Dicloreum retard

Leaflet attached to the packaging: information for the user

Dicloreum Retard 100 mg prolonged-release 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 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 Retard and what is it used for
• 2. Important information before taking Dicloreum Retard
• 3. How to take Dicloreum Retard
• 4. Possible side effects
• 5. How to store Dicloreum Retard
• 6. Contents of the pack and other information

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

Dicloreum Retard 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 Retard involves the inhibition of prostaglandin biosynthesis, which plays a key role in the pathogenesis of inflammation, pain, and fever.
The medicine is also available in 50 mg enteric-coated tablets and 75 mg/3ml solution for injection.
Dicloreum Retard 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 Retard

When not to take Dicloreum Retard

• if the patient is allergic to diclofenac or any other component of the 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, at least twice, due to NSAIDs or other causes
• Dicloreum Retard is contraindicated in the third trimester of pregnancy
• if the patient has severe renal, hepatic, or cardiac impairment
• if the patient has heart disease or cerebrovascular disease, such as myocardial infarction, stroke, transient ischemic attack (mini-stroke), or vascular occlusion of the heart or brain, or has undergone revascularization or bypass surgery

bleeding or vascular occlusion of the heart or brain, or has undergone revascularization or bypass surgery

• if the patient has circulatory disorders (peripheral vascular disease)
• if the patient has experienced asthma attacks, hives, or acute rhinitis after taking acetylsalicylic acid (aspirin) or other prostaglandin synthesis inhibitors (ibuprofen or naproxen)
• Dicloreum Retard is contraindicated in children under 18 years of age.

Warnings and precautions

• in patients with asthma and those prone to asthma attacks, as Dicloreum Retard 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 (reduced 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 Retard may enhance their effect
• in patients with liver dysfunction, diclofenac may worsen the condition; the doctor's instructions regarding liver function tests should be followed strictly.
• before taking Dicloreum Retard, the patient should inform their doctor if they have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as the medicine may sometimes impair the healing of intestinal wounds after surgery.

Taking such medications as Dicloreum Retard may be associated with a slight increase in the risk of myocardial infarction (heart attack) or stroke. This risk increases with long-term use of high doses. 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 Retard with other systemic NSAIDs, including selective cyclooxygenase-2 inhibitors (celecoxib).
Taking diclofenac may cause gastrointestinal bleeding, ulcers, or perforation (which can be fatal). This effect may be particularly dangerous when taking high doses of diclofenac, especially in patients with a history of gastrointestinal ulcers or the elderly.
If gastrointestinal symptoms occur while taking Dicloreum Retard (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.
If any of the above situations occur, the patient should inform their doctor before taking Dicloreum Retard.
The medicine may temporarily inhibit platelet aggregation.
In patients with severe liver impairment, close medical supervision is required.
During long-term use of Dicloreum Retard, it is recommended to monitor blood counts and renal and liver function preventively.
Certain individuals SHOULD NOT be given Dicloreum Retard.
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 other component of Dicloreum Retard (listed at the end of this leaflet). Symptoms of hypersensitivity include facial and lip edema (angioedema), difficulty breathing, chest pain, rhinitis, rash, or any other allergic reactions.

The risk of side effects can be reduced by using the smallest effective dose for the shortest duration necessary.

Dicloreum Retard 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 heart medication)
• Angiotensin-converting enzyme inhibitors, beta-adrenergic blockers (a group of medications used to treat hypertension and heart failure)
• Diuretics (medications that increase urine production)
• Non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen) and corticosteroids (medications used to relieve inflammation of the skin on various body surfaces)
• Anticoagulant and antiplatelet medications
• Antidiabetic medications (except insulin)
• Methotrexate (a medication used to treat certain cancers or arthritis)
• Cyclosporine and tacrolimus (medications used in organ transplant patients)
• Quinolone antibacterials and certain medications 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 Retard in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Dicloreum Retard 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. In the first 6 months of pregnancy, Dicloreum Retard should not be used unless the doctor considers it absolutely necessary. From the 20th week of pregnancy, Dicloreum Retard may cause renal disorders in the unborn child if taken for more than a few days.
This may lead to low amniotic fluid levels 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 Retard while breastfeeding, as it may harm 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 side effects that occur.
Elderly patients may be more sensitive to the effects of the medicine. The patient should follow the instructions in the leaflet, take the smallest effective dose as recommended by the doctor, and report any side effects that occur during treatment to their doctor.

Dicloreum Retard contains sodium

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 Retard

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient 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.
The recommended daily dose is 100 mg. The tablet should be swallowed whole, preferably during a meal.
The dosing regimen in elderly patients must be established 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 necessary duration reduces the risk of side effects.

Taking a higher dose of Dicloreum Retard than recommended

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

Missing a dose of Dicloreum Retard

If a dose 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 next dose should be taken according to the original schedule.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with Dicloreum Retard

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

4. Possible side effects

Like all medicines, Dicloreum Retard can cause side effects, although not everybody gets them.
Some side effects can 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 Retard, prolonged-release tablets, as well as those observed with other diclofenac formulations, used for short or long periods.
Very rare: thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), anemia (including hemolytic and aplastic anemia), agranulocytosis (lack of granulocytes), angioedema (including facial edema), disorientation, depression, insomnia, nightmares, irritability, psychotic disorders, paresthesia, memory disorders, seizures, anxiety, tremors, aseptic meningitis, taste disturbances, cerebrovascular accident; 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, stomatitis, oral and gastrointestinal lesions, esophageal disorders, intestinal stricture, pancreatitis, hepatic necrosis; bullous rash, urticaria, pruritus, photosensitivity, alopecia, allergic reactions to light, 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 duodenal ulcers (with or without bleeding and perforation), urticaria, edema.
Common: headache, dizziness of various origins; nausea, vomiting, diarrhea, dyspepsia, abdominal pain, bloating, anorexia, increased transaminase activity; rash.
Frequency not known: Kounis syndrome, ischemic colitis.
Taking such medications as Dicloreum Retard may be associated with a slight increase in the risk of myocardial infarction (heart attack) or stroke.
If the patient experiences any of the above or other side effects not listed in this leaflet, they should inform their doctor.

The patient should stop taking Dicloreum Retard and immediately contact their doctor if they notice:

• 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 Retard, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome (frequency not known - cannot be estimated from available data).

If the patient has been taking Dicloreum Retard 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 those not listed in this leaflet, they should inform 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:
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 Retard

Store in a temperature below 25°C.
Keep the medicine 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 Retard from damaged packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Dicloreum Retard contains

• The active substance is diclofenac sodium
• One prolonged-release tablet contains 100 mg of diclofenac sodium
• The other ingredients are talc, ethylcellulose, magnesium stearate, povidone, and the coating contains hydroxypropylcellulose, diethyl phthalate, ethylcellulose, magnesium stearate, and 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.
The blisters are made of PVC/PE/PVDC/Aluminum 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 last revision of the leaflet:

Logo of the marketing authorization holder Alfasigma