Diclac 100

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Diclac 100 (Diclac)
100 mg, suppositories
Diclofenacum natricum
Diclac 100 and Diclac are different trade names of the same medicinal product.
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 further 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents

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 properties. 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 indicated 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 syndromes associated with spinal changes, and extra-articular rheumatism;
• Acute attacks of gout;
• Pain caused by inflammatory conditions and oedema following trauma or surgery, e.g. after dental or orthopaedic procedures;
• Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea 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, as a single symptom, is not an indication for use.

Monitoring during treatment with Diclac 100
In patients diagnosed with heart disease or with significant risk factors for cardiovascular disease, the treating physician will periodically assess the patient's need for symptomatic treatment and response to therapy, 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 to discontinue treatment with Diclac 100 or adjust the dose.

2. Important information before using Diclac 100

When not to use Diclac 100

• if the patient is allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever had 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, gastrointestinal 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 inflammation,
• if the patient is in the last trimester of pregnancy,
• if the patient has hepatic insufficiency,
• if the patient has renal insufficiency,
• if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischemic attack (TIA), arterial thrombosis 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). The doctor should be informed about the presence of these conditions.

Warnings and precautions
Before using Diclac 100, consult 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. Diclofenac may cause gastrointestinal bleeding, ulceration, or perforation (which may be fatal). These effects may be particularly dangerous when high doses of the medicine are used. If any unusual abdominal symptoms (especially gastrointestinal bleeding) occur during treatment with Diclac 100, 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 swelling (e.g. due to nasal polyps), chronic obstructive pulmonary disease (COPD), or chronic respiratory tract infections, as they may be more susceptible 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 experiencing skin reactions, itching, or urticaria). The medicine should be taken with particular caution (preferably under medical supervision);
• the patient has impaired liver function, as diclofenac may exacerbate the disease. The patient must strictly follow the doctor’s recommendations regarding regular liver function 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 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, use the lowest effective dose of Diclac 100 that relieves pain and/or swelling, and use it for as short a time as possible.
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), they should contact a doctor or emergency department immediately.
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, or toxic epidermal necrolysis with skin and mucous membrane lesions, high fever, and severe general condition). If early signs of rash, mucosal changes, or other symptoms of allergic reaction appear, 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 may complicate accurate diagnosis. The doctor should be informed about the use of the 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.
Before using the medicine, inform the doctor or pharmacist about any of the above-mentioned conditions.
Taking medicines such as Diclac 100 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.
In case of heart problems, history of stroke, or suspicion of risk for these 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 100 is not recommended for children and adolescents under 14 years of age.

Elderly patients (aged 65 years and older)
Elderly patients may react more strongly to the medicine than younger adults. Follow the instructions in the leaflet, use the lowest effective dose as recommended by the doctor, and report any 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 about the use of the following medicines:

• lithium or antidepressants (selective serotonin reuptake inhibitors - SSRIs)
• digoxin – a medicine used in the treatment of heart conditions
• diuretics – medicines that increase urine output
• angiotensin-converting enzyme (ACE) inhibitors, beta-blockers – medicines used in the treatment of 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 reduce inflammation)
• anticoagulants and antiplatelet agents
• 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, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Pregnancy
Do not take Diclac 100 if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Diclac 100 may cause kidney and heart function disorders in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labor. During the first 6 months of pregnancy, Diclac 100 should not be used unless the doctor considers it 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 week 20 of pregnancy, Diclac 100 may cause kidney function disorders in the unborn child if used for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
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.

Fertility
Taking Diclac 100 may make it more difficult to become pregnant. If the patient is planning a pregnancy or has difficulty becoming pregnant, she should inform her doctor.

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

Diclac 100 contains sodium
The suppository contains less than 1 mmol (23 mg) of sodium, meaning the medicine is considered "sodium-free".

3. How to use Diclac 100

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
Do not exceed the recommended doses. If Diclac 100 is used for longer than a few weeks, regular medical check-ups are necessary to rule out any unnoticed 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 the effect of the medicine seems too strong or too weak, consult a 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 divided into 2 or 3 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).

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; 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 100 should begin with a 100 mg dose administered after the first signs 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 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 preparations containing 100 mg of diclofenac should not be used in children under 18 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 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 individuals 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 risk factors for cardiovascular events should be treated with diclofenac only after careful consideration and exclusively with doses ≤100 mg per day if treatment lasts longer than 4 weeks.

Renal function disorders
The use of Diclac 100 in patients with renal insufficiency is contraindicated.
Specific studies have not been conducted in patients with renal function disorders; therefore, appropriate dosage recommendations cannot be provided. Caution is advised in patients with mild to moderate renal impairment.

Hepatic function disorders
The use of Diclac 100 in patients with hepatic insufficiency is contraindicated.
Specific studies have not been conducted in patients with hepatic function disorders; therefore, appropriate dosage recommendations cannot 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 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 severe poisoning, acute renal failure and liver damage may occur. If a larger amount of the medicine than recommended is accidentally taken, seek immediate medical advice from a doctor or pharmacist, or go to a hospital emergency department.

Missed dose of Diclac 100
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 original schedule. Do not take 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- 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 1000 people taking the medicine):
• hypersensitivity, anaphylactic and anaphylactoid reactions (including sudden drop in blood pressure and shock),
• somnolence,
• asthma (including shortness of breath),
• gastric mucositis, gastrointestinal bleeding, haematemesis, bloody diarrhoea, melaena,
• gastric and (or) duodenal ulceration (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 platelet count), leukopenia (reduced white blood cell count), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (reduced number or absence of granulocytes),
• 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 mucositis (including oral ulceration), glossitis, oesophageal disorders, membranous stricture of the intestine, 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 with unknown frequency (frequency cannot be estimated from available data)

• mild painful abdominal cramps and tenderness beginning shortly after starting 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 taking Diclac 100 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 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 when high daily doses (150 mg) are used for prolonged periods:

• sudden, pressing chest pain (symptoms of myocardial infarction)
• shortness of breath, 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 adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.
Adverse effects can also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Diclac 100

• Keep the medicine out of 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 what to do with medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

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

What Diclac 100 looks like and contents of the pack
Blister in a cardboard box.
The pack contains 10 suppositories.

For more detailed information, please contact the responsible entity or 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. k.
ul. Działkowa 56
02-234 Warsaw

Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń

Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

German Marketing Authorisation Number (country of export): 6360.01.02
Parallel Import Authorisation Number: 22/25