Leaflet: information for the user

Dagesil 75 mg/3 ml injectable solution and for infusion EFG

diclofenac sodium

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Dagesil and what it is used for

2.What you need to know before starting to use Dagesil

3.How to use Dagesil

4.Possible side effects

5.Storage of Dagesil

6.Contents of the pack and additional information

Dagesil belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation.

Dagesil relieves symptoms of inflammation, including swelling and pain, by blocking the synthesis of molecules (prostaglandins) responsible for inflammation, pain, and fever. It has no effect on the causes of inflammation or fever.

When administered intramuscularly, Dagesil can be used for symptomatic treatment of the following conditions:

- Sudden worsening of rheumatic joint pain (arthritis), back pain, "frozen shoulder," "tennis elbow," and other types of rheumatism;

- Gout attack;

- Pain caused by gallstones or kidney stones;

- Postoperative and post-traumatic pain and swelling;

- Symptoms associated with severe migraine attacks.

When administered by intravenous infusion, Dagesil can be used in hospital settings to treat pain after surgeries.

If you have any doubts about how Dagesil works or why you have been prescribed it, consult your doctor.

Monitoring during treatment with Dagesil

If you have liver insufficiency, kidney insufficiency, or blood insufficiency, blood tests will be performed during treatment. These tests will allow monitoring of both your liver function (transaminase levels) and your kidney function (creatinine levels) or blood cell count (white blood cell, red blood cell, and platelet levels). Your doctor will consider the results of these blood tests to decide whether to interrupt treatment with Dagesil or adjust the dose.

Follow carefully all the instructions given by your doctor. They may differ from the general information included in this leaflet.

Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before using Dagesil, as Dagesil may sometimes worsen the healing of intestinal wounds after surgery.

Do not use Dagesil

- if you are allergic to diclofenac, sodium metabisulphite (or other sulphonates) or any of the other components of this medicine (listed in section 6);

- if you have a stomach or intestinal ulcer;

- if you have a cerebrovascular or other active bleeding, blood cell formation problems or coagulation problems, you should not take NSAIDs (e.g. acetylsalicylic acid, ibuprofen and diclofenac);

- if you have had any allergic reaction after taking anti-inflammatory or pain-relieving medicines (e.g. diclofenac, acetylsalicylic acid or ibuprofen). The reactions may include asthma, chest pain, nasal discharge, skin rash, facial swelling. If you think you may be allergic, consult your doctor;

- if you have gastrointestinal bleeding or perforation, whose symptoms may include blood in the stool or black stools;
- if you have severe kidney or liver disease;

- if you have established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA) or blockages in the coronary or cerebral blood vessels, or a procedure to remove an obstruction or bypass the coronary arteries;

- if you have or have had peripheral arterial disease;

- if you have severe heart failure;

- if you are in the third trimester of pregnancy.

If any of these conditions apply to you, consult your doctor and do not use Dagesil.

If you think you may be allergic, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dagesil:

- If you are using Dagesil at the same time as other anti-inflammatory medicines, including acetylsalicylic acid, corticosteroids, antithrombotics or SSRIs (see “Other medicines and Dagesil”);

- If you have asthma or hay fever (seasonal allergic rhinitis);

- If you have ever had gastrointestinal problems, such as stomach ulcers, bleeding or dark stools, or if you have had stomach discomfort or acid reflux after taking anti-inflammatory medicines in the past;

- If you have inflammatory bowel disease (ulcerative colitis) or intestinal tract disease (Crohn's disease);

- If you have or have had heart problems or high blood pressure;

- If you have liver or kidney problems;

- If you are dehydrated (e.g. due to illness, diarrhoea, before or after major surgery);

- If you have swollen feet without a traumatic cause;

- If you have blood clotting disorders or other blood disorders, including a rare liver condition called porphyria hepatica;

- If you have lupus erythematosus or mixed connective tissue disorders.

If any of these conditions apply to you, consult your doctor before starting to use Dagesil.

Dagesil may reduce the symptoms of an infection (e.g. headache, high temperature), making it more difficult to detect and treat the infection properly. If you do not feel well and need to see a doctor, remember to mention that you are using Dagesil.

In very rare cases, Dagesil, like other anti-inflammatory medicines, may cause severe allergic reactions in the skin (e.g. rash). Therefore, inform your doctor immediately if you experience any of these reactions.

There have been reports of reactions at the injection site after intramuscular administration of Dagesil, including pain at the injection site, redness, swelling, ulceration, sometimes with haematoma or pus, and destruction of the skin and tissue beneath the skin, a phenomenon known as Nicolau syndrome.

Medicines like Dagesil may be associated with a small increase in the risk of suffering heart attacks (myocardial infarction) or strokes. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or treatment duration.

If you have heart problems, have had a stroke or think you may be at risk of these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol levels or if you smoke), you should seek advice on treatment from your doctor or pharmacist.

- If at any time while taking Dagesil you experience signs or symptoms of heart or blood vessel problems, such as chest pain, difficulty breathing, weakness, difficulty speaking, contact your doctor immediately.

Ensure that before receiving diclofenac, your doctor knows:

- If you smoke

- If you have diabetes

- If you have angina, blood clots, high blood pressure, high cholesterol or triglycerides.

The adverse effects may be reduced if the lowest effective dose is used for the shortest possible time.

If you use Dagesil for more than a few weeks, you should ask your doctor to perform regular checks to ensure that you do not suffer any unintended adverse effects.

Older people

Older patients may be more sensitive to the effects of Dagesil. Therefore, they should follow the doctor's instructions with special care and be treated with the lowest effective dose for their condition. It is especially important that older patients inform their doctor immediately if they experience any adverse effects.

Renal and hepatic insufficiency

Care should be taken when administering an NSAID to patients with renal and hepatic insufficiency. In patients with mild to moderate renal and hepatic dysfunction, the initial dose should be reduced. Diclofenac should not be administered to patients with severe renal and/or hepatic insufficiency.

Children and adolescents

Dagesil injectable and infusion solution should not be used in children and adolescents under 18 years of age.

Other medicines and Dagesil

Inform your doctor or pharmacist if you are taking, have recently taken or may need to take any other medicine.

It is essential to inform your doctor if you are taking any of the following medicines:

- Lithium or selective serotonin reuptake inhibitors (SSRIs) (medicines for treating certain types of depression);

- Digoxin (a medicine for treating heart problems);

- Diuretics (medicines for increasing urine production);

- Inhibitors of the ECA or beta-blockers (classes of medicines used to treat high blood pressure);

- Other anti-inflammatory medicines such as acetylsalicylic acid or ibuprofen;

- Corticosteroids (medicines used to alleviate inflamed areas of the body);

- Anticoagulants (medicines for preventing blood clots);

- Medicines used to treat diabetes, except insulin;

- Methotrexate (a medicine for treating certain types of cancer or arthritis);

- Cyclosporin and tacrolimus (medicines used mainly in patients who have received an organ transplant);

- Trimethoprim (a medicine for preventing and treating urinary tract diseases);

- Quinolone antibiotics (used to treat infections);

- Probenecid;

- Voriconazole (a medicine used in the treatment of fungal infections);

- Phenobarbital (a medicine used in the treatment of seizures).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

- Do not take Dagesil if you are in the last 3 months of pregnancy, as it may harm the foetus or cause problems during delivery. It may cause kidney and heart problems in your foetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. Do not take Dagesil during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, Dagesil may cause kidney problems in your foetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Inform your doctor if you are breastfeeding.

Do not breastfeed if you are using Dagesil as it may harm your baby.

Consult your doctor or pharmacist before using any medicine. Your doctor will discuss with you the potential risk of using Dagesil during pregnancy or breastfeeding.

Driving and operating machinery

Dagesil is unlikely to affect your ability to drive, operate machinery or perform other activities that require special attention.

Dagesil contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml of injectable and infusion solution; it is essentially “sodium-free”.

Dagesil contains sodium metabisulphite (E 223)

Rarely it may cause severe hypersensitivity reactions and bronchospasm.

Dagesil contains benzyl alcohol

This medicine contains 120 mg of benzyl alcohol in each ampoule (containing 3 ml of injectable and infusion solution) equivalent to 40 mg/ml.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Dagesil contains propylene glycol (E 1520)

This medicine contains 600 mg of propylene glycol in each ampoule (containing 3 ml of injectable and infusion solution) equivalent to 200 mg/ml.

If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medicine.

If you have liver or kidney insufficiency, do not take this medicine unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medicine.

The propylene glycol in this medicine may produce effects similar to those produced by drinking alcohol and increase the risk of these adverse effects.

Use this medicine only if recommended by your doctor. Your doctor may perform additional checks while you are taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor. Do not exceed the recommended dose or treatment duration. In case of doubt, consult your doctor or pharmacist again.

Intramuscular injection: the solution must be extracted from the ampoule to a syringe and injected deeply into the gluteal muscle.

Intravenous infusion: The solution must be diluted with at least 100 ml of sodium chloride 0.9% solution or 5% glucose solution tamponed with sodium bicarbonate and infused slowly into a vein. It must not be administered rapidly into a vein.

How much Dagesil to use and when to use it

Do not exceed the recommended dose. It is essential to use the most effective dose to control your pain and not use Dagesil for longer than necessary. Adverse effects can be reduced if the lowest effective dose is used for the shortest time possible to control symptoms.

Your doctor will tell you exactly how many ampoules of Dagesil to use. Depending on your response to treatment, your doctor may suggest a higher or lower dose.

Adults

Generally, in adults, one ampoule content is administered per day for a maximum of two days; in some cases, it is possible to administer two ampoule contents per day. If additional treatment with diclofenac is necessary, it can be administered in the form of tablets or suppositories.

Instructions for opening ampoules OPC (One-Point-Cut), (One-Point-Cut):

1. Hold the ampoule body between your thumb and index finger, with the point upwards;

2. Place the index finger of your other hand to hold the upper part of the ampoule. Place your thumb to cover the point;

3. With your index fingers close to each other, press the point area to open the ampoule.

Use in children and adolescents

Due to the dose of the injectable and perfusion solution, Dagesil use is not recommended in children and adolescents under 18 years old.

How long to use Dagesil

Follow exactly the administration instructions for this medication as indicated by your doctor.

If you use more Dagesil than you should

If you have accidentally used more Dagesil than you should, consult your doctor immediately or go to the emergency service of a hospital. You may need medical attention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Dagesil

Do not use a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Medicines like Dagesil can be associated with a small increase in the risk of suffering heart attacks (myocardial infarction) or strokes.

Some side effects can be serious.

Inform your doctor immediately if you notice:

Reactions at the injection site, including pain at the injection site, redness, swelling, appearance of a hard nodule, ulcers, and rashes. These symptoms can evolve into skin and underlying tissue necrosis and scarring, known as Nicolau syndrome.

These rare side effects can affect between 1 and 10 of every 10,000 patients, especially if they are taking a high daily dose (150 mg) for a prolonged period:

- Sudden and oppressive chest pain (signs of myocardial infarction or heart attack);

- Labored breathing, difficulty breathing when lying down, swelling of feet and legs (signs of heart failure);

These rare or very rare side effects can affect fewer than 1 to 10 of every 10,000 patients

- Spontaneous bleeding or rashes (signs of thrombocytopenia);

- High fever, frequent infections, persistent sore throat (signs of agranulocytosis);

- Difficulty breathing or swallowing, skin rash, itching, dizziness (signs of hypersensitivity, anaphylactic, and anaphylactoid reactions);

- Swelling mainly of the face and throat (signs of angioedema);

- Mood disturbances (signs of psychotic disorders);

- Memory changes (signs of memory decline);

- Seizures;

- Anxiety;

- Neck stiffness, fever, nausea, vomiting, headache (signs of aseptic meningitis);

- Intense and sudden headache, nausea, dizziness, numbness, inability or difficulty speaking, weakness or paralysis of limbs or face (signs of stroke or cerebral hemorrhage);

- Difficulty hearing (signs of auditory impairment);

- Severe headache, dizziness (signs of high blood pressure, hypertension);

- Skin rash, purple-red patches, fever, itching (signs of vasculitis);

- Sudden difficulty breathing and feeling of chest oppression with wheezing or cough (signs of asthma or pneumonia, if accompanied by fever);

- Vomiting blood (signs of hematemesis) and/or black or bloody stools (signs of gastrointestinal hemorrhage);

- Bloody diarrhea (signs of hemorrhagic diarrhea);

- Black stools (signs of melena);
- Severe stomach pain, nausea (signs of gastrointestinal ulcers);

- Diarrhea, abdominal pain, fever, nausea, vomiting (signs of colitis, including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease);

- Intense stomach pain (signs of pancreatitis);

- Yellowing of the skin or eyes (signs of jaundice), nausea, loss of appetite, dark urine (signs of hepatitis/liver insufficiency);

- Flu-like symptoms, fatigue, muscle pain, elevated liver enzymes in blood tests (signs of liver disease, including fulminant hepatitis, liver necrosis, liver insufficiency);

- Blisters (signs of dermatitis bullous);

- Purple-red skin (possible signs of vascular inflammation), skin rash with blisters, blisters on lips, eyes, and mouth, skin inflammation with peeling (signs of erythema multiforme or with signs of fever, Stevens-Johnson syndrome, or toxic epidermal necrolysis);

- Skin irritation with peeling (signs of exfoliative dermatitis);

- Increased skin sensitivity to sunlight (signs of photosensitivity reaction);

- Purple patches on the skin (signs of purpura or Henoch-Schönlein purpura, if caused by allergy);

- Swelling, feeling of weakness or abnormal urination (signs of acute kidney insufficiency);

- Excess protein in urine (signs of proteinuria);

- Swelling of the face or abdomen, high blood pressure (signs of nephrotic syndrome);

- Increased or decreased urine production, drowsiness, confusion, nausea (signs of tubulointerstitial nephritis);

- Severe decrease in urine excretion (signs of papillary renal necrosis);

- Generalized swelling (signs of edema).

Inform your doctor immediately if you experience any of these symptoms.

Some side effects are common:

These can affect between 1 and 10 of every 100 patients

Headache, dizziness, vertigo, nausea, vomiting, diarrhea, indigestion (signs of dyspepsia), abdominal pain, flatulence, loss of appetite, abnormal liver function test results (e.g., elevated transaminases), skin rash, reaction at the injection site, pain at the injection site, induration at the injection site.

Some side effects are rare:

These can affect between 1 and 10 of every 10,000 patients

Somnolence, stomach pain (signs of gastritis), liver disease, skin rash with itching (signs of urticaria), necrosis at the injection site.

Some side effects are very rare:

These can affect fewer than 1 of every 10,000 patients

Anemia, leukopenia, disorientation, depression, insomnia, nightmares, irritability, psychotic disorders, tremors or swelling of hands and feet (signs of paresthesia), tremors, altered taste (signs of dysgeusia), visual disturbances (signs of visual impairment, blurred vision, diplopia), tinnitus, constipation, mouth ulcers (signs of stomatitis), swelling of the tongue, redness, and pain of the tongue (signs of glossitis), esophageal dysfunction (signs of dysphagia), abdominal cramps, especially after eating (signs of diaphragmatic intestinal disease), palpitations, chest pain, skin rash with itching, burning, and redness (signs of eczema), skin redness (signs of erythema), hair loss (signs of alopecia), itching (signs of pruritus), blood in urine (signs of hematuria), abscess at the injection site.

Some side effects have an unknown frequency:

Tissue lesions at the injection site.
Nicolau syndrome - a sudden and intense pain at the injection site, followed by redness, swelling, nodule, which can occur with the blockage of blood vessels, resulting in the destruction of the skin and underlying tissues.

Some side effects can be serious.
Stop using Dagesil and inform your doctor immediately if you observe:

- Chest pain, which may indicate a potentially severe allergic reaction called "Kounis syndrome".

- Mild abdominal cramps and sensitivity, which begin shortly after starting treatment with Dagesil and are followed by rectal bleeding or bloody diarrhea usually within 24 hours after the onset of abdominal pain (unknown frequency, cannot be estimated from available data).

Inform your doctor if you experience any of these side effects.

Reporting of side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store below 30°C.

Store in the original packaging to protect it from light.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Dagesil

- The active principle is diclofenac sodium. Each ml of injectable and perfusion solution contains 25 mg of diclofenac sodium.

- The other components (excipients) are: mannitol, sodium metabisulfite, benzyl alcohol, propylene glycol, sodium hydroxide, and water for injectable preparations.

Appearance of the product and contents of the package

This medication is a transparent and sterile injectable and perfusion solution presented in glass vials of 5 ml (which contain 3 ml of injectable and perfusion solution).

Dagesil is available in packaging of 3, 6, or 50 vials.

Holder of the marketing authorization

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua, Portugal

Tel.: +351 231 920 250

Fax: +351 231 921 055

E-mail: [email protected]

Responsible for manufacturing

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira Lotes 8, 15 e 16

3450-232 Mortágua

Portugal

Local Representative

Laphysan, S.A.U.

Calle Anabel Segura 11,

Complejo Empresarial Albatros, Edificio A, Planta 4, puerta D,

28108 Alcobendas (Madrid)

This medication is authorized in the member states of the European Economic Areawith the following names:

PortugalDagesil

SpainDagesil 75 mg/3 ml solution for injection EFG

LithuaniaDagesil 75 mg/3 ml injekcinis tirpalas

LithuaniaDagesil 75 mg/3 ml injekcinis tirpalas

EstoniaDagesil 75 mg/3 ml süstelahus

Date of the last review of this leaflet:

April 2023

Other sources of information

The detailed information ofthis medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/