Diclac

Package Leaflet: Information for the User

Diclac, 25 mg/ml (75 mg/3 ml), Solution for Injection

Diclofenac Sodium

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you; do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Diclac and What is it Used For
• 2. Important Information Before Using Diclac
• 3. How to Use Diclac
• 4. Possible Side Effects
• 5. How to Store Diclac
• 6. Package Contents and Other Information

1. What is Diclac and What is it Used For

Diclac contains diclofenac sodium, which belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs) that have anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties.
The mechanism of action of Diclac involves the inhibition of prostaglandin biosynthesis, which plays a crucial role in the pathogenesis of inflammation, pain, and fever.
Diclac is used in the following cases:
Treatment of:

• inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, psoriatic arthritis, and spondyloarthritis;
• acute gout attacks;
• renal and hepatic colic;
• pain caused by post-traumatic and post-operative inflammatory conditions and edema;
• severe migraine attacks.

Control Tests During Diclac Treatment

In patients with diagnosed heart disease or significant risk factors for heart disease, the doctor will periodically assess the patient's need for symptomatic treatment and their response to the medication, especially if treatment lasts longer than 4 weeks.
During treatment, regular blood tests should be performed in case of any liver or kidney function disorders, as well as changes in blood count. Liver function (aminotransferase activity), kidney function (creatinine levels), and blood cell count (white and red blood cell count and platelet count) should be monitored. The doctor will take into account the results of blood tests when deciding to discontinue Diclac treatment or change the dosage.

2. Important Information Before Using Diclac

When Not to Use Diclac

• if the patient is allergic to diclofenac or any other component of the medication (listed in section 6),
• if the patient has ever experienced an allergic reaction after using anti-inflammatory or analgesic medications (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 suspects 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 experienced discomfort in the stomach area or heartburn after taking anti-inflammatory medications,
• 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, such as after a heart attack, stroke, transient ischemic attack (TIA), or vascular occlusion, or after a procedure to clear or bypass blocked vessels,
• if the patient has circulatory disorders (peripheral vascular disease),
• in children and adolescents.

Patient should inform their doctor about the presence of these diseases.

Warnings and Precautions

Before using Diclac, the patient should discuss the following with their doctor:

• if the patient has diagnosed cardiovascular disease (see above) or significant risk factors, such as high blood pressure, elevated cholesterol or triglyceride levels;
• if the patient is a smoker and the doctor decides to prescribe Diclac; in this case, the dosage should not be increased above 100 mg per day if treatment lasts longer than 4 weeks;
• if the medication is used in patients with a history of gastrointestinal ulcers or in the elderly. Diclofenac may cause gastrointestinal bleeding, ulcers, or perforation, which can be life-threatening (especially with high doses of diclofenac); if any unusual abdominal symptoms occur (especially gastrointestinal bleeding), the medication should be discontinued immediately and the doctor consulted;
• if the patient has ulcerative colitis or Crohn's disease, as diclofenac may exacerbate the disease;
• if the patient has asthma, allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease (COPD), or chronic respiratory infections, as they may be more prone to allergic reactions to diclofenac (asthma exacerbation, angioedema, or urticaria). This warning also applies to patients allergic to other substances (e.g., those with skin reactions, itching, or urticaria). The medication should be used with caution (preferably under medical supervision);
• if the patient has liver function disorders, as diclofenac may worsen the condition. The patient should strictly follow the doctor's recommendations for monitoring liver function;
• if the patient has porphyria, as diclofenac may trigger a porphyria attack.

Before taking diclofenac, the patient should inform their doctor if they:

• smoke,
• have diabetes,
• have angina pectoris, thrombosis, high blood pressure, elevated cholesterol levels, or elevated triglyceride levels.

The risk of side effects can be minimized by using the lowest effective dose for the shortest possible time.
The patient should use the smallest dose of Diclac that provides relief from pain and/or inflammation and use it for the shortest possible time to minimize the risk of side effects.
If the patient experiences any symptoms suggesting heart or blood vessel problems, such as chest pain, shortness of breath, weakness, or slurred speech, they should immediately contact their doctor or visit the emergency room.
Taking medications like Diclac may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medication. The patient should not use higher doses or longer treatment than recommended.
In 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 their treatment with their doctor or pharmacist.
The medication may temporarily inhibit platelet aggregation.

Children and Adolescents

Diclac in ampoules is not recommended for use in children and adolescents due to the dosage.

Elderly Patients (65 Years and Older)

Elderly patients may be more sensitive to the effects of the medication than other adults. They should follow the recommendations in the package leaflet, use the smallest effective dose as recommended by their doctor, and report any side effects that occur during treatment to their doctor.

Diclac and Other Medications

The patient should tell their doctor about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

The Patient Should Inform Their Doctor About the Use of the Following Medications:

• lithium or antidepressant medications (selective serotonin reuptake inhibitors),
• digoxin - a medication used to treat heart conditions,
• diuretics - medications that increase urine production,
• angiotensin-converting enzyme (ACE) inhibitors, beta-blockers - groups of medications used to treat high blood pressure and heart failure,
• nonsteroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen) and corticosteroids (groups of medications used to alleviate inflammatory conditions),
• anticoagulant medications and medications that inhibit platelet aggregation,
• antidiabetic medications (except insulin),
• methotrexate - a medication used to treat certain cancers or arthritis,
• cyclosporine and tacrolimus - medications used in organ transplant patients,
• trimethoprim - a medication used to prevent or treat urinary tract infections,
• quinolone antibiotics and certain medications used to treat infections,
• colestipol and cholestyramine - medications that lower cholesterol levels in the blood,
• voriconazole - a medication used to treat fungal infections,
• phenytoin - a medication used to treat 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 medication.
Pregnancy
Diclac should not be used during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Diclac may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the mother and child and prolong labor. During the first 6 months of pregnancy, Diclac 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 may cause kidney problems in the unborn child if used for more than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Diclac should not be used in breastfeeding women, as it may harm the baby.
The doctor will discuss the potential risks of using Diclac during pregnancy and breastfeeding with the patient.
Fertility
Taking Diclac may make it more difficult to conceive. If the patient plans to conceive or is having trouble conceiving, they should inform their doctor.

Driving and Using Machines

The effect of Diclac on the ability to drive or use machines is unlikely.

Diclac Contains Benzyl Alcohol, Propylene Glycol, and Sodium

The medication contains 120 mg of benzyl alcohol in 1 ampoule (3 ml). Benzyl alcohol may cause allergic reactions.
Patient with liver or kidney disease should consult their doctor before using the medication, as high levels of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).
Pregnant or breastfeeding women should consult their doctor before using the medication, as high levels of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).
Diclac solution for injection should not be administered to premature infants or newborns. Benzyl alcohol may cause toxic reactions and pseudoanaphylactic reactions in infants and children under 3 years of age.
The medication contains 600 mg of propylene glycol in 1 ampoule (3 ml).
Patient with liver or kidney function disorders should not use this medication without consulting their doctor. The doctor may decide to perform additional tests on such patients.
Pregnant or breastfeeding women should not use this medication without consulting their doctor. The doctor may decide to perform additional tests on such patients.
The medication contains less than 1 mmol (23 mg) of sodium in 1 ampoule (3 ml), which means it is considered "sodium-free".

3. How to Use Diclac

This medication should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The patient should not exceed the recommended dose.
The general recommendation is to adjust the dose individually for each patient and use the smallest effective dose for the shortest possible time.
If the patient feels that the medication's effect is too strong or too weak, they should consult their doctor.

Adults

Diclac is administered intramuscularly.
The medication should not be administered for more than 2 days in a dose of 1 ampoule per day. In some cases, it may be administered in a dose of 2 ampoules per day. If necessary, treatment can be continued with tablets or suppositories.

Diagnosed Cardiovascular Disease or Significant Cardiovascular Risk Factors

Patient with diagnosed cardiovascular disease or significant cardiovascular risk factors should be treated with diclofenac only after careful consideration and with doses ≤100 mg per day if treatment lasts longer than 4 weeks.

Kidney Function Disorders

Using Diclac 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. Caution is recommended when administering Diclac to patients with mild to moderate kidney function disorders.

Liver Function Disorders

Using Diclac 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. Caution is recommended when administering Diclac to patients with mild to moderate liver function disorders.

How to Use Diclac

To avoid nerve or tissue damage at the injection site, the patient should follow the injection instructions.
The medication is usually administered in a dose of 75 mg (1 ampoule per day) in the upper outer quadrant of the buttock.
Exceptionally, in severe cases (e.g., renal colic), the daily dose may be increased to 2 injections of 75 mg, administered at an interval of several hours (1 injection in each buttock). The patient can also receive 1 ampoule of 75 mg in combination with another form of Diclac (tablets, suppositories), without exceeding a total dose of 150 mg per day.
Clinical experience with the use of Diclac in migraine attacks is limited to an initial dose of 1 ampoule containing 75 mg of diclofenac sodium as soon as possible, followed by the administration of suppositories in a dose of up to 100 mg on the same day. The total dose administered on the first day should not exceed 175 mg.

Using a Higher Than Recommended Dose of Diclac

Overdosing on Diclac may not cause characteristic symptoms, but the following may occur:
vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures.
In case of significant poisoning, acute kidney failure and liver damage may occur.
If the patient has accidentally taken more medication than recommended, they should immediately contact their doctor, pharmacist, or visit the emergency room.

Missing a Dose of Diclac

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

4. Possible Side Effects

Like all medications, Diclac can cause side effects, although not everyone will experience them.
The following side effects have been reported during the use of Diclac in ampoules and other forms of diclofenac, used for short or long periods.

Common(may occur in less than 1 in 10 people taking the medication):

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

Uncommon(may occur in less than 1 in 100 people taking the medication):

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

Rare(may occur in less than 1 in 1000 people taking the medication):

• hypersensitivity, anaphylactic and pseudoanaphylactic reactions (including sudden drop in blood pressure and shock),
• drowsiness,
• asthma (including shortness of breath),
• gastritis, gastrointestinal bleeding, hematemesis, melena,
• peptic ulcer disease (with or without bleeding and perforation),
• hepatitis, jaundice, liver function disorders,
• urticaria,
• edema, atrophy at the injection site.

Very Rare(may occur in less than 1 in 10,000 people taking the medication):

• abscesses at the injection site,
• thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), anemia (including hemolytic and aplastic anemia),

agranulocytosis (decreased granulocyte count),

• 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, diplopia,
• 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 obstruction, pancreatitis,
• 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)

• tissue damage at the injection site
• concomitant occurrence of chest pain and allergic reaction (Kounis syndrome symptoms).
• Nicolau syndrome - observed with immediate severe pain at the injection site, followed by redness, swelling, induration, ulceration, and possibly discoloration or abscess formation, leading to skin and subcutaneous tissue necrosis, also known as Nicolau syndrome.

Taking medications like Diclac may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
If the patient experiences any side effects not listed in this package leaflet, they should inform their doctor or pharmacist.

In Case of Any of the Following Side Effects, the Patient Should Immediately Stop Using Diclac and Inform Their Doctor:

• discomfort in the stomach, heartburn, or pain in the upper abdomen
• bloody vomiting, blood in stool, blood in urine
• skin disorders, 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
• mild painful abdominal cramps and tenderness, starting soon after taking Diclac, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain onset (frequency not known - cannot be estimated from the available data).

Some Side Effects Can Be Serious

These uncommon side effects may occur in 1 to 10 patients per 1000, especially with high daily doses (150 mg) and long-term use

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

The patient should immediately inform their doctor if they experience symptoms such as:
Reactions at the injection site, including pain, redness, swelling, induration, ulceration, and discoloration. This may lead to necrosis and scarring of the skin and surrounding tissues, a condition known as Nicolau syndrome.
If the patient uses Diclac for more than a few weeks, they should regularly consult their doctor to ensure that no side effects have occurred.
Reporting Suspected Side Effects
If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +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 medication.

5. How to Store Diclac

Keep the medication out of sight and reach of children.
Do not use the medication after the expiration date stated on the package: EXP. The expiration date refers to the last day of the month.
The batch number on the packaging is marked as "Lot".
Do not store the medication above 25°C. Keep the ampoules in the outer packaging to protect them from light.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Diclac Contains

• -The active substance of Diclac is diclofenac sodium. One 3 ml ampoule of Diclac contains 75 mg of diclofenac sodium.
• -The other ingredients are: N-acetylcysteine, benzyl alcohol, mannitol, sodium hydroxide, propylene glycol, water for injections.

What Diclac Looks Like and What the Package Contains

One package contains 5 or 10 ampoules of 3 ml each.

Marketing Authorization Holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
To obtain more detailed information, the patient should contact:
Sandoz Polska Sp. z o.o.
Domaniewska 50 C
02-672 Warsaw
phone: +48 22 209 70 00

Date of Last Revision of the Package Leaflet:

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