DICLOFENAC 75 mg Extended-Release Tablets

Зміст інструкції

1. Diclofenac Mylan 75 mg prolonged-release tablets
   1. What is Diclofenac Mylan 75 mg prolonged-release tablets and what are they for?
   2. How to take Diclofenac Mylan 75 mg prolonged-release tablets
   3. Possible side effects
   4. How to store Diclofenac Mylan 75 mg prolonged-release tablets
   5. Contents of the pack and other information

Diclofenac Mylan 75 mg prolonged-release tablets

diclofenac

Generic medicine

Read this leaflet carefully before taking this medicine because 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 Diclofenac Mylan 75 mg prolonged-release tablets are and what they are used for
• 2. What you need to know before you take Diclofenac Mylan 75 mg prolonged-release tablets
• 3. How to take Diclofenac Mylan 75 mg prolonged-release tablets
• 4. Possible side effects
• 5. How to store Diclofenac Mylan 75 mg prolonged-release tablets
• 6. Contents of the pack and other information

1. What is Diclofenac Mylan 75 mg prolonged-release tablets and what are they for?

Diclofenac Mylan 75 mg prolonged-release tabletsbelongs to a group of medicines
called non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation.
Diclofenac Mylan 75 mg prolonged-release tablets relieves the symptoms of inflammation, such as
pain and swelling. These symptoms are relieved by blocking the synthesis of molecules (prostaglandins)
responsible for inflammation, pain and fever. It does not act on the causes of inflammation or fever.
Diclofenac Mylan 75 mg prolonged-release tablets can be used in the following conditions:

• Inflammatory and degenerative forms of rheumatism: rheumatic joint pains (arthritis), back pain, “frozen shoulder”, “tennis elbow” and other forms of rheumatism
• Sprains, strains or other injuries
• Pain, inflammation and swelling after surgery
• Painful inflammatory gynecological conditions, including painful periods.

If you have any questions about how Diclofenac Mylan 75 mg prolonged-release tablets works
or why this medicine has been prescribed to you, ask your doctor.
Diclofenac Mylan 75 mg prolonged-release tablets can also be used to treat other
illnesses if established by your doctor.

Monitoring during treatment with Diclofenac Mylan 75 mg prolonged-release tablets
If you suffer from a confirmed heart condition or are at significant risk of cardiovascular disease, your
doctor will periodically reassess whether you should continue treatment with Diclofenac Mylan,
especially if you have been treated for more than 4 weeks.
If you suffer from liver failure, kidney failure or an alteration in the production of blood cells, you will need to undergo blood tests during treatment. These tests will monitor the
liver function (transaminase levels), as well as kidney function (creatinine levels) or
blood count (white blood cells, red blood cells and platelet levels). The doctor will consider the
results of these blood tests and decide whether to stop treatment with Diclofenac Mylan 75
mg prolonged-release tablets or to modify the dose.

• 2.What you need to know before you take Diclofenac Mylan 75 mg prolonged-release tablets

Follow all instructions given to you by your doctor carefully. These instructions may differ from
Do not take Diclofenac Mylan 75 mg prolonged-release tablets:

• if you are allergic to diclofenac sodium or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from gastric or intestinal ulcer.
• if you suffer from cerebrovascular hemorrhage or another active bleeding, alteration in the production of blood cells or blood coagulation disorders, you should not take non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. acetylsalicylic acid, ibuprofen and diclofenac).
• if you have ever had an allergic reaction after taking medicines to treat inflammation or pain (e.g. diclofenac, acetylsalicylic acid or ibuprofen). Allergic reactions can include: asthma, chest pain, runny nose, rash, swelling of the face. If you think you are allergic, talk to your doctor.
• if you suffer from bleeding or perforation of the gastrointestinal tract, the symptoms of which may include blood in the stool or black stools.
• if you suffer from severe kidney or liver disease.
• if you suffer from severe heart failure.
• if you have a confirmed heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA) or an obstruction of the blood vessels leading to the heart or brain, or surgery to eliminate or prevent such obstructions.
• if you suffer from or have suffered from problems with blood circulation (peripheral arterial disease).
• if you are in the last trimester of pregnancy.

If any of these conditions apply to you, consult your doctor and do not take Diclofenac
Mylan 75 mg prolonged-release tablets.
If you think you are allergic, contact your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Diclofenac Mylan 75 mg prolonged-release
tablets:

• if you are taking Diclofenac Mylan 75 mg prolonged-release tablets: simultaneously with other anti-inflammatory medicines, including acetylsalicylic acid, corticosteroids, antithrombotic agents or SSRIs (see “Other medicines and Diclofenac Mylan 75 mg prolonged-release tablets”).
• if you have ever had gastrointestinal problems, such as stomach ulcers, bleeding or black stools, or have had stomach upset or heartburn after taking anti-inflammatory medicines in the past.
• if you have asthma or hay fever (seasonal allergic rhinitis).
• if you have inflammation of the colon (ulcerative colitis) or the intestinal tract (Crohn's disease).
• if you have heart or high blood pressure problems.
• if you have kidney or liver problems.
• if you may be dehydrated (e.g. following illness, diarrhea, before or after major surgery).
• if you have swollen feet without any associated traumatic cause.
• if you have blood coagulation disorders or other blood disorders, including a rare liver condition known as hepatic porphyria.
• if you have lupus erythematosus or other mixed connective tissue diseases.
• if you have recently had or are about to undergo surgery on the stomach or intestinal tract, as Diclofenac Mylan can sometimes worsen wound healing in the intestine after surgery.

If any of these conditions apply to you, talk to your doctor before starting to
take Diclofenac Mylan 75 mg prolonged-release tablets:

• Diclofenac Mylan 75 mg prolonged-release tablets: can reduce the symptoms of an infection (e.g. headache, fever). This can make the infection more difficult to detect and be adequately treated. If you are not feeling well and need to consult a doctor, remember to tell them that you are taking Diclofenac Mylan 75 mg prolonged-release tablets.

In very rare cases, Diclofenac Mylan 75 mg prolonged-release tablets, like other anti-inflammatory
medicines, can cause serious skin allergic reactions (e.g. skin rash). Immediately inform your doctor if
one of these reactions occurs.
Medicines such as Diclofenac Mylan 75 mg prolonged-release tablets may be associated with a
slight increase in the risk of heart attack (myocardial infarction) or stroke
(CVA). The risk is higher with high doses and for prolonged treatments. Do not exceed the recommended dose or duration
of treatment.
If you have heart problems or have had a previous stroke or think you may be at
risk of these conditions (e.g. if you suffer from high blood pressure, diabetes, high cholesterol
levels or are a smoker), you should discuss the treatment with your doctor or pharmacist.
If at any time during the taking of Diclofenac Mylan you experience signs or symptoms of
heart problems, such as chest pain, shortness of breath or difficulty speaking, contact your doctor immediately.
Before taking diclofenac, make sure your doctor is aware of:

• if you smoke.
• if you suffer from diabetes.
• if you suffer from angina, blood clots, high blood pressure, high levels of cholesterol or triglycerides.

Side effects can be minimized by using the lowest effective dose for the shortest
duration necessary.

Children and adolescents
The use of Diclofenac Mylan 75 mg prolonged-release tablets is not recommended in children and
adolescents under the age of 14 years.

Elderly
Elderly patients may be more sensitive to the effects of Diclofenac Mylan 75 mg prolonged-release
tablets than other adults. Therefore, they should carefully follow their doctor's advice and take the minimum number of prolonged-release tablets needed to get relief
from symptoms. It is particularly important that elderly patients promptly report side effects to their treating physician.

Liver and kidney failure
Caution is required when an NSAID is administered to patients with renal and
hepatic insufficiency. In patients with mild to moderate renal and hepatic dysfunction, the initial dose should be
reduced. Diclofenac should not be administered to patients with severe hepatic and/or renal insufficiency.

Other medicines and Diclofenac Mylan 75 mg prolonged-release tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
It is particularly important to inform your doctor if you are taking any of the following medicines:

• lithium inhibitors or selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat some types of depression);
• digoxin (a medicine used for heart problems);
• diuretics (medicines used to increase the amount of urine);
• ACE inhibitors or beta-blockers (classes of drugs used to treat high blood pressure);
• other anti-inflammatory medicines, such as acetylsalicylic acid or ibuprofen;
• corticosteroids (medicines used to relieve pain in inflamed areas of the body);
• anticoagulants (medicines used to prevent blood clotting);
• medicines used to treat diabetes, except insulin;
• methotrexate (a medicine used to treat some types of cancer or arthritis);
• cyclosporine and tacrolimus (medicines mainly used in patients undergoing organ transplantation);
• trimethoprim (a medicine used to prevent or treat urinary tract infections);
• quinolone antibacterial agents (medicines used to treat infections);
• probenecid;
• voriconazole (a medicine used to treat fungal infections);
• phenytoin (a medicine used to treat seizures).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with milk
mother, ask your doctor or pharmacist before taking this medicine.
Do not take Diclofenac Mylan 75 mg prolonged-release tablets in the last 3 months of pregnancy,
as it may harm the fetus or cause problems during childbirth. It may cause problems with the fetus's kidneys and
heart. It may affect the tendency of the mother and child to bleed and delay or prolong labor longer than expected. You should not take Diclofenac Mylan 75 mg prolonged-release tablets in the first 6 months of pregnancy unless absolutely necessary and under medical advice.
If treatment is needed during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. If taken for more than a few
days from the 20th week of pregnancy onwards, Diclofenac Mylan 75 mg prolonged-release tablets
may cause kidney problems in the fetus, reducing the levels of amniotic fluid surrounding the baby
(oligohydramnios) or causing constriction of a blood vessel (ductus arteriosus) in the baby's heart.
If treatment is needed for more than a few days, your doctor may advise you to have additional monitoring.
Diclofenac Mylan 75 mg prolonged-release tablets may make it more difficult to conceive.
You should not take Diclofenac Mylan 75 mg prolonged-release tablets unless you are
absolutely necessary if you plan to conceive or if you have difficulty conceiving.
You should also inform your doctor if you are breastfeeding.
You should not breastfeed if you are taking Diclofenac Mylan 75 mg prolonged-release tablets,
as it may be harmful to the infant.
Ask your doctor or pharmacist before taking any medicine. The doctor will discuss
with you the potential risk of taking diclofenac during pregnancy or breastfeeding.

Driving and using machines
Diclofenac Mylan 75 mg prolonged-release tablets is unlikely to affect the ability to
drive vehicles, use machines or perform other activities that require special attention.

Diclofenac Mylan 75 mg prolonged-release tablets contains sucrose
This medicine contains sucrose. If you have been diagnosed with an intolerance to
certain sugars, contact your doctor before taking this medicine.

3. How to take Diclofenac Mylan 75 mg prolonged-release tablets

Take this medicine following the instructions of your doctor or pharmacist exactly.
Do not exceed the recommended dose and duration of treatment. If you have any doubts, consult your doctor or
pharmacist.

When and how much Diclofenac Mylan 75 mg prolonged-release tablets to take
Do not exceed the recommended dose. It is important to take the lowest effective dose of Diclofenac
Mylan 75 mg prolonged-release tablets that relieves pain and for the shortest possible time.
Undesirable effects can be minimized by administering the minimum effective dose for the
minimum duration necessary to control the symptoms.
The doctor will tell you exactly how many Diclofenac Mylan 75 mg prolonged-release tablets to take.
Based on your response to treatment, the doctor may recommend a lower or higher dose.
The tablets must be swallowed whole with some liquid, preferably during meals and should not
be divided or chewed.
Adults
At the beginning of treatment, the daily dose of diclofenac sodium is generally between 100 mg
and 150 mg. In milder cases, such as for long-term therapy, a daily dose of 75 to 100 mg is generally sufficient. Diclofenac Mylan 75 mg prolonged-release tablets are
administered once or twice a day. Do not exceed the maximum daily dose of 150 mg.

If you take more Diclofenac Mylan 75 mg prolonged-release tablets than you should
If you accidentally take more Diclofenac Mylan 75 mg prolonged-release tabletsthan
you should, inform your doctor or go immediately to the hospital emergency room. You may
need medical attention.

If you forget to take Diclofenac Mylan 75 mg prolonged-release tablets
If you forget to take a tablet, take it as soon as possible. If it is almost time for the next dose,
simply continue with your usual dosing schedule. Do not take a double dose to make up for a missed tablet.
If you have any questions 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.
Medicines such as Diclofenac Mylan 75 mg prolonged-release tabletsmay be associated
with a slight increase in the risk of heart attacks (myocardial infarction) or stroke.

Some rare or very rare side effects may be serious:
These side effects may affect less than 1 in 10,000 patients

• Spontaneous bleeding or bruising (signs of thrombocytopenia)
• High fever, frequent infections, persistent sore throat (signs of agranulocytosis)
• Difficulty breathing or swallowing, skin rash, itching, dizziness (signs of hypersensitivity, anaphylactic and anaphylactoid reactions)
• Swelling mainly of the face and throat (signs of angioedema)
• Mood disorders (signs of psychotic disorders)
• Memory impairment (signs of memory impairment)
• Convulsions
• Anxiety
• Stiff neck, fever, nausea, vomiting, headache (signs of aseptic meningitis)
• Sudden, severe headache, nausea, dizziness, numbness, inability or difficulty speaking, weakness or paralysis of the limbs or face (signs of cerebrovascular accident or stroke)
• Worsening of hearing (signs of hearing impairment)
• Shortness of breath, difficulty breathing when lying down, swelling of the feet and legs (signs of heart failure)
• Sudden, crushing chest pain (signs of myocardial infarction or heart attack)
• Headache, dizziness, signs of increased blood pressure (hypertension)
• Skin rash, reddish-purple spots, fever, itching (signs of vasculitis)
• Sudden difficulty breathing and a feeling of tightness in the chest with wheezing or coughing (signs of asthma or pneumonia, in the presence of fever)
• Vomiting blood (signs of hematemesis) and/or black stools or blood in the stools (signs of gastrointestinal bleeding)
• Diarrhea accompanied by bleeding (signs of hemorrhagic diarrhea)
• Black stools (signs of melena)
• Stomach pain, nausea (signs of gastrointestinal ulcer)
• Diarrhea, abdominal pain, fever, nausea, vomiting (signs of colitis, including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease)
• Serious problems with the stomach (signs of pancreatitis)
• Yellowing of the skin or eyes (signs of jaundice), nausea, loss of appetite, dark urine (signs of hepatitis/liver failure)
• Flu-like symptoms, fatigue, muscle aches, increased liver enzymes in blood tests (signs of liver disorders, including fulminant hepatitis, hepatic necrosis, liver failure)
• Blisters (signs of bullous dermatitis)
• Red or purple skin (possible signs of blood vessel inflammation), rash with blisters, blisters on lips, eyes and mouth, skin inflammation with scaling (signs of erythema multiforme or with the appearance of fever, Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Skin irritation with exfoliation (signs of exfoliative dermatitis)
• Increased sensitivity of the skin to the sun (signs of photosensitivity reaction)
• Purple spots on the skin (signs of purpura or Henoch-Schönlein purpura, if caused by an allergy)
• Swelling, feeling of decreased or abnormal urination (signs of acute renal failure)
• Excess protein in the urine, detected in test results (signs of proteinuria)
• Swollen face or abdomen, hypertension (signs of nephrotic syndrome)
• Increased or decreased urination (increased or decreased urine production), drowsiness, confusion, nausea (signs of tubulointerstitial nephritis)
• Severe reduction in urine production (signs of renal papillary necrosis)
• Generalized swelling (signs of edema).

If any of these symptoms occur, tell your doctor immediately.

Some side effects are common:
These side effects may affect less than 1 in 10 out of 100
Headache, dizziness, vertigo, nausea, vomiting, diarrhea, indigestion (signs of dyspepsia), abdominal
pain, flatulence, loss of appetite (signs of decreased appetite), abnormal results of liver function tests (e.g. transaminase level) and skin rash.

Some side effects are uncommon:
These side effects may affect between 1 and 10 patients per 1,000
Palpitations, chest pain, heart disorders, including heart attack or shortness of breath, difficulty
breathing when lying down or swelling of the feet and legs (signs of heart failure), especially if
a higher dose (150 mg per day) has been taken for a long period of time.

Some side effects are rare:
These side effects may affect between 1 and 10 patients per 10,000
Drowsiness, stomach pain (signs of gastritis), liver problems, itchy skin rash (signs
of urticaria).

Some side effects are very rare:
These side effects may affect less than 1 in 10,000
Decreased red blood cells in the blood (anemia), decreased white blood cells in the
blood (leukopenia), disorientation, depression, difficulty sleeping (signs of insomnia), nightmares,
irritability, psychotic disorders, tremor or tingling or burning sensation in the hands and feet (signs of
paresthesia), tremors, altered taste (signs of dysgeusia), visual disturbances (signs of
visual impairment, blurred vision, diplopia), perception of ringing in the ears (tinnitus),
constipation, mouth ulcers (signs of stomatitis), swollen, red and painful tongue (signs of glossitis),
problems with the esophagus (tube connecting the mouth to the stomach) (signs of esophageal disorder), cramps in the
upper part of the abdomen, especially after eating (signs of diaphragmatic intestinal disease), itching, itchy, red and burning rash (signs of eczema), redness of the
skin (signs of erythema), hair loss (signs of alopecia), itching (signs of pruritus), blood in the
urine (signs of hematuria).
Some side effects can be serious.
Stop taking Diclofenac Mylan 75 mg prolonged-release tablets and tell
your doctor immediately if you notice:

• Mild cramps and tenderness in the abdomen, which occur shortly after starting treatment with diclofenac, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at
https://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 Diclofenac Mylan 75 mg prolonged-release tablets

Store in the original package to protect the medicine from moisture. Keep this
medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package 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 eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Diclofenac Mylan 75 mg prolonged-release tablets contain
The active ingredient is diclofenac sodium. Each prolonged-release tablet contains 75 mg of
diclofenac sodium.
The other ingredients are sucrose, see paragraph 2 “Diclofenac Mylan 75 mg prolonged-release tablets contains sucrose”, povidone, cetyl alcohol, anhydrous colloidal silica, magnesium
stearate, hypromellose, titanium dioxide [E171], talc, polysorbate, red iron oxide [E172].

Description of the appearance of Diclofenac Mylan 75 mg prolonged-release tablets and contents
of the pack
Diclofenac Mylan 75 mg prolonged-release tablets are slightly curved triangular biconvex
tablets of pink color, smooth on both sides.
The prolonged-release tablets are packaged in PVC/PE/PVdC aluminum blisters in an
outer pack containing 10, 30 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan Spa, via Vittor Pisani 20 – 20124 Milan, Italy

Manufacturer
Pharmadox Healthcare
KW20A, Paola
Malta
Micro Labs GmbH
Lyoner Strasse 14
Frankfurt am Main, Hessen, 60528
Germany