Voltaren

Package leaflet: Information for the patient

Voltaren 50 mg enteric-coated tablets

sodium diclofenac
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Voltaren is and what it is used for

Voltaren contains the active substance sodium diclofenac, which belongs to the class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Sodium diclofenac is used to reduce pain and inflammation.
Voltaren is used to treat:

• joint diseases such as rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis
• conditions characterized by pain and inflammation affecting tissues surrounding the joints, such as tendons and ligaments (extra-articular rheumatism)
• pain due to non-rheumatic inflammation or trauma
• pain associated with menstruation

2. What you need to know before taking Voltaren

Do not take Voltaren

• if you are allergic (hypersensitive) to diclofenac or to any of the other ingredients of this medicine (listed in section 6)
• if you have ever had an allergic reaction after taking medicines used to treat inflammation, pain, or to reduce fever, such as acetylsalicylic acid (aspirin), diclofenac, or ibuprofen. Reactions may include: asthma, runny nose, skin redness, swelling of the face, lips, tongue, throat, and/or extremities (signs of angioedema), chest pain. If you think you may be allergic, consult your doctor
• if you have a stomach or intestinal ulcer, bleeding, or perforation
• if you currently have bleeding or are prone to bleeding
• if you have had bleeding (haemorrhage) or perforation of the stomach or intestine following previous treatment with NSAIDs
• if you have had recurrent stomach or duodenal ulcer or bleeding (two or more distinct episodes of proven ulceration or bleeding)
• if you have had liver problems
• if you have severe liver problems (hepatic insufficiency)
• if you have severe kidney problems (renal insufficiency)
• if you have established heart disease and/or cerebrovascular disease, e.g. if you have had a heart attack, stroke, mini-stroke (TIA), or blockage of blood vessels supplying the heart or brain, or undergone surgery to remove or prevent such blockages
• if you have a blood cell production disorder
• if you are taking high doses of medicines that increase urine production (diuretics) (see "Other medicines and Voltaren")
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”)
• if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”)
• if the patient is under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Voltaren.
Before taking Voltaren, 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
• if you have asthma
• if you have seasonal allergic rhinitis, nasal mucosa swelling (e.g. nasal polyps)
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
• if you have liver problems (e.g. hepatic insufficiency, hepatitis)
• if you have hepatic porphyria
• if you have ulcerative colitis or Crohn’s disease, as these conditions may worsen
• if you have kidney problems (e.g. renal insufficiency)
• if you are using medicines that increase urine production (diuretics) or other medicines that may affect kidney function
• if you have reduced body fluid volume (e.g. before or after major surgery)
• if you are undergoing or have recently undergone major surgery
• if you have blood clotting disorders (coagulation defects)
• if you have or have had high blood pressure, heart or brain problems (e.g. congestive heart failure, established heart disease, peripheral arterial disease, and/or stroke)
• if you have or have had stomach or intestinal problems (e.g. ulcer), or if you have had stomach or intestinal ulceration, bleeding, or perforation
• if you are taking medicines that may increase the risk of bleeding, ulceration, and perforation such as acetylsalicylic acid (e.g. aspirin) or other NSAIDs, corticosteroids taken by mouth, by injection, or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Voltaren”)
• if you have ever developed severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking Voltaren or other painkillers.

Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before taking Voltaren, as Voltaren may sometimes impair wound healing in the intestine following surgery.

Inform your doctor if, during treatment with Voltaren, you develop:

• skin reactions, even severe ones, because serious, potentially life-threatening skin reactions have been reported very rarely (see section 4 “Undesired effects”)
• fluid retention and swelling due to fluid accumulation (edema)
• any signs of an allergic reaction
• signs and symptoms of liver problems or if liver function test results are abnormal (as shown by blood tests)
• unusual stomach or intestinal symptoms, especially at the beginning of treatment with Voltaren, as they may indicate gastrointestinal bleeding or ulceration
• signs and symptoms typical of serious atherothrombotic events such as chest pain, shortness of breath, weakness, and difficulty speaking.

In such cases, your doctor will assess whether treatment with Voltaren should continue or be stopped.
Also pay particular attention:

• At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulceration, or perforation may occur, which can be fatal. Your doctor will prescribe the lowest effective dose of diclofenac to reduce the risk of gastrointestinal toxicity and may also prescribe medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
• If you are elderly, especially if you are frail and underweight, your doctor will prescribe a low dose of Voltaren
• Undesired effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 “How to take Voltaren”)
• Avoid using diclofenac during treatment with other NSAIDs taken orally, by injection, or rectally, including selective cyclooxygenase-2 inhibitors, as this increases the likelihood of undesired effects
• Voltaren may mask the signs and symptoms of infection.
• Medicines like Voltaren may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses or prolonged treatment.

Your doctor will monitor you closely and periodically reassess the need for treatment with Voltaren. In addition, your doctor may arrange periodic tests to monitor your condition during treatment with Voltaren.
Children and adolescents
Voltaren must not be used in children and adolescents under 14 years of age.
Elderly patients
Elderly patients have a higher likelihood of experiencing adverse reactions, particularly stomach or intestinal bleeding and perforation, which are usually more severe and can be fatal.
If you are elderly, especially if you are frail and underweight, your doctor will prescribe a low dose of Voltaren.
As a precaution, your doctor may monitor your kidney function and prescribe medicines that protect the gastrointestinal mucosa, such as misoprostol or proton pump inhibitors.
Inform your doctor of any unusual stomach or intestinal symptoms, especially at the beginning of treatment with this medicine.
Other medicines and Voltaren
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The blood concentration of the following medicines may increase when used together with Voltaren:

• lithium
• digoxin
• methotrexate
• phenytoin. Your doctor will perform tests to monitor blood levels of these medicines.

The effect of some medicines used to lower blood pressure, such as:

• medicines that increase urine production (diuretics)
• beta-blockers
• angiotensin-converting enzyme inhibitors (ACE inhibitors) may decrease when used together with Voltaren.

Your doctor will monitor you and carefully consider the administration of these medicines together with Voltaren, especially if you are elderly.
Pay particular attention and inform your doctor if you need to take Voltaren while already taking one or more of the following medicines.
Your doctor will monitor you and arrange tests.

• medicines to lower blood pressure or ACE inhibitors and angiotensin II antagonists, if you have kidney problems, or potassium-sparing diuretics (e.g. spironolactone)
• other anti-inflammatory medicines (non-steroidal anti-inflammatory drugs and corticosteroids)
• medicines to thin the blood (anticoagulants or antiplatelet agents)
• serotonin reuptake inhibitors (antidepressants)
• medicines for diabetes
• cyclosporine and tacrolimus (immunosuppressants used to modify the body’s immune system response)
• trimethoprim (an antibiotic)
• medicines for bacterial infections of the quinolone class
• colestipol and cholestyramine, as they may delay or reduce the absorption of diclofenac. Your doctor will advise when to take these medicines; usually diclofenac should be taken 1 hour before or 4–6 hours after colestipol and cholestyramine
• rifampicin (an antibiotic used to treat bacterial infections), as it may reduce diclofenac absorption
• other medicines that may increase diclofenac blood concentration, e.g. sulfinpyrazone (a medicine used to treat gout) and voriconazole (a medicine used to treat fungal infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Voltaren must not be used during the first and second trimesters of pregnancy unless clearly necessary. If you plan to become pregnant, or are in the first or second trimester of pregnancy and need to use Voltaren, your doctor will prescribe the lowest dose of diclofenac for the shortest possible time.
Do not take Voltaren during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby’s tendency to bleed and delay or prolong labour more than expected.
You should not take Voltaren during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From the 20th week of pregnancy, Voltaren may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.
Breastfeeding
Voltaren must not be used during breastfeeding to avoid adverse effects on the newborn.
Fertility
As with other NSAIDs, Voltaren is not recommended for women who are trying to conceive, as this medicine may impair female fertility. Your doctor will assess whether treatment with Voltaren should be discontinued if you have difficulty becoming pregnant or are undergoing fertility investigations.
Driving and using machines
Voltaren may cause visual disturbances, dizziness, vertigo, drowsiness, or other disturbances that may affect your ability to drive or operate machinery.
If you experience these symptoms, avoid driving or operating machinery.
Voltaren contains lactose and hydrogenated polyoxyl 40 castor oil
The gastro-resistant tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
The gastro-resistant tablets contain hydrogenated polyoxyl 40 castor oil, which may cause gastrointestinal disturbances and diarrhoea.

3. How to take Voltaren

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Voltaren tablets should be taken whole with a glass of liquid. Do not crush, split or chew them.
Use in adults
Initial therapy: the recommended dose is 100–150 mg daily.
For mild conditions or long-term treatment, the recommended dose is 75–100 mg daily.
The dose should be divided into 2–3 doses taken throughout the day.
Your doctor will tell you how much Voltaren to take and for how long.
Treatment of pain associated with menstruation (dysmenorrhoea)
The recommended dose is 50–150 mg daily, but should be adjusted individually for each patient.
Your doctor will initially prescribe 50–100 mg daily and, if necessary, may advise increasing the dose
during subsequent menstrual cycles, up to a maximum of 150 mg daily.
Start treatment when the first symptoms appear and continue for a few days, depending on your
symptoms.
Treatment of night-time pain and morning stiffness
Voltaren is also available as suppositories. In addition to Voltaren tablets taken during the day,
you may use a suppository before going to bed.
Do not exceed the maximum daily dose of 150 mg.
Use in children and adolescents
Voltaren must not be used in children and adolescents under 14 years of age.
Use in the elderly
In elderly patients, a dose reduction of diclofenac may be necessary. Your doctor will tell you how much
Voltaren you should take.
If you take more Voltaren than you should
If you accidentally take too much Voltaren, contact your doctor immediately or go to the nearest
hospital.
If you take an excessive dose of Voltaren, you may experience vomiting, stomach or intestinal
bleeding, diarrhoea, dizziness, ringing or buzzing in the ears, or seizures. In more severe cases, serious
kidney or liver damage may also occur.
Your doctor will treat acute poisoning caused by non-steroidal anti-inflammatory drugs, including
diclofenac, based on the symptoms you have.
If you forget to take Voltaren
Do not take a double dose to make up for a forgotten dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects may be serious.
Stop taking Voltaren and contact your doctor immediately if you experience:

• Mild abdominal cramps and tenderness occurring shortly after starting treatment with Voltaren, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).
• A severe skin allergic reaction which may include widespread red and/or dark patches, skin swelling, blisters, and itching (Fixed drug eruption with generalised bullous rash).

Common side effects (may affect up to 1 in 10 people)

• Headache, dizziness
• Vertigo
• Nausea, vomiting
• Diarrhoea, passing gas (flatulence)
• Indigestion (dyspepsia), abdominal pain
• Loss of appetite
• Abnormal blood test results (increase in certain liver enzymes: transaminases)
• Skin rash

Uncommon side effects (may affect up to 1 in 100 people)

• Awareness of your heartbeat (palpitations), chest pain, heart problems (heart failure), heart attack

Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reactions, severe and rapidly occurring allergic reactions (anaphylaxis), including hypotension and collapse (shock)
• Drowsiness
• Asthma, difficulty in breathing (dyspnoea)
• Inflammation of the stomach (gastritis), bleeding from the stomach or intestines, vomiting blood, stomach or intestinal ulcer with or without bleeding and perforation
• Blood in the stools
• Inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders
• Urticaria
• Oedema (swelling due to fluid accumulation). If you experience any of these effects, inform your doctor immediately.

Very rare side effects (may affect up to 1 in 10,000 people)

• Abnormal blood test results or low platelet count (thrombocytopenia), reduced number of white blood cells (leucopenia), reduced number of red blood cells (anaemia, including haemolytic and aplastic anaemia), low granulocyte count (agranulocytosis)
• Abnormal urine test results, blood in the urine (haematuria), protein in the urine (proteinuria)
• Allergic reaction with rapid swelling of the skin and mucous membranes (angioneurotic oedema), including facial oedema
• Disorientation, depression, insomnia, nightmares, irritability, severe mental disturbances (psychotic reactions)
• Memory impairment, seizures, anxiety, tremors
• Tingling sensations (paraesthesia)
• Taste disturbances
• Inflammation of the membranes covering the brain (aseptic meningitis), stroke
• Vision disorders, blurred vision, double vision
• Ringing or buzzing in the ears (tinnitus), worsening of hearing
• High blood pressure, inflammation of blood vessels (vasculitis)
• Pneumonitis
• Inflammation of the colon (colitis), including colitis with bleeding, worsening of ulcerative colitis or Crohn’s disease
• Constipation
• Inflammation of the mouth mucosa (stomatitis), including stomatitis with ulcers, inflammation of the tongue (glossitis)
• Problems with the oesophagus, narrowing of the intestine
• Inflammation of the pancreas (pancreatitis)
• A very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (hepatic failure)
• Skin reactions ranging from mild (bullous eruptions, eczema, erythema) to potentially fatal (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), exfoliative dermatitis)
• Appearance of red-brown spots on the skin (purpura), also as an allergic reaction
• Itching
• Hair loss
• Increased skin sensitivity to sunlight
• Kidney problems such as acute renal failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis

Side effects with frequency not known (frequency cannot be estimated from available data)

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
• A skin allergic reaction, which may include round or oval red and swollen patches, blistering rash, and itching (Drug eruption with fixed lesions). Darkening of the skin in the affected areas may also occur, which could persist after healing. A drug eruption with fixed lesions usually recurs at the same site (or sites) if the medicine is taken again.

Medicines such as Voltaren may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (see section “Warnings and precautions” above).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Voltaren

Store below 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Voltaren contains

• The active substance is sodium diclofenac. Each tablet contains 50 mg of sodium diclofenac.
• The other components are: maize starch, magnesium stearate, anhydrous colloidal silica, lactose monohydrate, microcrystalline cellulose, povidone, sodium carboxymethylstarch A, talc,

hypromellose, polyoxyl 35 hydrogenated castor oil, red iron oxide, yellow iron oxide,
titanium dioxide, 30% polyacrylate dispersion (copolymer), macrogols, silicone antifoaming emulsion.
Description of the appearance of Voltaren and contents of the pack
Each pack contains 30 gastro-resistant tablets for oral use.
Marketing Authorization Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milan MI
Italy
Manufacturer
Novartis Farma S.p.A
Via Provinciale Schito 131
80058 Torre Annunziata - NA
Italy
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milan MI
Italy
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Package leaflet: information for the patient

Voltaren 100 mg prolonged-release tablets, 75 mg prolonged-release tablets

sodium diclofenac
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Voltaren is and what it is used for

Voltaren contains the active substance sodium diclofenac, which belongs to the class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Sodium diclofenac is used to reduce pain and inflammation.
Voltaren is used to treat:

• joint diseases such as rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis
• conditions characterized by pain and inflammation affecting the tissues surrounding the joints, such as tendons and ligaments (extra-articular rheumatism)
• pain due to non-rheumatic inflammation or trauma
• pain associated with menstruation

2. What you should know before taking Voltaren

Do not take Voltaren

• if you are allergic (hypersensitive) to diclofenac or to any of the other ingredients of this medicine listed at the end of this leaflet
• if you have ever had an allergic reaction after taking medicines used to treat inflammation, pain, or fever, such as acetylsalicylic acid (aspirin), diclofenac, or ibuprofen. Reactions may include: asthma, runny nose, skin redness, swelling of the face, lips, tongue, throat, and/or extremities (signs of angioedema), chest pain. If you think you may be allergic, consult your doctor.
• if you have a stomach or intestinal ulcer, bleeding, or perforation
• if you currently have bleeding or a tendency to bleed
• if you have had bleeding (haemorrhage) or perforation of the stomach or intestine following previous treatment with NSAIDs
• if you have had recurrent bleeding/ulceration of the stomach or duodenum (two or more distinct episodes of proven ulceration or bleeding)
• if you have had liver problems
• if you have severe liver problems (hepatic insufficiency)
• if you have severe kidney problems (renal insufficiency)
• if you have established heart disease and/or cerebrovascular disease, e.g. you have had a heart attack, stroke, mini-stroke (TIA), or blockage of blood vessels supplying the heart or brain, or undergone surgery to remove or prevent such blockages
• if you have a blood cell production disorder
• if you are taking high doses of medicines that increase urine production (diuretics) (see "Other medicines and Voltaren")
• if you are in the third trimester of pregnancy (see section "Pregnancy, breastfeeding and fertility")
• if you are breastfeeding (see section "Pregnancy, breastfeeding and fertility")
• if the patient is under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Voltaren.
Before taking Voltaren, 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
• if you have asthma
• if you have seasonal allergic rhinitis, swelling of the nasal mucosa (e.g. nasal polyps)
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
• if you have liver problems (e.g. hepatic insufficiency, hepatitis)
• if you have hepatic porphyria
• if you have ulcerative colitis or Crohn’s disease, as these conditions may worsen
• if you have kidney problems (e.g. renal insufficiency)
• if you are using medicines that increase urine production (diuretics) or other medicines that may affect kidney function
• if you have reduced body fluid volume (e.g. before or after major surgery)
• if you are undergoing or have recently undergone major surgery
• if you have blood clotting disorders (haemostasis defects)
• if you have or have had high blood pressure, heart or brain problems (e.g. congestive heart failure, established heart disease, peripheral arterial disease, and/or stroke)
• if you have or have had stomach or intestinal problems (e.g. ulcer), or if you have had stomach or intestinal ulcers, bleeding, or perforation
• if you are taking medicines that may increase the risk of bleeding, ulceration, and perforation, such as acetylsalicylic acid (e.g. aspirin) or other NSAIDs, oral, injectable, or rectal corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Voltaren”)
• if you have ever developed severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking Voltaren or other analgesics.

Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before taking Voltaren, as Voltaren may occasionally impair wound healing in the intestine after surgery.

Inform your doctor if, during treatment with Voltaren, you develop:

• skin reactions, even severe ones, as very rare but serious and potentially fatal skin reactions have been reported (see section 4 “Undesired effects”)
• fluid retention and swelling due to fluid accumulation (oedema)
• any signs of allergic reaction
• signs and symptoms of liver problems or if liver function tests are abnormal (as shown by blood tests)
• unusual stomach or intestinal symptoms, especially at the beginning of treatment with Voltaren, as these could be signs of gastrointestinal bleeding or ulceration
• signs and symptoms typical of serious atherothrombotic events such as chest pain, shortness of breath, weakness, and difficulty speaking.

In these cases, your doctor will assess whether to continue or discontinue treatment with Voltaren.
Also pay particular attention:

• At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulceration, or perforation may occur, which can be fatal. Your doctor will prescribe the lowest effective dose of diclofenac to reduce the risk of gastrointestinal toxicity and may also prescribe protective medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
• If you are elderly, especially if frail and underweight, your doctor will prescribe a low dose of Voltaren
• Undesired effects can be minimized by using the lowest effective dose for the shortest possible duration (see section 3 “How to take Voltaren”)
• Avoid using diclofenac during treatment with other NSAIDs taken orally, by injection, or rectally, including selective COX-2 inhibitors, as this increases the likelihood of adverse effects
• Voltaren may mask the signs and symptoms of infection
• Medicines such as Voltaren may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with higher doses or prolonged treatment.

Your doctor will closely monitor you and periodically reassess the need for continued treatment with Voltaren. Additionally, your doctor may perform periodic tests to evaluate your condition during treatment with Voltaren.
Children and adolescents
Voltaren must not be used in children and adolescents under 14 years of age.
Elderly patients
Elderly patients have a higher likelihood of experiencing adverse reactions, particularly stomach or intestinal bleeding and perforation, which are generally more severe and may be fatal.
If you are elderly, especially if frail and underweight, your doctor will prescribe a low dose of Voltaren.
As a precaution, your doctor may monitor your kidney function and prescribe medicines that protect the gastrointestinal mucosa, such as misoprostol or proton pump inhibitors.
Inform your doctor of any unusual stomach or intestinal symptoms, especially at the beginning of treatment with this medicine.
Other medicines and Voltaren
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The blood concentration of the following medicines may increase when used together with Voltaren:

• lithium
• digoxin
• methotrexate
• phenytoin. Your doctor may monitor blood levels of these medicines.

The effect of some medicines used to lower blood pressure, such as:

• medicines that increase urine production (diuretics)
• beta-blockers
• angiotensin-converting enzyme (ACE) inhibitors may decrease when used together with Voltaren.

Your doctor will monitor you and carefully consider co-administration of these medicines with Voltaren, especially if you are elderly.
Pay particular attention and inform your doctor if you need to take Voltaren while already taking one or more of the following medicines.
Your doctor will monitor you and may perform tests.

• blood pressure-lowering medicines or ACE inhibitors and angiotensin II antagonists, if you have kidney problems, or potassium-sparing diuretics (e.g. spironolactone)
• other anti-inflammatory medicines (non-steroidal anti-inflammatory drugs and corticosteroids)
• blood-thinning medicines (anticoagulants or antiplatelets)
• serotonin reuptake inhibitors (antidepressants)
• diabetes medicines
• cyclosporine and tacrolimus (immunosuppressants used to modify the body’s immune response)
• trimethoprim (an antibiotic)
• medicines for bacterial infections in the quinolone class
• colestipol and cholestyramine, as they may delay or reduce diclofenac absorption. Your doctor will advise when to take these medicines; generally, diclofenac should be taken 1 hour before or 4–6 hours after colestipol or cholestyramine
• rifampicin (an antibiotic used to treat bacterial infections), as it may reduce diclofenac absorption
• other medicines that may increase diclofenac blood concentration, e.g. sulfinpyrazone (a medicine used to treat gout) and voriconazole (a medicine used to treat fungal infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Voltaren must not be used during the first and second trimesters of pregnancy unless strictly necessary. If you wish to become pregnant or are in the first or second trimester of pregnancy and need to use Voltaren, your doctor will prescribe the lowest dose of diclofenac for the shortest possible time.
Do not take Voltaren during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby’s tendency to bleed and delay or prolong labour beyond the expected time.
You should not take Voltaren during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From the 20th week of pregnancy, Voltaren may cause kidney problems in the fetus if taken for more than a few days, thereby reducing levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Voltaren must not be used during breastfeeding to avoid adverse effects on the newborn.
Fertility
As with other NSAIDs, Voltaren is not recommended for women who are trying to become pregnant, as this medicine may impair female fertility. Your doctor will assess whether treatment with Voltaren should be discontinued if you experience difficulty becoming pregnant or require fertility testing.
Driving and using machines
Voltaren may cause visual disturbances, dizziness, vertigo, drowsiness, or other disturbances that may affect your ability to drive or operate machinery.
If you experience these symptoms, avoid driving or operating machinery.
Voltaren contains sucrose
The prolonged-release tablets contain sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Voltaren

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The prolonged-release tablets of Voltaren must be taken whole with some liquid, preferably during meals. Prolonged-release tablets must not be crushed, divided or chewed.

Use in adults
The recommended initial dose is 100–150 mg per day (1 prolonged-release tablet of 100 mg or 2 prolonged-release tablets of 75 mg).
In mild cases and for long-term therapy, the recommended dose is 75–100 mg per day.
Your doctor will tell you how much Voltaren to take and for how long.
If symptoms are more severe at night or in the morning, take the prolonged-release tablets of Voltaren preferably in the evening.

Use in children and adolescents
Voltaren must not be used in children and adolescents under 14 years of age.

Use in the elderly
A reduced dose of diclofenac may be necessary in the elderly. Your doctor will tell you how much Voltaren you should take.

If you take more Voltaren than you should
If you accidentally take an excessive dose of Voltaren, contact your doctor immediately or go to the nearest hospital.
If you take too much Voltaren, you may experience vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus (ringing in the ears), or seizures. In more severe cases, serious kidney and liver damage may also occur.
Your doctor will treat acute poisoning from non-steroidal anti-inflammatory drugs, including diclofenac, based on the symptoms you present.

If you forget to take Voltaren
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects may be serious.
Stop taking Voltaren and contact your doctor immediately if you notice:

• Mild abdominal cramps and tenderness occurring shortly after starting treatment with Voltaren, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).
• A severe skin allergic reaction that may include widespread red and/or dark patches, skin swelling, blisters, and itching (Fixed generalized bullous eruption due to drugs).

Common side effects (may affect up to 1 in 10 people)

• Headache, dizziness
• Vertigo
• Nausea, vomiting
• Diarrhoea, passing gas (flatulence)
• Digestive problems (dyspepsia), abdominal pain
• Loss of appetite
• Abnormal results in blood tests (increase in certain liver enzymes: transaminases)
• Skin rash

Uncommon side effects (may affect up to 1 in 100 people)

• Awareness of your heartbeat (palpitations), chest pain, heart problems (heart failure), heart attack

Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reactions, severe and rapidly occurring allergic reactions (anaphylaxis) including low blood pressure and collapse (shock)
• Drowsiness
• Asthma, difficulty breathing (dyspnoea)
• Inflammation of the stomach (gastritis), bleeding from the stomach or intestine, vomiting blood, stomach or intestinal ulcer with or without bleeding and perforation
• Blood in the stools
• Inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes, and eyes (jaundice), liver disorders
• Urticaria
• Oedema (swelling due to fluid accumulation). If you experience any of these side effects, inform your doctor immediately.

Very rare side effects (may affect up to 1 in 10,000 people)

• Abnormal results in blood tests or low platelet count (thrombocytopenia) or reduced white blood cell count (leukopenia) or reduced red blood cell count (anaemia, including haemolytic and aplastic anaemia) or low granulocyte count (agranulocytosis)
• Abnormal results in urine tests or presence of blood in the urine (haematuria) or presence of protein in the urine (proteinuria)
• Allergic reaction with rapid swelling of the skin and mucous membranes (angioneurotic oedema), including facial oedema
• Disorientation, depression, insomnia, nightmares, irritability, severe mental disturbances (psychotic reactions)
• Memory impairment, seizures, anxiety, tremors
• Tingling sensations (paraesthesia)
• Taste disturbances
• Inflammation of the membranes covering the brain (aseptic meningitis), stroke
• Vision disorders, blurred vision, double vision
• Ringing or buzzing in the ears, worsening of hearing
• High blood pressure, inflammation of blood vessels (vasculitis)
• Pneumonia
• Inflammation of the colon (colitis), including colitis with bleeding, and worsening of ulcerative colitis or Crohn’s disease
• Constipation
• Inflammation of the mouth lining (stomatitis), including stomatitis with ulcers, inflammation of the tongue (glossitis)
• Problems with the oesophagus, narrowing of the intestine
• Inflammation of the pancreas (pancreatitis)
• A very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (hepatic failure)
• Skin reactions ranging from mild (bullous eruptions, eczema, erythema) to potentially fatal (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), exfoliative dermatitis)
• Appearance of red-brown spots on the skin (purpura), possibly as an allergic reaction
• Itching
• Hair loss
• Skin sensitivity to sunlight
• Kidney problems such as acute kidney failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Side effects with frequency not known (frequency cannot be estimated from available data)

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
• A skin allergic reaction, which may include round or oval red and swollen skin patches, skin rash with blisters, and itching (Drug-induced fixed eruption). Darkening of the skin in affected areas may also occur, which could persist after healing. A drug-induced fixed eruption usually recurs at the same site (or sites) if the medicine is taken again.

Medicines such as Voltaren may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (see section “Warnings and precautions” above).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Voltaren

Voltaren 100 mg prolonged-release tablets
This medicine does not require any special storage conditions.
Voltaren 75 mg prolonged-release tablets
Store below 30°C. Keep the blister in the outer packaging to protect the medicine from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Voltaren contains
Voltaren 100 mg prolonged-release tablets

• The active substance is sodium diclofenac. Each prolonged-release tablet contains 100 mg of sodium diclofenac.
• The other components are: anhydrous colloidal silica, cetyl alcohol, magnesium stearate, povidone, sucrose, hypromellose, red iron oxide, polysorbate 80, talc, titanium dioxide.

Voltaren 75 mg prolonged-release tablets

• The active substance is sodium diclofenac. Each prolonged-release tablet contains 75 mg of sodium diclofenac.
• The other components are: sucrose, anhydrous colloidal silica, povidone, magnesium stearate, cetyl alcohol, hypromellose, polysorbate 80, titanium dioxide, red iron oxide, talc.

Description of the appearance of Voltaren and contents of the pack
Each pack contains 21 prolonged-release tablets for oral use of 100 mg.
Each pack contains 30 prolonged-release tablets for oral use of 75 mg.
Marketing Authorization Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milan MI
Italy
Manufacturer
Novartis Farma S.p.A
Via Provinciale Schito 131
80058 Torre Annunziata - NA
Italy
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milan MI
Italy
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Patient Information Leaflet

Voltaren 100 mg suppositories

diclofenac sodium
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Voltaren is and what it is used for

Voltaren contains the active substance sodium diclofenac, which belongs to the class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Sodium diclofenac is used to reduce pain and inflammation.
Voltaren is used to treat:

• joint diseases such as rheumatoid arthritis, ankylosing spondylitis and osteoarthritis
• conditions characterized by pain and inflammation in the tissues surrounding the joints, such as tendons and ligaments (extra-articular rheumatism)
• pain due to non-rheumatic inflammation or trauma
• pain associated with menstruation

2. What you should know before taking Voltaren

Do not take Voltaren

• if you are allergic (hypersensitive) to diclofenac or to any of the other ingredients of this medicine (listed in section 6)
• if you have ever had an allergic reaction after taking medicines used to treat inflammation, pain or fever, such as acetylsalicylic acid (aspirin), diclofenac or ibuprofen. Reactions may include: asthma, runny nose, skin redness, swelling of the face, lips, tongue, throat and/or extremities (signs of angioedema), chest pain. If you think you may be allergic, consult your doctor. if you have a stomach or intestinal ulcer, bleeding or perforation
• if you currently have bleeding or are prone to bleeding
• if you have had bleeding (haemorrhage) or perforation of the stomach or intestine due to previous treatment with NSAIDs
• if you have had recurrent stomach or duodenal ulcer or bleeding (two or more distinct episodes of proven ulceration or bleeding)
• if you have had liver problems
• if you have severe liver problems (hepatic failure)
• if you have severe kidney problems (renal failure)
• if you have established heart disease and/or cerebrovascular disease, e.g. you have had a heart attack, stroke, mini-stroke (TIA), or blockage of blood vessels supplying the heart or brain, or surgery to remove or prevent such blockages
• if you have a blood cell production disorder
• if you are taking high doses of medicines that increase urine production (diuretics) (see “Other medicines and Voltaren”)
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”)
• if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”)
• if you have haemorrhoids or have recently had inflammation of the rectum (proctitis)
• if the patient is a child or adolescent.

Warnings and precautions
Talk to your doctor or pharmacist before taking Voltaren.
Before taking Voltaren, 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
• if you have asthma
• if you have seasonal allergic rhinitis, swelling of the nasal mucosa (e.g. nasal polyps)
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
• if you have liver problems (e.g. hepatic failure, hepatitis)
• if you have hepatic porphyria
• if you have ulcerative colitis or Crohn’s disease, as these conditions may worsen
• if you have kidney problems (e.g. renal failure)
• if you are taking medicines that increase urine production (diuretics) or other medicines that may affect kidney function
• if you have reduced body fluid volume (e.g. before or after major surgery)
• if you are undergoing or have recently undergone major surgery
• if you have blood clotting disorders (coagulation defects)
• if you have or have had high blood pressure, heart or brain problems (e.g. congestive heart failure, established heart disease, peripheral arterial disease and/or stroke)
• if you have or have had stomach or intestinal problems (e.g. ulcer), or if you have had stomach or intestinal ulceration, bleeding or perforation
• if you are taking medicines that may increase the risk of bleeding, ulceration and perforation, such as acetylsalicylic acid (e.g. aspirin) or other NSAIDs, corticosteroids taken orally, by injection or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Voltaren”)
• if you have ever developed severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking Voltaren or other analgesics.

Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before taking Voltaren, as Voltaren may sometimes impair wound healing in the intestine following surgery.

Inform your doctor if, during treatment with Voltaren, you develop:

• skin reactions, even severe ones, as very rare serious skin reactions, which may be life-threatening, have been reported (see section 4 “Undesired effects”)
• fluid retention and swelling due to fluid accumulation (oedema)
• any signs of allergic reaction
• signs and symptoms of liver problems or if liver function tests are abnormal (as shown by blood tests)
• unusual stomach or intestinal symptoms, especially at the beginning of treatment with Voltaren, as they may indicate gastrointestinal bleeding or ulceration
• signs and symptoms typical of serious atherothrombotic events such as chest pain, shortness of breath, weakness and difficulty speaking.

In these cases, your doctor will assess whether to continue or discontinue treatment with Voltaren.
Also pay particular attention:

• At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulceration or perforation may occur, which can be fatal. Your doctor will prescribe the lowest effective dose of diclofenac to reduce the risk of gastrointestinal toxicity and may also prescribe medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
• If you are elderly, especially if you are frail and underweight, your doctor will prescribe a low dose of Voltaren
• Undesired effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 “How to take Voltaren”)
• Avoid using diclofenac during treatment with other NSAIDs taken orally, by injection or rectally, including selective cyclooxygenase-2 inhibitors, as this increases the likelihood of adverse effects
• Voltaren may mask signs and symptoms of infection. Medicines like Voltaren may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses or prolonged treatment.

Your doctor will monitor you closely and periodically reassess the need for treatment with
Voltaren. In addition, your doctor may carry out periodic tests to monitor your condition
during treatment with Voltaren.
Children and adolescents
Voltaren must not be used in children and adolescents.
Elderly patients
Elderly patients have a higher likelihood of experiencing adverse reactions, particularly
gastrointestinal bleeding and perforation, which are generally more severe and may
be fatal.
If you are elderly, especially if you are frail and underweight, your doctor will prescribe a low dose of
Voltaren.
As a precaution, your doctor may monitor your kidney function and prescribe medicines that protect the gastrointestinal mucosa, such as misoprostol or
proton pump inhibitors.
Inform your doctor of any unusual stomach or intestinal symptoms, especially at the beginning of
treatment with this medicine.
Other medicines and Voltaren
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The blood concentration of the following medicines may increase when used together with
Voltaren:

• lithium
• digoxin
• methotrexate
• phenytoin. Your doctor will perform checks to monitor blood levels of these medicines.

The effect of some medicines used to lower blood pressure, such as:

• medicines that increase urine production (diuretics)
• beta-blockers
• angiotensin-converting enzyme (ACE) inhibitors may decrease when used together with Voltaren.

Your doctor will monitor you and carefully evaluate the administration of these medicines
with Voltaren, especially if you are elderly.
Pay particular attention and inform your doctor if you need to take Voltaren while already taking one or
more of the following medicines.
Your doctor will monitor you and perform tests.

• blood pressure-lowering medicines or ACE inhibitors and angiotensin II antagonists, if you have kidney problems or potassium-sparing diuretics (e.g. spironolactone)
• other anti-inflammatory medicines (non-steroidal anti-inflammatory drugs and corticosteroids)
• blood-thinning medicines (anticoagulants or antiplatelets)
• serotonin reuptake inhibitors (antidepressants)
• diabetes medicines
• cyclosporine and tacrolimus (immunosuppressants used to modify the body's immune response)
• trimethoprim (an antibiotic)
• antibacterial medicines of the quinolone class
• colestipol and cholestyramine, as they may delay or reduce absorption of diclofenac. Your doctor will advise when to take these medicines; generally, diclofenac should be taken 1 hour before or 4–6 hours after colestipol and cholestyramine
• rifampicin (an antibiotic used to treat bacterial infections), as it may reduce diclofenac absorption
• other medicines that may increase blood levels of diclofenac, e.g. sulfinpyrazone (a medicine used to treat gout) and voriconazole (a medicine used to treat fungal infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy
Voltaren must not be used during the first and second trimesters of pregnancy unless strictly necessary. If you wish to become pregnant or are in the first or second trimester of pregnancy and need
to use Voltaren, your doctor will prescribe the lowest dose of diclofenac for the shortest
possible time.
Do not take Voltaren during the last 3 months of pregnancy, as it may harm the foetus or cause
problems during delivery. It may cause kidney and heart problems in the foetus. It may affect your and your baby's tendency to bleed and may delay or prolong labour more than expected.
You should not take Voltaren during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used. From
the 20th week of pregnancy, Voltaren may cause kidney problems in the foetus if taken for more than
a few days, thereby reducing amniotic fluid levels surrounding the baby (oligohydramnios)
or causing narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Voltaren must not be used during breastfeeding to avoid adverse effects on the newborn.
Fertility
As with other NSAIDs, Voltaren is not recommended for women planning pregnancy, as this medicine may affect female fertility. Your doctor will assess whether Voltaren treatment should be discontinued if you experience difficulty becoming pregnant or require fertility testing.
Driving and using machines
Voltaren may cause visual disturbances, dizziness, vertigo, drowsiness or other disturbances that may
affect your ability to drive vehicles or operate machinery.
If you experience these symptoms, avoid driving or operating machinery.

3. How to take Voltaren

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Use the suppositories only after evacuating the bowels, and insert them properly into the rectum. The suppositories must
not be crushed or divided. In all cases where a dose lower than 100
mg is required, your doctor will instruct you to take other pharmaceutical forms of Voltaren (50 mg gastro-resistant tablets, 50 mg soluble tablets, or 75 mg prolonged-release tablets).
Do not swallow the suppositories; they are for rectal use only.

Use in adults
The recommended initial dose is 100–150 mg per day.
In mild cases and for long-term treatment, the recommended dose is 75–100 mg per day.
The dose should be divided into 2–3 administrations throughout the day.
Your doctor will tell you how much Voltaren to take and for how long.

Treatment of pain associated with menstruation (dysmenorrhoea)
The recommended dose is 50–150 mg per day, but it should be adjusted individually for each patient.
Your doctor will initially prescribe 50–100 mg per day and, if necessary, may advise increasing the dose during subsequent menstrual cycles, up to a maximum of 150 mg per day.
Start treatment when the first symptoms appear and continue for a few days, depending on your symptoms.

Treatment of night-time pain and morning stiffness
Voltaren is also available in tablet form. You may take Voltaren tablets during the day and use a Voltaren suppository before going to bed.
Do not exceed the maximum daily dose of 150 mg.

Use in children and adolescents
Voltaren must not be used in children and adolescents.

Use in the elderly
In elderly patients, a dose reduction of diclofenac may be necessary. Your doctor will advise you on the appropriate dose of Voltaren.

If you take more Voltaren than you should
If you accidentally ingest an excessive dose of Voltaren, contact your doctor immediately or go to the nearest hospital.
If you take an overdose of Voltaren, you may experience vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus (ringing or buzzing in the ears), or seizures. In more severe cases, serious kidney and liver damage may also occur.
Your doctor will treat acute poisoning from non-steroidal anti-inflammatory drugs, including diclofenac, based on the symptoms you present.

If you forget to take Voltaren
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious.
Stop taking Voltaren and contact your doctor immediately if you experience:

• Mild abdominal cramps and tenderness occurring shortly after starting treatment with Voltaren, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).
• A severe skin allergic reaction which may include widespread red and/or dark patches, skin swelling, blisters, and itching (fixed drug eruption with generalized bullous rash).

Common side effects (may affect up to 1 in 10 people)

• Headache, dizziness
• Vertigo
• Nausea, vomiting
• Diarrhoea, passing gas (flatulence)
• Digestive problems (dyspepsia), abdominal pain
• Loss of appetite
• Abnormal results in blood tests (increase in certain liver enzymes: transaminases)
• Skin rash
• Irritation at the site of suppository application

Uncommon side effects (may affect up to 1 in 100 people)

• Awareness of your heartbeat (palpitations), chest pain, heart problems (heart failure), heart attack

Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reactions, severe and rapidly developing allergic reactions (anaphylaxis), including hypotension and collapse (shock)
• Drowsiness
• Asthma, difficulty in breathing (dyspnoea)
• Inflammation of the stomach (gastritis), bleeding from the stomach or intestine, vomiting blood, stomach or intestinal ulcer with or without bleeding and perforation
• Blood in the stools
• Inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders
• Urticaria
• Oedema (fluid retention and swelling).

If you experience any of these side effects, inform your doctor immediately.
Very rare side effects (may affect up to 1 in 10,000 people)

• Abnormal blood test results or low platelet count (thrombocytopenia) or reduced number of white blood cells (leucopenia) or reduced number of red blood cells (anaemia, including haemolytic and aplastic anaemia) or low granulocyte count (agranulocytosis)
• Abnormal urine test results or blood in the urine (haematuria) or protein in the urine (proteinuria)
• Allergic reaction with rapid swelling of the skin and mucous membranes (angioneurotic oedema), including facial oedema
• Disorientation, depression, insomnia, nightmares, irritability, severe mental disturbances (psychotic reactions)
• Memory disturbances, seizures, anxiety, tremors
• Tingling sensations (paraesthesia)
• Taste disturbances
• Inflammation of the membranes covering the brain (aseptic meningitis), stroke
• Vision disorders, blurred vision, double vision
• Ringing or buzzing in the ears, worsening of hearing
• High blood pressure, inflammation of blood vessels (vasculitis)
• Pneumonia
• Inflammation of the colon (colitis), including colitis with bleeding, worsening of ulcerative colitis or Crohn’s disease
• Constipation
• Inflammation of the mouth lining (stomatitis), including stomatitis with ulcers, inflammation of the tongue (glossitis)
• Problems with the oesophagus, narrowing of the intestine
• Inflammation of the pancreas (pancreatitis)
• A very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (liver failure)
• Skin reactions ranging from mild (bullous eruptions, eczema, erythema) to potentially fatal (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), exfoliative dermatitis)
• Appearance of red-brown spots on the skin (purpura), also as an allergic reaction
• Itching
• Hair loss
• Skin sensitivity to sunlight
• Kidney problems such as acute kidney failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Side effects with frequency not known (frequency cannot be estimated from available data)

• Inflammation of the rectum (proctitis)
• Haemorrhoids
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
• A skin allergic reaction, which may include round or oval red and swollen patches on the skin, skin rash with blisters, and itching (drug eruption with fixed eruption). Darkening of the skin in the affected areas may also occur, which could persist after healing. A fixed drug eruption usually recurs at the same site (or sites) if the medicine is taken again.

Medicines such as Voltaren may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (see section “Warnings and precautions” above).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Voltaren

Store below 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp.. The
expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Voltaren contains

• The active substance is sodium diclofenac. Each suppository contains 100 mg of sodium diclofenac.
• The other components are solid semisynthetic glycerides.

Description of the appearance of Voltaren and contents of the pack
Each pack contains 10 rectal suppositories of 100 mg.
Marketing Authorization Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milan MI
Italy
Manufacturer
Novartis Farma S.p.A
Via Provinciale Schito 131
80058 Torre Annunziata - NA
Italy
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milan MI
Italy
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Package leaflet: information for the patient

Voltaren 75 mg/3 ml solution for injection for intramuscular use

diclofenac sodium
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Voltaren is and what it is used for

Voltaren contains the active substance sodium diclofenac, which belongs to the class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Sodium diclofenac is used to reduce pain and inflammation.
Voltaren is used to treat episodes of acute pain such as:

• inflammation of muscles, joints and bones
• smooth muscle spasms

2. What you need to know before taking Voltaren

Do not take Voltaren

• if you are allergic (hypersensitive) to diclofenac, sodium metabisulfite (or other sulfites), or to any of the other ingredients of this medicine (listed in section 6).
• if you have ever had an allergic reaction after taking medicines used to treat inflammation, pain, or fever, such as acetylsalicylic acid (aspirin), diclofenac, or ibuprofen. Reactions may include: asthma, runny nose, skin redness, swelling of the face, lips, tongue, throat, and/or extremities (signs of angioedema), chest pain. If you think you may be allergic, consult your doctor.
• if you have a stomach or intestinal ulcer, bleeding, or perforation
• if you currently have bleeding or are prone to bleeding
• if you have previously experienced bleeding (haemorrhage) or perforation of the stomach or intestine during previous treatment with NSAIDs
• if you have had recurrent stomach or duodenal ulcer or bleeding (two or more distinct episodes of proven ulceration or bleeding)
• if you have liver problems
• if you have severe liver problems (hepatic insufficiency)
• if you have severe kidney problems (renal insufficiency)
• if you suffer from established heart disease and/or cerebrovascular disease, e.g. you have had a heart attack, stroke, mini-stroke (TIA), or blockage of blood vessels supplying the heart or brain, or undergone surgery to remove or prevent such blockages
• if you have a disorder affecting blood cell production
• if you are taking high doses of medicines that increase urine production (diuretics) (see "Other medicines and Voltaren")
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”)
• if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”)
• if the patient is a child or adolescent.

Warnings and precautions
Talk to your doctor or pharmacist before taking Voltaren.
Before taking Voltaren, ensure your doctor knows:

• if you smoke
• if you have diabetes
• if you suffer from angina, blood clots, high blood pressure, high cholesterol, or high triglycerides
• if you have asthma
• if you have seasonal allergic rhinitis, nasal mucosa swelling (e.g. nasal polyps)
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
• if you have liver problems (e.g. hepatic insufficiency, hepatitis)
• if you have hepatic porphyria
• if you have ulcerative colitis or Crohn’s disease, as these conditions may worsen
• if you have kidney problems (e.g. renal insufficiency)
• if you are using medicines that increase urine production (diuretics) or other medicines that may affect kidney function
• if you have reduced body fluid volume (e.g. before or after major surgery)
• if you are undergoing or have recently undergone major surgery
• if you have blood clotting disorders (coagulation defects)
• if you have or have had high blood pressure, heart or brain problems (e.g. congestive heart failure, established heart disease, peripheral arterial disease, and/or stroke), or if you have had or have stomach or intestinal problems (e.g. ulcer), or ulceration, bleeding, or perforation of the stomach or intestine
• if you are taking medicines that may increase the risk of bleeding, ulceration, and perforation, such as acetylsalicylic acid (e.g. aspirin) or other NSAIDs, corticosteroids taken orally, by injection, or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Voltaren”)
• if you have ever developed severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking Voltaren or other analgesics.

Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before taking Voltaren, as Voltaren may occasionally impair wound healing in the intestine following surgery.

Inform your doctor if, during treatment with Voltaren, you develop:

• skin reactions, even severe ones, as very rare serious skin reactions have been reported, which may even be fatal (see section 4 “Undesired effects”)
• fluid retention and swelling due to fluid accumulation (oedema)
• any signs of allergic reaction
• signs and symptoms of liver problems or if liver function tests are abnormal (as shown by blood tests)
• unusual stomach or intestinal symptoms, especially at the beginning of treatment with Voltaren, as they may indicate gastrointestinal bleeding or ulceration
• signs and symptoms typical of serious atherothrombotic events such as chest pain, shortness of breath, weakness, and difficulty speaking.

In these cases, your doctor will assess whether to continue or discontinue treatment with Voltaren.
In addition, take particular care:

• At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulceration, or perforation may occur, which can be fatal. Your doctor will prescribe the lowest effective dose of diclofenac to reduce the

risk of gastrointestinal toxicity and may also prescribe medicines (e.g.
misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.

• If you are elderly, especially if you are frail and underweight, your doctor will prescribe a low dose of Voltaren.
• Undesired effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 “How to take Voltaren”).
• Avoid using diclofenac during treatment with other NSAIDs taken orally, by injection, or rectally, including selective cyclooxygenase-2 inhibitors, as this increases the likelihood of undesired effects.
• Voltaren may mask signs and symptoms of infection.
• Medicines like Voltaren may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses or prolonged treatment.
• Injection site reactions have been reported after intramuscular administration (a technique used to deliver the medicine deep into the muscle) of Voltaren, including pain at the injection site, redness, swelling/hardening, ulceration, sometimes with haematoma or pus collection, and damage to the skin and underlying tissue (especially after incorrect administration into fatty tissue) – a phenomenon known as Nicolau syndrome.

Your doctor will monitor you closely and periodically reassess the need for treatment with
Voltaren. Additionally, your doctor may arrange periodic tests to evaluate your condition
during treatment with Voltaren.
Children and adolescents
Voltaren must not be used in children and adolescents.
Elderly patients
Elderly patients have a higher likelihood of experiencing adverse reactions, particularly
gastrointestinal bleeding or perforation, which are generally more severe and may
be fatal.
If you are elderly, especially if you are frail and underweight, your doctor will prescribe a low dose of
Voltaren.
As a precaution, your doctor may monitor your kidney function and prescribe medicines that protect the gastrointestinal mucosa, such as misoprostol or
proton pump inhibitors.
Inform your doctor of any unusual stomach or intestinal symptoms, especially at the beginning of
treatment with this medicine.
Other medicines and Voltaren
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.
The blood concentration of the following medicines may increase when used together with
Voltaren:

• lithium
• digoxin
• methotrexate
• phenytoin. Your doctor will perform tests to monitor blood levels of these medicines.

The effect of some medicines used to lower blood pressure, such as:
o medicines that increase urine production (diuretics)
o beta-blockers
o angiotensin-converting enzyme inhibitors (ACE inhibitors)
may decrease when used together with Voltaren.
Your doctor will monitor you and carefully consider the use of these medicines
with Voltaren, especially if you are elderly.
Take particular care and inform your doctor if you need to take Voltaren while already taking one or
more of the following listed medicines.
Your doctor will monitor you and arrange for tests.

• medicines to lower blood pressure or ACE inhibitors and angiotensin II receptor antagonists, if you have kidney problems, or potassium-sparing diuretics (e.g. spironolactone)
• other anti-inflammatory medicines (non-steroidal anti-inflammatory drugs and corticosteroids)
• medicines to thin the blood (anticoagulants or antiplatelet agents)
• serotonin reuptake inhibitors (antidepressants)
• medicines for diabetes
• cyclosporine and tacrolimus (immunosuppressants used to modify the body's immune system response)
• trimethoprim (an antibiotic)
• medicines to treat bacterial infections of the quinolone class
• colestipol and cholestyramine, as they may delay or reduce diclofenac absorption. Your doctor will advise when to take these medicines; generally, diclofenac should be taken 1 hour before or 4–6 hours after colestipol and cholestyramine
• rifampicin (an antibiotic used to treat bacterial infections), as it may reduce diclofenac absorption
• other medicines that may increase blood levels of diclofenac, e.g. sulfinpyrazone (a medicine used to treat gout) and voriconazole (a medicine used to treat fungal infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy
Voltaren must not be used during the first and second trimesters of pregnancy except when strictly necessary. If you are planning a pregnancy or are in the first or second trimester and need to
use Voltaren, your doctor will prescribe the lowest dose of diclofenac for the shortest possible
time.
Do not take Voltaren during the last three months of pregnancy, as it may harm the fetus or cause
problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labour beyond the expected duration.
You should not take Voltaren during the first 6 months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From
the 20th week of pregnancy, Voltaren may cause kidney problems in the fetus if taken for more than
a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Voltaren must not be used during breastfeeding to avoid adverse effects on the newborn.
Fertility
As with other NSAIDs, Voltaren is not recommended for women who are planning a
pregnancy, as this medicine may affect female fertility. Your doctor will assess whether treatment with Voltaren should be discontinued if you have difficulty becoming pregnant or need fertility investigations.
Driving and using machines
Voltaren may cause visual disturbances, dizziness, vertigo, drowsiness, or other disturbances that may
affect your ability to drive or use machines.
If you experience these symptoms, avoid driving or operating machinery.
Voltaren contains sodium metabisulfite, benzyl alcohol, and propylene glycol
The injectable solution contains sodium metabisulfite, which may rarely cause severe
hypersensitivity reactions and bronchospasm.
The injectable solution contains 120 mg of benzyl alcohol, which may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant, or have liver or kidney disease.
This is because large amounts of benzyl alcohol may accumulate in the body and cause
undesired effects (such as metabolic acidosis).
This medicine contains 600 mg of propylene glycol per vial. If you are pregnant or have
liver or kidney disease, do not take this medicine unless otherwise recommended by
your doctor. Your doctor may perform additional monitoring during treatment.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially
‘sodium-free’.

3. How to take Voltaren

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
How to inject Voltaren
Voltaren injections must be administered following standard sterilization and aseptic techniques.
Voltaren must be injected into the muscle.
Inject the contents of one vial deeply into the upper outer quadrant of the buttock.
An appropriate injection technique must be used, and a needle of adequate length should be selected (taking into account the thickness of the patient's gluteal fat) to avoid inadvertent subcutaneous administration of the drug.
If you need to use two Voltaren vials, do not inject both contents into the same buttock (inject one vial into each buttock).
Use in adults
Voltaren injectable solution for intramuscular use should not be used for more than two days.
If necessary, treatment may be continued with Voltaren tablets or suppositories.
The recommended dose is one 75 mg vial per day, injected into the muscle.
Exceptionally, in severe cases (e.g. colic), two 75 mg vials per day may be administered.
The contents of the two vials must not be injected into the same buttock (inject one vial into each buttock).
Your doctor will tell you how much Voltaren to take and for how long.
Your doctor may combine injection therapy with Voltaren tablets or suppositories, up to a maximum daily dose of 150 mg.
How to open the Voltaren vial:

• Hold the vial as shown in the illustration, with the coloured mark facing upwards
• Break the vial with a sharp, quick motion

Use in children and adolescents
Voltaren must not be used in children and adolescents.
Use in the elderly
In elderly patients, a reduced dose of diclofenac may be necessary. Your doctor will advise you on the appropriate dose of Voltaren.
If you take more Voltaren than you should
If you accidentally ingest an excessive dose of Voltaren, contact your doctor immediately or go to the nearest hospital.
If you take too much Voltaren, you may experience vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus (ringing or buzzing in the ears), or seizures. In more severe cases, serious kidney and liver damage may also occur.
Your doctor will treat acute non-steroidal anti-inflammatory drug (NSAID) poisoning, including diclofenac, based on your symptoms.
If you forget to take Voltaren
Do not take a double dose to make up for a missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Some side effects may be serious.
Stop taking Voltaren and contact your doctor immediately if you notice:

• Mild abdominal cramps and tenderness occurring shortly after starting treatment with Voltaren, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).
• A severe skin allergic reaction which may include widespread red and/or dark patches, skin swelling, blisters, and itching sensation (Fixed generalized bullous drug eruption).

Common side effects (may affect up to 1 in 10 people)

• Headache, dizziness
• Vertigo
• Nausea, vomiting
• Diarrhoea, passing gas (flatulence)
• Digestive problems (dyspepsia), abdominal pain
• Loss of appetite
• Abnormal results in blood tests (increase in certain liver enzymes: transaminases)
• Skin rash
• Reactions, pain or hardening at the injection site.

Uncommon side effects (may affect up to 1 in 100 people)

• Awareness of your heartbeat (palpitations), chest pain, heart problems (heart failure), heart attack

Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reactions, severe and rapidly occurring allergic reactions (anaphylaxis) including low blood pressure and collapse (shock)
• Drowsiness
• Asthma, difficulty breathing (dyspnoea)
• Inflammation of the stomach (gastritis), bleeding from the stomach or intestines, vomiting blood, stomach or intestinal ulcer with or without bleeding and perforation
• Blood in the stools
• Inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders
• Hives
• Oedema (swelling due to fluid accumulation)
• Tissue damage at the injection site.

If you experience any of these side effects, inform your doctor immediately.
Very rare side effects (may affect up to 1 in 10,000 people)

• Abnormal results in blood tests or low platelet count (thrombocytopenia) or reduced number of white blood cells (leucopenia) or reduced number of red blood cells (anaemia, including haemolytic and aplastic anaemia) or low granulocyte count (agranulocytosis)
• Abnormal results in urine tests or presence of blood in the urine (haematuria) or presence of protein in the urine (proteinuria)
• Allergic reaction with rapid swelling of the skin and mucous membranes (angioedema), including facial swelling
• Disorientation, depression, insomnia, nightmares, irritability, severe mental disturbances (psychotic reactions)
• Memory impairment, seizures, anxiety, tremors
• Tingling sensations (paraesthesia)
• Taste disturbances
• Inflammation of the membranes covering the brain (aseptic meningitis), stroke
• Vision disorders, blurred vision, double vision
• Ringing or buzzing in the ears, worsening of hearing
• High blood pressure, inflammation of blood vessels (vasculitis)
• Pneumonia
• Inflammation of the colon (colitis), including colitis with bleeding and worsening of ulcerative colitis or Crohn’s disease
• Constipation
• Inflammation of the mouth lining (stomatitis), including stomatitis with ulcers, inflammation of the tongue (glossitis)
• Problems with the oesophagus, narrowing of the intestine
• Inflammation of the pancreas (pancreatitis)
• A very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (hepatic failure)
• Skin reactions ranging from mild (bullous eruptions, eczema, erythema) to potentially fatal (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), exfoliative dermatitis)
• Appearance of red-brown spots on the skin (purpura), also as an allergic reaction
• Itching
• Hair loss
• Skin sensitivity to sunlight
• Kidney problems such as acute kidney failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis
• Pus formation in tissue (abscess) at the injection site.

Side effects with unknown frequency (frequency cannot be determined from 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, hard nodule, ulcers and bruising. These reactions may worsen with darkening and death of the skin and underlying tissues surrounding the injection site, which then heal with scarring; this condition is known as Nicolau syndrome. Medicines such as Voltaren may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (see section “Warnings and precautions” above).
• A skin allergic reaction, which may include round or oval patches with redness and swelling of the skin, skin rash with blisters, and itching sensation (Fixed drug eruption). Darkening of the skin in the affected areas may also occur, which could persist after healing. A fixed drug eruption usually recurs at the same site (or same sites) if the medicine is taken again.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Voltaren

Store below 30°C. Keep the vials in the outer packaging to protect the medicine from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Voltaren contains

• The active substance is sodium diclofenac. Each vial contains 75 mg of sodium diclofenac.
• The other components are mannitol, sodium metabisulfite, benzyl alcohol, propylene glycol, sodium hydroxide, water for injections.

Description of the appearance of Voltaren and package contents
Each package contains 5 vials of Voltaren 75 mg/3 ml solution for injection for intramuscular use.
Marketing Authorization Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy
Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata - NA
Italy
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain