DICLAC 50 mg Suppositories

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Diclac 50, 50 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
   3. What is Diclac 50 and what is it used for
   4. Control tests during Diclac 50 treatment
3. Important information before using Diclac 50
   1. When not to use Diclac 50
   2. Warnings and precautions
   3. Children and adolescents
   4. Elderly patients (65 years and older)
   5. Diclac 50 and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Diclac 50 contains sodium
4. How to use Diclac 50
   1. Do not divide the suppositories!
   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 50 than recommended
   9. Missing a dose of Diclac 50
5. Possible side effects
   1. Side effects
   2. If any of the following side effects occur, the patient should stop using Diclac 50 and inform their doctor:
   3. Some side effects can be serious
6. How to store Diclac 50
7. Package contents and other information
   1. What Diclac 50 contains
   2. What Diclac 50 looks like and what the package contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet attached to the packaging: information for the user

Diclac 50, 50 mg, suppositories

Diclofenac sodium

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 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 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 as anti-rheumatic, anti-inflammatory, analgesic, and antipyretic agents. 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 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, and extra-articular rheumatism;
• acute gout attacks;
• pain 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 for 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 Diclac 50 treatment

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.

2. Important information before using Diclac 50

When not to use Diclac 50

• 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 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 proctitis,
• 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 vascular recanalization or bypass 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 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. Diclofenac use may cause gastrointestinal bleeding, ulceration, or perforation (with possible fatal outcome). This effect may be particularly dangerous in cases of high doses of the medicine. If any unusual abdominal symptoms occur during Diclac 50 treatment (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 edema (e.g., due to nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory infections, as they are more likely to experience an allergic reaction to diclofenac (asthma exacerbation, Quincke's edema, or urticaria). This warning also applies to patients allergic to other substances (e.g., those with 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 disease. The patient should strictly follow the doctor's recommendations for liver function tests;
• the patient has porphyria, as diclofenac may trigger a porphyria attack.

Before taking 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.

To minimize the risk of side effects, the smallest effective dose of Diclac 50 should be used, providing relief from pain and/or inflammation, and used for the shortest possible time.

If, at any time during Diclac 50 treatment, 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 visit the hospital emergency department.

Diclofenac use may transiently inhibit platelet aggregation.

Children and adolescents

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

Elderly patients (65 years and older)

Elderly patients may respond more strongly to the medicine than other adult patients. The patient should follow the recommendations in the leaflet, use the smallest effective dose according to the doctor's recommendations, and report all side effects that occur during treatment to their doctor.

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 urine production
• angiotensin-converting enzyme (ACE) inhibitors, beta-blockers - groups of medicines used to treat hypertension and heart failure

and other medicines.

• 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 insulin)
• methotrexate - a medicine used to treat certain cancers or arthritis
• cyclosporine and tacrolimus - medicines used in organ transplant patients
• trimethoprim - a medicine used to prevent and treat urinary tract infections
• quinolone antibacterial drugs - 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.

Pregnancy

Diclac 50 should not be used if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Diclac 50 may cause kidney and heart disorders in the unborn child. It may also increase the risk of bleeding in the patient and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Diclac 50 should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest effective dose should be used for the shortest possible time. From the 20th week of pregnancy, Diclac 50 may cause kidney disorders in the unborn child if used for more than a few days. This may lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

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.

Fertility

Taking Diclac 50 may make it more difficult to conceive. If the patient plans to conceive or has difficulty conceiving, they should inform their doctor.

Driving and using machines

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

Diclac 50 contains sodium

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

3. How to use Diclac 50

This medicine should always be used according to the doctor's recommendations. If in doubt, the patient should consult their doctor or pharmacist.

The patient should not exceed the recommended doses. If Diclac 50 is used for more than a few weeks, the patient should regularly undergo medical check-ups 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.

Do not divide the suppositories!

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 of 200 mg per day. Treatment should be started when the first symptoms appear and continued for several days, depending on their severity.

Treatment of migraine attacks with Diclac 50 should be started with a dose of 100 mg after the first symptoms appear. If necessary, an additional suppository of up to 100 mg can be used on the same day. 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 suppositories containing 50 mg of diclofenac should not be used in children under 14 years of age.

Juvenile rheumatoid arthritis

Depending on the severity of symptoms, 0.5 mg/kg to 2 mg/kg per day, in 2 or 3 divided doses. The daily dose can be increased to a maximum of 3 mg/kg in divided doses.

Do not exceed the daily dose of 150 mg.

Elderly patients (65 years and older)

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

Diagnosed 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 assessment of the situation and with doses ≤100 mg per day if treatment lasts longer than 4 weeks.

Kidney function disorders

Using Diclac 50 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

Using 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 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 medicine than recommended, the patient should immediately contact their doctor, pharmacist, or visit the 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 patient should not take the missed dose but take the next dose according to the previous dosing schedule. The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Diclac 50 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 taking 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 taking the medicine):

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

Rare(may occur in less than 1 in 1000 people taking 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,
• edema.

Very rare(may occur in less than 1 in 10,000 people taking 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, stroke,
• 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 obstruction, 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 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).

Taking medicines like Diclac 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

In some people, during Diclac 50 treatment, other side effects may occur.

If any side effect worsens or any side effect not listed in this leaflet occurs, 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 pain in the upper abdomen
• 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 legs
• severe migraine
• chest pain accompanied by cough

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 when lying down, swelling of the feet or legs (symptoms of heart failure)

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 suspected side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. 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: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Diclac 50

Keep the medicine out of the sight and reach of children.

Store in a temperature below 25°C, protected from moisture.

Do not use after the expiration date stated on the packaging after EXP. The expiration date refers to the last day of the specified month.

The batch number on the packaging is marked as "Lot".

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. 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 to the active substance, the medicine contains solid fat.

What Diclac 50 looks like and what the package contains

PVC/PE blister in a cardboard box.

The package contains 10 suppositories.

Marketing authorization holder

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

D-39179 Barleben, Germany

RubiePharm Arzneimittel GmbH

Brüder-Grimm-Str. 121

36396 Steinau an der Strasse, Germany

Amcapharm Pharmaceutical GmbH

Industriestraße 10-12

61191 Rosbach, Germany