MISOFENAC 75 mg /200 Mcg Modified-Release Tablet

Зміст інструкції

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

Misofenac 75 modified-release tablets

diclofenac sodium, misoprostol

Read this leaflet carefully before you start taking the 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 Misofenac is and what it is used for
• 2. What you need to know before you take Misofenac
• 3. How to take Misofenac
• 4. Possible side effects
• 5. How to store Misofenac
• 6. Contents of the pack and other information

1. What is Misofenac and what is it used for

Misofenac is used for the symptomatic treatment of rheumatoid arthritisand osteoarthritis, and may
be useful to protect patients at risk of irritation or ulceration of the stomach or
intestines.
Misofenac 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. Misofenac
also contains misoprostol which is very similar to prostaglandins and can help to protect the
stomach.

2. What you need to know before taking Misofenac

Do not take Misofenac if:

• you think you are allergic to diclofenac sodium, to aspirin (acetylsalicylic acid), to ibuprofen or to any other NSAID, to misoprostol or another medicine containing prostaglandins, or to any of the excipients of Misofenac (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 disease and/or cerebrovascular disease for example if you have had a heart attack, a stroke or a mini-stroke (TIA) or blockages of blood vessels in 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 Misofenac.
• you are a woman of childbearing potential and are not using an effective method of contraception to avoid pregnancy (see section “Pregnancy” for further information).

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

• have other health problems such as liver or kidney disease. Do not takeMisofenac if you have severe kidney or liver failure
• have had a stomach or intestinal ulcer or bleeding in the past. Do not takeMisofenac 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 Misofenac may mask fever or other signs of infection
• are dehydrated
• are over 65 years of age, as your doctor will subject you to periodic checks
• are pregnant or intend to become pregnant (see section “Pregnancy”). Treatment with Misofenac 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 Misofenac, as Misofenac may sometimes worsen wound healing in the intestine following surgery.

NSAIDs such as Misofenac can cause bleeding or ulcers. In this case, treatment
must be stopped. The use of Misofenac 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, Misofenac may cause
serious side effects, especially complications in the stomach and intestines.
Make sure your doctor, before prescribing Misofenac, knows:

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

Medicines like Misofenac 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), Misofenac may 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 Misofenac
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 to suppress 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. Misofenac 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 Misofenac. 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 Misofenac.
Your doctor will inform you of the risks if you become pregnant while taking
Misofenac, as it may cause miscarriage, premature birth, abnormal fetal development (congenital 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 scan 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 Misofenac while breastfeeding.

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

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

3. How to take Misofenac

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
Take one tablet twice a day.
Misofenac 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: Misofenac is only for adults. It should not be used for children (under 18
years of age).

If you take more Misofenac 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 Misofenac
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 missed dose.

If you stop taking Misofenac
Do not stop taking Misofenac 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 everyone will experience them.
If you are concerned about side effects, ask your doctor. It is important that you know what can
occur, so that you can take action if Misofenac causes a side effect. Misofenac sometimes
causes side effects, but these usually disappear during treatment, as
the body gets used to the medicine.

If any of the following conditions occur, stop taking Misofenac 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
• Misofenac 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 intestine, such as black stools or blood in the stools - 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 of the skin (DRESS syndrome, Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis) - the frequency with which these events can occur is unknown
• develop 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 the white of the eye): this occurs rarely
• experience a decrease in the number of platelets in the blood (with 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 Misofenac with food, you are less
likely to experience diarrhea. If you use an antacid (a substance to reduce stomach acidity), 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, gas, constipation, eructation (burping), gastritis (indigestion, stomach pain, vomiting)
• Ulcers in the stomach or intestine
• Headache, dizziness
• Difficulty falling asleep
• Changes in blood tests regarding the liver
• Inflammation of the digestive tract, including the intestine, such as nausea, diarrhea, abdominal pain
• Fetal malformation
• 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 delay in the menstrual cycle
• Chills or fever
• Feeling of tremor, drowsiness, fatigue
• Tinnitus (ringing in the ears)
• Depression and anxiety
• Tingling or prickling (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 based on 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 of confusion
• Difficulty with vision, changes in taste
• Inflammation
• Abnormal uterine contractions, uterine rupture, 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 mother's 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 Misofenac

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.
Do not use this medicine after the expiry date which is reported 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 eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Misofenac 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 Misofenac and contents of the pack
Misofenac is available as 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

Misofenac 50 mg + 200 mcg tablets

Diclofenac/misoprostol

Read this leaflet carefully before 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 they have the same symptoms as you, 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 Misofenac is and what it is used for
• 2. What you need to know before you take Misofenac
• 3. How to take Misofenac
• 4. Possible side effects
• 5. How to store Misofenac
• 6. Contents of the pack and other information

1. What is Misofenac and what is it used for

Misofenac 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. Misoprostol is a substance similar to prostaglandins (produced
naturally within the body) that protects the lining of the stomach and intestines from
possible problems caused by diclofenac.
Misofenac is used in the treatment of:

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

Misofenac 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 intestine,
of bleeding of the esophagus, stomach and/or the first part of the intestine (small intestine),
previous stomach problems 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. What you need to know before taking Misofenac

Do not take Misofenac

• if you think you are allergic to diclofenac sodium, to aspirin (acetylsalicylic acid), to ibuprofen or to any other NSAID, to misoprostol or another medicine containing prostaglandins, or to any of the excipients of Misofenac (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;
• if you have had episodes of bleeding, or perforation of the stomach or intestine in the past, 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 two or more distinct episodes of ulceration or bleeding confirmed by a doctor);

• if you have heart disease, i.e. if your heart is unable to pump an adequate amount of blood to the body (congestive heart failure) or if you suffer from blockages of the blood vessels leading to the heart or have had a heart attack (ischemic heart disease) and/or suffer from problems with blood circulation in the brain or have had a stroke (cerebrovascular disease);
• if you suffer from problems with blood circulation in the body (peripheral arteriopathy);
• if you are or think you may be pregnant;
• if you are a woman of childbearing potential and are not using an effective contraceptive method to avoid pregnancy (see section “Pregnancy” for further information);
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Misofenac if any of the following conditions apply to you:

• if you suffer from chronic inflammation of the intestine(ulcerative colitis or Crohn's disease);
• if you have heart problemsor believe you are at risk of such conditions (e.g. you have high blood pressure, high cholesterol and/or triglycerides, diabetes, blood clots in blood vessels (thrombi) that can cause myocardial infarction or stroke, suffer from chest pain (angina) or smoke). If you suffer from high blood pressure, your doctor will carefully monitor your blood pressure during the entire duration of treatment; you are easily prone to episodes of bleedingor bruising;
• if you have liver problemsor kidney problems. If liver or kidney problems worsen, stoptreatment with this medicine;
• if you are pregnant or intend to become pregnant (see section “Pregnancy”). Treatment with Misofenac must be stopped immediately due to the risk to the fetus;
• if you are a woman of childbearing potential (see also section on “Pregnancy”). It is important to use effective contraceptive measures while taking this medicine;
• if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/taking/using Misofenac, as Misofenac may sometimes worsen wound healing in the intestine following surgery.

Misofenac may cause:

• bleeding,lesions (ulcers) or perforationsof the stomach and/or intestine, even without warning symptoms or previous serious problems with the stomach or intestine, and which can be life-threatening. In this case, consult your doctor and stoptreatment. If you have suffered from these problems in the past or suffer from cardiovascular problems, if you are taking aspirin, corticosteroids, medicines that counteract blood clotting (anticoagulants), medicines for anxiety and depression (called selective serotonin reuptake inhibitors) (see “Other medicines and Misofenac”), if you are over 65 years of age or if you drink alcohol, you have a greater risk of developing these side effects. If you are over 65 years of age (are elderly) or have had gastrointestinal ulcers in the past (see “Do not take Misofenac”), your doctor will tell you to start treatment with the lowest available dose;
• a modest increase in the risk of heart attack(myocardial infarction) or stroke. These events are serious and can sometimes be fatal. The risk increases with high doses and prolonged treatments. Never exceed the recommended dose or duration of treatment;
• increased blood pressureand therefore your doctor may ask you to check your blood pressure regularly;
• fluid retentionin the body and swelling, especially of the legs and feet;
• severe skin reactions, sometimes fatal, characterized by blisters, lesions and peeling of the skin (such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic

epidermal necrolysis). Stoptreatment with this medicine immediately if you develop a skin rash, lesions or any other skin problems.
If you have heart, liver, or kidney problems or if you are over 65 years of age, your doctor will subject you to periodic checks of kidney function and prescribe you the lowest possible dose (see section 3 “How to take Misofenac”).
If you are undergoing long-term treatment, your doctor will subject you to periodic checks (e.g. of kidney function, liver function and blood tests).
The side effects caused by Misofenac can be minimized by using the lowest effective dose for the shortest period of time necessary.

Children
The safety and efficacy of this medicine have not been established in children.

Elderly
If you are over 65 years of age, you are more likely to experience side effects during treatment with Misofenac, in particular bleeding and perforations of the stomach and/or intestine, which can be fatal (see section 3 “How to take Misofenac”). Your doctor will prescribe you the lowest possible dose and monitor you regularly during treatment.

Other medicines and Misofenac
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicines can affect the efficacy and/or toxicity of Misofenac or Misofenac can affect the efficacy and/or toxicity of the following medicines:

• corticosteroids, medicines used against inflammation;
• acetylsalicylic acid(aspirin);
• other non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 selective inhibitors;
• oral anticoagulants(e.g. warfarin, apixaban, dabigatran and rivaroxaban), medicines that reduce blood clotting;
• antiplatelet agents, medicines used to reduce/inhibit platelet aggregation;
• selective serotonin reuptake inhibitors(SSRIs), medicines used for the treatment of anxiety and depression;
• diuretics, medicines used to increase urine production;
• ACE inhibitors, angiotensin II antagonistsand beta-blockers, medicines used to lower blood pressure. The doctor will carefully assess whether to prescribe these medicines together with Misofenac, especially if you are an elderly patient or have kidney problems;
• cyclosporineor tacrolimus, medicines used to reduce the activity of the immune system, for example after an organ transplant. If it is necessary for you to take these medicines simultaneously with Misofenac, your doctor will carefully monitor your kidney function. If taking Misofenac and cyclosporine simultaneously, your doctor may decide to prescribe you the lowest dose of Misofenac;
• digoxin,a medicine used for irregular heartbeat and/or heart failure;
• oral hypoglycemic agents, medicines used to lower blood sugar levels;
• lithium, a medicine used to treat some types of depression;
• methotrexate, a medicine used to treat rheumatoid arthritis, psoriasis and leukemia;
• voriconazole, sulfinpyrazone, or other medicines that reduce the metabolism of diclofenac (the active ingredient of Misofenac) in the body, because they can lead to an increase in the effects of the medicine. Your doctor will prescribe you the lowest recommended dose of Misofenac.

Misofenac and alcohol
Do not drink alcohol during treatment with Misofenac, as it may increase the risk of developing serious problems with the stomach or intestine (see section “Warnings and precautions”).

Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, suspect you are pregnant or are planning a pregnancy, do not take Misofenac.
Do not take Misofenac if you are or think you may be pregnant (see section 2 “Do not take Misofenac”), 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 at delivery). Due to the possible risk of damaging the fetus, you must make sure you are not pregnant before starting treatment.
If you are a woman of childbearing potential, you should 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 Misofenac, as it may cause a spontaneous abortion, premature delivery, abnormal formation of the fetus (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 scan of the pregnancy should be performed, with particular attention to the limbs and head.
Breastfeeding
Do not take Misofenac if you are breastfeeding as the active ingredients contained in Misofenac pass into breast milk.
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you take Misofenac 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 (oligo-hydramnios).
If you are using this medicine, you should be carefully monitored to check the volume of amniotic fluid.
Misofenac may cause reversible infertility. 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 Misofenac affects the ability to drive vehicles or use machines.

Misofenac contains lactose
Misofenac 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 Misofenac

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.
Misofenac 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 the one recommended for an adult. However, your doctor may decide to
start 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 MISOFENAC 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 Misofenac than you should
If you accidentally ingest/take an excessive dose of Misofenac, immediately inform 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 heartbeat.

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

If you stop taking Misofenac
Do not stop treatment with Misofenac unless your doctor tells you to.
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 everybody gets them.

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

• severe stomach pain or any sign of bleeding, lesion (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, tubulointerstitial 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 digestive problems. You can reduce the likelihood of experiencing diarrhea by taking Misofenac 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 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 from 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
• fluid accumulation 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 mother's 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 Misofenac

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 “Scad.”. 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 Misofenac 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 Misofenac and contents of the pack
Misofenac 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