Package leaflet: Information for the patient

Diclofenac Mylan 75 mg prolonged-release tablets

diclofenac
Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Diclofenac Mylan 75 mg prolonged-release tablets are and what they are used for
What you need to know before taking Diclofenac Mylan 75 mg prolonged-release tablets
How to take Diclofenac Mylan 75 mg prolonged-release tablets
Possible side effects
How to store Diclofenac Mylan 75 mg prolonged-release tablets
Contents of the pack and other information

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

Diclofenac Mylan 75 mg prolonged-release tablets belong 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 relieve symptoms of inflammation, such as pain and swelling. These symptoms are alleviated by blocking the synthesis of molecules (prostaglandins) responsible for inflammation, pain, and fever. It does not act on the underlying causes of inflammation or fever.
Diclofenac Mylan 75 mg prolonged-release tablets may be used in the following conditions:

Inflammatory and degenerative forms of rheumatism: rheumatic joint pain (arthritis), back pain, "frozen shoulder", "tennis elbow", and other forms of rheumatism
Sprains, strains, or other injuries
Pain, inflammation, and swelling after surgical procedures
Painful gynecological inflammatory conditions, including painful menstruation.

If you have any questions about how Diclofenac Mylan 75 mg prolonged-release tablets work or why this medicine has been prescribed for you, ask your doctor.
Diclofenac Mylan 75 mg prolonged-release tablets may also be used to treat other conditions if determined by your doctor.
Monitoring during treatment with Diclofenac Mylan 75 mg prolonged-release tablets
If you suffer from established heart disease 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 on treatment for more than 4 weeks.
If you suffer from liver failure, kidney failure, or a blood cell production disorder, you will need to undergo blood tests during treatment. These tests will monitor liver function (transaminase levels), kidney function (creatinine levels), and blood count (white blood cells, red blood cells, and platelet levels). Your doctor will consider the results of these blood tests and decide whether to discontinue treatment with Diclofenac Mylan 75 mg prolonged-release tablets or adjust the dose.

What you need to know before taking Diclofenac Mylan 75 mg prolonged-release tablets

Carefully follow all instructions given to you by your doctor. These instructions may differ from the information contained in this leaflet.
Do not take Diclofenac Mylan 75 mg prolonged-release tablets:

if you are allergic to sodium diclofenac or any of the other ingredients of this medicine (listed in section 6).
if you have gastric or intestinal ulcer.
if you have cerebrovascular bleeding or any other active bleeding, blood cell production disorder, or blood clotting disorders, you must 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 used to treat inflammation or pain (e.g., diclofenac, acetylsalicylic acid, or ibuprofen). Allergic reactions may include: asthma, chest pain, runny nose, rash, facial swelling. If you think you are allergic, speak to your doctor.
if you have gastrointestinal bleeding or perforation, whose symptoms may include blood in stools or black stools.
if you have severe kidney or liver disease.
if you have severe heart failure.
if you have established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or an obstruction of blood vessels supplying the heart or brain, or an intervention to remove or prevent such obstructions.
if you suffer from or have suffered from circulatory problems (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 have ever developed severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking Diclofenac Mylan 75 mg prolonged-release tablets or other analgesics.
if you are taking Diclofenac Mylan 75 mg prolonged-release tablets: concurrently 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 ulcer, bleeding, or black stools, or have experienced stomach discomfort 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 of the intestinal tract (Crohn's disease).
if you have heart problems or high blood pressure.
if you have kidney or liver problems.
if you may be dehydrated (e.g., due to illness, diarrhea, before or after major surgery).
if you have swollen feet without any associated traumatic cause.
if you have blood clotting disorders or other blood disorders, including a rare liver condition known as hepatic porphyria.
if you have systemic lupus erythematosus or other connective tissue diseases.
if you have recently had or are about to undergo stomach or intestinal surgery, as Diclofenac Mylan may sometimes impair wound healing in the intestine after surgery.

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

Diclofenac Mylan 75 mg prolonged-release tablets may reduce symptoms of infection (e.g., headache, fever). This may make an infection harder to detect and properly treat. If you feel unwell and need to see a doctor, remember to inform 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, may cause severe skin allergic reactions (e.g., skin rashes). Inform your doctor immediately if any of these reactions occur.
Medicines such as Diclofenac Mylan 75 mg prolonged-release tablets may be associated with a slight increase in the risk of heart attacks (myocardial infarction) or stroke (CVA). The risk is higher with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems or have had a previous CVA, or think you may be at risk of these conditions (e.g., if you have high blood pressure, diabetes, high cholesterol levels, or are a smoker), you should discuss treatment with your doctor or pharmacist.
If at any time during treatment with 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, ensure your doctor is aware:

if you smoke.
if you have diabetes.
if you have angina, blood clots, high blood pressure, high cholesterol or triglyceride levels.

Side effects can be minimized by using the lowest effective dose for the shortest necessary duration.
Children and adolescents
The use of Diclofenac Mylan 75 mg prolonged-release tablets is not recommended in children and adolescents under 14 years of age.
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 necessary to relieve symptoms. It is particularly important that elderly patients promptly report any side effects to their doctor.
Liver and kidney impairment
Caution is required when administering an NSAID to patients with liver or kidney impairment. In patients with mild to moderate renal or hepatic dysfunction, the initial dose should be reduced. Diclofenac must not be administered to patients with severe hepatic and/or renal impairment.
Other medicines and Diclofenac Mylan 75 mg prolonged-release tablets
Inform 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 certain types of depression);
digoxin (a medicine used for heart problems);
diuretics (medicines used to increase urine output);
ACE inhibitors or beta-blockers (classes of medicines 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 certain types of cancer or arthritis);
cyclosporine and tacrolimus (medicines mainly used in organ transplant patients);
trimethoprim (a medicine used to prevent or treat urinary tract infections);
quinolone antibiotics (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, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Diclofenac Mylan 75 mg prolonged-release tablets during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect the tendency of both mother and baby to bleed and may delay or prolong labor beyond the expected time. You should not take Diclofenac Mylan 75 mg prolonged-release tablets during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from week 20 of pregnancy onwards, Diclofenac Mylan 75 mg prolonged-release tablets may cause kidney problems in the fetus, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend 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 absolutely necessary if you are planning to conceive or have difficulty conceiving.
You should also inform your doctor if you are breastfeeding.
Do not breastfeed while taking Diclofenac Mylan 75 mg prolonged-release tablets, as it may be harmful to the nursing infant.
Ask your doctor or pharmacist for advice before taking any medicine. Your doctor will discuss with you the potential risks of taking diclofenac during pregnancy or breastfeeding.
Driving and using machines
Diclofenac Mylan 75 mg prolonged-release tablets are unlikely to affect your ability to drive, operate machinery, or perform other activities requiring special attention.
Diclofenac Mylan 75 mg prolonged-release tablets contain sucrose
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

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

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

When and how much Diclofenac Mylan 75 mg prolonged-release tablet 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, for the shortest possible time.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Your doctor will tell you exactly how many Diclofenac Mylan 75 mg prolonged-release tablets to take.
Depending on your response to treatment, your doctor may recommend a lower or higher dose.
The tablets must be swallowed whole with some liquid, preferably with food, and must not be divided or chewed.

Adults
At the beginning of treatment, the daily dose of sodium diclofenac is generally between 100 mg and 150 mg. In milder cases, such as long-term therapy, a daily dose of 75 mg to 100 mg is generally sufficient. Diclofenac Mylan 75 mg prolonged-release tablets are administered once or twice daily. 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 tablets than you should, inform your doctor or go immediately to the hospital emergency department. You may require medical treatment.

If you forget to take Diclofenac Mylan 75 mg prolonged-release tablets
If you forget to take a dose, take it as soon as possible. If it is almost time for the next dose, simply continue with your regular dosing schedule. Do not take a double dose to make up for the missed dose.

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.
Medicines such as Diclofenac Mylan 75 mg prolonged-release tablets may be associated with a slight increase in the risk of heart attacks (myocardial infarction) or CVA.
Some rare or very rare side effects could be serious:
These side effects may affect fewer 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 disturbances (signs of psychiatric disorders)
Memory impairment (signs of memory impairment)
Seizures
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 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 feet and legs (signs of heart failure)
Sudden, severe chest pain (signs of myocardial infarction or heart attack)
Headache, dizziness, signs of increased blood pressure (hypertension)
Skin rash, red-purple spots, fever, itching (signs of vasculitis)
Sudden difficulty breathing and chest tightness with wheezing or coughing (signs of asthma or pneumonia, especially with fever)
Vomiting blood (signs of haematemesis) and/or black stools or blood in stools (signs of gastrointestinal bleeding)
Diarrhoea accompanied by bleeding (signs of haemorrhagic diarrhoea)
Black stools (signs of melaena)
Stomach ache, nausea (signs of gastrointestinal ulcer)
Diarrhoea, abdominal pain, fever, nausea, vomiting (signs of colitis, including haemorrhagic colitis, and exacerbation of ulcerative colitis or Crohn’s disease)
Serious stomach problems (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 pain, 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), skin rash with blisters, blisters on lips, eyes and mouth, skin inflammation with peeling (signs of erythema multiforme, or with fever, Stevens-Johnson syndrome or toxic epidermal necrolysis)
Skin irritation with peeling (signs of exfoliative dermatitis)
Increased sensitivity of the skin to sunlight (signs of photosensitivity reaction)
Purple spots on the skin (signs of purpura or Henoch-Schönlein purpura, if caused by allergy)
Swelling, sensation of reduced 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 (greater or lesser urine production), drowsiness, confusion, nausea (signs of tubulointerstitial nephritis)
Severe reduction in urine production (signs of renal papillary necrosis)
Generalised swelling (signs of oedema).

If any of these symptoms occur, inform your doctor immediately.
Some side effects are common:
These side effects may affect fewer than 1 in 10 patients out of every 100
Headache, dizziness, vertigo, nausea, vomiting, diarrhoea, indigestion (signs of dyspepsia), abdominal pain, flatulence, loss of appetite (signs of decreased appetite), abnormal results in liver function tests (e.g. transaminase levels), and skin erythema.
Some side effects are uncommon:
These side effects may affect between 1 and 10 patients out of every 1,000
Palpitations, chest pain, heart problems, including heart attack or shortness of breath, difficulty breathing when lying down or swelling of feet and legs (signs of heart failure), especially if a higher dose (150 mg daily) has been taken for a long period of time.
Some side effects are rare:
These side effects may affect between 1 and 10 patients out of every 10,000
Drowsiness, stomach ache (signs of gastritis), liver problems, itchy skin rash (signs of urticaria).
Some side effects are very rare:
These side effects may affect fewer than 1 in 10,000 patients
Decrease in red blood cells in the blood (anaemia), decrease in white blood cells in the blood (leucopenia), disorientation, depression, difficulty sleeping (signs of insomnia), nightmares, irritability, psychiatric disorders, tremor or tingling or burning sensation in hands and feet (signs of paraesthesia), tremors, altered taste (signs of dysgeusia), vision 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 oesophagus (the tube connecting mouth to stomach) (signs of oesophageal disorder), cramps in the upper abdomen, especially after eating (signs of diaphragm disease of the intestine), itching, red, burning, itchy skin 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 haematuria).
Some side effects are not known:
Frequency cannot be estimated from the available data.
Skin reactions that often occur in the same body area after repeated administrations of the medicine.
Some side effects with unknown frequency (frequency cannot be estimated from the available data):
A skin allergic reaction, which may include round or oval red patches with redness and swelling of the skin, skin rash with blisters, and itching (Drug-induced fixed eruption). Darkening of the skin in the affected areas may also occur, which could persist after healing. A drug-induced fixed eruption usually recurs at the same site (or sites) if the medicine is taken again.
Some side effects may be serious.
Stop taking Diclofenac Mylan 75 mg prolonged-release tablets and contact your doctor immediately if you notice:

Mild cramps and abdominal tenderness, occurring shortly after starting treatment with diclofenac, followed by rectal bleeding or bloody diarrhoea, 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.
A severe skin allergic reaction which may include extensive, widespread red and/or dark patches, swelling of the skin, blisters, and itching (Generalised bullous fixed drug eruption).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at the website
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

Keep in the original packaging to protect the medicine from moisture. Store this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Do not dispose of medicines via 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 Diclofenac Mylan 75 mg prolonged-release tablets contain
The active substance is sodium diclofenac. Each prolonged-release tablet contains 75 mg of
sodium diclofenac.
The other ingredients are sucrose, see section 2 “Diclofenac Mylan 75 mg prolonged-release tablets contain sucrose”, povidone, cetyl alcohol, anhydrous colloidal silica, magnesium stearate, hypromellose, titanium dioxide [E171], talc, polysorbate, iron oxide red [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, biconvex triangular tablets, pink in colour, smooth on both sides.
The prolonged-release tablets are packed in PVC/PE/PVdC aluminium blisters within an outer carton containing 10, 30 or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan S.p.A.
via Vittor Pisani, 20
20124 Milan
Italy
Manufacturer
Pharmadox Healthcare
KW20A, Paola
Malta
Micro Labs GmbH
Lyoner Strasse 20
Frankfurt am Main, Hessen, 60528
Germany