Diclac 50

Patient Information Leaflet

Caution! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Diclac 50 (Diclac 50 mg Zäpfchen)
50 mg, suppositories
Diclofenacum natricum
Diclac 50 and Diclac 50 mg Zäpfchen are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult 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 those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Diclac 50 is and what it is used for
2. Important information before using Diclac 50
3. How to use Diclac 50
4. Possible side effects
5. How to store Diclac 50
6. Contents of the pack and other information

1. What Diclac 50 is and what it is used for

Diclac 50 contains sodium diclofenac, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It has anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of Diclac 50 primarily involves inhibition of prostaglandin biosynthesis. Prostaglandins play a key role in the pathogenesis of inflammation, pain, and fever.

Diclac 50 is used for the treatment of:

• Inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, juvenile rheumatoid arthritis (Still's disease), ankylosing spondylitis, osteoarthritis, spinal arthritis, painful conditions associated with spinal changes, and extra-articular rheumatism;
• Acute gout attacks;
• Pain caused by inflammatory conditions and swelling following trauma or surgery, e.g. after dental or orthopedic procedures;
• Painful and/or inflammatory conditions in gynecology, e.g. primary dysmenorrhea or adnexitis;
• Migraine attacks;
• Adjunctive treatment in severe, painful infections of the ear, nose, or throat (e.g. pharyngitis and tonsillitis, otitis). According to general therapeutic principles, causal treatment should be considered first in the above-mentioned conditions. Fever alone is not an indication for use.

Monitoring during treatment with Diclac 50
In patients with diagnosed heart disease or significant risk factors for cardiovascular disease, the treating physician will periodically assess the patient's need for symptomatic treatment and response to the medicine, especially if treatment lasts longer than 4 weeks.
During treatment, the physician may order regular blood tests to monitor liver function (aminotransferase activity), kidney function (creatinine concentration), and blood cell counts (white and red blood cells, and platelets). Based on the test results, the physician will decide whether treatment with Diclac 50 should be discontinued or the dose adjusted.

Page 1 of 9

2. Important information before using Diclac 50

When not to use Diclac 50

• if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever experienced an allergic reaction after taking anti-inflammatory or pain-relieving medicines (e.g. acetylsalicylic acid, diclofenac, or ibuprofen). Reactions may include asthma, rhinitis, skin rash, urticaria, swelling of the face, lips, tongue, throat, and/or limbs (symptoms of angioedema). If the patient suspects they may be allergic, they should consult a doctor,
• if the patient has active or a history of peptic ulcer disease of the stomach and/or duodenum, bleeding, or perforation; if the patient has previously experienced stomach discomfort or heartburn after taking anti-inflammatory drugs,
• if the patient has proctitis or anal fissure,
• if the patient is in the last trimester of pregnancy,
• if the patient has liver failure,
• if the patient has renal failure,
• if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischemic attack (TIA), arterial embolism in the heart or brain, or after revascularization or bypass surgery,
• if the patient has current or a history of circulatory disorders (peripheral vascular disease).

Inform your doctor if any of the above conditions apply.
Warnings and precautions
Before using Diclac 50, discuss with your doctor if:

• the patient has diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormally elevated blood lipid levels (cholesterol, triglycerides), or if the patient is a smoker, as in such cases the daily dose should not exceed 100 mg if treatment lasts longer than 4 weeks;
• the patient has a history of gastrointestinal ulceration or is elderly. Use of diclofenac may cause gastrointestinal bleeding, ulceration, or perforation (which may be fatal). This risk may be particularly serious when high doses are used. If any unusual abdominal symptoms (especially gastrointestinal bleeding) occur during treatment with Diclac 50, discontinue the medicine immediately and contact your doctor;
• the patient has ulcerative colitis or Crohn’s disease, as diclofenac may worsen the condition;
• the patient has asthma, allergic rhinitis, nasal mucosal swelling (e.g. due to nasal polyps), chronic obstructive pulmonary disease (COPD), or chronic respiratory tract infections, as they may be more prone to allergic reactions to diclofenac (worsening of asthma symptoms, Quincke’s edema, or urticaria). This warning also applies to patients allergic to other substances (e.g. those with skin reactions, itching, or urticaria). The medicine should be taken with particular caution (preferably under medical supervision);

Page 2 of 9

• the patient has impaired liver function, as diclofenac may worsen the condition. Strictly follow your doctor’s recommendations regarding regular liver function tests;
• the patient has hepatic porphyria, as diclofenac may trigger an attack.

Before taking Diclac 50, inform your doctor if:

• the patient smokes,
• the patient has diabetes,
• the patient has angina pectoris, thrombosis, hypertension, elevated cholesterol, or elevated triglycerides.

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary.
To minimize the risk of adverse effects, use the lowest dose of Diclac 50 that relieves pain and/or swelling, and use it for the shortest possible time.
If at any time during treatment with Diclac 50 the patient experiences symptoms suggesting heart or blood vessel problems (such as chest pain, shortness of breath, weakness, or slurred speech), seek immediate medical attention from a doctor or emergency department.
Diclofenac use may, very rarely (especially at the beginning of treatment), cause life-threatening skin reactions (e.g. exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever, and joint pain, or toxic epidermal necrolysis with skin and mucosal lesions, high fever, and severe general condition). At the first signs of rash, mucosal changes, or other symptoms of allergic reaction, discontinue the medicine and contact your doctor.
The medicine may mask symptoms of infection (e.g. headache, elevated body temperature) and may complicate accurate diagnosis. Inform your doctor during medical examinations that you are taking this medicine.
Do not use Diclac 50 simultaneously with other systemic non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors.
Before using the medicine, inform your doctor or pharmacist if any of the above conditions apply.
Taking medicines such as Diclac 50 may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment durations than recommended.
If the patient has heart problems, a history of stroke, or suspects they are at risk of such conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), discuss the treatment approach with a doctor or pharmacist.
The medicine may transiently inhibit platelet aggregation.
Children and adolescents
Due to the dosage, Diclac 50 is not recommended for use in children and adolescents under 14 years of age.
Elderly patients (aged 65 years and older)
Elderly individuals may be more sensitive to the effects of the medicine than younger adults. Follow the instructions in the leaflet, use the lowest effective dose as recommended by your doctor, and report any adverse effects occurring during treatment to your doctor.
Page 3 of 9
Diclac 50 and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Specifically inform your doctor if the patient is taking any of the following medicines:

• lithium or antidepressants (selective serotonin reuptake inhibitors),
• digoxin – a medicine used in the treatment of heart conditions,
• diuretics – medicines that increase urine output,
• angiotensin-converting enzyme (ACE) inhibitors, beta-blockers – groups of medicines used in the treatment of hypertension and heart failure,
• non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid, ibuprofen, selective cyclooxygenase-2 inhibitors) and corticosteroids (medicines used, among others, to relieve inflammatory conditions),
• anticoagulants and antiplatelet medicines,
• antidiabetic medicines, except insulin,
• methotrexate – a medicine used in the treatment of certain cancers or joint inflammation,
• cyclosporine and tacrolimus – medicines used in organ transplant recipients,
• trimethoprim – a medicine used to prevent and treat urinary tract infections,
• antibacterial quinolones – medicines used to treat infections,
• colestipol and cholestyramine – medicines that lower blood cholesterol levels,
• voriconazole – a medicine used to treat fungal infections,
• phenytoin – a medicine used to treat epileptic seizures.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Diclac 50 should not be used during the first two trimesters of pregnancy unless absolutely necessary.
As with other anti-inflammatory medicines, Diclac 50 must not be used during the last three months of pregnancy, as it may seriously harm the unborn child or adversely affect delivery.
Do not use Diclac 50 in breastfeeding women, as it may harm the infant.
Your doctor will discuss with you the potential risks of using Diclac 50 during pregnancy and breastfeeding.
Taking Diclac 50 may make it more difficult to become pregnant. If the patient is planning pregnancy or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
The effect of Diclac 50 on the ability to drive, operate machinery, or perform other tasks requiring special attention is unlikely.
Diclac 50 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per suppository, meaning the medicine is considered "sodium-free".

3. How to use Diclac 50

This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Page 4 of 9
Do not exceed the recommended doses. If Diclac 50 is used for longer than a few weeks, regular
medical check-ups should be performed to rule out any undetected adverse effects.
The dose is determined individually by the physician for each patient. The principle is to use the
lowest effective dose for the shortest possible duration.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Do not divide suppositories!
Do not use orally!
The suppository should be inserted properly into the rectum.
Adults
The recommended initial daily dose is 100 mg to 150 mg.
In milder cases and in chronic treatment, a daily dose of up to 100 mg is considered sufficient.
The total daily dose should be taken in 2 or 3 divided doses. To relieve nocturnal pain and morning
stiffness, daytime tablet treatment may be supplemented by administration of a suppository before
bedtime (without exceeding the maximum total daily dose of 150 mg).
In primary dysmenorrhoea, the daily dose should be individually adjusted for each patient. It usually
ranges from 50 mg to 150 mg. Initially, 50 mg to 100 mg should be administered, and if necessary,
the dose may be increased over several menstrual cycles up to a maximum of 200 mg per day.
Treatment should begin at the onset of the first symptoms and continued for several days, depending
on symptom severity.
Treatment of migraine attacks with Diclac 50 should be initiated with a 100 mg dose administered
after the first symptoms of an attack appear. If necessary, additional suppositories may be used the
same day, up to a total of 100 mg. If further treatment is required on subsequent days, the maximum
daily dose should be limited to 150 mg and administered in divided doses.
Use in children and adolescents
Diclac 50 suppositories containing 50 mg of diclofenac should not be used in children under 14 years
of age.
Juvenile idiopathic arthritis
Depending on the severity of symptoms, from 0.5 mg/kg body weight to 2 mg/kg body weight per day,
in 2 or 3 divided doses. The daily dose may be increased up to a maximum of 3 mg/kg body weight,
given in divided doses.
The daily dose should not exceed 150 mg.
Elderly patients (aged 65 years and above)
This medicine should be used with caution in elderly patients. In elderly patients and those with low
body weight, the lowest effective dose is recommended.
Established cardiovascular disease or significant cardiovascular risk factors
Patients with established cardiovascular disease or significant cardiovascular risk factors should be
treated with diclofenac only after careful assessment and only at doses ≤100 mg per day if treatment
lasts longer than 4 weeks.
Renal function impairment
The use of Diclac 50 in patients with renal insufficiency is contraindicated.
No specific studies have been conducted in patients with renal function impairment; therefore, no
specific dose adjustment recommendations can be provided. Caution is advised in patients with mild
to moderate renal impairment.
Page 5 of 9
Hepatic function impairment
The use of Diclac 50 in patients with hepatic insufficiency is contraindicated.
No specific studies have been conducted in patients with hepatic function impairment; therefore, no
specific dose adjustment recommendations can be provided. Caution is advised in patients with mild
to moderate hepatic impairment.
Method of administration
It is recommended to use suppositories after defecation.
Use of a higher than recommended dose of Diclac 50
Overdose with Diclac 50 does not typically cause characteristic symptoms, but the following may
occur: vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus, or convulsions. In cases of
severe poisoning, acute renal failure and liver damage may occur. In case of accidental ingestion of a
larger than recommended amount of medicine, contact a doctor, pharmacist, or go to the nearest
hospital emergency department immediately.
Missed dose of Diclac 50
If a patient misses a dose, it should be taken as soon as remembered. However, if more than half of
the interval between doses has passed, the missed dose should not be taken; instead, the next dose
should be taken according to the usual schedule. Do not use a double dose to make up for a missed
dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects listed below relate to diclofenac in suppository form and diclofenac in other pharmaceutical forms, used either short-term or long-term.

Adverse effects

Common (may occur in fewer than 1 in 10 people taking the medicine):

• headache, dizziness,
• nausea, vomiting, diarrhoea, indigestion, abdominal pain, bloating, decreased appetite,
• increased aminotransferase activity,
• rash,
• irritation at the site of administration.

Uncommon (may occur in fewer than 1 in 100 people taking the medicine):

• myocardial infarction, heart failure, palpitations, chest pain.

Rare (may occur in fewer than 1 in 1,000 people taking the medicine):

• hypersensitivity, anaphylactic and anaphylactoid reactions (including sudden drop in blood pressure and shock),
• somnolence,
• asthma (including breathlessness),
• gastric mucosal inflammation, gastrointestinal bleeding, vomiting of blood, bloody diarrhoea, melaena,
• peptic ulcer of the stomach and/or duodenum (with or without bleeding and perforation), proctitis,
• hepatitis, jaundice, liver function disorders,
• urticaria,
• oedema.

Very rare (may occur in fewer than 1 in 10,000 people taking the medicine):

• thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (reduced number or absence of granulocytes, a type of white blood cell),
• angioedema (including facial swelling),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
• paraesthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, stroke,
• visual disturbances, blurred vision, double vision,
• tinnitus, hearing disturbances,
• hypertension, vasculitis,
• pneumonia,
• colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, oral mucosal inflammation (including ulcerative stomatitis), glossitis, oesophageal disorders, membranous intestinal stricture, pancreatitis, exacerbation of haemorrhagic polyps,
• fulminant hepatitis, hepatic necrosis, liver failure,
• bullous rash, exanthema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, Schönlein-Henoch disease, pruritus, acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Adverse effects occurring with unknown frequency (frequency cannot be estimated from the available data):

• mild painful abdominal cramps and tenderness beginning shortly after starting Diclac 50, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain,
• simultaneous occurrence of chest pain and allergic reaction (symptoms of Kounis syndrome).

Taking medicines such as Diclac 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Some people may experience other adverse effects while taking Diclac 50.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.

If any of the following adverse effects occur, stop taking Diclac 50 immediately and contact your doctor:

• stomach discomfort, heartburn or upper abdominal pain,
• vomiting blood, blood in stool, blood in urine,
• skin problems such as rash or itching,
• wheezing or shortness of breath,
• yellowing of the skin or whites of the eyes,
• persistent sore throat or high fever,
• swelling of the face, feet or legs,
• severe migraine,
• chest pain associated with cough.

Some adverse effects may be serious
These uncommon adverse effects may occur in 1 to 10 patients out of 1,000, especially when high daily doses (150 mg) are used for a prolonged period:

• sudden, crushing chest pain (symptoms of myocardial infarction),
• breathlessness, difficulty breathing when lying down, swelling of feet or legs (symptoms of heart failure).

Page 7 of 9
If you are taking Diclac 50 for longer than a few weeks, you should visit your doctor regularly to ensure that no adverse effects have occurred.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181, 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 provide more information on the safety of the medicine.

5. How to store Diclac 50

• Keep this medicine out of sight and reach of children.
• Do not store above 25°C.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.

Translation of some information on the blister pack:
Ch.-B.:/verw. bis: siehe Prägung – Batch number/Expiry date: see imprint

• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Diclac 50 contains
The active substance is sodium diclofenac. Each suppository contains 50 mg of sodium diclofenac.
The product also contains hard fat.

What Diclac 50 looks like and contents of the pack
Blister packs in a cardboard box.
The pack contains 10 suppositories.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Germany, country of export:
Hexal AG, Industriestraße 25, 83607 Holzkirchen, Germany

Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

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

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

German marketing authorisation number, country of export: 6360.00.02
Page 8 of 9

Parallel import authorisation number: 107/22
Page 9 of 9