Dicloreum

Package leaflet: Information for the user

Dicloreum, 50 mg, enteric-coated tablets
Diclofenacum natricum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Dicloreum is and what it is used for

Dicloreum contains sodium diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It has anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of Dicloreum 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 prolonged-release tablets with a strength of 100 mg and as an injection solution with a strength of 75 mg/3 ml.
Dicloreum is used in the treatment of:

• Joint and periarticular tissue disorders: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, periarticular inflammation, tendinitis and bursitis, tendon and muscle inflammation, pain syndromes due to inflammation of nerve roots.
• Post-traumatic pain syndromes

2. Important information before taking Dicloreum

When not to use Dicloreum

• 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, 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 is contraindicated during 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. after myocardial infarction, stroke, transient ischaemic attack (TIA), or arterial embolism in the heart or brain, or after a procedure to unblock or bypass obstructed blood vessels
• if the patient has had or currently has 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 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 may trigger 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 bleed
• in cases of abnormal haematopoiesis (blood cell formation and differentiation)
• during treatment with anticoagulants (acenocoumarol, warfarin), as Dicloreum may enhance their effect
• in patients with hepatic dysfunction, diclofenac may exacerbate the disease; liver function tests should be monitored closely as advised by the physician
• before using Dicloreum, inform the doctor if the patient has recently undergone or is scheduled for surgery of the stomach or gastrointestinal tract, as Dicloreum may impair intestinal wound healing after surgery.

Use of medicines such as Dicloreum 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 you have heart problems, have had a stroke, or suspect you are at risk of such
conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss the
treatment approach with your doctor or pharmacist.
Do not use Dicloreum 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). These effects may be particularly dangerous when high doses of
diclofenac are used, or in patients with a history of gastrointestinal ulceration or in the
elderly.
If any abdominal symptoms occur during treatment with Dicloreum (especially
gastrointestinal bleeding), the medicine should be discontinued immediately and the
patient should 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
characterized by widespread rash, high fever and joint pain, or toxic epidermal
necrolysis involving extensive skin and mucous membrane lesions, accompanied by
high fever and severe general condition. If the first signs of rash, mucosal lesions or
other allergic reactions occur, the medicine should be discontinued and medical
advice sought immediately.
If any of the above conditions apply, inform the doctor before taking Dicloreum.
The medicine may transiently inhibit platelet aggregation.
Close medical supervision is required in patients with severe hepatic insufficiency.
During prolonged use of Dicloreum, preventive monitoring of blood counts and kidney
and liver function is recommended.
Some people should NOT take Dicloreum.
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 triglyceride levels
• if the patient suspects allergy to sodium diclofenac, acetylsalicylic acid, ibuprofen or any other NSAID, or to any of the other ingredients of Dicloreum (listed at the end of this leaflet). Symptoms of hypersensitivity include facial and lip swelling (angioedema), breathing difficulties, chest pain, rhinitis, rash or any other allergic-type reactions.

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

• Lithium or antidepressants (selective serotonin reuptake inhibitors)
• Digoxin (a medicine used in heart disease treatment)
• 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 arthritis)
• Cyclosporine and tacrolimus (medicines used in organ transplant recipients)
• Antibacterial quinolones and certain medicines used to treat infections
• Cardiac glycosides
• Mifepristone
• Phenytoin
• Colestyramine and colestipol
• Strong inhibitors of the CYP2C9 enzyme, such as sulfinpyrazone and voriconazole

Pregnancy, breastfeeding and fertility

If the patient is pregnant or 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 three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Dicloreum 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 six months of pregnancy unless the doctor considers it absolutely necessary. From week 20 of pregnancy, Dicloreum may cause kidney problems in the unborn child if used for more 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 should not be used during breastfeeding, as it may cause harm to 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 who experience dizziness or other central nervous system disturbances, 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 effects of the medicine. 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 your doctor.

Dicloreum contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Dicloreum

This medicine should always be used according to the doctor's or pharmacist's instructions. If in doubt,
consult your doctor or pharmacist.
Do not exceed the recommended doses or duration of treatment.
The general recommendation is for the doctor to individually adjust the dose for each patient and to use
the lowest effective dose for the shortest possible period.
Initially, one tablet three times daily is recommended.
For maintenance treatment, one tablet twice daily (morning and evening) is used; in some cases,
further dose reduction may be possible.
It is advisable to take the medicine during or immediately after meals.
Dosing in elderly patients must be determined by the doctor, who should consider reducing the recommended doses.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Using the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.

Taking more Dicloreum than recommended
Overdose with Dicloreum does not produce characteristic symptoms.
In case of accidental ingestion of more tablets than recommended, contact your doctor or pharmacist immediately, or go to hospital.

Missing a dose of Dicloreum
If a dose is missed, it should be taken as soon as remembered.
However, if more than half of the time between two doses has passed, the missed dose should not be taken;
instead, continue with the next scheduled dose according to the previous schedule.
Do not take a double dose to make up for a missed dose.

Stopping Dicloreum
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Treatment with Dicloreum should be discontinued if gastrointestinal bleeding or ulcers occur,
as well as rash, mucosal damage, or any other signs of hypersensitivity.
If abnormal liver function parameters persist or worsen, Dicloreum treatment must be discontinued.
The decision to discontinue treatment will be made by the doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects may be serious.
The frequency of adverse effects 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 effects listed below include those reported for Dicloreum enteric-coated tablets as well as those observed during use of other formulations of diclofenac, administered either short- or long-term.

Very rare: thrombocytopenia (reduced number of blood platelets), leukopenia (reduced number of white blood cells in peripheral blood), anemia (including hemolytic and aplastic anemia), agranulocytosis (deficiency of neutrophil granulocytes), angioedema (including facial swelling), disorientation, depression, insomnia, nightmares, irritability, psychotic disorders, paresthesia, memory disturbances, 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; pneumonia; colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, stomatitis, glossitis, esophageal disorders, membranous stricture of the intestine, 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 pseudoanaphylactic reactions (including hypotension and shock), hepatitis, jaundice, liver function abnormalities, somnolence, asthma (including dyspnea), gastric mucositis, gastrointestinal bleeding, haematemesis, bloody diarrhoea, melaena, peptic ulcer of the stomach and/or duodenum (with or without bleeding and 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, ischemic colitis.

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

If any of the above-mentioned or other unlisted adverse effects occur, inform your doctor.

Dicloreum treatment should be discontinued and medical advice sought immediately if the patient experiences:

• stomach discomfort, heartburn or upper abdominal pain
• vomiting blood, blood in stool, 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 beginning shortly after starting Dicloreum, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome (frequency not known – cannot be estimated from the available data).

If Dicloreum is taken for longer than a few weeks, regular contact with a doctor is recommended to ensure that no adverse effects have occurred.

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 effects can also be reported to the marketing authorization holder. Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Dicloreum

Store below 25°C.
Keep the medicine out of the sight and reach of 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 indicated month.
Do not use Dicloreum from packaging that has been previously damaged.
Medicines must not be disposed of 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 packaging and other information

What Dicloreum contains

• The active substance is sodium diclofenac.
• One enteric-coated tablet contains 50 mg of sodium diclofenac.
• The other ingredients are microcrystalline cellulose, monohydrate lactose, pregelatinized starch, magnesium stearate, cellulose acetate phthalate, diethyl phthalate, titanium dioxide (E 171), povidone.

What Dicloreum looks like and contents of the pack
Pack contains 15 tablets in 1 blister or 30 tablets (2 blisters with 15 tablets each).
Blister packs made of Aluminium/PVC/PE/PVDC 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, 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