Dicloberl retard

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

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 necessary.
• 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 the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Dicloberl retard and what is it used for
• 2. Important information before using Dicloberl retard
• 3. How to use Dicloberl retard
• 4. Possible side effects
• 5. How to store Dicloberl retard
• 6. Contents of the packaging 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).

Use

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 spinal disease,
• inflammatory rheumatic diseases of the soft tissues,
• post-traumatic inflammatory conditions and swelling.

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 using Dicloberl retard

When not to use 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 mucous membranes of the nose or skin reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• if the patient has non-specific blood disorders; Page 1 12
• 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 confirmed cases of 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, e.g., 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);
• in the last three months of pregnancy;
• in children and adolescents under 18 years of age due to the high content of the active substance.

Warnings and precautions

The following cases require special caution when taking Dicloberl retard and the medicine should only be used in a specific way (e.g., with longer intervals between doses or with smaller doses 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 COX-2 inhibitors, due to the lack of evidence of better therapeutic effect and the possibility of 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 use Dicloberl retard").

Gastrointestinal bleeding, ulcers, and perforation

Gastrointestinal bleeding, gastric and/or duodenal ulcers, and perforations with a fatal outcome have been reported in patients taking all NSAIDs, occurring at any time during treatment, with or without warning symptoms or previous severe gastrointestinal adverse effects.

The risk of gastrointestinal bleeding, gastric and/or duodenal ulcers, and perforation increases with increasing NSAID doses and is higher in patients with a history of gastric and/or duodenal ulcers, especially if complicated by bleeding or perforation, and in the elderly. In such patients, treatment should be started and continued with the lowest available dose.

In these patients, as well as in patients requiring concomitant use of low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal side effects, consideration should be given to concomitant use of medicines with a protective effect on the gastric mucosa (e.g., misoprostol or proton pump inhibitors).

Patients who have experienced gastrointestinal side effects, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the beginning of treatment.

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Caution is recommended when taking medicines that may increase the risk of developing gastric and/or duodenal ulcers or gastrointestinal 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 case of gastrointestinal bleeding or gastric and/or duodenal 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 gastrointestinal ulcers, bleeding, or perforation, and in patients with previous gastrointestinal disease (ulcerative colitis, Crohn's disease), as they may exacerbate these conditions (see section 4 "Possible side effects").

Before using Dicloberl retard, patients should tell their doctor if they 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, patients should inform their doctor:

• if they smoke
• if they have diabetes
• if they 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 case of heart disease or a history of stroke, patients should discuss their treatment with their doctor or pharmacist.

Skin reactions

Very rarely, severe skin reactions with redness and blisters, some of which were fatal, have been reported in association with NSAID use (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 within the first month of treatment.

In case 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 consulted.

Effect on the liver

Before starting 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 increased. If diclofenac is to be used for a long time or repeatedly, it is recommended to regularly monitor liver function parameters as a precaution. Dicloberl retard should be discontinued immediately in case of clinical symptoms of liver failure.

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Hepatitis may occur without preceding warning signs when taking diclofenac.

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, special caution is recommended in patients with impaired renal function, a history of hypertension, the elderly, patients taking diuretics or medicines that significantly affect renal function, and patients with significantly reduced extracellular fluid volume for any reason, e.g., before or after major surgery. In these cases, it is recommended to monitor renal function as a precaution.

Discontinuation of treatment usually leads to a return to the pre-treatment state.

Other

The doctor will use Dicloberl retard in 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 mucous membranes of the nose, or chronic respiratory diseases with bronchospasm, or chronic respiratory infections, as they are at 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 staff 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 of infection. In case of signs of infection (e.g., redness, swelling, increased temperature, pain, fever) or their worsening during treatment with Dicloberl retard, patients should immediately consult a doctor.

If patients are taking medicines that inhibit blood clotting or lower blood sugar levels, they should be monitored preventively for coagulation parameters or blood sugar levels.

During long-term use of Dicloberl retard, regular monitoring of liver function parameters, kidney function, and blood morphology is required.

Patients 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. Patients should consult a doctor if they experience frequent 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

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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

Due to the possibility of side effects in elderly patients, they should be monitored closely. Caution is recommended in elderly patients with 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 are usually more serious in the elderly and can lead to death.

Dicloberl retard and other medicines

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 hormone replacement therapy medicines) increases the risk of developing gastric 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 epileptic 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 diseases and lower blood pressure). Concomitant use of these medicines with Dicloberl retard may increase the risk of renal function disorders.

Patient should be properly hydrated and renal function should be monitored periodically after starting treatment and at appropriate intervals.

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 antidepressant medicines (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 types of cancer) may increase methotrexate levels in the blood and increase side effects.

Cyclosporin

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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). Patients should use 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 (medicines used to treat gout) may slow down the excretion of diclofenac. This may lead to increased side effects.

Antidiabetic medicines

When taking 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 precaution, it is recommended to monitor blood sugar levels at the same times.

Quinolone antibacterials

Quinolones (a type of antibiotic) may cause seizures when used concomitantly with NSAIDs.

Cholestyramine and colestipol

These substances (medicines used to lower lipid levels in the blood) 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 used 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 the levels of urea and creatinine (kidney function parameters) in the blood. 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 side effects. Therefore, the doctor should closely monitor patients taking deferasirox with NSAIDs.

Mifepristone

Used for abortion. NSAIDs should not be used 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 caution should be exercised when administering high doses of NSAIDs.

Dicloberl retard and alcohol

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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 using 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 consultation with 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 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, which may limit the ability to drive vehicles or operate machinery. This applies especially to situations where 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-mentioned symptoms occur, the patient should not drive vehicles or operate machinery. The patient 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 the medicine is considered "sodium-free".

3. How to use Dicloberl retard

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

Dosage

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If the doctor has not prescribed otherwise, 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 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 during meals.

Duration of treatment

The doctor will decide on the duration of treatment.

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.

Using a higher dose of Dicloberl retard than recommended

Dicloberl retard should be used as directed by the doctor or according to the dosage instructions in the leaflet. If the patient feels that the pain-relieving effect of the medicine is insufficient, they should not increase the dose but consult a doctor.

There are no characteristic clinical symptoms of 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, and vomiting. Additionally, gastrointestinal bleeding and liver and kidney function disorders may occur. Sudden blood pressure drop, breathing difficulties (respiratory depression), and blue discoloration of the skin and mucous membranes (cyanosis) may also occur. There is no specific antidote.

In case 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 using 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. Gastric and/or duodenal ulcers (peptic ulcers), perforation, or gastrointestinal bleeding may occur, 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, gastric mucosal inflammation, oral mucosal ulceration, exacerbation of ulcerative colitis, and Crohn's disease have been reported after taking the medicine.

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The risk of gastrointestinal bleeding is dose-dependent and increases with the duration of treatment.

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

• mild painful abdominal cramps and tenderness, starting soon after starting treatment with 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 use Dicloberl retard" and "Warnings and precautions").

Frequent:may affect up to 1 in 10 patients

• gastrointestinal disorders, such as nausea, vomiting, and diarrhea, as well as minor gastrointestinal bleeding, which may rarely lead to anemia (anemia);
• 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, abdominal cramps (abdominal pain), loss of appetite, gastric and/or duodenal ulcers (peptic 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 patients

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

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

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

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

• worsening of infections (e.g., development of necrotizing fasciitis) in temporal association with systemic use of NSAIDs (a group of medicines to which Dicloberl retard also belongs). In case 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 anti-infective medicines;
• symptoms of meningitis (e.g., headache, nausea, vomiting, fever, stiff neck, or changes in consciousness) have occurred during diclofenac treatment. It seems that patients with concomitant autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease) are more likely to experience these side effects;
• blood disorders [anemia (anemia), leukopenia (decreased white blood cell count), thrombocytopenia (decreased platelet count), pancytopenia (decreased red and white blood cell and platelet count), agranulocytosis (a serious, life-threatening decrease in neutrophil count), hemolytic or aplastic anemia (decrease in red blood cell count 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 bleeding from the skin. In such cases, the medicine should be discontinued immediately and a doctor 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, diclofenac should be discontinued and medical help sought immediately;
• allergic vasculitis and pulmonary inflammation;
• psychotic reactions, depression, anxiety, insomnia, nightmares;
• sensory disturbances, taste disturbances, memory disturbances, disorientation, seizures, tremors, stroke (cerebrovascular disorders);
• visual disturbances (blurred or double vision);
• tinnitus, hearing disturbances;
• palpitations, chest pain, heart failure (cardiac insufficiency), heart attack (myocardial infarction);
• high blood pressure (hypertension);

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Unknown frequency:frequency cannot be estimated from available data

• ischemic colitis.

Patients should follow the instructions above regarding certain side effects!

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C, 02-222 Warsaw

Phone: (22) 49-21-301

Fax: (22) 49-21-309

Website: https://smz.ezdrowie.gov.pl

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 sight and reach of children.

Dicloberl retard should not be used after the expiration date stated on the packaging.

The expiration date refers to the last day of the specified month.

Store at a temperature below 25°C.

Medicines should not be disposed of via wastewater or household waste. Patients should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What 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 PP-COC-PP/Aluminum blisters in a cardboard box.

The pack contains 10 or 20 prolonged-release hard capsules.

For more detailed information, patients should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the 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 by:

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

Marketing authorization number in Latvia, the country of export: 97-0034

Parallel import authorization number: 172/25

Date of leaflet approval: 08.05.2025

[Information about the trademark]

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