Package leaflet: Information for the user

Dicloreum Retard 100 mg prolonged-release tablets
Diclofenacum natricum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Dicloreum Retard is and what it is used for
Important information before taking Dicloreum Retard
How to take Dicloreum Retard
Possible side effects
How to store Dicloreum Retard
Contents of the pack and other information

1. What Dicloreum Retard is and what it is used for

Dicloreum Retard contains sodium diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), acting as anti-rheumatic, anti-inflammatory, analgesic, and antipyretic agents. The mechanism of action of Dicloreum Retard involves inhibition of prostaglandin biosynthesis, which play a key role in the pathogenesis of inflammation, pain, and fever.
This medicine is also available in the form of enteric-coated tablets at a strength of 50 mg and as a solution for injection at a strength of 75 mg/3 ml.
Dicloreum Retard is used in the treatment of:

Diseases of joints and periarticular tissues: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, periarthritis, tenosynovitis, tendonitis and bursitis, tendon and muscle inflammation, painful syndromes due to inflammation of nerve roots.
Post-traumatic painful conditions.

2. Important information before taking Dicloreum Retard

When not to use Dicloreum Retard

if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6)
if the patient has active peptic ulceration of the stomach and/or duodenum, gastrointestinal bleeding or perforation, or such conditions have occurred in the past during treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or for other reasons at least twice
Dicloreum Retard is contraindicated in the third trimester of pregnancy
if the patient has severe renal, hepatic, and/or cardiac insufficiency
if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g. following myocardial infarction, stroke, transient ischaemic attack (TIA), or arterial embolism in the heart or brain, or following revascularization or bypass surgery of blocked vessels
if the patient has current or previous circulatory disorders (peripheral vascular disease)
if the patient has experienced asthma attacks, urticaria, or acute rhinitis after taking acetylsalicylic acid (aspirin) or other prostaglandin synthetase inhibitors (e.g. ibuprofen or naproxen)
Dicloreum Retard is contraindicated in children under 18 years of age.

Warnings and precautions

in patients with asthma or predisposition to asthma attacks, as administration of Dicloreum Retard may provoke bronchospasm or severe allergic reactions
when patients are concurrently taking medications that may increase the risk of gastrointestinal ulcers or bleeding, such as: oral corticosteroids, anticoagulants (warfarin), selective serotonin reuptake inhibitors (fluoxetine, sertraline), or antiplatelet agents such as aspirin or ticlopidine
in elderly patients, due to increased risk of adverse effects associated with non-steroidal anti-inflammatory drugs (NSAIDs), particularly gastrointestinal bleeding and perforation
in elderly patients or those with a history of gastrointestinal ulceration, especially if complicated by bleeding or perforation
if the patient has ever had gastrointestinal disorders such as ulcerative colitis or Crohn's disease (chronic inflammatory bowel disease)
in patients with hypertension and/or cardiac dysfunction
in cases of hypoperfusion (reduced blood flow) or renal insufficiency, history of thrombosis with embolism, and in patients treated with diuretics or after major surgical procedures
in patients with severe hepatic dysfunction or hepatic porphyria
the lowest therapeutic dose should be used in patients with low body weight
during intensive treatment with diuretics
in patients with a tendency to bleeding
in cases of abnormal haematopoiesis (blood cell formation and differentiation)
during treatment with anticoagulants (acenocoumarol, warfarin), as Dicloreum Retard may enhance their effect
in patients with hepatic dysfunction, diclofenac may exacerbate the disease; liver function tests should be monitored regularly as advised by the physician
before using Dicloreum Retard, inform the doctor if the patient has recently undergone or is scheduled for surgery of the stomach or gastrointestinal tract, as Dicloreum Retard may impair intestinal wound healing after surgery.

Use of medicines such as Dicloreum Retard may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with prolonged use of high doses. Do not use higher doses or longer treatment duration than recommended. If the patient has heart problems, history of stroke, or risk factors for these conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss the treatment approach with a doctor or pharmacist.
Do not use Dicloreum Retard together with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 (COX-2) inhibitors (e.g. celecoxib).
Diclofenac use may cause gastrointestinal bleeding, ulceration, or perforation (which may be fatal). This risk is particularly dangerous when high doses of diclofenac are used, and in patients with a history of gastrointestinal ulceration or in the elderly.
If any abdominal symptoms occur during treatment with Dicloreum Retard (especially gastrointestinal bleeding), discontinue the medicine immediately and contact a doctor.
Diclofenac may, very rarely (especially at the beginning of treatment), cause life-threatening skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever and joint pain, or toxic epidermal necrolysis with lesions of the skin and mucous membranes, accompanied by high fever and severe general condition. If early signs of rash, mucosal lesions, or other allergic reactions occur, discontinue the medicine and contact a doctor immediately.
If any of the above conditions apply, inform the doctor before using Dicloreum Retard.
The medicine may transiently inhibit platelet aggregation.
Close medical supervision is required in patients with severe hepatic insufficiency.
During prolonged use of Dicloreum Retard, preventive monitoring of blood count, and renal and liver function is recommended.
Some people should NOT take Dicloreum Retard.
Before taking diclofenac, inform the doctor:

if the patient smokes
if the patient has diabetes
if the patient suffers from angina, thrombosis, hypertension, high cholesterol, or high triglycerides
if the patient suspects allergy to sodium diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other ingredients of Dicloreum Retard (listed at the end of this leaflet). Symptoms of hypersensitivity include facial and lip swelling (angioedema), breathing difficulties, chest pain, nasal discharge, rash, or any other allergic reaction.

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary.
Dicloreum Retard and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
Especially inform the doctor about the use of the following medicines:

Lithium or antidepressants (selective serotonin reuptake inhibitors)
Digoxin (a medicine used in heart disease)
Angiotensin-converting enzyme (ACE) inhibitors, beta-blockers (medicines used to treat hypertension and heart failure)
Diuretics (medicines that increase urine output)
Non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid or ibuprofen) and corticosteroids (medicines used to reduce inflammatory skin conditions)
Anticoagulants and antiplatelet agents
Antidiabetic medicines, except insulin
Methotrexate (a medicine used in treatment of certain cancers or joint inflammation)
Cyclosporine and tacrolimus (medicines used in organ transplant recipients)
Antibacterial quinolones and certain medicines used to treat infections
Cardiac glycosides
Mifepristone
Phenytoin
Colestipol and cholestyramine
Strong inhibitors of the CYP2C9 enzyme, such as sulfinpyrazone and voriconazole

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take Dicloreum during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Dicloreum Retard may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labour. Dicloreum should not be used during the first 6 months of pregnancy unless the doctor considers it absolutely necessary. From the 20th week of pregnancy, Dicloreum may cause kidney problems in the unborn child if used for longer than a few days. This may lead to low levels of amniotic fluid (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.
Breastfeeding
Dicloreum Retard should not be used during breastfeeding, as it may harm the infant.
Fertility
Diclofenac may impair fertility. If the patient plans to become pregnant or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
Patients experiencing dizziness or other central nervous system disorders, including visual disturbances, should refrain from driving and operating machinery and should inform their doctor about any adverse effects experienced.
Elderly patients may be more sensitive to the medicine's effects. Follow the instructions in the leaflet, use the lowest effective dose as recommended by the doctor, and report any adverse effects occurring during treatment to the doctor.
Dicloreum Retard contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Dicloreum Retard

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Do not exceed the recommended doses or duration of treatment.
The general recommendation is that the doctor adjusts the dose individually for each patient
and uses the lowest effective dose for the shortest possible duration.
The recommended daily dose is 100 mg. The tablet should be swallowed whole, preferably during a meal.
Dosage regimens for elderly patients must be determined by a doctor, who should consider reducing the recommended doses.
If the patient feels that the effect of the medicine is too strong or too weak, consult a doctor.
Taking the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.

Taking more Dicloreum Retard than recommended
Overdose with Dicloreum Retard does not produce characteristic symptoms.
If an excessive amount of tablets has been taken by accident, contact a doctor or pharmacist immediately or go to hospital.

Missing a dose of Dicloreum Retard
If a dose is missed, it should be taken as soon as the patient remembers.
However, if more than half of the time interval between doses has passed, the missed dose should not be taken; instead, the next dose should be taken according to the usual schedule.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Dicloreum Retard
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.
Treatment with Dicloreum Retard should be discontinued in the event of gastrointestinal bleeding or ulcers, as well as rash, mucosal damage, or any other signs of hypersensitivity.
If abnormal liver function parameters persist or worsen, treatment with Dicloreum Retard must be discontinued. The decision to discontinue treatment will be made by the doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious.
The frequency of adverse reactions is estimated as follows:
very common (affects 1 or more patients in 10); common (affects 1 to 10 patients in 100);
uncommon (affects 1 to 10 patients in 1,000); rare (affects 1 to 10 patients in 10,000);
very rare (affects less than 1 patient in 10,000); frequency not known (frequency cannot be estimated from
the available data).
The adverse reactions listed below include those observed with Dicloreum Retard, prolonged-release tablets, as well as those observed during the use of other forms of diclofenac, administered either short- or long-term.

Very rare: thrombocytopenia (reduced platelet count), leukopenia (reduced number of white blood cells in peripheral blood), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (deficiency of white blood cells - neutrophil granulocytes), angioedema (including facial swelling), disorientation, depression, insomnia, nightmares, irritability, psychotic disorders, paraesthesia, memory disorders, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, stroke; visual disturbances, blurred vision, double vision, tinnitus, hearing disorders; palpitations, chest pain, heart failure, myocardial infarction; hypertension, vasculitis; pulmonary inflammation; colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, oral mucosal inflammation, inflammation of the tongue, oesophageal disorders, membranous intestinal stricture, pancreatitis, fulminant hepatitis; bullous rash, exanthema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, Schönlein-Henoch disease, pruritus, acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, necrosis of renal papillae.

Rare: hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock), hepatitis, jaundice, liver function abnormalities, somnolence, asthma (including dyspnoea), gastric mucosal inflammation, gastrointestinal bleeding, haematemesis, bloody diarrhoea, melaena, peptic ulcer of the stomach and/or duodenum (with or without bleeding or perforation), urticaria, oedema.

Common: headache, dizziness of various origins; nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia, increased aminotransferase activity; rash.

Frequency not known: Kounis syndrome, ischaemic colitis.

The use of medicines such as Dicloreum Retard may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If any of the above-mentioned or other adverse reactions not described here occur, inform your doctor.
You must stop taking Dicloreum Retard and contact your doctor immediately if you notice any of the following symptoms:

stomach discomfort, heartburn, or pain in the upper abdomen
vomiting blood, blood in stool, or blood in urine
skin problems such as rash or itching
wheezing or shortness of breath
yellowing of the skin or whites of the eyes
persistent sore throat or increased body temperature
swelling of the face, feet, or legs
severe migraine
chest pain associated with cough
mild painful abdominal cramps and tenderness occurring shortly after starting Dicloreum Retard, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain
chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome (frequency not known - frequency cannot be estimated from the available data).

If you are taking Dicloreum Retard for longer than a few weeks, you should regularly consult your doctor to ensure that no adverse reactions have occurred.

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
ul. Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dicloreum Retard

Store below 25°C.
Keep the medicine in a place invisible and inaccessible to children.
Do not use this medicine after the expiry date stated on the packaging following: Expiry
date. The expiry date refers to the last day of the stated month.
Do not use Dicloreum Retard if the packaging has been previously damaged.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect the
environment.

6. Contents of the pack and other information

What Dicloreum Retard contains

The active substance is sodium diclofenac.
One prolonged-release tablet contains 100 mg of sodium diclofenac.
The other ingredients are talc, ethylcellulose, magnesium stearate, povidone, and coating components: hydroxypropylcellulose, diethyl phthalate, ethylcellulose, magnesium stearate, titanium dioxide (E 171).

What Dicloreum Retard looks like and contents of the pack
The pack contains 6 tablets in 1 blister, 10 tablets in 1 blister, or 20 tablets in 2 blisters.
Blister packs made of PVC/PE/PVDC/Aluminium foil are placed in a cardboard carton.

Marketing Authorisation Holder
Alfasigma S.p.A.
Via Ragazzi del '99, n. 5
40133 Bologna (BO), Italy

Manufacturer
Alfasigma S.p.A.
Via Enrico Fermi 1
65 020 Alanno (PE), Italy

For further information, please contact the local representative of the Marketing Authorisation Holder:
Alfasigma Polska Sp. z o.o.
Al. Jerozolimskie 96
00-807 Warsaw
Tel. +48 22 824 03 64

Logo of the Marketing Authorisation Holder Alfasigma