VOLTAREN 75 mg INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Voltarén75 mg solution for injection

Diclofenac sodium

Read all of this leaflet carefully before you start using this medicine.

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

1. What is Voltarén and what is it used for

Diclofenac sodium, the active substance of Voltarén, belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation.

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

• rheumatoid arthritis
• ankylosing spondylitis
• osteoarthritis
• soft tissue rheumatism
• renal colic
• acute gout attack
• lower back pain
• musculoskeletal pain
• postoperative and post-traumatic pain

2. What you need to know before you use Voltarén

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

Do not use Voltarén

• if you are allergic to diclofenac sodium, sodium metabisulfite (or other sulfites) or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic or have had allergic reactions to acetylsalicylic acid or other similar painkillers. Reactions can 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, have suffered from two or more occasions, a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• if you currently have or have had more than one occasion a 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 have had surgery to remove a blockage or perform a coronary bypass.
• if you have had problems with blood circulation (peripheral arterial disease)
• if you are in the third trimester of pregnancy.
• if you have coagulation disorders.

Make sure your doctor knows before taking diclofenac:

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

Side effects can be minimized by using the lowest effective dose for the shortest possible time.

Warnings and precautions

• if you have had or developed an ulcer, hemorrhage or perforation in the stomach or duodenum, which can be manifested by intense or persistent abdominal pain and/or black stools or even without previous warning symptoms.

This risk is greater when high doses and prolonged treatments are used 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 protective medication.

• if you suffer from any of the following conditions: asthma, mild heart disease, liver or kidney disease, high blood pressure (hypertension), bleeding disorders or other blood disorders including hepatic porphyria.

• if you are taking other anti-inflammatory medications, corticosteroids, anticoagulants, or antidepressants because it increases the risk of ulcer and/or gastrointestinal bleeding (see section "Other medications and Voltarén").
• if you are taking medications for blood pressure or cyclosporin, because it increases the risk of kidney damage (see section "Other medications and Voltarén").

Tell your doctor

• if you take medications that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents of the acetylsalicylic acid type. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• if you have Crohn's disease or ulcerative colitis, as medications like Voltarén can worsen these conditions.
• if you have high blood pressure, high cholesterol or triglycerides, diabetes, or are a smoker (cardiovascular risk factors), your doctor should periodically reassess whether you should continue treatment with this medication, especially if you have been taking it for more than 4 weeks.
• if you have liver or kidney failure, or blood disorders, you will need to have frequent blood tests during treatment. This will allow your doctor to monitor the functioning of your liver (transaminase levels) or kidneys (creatinine levels) or blood (lymphocyte, erythrocyte, and platelet levels). With this, your doctor can decide to interrupt or change the dose of this medication.
• if you have recently undergone or are going to undergo stomach or intestinal surgery before using this medication, as this medication can sometimes worsen wound healing in the intestine after surgery.
• if you notice reactions at the injection site. Reactions at the injection site have been reported after intramuscular administration of diclofenac, including pain at the injection site, redness, swelling/hard lump, ulcer, sometimes with hematoma or pus accumulation, and destruction of skin and tissue under the skin (especially after incorrect administration in fatty tissue) – a phenomenon known as Nicolau's syndrome.
• if you have ever had a severe skin rash or skin peeling or blisters in the mouth after taking Voltarén or other painkillers.

Patients with cardiovascular problems

Medications like Voltarén can be associated with an increased risk of heart attacks ("myocardial infarction") or strokes, especially when used in high doses and for 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 of having them (for example, you have high blood pressure, diabetes, high cholesterol or triglycerides, or are a smoker), and your doctor decides to treat you with this medication, you should not take more than 100 mg per day if the treatment lasts more than 4 weeks.

Similarly, this type of medication can cause fluid retention, especially in patients with heart disease and/or high blood pressure (hypertension).

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

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

Other medications and Voltarén

Tell your doctor or pharmacist if you are using, have recently used, or might use other medications.

Certain medications can interfere with this medication; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

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

• medications containing lithium or serotonin reuptake inhibitors (for treating some types of depression),
• medications containing methotrexate (for treating rheumatoid arthritis and cancer),
• medications containing cyclosporin, tacrolimus (after transplants),
• medications containing trimethoprim (for preventing and treating urinary tract diseases),
• medications for treating heart problems (digoxin, calcium antagonists such as verapamil or isradipine),
• medications used to treat diabetes, except insulin,
• medications for controlling blood pressure (diuretics, beta blockers, and ACE inhibitors),
• medications for preventing blood clots,
• medications containing quinolone or ceftriaxone (for treating infections),
• corticosteroids (medications that reduce inflammation and the action of the immune system),
• other medications of the same group as Voltarén (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
• medications containing voriconazole (a medication used in the treatment of fungal infections),
• phenytoin (a medication used to treat epileptic seizures),
• medications containing misoprostol (for treating stomach ulcers),
• medications containing cholestyramine and colestipol (for reducing cholesterol levels in the blood),
• medications containing pentazocine (for relieving pain),
• antibiotic medication used to treat bacterial infections (rifampicin).

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

Using Voltarén with food, drinks, and alcohol

Consuming alcoholic beverages with the use of this medication can increase its toxicity.

Children and adolescents

The use of this medication is not recommended in children and adolescents.

Elderly patients

Elderly patients, especially those who are frail or have low body weight, may be more sensitive to the effects of this medication. Therefore, it is especially important that elderly patients inform their doctor immediately of any adverse effects that occur.

Pregnancy, breastfeeding, and fertility

Pregnancy

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 could harm the fetus or cause problems during delivery. It can cause kidney and heart problems in your fetus. It can affect your and your baby's tendency to bleed and delay or prolong delivery more than expected. You should 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 from the 20th week of pregnancy, this medication can cause kidney problems in your fetus, which can 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 you need treatment for more than a few days, your doctor may recommend additional checks.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Fertility

For patients of childbearing age, it should be noted that medications like Voltarén have been associated with a decrease in fertility.

Driving and using machines

The influence of diclofenac on the ability to drive and use machines is zero 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 metabisulfite (E-223)

This medication contains less than 23 mg of sodium (1 mmol) per 3 ml; this is, essentially "sodium-free".

This medication contains 120 mg of benzyl alcohol in each 3 ml, equivalent to 40 mg/ml.

Benzyl alcohol can cause allergic reactions.

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

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

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

3. How to use Voltarén

Follow exactly the administration instructions of this medication 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 daily injections can be administered, separated by several hours.

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

Method of administration

Intramuscular route.

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

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

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

If you use more Voltarén than you should

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

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

4. Possible Adverse Effects

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

Some adverse effects can be serious.

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

Mild abdominal cramps and abdominal pain on palpation that begins shortly after starting treatment with this medicine, followed by rectal bleeding or bloody diarrhea, usually observed within 24 hours after the onset of abdominal pain (frequency not known, 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 bruising at the injection site. These symptoms can evolve into blackening and necrosis of the skin and surrounding tissues at the injection site, leaving a scar when healed. This complication is also known as Nicolau syndrome.

Severe skin allergic reaction, which can include large, generalized red or dark spots, skin swelling, blisters, and itching (generalized fixed medicament eruption).

Other adverse effects that have been reported with the use of this medicine are the following:

Reporting Adverse Effects:

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

5. Storage of Voltarén

Keep this medicine out of sight and reach of children.

Do not store above 30°C. Keep the ampoules in the outer packaging to protect them from light.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofVoltarén

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

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

Appearance of Voltarén and Package Contents

Clear, colorless or slightly yellowish solution, presented in 3 ml colorless ampoules.

Packaging of 6 ampoules.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

Date of Last Revision of this Prospectus:10/2023

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