DICLAC 100 mg Suppositories

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
3. Diclac 100 (Diclac 100 mg suppositories)
4. 100 mg, suppositories
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Diclac 100 and what is it used for
   1. Control tests during the use of Diclac 100
6. Important information before using Diclac 100
   1. When not to use Diclac 100
   2. Warnings and precautions
   3. Children and adolescents
   4. Elderly patients (65 years and older)
   5. Diclac 100 and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Diclac 100 contains sodium
7. How to use Diclac 100
   1. Suppositories should not be divided!
   2. Do not use orally!
   3. Elderly patients (65 years and older)
   4. Diagnosed cardiovascular disease or significant cardiovascular risk factors
   5. Kidney function disorders
   6. Liver function disorders
   7. Method of administration
   8. Using a higher dose of Diclac 100 than recommended
   9. Missing a dose of Diclac 100
8. Possible side effects
   1. Side effects
   2. If any of the following side effects occur, the patient should immediately stop using Diclac 100 and inform their doctor:
   3. Some side effects can be serious
   4. Reporting side effects
9. How to store Diclac 100
10. Contents of the packaging and other information
    1. What Diclac 100 contains
    2. What Diclac 100 looks like and what the packaging contains
    3. Marketing authorization holder in Germany, the country of export:
    4. Manufacturer:
    5. Parallel importer:
    6. Repackaged by:

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Diclac 100 (Diclac 100 mg suppositories)

100 mg, suppositories

Diclofenac sodium
Diclac 100 and Diclac 100 mg suppositories are different trade names for the same medicine.

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient 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 or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Diclac 100 and what is it 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 packaging and other information

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

Diclac 100 contains diclofenac sodium, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), with anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of Diclac 100 involves the inhibition of prostaglandin biosynthesis, which plays a key role in the pathogenesis of inflammation, pain, and fever.
Diclac 100 is used to treat:

• 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;
• pain caused by post-traumatic and post-operative inflammatory conditions and edema, 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 infections of the ear, nose, or throat (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 100

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 100 or change the dose of the medicine.

2. Important information before using Diclac 100

When not to use Diclac 100

• if the patient is hypersensitive 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 edema, lip edema, tongue edema, pharyngeal edema, and/or limb edema (symptoms of angioedema). If the patient thinks they may be allergic, they should consult a doctor.
• if the patient has active or past stomach or duodenal ulcers, bleeding, or perforation; if the patient has 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, vascular occlusion of the heart or brain, or after a bypass grafting or angioplasty procedure),
• if the patient has circulatory disorders (peripheral vascular disease).

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

Warnings and precautions

Before using Diclac 100, 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 effects may be particularly dangerous in the case of high doses of the medicine. If any unusual abdominal symptoms occur during the use of Diclac 100 (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the patient should consult a doctor;
• the patient has ulcerative colitis or Crohn's disease, as diclofenac may exacerbate 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). This 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);

• the patient has liver function disorders, as diclofenac may worsen the course of the disease. The patient should strictly follow the doctor's recommendations regarding liver function tests;
• the patient has porphyria, as diclofenac may trigger a porphyria attack.

Before using Diclac 100, the patient should inform their doctor if:

• the patient smokes,
• the patient has diabetes,
• the patient has 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.
To minimize the risk of side effects, the smallest effective dose of Diclac 100 should be used, which alleviates pain and/or inflammation, and it should be used for the shortest possible time.
If, at any time during the use of Diclac 100, 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 transiently inhibit platelet aggregation.

Children and adolescents

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

Elderly patients (65 years and older)

Elderly patients may react more strongly to the effects of the medicine than other adult patients. The recommendations contained in the leaflet should be followed, and the smallest effective doses should be used in accordance with the doctor's recommendations, and all side effects occurring during treatment should be reported to the doctor.

Diclac 100 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 especially inform their doctor 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 urine production
• 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 100 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 100 in the last 3 months of pregnancy is contraindicated, as it may seriously harm the fetus or have an adverse effect on labor.
Diclac 100 should not be used in breastfeeding women, as it may harm the infant.
The doctor will discuss the potential risks of using Diclac 100 during pregnancy and breastfeeding with the patient.
Taking Diclac 100 may make it difficult to become pregnant. If the patient plans to become pregnant or is having trouble becoming pregnant, they should inform their doctor.

Driving and using machines

The effect of Diclac 100 on the ability to drive vehicles, operate machinery, or perform other activities that require special attention is unlikely.

Diclac 100 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 100

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.
The recommended doses should not be exceeded. If Diclac 100 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 100 should be started with a dose of 100 mg after the first symptoms appear. If necessary, additional suppositories 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 100 containing 100 mg of diclofenac should not be used in children under the age of 18.

Elderly patients (65 years and older)

The medicine should be used with caution in elderly patients. In elderly patients and patients 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 100 in patients with kidney failure is contraindicated.
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 100 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 bowel movements.

Using a higher dose of Diclac 100 than recommended

Overdose of Diclac 100 does not cause characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In the case of significant poisoning, acute kidney failure and liver damage may occur. In the event of accidental use of a larger amount of the medicine than recommended, the patient should immediately contact their doctor, pharmacist, or go to the hospital emergency department.

Missing a dose of Diclac 100

If the patient misses a dose, they should take it as soon as they remember.
If, however, more than half of the time between two doses has passed, the missed dose should not be taken, but 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, Diclac 100 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 short or long periods.

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,
• skin 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 drop in blood pressure and shock),
• drowsiness,
• asthma (including shortness of breath),
• gastritis, gastrointestinal bleeding, hematemesis, melena,
• peptic ulcer disease of the stomach and/or duodenum (with or without bleeding and perforation), proctitis,
• hepatitis, jaundice, liver function disorders,
• urticaria,
• 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 edema),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
• paresthesia, memory disorders, seizures, anxiety, tremors, aseptic meningitis, taste disorders, cerebrovascular accident,
• visual disturbances, blurred vision, double vision,
• tinnitus, hearing disorders,
• hypertension, vasculitis,
• pneumonitis,
• ulcerative colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal disorders, intestinal stricture, pancreatitis, exacerbation of hemorrhoids,
• fulminant hepatitis, liver necrosis, liver failure,
• bullous dermatitis, exfoliative dermatitis, 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 100 treatment, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain onset.
• concomitant occurrence of chest pain and allergic reaction (Kounis syndrome symptoms). The use of such medicines as Diclac 100 may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.

In some people, during the use of Diclac 100, other side effects may occur.
If any of the side effects worsen or 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 immediately stop using Diclac 100 and inform their doctor:

• discomfort in the stomach, heartburn, or pain in the upper abdomen,
• hematemesis, blood in the stool, blood in the urine,
• skin problems, such as rash or itching,
• shortness of breath or wheezing,
• jaundice of the skin or whites of the eyes,
• prolonged sore throat or high fever,
• swelling of the face, feet, or legs,
• severe migraine,
• chest pain accompanied by coughing.

Some side effects can be serious

These uncommon side effects may occur in 1 to 10 patients per 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 when lying down, swelling of the feet or legs (symptoms of heart failure).

If the patient uses Diclac 100 for more than a few weeks, they should regularly visit their doctor to ensure that no side effects have occurred.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 100

• The medicine should be stored out of sight and reach of children.
• Do not store above 25°C.
• Do not use after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
• Translation of some information on the immediate packaging: Ch.-B./verw. bis: see imprint - batch number/expiry date: see imprint.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Diclac 100 contains

The active substance of the medicine is diclofenac sodium. One suppository contains 100 mg of diclofenac sodium.
In addition, the medicine contains solid fat.

What Diclac 100 looks like and what the packaging contains

Blister packs in a cardboard box.
The packaging 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:6360.01.02
Parallel import authorization number:169/17
Date of leaflet approval: 20.04.2022
[Information about the trademark]