Diclac 100

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep this leaflet, information on the immediate packaging is in a foreign language!
Diclac 100 (Diclac 100 mg Zäpfchen)
100 mg, suppositories
Diclofenacum natricum
Diclac 100 and Diclac 100 mg Zäpfchen are different brand names for 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 questions, 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, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Diclac 100 is and what it is used for

Diclac 100 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 effects. The mechanism of action of Diclac 100 involves inhibition of prostaglandin biosynthesis, which plays a key role in the pathogenesis of inflammation, pain, and fever.

Diclac 100 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, extra-articular rheumatism;
• acute gout attacks;
• pain caused by inflammatory and edematous post-traumatic and postoperative conditions, 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 applied first in the above-mentioned conditions. Fever, as the sole symptom, is not an indication for use.

Monitoring during treatment with Diclac 100
In patients diagnosed with 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 doctor 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 doctor will decide whether to discontinue treatment with Diclac 100 or adjust the dosage.

2. Important information before using Diclac 100

When not to use Diclac 100

• 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 allergy, they should consult a doctor.
• if the patient has active or a history of peptic ulceration of the stomach and/or duodenum, bleeding, or perforation; if the patient 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 third trimester of pregnancy,
• if the patient has hepatic failure,
• if the patient has renal failure,
• if the patient has diagnosed 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 vascular revascularization or bypass surgery,
• if the patient has current or previous circulatory disorders (peripheral vascular disease).

Inform the doctor if any of these conditions are present.

Warnings and precautions
Before using Diclac 100, discuss with a 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 should not exceed 100 mg per day 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 effect may be particularly dangerous when high doses are used. If any unusual abdominal symptoms (especially gastrointestinal bleeding) occur during treatment with Diclac 100, the medicine should be discontinued immediately and medical advice sought;
• the patient has ulcerative colitis or Crohn's disease, as diclofenac may exacerbate the disease;
• the patient has asthma, allergic rhinitis, nasal mucosal edema (e.g. due to nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory infections, as they may be more susceptible to allergic reactions to diclofenac (worsening of asthma, 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 condition. Strictly follow the doctor's recommendations regarding liver function monitoring tests;
• the patient has hepatic porphyria, as diclofenac may trigger an attack of porphyria.

Before taking Diclac 100, inform the 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 reduced by using the lowest effective dose for the shortest duration necessary.

To minimize the risk of adverse effects, use the lowest effective dose of Diclac 100 that relieves pain and/or swelling, and use it for the shortest possible time.
If at any time during treatment with Diclac 100 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 mucous membrane lesions, high fever, and severe general condition). At the first signs of rash, mucosal changes, or other allergic reaction symptoms, discontinue the medicine and contact a doctor.
The medicine may mask signs of infection (e.g. headache, elevated body temperature) and complicate accurate diagnosis. Inform the doctor about using this medicine during medical examinations.
Do not use Diclac 100 simultaneously with other systemic non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors.
Inform the doctor or pharmacist about any of the above-mentioned conditions.
Use of medicines such as Diclac 100 may be associated with a small increased risk of myocardial infarction 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 suspected risk of these conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss treatment options with a doctor or pharmacist.
The medicine may transiently inhibit platelet aggregation.

Children and adolescents
Due to the dosage, use of Diclac 100 is not recommended in children and adolescents under 14 years of age.

Elderly patients (aged 65 years and older)
Elderly patients 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 the doctor, and report all adverse effects occurring during treatment to the doctor.

Diclac 100 and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Specifically inform the doctor if taking the following medicines:

• lithium or antidepressants (selective serotonin reuptake inhibitors)
• digoxin – a medicine used in heart disease treatment
• diuretics – medicines that increase urine output
• angiotensin-converting enzyme (ACE) inhibitors, beta-blockers – medicine groups used in treating hypertension and heart failure
• non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid, ibuprofen, selective COX-2 inhibitors) and corticosteroids (medicines used, among others, to relieve inflammatory conditions)
• anticoagulants and platelet function inhibitors
• antidiabetic medicines, except insulin
• methotrexate – a medicine used in treating 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 a doctor before using this medicine.
Diclac 100 should not be used during the first two trimesters of pregnancy unless absolutely necessary.
As with other anti-inflammatory medicines, use of Diclac 100 during the last three months of pregnancy is contraindicated, as it may seriously harm the unborn child or adversely affect delivery.
Do not use Diclac 100 in breastfeeding women, as it may harm the infant.
The doctor will discuss with the patient the potential risks of using Diclac 100 during pregnancy and breastfeeding.
Use of Diclac 100 may make it more difficult to become pregnant. If the patient is planning pregnancy or has difficulty conceiving, she should inform the doctor.

Driving and operating machinery
The effect of Diclac 100 on the ability to drive, operate machinery, or perform other activities requiring special attention is unlikely.

Diclac 100 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 100

This medicine should always be used as directed by the physician. In case of doubt, consult your doctor or pharmacist.
Do not exceed the recommended doses. If Diclac 100 is used for longer than a few weeks, regular medical check-ups should be performed to rule out undetected adverse effects.
The dose is determined individually by the doctor for each patient. The general 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 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, administer 50 mg to 100 mg, and if necessary, this dose may be increased over several menstrual cycles up to the 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 100 should be initiated 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 further treatment is required 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 100 tablets containing 100 mg of diclofenac should not be used in children under 18 years of age.

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 may be increased up to a maximum of 3 mg/kg body weight in divided doses.
Do not exceed a daily dose of 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 diagnosed cardiovascular disease or significant cardiovascular risk factors should be treated with diclofenac only after careful assessment and at doses ≤100 mg per day, if treatment lasts longer than 4 weeks.

Renal function disorders
The use of Diclac 100 is contraindicated in patients with renal insufficiency.
No specific studies have been conducted in patients with renal function disorders; therefore, appropriate dose adjustment recommendations cannot be provided. Caution is advised in patients with mild to moderate renal function impairment.

Hepatic function disorders
The use of Diclac 100 is contraindicated in patients with hepatic insufficiency.
No specific studies have been conducted in patients with hepatic function disorders; therefore, appropriate dose adjustment recommendations cannot be provided. Caution is advised in patients with mild to moderate hepatic function impairment.

Method of administration
It is recommended to use suppositories after defecation.

Use of a higher than recommended dose of Diclac 100
Overdose with Diclac 100 does not typically produce characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus, or convulsions. In cases of significant poisoning, acute renal failure and liver damage may occur. In case of accidental ingestion of more medicine than recommended, contact your doctor, pharmacist, or go to the nearest hospital emergency department immediately.

Missed dose of Diclac 100
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 dosing 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 short-term or long-term.

Adverse effects

Common (may affect 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 application site.

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

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

Rare (may affect 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, tarry stools,
• 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 affect fewer than 1 in 10,000 people taking the medicine):

• thrombocytopenia (reduced number of blood platelets), leukopenia (reduced number of white blood cells), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (reduced number or absence of white blood cells – neutrophil granulocytes),
• angioedema (including facial swelling),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
• paraesthesia, memory disturbances, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, cerebral haemorrhage,
• 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 ulceration), glossitis, oesophageal disorders, membranous intestinal stricture, pancreatitis, exacerbation of haemorrhoidal nodules,
• fulminant hepatitis, hepatic necrosis, liver failure,
• blistering 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, necrosis of renal papillae.

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

• mild painful spasms and abdominal tenderness beginning shortly after starting treatment with Diclac 100, 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). Use of medicines such as Diclac 100 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Other adverse effects may occur in some people during treatment with Diclac 100.
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 using Diclac 100 immediately and inform 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 coughing.

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

• 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 using Diclac 100 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, 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Diclac 100

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 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. These measures will help protect the environment.

6. Contents of the pack and other information

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

What Diclac 100 looks like and contents of the pack
Blister pack in a cardboard box.
The pack contains 10 suppositories.
For further information, please contact the responsible party or the parallel importer.

Responsible party 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Poland

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
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

German marketing authorization number, country of export: 6360.01.02
Parallel import authorization number: 254/22