PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the immediate packaging in a foreign language!
Diclac 50 (Diclac 50 mg Zäpfchen)
50 mg, suppositories
Diclofenacum natricum
Diclac 50 and Diclac 50 mg Zäpfchen are different brand names of the same medicine
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Diclac 50 is and what it is used for
Important information before using Diclac 50
How to use Diclac 50
Possible side effects
How to store Diclac 50
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 called non-steroidal anti-inflammatory drugs (NSAIDs), with anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of Diclac 50 involves the inhibition of prostaglandin biosynthesis, which plays a key role in the pathogenesis of inflammation, pain, and fever.
Diclac 50 is used in the treatment of:

inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, juvenile rheumatoid arthritis (Still's disease), ankylosing spondylitis, osteoarthritis, spinal arthritis, painful syndromes associated with spinal changes, and extra-articular rheumatism;
acute gout attacks;
pain caused by traumatic and postoperative inflammatory conditions and swelling, 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 (i.e., pharyngitis and tonsillitis, otitis). According to general therapeutic principles, causal treatment should be applied first in the above-mentioned conditions. Fever, as the sole symptom, is not an indication for use.

Monitoring during treatment with Diclac 50
In patients diagnosed with heart disease or significant risk factors for heart disease, the treating physician will periodically assess the patient's need for symptomatic treatment and their 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 test results, the physician will decide whether to discontinue treatment with Diclac 50 or adjust the dosage.

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 analgesic medicines (e.g., acetylsalicylic acid, diclofenac, or ibuprofen). Reactions may include asthma, rhinitis, skin rash, urticaria, or 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 medicines,
if the patient has proctitis or anal inflammation,
if the patient is in the last trimester of pregnancy,
if the patient has liver failure,
if the patient has kidney failure,
if the patient has been diagnosed with heart disease and (or) cerebrovascular disease, e.g., after myocardial infarction, stroke, transient ischemic attack (mini-stroke), arterial embolism in the heart or brain, or after a revascularization or bypass procedure,
if the patient has current or past circulatory disorders (peripheral vascular disease).

Patients should inform their doctor if any of these conditions are present.
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 dose of the medicine should not exceed 100 mg per day if treatment lasts longer than 4 weeks;
the patient has a history of gastrointestinal ulcers or is elderly. Use of diclofenac may cause gastrointestinal bleeding, ulceration, or perforation (with potentially fatal outcome). Such effects may be particularly dangerous when high doses of the medicine are used.

If any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) occur during treatment with Diclac 50, the medicine should be discontinued immediately and the patient should contact their doctor;

the patient has ulcerative colitis or Crohn's disease, as diclofenac may worsen the course of the disease;
the patient has asthma, allergic rhinitis, nasal mucosal edema (e.g., due to nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory tract infections, as they are more likely to experience an allergic reaction to diclofenac (worsening of asthma symptoms, Quincke's edema, or urticaria). This warning also applies to patients allergic to other substances (e.g., those experiencing skin reactions, itching, or urticaria). The medicine should be used with particular caution (preferably under medical supervision);
the patient has impaired liver function, as diclofenac may worsen the disease course. Strict adherence to the doctor's recommendations regarding regular liver function tests is required;
the patient suffers from hepatic porphyria, as diclofenac may trigger an attack of porphyria.

Before taking Diclac 50, inform your doctor if:

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

The risk of adverse effects can be minimized by using the medicine at the lowest effective dose and for the shortest duration necessary.
To minimize the risk of adverse effects, the lowest effective dose of Diclac 50 that relieves pain and (or) swelling should be used, and it should be taken for as short a time as possible.
If at any time during treatment with Diclac 50 the patient experiences symptoms indicating heart or blood vessel problems (such as chest pain, shortness of breath, weakness, or slurred speech), they should contact their doctor or emergency department immediately.
Diclofenac use may, in very rare cases (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, the medicine should be discontinued and the patient should contact their doctor.
The medicine may mask symptoms of infection (e.g., headache, elevated body temperature) and complicate proper diagnosis. Inform the doctor about medicine use during medical examinations.
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 about any of the above-mentioned conditions.
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 duration than recommended.
If the patient has heart problems, has had a stroke, or suspects they are at risk of these conditions (e.g., high blood pressure, diabetes, elevated cholesterol, smoking), they should discuss the treatment approach with their doctor or pharmacist.
The medicine may transiently inhibit platelet aggregation.
Children and adolescents
Due to the dosage, the use of Diclac 50 is not recommended in children and adolescents under 14 years of age.
Elderly patients (aged 65 years and older)
Elderly individuals may react more strongly to the medicine than other adults. Follow the instructions in the leaflet, use the lowest effective doses as recommended by the doctor, and report all adverse effects occurring during treatment to the doctor.
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.
Inform your doctor especially if taking the following medicines:

lithium or antidepressants (selective serotonin reuptake inhibitors)
digoxin – a medicine used in the treatment of heart disease
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 alleviate inflammatory conditions)
anticoagulants and antiplatelet medicines
antidiabetic medicines except insulin
methotrexate – a medicine used in the treatment of certain cancers or arthritis
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 fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Diclac 50 should not be used during the first two trimesters of pregnancy unless the doctor considers it absolutely necessary.
As with other anti-inflammatory medicines, the use of Diclac 50 during the last three months of pregnancy is contraindicated, as it may seriously harm the unborn child or adversely affect delivery.
Diclac 50 may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and child and may delay or prolong labor.
From the 20th week of pregnancy, Diclac 50 may lead to impaired kidney function in the unborn child if taken for longer than a few days. This may result in low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment for longer than a few days is required, the doctor may recommend additional monitoring.
Diclac 50 should not be used by breastfeeding women, as it may harm the infant.
The doctor will discuss with the patient the potential risks of using Diclac 50 during pregnancy and while breastfeeding.
Taking Diclac 50 may make it more difficult to become pregnant. If the patient plans pregnancy or has difficulty becoming pregnant, she should inform her doctor.
Driving and operating machinery
The effect of Diclac 50 on the ability to drive, operate machinery, or perform other activities 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.
Do not exceed the recommended doses. If Diclac 50 is used for longer than a few weeks, regular medical check-ups are necessary to rule out any undetected adverse effects.
The dosage 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 properly inserted 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 with a suppository before bedtime (without exceeding the maximum total daily dose of 150 mg).

Primary dysmenorrhea
The daily dose should be individually adjusted for each patient. It usually ranges from 50 mg to 150 mg. Initially, administer 50 mg to 100 mg, and if necessary, the dose may be increased over several menstrual cycles up to a maximum daily dose of 200 mg. Treatment should begin at the onset of the first symptoms and, depending on their severity, continued for several days.

Treatment of migraine attacks with Diclac 50
Treatment should begin with a dose of 100 mg administered after the first symptoms of an attack appear. If necessary, additional suppositories may be used on the same day, up to a total of 100 mg. If the patient requires further treatment over the following 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, given in 2 or 3 divided doses. The daily dose may be increased up to a maximum of 3 mg/kg body weight in divided doses.
The total 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 exclusively at doses ≤100 mg per day if treatment lasts longer than 4 weeks.

Renal function disorders
The use of Diclac 50 in patients with renal impairment is contraindicated.
No specific studies have been conducted in patients with renal function disorders; therefore, no specific dosage recommendations can be made. Caution is advised in patients with mild to moderate renal impairment.

Hepatic function disorders
The use of Diclac 50 in patients with hepatic impairment is contraindicated.
No specific studies have been conducted in patients with hepatic function disorders; therefore, no specific dosage recommendations can be made. Caution is advised in patients with mild to moderate hepatic impairment.

Method of administration
Suppositories are best administered after defecation.

Use of a higher than recommended dose of Diclac 50
Overdose with Diclac 50 does not typically produce characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or convulsions.
In cases of significant poisoning, acute renal failure and liver damage may occur.
If an overdose is accidentally taken, contact a doctor, pharmacist, or go to a 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 the interval between doses has passed, the missed dose should not be taken; instead, the next dose should be taken according to the regular 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 to diclofenac
in other pharmaceutical forms, used short- 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),
drowsiness,
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 or 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 number of platelets), leukopenia (reduced number of white blood cells), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (reduced number or absence of neutrophil granulocytes),
angioedema (including facial oedema),
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 oral ulcerative stomatitis), glossitis, oesophageal disorders, mucosal stricture of the intestine, pancreatitis, exacerbation of haemorrhoidal nodules,
fulminant hepatitis, hepatic necrosis, liver failure,
bullous rash, eczema, 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 with unknown frequency (frequency cannot be estimated from available data):

mild painful cramps and abdominal tenderness occurring soon after starting Diclac 50, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of 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,
you should inform your doctor or pharmacist.
If any of the following adverse effects occur, stop taking Diclac 50 immediately and inform your doctor:

feeling of stomach discomfort, heartburn or pain in the upper abdomen
vomiting blood, blood in stools, 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 body temperature
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 per 1000, especially
during long-term use of high daily doses (150 mg)

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

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 suspected adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions
of the 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
By reporting adverse effects, more information on the safety of the medicine can be collected.

5. How to store Diclac 50

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use 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 immediate packaging:
Ch.-B./verw. bis: see imprint – 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. This will 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 other ingredient is 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, the country of export:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Germany

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

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland

Marketing Authorisation Number in Germany, the country of export: 6360.00.02
Parallel Import Licence Number: 449/22