Label: information for the user

Voltarén75 mg injectable solution

Diclofenaco sódico

Read this label carefully before starting to use this medication.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What isVoltarénand for what it is used

2. What you need to knowbefore starting to use Voltarén

3. How to useVoltarén

4. Possible adverse effects

5. Storage ofVoltarén

6. Contents of the package andadditional information

Sodium diclofenac, the active ingredient of Voltarén, belongs to the group of medications known as non-steroidal anti-inflammatory drugs, used to treat pain and inflammation.

It is used for symptomatic treatment of intense acute pain associated with:

• Rheumatoid arthritis
• Ankylosing spondylitis
• Osteoarthritis
• Musculoskeletal soft tissue rheumatism
• Renal colic
• Acute gout attack
• Lower back pain
• Musculoskeletal pain
• Postoperative and post-traumatic pain

It is essential to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

No use Voltarén

• if you are allergic to diclofenac sodium, sodium metabisulphite (or other sulphites) or any of the other components of this medication (listed in section 6).
• if you are allergic or have had allergic reactions to acetylsalicylic acid or other analgesics (pain medications) similar to it. Allergic reactions may include asthma (difficulty breathing), chest pain, urticaria (allergic reaction on the skin with itching), acute rhinitis (inflammation of the nasal mucosa) or swelling of the face, lips, tongue, throat, and/or limbs (signs of angioedema). If you think you may be allergic, consult your doctor.
• if you have had a stomach or duodenal hemorrhage in the past, have had it two or more times, or have had a perforation of the digestive tract while taking a non-steroidal anti-inflammatory medication.
• if you currently have or have had more than one stomach or duodenal ulcer or hemorrhage.
• if you have active Crohn's disease or ulcerative colitis(diseases that produce diarrhea with or without blood and abdominal pain).
• if you have severe kidney disease.
• if you have severe 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 a surgery to remove some obstruction or make a coronary bypass.
• if you have or have had circulation problems (peripheral arterial disease)
• if you are in the third trimester of pregnancy.
• if you have blood clotting disorders.

Make sure before taking diclofenac that your doctor knows:

• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides

The adverse effects can be minimized by using the lowest effective dose for the shortest possible period.

Advertencias y precauciones

-if you have had or develop a stomach or duodenal ulcer, hemorrhage, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatments in patients with a history of peptic ulcer and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector medication.

• if you have any of the following conditions: asthma, mild heart disease, liver disease, kidney disease, high blood pressure, bleeding disorders, or other blood disorders including porphyria hepatica.

-if you are taking other anti-inflammatory medications, corticosteroids, anticoagulants, or antidepressants, as it increases the risk of stomach ulcers and/or gastrointestinal bleeding (see section “Other medications and Voltarén”).

• if you are taking blood pressure medications or ciclosporin, as it increases the risk of kidney damage (see section “Other medications and Voltarén”).

Informe a su médico

• if you are taking medications that alter blood clotting or increase the risk of ulcers, such as oral anticoagulants or antiplatelet medications like acetylsalicylic acid. You must also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• if you have Crohn's disease or ulcerative colitis, as Voltarén medications may worsen these conditions.
• if you have high blood pressure, high cholesterol, high triglycerides, diabetes, or are a smoker (cardiovascular risk factors), your doctor will reevaluate periodically whether you should continue treatment with this medication, especially if you have been taking it for more than 4 weeks.
• if you have liver insufficiency, kidney insufficiency, or blood disorders, you will need to have frequent blood tests during treatment. This will allow your doctor to control the functioning of your liver (transaminase levels), kidneys (creatinine levels), or blood (lymphocyte, erythrocyte, and platelet levels). Your doctor will then decide whether to interrupt or change the dose of this medication.
• if you have recently undergone or are about to undergo a surgical intervention of the stomach or intestine before using this medication, as this medication may sometimes worsen the healing of intestinal wounds after surgery.
• if you observe reactions at the injection site. There have been reports of reactions at the injection site after intramuscular administration (technique used to administer a medication deeply into the muscles) of diclofenac, including pain at the injection site, redness, swelling/bulge, ulcer, sometimes with hematomas or accumulation of pus, and destruction of the skin and tissue underneath the skin (particularly after an incorrect administration in fatty tissue) – a phenomenon known as Nicolau syndrome.

Pacientes con problemas cardiovasculares

Medications like Voltarén may be associated with an increased risk of heart attacks or strokes, especially when used in high doses and prolonged treatments. Do not exceed the recommended dose or treatment duration.

If you have heart problems, a history of strokes, or think you may be at risk (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker) and your doctor decides to treat you with this medication, do not take more than 100 mg per day if the treatment lasts more than 4 weeks.

This type of medication may cause fluid retention, especially in patients with heart disease and/or high blood pressure.

In general, it is very important to take the lowest effective dose of this medication for the shortest possible time to relieve pain and/or inflammation to reduce the risk of cardiovascular adverse effects.

If you experience chest pain, shortness of breath, weakness, or difficulty speaking while taking this medication, contact your doctor immediately.

Otros medicamentos y Voltarén

Inform your doctor or pharmacist if you are using, have used recently, or may need to use another medication.

Certain medications may interact withthis medication; in these cases, you may need to change the dose or interrupt treatment with one of them.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

• medications containing lithiumor selective serotonin reuptake inhibitors(to treat some types of depression),
• medications containing methotrexate (to treat rheumatoid arthritis and cancer),
• medications containing ciclosporin, tacrolimus(after transplants),
• medications containing trimetroprim (to prevent and treat urinary tract diseases),
• medications to treat heart problems (digoxin, calcium channel blockers such as verapamil or isradipine),
• medications used to treat diabetes, except for insulin,
• medications to control blood pressure(diuretics, beta blockers, and ACE inhibitors),
• medications to prevent blood clots,
• medications containing quinolone or ceftriaxone (to treat infections,
• corticosteroids (medicationsthat reduce inflammation and the action of the immune system),
• other medications in the same group as Voltarén (non-steroidal anti-inflammatory medications), such as acetylsalicylic acid or ibuprofen,
• medications containing voriconazole (a medication used to treat fungal infections),
• phenytoin (a medication used to treat seizures),
• medications containing misoprostol (to treat stomach ulcers),
• medications containing cholestyramine and colestipol (to lower cholesterol levels in the blood),
• medications containing pentazocine (to relieve pain),
• antibiotic medication used to treat bacterial infections (rifampicin).

As a general rule, Voltarén ampoules should not be mixed with other injectable solutions.

Uso de Voltarén con alimentos, bebidas y alcohol

The consumption of alcoholic beverages with the use of this medication may increase its toxicity.

Niños y adolescentes

This medication is not recommended for use in children and adolescents.

Pacientes de edad avanzada

Older patients, especially those who are more fragile or have a low body weight, may be more sensitive to the effects of this medication. Therefore, it is especially important for older patients to inform their doctor immediately about any adverse effects they experience.

Embarazo, lactancia y fertilidad

Embarazo

Consult your doctor or pharmacist before using any medication.

Do not take this medication 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. Do not take this medication 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. If you take it for more than a few days after week 20 of pregnancy, this medication may cause kidney problems in your fetus, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

Lactancia

Consult your doctor or pharmacist before using any medication.

Small amounts of diclofenac may appear in breast milk, so you should not use this medication if you are breastfeeding.

Fertilidad

For fertile women, it should be noted that medications like Voltarén have been associated with a decrease in the ability to conceive.

Conducción y uso de máquinas

The influence of diclofenac on the ability to drive and use machines is negligible or insignificant. However, patients who experience visual disturbances, dizziness, vertigo, somnolence, or other central nervous system disorders while taking this medication should avoid driving vehicles or operating machinery.

Voltarén contains sodium, benzyl alcohol (e-1519), propylene glycol (e-1520), and sodium metabisulphite (e-223)

This medication contains less than 23 mg of sodium (1 mmol) per 3 ml; it is essentially “sodium-free”.

This medication contains 120 mg of benzyl alcohol per 3 ml, 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).

This medication contains 600 mg of propylene glycol (E-1520) per 3 ml, equivalent to 200 mg/ml.

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulphite.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Use in adults

The recommended dose is 1 ampoule (75 mg of diclofenac sodium) once a day.

Exceptionally, in severe cases, two injections may be administered daily, separated by several hours.

This medication should not be administered for more than two days. Once the acute crisis has stopped, you may continue treatment with diclofenac tablets or suppositories. If an ampoule is combined with any of the other two presentations (tablets or suppositories), the total diclofenac dose will not exceed 150 mg in 24 hours.

Administration form

Intramuscular route.

The medication will be administered by deep intragluteal injection in the upper right quadrant.

A suitable injection technique and needle length (considering the patient's gluteal fat thickness) should be used to avoid accidental subcutaneous administration of the medication.

To open the ampoule with a break point below, press with your thumb on the point and break it.

If you use more Voltarén than you should

Given the administration route of this medication, it is unlikely that overdose cases will occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91.562.04.20.

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

Some side effects can be serious.

Stop using this medicine and immediately inform your doctor if you notice:

Mild abdominal cramps and abdominal pain to palpation that begins shortly after starting treatment with this medicine, followed by rectal bleeding or bloody diarrhea observed normally within 24 hours after the onset of abdominal pain (with unknown frequency, cannot be determined from available data).

Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reactions at the injection site, including pain, redness, swelling, appearance of a hard lump, ulcers, or rashes at the injection site. These symptoms can evolve into skin and underlying tissue necrosis and blackening around the injection site, leaving a scar upon healing. This complication is also known as Nicolau syndrome.

Other side effects that have been reported with the use of this medicine are as follows:

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above30°C. Store the ampoules in the outer packaging to protect it from light.

Do not use this medication after the expiration datethat appearson the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofVoltarén

• The active principle is diclofenac sodium. Each 3 ml ampoule contains 75 mg of diclofenac sodium.

• The other components, per 3 ml ampoule are benzyl alcohol 120 mg (E-1519), sodium metabisulphite (E-223), mannitol (E-421), propylene glycol (E-1520), sodium hydroxide (E-524) and water for injectable preparations.

Appearance of Voltarén and contents of the packaging

Transparent, colourless or slightly yellow/yellowish solution, presented in colourless 3 ml ampoules.

6 ampoule packaging.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

Responsible for Manufacturing

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

Last review date of this leaflet:10/2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/