Dicloberl retard

Leaflet attached to the packaging: information for the user

Dicloberl retard

100 mg, prolonged-release hard capsules
Diclofenac sodium

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 Dicloberl retard and what is it used for
• 2. Important information before taking Dicloberl retard
• 3. How to take Dicloberl retard
• 4. Possible side effects
• 5. How to store Dicloberl retard
• 6. Package contents and other information

1. What is Dicloberl retard and what is it used for

Dicloberl retard is a pain-relieving and anti-inflammatory medicine (non-steroidal anti-inflammatory drug, NSAID).
Indications
Dicloberl retard is used to treat symptomatic pain and inflammation in the following indications:

• acute joint inflammation, including gout attacks,
• chronic joint inflammation, especially rheumatoid arthritis (chronic polyarthritis),
• Bechterew's disease (ankylosing spondylitis) and other rheumatic inflammatory diseases of the spine,
• exacerbations in degenerative joint disease and degenerative spine disease,
• inflammatory rheumatic diseases of the soft tissues,
• post-traumatic inflammatory conditions and edema.

Due to the delayed release of the active substance from Dicloberl retard, Dicloberl retard is not suitable for the treatment of conditions that require immediate therapeutic effect.
If there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Dicloberl retard

When not to take Dicloberl retard:

• if the patient is hypersensitive to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a history of breathing difficulties (bronchospasm), asthma attacks, chest pain, swelling of the nasal mucosa, or skin reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• if the patient has non-specific blood disorders;
• if the patient currently has stomach or intestinal ulcers, bleeding, or perforations (which may include bloody vomiting, bleeding during bowel movements, fresh blood in the stool, or black stools);
• if the patient has active or recurrent peptic ulcer disease and/or bleeding (two or more cases of confirmed ulcers or bleeding);
• if the patient has a history of gastrointestinal bleeding or perforation related to previous use of NSAIDs;
• if the patient has cerebral bleeding or other active bleeding;
• if the patient has severe liver or kidney failure;
• if the patient has heart disease and/or cerebrovascular disease, such as after a heart attack, stroke, transient cerebral ischemia, or vascular occlusion of the heart or brain, or after a procedure to clear or bypass blocked vessels;
• if the patient has circulatory disorders (peripheral arterial disease);
• within the last three months of pregnancy;
• in children and adolescents under 18 years of age due to too high a content of the active substance.

Warnings and precautions

The cases described below refer to situations in which particular caution should be exercised when taking Dicloberl retard, and it should only be used in a specific way (e.g., maintaining longer intervals between doses or using smaller doses of the medicine under medical supervision). You should ask your doctor about this. This also applies to situations that have occurred in the past.
Before starting treatment with Dicloberl retard, you should discuss it with your doctor or pharmacist.
General information
You should avoid taking Dicloberl retard and other anti-inflammatory medicines (NSAIDs), including medicines called COX-2 inhibitors, due to the lack of evidence of better therapeutic effect and the possibility of more or increased side effects.
Taking the medicine in the smallest effective dose for the shortest period necessary to alleviate symptoms may reduce the risk of side effects (see section 3, "How to take Dicloberl retard").
Gastrointestinal bleeding, ulcers, and perforation
There have been reports of gastrointestinal bleeding, stomach ulcers, and perforations with fatal outcomes in patients taking all NSAIDs, occurring at various times during treatment, with and without warning signs or previous severe gastrointestinal adverse effects.
The risk of gastrointestinal bleeding, stomach ulcers, and perforation increases with increasing NSAID doses and is higher in patients with a history of stomach ulcers and/or duodenal ulcers, especially if complicated by bleeding or perforation, as well as in the elderly. In such patients, treatment should be initiated and continued with the smallest available dose.
For such patients and patients requiring concomitant use of low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal adverse effects, concomitant use of medicines with a protective effect on the stomach lining (e.g., misoprostol or proton pump inhibitors) should be considered.
Patients who have experienced gastrointestinal adverse effects, especially the elderly, should report all abnormal abdominal symptoms (especially gastrointestinal bleeding), especially at the beginning of treatment.
Caution is advised when taking medicines that may increase the risk of stomach ulcers and/or duodenal ulcers or bleeding, such as systemic corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (used to treat depression), or antiplatelet agents (e.g., acetylsalicylic acid) (see section 2, "Dicloberl retard and other medicines").
In the event of gastrointestinal bleeding or stomach ulcers during treatment with Dicloberl retard, the medicine should be discontinued. The patient should be instructed to discontinue the medicine and consult a doctor if they experience severe abdominal pain, black stools, or bloody vomiting.
NSAIDs should be used with caution and under close medical supervision in patients with symptoms indicating gastrointestinal disease, in patients with a history of stomach ulcers and/or duodenal ulcers, bleeding, or perforations, and in patients with previous gastrointestinal disease (ulcerative colitis, Crohn's disease), as they may experience exacerbation of these conditions (see section 4, "Possible side effects").
Before taking Dicloberl retard, you should tell your doctor if you have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Dicloberl retard may sometimes cause impaired wound healing in the intestines after surgery.
Effect on the cardiovascular system
Taking medicines like Dicloberl retard may be associated with an increased risk of heart attack ("myocardial infarction") or stroke.
Before taking Dicloberl retard, you should inform your doctor

• if you smoke
• if you have diabetes
• if you have angina pectoris, blood clots, high blood pressure, high cholesterol levels, or high triglyceride levels.

Taking the medicine in the smallest effective dose for the shortest period necessary to alleviate symptoms reduces the risk of side effects.
In the event of heart disease or a previous stroke, you should discuss the treatment with your doctor or pharmacist.
Skin reactions
Very rarely, severe skin reactions with redness and blisters have been reported in association with NSAID use, some of which were fatal (exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis/Lyell's syndrome, see section 4, "Possible side effects"). It appears that the greatest risk of these reactions occurs at the beginning of treatment: in most cases, the onset of such a reaction occurs during the first month of treatment.
In the event of the first signs of a skin rash, mucosal lesions (e.g., oral or nasal), or other symptoms of hypersensitivity, Dicloberl retard should be discontinued immediately, and a doctor should be consulted.
Effect on the liver
Before deciding to start treatment with diclofenac in patients with liver function disorders, caution should be exercised (consult a doctor or pharmacist), as they may experience worsening of the disease. Like other non-steroidal anti-inflammatory drugs (NSAIDs) containing diclofenac, the activity of one or more liver enzymes may be elevated. If diclofenac is to be used for a long time or repeatedly, it is recommended as a precautionary measure to regularly monitor liver function parameters. Dicloberl retard should be discontinued immediately in the event of clinical symptoms of liver failure.
Liver inflammation may occur without prior warning signs during diclofenac use.
Caution should be exercised when using Dicloberl retard in patients with porphyria (a blood disorder), as the medicine may exacerbate the disease.
Effect on the kidneys
Due to reports of fluid retention and edema associated with NSAID treatment, including diclofenac, particular caution should be exercised in patients with renal function disorders, a history of hypertension, the elderly, patients taking diuretics or medicines that significantly affect kidney function, and patients with significantly reduced extracellular fluid volume for any reason, e.g., before or after major surgery. In these cases, as a precautionary measure, kidney function should be monitored after taking diclofenac. Discontinuation of treatment usually leads to a return to the pre-treatment state.
Other

The doctor will prescribe Dicloberl retard to the patient after careful consideration of the benefit-risk ratio:

• in certain congenital blood disorders (e.g., acute intermittent porphyria),
• in certain autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease).

Treatment with Dicloberl retard requires special medical supervision if:

• the patient has allergic reactions (e.g., skin reactions to other medicines, asthma, hay fever), chronic swelling of the nasal mucosa, or chronic respiratory diseases with bronchial obstruction, or chronic respiratory infections, as they have an increased risk of allergic reactions

Rarely, severe, acute hypersensitivity reactions (e.g., anaphylactic shock) may occur. After the first symptoms of a hypersensitivity reaction to Dicloberl retard, the medicine should be discontinued. Medical personnel will initiate appropriate symptomatic treatment.
Diclofenac may periodically inhibit platelet aggregation. Therefore, patients with coagulation disorders should be closely monitored.
Like other NSAIDs, Dicloberl retard may mask the signs and symptoms of infection. In the event of signs of infection (e.g., redness, swelling, increased temperature, pain, fever) or their worsening during treatment with Dicloberl retard, the patient should immediately consult a doctor.
If the patient is taking medicines that inhibit blood clotting or lower blood sugar levels, it is recommended to monitor coagulation parameters or blood sugar levels as a precautionary measure.
During long-term use of Dicloberl retard, regular monitoring of liver function parameters, kidney function, and blood morphology is required.
The patient should inform their doctor or dentist about taking Dicloberl retard before surgical procedures.
If painkillers are used for a long time, headaches may occur, which should not be treated by increasing the dose of these medicines. The patient should consult a doctor if they frequently experience headaches despite taking Dicloberl retard.
Habitual use of painkillers, especially combinations of several active substances with analgesic effects, may cause irreversible kidney damage, associated with the risk of kidney failure (analgesic nephropathy)

Children and adolescents

Dicloberl retard should not be used in children and adolescents under 18 years of age (see section 2, "When not to take Dicloberl retard").
Elderly
Due to the possibility of side effects in the elderly, they should be monitored particularly closely. Caution is advised in the elderly due to concomitant diseases. In particular, in frail elderly patients or those with low body weight, the use of the smallest effective dose is recommended. The frequency of side effects during NSAID treatment, especially gastrointestinal bleeding, ulcers, and perforation, is higher in the elderly. These gastrointestinal reactions usually have more serious consequences in the elderly and may lead to death.

Dicloberl retard and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Other NSAIDs (including acetylsalicylic acid) and corticosteroids
Taking Dicloberl retard concomitantly with other anti-inflammatory and analgesic medicines from the NSAID group or corticosteroids (anti-inflammatory or hormonal replacement therapy medicines) increases the risk of stomach ulcers and/or duodenal ulcers and gastrointestinal bleeding. Diclofenac should not be taken with other NSAIDs.
Digoxin, phenytoin, and lithium
Concomitant use of Dicloberl retard with digoxin (a medicine used to treat heart rhythm disorders), phenytoin (a medicine used to treat seizures), or lithium (a medicine used to treat mental disorders) may increase the levels of these medicines in the blood. Monitoring of lithium levels in the blood is necessary. Monitoring of digoxin and phenytoin levels in serum is recommended.
Diuretics, beta-blockers, ACE inhibitors, and angiotensin II antagonists
Dicloberl retard may reduce the effect of diuretics and blood pressure-lowering medicines (e.g., beta-blockers, ACE inhibitors, and angiotensin II antagonists). Therefore, blood pressure should be monitored periodically.
Dicloberl retard may reduce the effect of ACE inhibitors and angiotensin II antagonists (medicines used to treat heart disease and lower blood pressure). Concomitant use of these medicines with Dicloberl retard may increase the risk of kidney function disorders. Patients should be properly hydrated, and kidney function should be monitored periodically after starting treatment and at appropriate intervals thereafter.
Concomitant use of Dicloberl retard with potassium-sparing diuretics (certain diuretics) may lead to increased potassium levels in the blood. Therefore, regular monitoring of potassium levels is recommended.
Selective serotonin reuptake inhibitors (SSRIs)
Certain antidepressants (selective serotonin reuptake inhibitors [SSRIs]) may increase the risk of gastrointestinal bleeding and ulcers.
Methotrexate
Taking Dicloberl retard within 24 hours before or after methotrexate administration (a medicine used to treat inflammatory diseases and certain cancers) may increase methotrexate levels in the blood and increase side effects.
Cyclosporin
Non-steroidal anti-inflammatory drugs (including diclofenac) may increase the toxic effect of cyclosporin on the kidneys (a medicine used to prevent transplant rejection and treat rheumatic diseases). The patient should take a lower dose of diclofenac.
Anticoagulant and antiplatelet medicines:
Non-steroidal anti-inflammatory drugs may increase the effect of antiplatelet and anticoagulant medicines (used to prevent blood clotting), such as warfarin. More frequent medical check-ups may be necessary.
Probenecid
Medicines containing probenecid (used to treat gout) may slow down the excretion of diclofenac. This may lead to increased side effects.
Antidiabetic medicines
During treatment with medicines that lower blood sugar levels (antidiabetic medicines), there have been isolated reports of the effect of diclofenac on blood sugar levels, which required adjustment of the antidiabetic medicine dose. Therefore, as a precautionary measure, blood sugar levels should be monitored at the same times.
Quinolone antibacterials
Quinolones (a type of antibiotic) may cause seizures during concomitant use with NSAIDs.
Cholestyramine and colestipol
These substances (medicines used to lower blood lipid levels) may slow down or reduce the absorption of diclofenac. Therefore, it is recommended to take Dicloberl retard at least one hour before or 4 to 6 hours after taking cholestyramine or colestipol.
Strong CYP2C9 inhibitors
Voriconazole (a medicine used to treat severe fungal infections) and sulfinpyrazone (a medicine used to treat gout) may increase diclofenac levels in the blood when taken concomitantly. This may lead to accumulation of diclofenac in the body and increase its side effects.
Tenofovir
Taking tenofovir (a medicine used to treat viral hepatitis B and to prevent and treat HIV/AIDS) at the same time as NSAIDs (such as diclofenac) may increase urea and creatinine levels in the blood (kidney function parameters). Therefore, kidney function should be monitored to check for possible increases in these parameters.
Deferasirox
Taking deferasirox (a medicine used in patients undergoing multiple blood transfusions due to various types of anemia) at the same time as NSAIDs (such as diclofenac) may increase the risk of gastrointestinal adverse effects. Therefore, the doctor should closely monitor patients taking deferasirox with NSAIDs.
Mifepristone
Used to terminate pregnancy. NSAIDs should not be taken for 8-12 days after mifepristone administration due to the theoretical risk that prostaglandin synthesis inhibitors may alter the effectiveness of mifepristone.
Pemetrexed
Concomitant use of pemetrexed and NSAIDs may increase the effect of pemetrexed, so particular caution should be exercised when administering high doses of NSAIDs.

Dicloberl retard and alcohol

Alcohol should not be consumed during treatment with Dicloberl retard.

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 a doctor or pharmacist before taking this medicine.
Pregnancy
The doctor should be informed if the patient becomes pregnant during treatment with Dicloberl retard. Dicloberl retard may be used in the first and second trimester of pregnancy only after consulting a doctor.
Dicloberl retard should not be taken if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Dicloberl retard may cause kidney and heart disorders in the unborn child. It may also increase the risk of bleeding in the mother and child and cause delayed or prolonged labor. During the first six months of pregnancy, Dicloberl retard should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Dicloberl retard, if taken for more than a few days, may cause kidney disorders in the unborn child - this may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in the child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Like other NSAIDs, diclofenac passes into breast milk in small amounts. To avoid side effects in the infant, diclofenac should not be used during breastfeeding.
Fertility
Like all medicines that inhibit prostaglandin synthesis, Dicloberl retard may make it more difficult to conceive. If the patient plans to conceive or has problems conceiving, they should inform their doctor.

Driving and using machines

When taking high doses of Dicloberl retard, side effects related to the central nervous system, such as fatigue and dizziness, may occur, and the ability to drive vehicles or operate machinery may be impaired. This is especially true when the medicine is taken concomitantly with alcohol. The patient may have impaired ability to react quickly and appropriately to unexpected and sudden events. If the above-mentioned symptoms occur, the patient should not drive vehicles or operate machinery. They should not work without proper support for their feet.

Dicloberl retard contains sucrose

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

Dicloberl retard contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Dicloberl retard

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.

Dosage

If the doctor has not prescribed otherwise, the medicine should be taken as follows:

Diclofenac is dosed according to the severity of the disease. The recommended daily dose for adults is 50 to 150 mg of diclofenac sodium.
Adults: 1 prolonged-release hard capsule per day (corresponding to 100 mg of diclofenac sodium).

Method of administration

The Dicloberl retard capsule should be swallowed whole, with a large amount of liquid. In patients with sensitive stomachs, it is recommended to take Dicloberl retard with meals.

Treatment duration

The doctor will decide on the treatment duration.
In rheumatic diseases, long-term use of Dicloberl retard may be required.
Taking the medicine in the smallest effective dose for the shortest period necessary to alleviate symptoms reduces the risk of side effects (see "Warnings and precautions").
If the patient feels that the effect of Dicloberl retard is too strong or too weak, they should consult a doctor.

Taking a higher dose of Dicloberl retard than recommended

Dicloberl retard should be taken as directed by the doctor or according to the dosage information in the leaflet. If the patient feels that the analgesic effect of the medicine is insufficient, they should not increase the dose of the medicine but should consult a doctor.
There are no characteristic clinical symptoms resulting from diclofenac overdose.
Overdose symptoms may include central nervous system disorders, such as headache, dizziness, feeling of emptiness in the head, excitement, irritability, or drowsiness, as well as abdominal pain, nausea, vomiting, and gastrointestinal bleeding. Additionally, kidney or liver function disorders may occur, as well as a sudden decrease in blood pressure, breathing difficulties (respiratory depression), and blue discoloration of the skin and mucous membranes (cyanosis).
There is no specific antidote.
In the event of suspected overdose, the patient should inform their doctor. Depending on the severity of the poisoning, the doctor will decide on the appropriate treatment.

Missing a dose of Dicloberl retard

A double dose should not be taken to make up for a missed dose.
In case of doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Dicloberl retard can cause side effects, although not everybody gets them.
Some side effects can be serious. If the patient experiences any of the following side effects, they should discuss them with their doctor, who will decide on further action.
The occurrence of the following side effects depends mainly on the dose used and varies from person to person.
The most common side effects are gastrointestinal disorders. Stomach ulcers and/or duodenal ulcers (peptic ulcers) may occur, as well as perforation or gastrointestinal bleeding, sometimes leading to death, especially in the elderly (see section 2, "Warnings and precautions"). Nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bloody vomiting, stomach inflammation, and oral mucosal inflammation have been reported after taking the medicine (see section 2, "Warnings and precautions").

The patient should stop taking Dicloberl retard and consult a doctor immediately if they notice:

• mild painful abdominal cramps and tenderness, starting soon after taking Dicloberl retard, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain (frequency not known - cannot be estimated from available data).

The patient should tell their doctor immediately if they experience any of the following symptoms:

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Edema (fluid retention), high blood pressure, and heart failure have been reported in association with NSAID treatment.
Taking medicines like Dicloberl retard may be associated with an increased risk of arterial thrombosis, e.g., heart attack or stroke (see section 2, "When not to take Dicloberl retard" and "Warnings and precautions").
Common:may affect up to 1 in 10 people

• gastrointestinal disorders, such as nausea, vomiting, and diarrhea, as well as minor gastrointestinal bleeding, which may lead to anemia (a decrease in red blood cells);
• hypersensitivity reactions, such as rash and itching;
• central nervous system disorders, such as headache, dizziness, feeling of emptiness in the head, excitement, irritability, or drowsiness;
• digestive disorders (indigestion), bloating, stomach cramps (abdominal pain), loss of appetite, stomach ulcers and/or duodenal ulcers (with a risk of bleeding or perforation);
• increased liver enzyme activity in the blood;
• vertigo of labyrinthine origin.

Uncommon:may affect up to 1 in 100 people

• hives (in such cases, the medicine should be discontinued immediately, and a doctor should be consulted);
• bloody vomiting, blood in the stool, or bloody diarrhea;
• liver damage (especially during long-term treatment), liver inflammation with or without jaundice (very rarely having a fulminant course, even without preceding symptoms);
• hair loss;
• edema (fluid retention), especially in patients with hypertension or kidney function disorders.

Rare:may affect up to 1 in 1,000 people

• hypersensitivity, anaphylactic, and pseudoanaphylactic reactions (may manifest as bronchospasm, dyspnea, tachycardia, hypotension, and shock);
• stomach inflammation, gastrointestinal bleeding;
• kidney function disorders;
• asthma, including breathing difficulties (dyspnea).

Very rare:may affect up to 1 in 10,000 people

• worsening of infections (e.g., development of necrotizing fasciitis) in temporal relation to systemic use of NSAIDs (a group of medicines to which Dicloberl retard also belongs); In the event of signs of infection (e.g., redness, swelling, increased temperature, pain, fever) or their worsening during treatment with Dicloberl retard, the patient should immediately consult a doctor. The doctor will determine whether there are indications for treatment with antibiotics or other medicines;
• symptoms of meningitis (e.g., headache, nausea, vomiting, fever, stiff neck, or impaired consciousness) have occurred during diclofenac use. It appears that patients with concomitant autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are more likely to experience the above-mentioned side effects;
• blood disorders [anemia (a decrease in red blood cells), leukopenia (a decrease in white blood cells), thrombocytopenia (a decrease in platelets), pancytopenia (a decrease in red and white blood cells and platelets), agranulocytosis (a serious, life-threatening decrease in neutrophil count), hemolytic or aplastic anemia (a decrease in red blood cells due to their faster breakdown)]. The first symptoms of these disorders may be fever, sore throat, mouth ulcers, flu-like symptoms, significant fatigue, nosebleeds, and skin bleeding. In such cases, the medicine should be discontinued immediately, and a doctor should be consulted. The patient should not take painkillers or antipyretics on their own. During long-term use, blood parameters should be regularly monitored;
• angioedema (swelling of the face, tongue, or larynx). If one of these symptoms occurs, which can happen even after a single dose of the medicine, diclofenac should be discontinued, and medical help should be sought immediately;
• allergic vasculitis and lung inflammation;
• psychotic reactions, depression, anxiety, insomnia, nightmares;
• impaired sensation, impaired taste, impaired memory, disorientation, seizures, tremors, stroke (cerebrovascular disorders);
• visual disturbances (blurred or double vision);
• tinnitus, hearing disorders;
• palpitations, chest pain, impaired heart function (heart failure), heart attack (myocardial infarction);
• high blood pressure (hypertension);
• stomach inflammation, including oral mucosal inflammation, tongue inflammation, esophageal damage, as well as lower abdominal symptoms such as colon inflammation, including bloody colon inflammation or worsening of Crohn's disease or ulcerative colitis (inflammatory diseases of the colon with accompanying ulcers), pancreatitis. In the event of severe abdominal pain, bloody vomiting, black stools, or blood in the stool, Dicloberl retard should be discontinued, and a doctor should be consulted immediately;
• liver necrosis, liver failure (during long-term treatment, liver function parameters should be monitored at regular intervals);
• severe skin reactions, such as skin rash with redness (exanthema, rash, polymorphic erythema), skin rash with blisters (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell's syndrome), or skin peeling (exfoliative dermatitis), photosensitivity (hypersensitivity reactions to light), local skin bleeding (purpura), which may also have an allergic character;
• kidney damage (interstitial nephritis), which may be accompanied by acute kidney function disorders (kidney failure), proteinuria (protein in the urine), and/or hematuria (blood in the urine), nephrotic syndrome (edema and increased protein in the urine). Therefore, kidney function should be monitored at regular intervals. Decreased urine output, fluid retention in the body (edema), as well as general malaise may be symptoms of kidney disease, including kidney failure. If these symptoms occur or worsen during treatment with Dicloberl retard, the patient should discontinue the medicine and consult a doctor immediately;

Frequency not known:frequency cannot be estimated from available data

• ischemic colitis.

The patient should follow the instructions provided above regarding certain side effects!

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, or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: (22) 49-21-301
Fax: (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 Dicloberl retard

The medicine should be stored out of the sight and reach of children.
Dicloberl retard should not be taken after the expiration date stated on the carton after EXP. The expiration date refers to the last day of the month stated.
Store at a temperature below 25°C.
Store in the original packaging to protect from moisture.
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. Package contents and other information

What Dicloberl retard contains

The active substance of the medicine is diclofenac sodium.
Each prolonged-release hard capsule contains 100 mg of diclofenac sodium.
The other ingredients are sucrose, cornstarch, shellac, talc, ammonium methacrylate copolymer (type A) (Eudragit RL PO), sodium hydroxide, gelatin, titanium dioxide (E 171).

What Dicloberl retard looks like and contents of the pack

White gelatin capsules containing white to slightly yellowish granules, packaged in a blister pack of PP-COC-PP foil, closed with a soft aluminum foil, in a cardboard box.
The original packaging contains 10 or 20 prolonged-release hard capsules.

Marketing authorization holder and manufacturer

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin, Germany
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: +48 22 566 21 00
Fax: +48 22 566 21 01
Date of last revision of the leaflet:06/2023