Package leaflet: Information for the patient

Voltaren
25 mg/ml solution for injection or infusion concentrate
Diclofenacum natricum
Please read carefully the entire leaflet before using this medicine, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Voltaren is and what it is used for
Important information before using Voltaren
How to use Voltaren
Possible side effects
How to store Voltaren
Contents of the pack and other information

1. What Voltaren is and what it is used for
Voltaren contains sodium diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), with anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties.
The mechanism of action of Voltaren involves inhibition of prostaglandin biosynthesis, which plays a key role in the pathogenesis of inflammation, pain and fever.
Voltaren is indicated for the following conditions:
Intramuscular administration
Treatment of:

Acute exacerbations of inflammatory or degenerative rheumatic diseases: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spinal arthritis, pain syndromes associated with spinal changes, and extra-articular rheumatism.
Acute gout attacks.
Renal and hepatic colic.
Pain due to post-traumatic and postoperative inflammatory conditions and oedema.
Severe migraine attacks.

Intravenous administration:

For the treatment or prevention of postoperative pain in hospitalised patients.

Monitoring during Voltaren treatment
In patients with diagnosed heart disease or significant cardiovascular risk factors, the treating physician should periodically assess the need for symptomatic treatment and the patient's response to the medicine, especially if treatment lasts longer than 4 weeks.
Regular blood tests should be performed during treatment if there are any liver function disorders, kidney function disorders or blood abnormalities. Liver function (transaminase levels), kidney function (creatinine levels) and blood cell counts (white blood cells, red blood cells and platelets) should be monitored. The treating physician will consider blood test results when deciding whether to discontinue Voltaren treatment or adjust the dose.

2. Important information before using Voltaren

When not to use Voltaren:

if you are allergic to diclofenac, sodium metabisulfite or any of the other ingredients of this medicine (listed in section 6),
if you have ever experienced an allergic reaction after taking anti-inflammatory or analgesic medicines (e.g. acetylsalicylic acid, diclofenac or ibuprofen). Reactions may include asthma, rhinitis, skin rash, facial, lip, tongue, throat and/or limb swelling (symptoms of angioedema), breathing difficulties, chest pain or any other allergic-type reactions. If you think you may be allergic, you should consult your doctor,
if you have active or a history of peptic ulceration of the stomach and/or duodenum, bleeding or perforation; if you previously experienced stomach discomfort or heartburn after taking anti-inflammatory medicines,
if you are in the last trimester of pregnancy,
if you have hepatic insufficiency,
if you have renal insufficiency,
if you have heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischaemic attack (TIA) or arterial embolism in the heart or brain, or after revascularisation or bypass surgery,
if you have current or previous circulatory disorders (peripheral vascular disease).

Like other non-steroidal anti-inflammatory drugs (NSAIDs), Voltaren should not be used in individuals
in whom administration of acetylsalicylic acid or other prostaglandin synthesis inhibitors may
trigger an asthma attack, urticaria or acute rhinitis.
Do not administer to premature infants or newborns. The medicine may cause toxic and allergic
reactions in infants and children under 3 years of age.
Inform your doctor if any of the above conditions are present.
Warnings and precautions
Before using Voltaren, discuss with your doctor:

if you have diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormally elevated blood lipid levels (cholesterol, triglycerides) or if you are a smoker; if your doctor decides to prescribe Voltaren, the dose should not exceed 100 mg per day if treatment lasts longer than 4 weeks;
if the medicine is used in patients with a history of gastrointestinal ulceration or in elderly patients. Diclofenac use may cause gastrointestinal bleeding, ulceration or perforation (with potentially fatal outcome). This effect may be particularly dangerous when high doses of diclofenac are used. If any unusual abdominal symptoms (especially gastrointestinal bleeding) occur during Voltaren treatment, the medicine should be discontinued immediately and medical advice sought;
if you have ulcerative colitis or Crohn's disease; diclofenac may exacerbate the disease;
if you suffer from asthma, allergic rhinitis, nasal mucosal oedema (e.g. due to nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections, you are more likely to experience an allergic reaction to diclofenac (worsening of asthma symptoms, Quincke's oedema or urticaria). This warning also applies to patients allergic to other substances (e.g. those experiencing skin reactions, itching or urticaria). The medicine should be administered with particular caution (preferably under medical supervision);
if you have liver function disorders; diclofenac may worsen the course of the disease. Strictly follow your doctor's recommendations regarding periodic liver function tests;
if you suffer from hepatic porphyria; diclofenac may trigger an attack of porphyria.

Before taking diclofenac, inform your doctor

if you smoke,
if you have diabetes,
if you have angina pectoris, thrombosis, hypertension, elevated cholesterol or elevated triglycerides.

The risk of adverse effects can be reduced by using the lowest effective dose
and for the shortest duration necessary.
Use the lowest dose of Voltaren that relieves pain and (or) swelling, and use it for the shortest possible time to minimise the risk of adverse effects.
If at any time during Voltaren treatment you experience symptoms suggesting heart or blood vessel problems, such as chest pain, shortness of breath, weakness or slurred speech, seek immediate medical attention or go to the nearest emergency department.
Diclofenac use may, very rarely (especially at the beginning of treatment), cause life-threatening skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever and joint pain, or toxic epidermal necrolysis with skin and mucosal lesions, high fever and severe general condition. At the first signs of rash, mucosal changes or other allergic reaction symptoms, discontinue the medicine and contact your doctor.
Following intramuscular administration of Voltaren (a technique used to deliver the medicine deep into the muscle), local reactions at the injection site have been reported, including pain at the injection site, redness, swelling/hard nodule, ulceration, sometimes with bruising or pus formation, and skin and subcutaneous tissue necrosis (especially after incorrect administration into fatty tissue) – a phenomenon known as Nicolau syndrome.
The medicine may mask signs of infection (e.g. headache, elevated body temperature) and complicate accurate diagnosis. Inform your doctor about using this medicine during medical examinations.
Do not use Voltaren simultaneously with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors.
Inform your doctor or pharmacist if you have any of the above-mentioned conditions.
Taking medicines such as Voltaren 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. Do not use higher doses or longer treatment durations than recommended.
If you have heart problems, have had a stroke, or suspect you are at risk of these conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), discuss treatment options with your doctor or pharmacist.
The medicine may transiently inhibit platelet aggregation.
Before taking Voltaren, inform your doctor if you have recently undergone or are scheduled for surgery of the stomach or gastrointestinal tract, as Voltaren may sometimes impair intestinal wound healing after surgical procedures.
Children and adolescents
Use of Voltaren in ampoules is not recommended in children and adolescents due to the dosage.
Elderly patients (aged 65 years and above)
Elderly individuals may be more sensitive to the effects of the medicine than other adults. Follow the instructions in this leaflet, use the lowest effective dose as recommended by your doctor, and report any adverse effects occurring during treatment to your doctor.
Voltaren with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Especially inform your doctor if you are taking the following medicines:

Lithium or medicines belonging to the antidepressant group (selective serotonin reuptake inhibitors)
Digoxin – a medicine used in the treatment of heart diseases
Diuretics – medicines that increase urine output
Angiotensin-converting enzyme inhibitors, beta-blockers – groups of medicines used in the treatment of hypertension and heart failure
Non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid or ibuprofen) and corticosteroids (a group of medicines used to relieve inflammatory conditions in affected body areas)
Anticoagulants and platelet function inhibitors
Antidiabetic medicines, except insulin
Methotrexate – a medicine used in the treatment of certain cancers or arthritis
Cyclosporine and tacrolimus – medicines used in organ transplant recipients
Trimethoprim – a medicine used to prevent and treat urinary tract infections
Antibacterial quinolones and certain medicines used to treat infections
Colestipol and cholestyramine – medicines that lower blood cholesterol levels
Voriconazole – a medicine used to treat fungal infections
Phenytoin – a medicine used to treat epileptic seizures

Pregnancy, breastfeeding and fertility

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a child,
you should consult your 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 function disorders in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. Voltaren should not be used during the first 6 months of pregnancy unless your doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Voltaren may cause kidney function disorders in the unborn child if used for longer than a few days (this may lead to low amniotic fluid levels (oligohydramnios)) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment longer than a few days is required, your doctor may recommend additional monitoring.
Breastfeeding
Do not use Voltaren in breastfeeding women, as it may have harmful effects on the infant.
Your doctor will discuss with you the potential risks of using Voltaren during pregnancy and breastfeeding.
Fertility
Taking Voltaren may make it more difficult to become pregnant. If you are planning to become pregnant or have problems conceiving, inform your doctor.
Driving and operating machinery
The effect of Voltaren on the ability to drive, operate machinery or perform other tasks requiring special attention is unlikely.
Voltaren contains benzyl alcohol
The medicine contains 120 mg of benzyl alcohol per 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 adverse effects (so-called 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 adverse effects (so-called metabolic acidosis).
Voltaren contains propylene glycol
The medicine contains 600 mg of propylene glycol per ampoule (3 ml).
Pregnant or breastfeeding women should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.
Patients with impaired liver or kidney function should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.
Voltaren contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule (3 ml), meaning the medicine is considered "sodium-free".

3. How to use Voltaren

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Do not exceed the recommended doses.
The general recommendation is that the physician individually adjusts the dose for each patient and uses the lowest effective dose for the shortest possible duration.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Adults
Voltaren administered at a volume of one ampoule per day should not be used for longer than 2 days.
In certain cases, it may be administered at a volume of 2 ampoules per day. If necessary, treatment may be continued with tablets or suppositories.

Cardiovascular disease or significant cardiovascular risk factors
Patients with diagnosed cardiovascular disease or significant risk factors for cardiovascular events should only be treated with diclofenac after careful assessment and only at doses ≤100 mg per day if treatment lasts longer than 4 weeks.

Renal function disorders
Voltaren is contraindicated in patients with renal failure.
Specific studies have not been conducted in patients with renal function disorders; therefore, appropriate dose adjustment recommendations cannot be established. Caution is recommended when administering Voltaren to patients with mild to moderate renal impairment.

Hepatic function disorders
Voltaren is contraindicated in patients with hepatic failure.
Specific studies have not been conducted in patients with hepatic function disorders; therefore, appropriate dose adjustment recommendations cannot be established. Caution is recommended when administering Voltaren to patients with mild to moderate hepatic impairment.

How to use Voltaren

Intramuscular injection
To avoid nerve damage or other tissue injury at the injection site, follow the recommended injection procedures.
The usual dose is 75 mg – one ampoule per day – administered as a deep intramuscular injection into the upper outer quadrant of the buttock.
Exceptionally, in severe cases (e.g., acute colicky pain), the daily dose may be increased to two injections of 75 mg each, given several hours apart (one injection into each buttock). Alternatively, one 75 mg ampoule may be administered in combination with another formulation of Voltaren (tablets, suppositories), without exceeding a total daily dose of 150 mg.
Clinical experience with Voltaren in migraine attacks is limited to the administration of one ampoule containing 75 mg of sodium diclofenac as an initial dose, given as soon as possible, followed, if necessary, on the same day by suppositories up to a total dose of 100 mg. The total dose on the first day should not exceed 175 mg.

Intravenous infusion
Voltaren must not be administered as a single, rapid 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 intravenous infusion, mix 100 ml to 500 ml of 0.9% isotonic sodium chloride solution or 5% glucose solution with sodium bicarbonate for injection from a freshly opened vial (0.5 ml of 8.4% solution or 1 ml of 4.2% solution, or the appropriate volume of a solution with another concentration) immediately before use. Add the contents of one ampoule of Voltaren to the resulting solution. Only clear, transparent solutions free from insoluble particles should be used.

Two alternative methods of administering Voltaren in ampoules are recommended:
For the treatment of moderate to severe postoperative pain, 75 mg of the drug should be administered as a continuous infusion over 30 minutes to 2 hours. If necessary, administration may be repeated after several hours, but the total dose should not exceed 150 mg within 24 hours.
For prophylaxis of postoperative pain, an initial dose of 25 mg to 50 mg should be administered as an infusion over 15 minutes to 1 hour after completion of the surgical procedure, followed by continuous infusion of approximately 5 mg per hour, up to a maximum daily dose of 150 mg.

Use of a higher than recommended dose of Voltaren
Overdose with Voltaren does not typically produce characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures.
In cases of severe poisoning, acute renal failure and liver damage may occur.
If an amount greater than recommended is accidentally taken, contact a doctor, pharmacist, or go immediately to a hospital emergency department.

Missed dose of Voltaren
If a dose is missed, take it as soon as remembered. However, if more than half of the time interval between doses has passed, do not take the missed dose and take the next dose according to the original schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of adverse effects is estimated as follows:
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare
(≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (frequency cannot be determined from
available data).
The adverse effects listed below include those reported for Voltaren in ampoule form, as well as those observed during use of other formulations of diclofenac, administered either short- or long-term.

Adverse effects:
Common

headache, dizziness,
nausea, vomiting, diarrhoea, indigestion, abdominal pain, bloating, decreased appetite,
increased aminotransferase activity,
rash,
irritation, pain, hardening at the injection site.

Uncommon

myocardial infarction, heart failure, palpitations, chest pain.

Rare

hypersensitivity, anaphylactic and anaphylactoid reactions (including sudden drop in blood pressure and shock),
somnolence,
asthma (including breathlessness),
gastric mucosal inflammation, gastrointestinal bleeding, haematemesis, bloody diarrhoea, tarry stools,
peptic ulcer of the stomach and/or duodenum (with or without bleeding or perforation),
hepatitis, jaundice, liver function disorders,
urticaria,
oedema, tissue atrophy at the injection site.

Very rare

abscesses at the injection site,
thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count in peripheral blood), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (lack of granulocytes, a type of white blood cell),
angioedema (including facial swelling),
disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
paraesthesia, memory disturbances, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, stroke,
visual disturbances, blurred vision, double vision,
tinnitus, hearing disturbances,
hypertension, vasculitis,
pneumonia,
colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, oral mucosal inflammation (including ulcerative stomatitis), glossitis, oesophageal disorders, membranous stricture of the intestine, pancreatitis,
fulminant hepatitis, hepatic necrosis, liver failure,
blistering rash, exanthema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, Schönlein-Henoch disease, pruritus,
acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, necrosis of renal papillae.

Frequency not known

tissue damage at the injection site,
simultaneous occurrence of chest pain and allergic reactions (symptoms of Kounis syndrome),
Nicolau syndrome – characterised by immediate severe pain at the injection site, followed by redness, swelling, nodule formation, with possible vascular occlusion leading to destruction of skin and subcutaneous tissue.

Taking medicines such as Voltaren may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Some people may experience other adverse effects while taking Voltaren. If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.

If any of the following effects occur, stop taking Voltaren immediately and contact your doctor:

stomach discomfort, heartburn or upper abdominal pain,
vomiting blood, blood in stool, blood in urine,
skin reactions such as 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 legs,
severe migraine,
chest pain associated with cough,
mild but painful abdominal cramps and tenderness beginning shortly after starting Voltaren, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain (frequency not known – cannot be determined from available data),
chest pain which may be a sign of a potentially serious allergic reaction called Kounis syndrome,
injection site reactions, including pain, redness, swelling, hard lump, ulceration and bruising. This may lead to blackening and death of the skin and surrounding tissues at the injection site, healing with scarring, a condition also known as Nicolau syndrome.

Some adverse effects may be serious
These uncommon adverse effects may occur in 1 to 10 patients out of 1,000, especially
when high daily doses (150 mg) are used for a prolonged period

sudden, constricting chest pain (symptoms of myocardial infarction or heart attack),
breathlessness, difficulty breathing when lying down, swelling of ankles or legs (symptoms of heart failure).

If Voltaren is taken for longer than a few weeks, regular contact with a doctor is recommended to ensure that no adverse effects have occurred.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Voltaren

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

6. Contents of the pack and other information

What Voltaren contains

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

What Voltaren looks like and contents of the pack
One pack contains 5 ampoules of 3 ml each.
Marketing Authorisation Holder and Importer
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel. +48 22 37 54 888