Dicloberl retard: detailed information

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Dicloberl retard
100 mg, prolonged-release capsules, hard
Diclofenacum natricum
Please read the entire leaflet carefully before using this 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, 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 you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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

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

Dicloberl retard is a pain-relieving and anti-inflammatory medicine (non-steroidal anti-inflammatory drug, NSAID).
Indications
Dicloberl retard is used for the symptomatic treatment of pain and inflammation in the following conditions:

Acute arthritis, including gout attacks,
Chronic arthritis, particularly rheumatoid arthritis (chronic polyarthritis),
Ankylosing spondylitis (Bechterew's disease) and other inflammatory rheumatic diseases of the spine,
Exacerbations in osteoarthritis and degenerative spinal disease,
Inflammatory rheumatic diseases of soft tissues,
Post-traumatic inflammatory conditions and oedema.

Due to the delayed release of the active substance from Dicloberl retard, this medicine is not suitable for treating conditions requiring immediate therapeutic action.
If there is no improvement or if the patient feels worse, medical advice should be sought.

2. Important information before using Dicloberl retard

When not to use Dicloberl 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 previously experienced breathing difficulties (bronchospasm), asthma attacks, chest pain, nasal mucosal swelling, or skin reactions after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
if the patient has non-specific blood disorders; Page 1 of 12
if the patient currently has gastric or intestinal ulcers, bleeding, or perforations (this may include bloody vomiting, bleeding during defecation, fresh blood in stool, or tarry stools);
if the patient has active or recurrent peptic ulcer or duodenal ulcer and (or) bleeding (two or more episodes of confirmed ulceration or bleeding);
if the patient has a history of gastrointestinal bleeding or perforation related to previous use of NSAIDs;
if the patient has cerebral haemorrhage or any other active bleeding;
if the patient has severe liver or kidney failure;
if the patient has heart disease and (or) cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischaemic attack, or arterial embolism in the heart or brain, or after a procedure to open blocked vessels or bypass surgery;
if the patient has peripheral vascular disease (circulatory disorders);
during the last three months of pregnancy;
in children and adolescents under 18 years of age due to the high content of active substance.

Warnings and precautions
The situations described below require special caution when using Dicloberl retard, and the medicine should only be used in a specific manner (e.g. with longer intervals between doses or lower doses under medical supervision). Please consult your doctor about this. This also applies to conditions that occurred in the past.
Before starting treatment with Dicloberl retard, discuss this with your doctor or pharmacist.
General information
Avoid concomitant use of Dicloberl retard and other anti-inflammatory drugs (NSAIDs), including drugs known as cyclooxygenase-2 (COX-2) inhibitors, due to lack of evidence of better therapeutic effect and the possibility of increased number or severity of adverse effects.
Taking the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms may reduce the risk of adverse effects (see section 3 "How to use Dicloberl retard").
Gastrointestinal bleeding, peptic ulcer, and perforation
Gastrointestinal bleeding, gastric and (or) duodenal ulcers, and perforations with fatal outcomes have been reported with the use of all NSAIDs, occurring at various times during treatment, with or without warning symptoms or prior serious gastrointestinal adverse effects.
The risk of gastrointestinal bleeding, gastric and (or) duodenal ulcers, and perforation increases with higher NSAID doses, is greater in patients with a history of peptic ulcer disease, especially if complicated by bleeding or perforation, and in elderly patients. In such patients, treatment should be initiated and continued using the lowest available dose.
In such patients and in patients requiring concomitant use of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal adverse effects, consider concomitant use of gastroprotective agents (e.g. misoprostol or proton pump inhibitors).
Patients who experience gastrointestinal adverse effects, especially elderly patients, should report any abnormal abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.
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Caution is advised when taking drugs that may increase the risk of gastric and (or) duodenal ulcers or bleeding, such as systemic corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors used, among others, in the treatment of depression, or antiplatelet drugs such as acetylsalicylic acid (see section 2 "Dicloberl retard with other medicines").
If gastrointestinal bleeding or gastric and (or) duodenal ulcer occurs during treatment with Dicloberl retard, the medicine should be discontinued. The patient should be instructed to stop taking the medicine and seek medical advice if acute upper abdominal pain, tarry stools, or bloody vomiting occur.
NSAIDs should be used cautiously and under strict medical supervision in patients with symptoms indicating gastrointestinal disorders, in patients with a history of gastric and (or) duodenal ulcer symptoms, bleeding or perforation, and in patients with previous gastrointestinal diseases (ulcerative colitis, Crohn's disease), as these conditions may worsen (see section 4 "Possible side effects").
Before using Dicloberl retard, inform your doctor if the patient has recently undergone or has planned surgery on the stomach or gastrointestinal tract, as Dicloberl retard may sometimes impair intestinal wound healing after surgery.
Effect on the cardiovascular system
Taking medicines such as Dicloberl retard may be associated with an increased risk of heart attack ("myocardial infarction") or stroke.
Before taking Dicloberl retard, inform your doctor

if the patient smokes
if the patient has diabetes
if the patient has angina, blood clots, hypertension, elevated cholesterol, or elevated triglycerides.

Taking the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.
In case of heart disease or previous stroke, discuss the treatment approach with your doctor or pharmacist.
Skin reactions
Severe skin reactions with redness and blisters, some fatal (exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis/Lyell's syndrome) have been very rarely reported with NSAID use (see section 4 "Possible side effects"). The highest risk of these reactions appears to occur early in treatment: in most cases, onset occurs within the first month of treatment.
If the first signs of skin rash, mucosal changes (e.g. in the mouth or nose), or other hypersensitivity symptoms occur, discontinue Dicloberl retard immediately and contact your doctor.
Effect on the liver
Exercise caution before starting diclofenac treatment in patients with liver function disorders (consult your doctor or pharmacist), as their condition may worsen. Like other nonsteroidal anti-inflammatory drugs (NSAIDs) containing diclofenac, the activity of one or more liver enzymes may increase. If diclofenac is to be used long-term or repeatedly, regular monitoring of liver function parameters is recommended as a precaution. Dicloberl retard should be discontinued immediately if clinical signs of liver failure occur.
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Hepatitis without preceding warning symptoms may occur during diclofenac use.
Exercise caution when using Dicloberl retard in patients with hepatic porphyria (a blood disorder), as the medicine may trigger an exacerbation of the disease.
Effect on the kidneys
Due to reported cases of fluid retention and oedema associated with NSAID treatment, including diclofenac, special caution is required in patients with kidney function disorders, a history of hypertension, elderly patients, patients concurrently using diuretics or drugs that significantly affect kidney function, and patients with significant reduction in extracellular fluid volume for any reason, e.g. before or after major surgery. In these cases, monitoring of kidney function is recommended as a precaution after diclofenac use. Discontinuation of treatment usually leads to return to the pre-treatment state.
Other
The doctor will prescribe Dicloberl retard only after careful consideration of the benefit-risk ratio:

in certain inherited 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 monitoring if:

the patient has allergic reactions (e.g. skin reactions to other drugs, asthma, hay fever), chronic nasal mucosal oedema, or chronic respiratory diseases with airway narrowing, or chronic respiratory infections, as they have an increased risk of allergic reactions.

Severe, acute hypersensitivity reactions (e.g. anaphylactic shock) may rarely occur. If the first symptoms of hypersensitivity occur after taking Dicloberl retard, discontinue the medicine. Medical professionals will initiate appropriate symptomatic treatment.
Diclofenac may temporarily inhibit platelet aggregation. Therefore, patients with coagulation disorders should be carefully monitored.
Like other NSAIDs, Dicloberl retard may mask objective and subjective signs of infection. If signs of infection (e.g. redness, swelling, warmth, pain, fever) occur or worsen during treatment with Dicloberl retard, contact your doctor immediately.
If the patient is concurrently taking drugs that inhibit blood coagulation or lower blood glucose, coagulation parameters or blood glucose levels should be monitored preventively.
During long-term use of Dicloberl retard, regular monitoring of liver function, kidney function, and blood morphology is required.
Inform your doctor or dentist about taking Dicloberl retard before surgical procedures.
If analgesics are used long-term, headache may occur, which should not be treated by increasing the dose of these medicines. Consult your doctor if the patient frequently experiences headaches despite using Dicloberl retard.
Habitual use of analgesics, 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
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Dicloberl retard should not be used in children and adolescents under 18 years of age (see section 2 "When not to use Dicloberl retard").
Elderly patients
Due to the risk of adverse effects in elderly patients, they should be monitored particularly closely. Caution is advised in elderly patients due to coexisting diseases. In particular, in frail elderly patients or those with low body weight, the lowest effective dose is recommended. The frequency of adverse effects during NSAID treatment, especially gastrointestinal bleeding, ulcers, and perforations, is higher in elderly patients. These gastrointestinal reactions usually have more serious consequences in elderly patients and may lead to death.
Dicloberl retard with other medicines
Inform your doctor about all medicines currently or recently taken by the patient, as well as medicines the patient plans to take.
Other NSAIDs (including acetylsalicylic acid) and corticosteroids
Concomitant use of Dicloberl retard with other anti-inflammatory and analgesic NSAIDs or corticosteroids (anti-inflammatory drugs or used in hormone replacement therapy) increases the risk of gastric and (or) duodenal ulcers and gastrointestinal bleeding. Do not take diclofenac with other NSAIDs.
Digoxin, phenytoin, and lithium
Concomitant use of Dicloberl retard with digoxin (used to treat heart rhythm disorders), phenytoin (used to treat epileptic seizures), or lithium (used to treat psychiatric disorders) may increase blood levels of these drugs. Monitoring of lithium blood levels is necessary. Monitoring of digoxin and phenytoin serum levels is recommended.
Diuretics, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and angiotensin II antagonists
Dicloberl retard may reduce the effectiveness of diuretics and antihypertensive drugs (diuretics and antihypertensives, e.g. beta-blockers, ACE inhibitors, and angiotensin II antagonists). Therefore, blood pressure should be monitored periodically.
Dicloberl retard may reduce the effectiveness of ACE inhibitors and angiotensin II antagonists (drugs used in heart diseases and antihypertensives). Concomitant use of these drugs with Dicloberl retard may increase the risk of kidney function disorders.
Patients should be adequately hydrated, and kidney function should be monitored periodically after starting treatment and subsequently at appropriate intervals.
Concomitant use of Dicloberl retard with potassium-sparing diuretics (some diuretics) may lead to increased blood potassium levels. Therefore, regular monitoring of potassium levels is recommended.
Selective serotonin reuptake inhibitors (SSRIs)
Some 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 (used in inflammatory diseases and treatment of certain cancers) may increase methotrexate blood levels and increase adverse effects.
Cyclosporine
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Nonsteroidal anti-inflammatory drugs (including diclofenac) may increase the nephrotoxic effects of cyclosporine (used to prevent transplant rejection and in the treatment of rheumatic diseases). The patient should use a lower dose of diclofenac.
Anticoagulants and antiplatelet drugs:
Nonsteroidal anti-inflammatory drugs may enhance the effects of antiplatelet and anticoagulant drugs (used to prevent blood clotting), such as warfarin. More frequent doctor visits may be necessary.
Probenecid
Drugs containing probenecid (used to treat gout) may slow the elimination of diclofenac. This may lead to increased adverse effects.
Antidiabetic drugs
Single cases of diclofenac affecting blood glucose levels have been reported during use of glucose-lowering drugs (antidiabetics), necessitating dose adjustment of antidiabetic drugs. Therefore, as a precaution, blood glucose levels should be monitored at the same times when these drugs are used concomitantly.
Antibacterial quinolones
Quinolones (some types of antibiotics) may cause epileptic seizures when used concomitantly with NSAIDs.
Colestipol and cholestyramine
These compounds (drugs used to lower blood lipid levels) may slow or reduce the absorption of diclofenac. Therefore, Dicloberl retard should be taken at least one hour before or 4 to 6 hours after colestipol or cholestyramine.
Strong CYP2C9 inhibitors
Voriconazole (used to treat severe fungal infections) and sulfinpyrazone (used to treat gout) may increase diclofenac blood levels when used concomitantly. This may lead to accumulation of diclofenac in the body and intensify its adverse effects.
Tenofovir
Concomitant use of tenofovir (used to treat hepatitis B and to prevent and treat HIV/AIDS) with NSAIDs (such as diclofenac) may increase blood urea nitrogen and creatinine levels (kidney function parameters). Kidney function should therefore be monitored to check for possible increases in these parameters.
Deferasirox
Concomitant use of deferasirox (used in patients undergoing repeated blood transfusions due to various types of anaemia) with NSAIDs (such as diclofenac) may increase the risk of gastrointestinal adverse effects. Therefore, physicians should carefully monitor patients taking deferasirox concomitantly with NSAIDs.
Mifepristone
Used to terminate pregnancy. Do not use NSAIDs for 8-12 days after mifepristone administration due to the theoretical risk that prostaglandin synthesis inhibitors may alter mifepristone's effectiveness.
Pemetrexed
Concomitant use of pemetrexed and NSAIDs may intensify pemetrexed's effects; therefore, special caution is required when administering high doses of NSAIDs.
Dicloberl retard and alcohol
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Do not consume alcohol during treatment with Dicloberl retard.
Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if pregnancy is detected during treatment with Dicloberl retard. Dicloberl retard may be used during the first and second trimesters of pregnancy only after consultation with a doctor.
Do not take Dicloberl retard during 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 function disorders in the unborn child. It may increase the tendency to bleeding in both the mother and child and may delay or prolong labour. Dicloberl retard should not be used during the first 6 months of pregnancy unless the doctor considers its use absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Dicloberl retard, if taken for longer than a few days, may cause kidney function disorders in the unborn child—this may lead to reduced amniotic fluid volume surrounding the child (oligohydramnios) or narrowing of blood vessels (ductus arteriosus) in the child's heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.
Breastfeeding
Like other NSAIDs, diclofenac passes into small amounts into breast milk of nursing mothers. To avoid adverse effects in the infant, diclofenac should not be used during breastfeeding.
Effect on fertility
Like all drugs that inhibit prostaglandin synthesis, Dicloberl retard may impair fertility. If the patient plans to conceive or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
When taking high doses of Dicloberl retard, adverse effects on the central nervous system such as fatigue and dizziness may occur. In individual cases, the ability to drive motor vehicles and operate mechanical equipment may be impaired. This is especially relevant when the medicine is taken concomitantly with alcohol. The patient may have limited ability to react quickly and appropriately to unexpected and sudden events. If the above symptoms occur, do not drive or operate machinery. Do not work without proper foot support.
Dicloberl retard contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.
Dicloberl retard contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Dicloberl retard

This medicine should always be used as directed by the physician. If in doubt, consult a
doctor or pharmacist.
Dosage
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Unless otherwise directed by the physician, the medicine should be used as follows:
Diclofenac is dosed according to the severity of the disease. The recommended daily dose for
adults is 50 to 150 mg of sodium diclofenac.
Adults: 1 prolonged-release hard capsule per day (corresponding to 100 mg of sodium diclofenac).
Method of administration
Dicloberl retard capsules should be swallowed whole with a large amount of fluid. In patients with a sensitive stomach, it is recommended to take Dicloberl retard with food.
Duration of treatment
The duration of treatment will be determined by the physician.
Long-term use of Dicloberl retard may be required in rheumatic diseases.
Taking the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects (see “Warnings and precautions”).
If you feel that the effect of Dicloberl retard is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Dicloberl retard
Dicloberl retard should be used as directed by the physician or as stated in the dosage instructions in this leaflet. If the patient feels that the analgesic effect of the medicine is insufficient, the dose should not be increased; instead, contact the physician.
There are no specific clinical symptoms characteristic of diclofenac overdose.
Symptoms of overdose may include central nervous system disturbances such as headache, dizziness, feeling of faintness, and loss of consciousness (in children, also myoclonic seizures), as well as abdominal pain, nausea, and vomiting. Additionally, gastrointestinal bleeding and disturbances in liver and kidney function may occur. A sudden drop in blood pressure, breathing difficulties (respiratory depression), and blue-red discoloration of the skin and mucous membranes (cyanosis) may also occur.
There is no specific antidote.
In case of suspected overdose, inform a doctor immediately. Depending on the severity of poisoning, the doctor will decide on appropriate treatment.
Missed dose of Dicloberl retard
Do not take a double dose to make up for a missed dose.
If in doubt about the use of this medicine, consult a doctor or pharmacist.

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. If any of the adverse effects listed below occur, discuss them with your physician, who will decide on further management.
The occurrence of the following adverse effects primarily depends on the dose used and may vary between individuals.
The most commonly observed adverse effects are gastrointestinal disorders. Gastric and/or duodenal ulceration (peptic ulcers), gastrointestinal perforation or bleeding may occur, sometimes leading to death, particularly in elderly patients (see section 2 "Warnings and precautions"). Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, tarry stools, haematemesis (vomiting blood), gastritis, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn’s disease (see section 2 "Warnings and precautions") have been reported after administration of Dicloberl retard.

The risk of gastrointestinal bleeding particularly depends on the dose administered and the duration of treatment.

Dicloberl retard must be discontinued and medical advice sought immediately if the patient notices:

mild painful abdominal cramps and tenderness occurring soon after starting Dicloberl retard, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency unknown – cannot be estimated from available data).

Inform your doctor immediately if any of the following symptoms occur:

chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome. Oedema (fluid accumulation in tissues), high blood pressure and heart failure have been reported in association with NSAID therapy.

Use of medicines such as Dicloberl retard may be associated with an increased risk of arterial thrombosis, e.g. myocardial infarction or stroke (see section 2 "When not to use Dicloberl retard" and "Warnings and precautions").

Common: may affect up to 1 in 10 patients

gastrointestinal disturbances such as nausea, vomiting, diarrhoea, as well as minor gastrointestinal blood loss, which in rare cases may lead to a deficiency in red blood cells (anaemia);
hypersensitivity reactions such as rash and itching;
central nervous system disorders such as headache, dizziness, feeling of emptiness in the head, restlessness, irritability or drowsiness;
digestive disturbances (dyspepsia), flatulence, stomach cramps (abdominal pain), loss of appetite, gastric and/or duodenal ulceration (with risk of bleeding or perforation);
increased liver enzyme activity in blood;
labyrinthine dizziness.

Uncommon: may affect up to 1 in 100 patients

urticaria (in such cases, treatment must be stopped immediately and medical advice sought);
haematemesis (vomiting blood), blood in stool or bloody diarrhoea;
liver damage (especially during prolonged treatment), hepatitis with or without jaundice (very rarely fulminant, even without preceding symptoms);
hair loss;
oedema (fluid retention), particularly in patients with hypertension or impaired renal function.

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

hypersensitivity, anaphylactic and anaphylactoid reactions (may present as airway constriction, shortness of breath, rapid heartbeat, low blood pressure (hypotension) and shock);
gastritis, gastrointestinal bleeding;
liver function disorders;
asthma, including breathing difficulties (dyspnoea).

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

worsening of infection-related inflammation (e.g. development of necrotizing fasciitis) occurring temporally after systemic use of NSAIDs (the drug class to which Dicloberl retard belongs). If signs of infection (e.g. redness, swelling, increased warmth, pain, fever) or their worsening occur during treatment with Dicloberl retard, the patient should seek immediate medical advice. The physician will determine whether treatment with anti-infective agents or antibiotics is indicated;
symptoms of meningitis (aseptic meningitis), such as headache, nausea, vomiting, fever, neck stiffness or altered consciousness, have occurred during diclofenac use. Patients with concomitant autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) appear to be at higher risk of the above-mentioned adverse effects;
blood disorders [anaemia, leukopenia (reduced white blood cell count), thrombocytopenia (reduced platelet count), pancytopenia (reduced red and white blood cells and platelets), agranulocytosis (acute, life-threatening drop in neutrophil count), haemolytic or aplastic anaemia (reduced red blood cells due to increased destruction)]. Initial symptoms may include fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding. In such cases, the medicine must be discontinued immediately and medical advice sought. Do not self-medicate with antipyretics or analgesics. Blood parameters should be monitored regularly during long-term use;
angioedema (swelling of the face, tongue or larynx). If any of these symptoms occur, even after a single dose, diclofenac must be discontinued and immediate medical help sought;
allergic vasculitis and pneumonitis;
psychotic reactions, depression, anxiety, insomnia, nightmares;
sensory disturbances, taste disturbances, memory impairment, disorientation, seizures, tremors, stroke (cerebrovascular disorders);
visual disturbances (blurred or double vision);
tinnitus, hearing disturbances;
palpitations, chest pain, reduced cardiac function (heart failure), heart attack (myocardial infarction);
high blood pressure (hypertension);
inflammation of the oral mucosa including ulcerative stomatitis, glossitis, oesophageal damage, constipation, as well as lower abdominal symptoms such as colitis including haemorrhagic colitis, or exacerbation of Crohn’s disease or ulcerative colitis (inflammatory bowel diseases with associated ulceration), pancreatitis, intestinal stricture. If severe upper abdominal pain, haematemesis, black stools or blood in stool occur, Dicloberl retard must be discontinued and the physician contacted immediately;
hepatic necrosis, liver failure (during prolonged treatment, liver parameters should be monitored at regular intervals);
severe skin reactions such as erythematous skin rash (urticaria, rash, erythema multiforme), blistering skin rash (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis/Lyell’s syndrome), or skin peeling (exfoliative dermatitis), photosensitivity (light sensitivity reactions), local skin bleeding (purpura), which may also have an allergic character;
kidney damage (interstitial nephritis, papillary necrosis), which may be accompanied by acute kidney function disorders (renal failure), protein in urine (proteinuria) and/or blood in urine (haematuria), nephrotic syndrome (oedema and increased protein in urine). Therefore, kidney function should be monitored regularly at regular intervals. Reduced urine output, fluid retention in the body (oedema), as well as general malaise may be symptoms of kidney disease, including renal failure. In

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the event of these symptoms occurring or worsening during treatment with Dicloberl retard, the patient should discontinue the medicine and seek immediate medical advice.

Frequency not known: frequency cannot be estimated from available data

ischaemic colitis.

Follow the instructions provided above regarding certain adverse effects!

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: (22) 49-21-301
Fax: (22) 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Dicloberl retard

Keep this medicine out of sight and reach of children.
Do not use Dicloberl retard after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Store below 25°C.
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 Dicloberl retard contains
The active substance is sodium diclofenac.
Each prolonged-release hard capsule contains 100 mg of sodium diclofenac.
The other ingredients are: sucrose, maize starch, shellac, talc, ammonio 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, packed in blisters made of PP-COC-PP/Aluminium foil and placed in a cardboard box.
The pack contains 10 or 20 prolonged-release hard capsules.
For further detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Latvia, country of export:
Berlin-Chemie AG, Glienicker Weg 125, 12489 Berlin, Germany

Manufacturer:
Berlin-Chemie AG, Glienicker Weg 125, 12489 Berlin, Germany
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Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing Authorisation Number in Latvia, country of export: 97-0034
Parallel Import Licence Number: 172/25
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