Dicloreum

Leaflet attached to the packaging: information for the user

Dicloreum, 50 mg, enteric-coated tablets

Diclofenac sodium

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Dicloreum and what is it used for

Dicloreum contains diclofenac sodium, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), with anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of Dicloreum involves the inhibition of prostaglandin biosynthesis, which plays a fundamental role in the pathogenesis of inflammation, pain, and fever.
The medicine is also available in the form of prolonged-release tablets of 100 mg and injection solution of 75 mg/3ml.
Dicloreum is used to treat:

• joint and periarticular tissue diseases: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, periarticular inflammation, tendonitis, and bursitis, as well as pain syndromes resulting from nerve root inflammation.
• post-traumatic pain syndromes

2. Important information before taking Dicloreum

When not to take 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 gastric or duodenal ulcer, bleeding, or perforation, or has had such disorders in the past after treatment with NSAIDs or for other reasons at least twice
• Dicloreum is contraindicated in the last trimester of pregnancy
• if the patient has severe renal, hepatic, or cardiac impairment
• if the patient has heart disease and/or cerebrovascular disease, such as myocardial infarction, stroke, transient ischemic attack (mini-stroke), or venous thrombosis of the heart or brain, or has undergone vascular surgery or bypass grafting
• if the patient 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 (ibuprofen or naproxen)
• Dicloreum is contraindicated in children under 18 years of age.

Warnings and precautions

• in patients with asthma and those with a predisposition to asthma attacks, as Dicloreum may cause bronchospasm or severe allergic reactions
• when patients are taking medications that may increase the risk of 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 the increased frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation
• in elderly patients or those with a history of gastrointestinal ulcers, especially those with complications such as bleeding or perforation
• if the patient has had gastrointestinal disorders such as ulcerative colitis or Crohn's disease (chronic non-specific inflammation of the intestine)
• in patients with hypertension and/or heart failure
• in cases of hypoperfusion (decreased blood flow) or renal failure, previous thrombosis, or patients treated with diuretics and after major surgery
• in patients with severe liver dysfunction or porphyria
• the smallest effective dose is recommended for patients with low body weight
• during intensive diuretic treatment
• in patients with a tendency to bleeding
• in cases of abnormal hematopoiesis (formation and differentiation of blood cells)
• when taking anticoagulant medications (acenocoumarol, warfarin), as Dicloreum may enhance their effect
• in patients with liver dysfunction, diclofenac may worsen the course of the disease; the doctor's recommendations for liver function tests should be strictly followed.
• before taking Dicloreum, the patient should inform their doctor if they have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Dicloreum may sometimes cause delayed wound healing in the intestines after surgery.

Taking such medications as Dicloreum may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not exceed the recommended dose and duration of treatment.
In case of heart problems, previous stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), the patient should discuss their treatment with their doctor or pharmacist.
Do not take Dicloreum with other systemic NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors (celecoxib).
Taking diclofenac may cause gastrointestinal bleeding, ulcers, or perforation (which can be fatal). This effect may be particularly dangerous in cases of high doses of diclofenac and in elderly patients or those with a history of gastrointestinal ulcers.
If gastrointestinal symptoms occur while taking Dicloreum (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the patient should consult their doctor.
Taking diclofenac may, in rare cases (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, as well as toxic epidermal necrolysis with skin and mucous membrane lesions, accompanied by high fever and severe general condition. If the patient experiences the first signs of a rash, mucous membrane lesions, or other symptoms of an allergic reaction, they should discontinue the medicine and consult their doctor.
In case of any of the above situations, the patient should inform their doctor before taking Dicloreum.
The medicine may temporarily inhibit platelet aggregation.
In patients with severe liver impairment, close medical supervision is required.
During long-term use of Dicloreum, it is recommended to monitor blood counts and liver and kidney function preventively.
Certain individuals SHOULD NOT be given Dicloreum.
Before taking diclofenac, the patient should inform their doctor:

• if they smoke
• if they have diabetes
• if they have angina pectoris, thrombosis, hypertension, high cholesterol, or high triglycerides
• if they think they may be allergic to diclofenac sodium, acetylsalicylic acid, ibuprofen, or any other NSAID, or any of the other ingredients of Dicloreum (listed at the end of this leaflet). Hypersensitivity symptoms include facial and lip edema (angioedema), difficulty breathing, chest pain, rhinitis, rash, or any other allergic reactions.

Taking the smallest effective dose of the medicine for the shortest duration necessary to relieve symptoms reduces the risk of adverse reactions.

Dicloreum and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The patient should inform their doctor especially about taking the following medicines:

• Lithium or antidepressant medications (selective serotonin reuptake inhibitors)
• Digoxin (a medicine used to treat heart conditions)
• Angiotensin-converting enzyme inhibitors, beta-adrenergic blockers (a group of medicines used to treat hypertension and heart failure)
• Diuretics (medicines that increase urine production)
• NSAIDs (e.g., acetylsalicylic acid or ibuprofen) and corticosteroids (medicines used to relieve inflammatory conditions of the skin on various body surfaces)
• Anticoagulants and antiplatelet agents
• Antidiabetic medicines (except insulin)
• Methotrexate (a medicine used to treat certain cancers or arthritis)
• Cyclosporine and tacrolimus (medicines used in organ transplant patients)
• Quinolone antibacterials and some medicines used to treat infections
• Cardiac glycosides
• Mifepristone
• Phenytoin
• -Cholestyramine and colestipol
• Strong CYP2C9 enzyme inhibitors such as sulfinpyrazone and voriconazole

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking 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 may cause renal and cardiac disorders in the unborn child. It may also increase the risk of bleeding in the mother and child and prolong labor. During the first 6 months of pregnancy, Dicloreum should not be used unless the doctor considers it absolutely necessary. From the 20th week of pregnancy, Dicloreum may cause renal disorders in the unborn child if taken for more than a few days.
This may lead to low amniotic fluid levels around the baby (oligohydramnios) or narrowing of the arterial duct in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Do not take Dicloreum while breastfeeding, as it may have harmful effects on the baby.
Fertility
Diclofenac may make it more difficult to become pregnant. If the patient plans to become pregnant or is having trouble becoming pregnant, they should inform their doctor.

Driving and using machines

Patients who experience dizziness or other central nervous system disorders, including vision disturbances, should stop driving and operating machines and inform their doctor about any adverse reactions that have occurred.
Elderly patients may be more sensitive to the effects of the medicine. The patient should follow the recommendations in the leaflet, take the smallest effective dose as recommended by the doctor, and report any adverse reactions that occur during treatment to their doctor.

Dicloreum contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Dicloreum

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Do not exceed the recommended dose and duration of treatment.
The general recommendation is for the doctor to adjust the dose individually for each patient and use the smallest effective dose for the shortest possible duration.
Initially, take 1 tablet three times a day.
As maintenance treatment, take 1 tablet twice a day (morning and evening); in some cases, it may be possible to further reduce the dose.
It is recommended to take the medicine during or immediately after a meal.
The dosing regimen for elderly patients must be determined by the doctor, who should consider reducing the recommended dose.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.
Taking the medicine in the smallest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse reactions.

Taking a higher dose of Dicloreum than recommended

Overdose of Dicloreum does not produce characteristic symptoms.
In case of accidental ingestion of a larger number of tablets than prescribed, the patient should immediately consult their doctor, pharmacist, or go to the hospital.

Missing a dose of Dicloreum

If a dose of the medicine is missed, the patient should take it as soon as they remember.
However, if more than half of the time has passed between two doses, the missed dose should not be taken, and the patient should take the next dose according to the previous schedule.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Dicloreum

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.
Treatment with Dicloreum should be discontinued in case of gastrointestinal bleeding or ulcers, as well as in case of rash, mucous membrane lesions, or any other symptoms of hypersensitivity.
If abnormal liver function parameters persist or worsen, treatment with Dicloreum must be discontinued. The doctor will decide whether to discontinue treatment.

4. Possible side effects

Like all medicines, Dicloreum can cause side effects, although not everybody gets them.
Some side effects may be serious.
The frequency of side 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); not known (frequency cannot be estimated from the available data).
The following side effects include those reported with Dicloreum, enteric-coated tablets, as well as those observed with other forms of diclofenac, used for short or long periods.
Very rare: thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), anemia (including hemolytic and aplastic anemia), agranulocytosis (deficiency of granulocytes), angioedema (including facial edema), disorientation, depression, insomnia, nightmares, irritability, psychotic disorders, paresthesia, memory disorders, seizures, anxiety, tremors, aseptic meningitis, taste disturbances, stroke; visual disturbances, blurred vision, double vision, tinnitus, hearing disturbances; palpitations, chest pain, heart failure, myocardial infarction; hypertension, vasculitis; pneumonia; colitis (including hemorrhagic and exacerbation of ulcerative colitis, Crohn's disease), constipation, oral mucosal inflammation, esophageal disorders, intestinal stricture, pancreatitis, fulminant hepatitis; bullous rash, urticaria, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity, purpura, Henoch-Schönlein purpura, pruritus, acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
Rare: hypersensitivity, anaphylactic and pseudoanaphylactic reactions (including hypotension and shock), hepatitis, jaundice, liver function disorders, drowsiness, asthma (including dyspnea), gastritis, gastrointestinal bleeding, hematemesis, melena, black stools, gastric and/or duodenal ulcer (with or without bleeding and perforation), urticaria, edema.
Common: headache, dizziness of various origins; nausea, vomiting, diarrhea, dyspepsia, abdominal pain, bloating, anorexia, increased aminotransferase activity, rash.
Frequency not known: Kounis syndrome, ischemic colitis.
Taking such medicines as Dicloreum may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
If any of the above or other side effects not listed in this leaflet occur, the patient should inform their doctor.

The patient should stop taking Dicloreum and immediately consult their doctor if they experience:

• discomfort in the stomach, heartburn, or pain in the upper abdomen
• bloody vomiting, blood in the stool, blood in the urine
• skin problems such as rash or itching
• shortness of breath or difficulty breathing
• yellowing of the skin or whites of the eyes
• persistent sore throat or elevated body temperature
• swelling of the face, feet, or ankles
• severe migraine
• chest pain accompanied by coughing
• mild painful abdominal cramps and tenderness, starting soon after taking Dicloreum, followed by rectal bleeding or bloody diarrhea, usually within 24 hours 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 the patient has been taking Dicloreum for more than a few weeks, they should regularly consult their doctor to ensure that no side effects have occurred.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
ul. Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Dicloreum

Store at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: Expiry date. The expiry date refers to the last day of the month.
Do not use Dicloreum from packaging that has been damaged previously.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dicloreum contains

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

What Dicloreum looks like and what the packaging contains

The packaging contains 15 tablets in 1 blister pack or 30 tablets (2 blister packs of 15 tablets)
The blisters are made of aluminum/PVC/PE/PVDC and are placed in a cardboard box.

Marketing authorization 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
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
Alfasigma Polska Sp. z o.o.
ul. Al. Jerozolimskie 96
00-807 Warsaw
Phone: +48 22 824 03 64

Date of the last update of the leaflet:

Logo of the marketing authorization holder Alfasigma