Dicloberl retard: detailed information

Package leaflet: Information for the patient

Warning! Keep the 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 for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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).
Uses
Dicloberl retard is used for 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 of osteoarthritis and spinal osteoarthritis,
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, consult a doctor.

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 components of this medicine (listed in section 6);
if in the past the patient has experienced breathing difficulties (bronchospasm), asthma attacks, chest pain, nasal mucosal swelling or skin reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
if the patient has non-specific blood disorders;
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 gastric and/or duodenal ulcer disease and bleeding (two or more episodes of ulcers or bleeding confirmed);
if the patient has a history of gastrointestinal bleeding or perforation associated with previous use of NSAIDs;
if the patient has cerebral haemorrhage or 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 current or previous circulatory disorders (peripheral arterial disease);
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 following situations require special caution when taking Dicloberl retard, and the medicine should be used only in a specific way (e.g. with longer intervals between doses or lower doses under medical supervision). 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 for superior 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, ulcer disease and perforation
Gastrointestinal bleeding, gastric and/or duodenal ulcer disease and perforation, sometimes fatal, have been reported with all NSAIDs, occurring at various times during treatment, with or without warning symptoms or previous serious gastrointestinal adverse effects.
The risk of gastrointestinal bleeding, gastric and/or duodenal ulcer disease and perforation increases with increasing NSAID doses, is higher in patients with a history of gastric and/or duodenal ulcer disease, particularly if complicated by bleeding or perforation, and in elderly patients. In such patients, treatment should be initiated and maintained using the lowest available dose.
In such patients and in patients requiring concomitant administration of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal adverse effects, consider concomitant use of drugs with protective effects on the gastric mucosa (e.g. misoprostol or proton pump inhibitors).
Patients who have experienced adverse gastrointestinal effects, especially elderly patients, should report any abnormal abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.
Caution is advised when taking concomitantly drugs that may increase the risk of gastric and/or duodenal ulcer disease or bleeding, such as systemic corticosteroids, anticoagulants such as 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 disease occurs during treatment with Dicloberl retard, the medicine should be discontinued. The patient should be instructed to discontinue the medicine and consult a doctor 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 disease, bleeding or perforation, and in patients with previous gastrointestinal disorders (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 is scheduled for stomach or gastrointestinal surgery, as Dicloberl retard may impair intestinal wound healing after surgical procedures.

Effects 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 pectoris, blood clots, hypertension, increased cholesterol levels or increased triglyceride levels.

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
Rarely, severe skin reactions with redness and blisters, some fatal, have been reported with NSAID use (e.g. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell's syndrome, see section 4 "Possible side effects"). The highest risk of these reactions appears to occur at the beginning of 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.

Effects 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 non-steroidal anti-inflammatory drugs (NSAIDs) containing diclofenac, 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.
Hepatitis without preceding symptoms may occur during diclofenac treatment.
Exercise caution when using Dicloberl retard in patients with hepatic porphyria (a blood disorder), as the medicine may trigger disease exacerbation.

Effects on the kidneys
Since fluid retention and oedema have been reported with NSAID treatment, including diclofenac, particular caution is required in patients with kidney function disorders, history of hypertension, elderly patients, patients taking diuretics or drugs that significantly affect kidney function, and patients with markedly reduced extracellular fluid volume for any reason, e.g. before or after major surgery. As a precaution, kidney function should be monitored after diclofenac administration in these cases.
Discontinuation of treatment usually leads to recovery to the pre-treatment state.

Other
Your doctor will prescribe Dicloberl retard only after carefully considering 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 medicines, asthma, hay fever), chronic nasal mucosal swelling 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. Healthcare 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 subjective and objective 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 taking drugs that inhibit blood coagulation or lower blood glucose levels, coagulation parameters or blood glucose levels should be monitored preventively.
During long-term treatment with 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 painkillers 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.
Chronic use of painkillers, especially combinations of multiple active substances with analgesic effects, may cause irreversible kidney damage associated with 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 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 concomitant diseases. In particular, in frail elderly patients or those with low body weight, the lowest effective dose should be used. 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 the elderly 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 administration 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 ulcer disease 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 effect of diuretics and antihypertensive drugs (diuretics and antihypertensives such as 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 (drugs used in heart disease and antihypertensive drugs). Concomitant use of these drugs with Dicloberl retard may increase the risk of kidney function disorders. Patients should be adequately hydrated and kidney function monitored periodically after starting treatment, and subsequently at appropriate intervals.
Concomitant use of Dicloberl retard with potassium-sparing diuretics (certain diuretics) may lead to increased blood potassium levels. Therefore, regular monitoring of potassium levels is recommended.

Selective serotonin reuptake inhibitors (SSRI)
Some antidepressants (selective serotonin reuptake inhibitors [SSRI]) 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 adverse effects.

Cyclosporine
Non-steroidal anti-inflammatory drugs (including diclofenac) may increase the nephrotoxic effect of cyclosporine (used to prevent transplant rejection and in treatment of rheumatic diseases). The patient should use a lower dose of diclofenac.

Anticoagulants and antiplatelet drugs:
Non-steroidal anti-inflammatory drugs may enhance the effect of antiplatelet and anticoagulant drugs (used to prevent blood clotting), such as warfarin. More frequent doctor visits may be necessary.

Probenecid
Medicines containing probenecid (used to treat gout) may slow down diclofenac elimination. This may lead to increased adverse effects.

Antidiabetic medicines
Isolated cases of diclofenac affecting blood glucose levels, requiring dose adjustment of antidiabetic medicines, have been reported during use of glucose-lowering drugs (antidiabetic medicines). Therefore, as a precaution, blood glucose levels should be monitored at the same times when these medicines are used concomitantly.

Antibacterial quinolones
Quinolones (certain types of antibiotics) may cause epileptic seizures when used concomitantly with NSAIDs.

Colestipol and cholestyramine
These compounds (used to lower blood lipid levels) may slow down or reduce diclofenac absorption. Therefore, Dicloberl retard should be taken at least one hour before or 4 to 6 hours after taking 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, the doctor should carefully monitor patients taking deferasirox concomitantly with NSAIDs.

Mifepristone
Used to terminate pregnancy. NSAIDs should not be used within 8-12 days after mifepristone administration due to the theoretical risk that prostaglandin synthesis inhibitors may alter mifepristone efficacy.

Pemetrexed
Concomitant use of pemetrexed and NSAIDs may intensify pemetrexed effects; therefore, special caution is required when administering high-dose NSAIDs.

Dicloberl retard and alcohol
Do not consume alcohol during treatment with Dicloberl retard.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Inform your doctor if pregnancy is confirmed 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 delivery complications. Dicloberl retard may cause kidney and heart function disorders in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. Dicloberl retard should not be used during the first six months of pregnancy unless the doctor considers its use absolutely necessary. If treatment is required 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 is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Like other NSAIDs, diclofenac passes into small amounts into breast milk. To avoid adverse effects in the infant, diclofenac should not be used during breastfeeding.

Effects on fertility
Like all drugs inhibiting prostaglandin synthesis, Dicloberl retard may impair fertility. If the patient plans to become pregnant or has difficulty conceiving, she should inform her doctor.

Driving and operating machinery
During use of 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 machinery 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 consult their 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 doctor. If in doubt, consult your doctor or pharmacist.

Dosage
If the doctor has not advised otherwise, the medicine should be used as follows:
Diclofenac dosage depends on disease severity. The recommended daily dose for adults is 50 to 150 mg of sodium diclofenac.
Adults: 1 prolonged-release capsule per day (corresponding to 100 mg sodium diclofenac).

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 during meals.

Duration of treatment
The doctor will decide on the duration of treatment.
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 the effect of Dicloberl retard seems too strong or too weak, consult your doctor.

Taking more than the recommended dose of Dicloberl retard
Use Dicloberl retard as directed by the doctor or as specified in the dosage instructions in the leaflet. If the patient feels that the analgesic effect is insufficient, do not increase the dose but contact the doctor.
There are no characteristic clinical symptoms of diclofenac overdose.
Symptoms of overdose may include central nervous system disturbances such as headache, dizziness, drowsiness and loss of consciousness (in children also myoclonic seizures), as well as abdominal pain, nausea and vomiting. Gastrointestinal bleeding and liver and kidney function disorders may also occur. Sudden drop in blood pressure, breathing difficulties (respiratory depression) and blue-red discoloration of skin and mucous membranes (cyanosis) may occur.
There is no specific antidote.
If overdose is suspected, inform the doctor. 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 using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, 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 varies individually.
The most commonly observed adverse effects are gastrointestinal disorders. Peptic ulcer disease of the stomach and/or duodenum (peptic ulcers), gastrointestinal perforation or bleeding, sometimes leading to death, particularly in elderly patients, may occur (see section 2 "Warnings and precautions"). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, tarry stools, haematemesis, gastritis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 2 "Warnings and precautions") have been reported following administration of the medicine.
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 abdominal cramps and tenderness starting shortly after beginning treatment with 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 retention), 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 and diarrhoea, as well as minor gastrointestinal bleeding, which in rare cases may lead to anaemia (low red blood cell count);
hypersensitivity reactions such as rash and pruritus;
central nervous system disorders such as headache, dizziness, sensation of emptiness in the head, restlessness, irritability or drowsiness;
digestive disturbances (dyspepsia), flatulence, gastric spasms (abdominal pain), loss of appetite, peptic ulcer disease of the stomach and/or duodenum (with risk of bleeding or perforation);
increased liver enzyme activity in blood;
vestibular dizziness.

Uncommon: may affect up to 1 in 100 patients

urticaria (in such cases, treatment must be stopped immediately and medical advice sought);
haematemesis, blood in stool or bloody diarrhoea;
liver damage (especially during long-term 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 1000 patients

hypersensitivity, anaphylactic and anaphylactoid reactions (may manifest as airway constriction, dyspnoea, tachycardia, hypotension and shock);
gastritis, gastrointestinal bleeding;
liver function disorders;
asthma, including breathing difficulties (dyspnoea).

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

exacerbation of infection-related inflammation (e.g. development of necrotizing fasciitis) temporally associated with systemic use of NSAIDs (the group of medicines to which Dicloberl retard belongs); if signs of infection (e.g. redness, swelling, increased warmth, pain, fever) or worsening of such symptoms occur during treatment with Dicloberl retard, the patient should seek immediate medical advice. The physician will determine whether treatment with antimicrobial 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 treatment. Patients with concomitant autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) appear to be at greater 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 condition associated with severe, life-threatening reduction in neutrophils), haemolytic or aplastic anaemia (reduced red blood cells due to accelerated breakdown)]. Initial symptoms may include fever, sore throat, oral ulcers, influenza-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. During prolonged use, blood parameters should be monitored regularly;
angioedema (swelling of the face, tongue or larynx). If any of these symptoms occur, which may happen even after a single dose, diclofenac should be discontinued and immediate medical assistance sought;
allergic vasculitis and pneumonitis;
psychotic reactions, depression, anxiety, insomnia, nightmares;
sensory disturbances, taste disturbances, memory impairment, disorientation, seizures, tremors, stroke (cerebrovascular events);
visual disturbances (blurred or double vision);
tinnitus, hearing disturbances;
palpitations, chest pain, impaired cardiac function (heart failure), heart attack (myocardial infarction);
high blood pressure (hypertension);
stomatitis, including ulcerative stomatitis, glossitis, oesophageal injury, constipation, as well as lower abdominal symptoms such as colitis including haemorrhagic colitis or exacerbation of Crohn's disease or ulcerative colitis (inflammatory conditions of the large intestine associated with ulceration), pancreatitis, intestinal stenosis. In case of sudden severe upper abdominal pain, haematemesis, black stools or blood in stool, Dicloberl retard should be discontinued and medical advice sought immediately;
hepatic necrosis, liver failure (during long-term treatment, liver parameters should be monitored at regular intervals);
severe skin reactions such as erythematous skin rash (urticaria, exanthema, erythema multiforme), blistering skin rash (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell's syndrome) or skin desquamation (exfoliative dermatitis), photosensitivity (light sensitivity reactions), local skin bleeding (purpura), which may also have an allergic nature;
kidney damage (interstitial nephritis, papillary necrosis), which may be accompanied by acute renal function impairment (renal failure), protein in urine (proteinuria) and/or blood in urine (haematuria), nephrotic syndrome (oedema and increased protein in urine). For this reason, renal function should be monitored at regular intervals. Reduced urine output, fluid retention (oedema) and general malaise may be symptoms of kidney disease, including renal failure. If these symptoms occur or worsen during treatment with Dicloberl retard, the patient should discontinue treatment and seek immediate medical advice;

Frequency unknown: frequency cannot be estimated from available data

ischaemic colitis.

Follow the instructions above regarding certain adverse effects!
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Dicloberl retard
Keep the 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package 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, 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, packed in PP-COC-PP/Al blisters, in a cardboard box.
The pack contains 20 prolonged-release hard capsules.
For more detailed information, please contact the Marketing Authorisation Holder 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

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation number in Latvia, country of export: 97-0034
Parallel import authorisation number: 201/24