Package leaflet: Information for the user

Diclac, 25 mg/ml (75 mg/3 ml), solution for injection
Diclofenacum natricum
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine 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 or pharmacist. See section 4.

Table of contents of the leaflet

What Diclac is and what it is used for
Important information before using Diclac
How to use Diclac
Possible side effects
How to store Diclac
Contents of the pack and other information

1. What Diclac is and what it is used for

Diclac 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 involves inhibition of prostaglandin biosynthesis, which play a key role in the pathogenesis of inflammation, pain and fever.
Diclac is indicated for the treatment of:

Acute flare-ups of inflammatory or degenerative rheumatic diseases: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spinal arthritis, painful syndromes associated with spinal changes, and extra-articular rheumatism;
Acute attacks of gout;
Renal and hepatic colic;
Pain caused by post-traumatic and postoperative inflammatory conditions and oedema;
Severe migraine attacks.

Monitoring during Diclac treatment
In patients with diagnosed heart disease or significant risk factors for cardiovascular disease, the treating physician should periodically assess the patient's need for symptomatic treatment and response to therapy, especially if treatment lasts longer than 4 weeks.
During treatment, regular blood tests are recommended if there are any signs of liver dysfunction, kidney impairment, or blood abnormalities. Liver function (aminotransferase activity), kidney function (creatinine concentration), and blood cell counts (white and red blood cells and platelets) should be monitored. The treating physician will consider blood test results when deciding whether to discontinue Diclac treatment or adjust the dose.

2. Important information before using Diclac

When not to use Diclac

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 pain-relieving medicines (e.g. acetylsalicylic acid, diclofenac or ibuprofen). Reactions may include asthma, nasal congestion, 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, bleeding or perforation; if the patient has previously experienced stomach discomfort or heartburn after taking anti-inflammatory drugs,
if the patient is in the last trimester of pregnancy,
if the patient has liver failure,
if the patient has kidney failure,
if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischaemic attack (TIA), arterial thrombosis in the heart or brain, or a procedure to unblock or bypass blocked blood vessels,
if the patient has current or previous circulatory disorders (peripheral vascular disease),
in children and adolescents.

Patients should inform their doctor if any of these conditions apply.
Warnings and precautions
Talk to your doctor before starting treatment with Diclac 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);
the patient is a smoker and the doctor decides to prescribe Diclac; in this case, the dose should not exceed 100 mg per day if treatment lasts longer than 4 weeks;
the medicine is used in patients with a history of gastrointestinal ulcers or in elderly patients. Use of diclofenac may cause gastrointestinal bleeding, ulceration or perforation, which may be fatal (this effect may be particularly dangerous when high doses of diclofenac are used); if any unusual abdominal symptoms occur during treatment with Diclac (especially gastrointestinal bleeding), 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 suffers from asthma, allergic rhinitis, nasal mucosal swelling (e.g. due to nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections, as they are more likely to experience an allergic reaction to diclofenac (worsening of asthma symptoms, Quincke's edema 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 administered with particular caution (preferably under medical supervision);
the patient has impaired liver function, as diclofenac may worsen the disease. Strict adherence to the doctor's recommendations regarding regular liver function tests is essential;
the patient suffers from hepatic porphyria, as diclofenac may trigger an attack of porphyria.
the patient has previously experienced severe skin rash or skin peeling, blistering and/or oral ulcers after using Diclac or other painkillers.

Before taking diclofenac, inform the doctor if the patient:

smokes,
has diabetes,
suffers from angina pectoris, thrombosis, hypertension, elevated cholesterol or elevated triglyceride levels.

The risk of adverse effects can be minimized by using the medicine at the lowest effective dose and for the shortest duration necessary.
Use the lowest dose of Diclac that relieves pain and/or swelling, and use it for as short a time as possible to minimize the risk of adverse effects.
If at any time during treatment with Diclac the patient experiences symptoms indicating 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.
Very rarely (especially at the beginning of treatment), diclofenac may cause life-threatening skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever and joint pain, or toxic epidermal necrolysis with skin and mucosal lesions, high fever and severe general condition. At the first signs of rash, mucosal changes or other symptoms of allergic reaction, the medicine should be discontinued and the patient should contact their doctor.
Local reactions at the injection site have been reported after intramuscular administration of Diclac (a technique used to deliver the medicine deep into the muscle), including pain at the injection site, redness, swelling/hard lump, ulceration, sometimes with bruising or pus formation, and skin and subcutaneous tissue damage (especially after incorrect administration into fatty tissue) – a condition known as Nicolau syndrome.
The medicine may mask symptoms of infection (e.g. headache, elevated body temperature) and make correct diagnosis more difficult. Inform the doctor about using this medicine during medical examinations.
Do not use Diclac together with other systemic non-steroidal anti-inflammatory drugs, 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 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. Do not use higher doses or longer treatment durations than recommended.
If the patient has heart problems, a history of stroke, or suspects they may be at risk of these conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), they should discuss the treatment approach with their doctor or pharmacist.
The medicine may transiently inhibit platelet aggregation.
Children and adolescents
Diclac in ampoules is not recommended for use in children and adolescents due to the dosage.
Elderly patients (aged 65 years and above)
Elderly patients may react more strongly to the medicine than other adults. Follow the instructions in the leaflet, use the lowest effective doses as recommended by the doctor, and report all adverse effects occurring during treatment to the doctor.
Diclac and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking any of the following medicines:

lithium or antidepressants (so-called selective serotonin reuptake inhibitors),
digoxin – a medicine used in the treatment of heart conditions,
diuretics – medicines that increase urine output,
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 or ibuprofen) and corticosteroids (groups of medicines used to reduce inflammation),
anticoagulants and medicines that inhibit platelet function,
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,
quinolone antibiotics and certain 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 effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Pregnancy
Do not take Diclac if the patient is in the last three 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 increase the tendency to bleeding in both mother and child and may delay or prolong labour. Diclac should not be used during the first six months of pregnancy unless the doctor considers its use 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 may cause kidney problems 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 is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Do not use Diclac in breastfeeding women, as it may have harmful effects on the infant.
The doctor will discuss with the patient the potential risks of using Diclac during pregnancy and breastfeeding.
Fertility
Taking Diclac may make it more difficult to become pregnant. If the patient is planning a pregnancy or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
The effect of Diclac on the ability to drive, operate machinery or perform other tasks requiring special attention is unlikely.
Diclac contains benzyl alcohol, propylene glycol and sodium
The medicine contains 120 mg of benzyl alcohol in 1 ampoule (3 ml). Benzyl alcohol may cause allergic reactions.
Patients with liver or kidney disease should consult their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Pregnant or breastfeeding women should consult their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Do not administer Diclac injection solution to premature infants or newborns. Benzyl alcohol may cause toxic reactions and pseudo-anaphylactic reactions in infants and children up to 3 years of age.
The medicine contains 600 mg of propylene glycol in 1 ampoule (3 ml).
Patients with impaired liver or kidney function should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.
Pregnant or breastfeeding women should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.
The medicine contains less than 1 mmol (23 mg) of sodium in 1 ampoule (3 ml), meaning the medicine is considered "sodium-free".

3. How to use Diclac

This medicine should always be used as directed by the physician. In case of doubt, consult a doctor or pharmacist.
Do not exceed the recommended doses.
The general recommendation is that the physician individually adjusts the dose for each patient and uses the lowest effective dose for the shortest possible duration.
If you feel the medicine's effect is too strong or too weak, consult your doctor.

Adults
Diclac is administered intramuscularly.
The volume of one vial per day should not be administered for longer than 2 days. In certain cases, the dose may be increased to two vials per day. If necessary, treatment may be continued with tablets or suppositories.

Established cardiovascular disease or significant cardiovascular risk factors
Patients with established cardiovascular disease or significant risk factors for cardiovascular events should only be treated with diclofenac after careful consideration and only at doses ≤100 mg per day if treatment lasts longer than 4 weeks.

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

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

How to use Diclac
To avoid nerve damage or other tissue injury at the injection site, follow the recommended injection procedures.
The medicine is usually administered at a dose of 75 mg (one vial per day) by deep intramuscular injection into the upper outer quadrant of the buttock.

Exceptionally, in severe cases (e.g., an attack of colicky pain), the daily dose may be increased to two injections of 75 mg each, administered several hours apart (one injection into each buttock). Alternatively, one 75 mg vial may be given in combination with another formulation of Diclac (tablets, suppositories), without exceeding a total daily dose of 150 mg.

Clinical experience with the use of this medicine in migraine attacks is limited to the administration of an initial dose of 1 vial containing 75 mg of sodium diclofenac as soon as possible, followed, if necessary, on the same day by suppositories up to a total dose of 100 mg. The total dose on the first day should not exceed 175 mg.

Use of a higher than recommended dose of Diclac
Overdose with Diclac 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 an excessive amount of medicine has been administered by mistake, contact a doctor, pharmacist, or go to a hospital emergency department immediately.

Missed dose of Diclac
If a dose of medicine is missed, take it as soon as you remember.
However, if more than half of the time between two doses has passed, do not take the missed dose; instead, take the next dose according to the previous 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 have been reported during the use of Diclac in ampoules and other formulations of diclofenac, administered for short- or long-term treatment.

Common (may affect up to 1 in 10 patients):

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

Uncommon (may affect up to 1 in 100 patients):

myocardial infarction, heart failure, palpitations, chest pain.

Rare (may affect up to 1 in 1000 patients):

hypersensitivity, anaphylactic and anaphylactoid reactions (including sudden drop in blood pressure and shock),
somnolence,
asthma (including dyspnoea),
gastric mucosal inflammation, gastrointestinal bleeding, vomiting blood, bloody diarrhoea, tarry stools,
gastric and (or) duodenal ulcer disease (with or without bleeding and perforation),
hepatitis, jaundice, liver function disorders,
urticaria,
swelling, tissue atrophy at the injection site.

Very rare (may affect up to 1 in 10,000 patients):

abscesses at the injection site,
thrombocytopenia (reduced platelet count), leukopenia (reduced number of white blood cells in peripheral blood), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (deficiency of granulocytes, a type of white blood cells),
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, exacerbation of ulcerative colitis, Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorders, mucosal intestinal stricture, pancreatitis,
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 occurring with unknown frequency (frequency cannot be estimated from the available data):

tissue damage at the injection site,
simultaneous occurrence of chest pain and allergic reaction (symptoms of Kounis syndrome),
Nicolau syndrome – characterised by immediate severe pain at the injection site, followed by redness, swelling, nodule formation, with possible vascular occlusion leading to destruction of skin and subcutaneous tissue,
allergic skin reaction, which may present as round or oval redness and swelling of the skin, blisters and itching (persistent erythema). The skin in affected areas may also appear darker, which may persist after healing. Upon re-administration of the drug, persistent erythema usually reappears in the same locations.

Taking medicines such as Diclac may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Some patients may experience other adverse effects during treatment with Diclac. If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.

Diclac treatment must be stopped immediately and medical advice sought without delay if any of the following adverse effects occur – urgent treatment may be required:

stomach discomfort, heartburn or upper abdominal pain,
vomiting blood, blood in stool, blood in urine,
skin disorders such as rash or itching,
severe allergic skin reaction, which may present as extensive red and (or) dark patches, skin swelling, blisters and itching (generalised bullous fixed drug eruption),
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 cough,
mild painful abdominal cramps and tenderness beginning shortly after starting Diclac treatment, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain (frequency unknown – cannot be estimated from available data).

Some adverse effects may be serious
These uncommon adverse effects may occur in up to 1 in 100 patients, particularly when high daily doses (150 mg) are used for prolonged periods:

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

Inform your doctor immediately if any of the following symptoms occur:
Reactions at the injection site, including pain, redness, swelling, hard nodule, ulceration and bruising. These may lead to blackening and necrosis of the skin and surrounding tissues at the injection site, healing with scarring, a condition also known as Nicolau syndrome.

If Diclac is used for longer than a few weeks, regular contact with your doctor is recommended to ensure 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 4921 301, Fax: +48 22 4921 309, Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Diclac

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the stated month.
The batch number on the packaging is marked as "Lot".
Do not store above 25°C. Keep the ampoules in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Diclac contains

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

What Diclac looks like and contents of the pack
One pack contains 5 or 10 vials of 3 ml each.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. +48 22 209 70 00