had asthma or an allergic condition
• have an infection, as Artrotec may mask fever or other signs of infection
• are dehydrated
• are over 65 years old, as your doctor will subject you to periodic checks
• are pregnant or intend to become pregnant (see section “Pregnancy”). Treatment with Artrotec must be stopped immediately due to the risk to the fetus.
• are a woman of childbearing potential (see also section on “Pregnancy”). It is important to use effective contraceptive measures while taking this medicine
• have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/taking/using Artrotec, as Artrotec may sometimes worsen wound healing in the intestine following surgery.

NSAIDs like Artrotec can cause bleeding or ulcers. In this case, treatment must
be stopped. The use of Artrotec in combination with another NSAID other than aspirin (e.g.
ibuprofen) may further increase the frequency of ulcers or bleeding in the stomach or
intestine.
If you are taking a corticosteroid (e.g. prednisone), an oral anticoagulant or a selective
serotonin reuptake inhibitor (e.g. sertraline) or if you drink alcohol, Artrotec may cause adverse
effects, especially complications in the stomach and intestines.
Make sure your doctor, before prescribing Artrotec, knows:

• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, high cholesterol or high triglycerides.

Medicines like Artrotec may be associated with a slight increase in the risk of heart attack
(myocardial infarction) or stroke. The risk increases with high doses and prolonged treatments. Do not exceed
the recommended dose or duration of treatment.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration
necessary.
As with other NSAIDs (e.g. ibuprofen), Artrotec can lead to an increase in blood pressure and therefore your doctor may ask you to check your blood pressure regularly.
If you have heart, liver or kidney problems, your doctor will subject you to periodic checks.

Other medicines and Artrotec
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 for the treatment of osteoarthritis or rheumatoid arthritis, called cyclo-oxygenase-2 (COX-2) inhibitors.
• Diuretics (used for the treatment of excess fluid in the body)
• Cyclosporine or tacrolimus (used for the suppression of the immune system, e.g. after transplantation)
• Lithium (used to treat some types of depression)
• Digoxin (a medicine used for irregular heartbeat and/or heart failure)
• Warfarin or other oral anticoagulants (drugs that reduce blood clotting, e.g. aspirin)
• Medicines used for the treatment of anxiety and depression called Selective Serotonin Reuptake Inhibitors (SSRIs)
• Medicines used to control blood sugar levels (oral hypoglycemic agents for diabetes)
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukemia)
• Steroid-based drugs (e.g. corticosteroids, often used as anti-inflammatory drugs)
• Medicines for high blood pressure (antihypertensives)
• Antacids containing magnesium (used for the treatment of heartburn and indigestion)
• Quinolone antibiotics (used for the treatment of some infections)
• Ketoconazole, fluconazole, miconazole and voriconazole (used for the treatment of some fungal infections)
• Amiodarone (used for the treatment of heart rhythm abnormalities)
• Sulfinpyrazone (used for the treatment of gout)
• If you have taken a medicine called mifepristone (used to terminate a pregnancy) in the last 12 days. Artrotec should not be taken before 8-12 days after taking mifepristone.

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you are pregnant or are planning a pregnancy, do not take
Artrotec. If you are planning a pregnancy, tell your doctor. Due to the possible risk of
harming the fetus, you must make sure you are not pregnant before starting treatment. Women who
have not reached menopause must use suitable contraceptive measures during the period in which
they take Artrotec.
Your doctor will inform you of the risks if you become pregnant while taking Artrotec,
as it may cause miscarriage, premature delivery, abnormal fetal development (birth defects). You should NEVER take this medicine if you are pregnant, as it can also have serious
consequences for the baby, especially the heart, lungs and/or kidneys, including death. If you have received
treatment with this medicine during pregnancy, consult your doctor. If you decide to continue
the pregnancy, a careful ultrasound examination of the pregnancy should be performed, with
particular attention to the limbs and head.
Breastfeeding
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine. Do not use Artrotec during breastfeeding.

Driving and operating machinery
If you feel dizzy or drowsy after taking Artrotec, do not drive and do not use
tools or machinery until these effects have disappeared.
Artrotec contains

Lactose(a type of sugar). If your doctor has diagnosed you with intolerance to some sugars, contact
him/her before taking Artrotec.

3. How to take Artrotec

Always take this medicine exactly as your doctor or pharmacist has told you. If you have doubts,
consult your doctor or pharmacist.
Take one tablet twice a day.
Artrotec tablets must be swallowed whole with a glass of water (do not chew), during or
after meals.

Elderly patients and patients with kidney or liver problems: your doctor may subject you to more careful monitoring. No
dose adjustment is necessary.

Use in children: Artrotec is only for adults. It should not be used for children (under 18
years of age).

If you take more Artrotec than you should
Do not take more tablets than prescribed by your doctor. If you take too many tablets, contact
your doctor, pharmacist or hospital as soon as possible and take the medicine with you.

If you forget to take Artrotec
If you forget to take a tablet, take it as soon as you remember. Do not take a double dose to
make up for the missed dose.

If you stop taking Artrotec
Do not stop taking Artrotec unless your doctor has told you to do so. If you have any doubts about the use of this
medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you are concerned about side effects, ask your doctor. It is important that you know what can
happen, so that you can take action if Artrotec causes a side effect. Artrotec sometimes causes side
effects, but these usually disappear during treatment, as the body
gets used to the medicine.

If any of the following occur, stop taking Artrotec and immediately inform your
doctor:
If you

• experience weakness or inability to move one side of the body, slurred speech (stroke) or chest pain (heart attack) or heart failure or palpitations (awareness of your heartbeat) - the frequency with which these events can occur is uncommon
• experience shortness of breath - the frequency with which these events can occur is uncommon
• Artrotec can cause a decrease in a type of white blood cells (which help protect the body from infections and diseases) and can lead to infections with symptoms such as chills, sudden fever, sore throat or flu-like symptoms - the frequency with which these events can occur is uncommon
• experience severe stomach pain or any sign of bleeding or injury to the stomach or intestines, such as black stools or blood in the stool - the frequency with which these events can occur is uncommon, or vomiting blood - this occurs rarely
• develop a severe skin reaction such as rash, blisters or peeling skin (DRESS syndrome, Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis) - the frequency with which these events can occur is unknown.
• experience a severe allergic reaction such as rash, facial swelling, wheezing or difficulty breathing (anaphylactic shock) - this occurs rarely
• develop jaundice (yellowing of the skin or whites of the eyes) - this occurs rarely
• experience a decrease in the number of platelets in the blood (with an increased risk of bleeding or bruising) - the frequency with which these events can occur is unknown.
• experience symptoms of meningitis (stiff neck, headache, nausea (feeling sick), vomiting, fever or loss of consciousness) - the frequency with which these events can occur is unknown.
• experience chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome - the frequency with which this event can occur is unknown.

If any side effect occurs, including those not listed in this leaflet, tell your
doctor or pharmacist.

• Very common: may affect more than 1 in 10 people
• Stomach pain, diarrhea, nausea, indigestion

Diarrhea is the most common problem and is sometimes severe. If you take Artrotec with food, you are less
likely to get diarrhea. If you use an antacid (a substance to reduce stomach acid), you should
avoid antacids containing magnesium, as these can worsen diarrhea. Your pharmacist can
help you choose a suitable antacid. If diarrhea persists and is severe, tell your doctor.

• Common: may affect up to 1 in 10 people
• Rash, itching
• Vomiting, burping, constipation, eructation, gastritis (indigestion, stomach pain, vomiting)
• Ulcers in the stomach or intestines
• Headache, dizziness
• Difficulty falling asleep
• Changes in blood tests regarding the liver
• Inflammation of the digestive tract, including the intestines, such as nausea, diarrhea, abdominal pain
• Abnormal fetal formation
• Uncommon: may affect up to 1 in 100 people
• Swelling of the mouth
• Fluid retention in the body, which can cause swollen legs and ankles
• Abnormal or unexpected vaginal bleeding, menstrual disorders
• Decreased number of platelets in the blood (increased risk of bleeding or bruising)
• Purpura (purple spots on the skin)
• Urticaria (itchy rash)
• Vaginal infection (itching, burning, redness, pain, especially during intercourse or when urinating)
• Blurred vision
• High blood pressure
• Loss of appetite
• Menstrual disorders, such as generally heavy or light bleeding or a delayed menstrual cycle
• Chills or fever
• Tremor, drowsiness, fatigue
• Tinnitus (ringing in the ears)
• Depression and anxiety
• Tingling or pins and needles
• Mouth ulcers and dry mouth
• Rare: may affect up to 1 in 1,000 people
• Inflammation of the liver (possible yellowing of the skin, headache, fever, chills, general weakness)
• Inflammation of the pancreas, causing severe pain in the abdomen and back
• Lung inflammation such as cough, increased sputum
• Breast pain
• Vomiting blood
• Worsening of ulcerative colitis (inflammation of the lower intestine)
• Damage to the esophagus
• Swollen 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:the frequency cannot be estimated from the available data
• Worsening of Crohn's disease (inflammation of the intestine)
• Kidney problems
• Convulsions
• Inflammation of blood vessels (which can cause fever, pain, purple spots)
• Psychotic disorder (mental disorder characterized by loss of contact with reality)
• Changes in mood, irritability, memory problems, feeling confused
• Difficulty with vision, changes in taste
• Inflammation
• Abnormal uterine contractions, rupture of the uterus, retention of the placenta after delivery, a life-threatening reaction for the mother due to the passage of amniotic fluid (the fluid covering the fetus) or other fetal material into the maternal bloodstream, uterine bleeding, abortion, neonatal death, premature delivery
• Anemia (low number of red blood cells) which can cause pale skin and cause weakness or shortness of breath
• Menstrual pain/uterine cramps
• Reduced fertility in women

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 through the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Artrotec

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25 °C. Store in the original packaging.
Do not use this medicine after the expiry date which is stated on the blister and on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Artrotec contains
The active ingredients are diclofenac sodium and misoprostol.
Each tablet contains 75 mg of diclofenac sodium and 0.2 mg of misoprostol.
The excipients are:
Lactose monohydrate, microcrystalline cellulose, corn starch, povidone K-30, magnesium stearate,
methacrylic acid copolymer type C, sodium hydroxide, talc, triethyl citrate, hypromellose, crospovidone,
anhydrous colloidal silica and hydrogenated castor oil.

Description of the appearance of Artrotec and contents of the pack
Artrotec is available in the form of round, white, biconvex tablets, marked on one side
“SEARLE” and “1421”, and on the other “75” with four “A” around it.
The tablets are packaged in blisters contained in cartons of 10, 20, 30, 60, 90, 100 and 140
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo, 71 – 04100 Latina

Manufacturer:
Piramal Healthcare UK Limited
Morpeth
Northumberland
NE61 3YA
United Kingdom
Piramal Pharma Solutions (Dutch) B.V.
Level, 7th floor
Bargelaan 200
2333 CW
Leiden
Netherlands

Artrotec 50 mg + 200 mcg tablets

Diclofenac/misoprostol

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Artrotec is and what it is used for
• 2. What you need to know before you take Artrotec
• 3. How to take Artrotec
• 4. Possible side effects
• 5. How to store Artrotec
• 6. Contents of the pack and other information

1. What is Artrotec and what is it used for

Artrotec contains the active ingredients diclofenac and misoprostol. Diclofenac belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and works by reducing inflammation
and pain. Misoprostolo is a substance similar to prostaglandins (produced naturally within the
body) that protects the wall of the stomach and intestines from possible problems caused by
diclofenac.
Artrotec is used in the treatment of:

• rheumatoid arthritisand osteoarthritis(chronic inflammatory rheumatic diseases of the joints);
• ankylosing spondylitis(rheumatism of the spine);
• inflammationsof non-rheumatic origin or resulting from trauma.

Artrotec is indicated in patients with problems with the stomach or intestines (e.g. gastritis with erosions
of the inner wall of the stomach, previous episodes of lesion (ulcer) of the stomach or intestines,
of bleeding of the esophagus, stomach and/or the first part of the intestine (small intestine), previous
problems with the stomach due to the use of this type of medicine (NSAIDs)), in whom it is considered
essential to use non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac.

2. Cosa deve sapere prima di prendere Artrotec

Non prenda Artrotec

• pensa di essere allergico a diclofenac sodio, ad aspirina (acido acetilsalicilico), a ibuprofene o a qualsiasi altro FANS, a misoprostolo o un altro medicinale a base di prostaglandine, o uno

qualsiasi degli eccipienti di Artrotec (vedere paragrafo 6). Signs of a reaction of
hypersensitivity include skin rash, swelling or itching of the skin, swelling of the
face and mouth (angioedema), severe nasal congestion, asthma (breathing problems), chest
pain, wheezing or any other allergic-type reaction;

• se ha avuto in passato episodi di bleeding or perforation of the stomach or intestine, caused by previous treatments with NSAIDs or if you have suffered in the past from recurrent episodes of bleeding or lesions of the wall of the stomach or intestine (peptic ulcer) (i.e. if you have suffered from two or more distinct episodes of ulceration or bleeding confirmed by a doctor);
• se ha una malattia cardiaca, ossia se il suo cuore non è in grado di pompare una quantità adeguata di sangue all’organismo (congestive heart failure) oppure se soffre di obstructions of the blood vessels leading to the heart or has had a heart attack (ischemic heart disease) and/or suffers from problems with blood circulation in the brain or has had a stroke (cerebrovascular disease);
• se soffre di problemi di circolazione del sangue nell’organismo (peripheral arterial disease);
• se è o pensa di essere in gravidanza;
• se è una donna in età fertile e non sta usando un metodo contraccettivo efficace per evitare la gravidanza (vedere paragrafo “Gravidanza” per ulteriori informazioni); se sta allattando al seno.

Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di prendere Artrotec se una delle seguenti condizioni la
riguarda:

• soffre di infiammazione cronica all’intestino(ulcerative colitis or Crohn's disease);
• ha problemi al cuoreo ritiene di essere a rischio di tali condizioni (ad es. ha la pressione alta, colesterolo e/o trigliceridi elevati, diabete, blood clots in the blood vessels (thrombi) that can cause myocardial infarction or stroke, suffers from chest pain (angina) or smokes). If you have high blood pressure, your doctor will carefully monitor your blood pressure during the entire duration of treatment; è facilmente soggetto a episodi di sanguinamentoo alla formazione di lividi;
• ha problemi al fegatoo ai reni. Se i problemi al fegato o ai reni peggiorano, interrompail trattamento con questo medicinale;
• è incinta o ha intenzione di avere un bambino (vedere paragrafo “Gravidanza”). The treatment with Artrotec must be interrupted immediately due to the risk to the fetus;
• è una donna in età fertile (vedere anche paragrafo sulla “Gravidanza”). It is important to use effective contraceptive measures while taking this medicine;
• se di recente è stato sottoposto o è in procinto di sottoporsi a un intervento chirurgico allo stomaco o al tratto intestinale prima di ricevere/assumere/utilizzare Artrotec, in quanto Artrotec può talvolta peggiorare la guarigione della ferita nell’intestino a seguito di un intervento chirurgico.

Artrotec può causare:

• sanguinamento,lesioni ( ulcere) o perforazioniallo stomaco e/o all’intestino, anche in assenza di sintomi di preavviso o di precedenti problemi gravi allo stomaco o all’intestino, e che possono essere pericolosi per la vita. In questo caso si rivolga al medico e interrompail trattamento. Se lei ha già sofferto in passato di questi problemi o soffre di problemi cardiovascolari, se lei sta assumendo aspirina, corticosteroids, medicines that counteract blood clotting (anticoagulants), medicines against anxiety and depression (called selective serotonin reuptake inhibitors) (vedere “Altri medicinali e Artrotec”), se ha più di 65 anni o se assume alcol, lei ha un maggiore rischio di manifestare questi effetti indesiderati. If you are over 65 years old (are elderly) or have had gastrointestinal ulcers in the past (see “Do not take Artrotec”), your doctor will tell you to start treatment with the lowest available dose;
• modesto aumento del rischio di attacco cardiaco(myocardial infarction) o ictus. These events are serious and can sometimes be fatal. The risk increases with high doses and prolonged treatments. Do not ever exceed the recommended dose or duration of treatment;
• aumento della pressione del sanguee pertanto il medico può chiederle di controllare la pressione sanguigna regolarmente;
• ritenzione di liquidinell’organismo e gonfiore, soprattutto delle gambe e dei piedi;
• gravi reazionia livello della pelle, a volte fatali, caratterizzate da blisters, lesions and peeling of the skin (such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). Interruptimmediately the treatment with this medicine if you develop skin rash, lesions or any other skin problem.

Se ha problemi al cuore, al fegato, ai reni o se ha più di 65 anni, il medico la sottoporrà a controlli
periodici della funzione renale e le prescriverà la minor dose possibile (vedere paragrafo 3 “ Come
prendere Artrotec”).
Se lei sta effettuando un trattamento di lunga durata, il medico la sottoporrà a controlli periodici (ad
esempio della funzione renale, epatica e ad esami del sangue).
Gli effetti indesiderati causati da Artrotec possono essere ridotti al minimo usando la dose efficace più bassa
per il più breve periodo di tempo necessario.

Bambini
La sicurezza e l’efficacia di questo medicinale non sono state stabilite nei bambini.

Anziani
Se lei ha più di 65 anni avrà una maggiore probabilità di manifestare effetti indesiderati durante il trattamento
con Artrotec, in particolare sanguinamenti e perforazioni dello stomaco e/o dell’intestino, che possono essere
fatali (vedere paragrafo 3 “Come prendere Artrotec”). Il medico le prescriverà la dose più bassa possibile e
la controllerà regolarmente durante il trattamento.

Altri medicinali e Artrotec
Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere
qualsiasi altro medicinale.
I seguenti medicinali possono influenzare l’efficacia e/o la tossicità di Artrotec oppure Artrotec può
influenzare l’efficacia e/o la tossicità dei seguenti medicinali:

• corticosteroidi, medicinali usati contro le infiammazioni;
• acido acetilsalicilico(aspirina);
• altri farmaci antinfiammatori non steroidei ( FANS) inclusi gli inibitori selettivi della COX-2;
• anticoagulanti orali(es. warfarin, apixaban, dabigatran e rivaroxaban), medicinali che riducono la coagulazione del sangue;
• agenti antiaggraganti, medicinali usati per ridurre/inibire l’aggregazione delle piastrine;
• inibitori selettivi del reuptake della serotonina(SSRIs), medicinali usati per il trattamento dell’ansia e della depressione;
• diuretici, medicinali usati per aumentare la produzione di urina;
• ACE-inibitori, antagonisti dell’angiotensina IIe beta-bloccanti, medicinali usati per abbassare la pressione del sangue. The doctor will carefully assess whether to prescribe these medicines together with Artrotec, especially if you are an elderly patient or have kidney problems;
• ciclosporinao tacrolimus, medicinali usati per ridurre l’attività del sistema immunitario, ad esempio dopo il trapianto di un organo. If it is necessary for you to take these medicines simultaneously with Artrotec, the doctor will carefully monitor your kidney function. If taking Artrotec and cyclosporine at the same time, the doctor may decide to prescribe the lowest dose of Artrotec;
• digossina,medicinale usato per il battito cardiaco irregolare e/o insufficienza cardiaca;
• ipoglicemizzanti orali, medicinali usati per abbassare i livelli di zuccheri nel sangue;
• litio, medicinale usato per trattare alcuni tipi di depressione;
• metotressato, medicinale usato per trattare l’artrite reumatoide, la psoriasi e la leucemia;
• voriconazolo, sulfinpirazone, o altri medicinali che riducono il metabolismo del diclofenac (principio attivo di Artrotec) nell’organismo, perché possono portare ad un aumento degli effetti del medicinale. The doctor will prescribe you the lowest recommended dose of Artrotec.

Gravidanza, allattamento e fertilità
Gravidanza
If you are pregnant, suspect you are pregnant or are planning a pregnancy, do not take Artrotec.
Do not take Artrotec if you are or think you may be pregnant (see paragraph 2 “Do not take Artrotec”), as it may endanger the pregnancy (increased risk of abortion), the development of the fetus (increased risk of birth defects) and your health (delay or prolongation of labor and increased risk of prolonged bleeding during childbirth). Due to the possible risk of harming the fetus, you must make sure you are not pregnant before starting treatment.
If you are a woman of childbearing potential, you must use effective contraceptive methods to avoid pregnancy during treatment with this medicine.
The doctor will inform you of the risks if you become pregnant while taking Artrotec, as it may cause a spontaneous abortion, premature delivery, abnormal fetal formation (birth defects). You must NEVER take this medicine if you are pregnant, as it can also have serious consequences for the baby, especially the heart, lungs and/or kidneys, including death. If you have received treatment with this medicine during pregnancy, consult your doctor. If you decide to continue the pregnancy, a careful ultrasound examination of the pregnancy must be performed, with particular attention to the limbs and head.
Breastfeeding
Do not take Artrotec if you are breastfeeding as the active ingredients contained in Artrotec pass into breast milk.
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you take Artrotec or other similar medicines (called non-steroidal anti-inflammatory drugs or NSAIDs) during the secondor third trimesterof pregnancy, kidney changes may occur in the fetus with a resulting even severe reduction in amniotic fluid (oligohydramnios).
If you use this medicine, you will be carefully monitored to check the volume of amniotic fluid.
Artrotec may cause infertilitythat is reversible. Do not take this medicine if you intend to become pregnant, if you have fertility problems or if you are undergoing fertility investigations.

Driving and using machines
It is not known whether Artrotec affects the ability to drive vehicles or use machines.

Artrotec contains lactose
Artrotec contains lactose, a type of sugar. If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Artrotec

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

Adults: the recommended dose is 1 tablet 2-3 times a day.
Artrotec tablets must be swallowed whole with a glass of water (do not chew) during
meals.

If you are over 65 years old (are elderly) or have kidney or liver problems:you do not need to take
a different dose than that recommended for an adult. However, your doctor may decide to start the
therapy with the lowest possible dose for you.
If you have severe kidney or liver problems, your doctor will monitor you carefully (see section Undesirable
Effects).

Use in children
The safety and efficacy of ARTROTEC in children have not been established.
Undesirable effects can be minimized if you take the lowest possible dose for the shortest
time possible with which you can control your symptoms (see “Precautions for use”).

If you take more Artrotec than you should
If you accidentally ingest/take an excessive dose of Artrotec, immediately notify your doctor or
go to the nearest hospital.
Symptoms may include drowsiness, tremor, convulsions, difficulty breathing, abdominal pain, diarrhea,
fever, palpitations, low blood pressure, slowed heart rate.

If you forget to take Artrotec
Do not take a double dose to make up for a missed dose.

If you stop taking Artrotec
Do not stop treatment with Artrotec unless your doctor tells you to.
If you have any doubts about 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.

Stop taking Artrotec and tell your doctor immediately if you experience:

• severe stomach pain or any sign of bleeding, injury (ulcer) or perforation of the stomach or intestine, such as black stools, blood in the stools or vomit. Perforation and gastrointestinal bleeding can sometimes be fatal, especially in the elderly (see “Warnings and precautions”);
• severe skin reaction such as rash, blisters, necrosis or peeling of the skin, lesions of the mucous membranes (DRESS syndrome, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, mucocutaneous reactions) - the frequency with which these events may occur is unknown;
• worsening of ulcerative colitis or Crohn's disease (inflammation of the intestine);
• severe allergic reaction such as rash, swelling of the face, wheezing or difficulty breathing (anaphylactic shock and angioedema);
• heart attack;
• kidney problems (renal failure or impairment, renal papillary necrosis, nephrotic syndrome, tubulo interstitial nephritis, membranous glomerulonephritis, minimal change glomerulopathy);
• stroke;
• jaundice (yellowing/yellowish discoloration of the skin and the white of the eye);
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome - the frequency with which this event may occur is unknown.

See your doctor if you experience the following side effects:

Very common(may affect more than 1 in 10 people):

• abdominal pain, diarrhea, nausea and indigestion. You can reduce the likelihood of experiencing diarrhea by taking Artrotec during meals and avoiding taking antacids (substances used to reduce stomach acidity) containing magnesium at the same time.

Common(may affect up to 1 in 10 people):

• difficulty falling asleep
• headache, dizziness
• inflammation of the duodenum (a portion of the intestine), gastritis, inflammation of the esophagus
• inflammation of the stomach and intestine
• vomiting, constipation, flatulence, belching
• rash, itching
• alteration of blood tests related to liver function
• reduction of hematocrit (blood test that determines the percentage of blood volume made up of red blood cells)
• Fetal malformation

Uncommon(may affect up to 1 in 100 people):

• inflammation of the vagina
• reduction in the number of platelets in the blood (thrombocytopenia)
• blurred vision
• heart failure
• high blood pressure
• difficulty breathing (dyspnea)
• mouth ulcers (stomatitis)
• urticaria, purpura (reddish-brown spots on the skin)
• very heavy menstrual periods (menorrhagia) or heavy bleeding between periods (metrorrhagia), vaginal bleeding (which can also occur after menopause), menstrual disorders
• fever
• swelling (edema)
• chills
• increased aspartate aminotransferase, a value in blood tests related to liver function

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

• nightmare
• inflammation of the pancreas (pancreatitis)
• inflammation of the liver (hepatitis)
• skin rashes characterized by the formation of blisters (bullous eruption)
• breast pain
• increased pain accompanying menstruation

Frequency not known(the frequency cannot be estimated from the available data):

• anemia
• reduction in the number of white blood cells
• inhibition of platelet aggregation with a consequent increase in the possibility of bleeding and its duration
• accumulation of fluid in the body, which can cause swelling of the ankles and legs
• mood alteration
• inflammation of the membranes lining the brain (aseptic meningitis)
• inflammation of blood vessels
• liver failure
• fetal death, a life-threatening reaction for the mother due to the passage of amniotic fluid (the fluid surrounding the fetus) or other fetal material into the maternal bloodstream (pregnancy-associated anaphylactoid syndrome), abortion, premature birth, abnormal uterine contractions, retention of the placenta or membranes
• uterine bleeding, uterine cramps
• infertility or reduced fertility in women
• rupture/perforation of the uterus

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Artrotec

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25 °C.
Store in the original package to protect the medicine from moisture.
Do not use this medicine after the expiry date which is stated on the box and blister after “Exp.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Artrotec contains
The active ingredients are diclofenac and misoprostol.
Each tablet contains 50 mg of diclofenac and 200 mcg of misoprostol.
The other ingredients are: lactose, microcrystalline cellulose, corn starch, polyvinylpyrrolidone K-30,
magnesium stearate, methacrylic acid copolymer C, sodium hydroxide, talc, triethyl citrate, methylhydroxypropyl
cellulose, insoluble polyvinylpyrrolidone, anhydrous colloidal silica and hydrogenated castor oil.

Description of the appearance of Artrotec and contents of the pack
Artrotec tablets are packaged in Al/PVC blisters contained in boxes of 10, 30 and 60
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina

Manufacturer
Piramal Healthcare UK Limited.
Whalton Road, Morpeth
Northumberland
United Kingdom
Piramal Pharma Solutions (Dutch) B.V.
Level, 7th floor
Bargelaan 200
2333 CW
Leiden
Netherlands