Diclofenac EG

Italy
Brand name Diclofenac EG
Form tablets, enteric-coated
Active substance / Dosage
DICLOFENAC SODIUM
Prescription type Prescription only
ATC code
M01AB05
Registration number 029456
Manufacturer EG S.P.A.
Diclofenac EG tablets, enteric-coated

Table of Contents

Package leaflet: Information for the patient

Diclofenac EG 50 mg gastro-resistant 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 others, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Diclofenac EG is and what it is used for

Diclofenac EG contains the active substance diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These work by reducing inflammation, pain and fever.
This medicine is indicated for the treatment of:

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

2. What you should know before taking Diclofenac EG

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

Some people MUST NOT use Diclofenac EG. Consult your doctor if:

  • you think you are allergic to sodium diclofenac, aspirin, ibuprofen, or any other NSAID, or to any other component of Diclofenac EG (a list of components is provided at the end of this leaflet). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic-type reaction.

Do not take Diclofenac EG

  • if you have stomach or intestinal lesions (ulcers), bleeding, perforation, or pain, or if you have previously experienced stomach or intestinal bleeding or perforation due to treatment with NSAIDs, or if you have had recurrent bleeding/peptic ulcer (two or more distinct episodes of confirmed ulceration or bleeding);
  • if you are in the last trimester of pregnancy or if you are breastfeeding (see section “Pregnancy and breastfeeding”);
  • if you have bleeding (haemorrhage) or are predisposed to bleeding (haemorrhagic diathesis);
  • if you have severe liver, kidney, or heart disease;
  • if you have had a heart attack, stroke, mini-stroke (TIA), or blockage of blood vessels supplying the heart or brain, or undergone surgery to remove or prevent such blockages;
  • if you suffer or have suffered from circulation problems (peripheral arterial disease);
  • if you are taking high doses of medicines that promote urine elimination (diuretics);
  • if you have a disorder affecting blood cell production;
  • if you are under 14 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking Diclofenac EG:

  • if you have ever developed severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking Diclofenac EG or other painkillers.

Inform your doctor and take this medicine with caution in the following cases:

  • if you are elderly or debilitated; in such cases, the lowest effective dose should be used to minimize the risk of adverse effects, especially stomach bleeding and perforation, which may be fatal;
  • if you have stomach or intestinal disorders such as lesions (ulcers), ulcerative colitis, or Crohn’s disease; in these cases, accurate diagnosis and close medical supervision during treatment are essential;
  • if you have mild or moderate heart problems (congestive heart failure, high blood pressure (hypertension), ischaemic heart disease, circulation problems) or are at high risk of developing them; in such cases, the lowest effective dose for the shortest possible duration is recommended;
  • if you have liver function disorders or suffer from a liver disease called hepatic porphyria; in these cases, accurate diagnosis and close medical supervision during treatment are essential;
  • if you have kidney function problems, as the medicine may cause fluid retention and swelling due to fluid accumulation (oedema);
  • 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 such cases, you may experience breathing difficulties (bronchospasm) or even severe allergic reactions such as anaphylactic shock;
  • if you have blood disorders; in this case, platelet aggregation should be carefully monitored, as there may be coagulation problems, especially with prolonged treatment.

Inform your doctor if you experience any of the following symptoms during treatment:

  • stomach or intestinal bleeding or ulceration. In this case, stop treatment immediately;
  • if you develop severe skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis). These reactions usually occur within the first month of treatment. Discontinue treatment at the first sign of skin rash, mucosal lesions, or any other reaction.

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, make sure 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, or high cholesterol or triglyceride levels.

This medicine may mask signs of infection or cause even severe allergic reactions.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary.

Children and adolescents
Diclofenac EG is not recommended for children under 14 years of age due to lack of safety and efficacy data.

Other medicines and Diclofenac EG
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Diclofenac 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;
  • 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, a medicine used after organ transplants;
  • quinolone antibiotics, used to treat infections;
  • phenytoin, a medicine used for epilepsy;
  • colestipol and cholestyramine, medicines used to reduce intestinal fat absorption;
  • sulfinpyrazone, voriconazole, or other medicines that inhibit diclofenac metabolism, which may lead to increased effects of the medicine.

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 EG during the last 3 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 delay or prolong labour more than expected.
You should not take Diclofenac EG during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, Diclofenac EG may cause kidney problems in the foetus 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 needed for more than a few days, your doctor may recommend additional monitoring.
Do not take this medicine while breastfeeding to avoid harm to the infant, as diclofenac passes into breast milk.
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 infertility 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 EG 50 mg gastro-resistant tablets contain lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

Diclofenac EG 100 mg prolonged-release tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

3. How to take Diclofenac EG

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.
The recommended initial dose is 100–150 mg per day.
For milder cases and for long-term treatment, 100 mg per day is usually sufficient.
The daily dose should be divided into 2–3 administrations.
Gastro-resistant tablets: the recommended initial dose is 1 tablet three times daily. The recommended
maintenance dose is 1 tablet twice daily.
For the treatment of menstrual pain, the recommended initial dose is 50–100 mg per day and may be
increased up to a maximum of 150 mg per day, depending on need. Begin treatment at the onset of the
first symptoms and continue for several days, according to symptom severity.
The daily dose should be divided into 2–3 administrations.
Prolonged-release tablets: the recommended dose is 1 tablet per day. If necessary, your doctor may
increase the dose to 150 mg per day, in which case you will also be prescribed 50 mg tablets. If symptoms
are more pronounced at night or in the morning, take the tablets preferably in the evening.
Use in the elderly
For elderly patients, your doctor will adjust the dose according to the patient's condition.
If you take more Diclofenac EG than you should
Overdose may cause symptoms such as vomiting, gastrointestinal bleeding, diarrhoea, dizziness, ringing in
the ears (tinnitus), or seizures. In more severe cases, serious kidney problems (acute renal failure) and liver
damage may occur.
If you accidentally take or ingest too much Diclofenac EG, contact your doctor immediately or go to the
nearest hospital.
If you forget to take Diclofenac EG
Do not take a double dose to make up for the forgotten 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 will experience them.
Some side effects may be serious.
Stop using Diclofenac EG and contact your doctor immediately if you notice:

  • mild abdominal cramps and tenderness occurring shortly after starting treatment with Diclofenac EG, followed by rectal bleeding or haemorrhagic 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 widespread red and/or dark patches, skin swelling, blisters, and itching sensation (Fixed drug eruption with generalised bullous rash).

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

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

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

  • allergic reactions, including severe ones such as anaphylactic and anaphylactoid reactions (including hypotension and shock);
  • drowsiness;
  • asthma and breathing difficulties (dyspnoea);
  • stomach disorders such as gastritis, gastrointestinal bleeding, blood in vomit (haematemesis), blood in stools (haemorrhagic diarrhoea, melena), gastrointestinal ulcer (with or without bleeding or perforation);
  • liver problems such as hepatitis and jaundice;
  • skin irritation (urticaria);
  • swelling due to fluid accumulation (oedema).

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

  • decrease in blood platelets (thrombocytopenia);
  • decrease in white blood cells (leucopenia, agranulocytosis);
  • decrease in red blood cells (anaemia, including haemolytic and aplastic anaemia);
  • swelling of the skin and mucous membranes, particularly of the face (angioedema);
  • disorientation, depression, insomnia, nightmares, irritability, psychotic reactions;
  • altered sensation in limbs (paraesthesiae), tremors;
  • memory impairment, seizures, anxiety, inflammation of the membranes protecting the brain (aseptic meningitis), taste disturbances, cerebrovascular events;
  • visual disturbances, blurred vision, double vision (diplopia);
  • ringing sensation in the ears (tinnitus) and worsening of hearing;
  • increased awareness of heartbeat (palpitations);
  • chest pain, heart failure, heart attack;
  • increased blood pressure (hypertension);
  • inflammation of blood vessels (vasculitis);
  • lung inflammation (pneumonitis);
  • intestinal inflammation (colitis) (including haemorrhagic colitis and worsening of ulcerative colitis or Crohn’s disease);
  • constipation, intestinal blockage (diaphragm-like intestinal stenosis);
  • inflammation of the mouth (stomatitis), tongue (glossitis), oesophagus or pancreas (pancreatitis);
  • severe liver problems (fulminant hepatitis, hepatic necrosis, liver failure);
  • skin and mucous membrane inflammation such as blistering rashes, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), exfoliative dermatitis;
  • hair loss;
  • light sensitivity (photosensitivity);
  • skin redness with bleeding (purpura, allergic purpura);
  • itching;
  • kidney problems such as acute renal failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis;
  • presence of blood or protein in urine (haematuria, proteinuria).

Not known (frequency cannot be estimated from available data)

  • a skin allergic reaction, which may include round or oval-shaped red or swollen skin patches, blistering rash, and itching (Drug eruption with fixed lesions). 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.

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 EG

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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Diclofenac EG contains
Diclofenac EG 50 mg gastro-resistant tablets

  • The active substance is sodium diclofenac. Each tablet contains 50 mg of sodium diclofenac.
  • The other components are: maize starch, precipitated silica, lactose, microcrystalline cellulose, povidone, sodium carboxymethylcellulose, diethyl phthalate, talc, polysorbate 80, magnesium stearate, iron oxide (E172), ethyl acrylate-methyl methacrylate.

Diclofenac EG 100 mg prolonged-release tablets

  • The active substance is sodium diclofenac. Each tablet contains 100 mg of sodium diclofenac.
  • The other components are: povidone, hypromellose, talc, mannitol, microcrystalline cellulose, diethyl phthalate, magnesium stearate, titanium dioxide, iron oxide (E172).

Description of the appearance of Diclofenac EG and contents of the pack
50 mg gastro-resistant tablets: box of 30 tablets.
100 mg prolonged-release tablets: box of 21 tablets.
Marketing Authorization Holder
EG S.p.A., Via Pavia 6, - 20136 Milan.
Manufacturer
Gastro-resistant tablets: Doppel Farmaceutici S.r.l., Via Volturno 48, 20089 Quinto de’ Stampi, Rozzano (MI).
Prolonged-release tablets: Cosmo S.p.A., Via C. Colombo 1, 20045 Lainate (MI).