Diclofenac Mylan Generics

Package leaflet: Information for the patient

Diclofenac Mylan Generics 100 mg prolonged-release tablets

sodium diclofenac
Generic medicine
Read this entire 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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Diclofenac Mylan Generics is and what it is used for

Diclofenac Mylan Generics contains the active substance diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is indicated for the treatment of:

• inflammatory rheumatic diseases such as rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, and non-articular rheumatism;
• pain caused by inflammation of non-rheumatic origin or by trauma;
• menstrual pain.

2. What you need to know before taking Diclofenac Mylan Generics

Do not take Diclofenac Mylan Generics

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you have ever had an allergic reaction after taking medicines used to treat inflammation, pain or to reduce fever, such as acetylsalicylic acid (aspirin), diclofenac or ibuprofen. Reactions may include: asthma, runny nose, skin redness, swelling of the face, lips, tongue, throat and/or extremities (signs of angioedema);
• if you currently have bleeding or are prone to bleeding;
• if you have lesions (ulcers), bleeding or perforation in the stomach or intestine;
• if you have previously experienced bleeding or perforation in the stomach or intestine caused by treatment with NSAIDs, or if you have suffered from recurrent peptic haemorrhage/ulcer (two or more distinct episodes of proven ulceration or bleeding);
• if you have had liver problems;
• if you have severe liver problems (hepatic insufficiency);
• if you have severe kidney problems (renal insufficiency);
• if you have established heart disease and/or cerebrovascular disease, e.g. if you have had a heart attack, stroke, mini-stroke (TIA), or obstruction of blood vessels supplying the heart or brain, or a surgical procedure to remove or prevent such obstructions;
• if you have a disorder affecting blood cell production;
• if you suffer or have suffered from circulatory problems (peripheral arterial disease);
• if you are taking high doses of medicines that promote urine elimination (diuretics);
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
• if you are under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Diclofenac Mylan Generics.
Consult your doctor and take this medicine with caution in the following cases:

• if you are elderly or debilitated; in this case, the use of the lowest effective dose is recommended to avoid an increased frequency of adverse effects, especially stomach bleeding and perforation, which can be fatal;
• if you have stomach or intestinal problems such as lesions (ulcers), ulcerative colitis or Crohn’s disease; in these cases, accurate diagnosis and close medical supervision during treatment are necessary;
• if you have mild or moderate heart problems (congestive heart failure, high blood pressure - hypertension, ischaemic heart disease, circulatory problems), or are at high risk of developing them; in these cases, the use of the lowest effective dose for the shortest possible time is recommended;
• if you have liver function problems, or have a liver disease called hepatic porphyria; in these cases, accurate diagnosis and close medical supervision during treatment are necessary;
• if you develop signs and symptoms of liver problems (e.g. hepatic insufficiency, hepatitis) or other manifestations such as eosinophilia (a blood disorder) or skin irritation, your doctor may advise you to stop treatment;
• if you have kidney function problems (e.g. renal insufficiency), as the medicine may cause fluid retention and swelling due to fluid accumulation (oedema);
• if you are taking medicines that increase urine production (diuretics) or other medicines that may affect kidney function;
• if you have reduced body fluid volume (e.g. before or after major surgery);
• if you are undergoing or have recently undergone major surgery;
• if you suffer from asthma, seasonal allergic rhinitis, nasal mucosa swelling (nasal polyps), obstructive lung diseases or chronic respiratory tract infections, or other allergic reactions such as skin reactions, itching or urticaria. In these cases, breathing difficulties (bronchospasm) or even severe allergic reactions such as anaphylactic shock may occur;
• if you have ever developed severe skin rash or skin exfoliation, skin rash with blisters and/or mouth ulcers after taking Diclofenac Mylan Generics or other analgesics;
• if you have blood disorders; in this case, platelet aggregation should be carefully monitored, as there may be coagulation problems, especially with prolonged treatment.

Like other NSAIDs, diclofenac may mask signs and symptoms of infection.
Inform your doctor if, during treatment, you experience any of the following symptoms:

• bleeding in the stomach or intestine, or ulceration. In this case, stop treatment. Caution is advised in people taking other medicines that may increase the risk of ulceration or bleeding, such as acetylsalicylic acid, systemic corticosteroids, anticoagulants, antiplatelet agents, or selective serotonin reuptake inhibitors (see section “Other medicines and Diclofenac Mylan Generics”). In these cases, your doctor may also prescribe a medicine to protect your stomach;
• chest pain, shortness of breath, weakness, difficulty speaking (symptoms of a serious atherothrombotic event);
• if you develop severe skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis). These reactions usually occur within the first month of treatment. Stop treatment at the first sign of skin rash, mucosal lesions, or any other reaction;
• fluid retention and swelling due to fluid accumulation (oedema);
• any sign of allergic reaction;
• signs and symptoms of liver problems or if liver function tests are abnormal (as shown by blood tests).

In these cases, your doctor will assess whether to continue or discontinue treatment with Diclofenac Mylan Generics.
This medicine may increase the risk of heart attack or stroke, especially when high doses are used or treatment is prolonged. Do not exceed the recommended dose or duration of treatment.
Before taking diclofenac, ensure your doctor is aware:

• if you have heart problems, a history of stroke, or think you may be at risk for these conditions;
• if you smoke;
• if you have diabetes;
• if you suffer from chest pain due to heart problems (angina), blood clots, high blood pressure, high cholesterol or triglyceride levels.

Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/taking/using Diclofenac Mylan Generics, as Diclofenac Mylan Generics may sometimes impair wound healing in the intestine following surgery.
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.

Children and adolescents
Diclofenac Mylan Generics must not be used in children under 14 years of age due to lack of safety and efficacy data for this medicine.

Elderly patients
Elderly patients have a higher likelihood of experiencing adverse reactions, especially stomach or intestinal bleeding and perforation, which are generally more severe and may be fatal. If you are elderly, particularly if you are frail and underweight, your doctor will prescribe a low dose of Diclofenac Mylan Generics.
As a precaution, your doctor may perform kidney function tests and prescribe medicines that protect the gastrointestinal mucosa, such as misoprostol or proton pump inhibitors.
Inform your doctor of any unusual stomach or intestinal symptoms, especially at the beginning of treatment with this medicine.

Other medicines and Diclofenac Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diclofenac Mylan Generics may affect or be affected by other medicines containing the following active substances:

• lithium, a medicine used for psychiatric disorders;
• digoxin, a medicine used to treat heart conditions;
• phenytoin;
• medicines used to lower high blood pressure such as diuretics, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors or angiotensin II antagonists; other anti-inflammatory medicines, both NSAIDs and corticosteroids;
• anticoagulant and antiplatelet medicines used to improve blood circulation, such as warfarin;
• medicines used for depression, such as selective serotonin reuptake inhibitors (SSRIs);
• medicines used for diabetes;
• methotrexate, a medicine used for psoriasis, rheumatism and certain tumours;
• cyclosporine and tacrolimus, medicines used after organ transplants;
• trimethoprim, an antibiotic;
• quinolone antibiotics, used to treat infections;
• rifampicin (an antibiotic used to treat bacterial infections), as it may reduce diclofenac absorption;
• phenytoin, a medicine used for epilepsy;
• colestipol and cholestyramine, medicines used to reduce intestinal fat absorption. Your doctor will advise you on when to take these medicines; generally, diclofenac should be taken 1 hour before or 4–6 hours after colestipol and cholestyramine;
• sulfinpyrazone, voriconazole, or other medicines that inhibit diclofenac metabolism, as they may increase the medicine’s effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take Diclofenac Mylan Generics during the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the foetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labour more than expected. You should not take Diclofenac Mylan Generics 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. From week 20 of pregnancy, Diclofenac Mylan Generics may cause kidney problems in the foetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or constricting 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.

Breastfeeding
Do not take this medicine while breastfeeding, as diclofenac passes into breast milk.

Fertility
The use of diclofenac may affect female fertility and is not recommended in women wishing to conceive. Discontinue use of this medicine if you experience difficulty conceiving or are undergoing fertility investigations.

Driving and using machines
This medicine may cause visual disturbances, dizziness, vertigo or drowsiness. Avoid driving or operating machinery if you experience these symptoms.

Diclofenac Mylan Generics contains lactose
This medicine contains a sugar called lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Diclofenac Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the tablets whole with some liquid, preferably during meals.
Undesirable effects can be minimized by using the lowest effective dose for the
shortest duration necessary to control symptoms.

Use in adults
The recommended starting dose is 100–150 mg daily.
In milder cases, and for long-term treatment, usually 75–100 mg daily is sufficient.
The daily dose should be divided into 2–3 administrations.
If symptoms are more pronounced at night or in the morning, take the tablet preferably in the
evening.
To relieve nocturnal pain and morning stiffness, daytime treatment with tablets may
be supplemented with the administration of a suppository at bedtime (up to a maximum
daily dosage of 150 mg).

Treatment of menstrual pain: the recommended starting dose is 50–100 mg daily and may be
increased, as needed, up to a maximum of 150 mg daily. Begin treatment at the onset of the first
symptoms and continue, depending on symptom severity, for a few days.
The daily dose should be divided into 2–3 administrations.

Use in children and adolescents
Diclofenac Mylan Generics must not be used in children and adolescents under 14 years of age.

Use in the elderly
In treating elderly patients, the doctor will adjust the dosage according to the patient's condition.

Use in patients with heart failure
If you have mild or moderate heart problems or cardiovascular risk factors, your
doctor will carefully evaluate whether to initiate cardiovascular treatment.

Use in patients with renal or hepatic impairment
If you suffer from mild or moderate liver or kidney problems, your doctor will carefully evaluate the
treatment.

If you take more Diclofenac Mylan Generics than you should
Overdose may cause symptoms such as vomiting, gastrointestinal bleeding, diarrhoea,
dizziness, tinnitus, or seizures; in more severe cases, serious kidney and liver problems may occur.
In case of accidental ingestion or overdose of Diclofenac Mylan Generics, contact your doctor immediately or go to the nearest hospital emergency department. The doctor will treat acute poisoning from non-steroidal anti-inflammatory drugs, including diclofenac, based on the symptoms presented.

If you forget to take Diclofenac Mylan Generics
Do not take a double dose to make up for the missed dose.
If you have any questions 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.
Some side effects may be serious.
Stop taking Diclofenac Mylan Generics and consult your doctor immediately if you notice any of the following serious side effects. You may require urgent medical treatment:

• Mild cramps and abdominal pain, starting shortly after beginning treatment with Diclofenac Mylan Generics, followed by rectal bleeding or hemorrhagic diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated based on available data).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
• A severe skin allergic reaction that may include widespread red and/or dark patches, skin swelling, blisters, and itching sensation (fixed drug eruption with generalized bullous eruption).

The following side effects may occur:
Common (may affect up to 1 in 10 people)

• headache, dizziness;
• vertigo;
• nausea, vomiting, diarrhoea, indigestion, abdominal pain, flatulence, decreased appetite;
• liver function problems (increased transaminases);
• skin irritation (rash).

Uncommon (may affect up to 1 in 100 people)

• increased awareness of heartbeat, chest pain, reduced heart function (heart failure), heart attack.

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

• allergic reactions, including severe anaphylactic and anaphylactoid reactions (including low blood pressure and shock);
• drowsiness;
• asthma, difficulty breathing (dyspnoea);
• stomach problems such as gastritis, bleeding in the stomach and intestines, blood in vomit, blood in stools, stomach or intestinal ulcer (with or without bleeding or perforation);
• liver problems such as hepatitis and jaundice;
• skin irritation (urticaria);
• swelling due to fluid accumulation (oedema). If you experience any of these effects, inform your doctor immediately.

Very rare (may affect up to 1 in 10,000 people)

• decreased platelets in the blood (thrombocytopenia);
• decreased white blood cells (leucopenia, agranulocytosis);
• decreased red blood cells in the blood (anaemia, including haemolytic and aplastic anaemia);
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema);
• confusion, depression, insomnia, nightmares, irritability, severe mental disturbances (psychotic reactions);
• altered sensation in limbs (paraesthesiae), tremors;
• memory impairment, seizures, anxiety, inflammation of the brain (aseptic meningitis), altered taste, stroke;
• visual disturbances, blurred vision, double vision;
• ringing sensation in the ear (tinnitus) and worsening of hearing;
• increased blood pressure, inflammation of blood vessels (vasculitis);
• inflammation of the lung (pneumonitis);
• inflammation of the colon (colitis), including colitis with bleeding, worsening of ulcerative colitis or Crohn’s disease, constipation, intestinal obstruction, inflammation of the mouth (stomatitis), including stomatitis with ulcers, inflammation of the tongue (glossitis), oesophageal problems, narrowing of the intestine;
• inflammation of the pancreas (pancreatitis);
• severe liver problems (fulminant hepatitis, hepatic necrosis, liver failure);
• skin rash, blister formation on the skin, redness of the skin, severe skin condition that may affect areas around the mouth and other parts of the body (erythema multiforme), rare skin condition with blisters and bleeding of lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), severe skin disease (toxic epidermal necrolysis), skin peeling (exfoliative dermatitis);
• hair loss;
• increased sensitivity of the skin to sunlight, unusual bleeding and bruising under the skin (purpura), itching;
• kidney problems such as acute kidney failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis;
• presence of blood or protein in the urine (haematuria, proteinuria).

Side effects with unknown frequency

• Concurrent occurrence of chest pain and allergic reactions (signs of Kounis syndrome);
• A skin allergic reaction, which may include round or oval-shaped red and swollen skin patches, blistering rash, and itching sensation (fixed drug eruption). Darkening of the skin in affected areas may also occur, which could persist after healing. A fixed drug eruption usually recurs at the same site (or sites) if the medicine is taken again. Medicines such as Diclofenac Mylan Generics may be associated with a modestly increased risk of heart attack (myocardial infarction) or stroke (see section “Warnings and precautions” above).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Generics

Keep 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.
Store in the original packaging to protect the medicine from moisture.
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. Package contents and other information

What Diclofenac Mylan Generics 100 mg prolonged-release tablets contain:

• The active substance is sodium diclofenac. Each tablet contains 100 mg of sodium diclofenac.
• The other components are: hypromellose, microcrystalline cellulose, maize starch, lactose monohydrate, povidone, magnesium stearate, cellulose acetate phthalate, poloxamers, triethyl citrate, titanium dioxide (E171).

Description of the appearance of Diclofenac Mylan Generics and pack sizes
100 mg prolonged-release tablets: carton box containing 21 tablets.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano, 43 - 24041 Brembate (BG)