Diclofenac Doc Generici

Package leaflet: Information for the patient

DICLOFENAC DOC Generici 75 mg prolonged-release tablets, 100 mg prolonged-release tablets

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 they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DICLOFENAC DOC Generici is and what it is used for

DICLOFENAC DOC Generici contains the active substance sodium diclofenac, which belongs to the class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Sodium diclofenac is used to reduce pain and inflammation.
This medicine is indicated for the treatment of:

• joint diseases such as rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis;
• conditions characterized by pain and inflammation affecting the tissues surrounding the joints, such as tendons and ligaments (extra-articular rheumatism);
• pain caused by non-rheumatic inflammation or trauma;
• menstrual pain.

2. What you should know before taking DICLOFENAC DOC Generici

Do not take DICLOFENAC DOC Generici

• if you are allergic (hypersensitive) 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 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), chest pain. If you think you may be allergic, consult your doctor.
• if you have a stomach or intestinal ulcer, bleeding, or perforation;
• if you currently have bleeding or are prone to bleeding;
• if you have previously experienced bleeding (haemorrhage) or perforation of the stomach or intestine after previous treatment with NSAIDs;
• if you have had recurrent stomach or duodenal ulcer/bleeding (two or more distinct episodes of proven ulceration or bleeding);
• if you are in the last three months of pregnancy or if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
• if you have had liver problems;
• if you have severe liver problems (hepatic insufficiency);
• if you have severe kidney problems (renal insufficiency);
• if you suffer from heart disease (established cardiopathy) and/or cerebrovascular disease (e.g. you have had a heart attack, stroke, mini-stroke (TIA), or obstruction of blood vessels supplying the heart or brain, or a procedure to remove or prevent such obstructions);
• if you suffer from or have suffered from circulatory problems (peripheral arterial disease);
• if you are taking high doses of medicines that increase urine production (diuretics) (see section “Other medicines and DICLOFENAC DOC Generici”);
• if you have a disorder affecting blood cell production;
• if you are under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking DICLOFENAC DOC Generici.
Before taking DICLOFENAC DOC Generici, inform your doctor:

• if you have ever developed severe skin rash or skin exfoliation, skin rash with blisters and/or mouth ulcers after taking DICLOFENAC DOC Generici or other analgesics;
• if you smoke;
• if you have diabetes;
• if you suffer from angina, blood clots, high blood pressure, high cholesterol or high triglycerides;
• if you have asthma;
• if you have seasonal allergic rhinitis, nasal mucosa swelling (e.g. nasal polyps);
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections;
• if you have liver problems (e.g. hepatic insufficiency, hepatitis);
• if you have hepatic porphyria;
• if you have ulcerative colitis or Crohn’s disease, as these conditions may worsen;
• if you have kidney problems (e.g. renal insufficiency);
• 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 have blood clotting disorders (haemostasis defects);
• if you have or have had high blood pressure, heart or brain problems (e.g. congestive heart failure, established cardiopathy, peripheral arterial disease and/or stroke), or if you have or have had stomach or intestinal problems (e.g. ulcer), or if you have had stomach or intestinal ulcers, bleeding or perforation;
• if you are taking medicines that may increase the risk of bleeding, ulcers and perforation, such as acetylsalicylic acid (e.g. aspirin) or other NSAIDs, corticosteroids taken orally, by injection or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and DICLOFENAC DOC Generici”);
• if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/taking/using DICLOFENAC DOC Generici, as DICLOFENAC DOC Generici may sometimes impair wound healing in the intestine following surgery.

Inform your doctor if, during treatment with DICLOFENAC DOC Generici, you develop:

• skin reactions, even severe ones, because very rare serious skin reactions, which may even be fatal, have been reported (see section 4 “Possible side effects”);
• fluid retention and swelling due to fluid accumulation (oedema);
• any signs of allergic reaction;
• signs and symptoms of liver problems or if liver function tests are abnormal (as shown by blood tests);
• unusual stomach or intestinal symptoms, especially at the beginning of treatment with DICLOFENAC DOC Generici, as they may indicate gastrointestinal bleeding or ulceration;
• signs and symptoms typical of serious atherothrombotic events such as chest pain, shortness of breath, weakness, and difficulty speaking.

In these cases, your doctor will assess whether to continue or discontinue treatment with DICLOFENAC DOC Generici.
Additionally, take particular care:

• at any time during treatment with NSAIDs, including diclofenac, as gastrointestinal bleeding, ulceration or perforation may occur, which can be fatal. Your doctor will prescribe the lowest effective dose of diclofenac to reduce the risk of gastrointestinal toxicity and may also prescribe medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa;
• if you are elderly, particularly if you are frail and underweight, your doctor will prescribe a low dose of DICLOFENAC DOC Generici;
• avoid using diclofenac during treatment with other NSAIDs taken orally, by injection or rectally, including selective cyclooxygenase-2 inhibitors, as this increases the likelihood of adverse effects;
• DICLOFENAC DOC Generici may mask signs and symptoms of infection;
• medicines such as DICLOFENAC DOC Generici may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with higher doses or prolonged treatment.

Your doctor will monitor you closely and periodically reassess the need for treatment with DICLOFENAC DOC Generici. In addition, your doctor may perform periodic tests to evaluate your condition during treatment with DICLOFENAC DOC Generici.
Side effects can be minimized by using the lowest effective dose for the shortest necessary duration.

Children and adolescents
DICLOFENAC DOC Generici must not be used in children and adolescents under 14 years of age.

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 DOC Generici.
As a precaution, your doctor may monitor your kidney function 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 DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The blood concentration of the following medicines may increase when used together with DICLOFENAC DOC Generici:

• lithium;
• digoxin;
• methotrexate;
• phenytoin.

Your doctor will perform checks to monitor the blood levels of these medicines.

The effect of some medicines used to lower blood pressure, such as:

• medicines that increase urine production (diuretics);
• beta-blockers;
• angiotensin-converting enzyme inhibitors (ACE inhibitors)

may decrease when used together with DICLOFENAC DOC Generici.

Your doctor will monitor you and carefully evaluate the administration of these medicines together with DICLOFENAC DOC Generici, especially if you are elderly.
Take particular care and inform your doctor if you need to take DICLOFENAC DOC Generici and are already taking one or more of the following medicines. Your doctor will monitor you and perform tests.

• blood pressure-lowering medicines
  • ACE inhibitors and angiotensin II antagonists, if you have kidney problems
  • potassium-sparing diuretics (e.g. spironolactone)
• other anti-inflammatory medicines (non-steroidal anti-inflammatory drugs and corticosteroids)
• blood-thinning medicines (anticoagulants or antiplatelets)
• serotonin reuptake inhibitors (antidepressants)
• medicines for diabetes
• cyclosporine and tacrolimus (immunosuppressants used to modify the body's immune response)
• trimethoprim (an antibiotic)
• medicines for bacterial infections of the quinolone class
• colestipol and cholestyramine, as they may delay or reduce diclofenac absorption. Your doctor will advise you when to take these medicines; generally, diclofenac should be taken 1 hour before or 4–6 hours after colestipol and cholestyramine
• rifampicin (an antibiotic used to treat bacterial infections), as it may reduce diclofenac absorption
• other medicines that may increase blood concentration of diclofenac, e.g. sulfinpyrazone (a medicine used to treat gout) and voriconazole (a medicine used to treat fungal infections).

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 DOC Generici during the last three months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labour beyond the expected time.
You should not take DICLOFENAC DOC Generici 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 DOC Generici may cause kidney problems in the fetus if taken for more than a few days, thereby reducing amniotic fluid levels surrounding the baby (oligohydramnios) or causing 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.

Breastfeeding
DICLOFENAC DOC Generici must not be used during breastfeeding to avoid adverse effects on the newborn.

Fertility
As with other NSAIDs, DICLOFENAC DOC Generici is not recommended for women who are trying to become pregnant, as this medicine may affect female fertility. Your doctor will assess whether it is necessary to discontinue treatment with DICLOFENAC DOC Generici if you experience difficulty becoming pregnant or require fertility testing.

Driving and using machines
DICLOFENAC DOC Generici may cause visual disturbances, dizziness, vertigo, drowsiness or other disturbances that may affect your ability to drive or operate machinery.
If you experience these symptoms, avoid driving or operating machinery.

DICLOFENAC DOC Generici contains glucose
This medicine contains dextrates, a source of glucose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take DICLOFENAC DOC Generici

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The prolonged-release tablets of DICLOFENAC DOC Generici must be swallowed whole with
some liquid, preferably during meals. The prolonged-release tablets must not
be crushed, split, or chewed.

Use in adults
The recommended initial dose is 100–150 mg daily (1 prolonged-release tablet of
diclofenac 100 mg or 2 prolonged-release tablets of diclofenac 75 mg).
For mild cases and long-term therapy, the recommended dose is 75–100 mg daily.
Your doctor will tell you how much DICLOFENAC DOC Generici to take and for how long.
If symptoms are more severe at night or in the morning, take the prolonged-release tablets of
DICLOFENAC DOC Generici preferably in the evening.
The daily dose should be divided into 2–3 administrations.
To relieve nocturnal pain and morning stiffness, daytime treatment with tablets may be
supplemented with administration of a suppository at bedtime (up to a maximum daily dose of 150 mg).

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

Use in children and adolescents
DICLOFENAC DOC Generici must not be used in children and adolescents under 14 years of
age.

Use in the elderly
In elderly patients, a reduced dose of diclofenac may be necessary. Your doctor will tell you how
much DICLOFENAC DOC Generici you should take.

If you take more DICLOFENAC DOC Generici than you should
In case of accidental ingestion/overdose of DICLOFENAC DOC Generici,
contact your doctor immediately or go to the nearest hospital.
If you take an excessive dose of DICLOFENAC DOC Generici, you may experience vomiting,
gastrointestinal or stomach bleeding, diarrhea, dizziness, tinnitus (ringing or buzzing in the ears), or seizures.
In more severe cases, serious kidney and liver damage may also occur.
Your doctor will treat acute poisoning from non-steroidal anti-inflammatory drugs, including diclofenac, based on the symptoms you present.

If you forget to take DICLOFENAC DOC Generici
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 everybody gets them.
Some side effects can be serious.
Stop taking DICLOFENAC DOC Generici and inform your doctor immediately if you notice any of the following serious side effects. You may need urgent medical treatment:

• A severe skin allergic reaction which may include widespread red and/or dark patches, swelling of the skin, blisters, and itching sensation (Fixed generalized bullous eruption due to drugs).
• Mild cramps and abdominal tenderness occurring shortly after starting treatment with DICLOFENAC DOC Generici, 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.

Common side effects (may affect up to 1 in 10 people)

• Headache and dizziness;
• Vertigo;
• Nausea, vomiting;
• Diarrhoea, gas release (flatulence);
• Digestive problems (dyspepsia), abdominal pain;
• Decreased appetite;
• Abnormal blood test results (increase in certain liver enzymes: transaminases);
• Skin rash.

Uncommon side effects (may affect up to 1 in 100 people)

• Awareness of your heartbeat (palpitations), chest pain, heart problems (heart failure), heart attack.

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

• Allergic reactions, severe and rapidly occurring allergic reactions (anaphylaxis), including hypotension and collapse (shock);
• Drowsiness;
• Asthma and breathing difficulties (dyspnoea);
• Inflammation of the stomach (gastritis), bleeding from the stomach or intestine, vomiting blood, stomach or intestinal ulcer with or without bleeding, and perforation;
• Blood in the stools;
• Inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders;
• Skin irritation (urticaria);
• Swelling due to fluid accumulation (oedema). If you experience any of these side effects, inform your doctor immediately.

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

• Abnormal blood test results or low platelet count (thrombocytopenia); or decreased number of white blood cells (leucopenia); or decreased number of red blood cells (anaemia, including haemolytic and aplastic anaemia); or low granulocyte count (agranulocytosis);
• Abnormal urine test results or presence of blood in the urine (haematuria) or presence of protein in the urine (proteinuria);
• Allergic reaction with rapid swelling of the skin and mucous membranes (angioneurotic oedema), including facial oedema;
• Disorientation, depression, insomnia, nightmares, irritability, severe mental disturbances (psychotic reactions);
• Memory impairment, seizures, anxiety, tremors;
• Tingling sensations (paraesthesia);
• Taste disturbances;
• Inflammation of the membranes covering the brain (aseptic meningitis), stroke;
• Vision disorders, blurred vision, double vision (diplopia);
• Ringing or buzzing in the ears (tinnitus), worsening of hearing;
• Increased blood pressure (hypertension);
• Inflammation of blood vessels (vasculitis);
• Inflammation of the lung (pneumonitis);
• Inflammation of the colon (colitis), including colitis associated with bleeding and worsening of ulcerative colitis or Crohn's disease;
• Constipation;
• Inflammation of the mouth mucosa (stomatitis, including stomatitis with ulcers), inflammation of the tongue (glossitis);
• Problems with the oesophagus, intestinal narrowing;
• Inflammation of the pancreas (pancreatitis);
• A very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (hepatic failure);
• Skin reactions ranging from mild (bullous eruptions, eczema, erythema) to potentially fatal (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis);
• Appearance of red-brown spots on the skin (purpura), also as an allergic reaction;
• Hair loss;
• Skin sensitivity to sunlight (photosensitivity);
• Itching;
• Kidney problems such as acute renal failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis;

Side effects with unknown frequency (frequency cannot be estimated from available data)

• A skin allergic reaction, which may include round or oval patches with redness and swelling of the skin, skin rash with blisters, and itching sensation (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.
• Concurrent onset of chest pain and allergic reactions (signs of Kounis syndrome). Medicines such as DICLOFENAC DOC Generici may be associated with a small 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store DICLOFENAC DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
Store below 25 °C and in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine 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 DOC Generici contains
DICLOFENAC DOC Generici 75 mg prolonged-release tablets:

• The active substance is sodium diclofenac. Each tablet contains 75 mg of sodium diclofenac.
• The other components are: dextrates, microcrystalline cellulose, hydroxyethylcellulose, magnesium stearate, hypromellose, polyethylene glycol 3350, titanium dioxide (E171), red iron oxide (E172), carnauba wax.

DICLOFENAC DOC Generici 100 mg prolonged-release tablets:

• The active substance is sodium diclofenac. Each tablet contains 100 mg of sodium diclofenac.
• The other components are: dextrates, microcrystalline cellulose, hydroxyethylcellulose, magnesium stearate, hypromellose, polyethylene glycol 3350, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), carnauba wax.

Description of the appearance of DICLOFENAC DOC Generici and pack sizes
Prolonged-release 75 mg tablets: box of 30 tablets.
Prolonged-release 100 mg tablets: box of 21 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan – Italy.
Manufacturer
S.I.I.T. S.r.l. - Via L. Ariosto, 50/60 - 20090 Trezzano sul Naviglio (Milan) - Italy.
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano 43 - 24041 Brembate (Bergamo) – Italy.