Dicloberl 100 mg

Patient Information Leaflet

Warning! Keep this leaflet! Information on the outer packaging in a foreign language.
Dicloberl 100 mg
100 mg, suppositories
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 identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of Contents

1. What Dicloberl 100 mg is and what it is used for
2. Important information before using Dicloberl 100 mg
3. How to use Dicloberl 100 mg
4. Possible side effects
5. How to store Dicloberl 100 mg
6. Contents of the pack and other information

1. What Dicloberl 100 mg is and what it is used for

Dicloberl 100 mg is an anti-inflammatory and analgesic medicine (non-steroidal anti-inflammatory drug, NSAID).
It is used for symptomatic treatment of pain and inflammation in:

• acute joint inflammation, including gout;
• chronic joint inflammation, particularly rheumatoid arthritis (chronic polyarthritis);
• ankylosing spondylitis (Bechterew's disease) and other inflammatory rheumatic conditions of the spine;
• exacerbations of degenerative joint disease in peripheral joints and degenerative spinal disease;
• inflammation of soft tissues associated with rheumatic disorders;
• painful swelling or inflammation following injuries.

Dicloberl 100 mg is intended for use in adults.
If there is no improvement or if the patient's condition worsens, consult a doctor.

2. Information before using Dicloberl 100 mg

When not to use Dicloberl 100 mg

• 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 problems (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 black discoloration of stool, tarry stools);
• if the patient has active or recurrent history of peptic ulcer disease of the stomach and/or duodenum or bleeding (two or more separate 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 renal or hepatic insufficiency;
• if the patient has heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, mini-stroke (transient ischaemic attack), or vascular occlusion in the heart or brain, or following a procedure to unblock or bypass blocked vessels;
• if the patient has current or previous circulatory disorders (peripheral vascular disease);
• during the last three months of pregnancy;
• if the patient has inflammation of the rectal mucosa or anus;
• in children and adolescents under 18 years of age due to excessive content of active substance.

Warnings and precautions
The following situations require special caution when taking Dicloberl 100 mg, 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. This also applies to past medical conditions.
Before starting treatment with Dicloberl 100 mg, discuss this with your doctor or pharmacist.

General information
Avoid concomitant use of Dicloberl 100 mg with other NSAIDs, including so-called COX-2 inhibitors (selective cyclooxygenase-2 inhibitors), due to lack of data confirming better efficacy and the possibility of increased frequency and severity of adverse effects.
Use of the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects (see section 3 "How to use Dicloberl 100 mg").

Gastrointestinal bleeding, peptic ulcer disease and perforation
Gastrointestinal bleeding, peptic ulcer disease of the stomach and/or duodenum, and perforation, sometimes fatal, have been reported with all NSAIDs, occurring at any time during treatment, with or without warning symptoms, and with or without prior serious gastrointestinal adverse events.
The risk of gastrointestinal bleeding, peptic ulcer disease and perforation increases with higher NSAID doses and is greater in patients with a history of peptic ulcer disease of the stomach and/or duodenum, especially if complicated by bleeding or perforation, and in elderly patients. In such patients, treatment should be initiated and maintained with the lowest available dose.
In such patients and in those requiring concomitant administration of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, consider concomitant use of gastroprotective agents (e.g. misoprostol or proton pump inhibitors).
Patients who have experienced gastrointestinal adverse effects, especially elderly individuals, should report any abnormal abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.
The doctor will use Dicloberl 100 mg with caution in patients concurrently receiving drugs that may increase the risk of peptic ulcer disease and/or bleeding, such as systemic corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors used in depression treatment, or antiplatelet drugs like acetylsalicylic acid (see section 2 "Dicloberl 100 mg and other medicines").
If gastrointestinal bleeding or peptic ulcer disease of the stomach and/or duodenum occurs in a patient taking Dicloberl 100 mg, the medicine should be discontinued. The patient should be instructed to stop taking the medicine and seek immediate medical attention if they experience acute upper abdominal pain, tarry stools, or bloody vomiting (see section 4 "Possible side effects").
NSAIDs should be administered cautiously and under strict medical supervision to patients with symptoms indicating gastrointestinal disorders, history of peptic ulcer disease of the stomach and/or duodenum, bleeding or perforation, or history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), as exacerbation of the disease may occur (see section 4 "Possible side effects").
Before using Dicloberl 100 mg, inform the doctor if the patient has recently undergone or is scheduled for surgery of the stomach or gastrointestinal tract, as Dicloberl 100 mg may sometimes impair intestinal wound healing after surgical procedures.

Effect on the circulatory system
Taking medicines such as Dicloberl 100 mg may be associated with an increased risk of heart attack ("myocardial infarction") or stroke.
Before taking Dicloberl 100 mg, inform the doctor:

• if the patient smokes
• if the patient has diabetes
• if the patient has angina, thrombosis, hypertension, increased cholesterol levels, or increased triglyceride levels.

Using the lowest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.
If the patient has heart problems or has had a stroke, discuss the treatment approach with the doctor or pharmacist.

Skin reactions
Very rarely, severe skin reactions with redness and blisters, some fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (Lyell's syndrome), have been reported in association 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 early signs of skin rash, mucosal lesions (oral or nasal), or other hypersensitivity symptoms occur, discontinue Dicloberl 100 mg immediately and contact a doctor without delay.

Effect on the liver
Exercise caution (consult a doctor or pharmacist) before initiating diclofenac treatment in patients with liver function disorders, as the condition may worsen. During treatment with NSAIDs, including diclofenac, increased activity of one or more liver enzymes may occur. If diclofenac is to be used long-term or repeatedly, regular monitoring of liver function parameters is recommended as a precaution. Dicloberl 100 mg should be discontinued immediately if symptoms of liver dysfunction occur.
Hepatitis without preceding warning symptoms may occur during diclofenac treatment.
Exercise caution when using Dicloberl 100 mg in patients with hepatic porphyria (a blood disorder), as it may trigger an exacerbation of the disease.

Effect on the kidneys
Since fluid retention and oedema have been reported with NSAID treatment, including diclofenac, particular caution is required in patients with impaired renal function, history of hypertension, elderly patients, patients concurrently receiving diuretics or drugs that significantly reduce renal function, and patients with marked reduction in extracellular fluid volume for any reason (e.g. before or after major surgical procedures). In such cases, monitoring of renal function is recommended as a precaution during diclofenac treatment.
Discontinuation of treatment usually results in return to the pre-treatment condition.

Other
Dicloberl 100 mg should only be used after careful consideration of 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).

Dicloberl 100 mg should only be used under strict medical supervision:

• in patients with allergies (e.g. skin reactions to other drugs, asthma, hay fever), chronic nasal mucosal oedema, or chronic respiratory disease with airway narrowing or chronic respiratory infections, as such patients 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 administration of Dicloberl 100 mg, treatment should be discontinued. 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, diclofenac may mask signs of infection. If symptoms of infection (e.g. redness, swelling, warmth, pain, fever) appear or worsen during treatment with Dicloberl 100 mg, the patient should contact a doctor immediately.
If the patient is concurrently taking drugs that inhibit blood coagulation or lower blood glucose levels, coagulation or blood glucose levels should be monitored preventively.
During long-term treatment with Dicloberl 100 mg, regular monitoring of liver function, kidney function, and blood morphology is required.
Inform the doctor or dentist about taking Dicloberl 100 mg before surgical procedures.
During long-term use of analgesics, headache may occur, which should not be treated by increasing the dose of these medicines. Consult a doctor if headaches occur frequently despite using Dicloberl 100 mg.
Generally, habitual use of analgesics, especially combinations of multiple active substances with analgesic effects, may cause irreversible kidney damage associated with risk of renal failure (analgesic nephropathy).

Children and adolescents
Dicloberl 100 mg should not be used in children and adolescents under 18 years of age (see section 2 "When not to use Dicloberl 100 mg").

Elderly patients
Due to the possibility of adverse effects, elderly patients 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 elderly patients and may lead to death.

Dicloberl 100 mg and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take.

Other NSAIDs (including acetylsalicylic acid) and corticosteroids
Concomitant use of Dicloberl 100 mg with other anti-inflammatory and analgesic NSAIDs or glucocorticosteroids (anti-inflammatory drugs or used in hormone replacement therapy) increases the risk of peptic ulcer disease of the stomach and/or duodenum and gastrointestinal bleeding. Diclofenac should not be taken with other NSAIDs.

Digoxin, phenytoin and lithium
Concomitant use of Dicloberl 100 mg with digoxin (used in cardiac arrhythmia treatment), phenytoin (used in epilepsy treatment), or lithium (used in psychiatric disorder treatment) 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 100 mg may reduce the effectiveness of diuretics and antihypertensive drugs (diuretics and blood pressure-lowering drugs, e.g. beta-blockers, ACE inhibitors, and angiotensin II antagonists). Therefore, blood pressure should be monitored periodically.
Dicloberl 100 mg may reduce the effectiveness of ACE inhibitors and angiotensin II antagonists (drugs used in heart disease and blood pressure reduction). Concomitant use of these drugs with Dicloberl 100 mg may increase the risk of renal function disorders. Patients should be adequately hydrated and renal function should be monitored periodically after starting treatment and subsequently at appropriate intervals.
Concomitant use of Dicloberl 100 mg with potassium-sparing diuretics (some diuretics) may lead to increased potassium levels in blood. 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 100 mg within 24 hours before or after methotrexate (used in inflammatory diseases and treatment of certain cancers) may increase methotrexate blood levels and enhance adverse effects.

Cyclosporine
Non-steroidal anti-inflammatory drugs (including diclofenac) may increase the nephrotoxic effects 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 effects of antiplatelet and anticoagulant drugs (used to prevent blood clotting), such as warfarin. Regular visits to the doctor are recommended.

Probenecid
Medicines containing probenecid (used in gout treatment) may slow down diclofenac elimination. This may intensify adverse effects.

Antidiabetic drugs
During concomitant use of blood glucose-lowering drugs (antidiabetic drugs), isolated cases of diclofenac affecting blood glucose levels have been reported, necessitating adjustment of antidiabetic drug dosage. Therefore, as a precaution, blood glucose monitoring is recommended when these drugs are used together.

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

Colestipol and cholestyramine
These drugs (used to reduce blood cholesterol levels) may prolong or reduce diclofenac absorption. Therefore, diclofenac should be taken at least one hour before or 4 to 6 hours after colestipol or cholestyramine.

Strong CYP2C9 inhibitors
Voriconazole (used in treatment of severe fungal infections) and sulfinpyrazone (used in gout treatment) may increase diclofenac blood levels when used concomitantly. This may lead to diclofenac accumulation in the body and intensify its adverse effects.

Tenofovir
Concomitant use of tenofovir (used in treatment of hepatitis B virus and prevention and treatment of HIV/AIDS) with NSAIDs (such as diclofenac) may increase blood levels of urea nitrogen and creatinine (renal function parameters). Renal function should therefore be monitored to detect possible increases in these parameters.

Deferasirox
Concomitant use of deferasirox (used in patients undergoing multiple 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 receiving deferasirox concomitantly with NSAIDs.

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

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

Dicloberl 100 mg and alcohol
Do not consume alcohol during treatment with Dicloberl 100 mg.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Inform the doctor if pregnancy is detected during treatment with Dicloberl 100 mg. Dicloberl 100 mg may be used during the first and second trimesters of pregnancy only after consultation with a doctor.
Do not take Dicloberl 100 mg during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Dicloberl 100 mg 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 100 mg 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, the lowest possible dose should be used for the shortest possible duration.
From week 20 of pregnancy, Dicloberl 100 mg, if taken for longer than a few days, may cause kidney dysfunction in the unborn child, leading to reduced amniotic fluid volume (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 breast milk in small amounts. To avoid adverse effects in the infant, diclofenac should not be used during breastfeeding.

Effect on fertility
Like other drugs inhibiting prostaglandin synthesis, Dicloberl 100 mg may impair fertility. If the patient plans to become pregnant or has difficulty conceiving, she should inform her doctor.

Driving and operating machinery
When using high doses of Dicloberl 100 mg, 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 respond quickly and appropriately to unexpected or sudden events. If the above symptoms occur, do not drive vehicles or operate machinery! Do not use tools or operate machinery! Do not work without proper foot support!

3. How to use Dicloberl 100 mg

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Dosage
Unless otherwise directed by the physician, the medicine should be used as follows:
Diclofenac is dosed according to the severity of the condition. Diclofenac in suppository form
allows an alternative route of administration in patients in whom oral administration is not possible.
The recommended daily dose for adults is 50 to 150 mg of sodium diclofenac.
Adults: 1 suppository of Dicloberl 100 mg per day (corresponding to 100 mg of sodium diclofenac).
Method of administration
To remove a suppository from the packaging, repeatedly bend the perforation and detach one
suppository from the blister, or cut the suppository along the perforation line using scissors.
Then, holding the free ends of the foil located at the top of the suppository between the index fingers
and thumbs of each hand, carefully tear it open until the suppository can be removed
(see picture).

The suppository should be inserted deeply into the rectum, preferably after defecation.
To improve lubrication, the suppository may be warmed in the hand or briefly immersed in
hot water.
Duration of treatment
The duration of treatment will be determined by the physician.
In rheumatic diseases, long-term use of Dicloberl 100 mg may be required.
The medicine should be used at the lowest effective dose for the shortest duration necessary to relieve
symptoms, in order to reduce the risk of adverse effects (see section 2 "Warnings and precautions").
If you feel that the effect of Dicloberl 100 mg is too strong or too weak, consult your doctor.
Use of more than the recommended dose of Dicloberl 100 mg
Dicloberl 100 mg should be used strictly according to the physician's instructions or the dosage
information provided in this leaflet. If the patient feels that the analgesic effect is insufficient,
the dose should not be increased; instead, consult your doctor.
There are no characteristic clinical symptoms specifically associated with 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. 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 your doctor immediately.
Depending on the severity of poisoning, the doctor will decide on appropriate treatment.
Missed dose of Dicloberl 100 mg
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your 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 adverse symptoms occur,
you should inform your doctor, who will decide on further management.
The occurrence of the following adverse effects of the medicine depends primarily on the dose used and varies between individuals.
The most commonly observed adverse effects are gastrointestinal disorders. Peptic ulcer disease of the stomach and/or duodenum (peptic ulcers), gastrointestinal perforation or bleeding may occur, sometimes leading to death, especially in elderly patients (see section 2 "Warnings and precautions"). Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, tarry stools, bloody vomiting, gastric mucositis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration of the medicine (see section 2 "Warnings and precautions"). Gastritis has been observed less frequently. The risk of gastrointestinal bleeding particularly depends on the dose used and duration of treatment.

Dicloberl 100 mg should be discontinued and medical advice sought immediately if the patient notices:

• mild painful cramps and abdominal tenderness occurring soon after starting Dicloberl 100 mg, 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 indicate a potentially serious allergic reaction known as Kounis syndrome.

Cases of fluid retention (oedema), high blood pressure and heart failure associated with NSAID treatment have been described.
The use of medicines such as Dicloberl 100 mg may be associated with an increased risk of arterial thrombotic events, e.g. heart attack (myocardial infarction) or stroke (see section 2 "When not to use Dicloberl 100 mg" and "Warnings and precautions").

Common: may affect up to 1 in 10 patients

• gastrointestinal discomfort such as nausea, vomiting, diarrhoea, as well as minor gastrointestinal blood loss, which in rare cases may lead to anaemia (low red blood cell count);
• hypersensitivity reactions such as skin rash and itching;
• central nervous system disorders such as headache, dizziness, feeling of emptiness in the head, restlessness (excitation), irritability, fatigue;
• digestive disturbances (dyspepsia), bloating, stomach cramps (abdominal pain), loss of appetite, as well as peptic ulcer disease of the stomach or duodenum (with risk of bleeding or perforation);
• increased liver enzyme activity in blood;
• vertigo of labyrinthine origin;
• local irritation symptoms, passage of mucus with blood or painful defecation may frequently occur after suppository administration.

Uncommon: may affect up to 1 in 100 patients

• urticaria – in such cases, the medicine should be discontinued immediately and medical advice sought;
• vomiting blood, blood in stools or bloody diarrhoea;
• liver damage (particularly during long-term therapy), hepatitis with or without jaundice (in rare cases with fulminant course, even without preceding symptoms);
• alopecia (hair loss);
• development of oedema (fluid retention), particularly in patients with high blood pressure or impaired kidney function.

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

• hypersensitivity, anaphylactic and anaphylactoid reactions (may manifest as airway narrowing, shortness of breath (respiratory failure), rapid heartbeat, decreased blood pressure (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

• worsening of infections (e.g. development of necrotizing fasciitis) associated with the use of anti-inflammatory drugs (non-steroidal anti-inflammatory drugs, including Dicloberl 100 mg). If signs of infection (e.g. redness, swelling, warmth, pain, fever) or their worsening occur during treatment with Dicloberl 100 mg, the patient should seek medical advice immediately. The doctor will determine whether treatment with infection-specific medicines 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 condition associated with severe, life-threatening reduction in neutrophils), haemolytic and aplastic anaemia (lack of red blood cells due to accelerated breakdown)]. Initial symptoms may include fever, sore throat, mouth ulcers, flu-like symptoms, marked fatigue, nosebleeds and skin bleeding. In such cases, the medicine should be discontinued immediately and medical advice sought. Do not self-medicate with antipyretic or analgesic medicines. During long-term treatment, regular monitoring of blood morphology parameters is recommended;
• angioedema (swelling of the face, tongue and larynx) – if any of these symptoms occur, even after a single dose, diclofenac should be discontinued and immediate medical help sought;
• allergic vasculitis and lung inflammation;
• psychotic reactions, depression, anxiety, insomnia, nightmares;
• sensory disturbances, taste disturbances, memory impairment, disorientation, seizures, tremor, stroke;
• visual disturbances (blurred and double vision);
• tinnitus, hearing disturbances;
• palpitations, chest pain, reduced cardiac function (heart failure), myocardial infarction;
• high blood pressure (hypertension);
• inflammation of the oral mucosa, including ulceration-related inflammation (ulcerative stomatitis), glossitis, oesophageal damage, constipation, as well as lower abdominal symptoms such as colitis including bloody colitis or exacerbations of Crohn's disease or ulcerative colitis (inflammation of the large intestine with associated ulceration), pancreatitis, intestinal stricture. If acute upper abdominal pain, vomiting blood, black stools or blood in stools occur, Dicloberl 100 mg should be discontinued and the doctor informed;
• liver necrosis, liver failure. During long-term treatment, liver parameters should be monitored regularly;
• severe skin reactions such as erythematous skin rash (rash, exanthema, erythema, erythema multiforme) and skin rash with epidermal detachment (e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell's syndrome) or epidermal necrosis (exfoliative dermatitis), photosensitivity (light sensitivity reactions), local skin bleeding (purpura), which may be of allergic nature;
• kidney damage (interstitial nephritis, papillary necrosis), which may be accompanied by acute kidney failure, proteinuria and/or haematuria, nephrotic syndrome (oedema and presence of protein in urine). Kidney function should be monitored regularly. Reduced urine output, fluid retention (oedema) and general malaise may be symptoms of kidney dysfunction, including kidney failure. If these symptoms occur or worsen, Dicloberl 100 mg should be discontinued and medical advice sought immediately.

Frequency not known: frequency cannot be estimated from available data

• ischaemic colitis.

Follow the instructions given 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 this medicine.

5. How to store Dicloberl 100 mg

Keep this medicine out of sight and reach of children.
Do not use Dicloberl 100 mg after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Dicloberl 100 mg contains

• The active substance is sodium diclofenac. Each suppository contains 100 mg of sodium diclofenac.
• The other component is: hard fat.

What Dicloberl 100 mg looks like and contents of the pack
Ivory-coloured, elongated, torpedo-shaped suppositories in soft blisters made of PVC-PE foil, packed in a cardboard box.
The cardboard box contains 10 suppositories.
For more detailed information, please contact the responsible entity 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: 99-0013
Parallel Import Authorisation Number: 234/25