Diclac 50

Leaflet attached to the packaging: information for the user

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

Diclac 50 (Diclac 50 mg suppositories)

50 mg, suppositories

Diclofenac sodium
Diclac 50 and Diclac 50 mg suppositories are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Diclac 50 and what is it 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. Package contents and other information

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

Diclac 50 contains diclofenac sodium, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), acting anti-rheumatically, anti-inflammatory, analgesic, and antipyretic. The mechanism of action of Diclac 50 involves the inhibition of prostaglandin biosynthesis, which plays a fundamental 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, psoriatic arthritis, spinal arthritis, pain syndromes associated with spinal changes, extra-articular rheumatism;
• acute attacks of gout;
• pains caused by post-traumatic and post-operative 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;
• supportive treatment in severe, painful ear, nose, or throat infections (i.e., pharyngitis and tonsillitis, otitis). According to general therapeutic principles, in the case of the above-mentioned diseases, causal treatment should be applied first. Fever, as the only symptom, is not an indication for use.

Control tests during the use of Diclac 50

In patients with diagnosed heart disease or significant risk factors for heart disease, the attending 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 doctor will order regular blood tests to monitor liver function (aminotransferase activity), kidney function (creatinine levels), and blood cell count (white and red blood cells and platelets). Based on the test results, the doctor will decide whether to discontinue treatment with Diclac 50 or change the dose of the medicine.

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 had an allergic reaction after using anti-inflammatory or analgesic drugs (e.g., acetylsalicylic acid, diclofenac, or ibuprofen). Reactions may include asthma, rhinitis, skin rash, urticaria, facial swelling, lip swelling, tongue swelling, throat swelling, and/or limb swelling (symptoms of angioedema). If the patient thinks they may be allergic, they should consult a doctor,
• if the patient has active or a history of stomach or duodenal ulcers, bleeding, or perforation; if the patient has previously experienced discomfort in the stomach area or heartburn after taking anti-inflammatory drugs,
• if the patient has proctitis or proctocolitis,
• if the patient is in the third trimester of pregnancy,
• if the patient has liver failure,
• if the patient has kidney failure,
• if the patient has heart disease and/or cerebrovascular disease, e.g., after a heart attack, stroke, transient cerebral ischemia (mini-stroke), vascular occlusion of the heart or brain, or after a revascularization or bypass procedure,
• if the patient has circulation disorders (peripheral vascular disease).

The patient should inform their doctor about the presence of these diseases.

Warnings and precautions

Before using Diclac 50, the patient should discuss it with their doctor if:

• the patient has diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, elevated lipid levels (cholesterol, triglycerides), or if the patient is a smoker, as in such cases, the dose of the medicine should not be increased above 100 mg per day if treatment lasts longer than 4 weeks;
• the patient has undergone gastrointestinal ulceration or is elderly. The use of diclofenac may cause gastrointestinal bleeding, ulceration, or perforation (with possible fatal outcome). Such action may be particularly dangerous in the case of using high doses of the medicine. If any unusual abdominal symptoms occur during the use of Diclac 50 (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the doctor consulted;
• the patient has ulcerative colitis or Crohn's disease, as diclofenac may exacerbate the course of the disease;
• the patient has asthma, allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease, or chronic respiratory infections, as they are more likely to experience an allergic reaction to diclofenac (exacerbation of asthma symptoms, angioedema, or urticaria). The warning also applies to patients allergic to other substances (e.g., those who experience skin reactions, itching, or urticaria). The medicine should be used with caution (preferably under medical supervision);

Before using Diclac 50, the patient should inform their doctor if:

• they smoke,
• they have diabetes,
• they have angina pectoris, thrombosis, hypertension, elevated cholesterol levels, or elevated triglyceride levels.

The occurrence of side effects can be limited by using the medicine in the smallest effective dose and for no longer than necessary.
In order to minimize the risk of side effects, the smallest dose of Diclac 50 that provides relief from pain and/or swelling should be used, and it should be used for the shortest possible time.
If, at any time during the use of Diclac 50, the patient experiences symptoms indicating heart or vascular problems (such as chest pain, shortness of breath, weakness, or slurred speech), they should immediately contact their doctor or hospital emergency department.
The use of diclofenac 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, and toxic epidermal necrolysis with skin and mucous membrane changes, high fever, and severe general condition). After the first signs of rash, mucous membrane changes, or other symptoms of an allergic reaction, the medicine should be discontinued and the doctor consulted.
The medicine may mask the symptoms of infection (e.g., headache, elevated body temperature) and make it difficult to diagnose correctly. During medical examinations, the doctor should be informed about the use of the medicine.
Diclac 50 should not be used simultaneously with other systemic non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors.
Before using the medicine, the patient should inform their doctor or pharmacist about the presence of the above-mentioned diseases.
Taking such medicines 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 of the medicine. The medicine should not be used in higher doses or for longer than recommended.
In the case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, elevated cholesterol levels, smoking), the patient should discuss the treatment with their doctor or pharmacist.
The medicine may temporarily inhibit platelet aggregation.

Children and adolescents

Due to the dose, the use of Diclac 50 is not recommended in children and adolescents under the age of 14.

Elderly patients (65 years and older)

Elderly people may react more strongly to the action of the medicine than other adults. The patient should follow the recommendations contained in the leaflet, use the smallest effective doses in accordance with the doctor's recommendations, and report all side effects that occur during treatment to their doctor.
Page 3 of 9

Diclac 50 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor especially about taking the following medicines:

• lithium or antidepressant drugs (selective serotonin reuptake inhibitors),
• digoxin - a medicine used to treat heart diseases,
• diuretics - medicines that increase the amount of urine excreted,
• angiotensin-converting enzyme (ACE) inhibitors, beta-blockers - groups of medicines used to treat 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),
• anticoagulant and antiplatelet drugs,
• antidiabetic drugs, except for insulin,
• methotrexate - a medicine used to treat certain cancers or arthritis,
• cyclosporine and tacrolimus - medicines used in patients with organ transplants,
• trimethoprim - a medicine used to prevent and treat urinary tract infections,
• quinolone antibacterials - medicines used to treat infections,
• cholestyramine and colestipol - medicines that lower cholesterol levels in the blood,
• 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, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Diclac 50 should not be used during the first two trimesters of pregnancy unless it is absolutely necessary.
As with other anti-inflammatory drugs, the use of Diclac 50 in the last three months of pregnancy is contraindicated, as it may seriously harm the fetus or have an adverse effect on delivery.
Diclac 50 should not be used in breastfeeding women, as it may harm the infant.
The doctor will discuss the potential risks of using Diclac 50 during pregnancy and breastfeeding with the patient.
Taking Diclac 50 may make it difficult to become pregnant. If the patient plans to become pregnant or has problems becoming pregnant, they should inform their doctor.

Driving and using machines

The effect of Diclac 50 on the ability to drive vehicles, operate machines, or perform other activities that require special attention is unlikely.

Diclac 50 contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per suppository, which means the medicine is considered "sodium-free".

3. How to use Diclac 50

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Page 4 of 9
The recommended doses should not be exceeded. If Diclac 50 is used for more than a few weeks, regular medical check-ups should be performed to rule out unnoticed side effects.
The dose of the medicine is determined by the doctor individually for each patient. The rule is to use the smallest effective dose for the shortest possible time.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Suppositories should not be divided!

Do not use orally!

The suppository should be inserted well into the rectum.
Adults
The recommended initial daily dose is 100 mg to 150 mg.
In milder cases and in chronic treatment, a dose of up to 100 mg per day is considered sufficient.
The total daily dose should be taken in 2 or 3 divided doses. To alleviate nocturnal pain and morning stiffness, treatment with tablets during the day can be supplemented with a suppository before bedtime (without exceeding the maximum daily dose of 150 mg).
In primary dysmenorrhea, the daily dose should be determined individually 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 can be increased over several menstrual cycles to a maximum dose of 200 mg per day. Treatment should be started when the first symptoms appear and, depending on their severity, continued for several days.
Treatment of migraine attacks with Diclac 50 should be started with a dose of 100 mg administered after the first symptoms appear. If necessary, an additional suppository can be used on the same day, up to 100 mg. If the patient requires further treatment over the next few days, the maximum daily dose should be limited to 150 mg and taken in divided doses.
Use in children and adolescents
Diclac 50 in the form of suppositories containing 50 mg of diclofenac should not be used in children under the age of 14.
Juvenile rheumatoid 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 can be increased to a maximum of 3 mg/kg body weight in divided doses.
The daily dose should not be exceeded 150 mg.

Elderly patients (65 years and older)

The medicine should be used with caution in elderly people. In elderly people and people with low body weight, the smallest effective dose is recommended.

Diagnosed cardiovascular disease or significant cardiovascular risk factors

Patients with diagnosed cardiovascular disease or patients with significant risk factors for cardiovascular events should be treated with diclofenac only after careful assessment of the situation and only with doses ≤100 mg per day if treatment lasts longer than 4 weeks.

Kidney function disorders

The use of Diclac 50 in patients with kidney failure is contraindicated.
Page 5 of 9
No special studies have been conducted in patients with kidney function disorders, so no specific dosage recommendations can be made. In patients with mild to moderate kidney function disorders, caution is recommended.

Liver function disorders

The use of Diclac 50 in patients with liver failure is contraindicated.
No special studies have been conducted in patients with liver function disorders, so no specific dosage recommendations can be made. In patients with mild to moderate liver function disorders, caution is recommended.

Method of administration

It is recommended to use the suppositories after defecation.

Using a higher dose of Diclac 50 than recommended

Overdose of Diclac 50 does not cause characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or convulsions. In the case of significant poisoning, acute kidney failure and liver damage may occur. In the event of accidental use of a higher dose of the medicine than recommended, the patient should immediately contact their doctor, pharmacist, or hospital emergency department.

Missing a dose of Diclac 50

If the patient misses a dose, they should take it as soon as they remember. However, if more than half of the time between two doses has passed, the missed dose should not be taken, and the next dose should be taken according to the previous dosing schedule. A double dose should not be taken to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are related to diclofenac in the form of suppositories and diclofenac in other pharmaceutical forms, used for a short or long time.

Side effects

Common(may occur in less than 1 in 10 people using the medicine):

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

Uncommon(may occur in less than 1 in 100 people using the medicine):

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

Rare(may occur in less than 1 in 1000 people using the medicine):

• hypersensitivity, anaphylactic and pseudo-anaphylactic reactions (including sudden decrease in blood pressure and shock),
• drowsiness,
• asthma (including shortness of breath),
• gastritis, gastrointestinal bleeding, bloody vomiting, bloody diarrhea, melena,
• peptic ulcer disease of the stomach and/or duodenum (with or without bleeding and perforation), proctitis,
• hepatitis, jaundice, liver function disorders,
• urticaria,

Page 6 of 9

• edema.

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

• thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), anemia (including hemolytic and aplastic anemia), agranulocytosis (decreased or absent granulocytes),
• angioedema (including facial swelling),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
• paresthesia, memory disorders, convulsions, anxiety, tremors, aseptic meningitis, taste disorders, cerebrovascular accident,
• visual disturbances, blurred vision, double vision,
• tinnitus, hearing disorders,
• hypertension, vasculitis,
• pneumonitis,
• ulcerative colitis (including bloody colitis and exacerbation of ulcerative colitis and Crohn's disease), constipation, oral mucositis (including ulcerative stomatitis), glossitis, esophageal disorders, intestinal stricture, pancreatitis, exacerbation of hemorrhoids,
• fulminant hepatitis, liver necrosis, liver failure,
• bullous rash, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, Henoch-Schönlein purpura, pruritus, acute kidney failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Frequency not known(frequency cannot be estimated from the available data):

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

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

If any of the following side effects occur, the patient should stop using Diclac 50 and inform their doctor:

• discomfort in the stomach, heartburn, or abdominal pain,
• bloody vomiting, blood in the stool, blood in the urine,
• skin problems, such as rash or itching,
• shortness of breath or difficulty breathing,
• yellowing of the skin or whites of the eyes,
• prolonged sore throat or high fever,
• swelling of the face, feet, or ankles,
• severe migraine,
• chest pain accompanied by coughing.

Some side effects can be serious

These uncommon side effects may occur in 1 to 10 patients out of 1000, especially when using high daily doses (150 mg) for a long time

• sudden, crushing chest pain (symptoms of myocardial infarction),
• shortness of breath, difficulty breathing while lying down, swelling of the feet or ankles (symptoms of heart failure).

Page 7 of 9
If the patient uses Diclac 50 for more than a few weeks, they should regularly visit their doctor to ensure that no side effects have occurred.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Diclac 50

• The medicine should be stored out of sight and reach of children.
• The medicine should not be stored at a temperature above 25°C.
• The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.

Translation of some information on the blister pack:

Ch.-B.:/verw. bis: see imprint – Batch number/Expiry date: see embossing

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

6. Package contents and other information

What Diclac 50 contains

The active substance of the medicine is diclofenac sodium. One suppository contains 50 mg of diclofenac sodium.
In addition, the medicine contains solid fat.

What Diclac 50 looks like and what the package contains

Blister packs in a cardboard box.
The package contains 10 suppositories.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization 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:

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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German marketing authorization number: 6360.00.02
Page 8 of 9

Parallel import authorization number: 107/22 Date of leaflet approval: 01.03.2022

[Information about the trademark]
Page 9 of 9