Voltaren 75 mg solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Voltarén 75 mg injection solution

Diclofenac sodium

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Voltarén is and what it is used for

Diclofenac sodium, the active substance in Voltarén, belongs to a group of medicines known as non-steroidal anti-inflammatory drugs, used to treat pain and inflammation.

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

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

2. What you need to know before using Voltarén

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

Do not use Voltarén

• if you are allergic to sodium diclofenac, sodium metabisulfite (or other sulfites), or to 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 to other similar painkillers (analgesics). Reactions may include asthma (difficulty breathing), chest pain, urticaria (skin allergic reaction 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 previously had a stomach or duodenal bleed, or have experienced two or more episodes of gastrointestinal perforation while taking a non-steroidal anti-inflammatory drug (NSAID).
• if you currently have or have had more than one episode of stomach or duodenal ulcer or bleeding.
• if you have active Crohn’s disease or active ulcerative colitis (conditions causing 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 undergone surgery to remove an obstruction or 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.

Before taking diclofenac, make sure your doctor knows:

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

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.

Warnings and precautions

• if you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

This risk is higher when high doses are used or treatment is prolonged, especially in patients with a history of peptic ulcer or in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.

• if you have 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 medicines, corticosteroids, anticoagulants, or antidepressants, as this increases the risk of ulcer and/or gastrointestinal bleeding (see section “Other medicines and Voltarén”).

  • if you are taking medicines for high blood pressure or cyclosporine, as this increases the risk of kidney damage (see section “Other medicines and Voltarén”).

Tell your doctor

• if you are simultaneously taking medicines that affect blood clotting or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• if you have Crohn’s disease or ulcerative colitis, as medicines like Voltarén may worsen these conditions.
• if you have high blood pressure, elevated cholesterol or triglyceride levels, diabetes, or are a smoker (cardiovascular risk factors), your doctor should periodically reassess whether you should continue this treatment, especially if it lasts more than 4 weeks.
• if you have liver impairment, kidney impairment, or blood disorders, you will need frequent blood tests during treatment. These tests monitor liver function (transaminase levels), kidney function (creatinine levels), or blood parameters (lymphocyte, erythrocyte, and platelet levels). This allows your doctor to decide whether to stop or adjust your dose.
• if you have recently undergone or are about to undergo stomach or intestinal surgery, as this medicine may sometimes impair wound healing in the intestine after surgery.
• if you notice any reactions at the injection site. Reactions at the injection site have been reported after intramuscular administration (a technique used to deliver a medicine deep into the muscle) of diclofenac, including pain at the injection site, redness, swelling/hard lump, ulceration, sometimes with bruising or pus accumulation, and skin and underlying tissue damage (particularly after incorrect administration into fatty tissue) – a phenomenon known as Nicolau syndrome.
• if you have ever had a severe skin rash, skin peeling, blisters, or mouth sores after taking Voltarén or other painkillers.

Patients with cardiovascular problems

Medicines like Voltarén may be associated with an increased risk of heart attack ("myocardial infarction") or stroke, especially when used at high doses or for prolonged periods. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of stroke, or think you may be at risk (for example, you have high blood pressure, diabetes, high cholesterol or triglycerides, or you smoke) and your doctor decides to treat you with this medicine, you should not take more than 100 mg per day if treatment lasts longer than 4 weeks.

Also, this type of medicine may cause fluid retention, particularly 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 medicine for the shortest time needed to relieve your pain and/or inflammation, in order to reduce the risk of cardiovascular adverse effects.

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

Other medicines and Voltarén

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

Certain medicines may interfere with this medicine; in such cases, it may be necessary to adjust the dose or discontinue 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 medicines:

• medicines containing lithium or serotonin reuptake inhibitors (used to treat certain types of depression),
• medicines containing methotrexate (used to treat rheumatoid arthritis and cancer),
• medicines containing cyclosporine, tacrolimus (used after organ transplants),
• medicines containing trimethoprim (used to prevent and treat urinary tract infections),
• medicines used to treat heart problems (digoxin, calcium antagonists such as verapamil or isradipine),
• medicines used to treat diabetes, except insulin,
• medicines to control blood pressure (diuretics, beta-blockers, and ACE inhibitors),
• medicines used to prevent blood clots,
• medicines containing quinolone or ceftriaxone (used to treat infections),
• corticosteroids (medicines that reduce inflammation and suppress the immune system),
• other medicines in the same group as Voltarén (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
• medicines containing voriconazole (a medicine used to treat fungal infections),
• phenytoin (a medicine used to treat epileptic seizures),
• medicines containing misoprostol (used to treat stomach ulcers),
• medicines containing cholestyramine and colestipol (used to lower blood cholesterol levels),
• medicines containing pentazocine (used to relieve pain),
• antibiotic medicine used to treat bacterial infections (rifampicin).

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

Use of Voltarén with food, drinks and alcohol

Consumption of alcoholic beverages together with the use of this medicine may increase its toxicity.

Children and adolescents

The use of this medicinal product 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 they experience.

Pregnancy, breastfeeding and fertility

Pregnancy

Consult your doctor or pharmacist before taking any medicine.

Do not take this medicine during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labour more than expected. You should not take this medicine during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is required during this period or while trying to become pregnant, you should take the lowest effective dose for the shortest possible time. If taken for more than a few days starting from week 20 of pregnancy, this medicine may cause kidney problems in the fetus, which could 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 treatment for more than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding

Consult your doctor or pharmacist before taking any medicine.

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 potential, it should be noted that medications of the Voltaren type have been associated with a reduced ability to conceive.

Driving and operating machinery

The influence of diclofenac on the ability to drive or operate machinery is none or negligible. However, patients who experience visual disturbances, dizziness, vertigo, somnolence, or other central nervous system disorders during treatment with this medicinal product should avoid driving vehicles or operating machinery.

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

This medicine contains less than 23 mg of sodium (1 mmol) per 3 ml, which means it is essentially "sodium-free".

This medicine contains 120 mg of benzyl alcohol in each 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 medicine contains 600 mg of propylene glycol (E-1520) in each 3 ml, equivalent to 200 mg/ml.

This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sodium metabisulfite.

3. How to use Voltarén

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Use in adults

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

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

This medicine must not be administered for more than two days. Once the acute episode has resolved, treatment may continue with diclofenac tablets or suppositories. If an ampoule is combined with either of the other two formulations (tablets or suppositories), the total daily dose of diclofenac must not exceed 150 mg in 24 hours.

Administration method

Intramuscular route.

The medicine should be administered by deep intragluteal injection into the upper right quadrant.

Appropriate injection technique and needle length (considering the patient's gluteal fat thickness) must be used to avoid accidental subcutaneous administration of the medicine.

To open the breakable ampoule at the marked point, press with the thumb on the point and snap it open.

If you use more Voltarén than you should

Due to the route of administration of this medicine, overdose reactions are unlikely.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious.

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

Mild abdominal cramps and abdominal tenderness beginning shortly after starting treatment with this medicine, followed by rectal bleeding or diarrhoea with blood, usually observed within 24 hours after onset of abdominal pain (frequency unknown, cannot be estimated from the available data).

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

Reactions at the injection site, including pain, redness, swelling, formation of a hard lump, ulcers, or bruising at the injection site. These symptoms may progress to blackening and necrosis of the skin and underlying surrounding tissues at the injection site, which may leave a scar upon healing. This complication is also known as Nicolau syndrome.

Severe allergic skin reaction, which may include widespread large red or dark spots, skin swelling, blisters, and itching (generalized fixed bullous drug eruption).

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

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http;//www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Voltarén

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

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Voltarén

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

• The other components, 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 injections.

Appearance of Voltarén and contents of the pack

Clear, colourless or slightly yellow/yellowish solution supplied in colourless 3 ml ampoules.

Pack sizes 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 the most recent review of this leaflet: 10/2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/