Dicloberl 100 mg

Package leaflet: Information for the patient

Dicloberl 100 mg
100 mg, suppositories
Diclofenacum natricum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Dicloberl 100 mg is and what it is used for
2. What you need to know 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 (spinal joint inflammation) and other rheumatic spinal disorders;
• exacerbations of degenerative joint disease in peripheral joints and degenerative spinal disease;
• soft tissue inflammation 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 feels worse, consult a doctor.

2. Important 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 currently has non-specific blood disorders;
• if the patient currently has gastric or intestinal ulcers, bleeding, or perforations (this may include vomiting blood, bleeding during defecation, fresh blood in stool, or black-coloured stool, tarry stools);
• if the patient has active or recurrent peptic ulcer disease of the stomach and/or duodenum or gastrointestinal bleeding (two or more separate episodes of ulcers or bleeding);
• if the patient has a history of gastrointestinal bleeding or perforation associated with 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 arterial embolism in the heart or brain, or after revascularisation or bypass surgery of 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 the high content of active substance.

Warnings and precautions
The situations described below require special caution when taking Dicloberl 100 mg. The medicine should be used only in a specific manner (e.g. with longer intervals between doses or lower doses under medical supervision). Please consult your doctor about this. This also applies to conditions that occurred in the past.
Before starting treatment with Dicloberl 100 mg, discuss this with your doctor or pharmacist.
General information
Concomitant use of Dicloberl 100 mg with other NSAIDs, including so-called COX-2 inhibitors (selective cyclooxygenase-2 inhibitors), should be avoided due to lack of evidence for improved efficacy and the possibility of increased number and severity of adverse effects.
Treatment with 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 perforations, sometimes fatal, have been reported with all NSAIDs. These may occur at any time during treatment, with or without warning symptoms, and with or without previous serious gastrointestinal adverse effects.
The risk of gastrointestinal bleeding, peptic ulcer disease of the stomach and/or duodenum, and perforation increases with higher NSAID doses, 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 continued with the lowest available dose.
In such patients and in patients requiring concomitant use of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, concomitant use of gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
Patients who have experienced gastrointestinal adverse effects, particularly elderly patients, should report any abnormal abdominal symptoms (especially gastrointestinal bleeding), particularly 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 of the stomach and/or duodenum or bleeding, such as systemic corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors used, among others, in the treatment of depression, or antiplatelet drugs such as acetylsalicylic acid (see section 2 "Dicloberl 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 drug should be discontinued. The patient should be instructed to discontinue the medicine and seek immediate medical attention if acute upper abdominal pain, tarry stools, or bloody vomiting occur (see section 4 "Possible side effects").
NSAIDs should be administered with caution and under strict medical supervision to patients with symptoms indicating gastrointestinal disorders, with a history of peptic ulcer disease of the stomach and/or duodenum, bleeding or perforation, or with gastrointestinal diseases (ulcerative colitis, Crohn's disease) in the past, as disease exacerbation 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 pectoris, thrombosis, hypertension, elevated cholesterol levels, or elevated triglyceride levels.

Taking the medicine at 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 blistering, some of which were 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 risk of these reactions appears to be highest at the beginning of treatment: in most cases, the onset of such a reaction occurs during the first month of treatment.
Before using Dicloberl 100 mg, inform the doctor if the patient has ever experienced severe skin rash, skin peeling, blistering, and/or oral ulcers after taking Dicloberl 100 mg or other pain-relieving medicines.
If the first signs of skin rash, mucosal changes (oral or nasal mucosa), or other signs of hypersensitivity occur, discontinue Dicloberl 100 mg immediately and contact a doctor without delay.
Effect on the liver
Caution should be exercised before initiating diclofenac treatment in patients with liver function disorders (consult a doctor or pharmacist), as disease exacerbation may occur. 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.
Caution should be exercised when using Dicloberl 100 mg in patients with hepatic porphyria (a blood disorder), as it may trigger disease exacerbation.
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, a history of hypertension, elderly patients, patients concurrently receiving diuretics or drugs that significantly reduce renal function, and patients with significant 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 leads to return to the pre-treatment state.
Other
Dicloberl 100 mg may be used only 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 may be used only under strict medical supervision:

• in patients with allergies (e.g. skin reactions to other medicines, 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 taking 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) occur 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, renal function, and blood morphology is required.
Inform the doctor or dentist about taking Dicloberl 100 mg before surgical procedures.
During long-term use of painkillers, headache may occur, which should not be treated by increasing the dose of these medicines. Consult a doctor if the patient frequently experiences headaches despite using Dicloberl 100 mg.
Generally, habitual use of painkillers, especially combinations of several active substances with analgesic effects, may cause irreversible kidney damage associated with the 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 risk 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 or recently taken by the patient, 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 (a drug used to treat cardiac arrhythmias), phenytoin (a drug used to treat epileptic seizures), or lithium (a drug 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 100 mg may reduce the effect of diuretics and antihypertensive drugs (diuretics and antihypertensive drugs such as beta-blockers, ACE inhibitors, and angiotensin II antagonists). Therefore, blood pressure should be monitored periodically.
Dicloberl 100 mg 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 100 mg may increase the risk of renal dysfunction. Patients should be adequately hydrated and renal function should be monitored periodically after initiation of treatment and subsequently at appropriate intervals.
Concomitant use of Dicloberl 100 mg with potassium-sparing diuretics (some diuretics) may lead to increased blood potassium levels. Therefore, regular monitoring of potassium levels is recommended.
Selective serotonin reuptake inhibitors (SSRIs)
Some antidepressants (selective serotonin reuptake inhibitors [SSRIs]) may increase the risk of gastrointestinal bleeding and ulcers.
Methotrexate
Taking Dicloberl 100 mg within 24 hours before or after methotrexate (a drug used in inflammatory diseases and treatment of certain cancers) may increase methotrexate blood levels and increase adverse effects.
Cyclosporine
Non-steroidal anti-inflammatory drugs (including diclofenac) may increase the nephrotoxic effect of cyclosporine (a drug used to prevent transplant rejection and in the treatment of rheumatic diseases). The patient should use a lower dose of diclofenac.
Anticoagulants and antiplatelet drugs
Non-steroidal anti-inflammatory drugs may enhance the effect of antiplatelet and anticoagulant drugs (used to prevent blood clotting), such as warfarin. Regular visits to the doctor are recommended.
Probenecid
Drugs containing probenecid (used in the treatment of gout) may slow down the elimination of diclofenac. This may lead to increased adverse effects.
Antidiabetic drugs
During treatment with blood glucose-lowering drugs (antidiabetic drugs), isolated cases of diclofenac affecting blood glucose levels have been reported, requiring dose adjustment of antidiabetic drugs. Therefore, as a precaution, blood glucose monitoring is recommended when these drugs are used concomitantly.
Antibacterial quinolones
Quinolones (some types of antibiotics) may cause epileptic seizures when used concomitantly with NSAIDs.
Colestipol and cholestyramine
These drugs (used to lower blood cholesterol levels) induce prolonged or reduced absorption of diclofenac. Therefore, diclofenac should be taken at least one hour before or 4 to 6 hours after taking colestipol or cholestyramine.
Strong CYP2C9 inhibitors
Voriconazole (a drug used to treat severe fungal infections) and sulfinpyrazone (a drug 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 (a drug used to treat hepatitis B virus infection and in prevention and treatment of HIV/AIDS) with NSAIDs (such as diclofenac) may increase blood urea nitrogen and creatinine levels (renal function parameters). Renal function should therefore be monitored to check for possible increases in these parameters.
Deferasirox
Concomitant use of deferasirox (a drug 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 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 the efficacy of mifepristone.
Pemetrexed
Concomitant use of pemetrexed and NSAIDs may intensify the effect of pemetrexed; therefore, particular caution is required when administering high doses of NSAIDs.
Dicloberl 100 mg and alcohol
Do not consume alcohol during treatment with Dicloberl 100 mg.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Inform the doctor if pregnancy is diagnosed 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 if the patient is in 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 dysfunction in the unborn child. It may increase the tendency to bleeding in both the mother and child and may delay or prolong labour. Dicloberl 100 mg should not be used during the first 6 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 time.
From the 20th week 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 is required for longer than a few days, 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 conceive or has difficulty conceiving, she should inform the 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 react quickly and appropriately to unexpected or sudden events. If the above-mentioned 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 exactly as your doctor has instructed. If in doubt, consult your
doctor or pharmacist.
Dosage
If your doctor has not prescribed otherwise, the medicine should be used as follows:
Diclofenac dosage depends on the severity of the condition. Diclofenac in suppository form offers an alternative route of administration for 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 along the perforated line with scissors.
Then, holding the free ends of the foil at the top of the suppository between the thumbs and index fingers of each hand, gently tear it open until the suppository can be removed (see figure).

The suppository should be inserted deeply into the rectum, preferably after a bowel movement.
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 your doctor.
In rheumatic diseases, long-term use of Dicloberl 100 mg may be required.
Using the medicine at the lowest effective dose for the shortest duration necessary to relieve symptoms reduces 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 a higher than recommended dose of Dicloberl 100 mg
Dicloberl 100 mg should be used strictly according to your doctor's instructions or the dosage information provided in this leaflet. If the patient feels that the pain-relieving effect is insufficient, the dose should not be increased without consulting a doctor.
There are no specific clinical signs characteristic 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. 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 about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious. If any adverse symptoms occur,
inform your doctor, who will decide on further management.
The occurrence of the following adverse reactions of the medicine primarily depends on the dose used and may vary between individuals.
The most commonly observed adverse reactions are gastrointestinal disorders. Gastric and/or duodenal ulcer disease (peptic ulcers), perforation or gastrointestinal bleeding may occur, sometimes leading to death, particularly in elderly patients (see section 2 "Warnings and precautions"). Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, tarry stools, haematemesis, gastritis, 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 any of the following:

• mild painful abdominal cramps and 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),
• severe allergic skin reaction, which may manifest as extensive red and/or dark patches, skin swelling, blisters and itching (generalised fixed bullous eruption).

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

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

Cases of fluid retention (oedema), high blood pressure and heart failure associated with NSAID therapy have been reported.
The use of medicines such as Dicloberl 100 mg may be associated with an increased risk of arterial thrombotic events, such as myocardial infarction (heart attack) 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 disorders 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;
• disorders of the central nervous system such as headache, dizziness, feeling of emptiness in the head, anxiety (agitation), irritability, fatigue;
• digestive disturbances (dyspepsia), flatulence, stomach cramps (abdominal pain), loss of appetite, as well as gastric or duodenal ulcer disease (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;
• haematemesis, blood in stool 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;
• oedema formation (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 constriction, dyspnoea (respiratory failure), tachycardia, 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 infection-related inflammation (e.g. development of necrotising fasciitis) associated with the use of anti-inflammatory medicines (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 immediate medical advice. The doctor 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 use. Patients with concomitant autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) appear to be at higher risk of the above-mentioned adverse reactions;
• 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 neutrophil count), haemolytic and aplastic anaemia (lack of red blood cells due to accelerated breakdown)]. Initial symptoms may include fever, sore throat, oral ulcers, flu-like symptoms, severe 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 (facial, tongue and laryngeal swelling). If any of these symptoms occur, even after a single dose, diclofenac should be discontinued and immediate medical help sought;
• allergic vasculitis and pneumonitis;
• psychotic reactions, depression, anxiety, insomnia, nightmares;
• sensory disturbances, taste disturbances, memory impairment, disorientation, seizures, 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. In case of sudden upper abdominal pain, haematemesis, black stools or blood in stool, 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 skin necrosis (exfoliative dermatitis), photosensitivity (photosensitivity reactions), local skin bleeding (purpura), which may be of allergic nature;
• kidney damage (interstitial nephritis, papillary necrosis), which may be associated with 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 signs of kidney dysfunction, including kidney failure. If these symptoms occur or worsen, Dicloberl 100 mg should be discontinued and immediate medical advice sought.

Frequency not known: frequency cannot be estimated from available data

• allergic skin reaction, which may present as round or oval erythematous areas and skin swelling, blisters and itching (fixed erythema). The skin in affected areas may also appear darker, which may persist after healing. Upon re-administration of the medicine, fixed erythema usually reappears in the same locations.
• ischaemic colitis.

Follow the instructions given above regarding certain adverse reactions!
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dicloberl 100 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and outer packaging following the abbreviation "EXP". The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging in order 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 pack and other information

What Dicloberl 100 mg contains

• The active substance is sodium diclofenac. One suppository contains 100 mg of sodium diclofenac.
• Other ingredients: hard fat.

What Dicloberl 100 mg looks like and contents of the pack
Ivory-coloured, elongated, torpedo-shaped suppositories in soft blisters made of opaque PVC/PE foil with an embossed batch number.
The cardboard pack contains 5 or 10 suppositories.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

For further information, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel. + 48 22 566 21 00
Fax: + 48 22 566 21 01