Voltaren

Package Leaflet: Information for the Patient

Voltaren

25 mg/ml solution for injection or for preparing an infusion solution

Diclofenac sodium

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you; do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Voltaren and what is it used for
• 2. Important information before using Voltaren
• 3. How to use Voltaren
• 4. Possible side effects
• 5. How to store Voltaren
• 6. Contents of the package and other information

1. What is Voltaren and what is it used for

Voltaren contains diclofenac sodium, which belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs) with anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of Voltaren involves the inhibition of prostaglandin biosynthesis, which plays a crucial role in the pathogenesis of inflammation, pain, and fever. Voltaren is used in the following cases:

Intramuscular Administration

Treatment:

• Exacerbations of inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, psoriatic arthritis, spondyloarthritis, pain syndromes associated with spinal changes, and extra-articular rheumatism.
• Acute attacks of gout.
• Renal and hepatic colic.
• Pain caused by post-traumatic and post-operative inflammatory and edematous conditions.
• Severe migraine attacks.

Intravenous Administration:

• In the treatment or prevention of post-operative pain in patients undergoing hospital treatment.

Control Tests During Voltaren Treatment

In patients with diagnosed heart disease or significant risk factors for heart disease, the doctor will periodically assess the patient's need for symptomatic treatment and their response to the medicine, especially if treatment lasts longer than 4 weeks. During treatment, regular blood tests should be performed in case of any liver function disorders, kidney function disorders, or blood count abnormalities. Both liver function (transaminase levels), kidney function (creatinine levels), and blood cell count (white blood cell count, red blood cell count, and platelet count) should be monitored. The doctor will consider the results of the blood tests when deciding to discontinue Voltaren treatment or change the dose.

2. Important Information Before Using Voltaren

When Not to Use Voltaren:

• if the patient is allergic to diclofenac, sodium metabisulfite, or any other component of this medicine (listed in section 6),
• if the patient has ever had an allergic reaction after using anti-inflammatory or analgesic drugs (e.g., acetylsalicylic acid, diclofenac, or ibuprofen). Reactions may include asthma, rhinitis, skin rash, facial swelling, lip swelling, tongue swelling, throat swelling, and/or limb swelling (symptoms of angioedema), difficulty breathing, chest pain, or any other allergic reactions. If the patient thinks they may be allergic, they should consult their doctor,
• if the patient has active or a history of stomach or duodenal ulcers, bleeding, or perforation; if the patient has experienced discomfort in the stomach area or heartburn after taking anti-inflammatory drugs,
• if the patient is in the last trimester of pregnancy,
• if the patient has liver failure,
• if the patient has kidney failure,
• if the patient has heart disease or cerebrovascular disease (e.g., after a heart attack, stroke, transient ischemic attack, or vascular surgery),
• if the patient has circulatory disorders (peripheral vascular disease).

Like other non-steroidal anti-inflammatory drugs (NSAIDs), Voltaren should not be used in people who may experience asthma attacks, hives, or acute rhinitis after taking acetylsalicylic acid or other prostaglandin synthesis inhibitors. It should not be administered to premature infants or newborns. The medicine may cause toxic and allergic reactions in infants and children under 3 years of age. The patient should inform their doctor about these diseases.

Warnings and Precautions

Before using Voltaren, the patient should discuss the following with their doctor:

• if the patient has diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, elevated lipid levels (cholesterol, triglycerides), or if the patient is a smoker, and the doctor decides to prescribe Voltaren, the dose should not be increased above 100 mg per day if treatment lasts longer than 4 weeks;
• if the medicine is used in patients with a history of gastrointestinal ulcers or in the elderly. Diclofenac may cause gastrointestinal bleeding, ulcers, or perforation (with possible fatal outcome). This effect may be particularly dangerous when using high doses of diclofenac. If the patient experiences any unusual abdominal symptoms (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the doctor consulted;
• if the patient has ulcerative colitis or Crohn's disease; diclofenac may exacerbate the disease;
• if the patient has asthma, allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease, or chronic respiratory infections, they are more likely to experience an allergic reaction to diclofenac (exacerbation of asthma, angioedema, or hives). This warning also applies to patients allergic to other substances (e.g., those experiencing skin reactions, itching, or hives). The medicine should be administered with caution (preferably under medical supervision);
• if the patient has liver function disorders; diclofenac may worsen the disease. The patient should strictly follow the doctor's recommendations for monitoring liver function;
• if the patient has porphyria; diclofenac may trigger a porphyria attack.

Before taking diclofenac, the patient should inform their doctor

• if they smoke,
• if they have diabetes,
• if they have angina pectoris, thrombosis, hypertension, elevated cholesterol levels, or elevated triglyceride levels.

The occurrence of side effects can be minimized by using the smallest effective dose and not exceeding the recommended treatment duration. The patient should use the smallest dose of Voltaren that provides relief from pain and/or inflammation and use it for the shortest possible time to minimize the risk of side effects. If the patient experiences any symptoms suggesting cardiovascular or cerebrovascular disorders, such as chest pain, shortness of breath, weakness, or slurred speech, they should immediately contact their doctor or visit the emergency department. Taking diclofenac may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses. The patient should not exceed the recommended dose or duration of treatment. If they have heart problems, have had a stroke, or suspect they are at risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol levels, smoking), they should discuss their treatment with their doctor or pharmacist. The medicine may temporarily inhibit platelet aggregation. Before taking Voltaren, the patient should tell their doctor if they have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Voltaren may sometimes cause impaired wound healing in the intestines after surgery.

Children and Adolescents

Voltaren in ampoules is not recommended for children and adolescents due to the dose.

Elderly Patients (65 Years and Older)

Elderly patients may be more sensitive to the effects of the medicine than other adults. They should follow the recommendations in the package leaflet, use the smallest effective dose as recommended by their doctor, and report any side effects that occur during treatment to their doctor.

Voltaren and Other Medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The Patient Should Inform Their Doctor Especially About Taking the Following Medicines:

• Lithium or antidepressant medicines (selective serotonin reuptake inhibitors)
• Digoxin - a medicine used to treat heart conditions
• Diuretics - medicines that increase urine production
• Angiotensin-converting enzyme inhibitors, beta-blockers - groups of medicines used to treat hypertension and heart failure
• Non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen) and corticosteroids (groups of medicines used to alleviate inflammatory conditions)
• Anticoagulant and antiplatelet medicines
• Antidiabetic medicines (except insulin)
• Methotrexate - a medicine used to treat certain cancers or arthritis
• Cyclosporine and tacrolimus - medicines used in organ transplant patients
• Trimethoprim - a medicine used to prevent or treat urinary tract infections
• Quinolone antibiotics and some medicines used to treat infections
• Colestyramine and cholestyipol - medicines that lower cholesterol levels in the blood
• Voriconazole - a medicine used to treat fungal infections
• Phenytoin - a medicine used to treat epileptic seizures

Pregnancy, Breastfeeding, and Fertility

Pregnancy
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Do not take Voltaren if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Voltaren may cause kidney and heart disorders in the unborn child. It may also increase the risk of bleeding in the mother and child and prolong labor. During the first 6 months of pregnancy, do not use Voltaren unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the smallest effective dose for the shortest possible time. From the 20th week of pregnancy, Voltaren may cause kidney disorders in the unborn child if used for more than a few days (which may lead to low amniotic fluid levels around the baby or narrowing of the arterial duct in the baby's heart). If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Do not use Voltaren while breastfeeding, as it may harm the baby.
The doctor will discuss the potential risks of using Voltaren during pregnancy and breastfeeding with the patient.
Fertility
Taking Voltaren may make it harder to get pregnant. If the patient plans to get pregnant or is having trouble getting pregnant, they should tell their doctor.

Driving and Using Machines

The effect of Voltaren on the ability to drive and use machines is unlikely.

Voltaren Contains Benzyl Alcohol

The medicine contains 120 mg of benzyl alcohol in 1 ampoule (3 ml).
Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women should consult their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

Voltaren Contains Propylene Glycol

The medicine contains 600 mg of propylene glycol in 1 ampoule (3 ml).
Pregnant or breastfeeding women should not take this medicine without consulting their doctor. The doctor may decide to perform additional tests on these patients.
Patients with liver or kidney function disorders should not take this medicine without consulting their doctor. The doctor may decide to perform additional tests on these patients.

Voltaren Contains Sodium

The medicine contains less than 1 mmol (23 mg) of sodium in 1 ampoule (3 ml), which means the medicine is considered "sodium-free".

3. How to Use Voltaren

This medicine should always be used as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Do not exceed the recommended dose.
The general recommendation is for the doctor to adjust the dose individually for each patient and use the smallest effective dose for the shortest possible period.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Adults

Voltaren administered in a single ampoule per day should not be used for more than 2 days.
In some cases, it may be administered in a dose of 2 ampoules per day. If necessary, treatment can be continued with tablets or suppositories.

Diagnosed Cardiovascular Disease or Significant Cardiovascular Risk Factors

Patients with diagnosed cardiovascular disease or significant cardiovascular risk factors should be treated with diclofenac only after careful consideration and with doses not exceeding 100 mg per day if treatment lasts longer than 4 weeks.

Kidney Function Disorders

Voltaren is contraindicated in patients with kidney failure.
No special studies have been conducted in patients with kidney function disorders, so no specific dosage recommendations can be made. Caution is recommended when administering Voltaren to patients with mild to moderate kidney function disorders.

Liver Function Disorders

Voltaren is contraindicated in patients with liver failure.
No special studies have been conducted in patients with liver function disorders, so no specific dosage recommendations can be made. Caution is recommended when administering Voltaren to patients with mild to moderate liver function disorders.

How to Use Voltaren

Intramuscular Injection

To avoid nerve or tissue damage at the injection site, the patient should follow the injection instructions.
The medicine is usually administered in a dose of 75 mg - one ampoule per day, in a deep intramuscular injection into the upper outer quadrant of the buttock.
Exceptionally, in severe cases (e.g., renal colic), the daily dose may be increased to two injections of 75 mg, at intervals of several hours (one injection in each buttock). The patient can also receive one ampoule of 75 mg in combination with another form of Voltaren (tablets, suppositories), without exceeding a total dose of 150 mg per day.
Clinical experience with the use of Voltaren in migraine attacks is limited to the administration of 1 ampoule containing 75 mg of diclofenac sodium as soon as possible as the initial dose, and if necessary, the administration of suppositories in a dose of up to 100 mg on the same day. The total dose administered on the first day should not exceed 175 mg.

Intravenous Infusion

Voltaren should not be administered as a single intravenous bolus injection.
Immediately before starting the infusion, Voltaren should be diluted in 0.9% sodium chloride solution or 5% glucose solution for infusion, buffered with sodium bicarbonate.
Depending on the required duration of the intravenous infusion, 100 ml to 500 ml of 0.9% isotonic sodium chloride solution or 5% glucose solution should be mixed with the contents of one ampoule of Voltaren. Only clear solutions free from insoluble impurities should be used.
Two alternative methods of administering Voltaren in ampoules are recommended:
In the treatment of moderate to severe post-operative pain, 75 mg of the medicine is administered in a continuous infusion over 30 minutes to 2 hours. If necessary, administration can be repeated after several hours, but the dose should not exceed 150 mg in 24 hours.
In the prevention of post-operative pain, an initial dose of 25 mg to 50 mg is administered after the surgical procedure in an infusion over 15 minutes to 1 hour, followed by a continuous infusion of approximately 5 mg per hour, up to a maximum daily dose of 150 mg.

Using a Higher Than Recommended Dose of Voltaren

Overdose of Voltaren does not cause characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In cases of significant poisoning, acute kidney failure and liver damage may occur. If the patient has accidentally taken more medicine than recommended, they should immediately contact their doctor, pharmacist, or visit the emergency department.

Missing a Dose of Voltaren

If the patient misses a dose, they should take it as soon as they remember. However, if more than half of the time between two doses has passed, they should not take the missed dose and should take the next dose according to the previous dosing schedule. The patient should not take a double dose to make up for the missed dose.

4. Possible Side Effects

Like all medicines, Voltaren can cause side effects, although not everybody gets them. The frequency of side effects is estimated as follows: very common (≥1/10); common (≥1/100 to <1>

Side Effects:

Common

• headache, dizziness,
• nausea, vomiting, diarrhea, indigestion, abdominal pain, bloating, decreased appetite,
• increased transaminase activity,
• rash,
• irritation, pain, induration at the injection site.

Uncommon

• myocardial infarction, heart failure, palpitations, chest pain.

Rare

• hypersensitivity, anaphylactic and pseudo-anaphylactic reactions (including sudden drop in blood pressure and shock),
• drowsiness,
• asthma (including shortness of breath),
• gastritis, gastrointestinal bleeding, hematemesis, melena,
• peptic ulcer disease (with or without bleeding and perforation),
• hepatitis, jaundice, liver function disorders,
• urticaria,
• edema, atrophy at the injection site.

Very Rare

• abscesses at the injection site,
• thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), anemia (including hemolytic and aplastic anemia), agranulocytosis (decreased granulocyte count),
• angioedema (including facial edema),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
• paresthesia, memory disorders, seizures, anxiety, tremors, aseptic meningitis, taste disorders, cerebrovascular accident,
• visual disturbances, blurred vision, diplopia,
• tinnitus, hearing disorders,
• hypertension, vasculitis,
• pneumonitis,
• ulcerative colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal disorders, intestinal stricture, pancreatitis,
• fulminant hepatitis, liver necrosis, liver failure,
• bullous rash, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, Henoch-Schönlein purpura, pruritus,
• acute kidney failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Frequency Not Known

• tissue damage at the injection site,
• concomitant occurrence of chest pain and allergic reactions (symptoms of Kounis syndrome)
• Nicolau syndrome - observed with immediate severe pain at the injection site, followed by redness, swelling, induration, and ulceration, which may lead to skin and subcutaneous tissue necrosis, resulting in scarring, also known as Nicolau syndrome.

Taking medicines like Voltaren may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. If the patient experiences any of the following side effects, they should stop taking Voltaren and inform their doctor immediately: abdominal discomfort, heartburn, or stomach pain; vomiting blood, blood in stool, or black stools; skin rash or itching; wheezing or shortness of breath; yellowing of the skin or whites of the eyes; persistent sore throat or high fever; swelling of the face, feet, or ankles; severe headache; chest pain accompanied by coughing. Some side effects can be serious. These uncommon side effects may occur in 1-10 patients per 1,000, especially when using high daily doses (150 mg) for a long time.

• sudden, crushing chest pain (symptoms of myocardial infarction or heart attack).
• shortness of breath, difficulty breathing when lying down, swelling of the feet or ankles (symptoms of heart failure).

If the patient is taking Voltaren for more than a few weeks, they should regularly consult their doctor to ensure that no side effects have occurred.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to Store Voltaren

Keep out of the sight and reach of children.
Do not use this medicine after the expiration date stated on the carton.
Store below 30°C. Protect from light.

6. Contents of the Package and Other Information

What Voltaren Contains

• -The active substance of Voltaren is diclofenac sodium. One 3 ml ampoule of Voltaren contains 75 mg of diclofenac sodium.
• -The other ingredients are: mannitol, sodium metabisulfite, benzyl alcohol, propylene glycol, sodium hydroxide, water for injections.

What Voltaren Looks Like and Contents of the Package

One package contains 5 ampoules of 3 ml each.

Marketing Authorization Holder and Importer

Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel. +48 22 37 54 888

Date of Last Revision of the Package Leaflet: