Dicloreum

Leaflet accompanying the packaging: information for the user

Dicloreum, 75 mg/3 ml, solution for injection

Diclofenac sodium

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should 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 as yours.
• 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 Dicloreum and what is it used for
• 2. Important information before using Dicloreum
• 3. How to use Dicloreum
• 4. Possible side effects
• 5. How to store Dicloreum
• 6. Contents of the packaging and other information

1. What is Dicloreum and what is it used for

Dicloreum contains diclofenac sodium, belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), with anti-rheumatic, anti-inflammatory, analgesic and antipyretic effects. The mechanism of action of Dicloreum involves the inhibition of prostaglandin biosynthesis, which plays a fundamental role in the pathogenesis of inflammation, pain and fever.
The medicine is also available in the form of enteric-coated tablets with a strength of 50 mg and prolonged-release tablets with a strength of 100 mg.
Dicloreum is used to treat symptomatic episodes of acute pain in inflammatory diseases of the musculoskeletal system.

2. Important information before using Dicloreum

When not to use Dicloreum

• if the patient is allergic to diclofenac, sodium metabisulfite or any of the other ingredients of this medicine (listed in section 6)
• if the patient has active gastric or duodenal ulcer, bleeding or perforation, or such disorders have occurred in the past after treatment with NSAIDs or for other reasons at least twice
• Dicloreum is contraindicated in the last trimester of pregnancy
• if the patient has severe renal, hepatic and/or cardiac impairment
• if the patient has heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient cerebral ischemia (mini-stroke) or vascular occlusion of the heart or brain, or after revascularization or bypass surgery
• if the patient has circulatory disorders (peripheral vascular disease)
• if the patient has had asthma attacks, urticaria or acute rhinitis after administration of acetylsalicylic acid (aspirin) or other prostaglandin synthesis inhibitors (ibuprofen or naproxen)
• Dicloreum is contraindicated in children under 18 years of age.

Warnings and precautions

• in patients with asthma and those with a tendency to develop asthma attacks, as Dicloreum may cause bronchospasm or severe allergic reactions
• when patients are taking medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (warfarin), selective serotonin reuptake inhibitors (fluoxetine, sertraline) or antiplatelet agents such as aspirin or ticlopidine
• in elderly patients, due to the increased frequency of adverse reactions after using non-steroidal anti-inflammatory drugs (NSAIDs), particularly bleeding and perforation (rupture of the gastrointestinal tract)
• in elderly patients or those who have had gastrointestinal ulcers, especially those with complications such as bleeding or perforation of the gastrointestinal tract
• if the patient has ever had gastrointestinal disorders such as ulcerative colitis, Crohn's disease (chronic non-specific inflammation of the intestine)
• in patients with hypertension and/or heart failure
• in case of hypoperfusion (decreased blood flow) or renal failure, past thrombosis with embolism, and in patients treated with diuretics and after major surgical procedures
• in patients with severe liver dysfunction or porphyria
• the smallest therapeutic dose is recommended for patients with low body weight
• during intensive diuretic treatment
• in patients with a tendency to bleed
• in case of abnormal hematopoiesis (formation and differentiation of blood cells)
• during treatment with anticoagulant medications (acenocoumarol, warfarin), as Dicloreum may enhance their effect
• in patients with liver dysfunction, diclofenac may exacerbate the course of the disease; the doctor's recommendations regarding regular liver function tests should be strictly followed.
• before using Dicloreum, the patient should tell their doctor if they have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Dicloreum may sometimes cause impaired wound healing in the intestines after surgery.

Taking such medications as Dicloreum 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 medicine. Do not use higher doses or longer treatment than recommended.
In case of heart problems, past stroke, or suspected risk of these disorders (e.g. high blood pressure, diabetes, high cholesterol, smoking), the treatment should be discussed with a doctor or pharmacist.
Do not use Dicloreum at the same time as other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors (celecoxib).
Taking diclofenac may cause gastrointestinal bleeding, ulceration or perforation (which may be fatal). Such effects may be particularly dangerous in case of high doses of diclofenac and in elderly patients or those with a history of gastrointestinal ulcers.
If gastrointestinal symptoms (especially gastrointestinal bleeding) occur during treatment with Dicloreum, the medicine should be discontinued immediately and a doctor consulted.
Taking diclofenac may, in very rare cases (especially at the beginning of treatment), cause life-threatening skin reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever and joint pain, and toxic epidermal necrolysis with skin and mucous membrane lesions, accompanied by high fever and severe general condition. If the first signs of a rash, mucous membrane lesions or other symptoms of an allergic reaction appear, the medicine should be discontinued and a doctor consulted.
In case of any of the above situations, the doctor should be informed before using Dicloreum.
The medicine may temporarily inhibit platelet aggregation.
In patients with severe liver impairment, close medical supervision is required.
Dicloreum solution for injection is not an emergency pain reliever and must be used under strict medical supervision.
Some people SHOULD NOT be given Dicloreum.
Before taking diclofenac, the patient should tell their doctor:

• if they smoke
• if they have diabetes
• if they have angina, thrombosis, hypertension, high cholesterol or high triglycerides
• if they think they may be allergic to diclofenac sodium, acetylsalicylic acid, ibuprofen or any other NSAID, or any of the other ingredients of Dicloreum (listed at the end of this leaflet). Hypersensitivity symptoms include face and mouth edema (angioedema), difficulty breathing, chest pain, rash or any other allergic reactions.

The occurrence of side effects can be reduced by using the medicine in the smallest effective dose and for no longer than necessary.

Dicloreum and other medicines

The patient should tell their doctor or pharmacist 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 medications (selective serotonin reuptake inhibitors)
• Digoxin (a medicine used to treat heart conditions)
• Angiotensin-converting enzyme inhibitors, beta-adrenergic blockers (a group of medicines used to treat hypertension and heart failure)
• Diuretics (medicines that increase urine production)
• Non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid or ibuprofen) and corticosteroids (medicines used to relieve inflammatory conditions of the skin on various body surfaces)
• Anticoagulant and antiplatelet medications
• Oral antidiabetic medications (except insulin)
• Methotrexate (a medicine used to treat certain cancers or arthritis)
• Cyclosporine and tacrolimus (medicines used in organ transplant patients)
• Quinolone antibacterials and some medicines used to treat infections
• Cardiac glycosides
• Mifepristone
• Phenytoin
• -Cholestyramine and colestipol
• Strong CYP2C9 enzyme inhibitors such as sulfinpyrazone and voriconazole

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 a doctor or pharmacist before using this medicine.
Pregnancy
Do not take Dicloreum in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Dicloreum may cause renal and cardiac disorders in the unborn child. It may increase the risk of bleeding in the mother and child and cause prolonged or delayed labor. In the first 6 months of pregnancy, Dicloreum should not be used unless the doctor considers it absolutely necessary. From the 20th week of pregnancy, Dicloreum may cause renal disorders in the unborn child if used for more than a few days.
This may lead to low levels 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 period longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Do not use Dicloreum while breastfeeding, as it may harm the child.
Fertility
Diclofenac may make it more 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

Patients who experience dizziness or other central nervous system disorders, including vision disturbances, should stop driving or operating machines and inform their doctor about the adverse reactions that have occurred.
Elderly patients may be more sensitive to the effects of the medicine. The recommendations in the leaflet should be followed, the smallest effective dose should be used as directed by the doctor, and all adverse reactions that occur during treatment should be reported to the doctor.

Dicloreum contains benzyl alcohol, propylene glycol, sodium metabisulfite and sodium.

The medicine contains 119 mg of benzyl alcohol in each ampoule (3 ml). Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women should consult a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their body and cause adverse reactions (metabolic acidosis). Patients with liver or kidney disease should consult a doctor before using the product, as large amounts of benzyl alcohol may accumulate in their body and cause adverse reactions (metabolic acidosis).
The medicine contains 581 mg of propylene glycol in each ampoule (3 ml).
The medicine contains sodium metabisulfite. The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule (3 ml), which means the medicine is considered "sodium-free".

3. How to use Dicloreum

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the patient should consult a doctor or pharmacist.
Do not exceed the recommended dose and treatment duration.
The general recommendation is for the doctor to adjust the dose individually for each patient and use the smallest effective dose for the shortest possible period.
It is recommended to administer 1 ampoule of Dicloreum containing 75 mg of diclofenac sodium per day.
Administer deeply intramuscularly, in the upper outer quadrant of the buttock (the medicine should be administered alternately in both buttocks). In severe cases, two ampoules can be administered per day, and tablet administration should be started as soon as possible.
The dosing regimen in elderly patients must be determined by the doctor, who should consider reducing the recommended doses.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor.
Taking the medicine in the smallest effective dose for the shortest necessary period reduces the risk of side effects.

Using a higher dose of Dicloreum than recommended

Overdose of Dicloreum does not produce characteristic symptoms.
In case of accidental ingestion of a larger amount of the medicine than recommended, the patient should immediately consult a doctor, pharmacist or go to the hospital.

Missing a dose of Dicloreum

In case of a missed dose, the patient should take it as soon as they remember.
However, if more than half of the time between two doses has passed, the missed dose should not be taken, and the next dose should be taken according to the previous schedule.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with Dicloreum

In case of any further doubts about using this medicine, the patient should consult a doctor or pharmacist.
Treatment with Dicloreum should be discontinued in case of gastrointestinal bleeding or ulcers, as well as rash, mucous membrane lesions or any other symptoms of hypersensitivity.
If abnormal liver function parameters persist or worsen, Dicloreum treatment must be discontinued. The decision to discontinue treatment will be made by the doctor.

4. Possible side effects

Like all medicines, Dicloreum can cause side effects, although not everybody gets them.
Some side effects may be serious.
The frequency of side effects is estimated as follows:
very common (affects 1 or more patients in 10); common (affects 1 to 10 patients in 100);
uncommon (affects 1 to 10 patients in 1,000); rare (affects 1 to 10 patients in 10,000);
very rare (affects less than 1 patient in 10,000), unknown (frequency cannot be estimated from the available data).
The following side effects include those reported with Dicloreum solution for injection, as well as those observed with other forms of diclofenac, used for short or long periods.
Very rare: thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), anemia (including hemolytic and aplastic anemia), agranulocytosis (lack of granulocytes), angioedema (including face 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; palpitations, chest pain, heart failure, myocardial infarction; hypertension, vasculitis; pneumonia; colitis (including hemorrhagic and exacerbation of ulcerative colitis, Crohn's disease), constipation, stomatitis, oral and tongue disorders, esophageal disorders, intestinal stricture, pancreatitis, fulminant hepatitis; bullous rash, urticaria, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, alopecia, photosensitivity, pruritus, Henoch-Schönlein purpura, acute renal failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
Rare: hypersensitivity, anaphylactic and pseudo-anaphylactic reactions (including hypotension and shock), hepatitis, jaundice, liver function disorders, drowsiness, asthma (including dyspnea), gastritis, gastrointestinal bleeding, hematemesis, melena, black stools, gastric and duodenal ulcer (with or without bleeding and perforation), urticaria, edema.
Common: headache, dizziness of various origins, nausea, vomiting, diarrhea, indigestion, abdominal pain, bloating, anorexia, increased transaminase activity; rash.
Unknown frequency: tissue damage at the injection site, Kounis syndrome, ischemic colitis.
Taking such medications as Dicloreum may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
In case of any of the above or other side effects not listed in this leaflet, the patient should inform their doctor.

The patient should stop using Dicloreum and immediately consult a doctor if they notice:

• discomfort in the stomach, heartburn or pain in the upper abdomen
• bloody vomiting, blood in stool, blood in urine
• skin problems such as rash or itching
• shortness of breath or wheezing
• yellowing of the skin or whites of the eyes
• persistent sore throat or elevated body temperature
• swelling of the face, feet or ankles
• severe migraine
• chest pain accompanied by cough
• mild painful abdominal cramps and tenderness, starting soon after the start of Dicloreum treatment, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain onset
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome (unknown frequency - cannot be estimated from available data).
• reactions at the injection site, including pain at the injection site, redness, swelling, hard lump, ulceration and discoloration. This may lead to skin and tissue necrosis around the injection site, which heals with scarring, also known as Nicolau syndrome.

In case of taking Dicloreum for more than a few weeks, the patient should regularly consult their doctor to ensure that no side effects have occurred.

Reporting side effects

If any 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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
ul. Al. Jerozolimskie 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 medicine.

5. How to store Dicloreum

Store at a temperature below 25°C.
The medicine should be stored in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule label or on the carton after: Expiry date. The expiry date refers to the last day of the month stated.
Do not use this medicine if visible particles are present or if the solution is cloudy or has changed color.
Do not use Dicloreum from damaged packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dicloreum contains

• The active substance of Dicloreum is diclofenac sodium
• 1 ampoule contains 75 mg/3 ml (25 mg/ml) of diclofenac sodium
• The other ingredients are propylene glycol, benzyl alcohol, sodium hydroxide, sodium metabisulfite, water for injections

What Dicloreum looks like and contents of the pack

Dicloreum is packaged in 6 ampoules of orange glass, packed in a carton box.

Marketing authorization holder

Alfasigma S.p.A.

Via Ragazzi del ’99, n. 5
40133 Bologna (BO), Italy

Manufacturer

Alfasigma S.p.A.

Via Enrico Fermi 1
65 020 Alanno (PE), Italy
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
Alfasigma Polska Sp. z o.o.
ul. Al. Jerozolimskie 96
00-807 Warsaw
Phone: +48 22 824 03 64

Date of last revision of the leaflet:

Logo of the marketing authorization holder Alfasigma