DAGESIL 75 mg/3 mL Injectable Solution and Perfusion Solution

Introduction

Package Leaflet: Information for the User

Dagesil 75 mg/3 ml Solution for Injection and Infusion EFG

diclofenac sodium

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

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

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Dagesil and what is it used for
2. What you need to know before you use Dagesil
3. How to use Dagesil
4. Possible side effects
5. Storing Dagesil
6. Contents of the pack and other information

1. What is Dagesil and what is it used for

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

Dagesil relieves the symptoms of inflammation, including swelling and pain, by blocking the production 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 the 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 surgery.

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

Monitoring during your treatment with Dagesil

If you have liver, kidney, or blood disorders, you will need to have blood tests during treatment. These tests will allow your doctor to monitor your liver function (transaminase levels) and your kidney function (creatinine levels) or your 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 stop treatment with Dagesil or adjust the dose.

2. What you need to know before you use Dagesil

Follow your doctor's instructions carefully. They may differ from the general information included in this leaflet.

Tell your doctor if you have recently undergone or are going to undergo stomach or intestinal surgery before using Dagesil, as Dagesil may sometimes worsen wound healing in the intestine after surgery.

Do not use Dagesil

• if you are allergic to diclofenac, sodium metabisulfite (or other sulfites), or any of the other ingredients of this medicine (listed in section 6);
• if you have a stomach or intestinal ulcer;
• if you have a stroke 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 an allergic reaction after taking medicines to treat inflammation or pain (e.g., diclofenac, acetylsalicylic acid, or ibuprofen). Reactions may include asthma, chest pain, nasal discharge, skin rash, or facial swelling. If you think you may be allergic, consult your doctor;
• if you have gastrointestinal bleeding or perforation, whose symptoms may include bloody stools 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 blood vessels of the heart or brain, or have had surgery to remove a blockage or perform a coronary bypass;
• if you have problems with blood circulation (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 upset or heartburn after taking anti-inflammatory medicines in the past;
• If you have inflammation of the colon (ulcerative colitis) or the intestinal tract (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, diarrhea, before or after major surgery);
• If you have swollen feet without a traumatic cause associated with them;
• If you have blood coagulation disorders or other blood disorders, including a rare liver condition called porphyria;
• 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 consult a doctor, remember to mention that you are using Dagesil.

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

Reactions at the injection site have been reported after intramuscular administration of Dagesil, including pain at the injection site, redness, swelling, ulceration, sometimes with hematoma or pus, and destruction of the skin and tissue underneath the skin, a phenomenon known as Nicolau syndrome.

Medicines like Dagesil may be associated with a small increased risk of having a heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatments. 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 having these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, 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.

Make sure your doctor knows before you receive diclofenac:

• If you smoke
• If you have diabetes
• If you have angina pectoris, blood clots, high blood pressure, high cholesterol, or high triglycerides.

Side effects can 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 check-ups to ensure that you do not suffer from unnoticed side effects.

Elderly people

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

Kidney and liver disorders

Caution should be exercised when administering an NSAID to patients with kidney and liver disorders. In patients with mild to moderate kidney and liver dysfunction, the initial dose should be reduced. Diclofenac should not be administered to patients with severe kidney and/or liver disorders.

Children and adolescents

The use of Dagesil solution for injection and infusion is not recommended in children and adolescents under 18 years of age.

Other medicines and Dagesil

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is important that you tell your doctor if you are taking any of the following medicines:

• Lithium or serotonin reuptake inhibitors (SSRIs) (medicines for treating some types of depression);
• Digoxin (a medicine for treating heart problems);
• Diuretics (medicines for increasing urine production);
• ACE inhibitors 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 relieve inflamed areas of the body);
• Anticoagulants (medicines for preventing blood clots);
• Medicines used to treat diabetes, except insulin;
• Methotrexate (a medicine for treating some 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 antibacterials (used to treat infections);
• Probenecid;
• Voriconazole (a medicine used in the treatment of fungal infections);
• Phenytoin (a medicine used in the treatment of seizures).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

• Do not take Dagesil if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. You should not take Dagesil during the first 6 months of pregnancy unless it is clearly necessary and as directed 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 the 20th week of pregnancy, Dagesil may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of the fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

You should tell your doctor if you are breastfeeding.

You should not breastfeed if you are using Dagesil, as it may harm your baby.

Ask your doctor or pharmacist for advice before using any medicine. Your doctor will discuss with you the potential risks of using Dagesil during pregnancy or breastfeeding.

Driving and using machines

Dagesil is unlikely to affect your ability to drive, use machines, 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 solution for injection and infusion; this is essentially "sodium-free".

Dagesil contains sodium metabisulfite (E223)

It can rarely cause severe hypersensitivity reactions and bronchospasm.

Dagesil contains benzyl alcohol

This medicine contains 120 mg of benzyl alcohol in each ampoule (which contains 3 ml of solution for injection and infusion), equivalent to 40 mg/ml.

Benzyl alcohol may cause allergic reactions.

Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Ask your doctor or pharmacist for advice if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Dagesil contains propylene glycol (E 1520)

This medicine contains 600 mg of propylene glycol in each ampoule (which contains 3 ml of solution for injection and infusion), equivalent to 200 mg/ml.

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

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

The propylene glycol in this medicine may produce effects similar to those of alcohol and increase the likelihood of these side effects.

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

3. How to use Dagesil

Follow your doctor's instructions for administration of this medicine exactly. Do not exceed the recommended dose or treatment duration. If in doubt, consult your doctor or pharmacist again.

Intramuscular injection: the solution should be drawn from the ampoule into a syringe and injected deeply into the gluteal muscle.

Intravenous infusion: the solution should be diluted with at least 100 ml of 0.9% sodium chloride solution or 5% glucose solution buffered with sodium bicarbonate and infused slowly into a vein. It should 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 important that you use the lowest effective dose to control your pain and do not use Dagesil for longer than necessary. Side effects can be reduced if the lowest effective dose is used for the shortest possible time to control symptoms.

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

Adults

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

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

1. Hold the body of the ampoule between your thumb and index finger, with the point facing upwards;
2. Place the index finger of your other hand to hold the top part of the ampoule. Place your thumb to cover the point;
3. With your index fingers close together, press the area of the point to open the ampoule.

Use in children and adolescents

Due to the dose of the solution for injection and infusion, the use of Dagesil is not recommended in children and adolescents under 18 years of age.

How long to use Dagesil

Follow your doctor's instructions for administration of this medicine exactly.

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 department of a hospital. You may need medical attention.

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

If you forget to use Dagesil

Do not use a double dose to make up for forgotten doses.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Medicines like Dagesil may be associated with a small increased risk of suffering heart attacks (myocardial infarction) or strokes.

Some adverse 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 bruising. These symptoms can evolve into blackening and necrosis of the skin and surrounding tissues at the injection point, which leave a scar when healed, also known as Nicolau's syndrome.

These rare effects may affect between 1 and 10 out of every 1,000 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);
• Shortness of breath, difficulty breathing when lying down, swelling of feet and legs (signs of heart failure);

These rare or very rare effects may affect less than 1 to 10 out of every 10,000 patients

• Spontaneous bleeding or bruising (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 disorder (signs of psychotic disorders);
• Memory changes (signs of memory impairment);
• Seizures;
• Anxiety;
• Neck stiffness, fever, nausea, vomiting, headache (signs of aseptic meningitis);
• Sudden and severe headache, nausea, dizziness, numbness, inability or difficulty speaking, weakness or paralysis of the limbs or face (signs of stroke or cerebral hemorrhage);
• Difficulty hearing (signs of hearing impairment);
• Headache, dizziness (signs of high blood pressure, hypertension);
• Skin rash, purple-colored spots, fever, itching (signs of vasculitis);
• Sudden difficulty breathing and feeling of oppression in the chest with wheezing or coughing (signs of asthma or pneumonia, if accompanied by fever);
• Vomiting blood (signs of hematemesis) and/or black or bloody stools (signs of gastrointestinal bleeding);
• Bloody diarrhea (signs of hemorrhagic diarrhea);
• Black stools (signs of melena); Stomach pain, nausea (signs of gastrointestinal ulcer);
• Diarrhea, abdominal pain, fever, nausea, vomiting (signs of colitis, including hemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease);
• Severe stomach pain (signs of pancreatitis);
• Yellowing of the skin or eyes (signs of jaundice), nausea, loss of appetite, dark urine (signs of hepatitis/liver failure);
• Flu-like symptoms, fatigue, muscle pain, elevated liver enzymes in blood tests (signs of liver disease, including fulminant hepatitis, liver necrosis, liver failure);
• Blisters (signs of bullous dermatitis);
• Purple-colored skin (possible signs of blood vessel inflammation), skin rash with blisters, blisters on the 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 when exposed to sunlight (signs of photosensitivity reaction);
• Purple spots 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 failure);
• Excess protein in the 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 renal papillary necrosis);
• Generalized swelling (signs of edema).

If you experience any of these symptoms, inform your doctor immediately.

Some adverse effects are frequent:

These may affect 1 to 10 out 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 redness, reaction at the injection site, pain at the injection site, induration at the injection site.

Some adverse effects are rare:

These may affect between 1 and 10 out of every 10,000 patients

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

Some adverse effects are very rare:

These may affect less than 1 out of every 10,000 patients

Low red blood cell count (anemia), low white blood cell count (leukopenia), disorientation, depression, difficulty sleeping (signs of insomnia), nightmares, irritability, psychotic disorders, tremor or swelling of hands and feet (signs of paresthesia), tremors, taste disturbances (signs of dysgeusia), visual disturbances (signs of visual impairment, blurred vision, diplopia), ringing in the ears (tinnitus), constipation, canker sores (signs of stomatitis), tongue swelling, redness, and pain of the tongue (signs of glossitis), disorders of the esophagus (signs of esophageal dysfunction), cramps in the upper abdomen, especially after eating (signs of diaphragmatic intestinal disease), palpitations, chest pain, skin rashes with itching, burning, and redness (signs of eczema), skin redness (signs of erythema), hair loss (signs of alopecia), itching (signs of pruritus), blood in the urine (signs of hematuria), abscess at the injection site.

Some adverse effects have an unknown frequency:

Tissue damage at the injection site. Nicolau's syndrome - a sensation of intense and immediate pain at the injection site, followed by redness, swelling, nodule, may occur with blockage of blood vessels, resulting in destruction of the skin and tissues underneath the skin.

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

• Chest pain, which may indicate a potentially serious allergic reaction called "Kounis syndrome".
• Mild cramps and sensitivity in the abdomen, 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 (frequency not known, cannot be estimated from available data).

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

Reporting Adverse Effects

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

5. Storage of Dagesil

Store below 30°C.

Keep in the original packaging to protect from light.

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

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Dagesil Composition

• The active ingredient is sodium diclofenac. Each ml of injectable and infusion solution contains 25 mg of sodium diclofenac.
• The other components (excipients) are: mannitol, sodium metabisulfite, benzyl alcohol, propylene glycol, sodium hydroxide, and water for injectable preparations.

Product Appearance and Package Contents

This medicine is a clear and sterile injectable and infusion solution presented in 5 ml glass ampoules (containing 3 ml of injectable and infusion solution).

Dagesil is available in packs of 2, 3, 6, or 50 ampoules.

Marketing Authorization Holder

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]

Manufacturer

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Portugal Dagesil

Spain Dagesil 75 mg/3 ml solution for injection EFG

Latvia Dagesil 75 mg/3 ml injekcijas šķīdums

Lithuania Dagesil 75 mg/3 ml injekcinis tirpalas

Estonia Dagesil 75 mg/3 ml süstelahus

Date of the Last Revision of this Leaflet:

April 2023

Other Sources of Information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/