Package leaflet: Information for the patient

Dicloreum 50 mg oral solution granules

diclofenac hydroxyethylpyrrolidine
Equivalent medicine
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 they have the same symptoms as you, because 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:

What Dicloreum is and what it is used for
What you need to know before taking Dicloreum
How to take Dicloreum
Possible side effects
How to store Dicloreum
Contents of the pack and other information

1. What Dicloreum is and what it is used for

Dicloreum contains the active substance diclofenac hydroxyethylpyrrolidine, which belongs to the class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Diclofenac hydroxyethylpyrrolidine is used to reduce pain and inflammation.
Dicloreum is used to treat symptoms of severe pain due to inflammation of the joints, muscles and bones, and muscle spasms, such as osteoarthritis in various locations, rheumatoid arthritis, gouty arthropathy, periarthritis, fibromyositis, and lumbago.
If you do not feel better or if you feel worse after the prescribed treatment period, talk to your doctor.

2. What you need to know before taking Dicloreum

Do NOT take Dicloreum

if you are allergic to diclofenac hydroxyethylpyrrolidine, or to other non-steroidal anti-inflammatory drugs (NSAIDs), and in particular to acetylsalicylic acid, or to painkillers (analgesics), fever-reducing medicines (antipyretics), or to any of the other ingredients of this medicine (listed in section 6)
if you have liver problems (e.g. severe hepatic insufficiency)
if you have a stomach or intestinal ulcer, bleeding, or perforation
if you have previously experienced gastrointestinal bleeding or perforation after taking NSAIDs
if you have had recurrent stomach or duodenal ulcer or bleeding (two or more distinct episodes of proven ulceration or bleeding)
if you are in the last trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”)
if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”)
if you have severe kidney problems (severe renal insufficiency)
if you have confirmed heart or cerebral blood vessel problems (cerebrovascular disease), for example, if you have had a heart attack, stroke, or mini-stroke (also known as transient ischemic attack, TIA)
if you have a blockage in the blood vessels supplying the heart or brain, or have undergone a procedure to remove or prevent such blockages
if you have current or past circulatory problems in the arteries (peripheral arterial disease)
if you currently have bleeding or a tendency to bleed
if you have experienced asthma attacks, chest pain, hives, or acute rhinitis after taking acetylsalicylic acid or other NSAIDs
if you have a disorder affecting blood cell production
if you are taking high doses of medicines that increase urine production (diuretics) (see section “Other medicines and Dicloreum”)
if you have phenylketonuria, because Dicloreum contains aspartame (see section “Dicloreum contains aspartame”)

Do not administer Dicloreum to children under 14 years of age
Warnings and precautions
Talk to your doctor or pharmacist before taking Dicloreum if:

you have or have had high blood pressure
you have heart, brain, or blood vessel problems (e.g. congestive heart failure, confirmed cardiomyopathy, peripheral arterial disease, and/or stroke)
you have risk factors for heart, brain, or blood vessel adverse events (e.g. high blood pressure, diabetes, smoking, high cholesterol or triglycerides, etc.)
you have chest pain (angina) or blood clots
you have had blood clots (thrombosis) or embolism
you have blood clotting disorders (hemostasis defects)
you have kidney problems (e.g. renal hypoperfusion, renal insufficiency), except in cases of severe kidney problems (severe renal insufficiency), in which case you must not take Dicloreum (see section “Do NOT take Dicloreum”)
you are taking medicines that increase urine production (diuretics) or other medicines that may affect kidney function
you are taking medicines that may increase the risk of bleeding, ulceration, and perforation, such as acetylsalicylic acid (e.g. aspirin), corticosteroids taken orally, by injection, or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), or selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Dicloreum”)
you have or have had stomach or intestinal problems (e.g. ulcer), or have previously experienced stomach or intestinal ulceration, bleeding, or perforation, as Dicloreum may not be suitable for you
you have ulcerative colitis or Crohn’s disease, as these conditions may worsen
you have recently undergone or are about to undergo stomach or intestinal surgery, as Dicloreum may sometimes impair wound healing in the intestine after surgery
you have asthma or are predisposed to it, as this medicine may cause respiratory distress (bronchospasm attacks) and, in some cases, shock or other allergic reactions
you have seasonal allergic rhinitis, nasal mucosa swelling (e.g. nasal polyps)
you have chronic obstructive pulmonary disease or chronic respiratory tract infections
you have or have had liver problems (e.g. hepatic insufficiency), except in cases of severe liver problems (severe hepatic insufficiency), in which case you must not take Dicloreum (see section “Do NOT take Dicloreum”)
you have hepatic porphyria
you have undergone major surgical procedures
you have reduced body fluid volume (e.g. before or after major surgery)
you are underweight, as you will be prescribed a low dose of Dicloreum
you are elderly, particularly if frail and underweight, as you will be prescribed a low dose of Dicloreum (see section “Elderly patients”)

In these cases, your doctor will monitor you closely and may reassess the need for treatment with Dicloreum. Additionally, your doctor may prescribe periodic tests to evaluate your condition during treatment with Dicloreum.
Inform your doctor if, during treatment with Dicloreum, you develop:

skin reactions, even severe ones, as serious, potentially fatal skin reactions have very rarely been reported
fluid retention and swelling due to fluid accumulation (edema)
signs and symptoms of liver problems or abnormal liver function test results (blood test results)
unusual stomach or intestinal symptoms, especially at the beginning of treatment with Dicloreum. In such cases, your doctor will assess whether to continue or discontinue treatment with Dicloreum.

In addition, pay special attention to the following:

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 minimize the risk of gastrointestinal toxicity and may also prescribe medicines to protect the gastrointestinal mucosa (e.g. misoprostol or proton pump inhibitors).
Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration (see section 3 “How to take Dicloreum”).
Avoid using diclofenac during treatment with other NSAIDs taken orally, by injection, or rectally, including selective cyclooxygenase-2 (COX-2) inhibitors, as this increases the risk of adverse effects.
Dicloreum may mask the signs and symptoms of infection.

Elderly patients
Elderly patients are more likely to experience adverse reactions, particularly gastrointestinal bleeding and perforation, which are generally more severe and may be fatal. Inform your doctor of any unusual stomach or intestinal symptoms, especially at the beginning of treatment with this medicine.
If you are elderly, particularly if frail and underweight, your doctor will prescribe a low dose of Dicloreum.
Other medicines and Dicloreum
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 Dicloreum:

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

The blood pressure-lowering effect of the following medicines may decrease when used together with Dicloreum:

medicines used to lower blood pressure or medicines that increase urine production (diuretics), beta-blockers, or angiotensin-converting enzyme inhibitors (ACE inhibitors)
Your doctor will monitor you closely and carefully consider co-administration of these medicines with Dicloreum, especially if you are elderly. Your doctor will monitor you and perform tests if you need to take one or more of the following medicines together with Dicloreum:
blood pressure-lowering medicines or ACE inhibitors and angiotensin II receptor antagonists, especially if you have kidney problems or potassium-sparing agents (e.g. spironolactone)
other non-steroidal anti-inflammatory drugs
corticosteroids (hormone-like medicines used, for example, to reduce inflammation)
blood-thinning medicines (anticoagulants or antiplatelet agents)
serotonin reuptake inhibitors (antidepressants)
diabetes medicines
cyclosporine (an immunosuppressant used to modify the body’s immune response)
antibiotics of the quinolone class
colestipol and cholestyramine, as they may delay or reduce diclofenac absorption. Your doctor will advise you when to take these medicines; diclofenac should generally be taken 1 hour before or 4–6 hours after colestipol and cholestyramine
strong CYP2C9 inhibitors, e.g. sulfinpyrazone and voriconazole.

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
Do NOT take Dicloreum during the last three months of pregnancy (during the third trimester), as it may harm the fetus or cause problems during delivery. It may cause heart, lung, or kidney problems in the fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labor beyond the expected time.
Do not take Dicloreum during the first and second trimesters of pregnancy unless strictly necessary and under medical advice, as it may increase the risk of miscarriage and birth defects.
The risk increases with higher doses and longer duration of diclofenac therapy. 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 week 20 of pregnancy, diclofenac may cause kidney problems in the fetus if taken for more than a few days, leading to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Diclofenac passes into breast milk in small amounts; therefore, do not use Dicloreum during breastfeeding to avoid potential adverse effects on the newborn.
Fertility
As with other NSAIDs, do not use Dicloreum if you are planning a pregnancy, as this medicine may impair fertility. Your doctor will assess whether treatment with Dicloreum should be discontinued if you experience difficulty conceiving or require fertility testing.
Driving and using machines
Diclofenac 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.
Dicloreum contains aspartame, sorbitol, sodium
This medicine contains 40 mg of aspartame per sachet, equivalent to 2 mg/100 mg of granulate.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing phenylalanine accumulation due to the body’s inability to properly metabolize it.
This medicine contains 1570 mg of sorbitol per sachet. Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot properly metabolize fructose, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially ‘sodium-free’.

3. How to take Dicloreum

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use in adults
The recommended dose is 1 sachet twice daily with food (at breakfast and dinner). Dissolve the
contents of one sachet in half a glass of water.
Your doctor will prescribe Dicloreum granulate only for short periods to treat episodes of
severe pain; as soon as possible, your doctor will instruct you to continue treatment with diclofenac using tablets.
Use in the elderly
A reduced dose of diclofenac may be necessary in elderly patients. Your doctor will advise you on how much Dicloreum to take.
Use in children and adolescents
Dicloreum must not be used in children and adolescents under 14 years of age.
If you take more Dicloreum than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
If you take an excessive dose of Diclofenac, you may experience vomiting, stomach or intestinal bleeding,
diarrhea, dizziness, tinnitus 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 presented.
If you forget to take Dicloreum
Do not take a double dose to make up for the missed dose.
If you stop treatment with Dicloreum
If you have any doubts about using 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 Dicloreum and contact your doctor immediately if you notice any of the following serious side effects. You may require urgent medical treatment:

severe skin allergic reactions which may include extensive red and/or dark patches spreading over the skin, swelling of the skin, blisters, and itching sensation (Fixed generalized bullous drug eruption)
mild cramps and abdominal pain occurring shortly after starting treatment with Dicloreum, 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)
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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 or reduction of appetite (anorexia)
abnormal results in blood tests (increase in certain liver enzymes: transaminases)
skin rash

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

allergic reactions, severe allergic reactions (anaphylaxis) including hypotension and shock
somnolence
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
diarrhoea accompanied by bleeding, blood in stools
inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders
urticaria
oedema (swelling due to fluid accumulation)

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

abnormal blood test results: low platelet count (thrombocytopenia), reduced number of white blood cells (leucopenia), reduced number of red blood cells (anaemia, including haemolytic and aplastic anaemia), reduced number of granulocytes (agranulocytosis)
abnormal urine test results: presence of blood in urine (haematuria), presence of protein in 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 (delirium, hallucinations)
memory impairment, excitement, seizures, anxiety, tremors
tingling sensations (paraesthesia)
taste disturbances
inflammation of the membranes covering the brain (aseptic meningitis), damage to blood vessels in the brain
vision disorders, blurred vision, double vision
ringing or buzzing in the ears, worsening of hearing
awareness of your heartbeat (palpitations), chest pain, heart problems (heart failure), heart attack
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)
oesophageal problems, intestinal narrowing
inflammation of the pancreas (pancreatitis)
very severe and sudden onset hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (hepatic failure)
various types of skin reactions (redness, blistering, peeling, etc.), ranging from mild to potentially fatal
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
fatigue

Frequency not known (frequency cannot be estimated from available data)

A skin allergic reaction, which may include round or oval-shaped red and swollen skin patches, blistering rash, 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 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 Dicloreum

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not use this medicinal product if the packaging is open or damaged.
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 Dicloreum contains

The active substance is diclofenac hydroxyethylpyrrolidine. Each sachet contains 65 mg of diclofenac hydroxyethylpyrrolidine, equivalent to 50 mg of sodium diclofenac.
The other ingredients are aspartame, sodium citrate, povidone, grapefruit flavour, sorbitol.

Description of the appearance of Dicloreum and contents of the pack
Each pack contains 20 sachets of oral solution granules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Alfasigma S.p.A. – Via Ragazzi del ‘99, n. 5 - 40133 Bologna (BO)
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)

Patient information leaflet

Dicloreum 50 mg gastro-resistant tablets

diclofenac sodium
Generic medicine
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 may 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:

What Dicloreum is and what it is used for
What you need to know before taking Dicloreum
How to take Dicloreum
Possible side effects
How to store Dicloreum
Package contents and other information

1. What Dicloreum is and what it is used for

Dicloreum 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.
Dicloreum is used to treat:

joint diseases such as rheumatoid arthritis and osteoarthritis
muscle, tendon and bone disorders such as periarthritis, bursitis, tendinitis, myositis, lumbosacral and sciatic pain
inflammation and swelling following trauma.

Consult your doctor if you do not feel better or if you feel worse after the prescribed treatment period.

2. What you need to know before taking Dicloreum

DO NOT take Dicloreum

if you are allergic to sodium diclofenac, or to other non-steroidal anti-inflammatory drugs (NSAIDs), particularly acetylsalicylic acid, or to pain-relieving medicines (analgesics), fever-reducing medicines (antipyretics), or to any of the other ingredients of this medicine (listed in section 6)
if you have liver problems (e.g. severe hepatic insufficiency)
if you have a stomach or intestinal ulcer, bleeding, or perforation
if you have had gastrointestinal bleeding or perforation following previous treatment with NSAIDs
if you have had recurrent stomach or duodenal bleeding/ulceration (two or more distinct episodes of proven ulceration or bleeding)
if you are in the last trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”)
if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”)
if you have severe kidney problems (severe renal insufficiency)
if you have confirmed heart or cerebral blood vessel problems (cerebrovascular disease), for example if you have had a heart attack, stroke, or mini-stroke (also known as transient ischemic attack, TIA)
if you have a blockage in the blood vessels supplying the heart or brain, or have undergone surgery to remove or prevent such blockages
if you have or have had peripheral arterial disease (poor blood circulation in the arteries)
if you currently have bleeding or a tendency to bleed
if you have experienced asthma attacks, chest pain, hives, or acute rhinitis after taking acetylsalicylic acid or other NSAIDs
if you have a blood cell production disorder
if you are taking high doses of medicines that increase urine production (diuretics) (see section “Other medicines and Dicloreum”)

Do not administer Dicloreum to children under 14 years of age
Warnings and precautions
Talk to your doctor or pharmacist before taking Dicloreum.
Tell your doctor before taking Dicloreum:

if you have ever developed severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking Dicloreum or other analgesics
if you have or have had high blood pressure
if you have or have had heart, brain, or blood vessel problems (e.g. congestive heart failure, confirmed cardiomyopathy, peripheral arterial disease, and/or stroke)
if you have risk factors for adverse cardiovascular, cerebrovascular, or vascular events (e.g. high blood pressure, diabetes, smoking, high cholesterol or triglycerides, etc.)
if you have chest pain (angina), blood clots
if you have had blood clots (thrombosis) or embolism
if you have blood clotting disorders (coagulation defects)
if you have kidney problems (e.g. renal hypoperfusion, renal insufficiency), except in cases of severe kidney problems (severe renal insufficiency), as you must not take Dicloreum (see section “DO NOT take Dicloreum”)
if you are taking medicines that increase urine production (diuretics) or other medicines that may affect kidney function
if you are taking medicines that may increase the risk of bleeding, ulcers, and perforations, such as acetylsalicylic acid (e.g. aspirin), corticosteroids taken orally, by injection, or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), or selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Dicloreum”)
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, as Dicloreum may not be suitable for you
if you have ulcerative colitis or Crohn’s disease, as these conditions may worsen
if you have recently undergone or are about to undergo stomach or intestinal surgery, as Dicloreum may sometimes impair wound healing in the intestine after surgery
if you have asthma or are prone to asthma, as this medicine may cause respiratory distress (bronchospasm attacks) and, in some cases, shock and other allergic reactions
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 or have had liver problems (e.g. hepatic insufficiency), except in cases of severe liver problems (severe hepatic insufficiency), as you must not take Dicloreum (see section “DO NOT take Dicloreum”)
if you have hepatic porphyria
if you have undergone major surgery
if you have reduced body fluid volume (e.g. before or after major surgery)
if you are underweight, as you will be prescribed a low dose of Dicloreum
if you are elderly, particularly if frail and underweight, as you will be prescribed a low dose of Dicloreum (see section “Elderly patients”)

In these cases, your doctor will monitor you closely and may reassess the need for treatment with Dicloreum. Additionally, your doctor may prescribe periodic tests to monitor your condition during treatment with Dicloreum.
Inform your doctor if, during treatment with Dicloreum, you develop:

skin reactions, even severe ones, as very rarely serious skin reactions have been reported, which may even be fatal
fluid retention and swelling due to fluid accumulation (edema)
signs and symptoms of liver problems or if liver function test results are abnormal (blood test results)
unusual stomach or intestinal symptoms, especially at the beginning of treatment with Dicloreum. In such cases, your doctor will evaluate whether to continue or discontinue treatment with Dicloreum.

Also, take particular care:

At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulceration, or perforation may occur, which can also be fatal. Your doctor will prescribe the lowest effective dose of diclofenac to reduce the risk of gastrointestinal toxicity and may also prescribe medicines to protect the gastrointestinal mucosa (e.g. misoprostol or proton pump inhibitors).
Side effects can be minimized by using the lowest effective dose for the shortest possible duration (see section 3 “How to take Dicloreum”).
Avoid using diclofenac during treatment with other NSAIDs taken orally, by injection, or rectally, including selective COX-2 inhibitors, as this increases the risk of adverse effects.
Dicloreum may mask the signs and symptoms of infection.

Elderly patients
Elderly patients are more likely to experience adverse reactions, particularly gastrointestinal bleeding and perforation, which are usually more severe and may be fatal. Inform your doctor of any unusual stomach or intestinal symptoms, especially at the beginning of treatment with this medicine.
If you are elderly, particularly if frail and underweight, your doctor will prescribe a low dose of Dicloreum.
Other medicines and Dicloreum
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 Dicloreum:

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

The blood pressure-lowering effect of the following medicines may decrease when used together with Dicloreum:

medicines used to lower blood pressure or increase urine production (diuretics), beta-blockers, or angiotensin-converting enzyme inhibitors (ACE inhibitors)
Your doctor will monitor you closely and carefully consider combining these medicines with Dicloreum, especially if you are elderly. Your doctor will monitor you and may order tests if you need to take one or more of the following medicines together with Dicloreum:
blood pressure-lowering medicines or ACE inhibitors and angiotensin II receptor antagonists, and if you have kidney problems or potassium-sparing agents (e.g. spironolactone)
other non-steroidal anti-inflammatory drugs
corticosteroids (hormone-like medicines used, for example, to reduce inflammation)
blood-thinning medicines (anticoagulants or antiplatelet agents)
selective serotonin reuptake inhibitors (antidepressants)
diabetes medicines
cyclosporine (an immunosuppressant used to modify the body’s immune response)
antibacterial medicines of the quinolone class
colestipol and cholestyramine, as they may delay or reduce diclofenac absorption. Your doctor will advise you when to take these medicines; generally, diclofenac should be taken 1 hour before or 4–6 hours after colestipol and cholestyramine
strong CYP2C9 inhibitors, e.g. sulfinpyrazone and voriconazole.

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
Do not take Dicloreum during the last 3 months of pregnancy (during the third trimester) as it may harm the fetus or cause delivery complications. It may cause problems with the baby’s heart, lungs, and kidneys. It may affect your and your baby’s tendency to bleed and may delay or prolong labor beyond the expected duration.
Do not take Dicloreum during the first and second trimesters of pregnancy unless strictly necessary and under medical advice, as it may increase the risk of miscarriage and birth defects.
The risk increases with higher doses and longer duration of diclofenac therapy. 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 week 20 of pregnancy, diclofenac 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 is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Diclofenac passes into breast milk in small amounts; therefore, do not use Dicloreum during breastfeeding to avoid potential adverse effects on the newborn.
Fertility
As with other NSAIDs, do not use Dicloreum if you are planning a pregnancy, as this medicine may impair fertility. Your doctor will assess whether treatment with Dicloreum should be discontinued if you experience difficulty conceiving or are undergoing fertility testing.
Driving and using machines
Diclofenac 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.
Dicloreum contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially ‘sodium-free’.

3. How to take Dicloreum

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Dicloreum tablets must be swallowed whole with some liquid and must not be crushed,
split, or chewed.
Use in adults
Initial therapy: the recommended dose is 1 tablet 3 times a day.
Long-term therapy: the recommended dose is 1 tablet 2 times a day, taken in the morning and evening.
Your doctor will advise you whether the dosage may be further reduced. Take Dicloreum preferably during or
after meals (breakfast and dinner).
Use in the elderly
A reduced dose of diclofenac may be necessary in elderly patients. Your doctor will advise you on how much Dicloreum you should take.
Use in children and adolescents
Dicloreum must not be used in children and adolescents under 14 years of age.
If you take more Dicloreum than you should
If you accidentally take an excessive dose of Dicloreum, inform your doctor immediately or go to the nearest hospital.
If you take an overdose of diclofenac, you may experience vomiting, gastrointestinal bleeding,
diarrhea, dizziness, tinnitus, 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, according to the symptoms you present.
If you forget to take Dicloreum
Do not take a double dose to make up for the missed dose.
If you stop taking Dicloreum
If you have any doubts about using 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 Dicloreum and inform your doctor immediately if you notice any of the following serious side effects. You may need urgent medical treatment:

severe skin allergic reactions that may include extensive red and/or dark patches spreading across the skin, skin swelling, blisters, and itching sensation (Fixed drug eruption with generalized bullous presentation)
mild cramps and abdominal tenderness occurring shortly after starting treatment with Dicloreum, 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)
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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

headache, dizziness
vertigo
nausea, vomiting
diarrhoea, gas (flatulence)
digestive problems (dyspepsia), abdominal pain
loss of appetite or reduced appetite (anorexia)
abnormal results in blood tests (increase in certain liver enzymes: transaminases)
skin rash

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

allergic reactions, severe allergic reactions (anaphylaxis), including hypotension and 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
diarrhoea accompanied by bleeding, blood in the stool
inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders
urticaria
oedema (swelling due to fluid accumulation)

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

abnormal blood test results: low platelet count (thrombocytopenia), reduced white blood cell count (leucopenia), reduced red blood cell count (anaemia, including haemolytic and aplastic anaemia), reduced granulocyte count (agranulocytosis)
abnormal urine test results: presence of blood in urine (haematuria), presence of protein in 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 (delirium, hallucinations)
memory impairment, excitement, seizures, anxiety, tremors
tingling sensations (paraesthesia)
taste disturbances
inflammation of the membranes covering the brain (aseptic meningitis), damage to blood vessels in the brain
vision disorders, blurred vision, double vision
ringing or buzzing in the ears (tinnitus), worsening of hearing
awareness of your heartbeat (palpitations), chest pain, heart problems (heart failure), heart attack
high blood pressure, inflammation of blood vessels (vasculitis)
pneumonia
inflammation of the colon (colitis), including colitis with bleeding, worsening of ulcerative proctocolitis or Crohn's disease
constipation
inflammation of the mouth mucosa (stomatitis), including stomatitis with ulcers, inflammation of the tongue (glossitis)
oesophageal problems, intestinal narrowing
inflammation of the pancreas (pancreatitis)
very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (hepatic failure)
various types of skin reactions (redness, blistering, peeling, etc.), ranging from mild to potentially fatal
appearance of red-brown spots on the skin (purpura), also as an allergic reaction
itching (pruritus)
hair loss
skin sensitivity to sunlight
kidney problems such as acute kidney failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis
fatigue

Frequency not known (frequency cannot be estimated from the available data)

A skin allergic reaction that may include round or oval-shaped red patches with skin redness and swelling, blistering rash, and itching sensation (Fixed drug eruption). Darkening of the skin in the affected areas may also occur, which could persist after healing. Fixed drug eruptions usually recur at the same site (or 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Dicloreum

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not use this medicine if the packaging is open or damaged.
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 Dicloreum contains

The active substance is sodium diclofenac. Each tablet contains 50 mg of sodium diclofenac.
The other components are microcrystalline cellulose, monohydrate lactose, pregelatinized starch, magnesium stearate, cellulose acetate phthalate, diethyl phthalate, titanium dioxide, povidone.

Description of the appearance of Dicloreum and pack contents
Each package contains 30 tablets for oral use.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Alfasigma S.p.A. – Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)

Patient Information Leaflet

Dicloreum 100 mg prolonged-release tablets

sodium diclofenac
Equivalent medicine
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 could be harmful.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Dicloreum is and what it is used for
What you need to know before taking Dicloreum
How to take Dicloreum
Possible side effects
How to store Dicloreum
Package contents and other information

1. What Dicloreum is and what it is used for

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

joint diseases such as rheumatoid arthritis and osteoarthritis
muscle, tendon and bone disorders such as periarthritis, bursitis, tendinitis, myositis, lumbosciatica
inflammation and swelling following injuries.

Consult your doctor if you do not feel better or if you feel worse after the prescribed treatment period.

2. What you need to know before taking Dicloreum

DO NOT take Dicloreum

if you are allergic to sodium diclofenac, or to other non-steroidal anti-inflammatory drugs (NSAIDs), particularly acetylsalicylic acid, or to painkillers (analgesics), fever-reducing medicines (antipyretics), or to any of the other ingredients of this medicine (listed in section 6)
if you have liver problems (e.g. severe hepatic insufficiency)
if you have a stomach or intestinal ulcer, bleeding, or perforation
if you have experienced gastrointestinal bleeding or perforation 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 are in the last trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”)
if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”)
if you have severe kidney problems (severe renal insufficiency)
if you have confirmed heart problems or cerebrovascular disease (cerebral vasculopathy), for example if you have had a heart attack, stroke, or mini-stroke (also known as transient ischemic attack, TIA)
if you have obstruction of blood vessels supplying the heart or brain, or have undergone surgery to remove or prevent such obstructions
if you have or have had peripheral arterial disease (peripheral arteriopathy)
if you currently have bleeding or are predisposed to bleeding
if you have experienced asthma attacks, chest pain, hives, or acute rhinitis after taking acetylsalicylic acid or other NSAIDs
if you have a blood cell production disorder
if you are taking high doses of diuretics (medicines that increase urine production) (see section “Other medicines and Dicloreum”)

Do not administer Dicloreum to children under 14 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dicloreum.
Inform your doctor before taking Dicloreum if:

you have ever developed severe skin rash or skin peeling, or skin rash with blisters and/or mouth ulcers after taking Dicloreum or other analgesics
you have or have had high blood pressure
you have or have had heart, brain, or blood vessel problems (e.g. congestive heart failure, confirmed cardiomyopathy, peripheral arterial disease, and/or stroke)
you have risk factors for cardiovascular, cerebrovascular, or blood vessel events (e.g. high blood pressure, diabetes, smoking, high cholesterol or triglycerides, etc.)
you have chest pain (angina), blood clots
you have had thrombosis or embolism
you have blood coagulation disorders (hemostasis defects)
you have kidney problems (e.g. renal hypoperfusion, renal insufficiency), except in cases of severe kidney problems (severe renal insufficiency), as you must not take Dicloreum (see section “DO NOT take Dicloreum”)
you are taking diuretics (medicines that increase urine production) or other medicines that may affect kidney function
you are taking medicines that may increase the risk of bleeding, ulceration, and perforation, such as acetylsalicylic acid (e.g. aspirin), corticosteroids taken orally, by injection, or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), or selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Dicloreum”)
you have or have had stomach or intestinal problems (e.g. ulcer), or have had stomach or intestinal ulceration, bleeding, or perforation, as Dicloreum may not be suitable for you
you have ulcerative colitis or Crohn’s disease, as these conditions may worsen
you have recently undergone or are about to undergo stomach or intestinal surgery, as Dicloreum may sometimes impair wound healing in the intestine after surgery
you have asthma or are prone to asthma, as this medicine may cause respiratory distress (bronchospasm attacks), and in some cases shock or other allergic reactions
you have seasonal allergic rhinitis, nasal mucosa swelling (e.g. nasal polyps)
you have chronic obstructive pulmonary disease or chronic respiratory tract infections
you have or have had liver problems (e.g. hepatic insufficiency), except in cases of severe liver problems (severe hepatic insufficiency), as you must not take Dicloreum (see section “DO NOT take Dicloreum”)
you have hepatic porphyria
you have undergone major surgery
you have reduced body fluid volume (e.g. before or after major surgery)
you are underweight, as you will be prescribed a low dose of Dicloreum
you are elderly, particularly if frail and underweight, as you will be prescribed a low dose of Dicloreum (see section “Elderly patients”)

skin reactions, even severe ones, as serious, potentially fatal skin reactions have very rarely been reported
fluid retention and swelling due to fluid accumulation (edema)
signs or symptoms of liver problems or abnormal liver function test results (blood test results)
unusual stomach or intestinal symptoms, especially at the beginning of treatment with Dicloreum. In such cases, your doctor will assess whether to continue or discontinue treatment with Dicloreum.

Also, pay particular attention to the following:

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 minimize gastrointestinal toxicity and may also prescribe medicines to protect the gastrointestinal mucosa (e.g. misoprostol or proton pump inhibitors).
Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration (see section 3 “How to take Dicloreum”).
Avoid using diclofenac during treatment with other NSAIDs taken orally, by injection, or rectally, including selective COX-2 inhibitors, as this increases the risk of adverse effects.
Dicloreum may mask the signs and symptoms of infection.

Elderly patients
Elderly patients have a higher likelihood of experiencing adverse reactions, particularly gastrointestinal bleeding and perforation, which are generally more severe and potentially fatal. Inform your doctor of any unusual stomach or intestinal symptoms, especially at the beginning of treatment with this medicine.
If you are elderly, particularly if frail and underweight, your doctor will prescribe a low dose of Dicloreum.
Other medicines and Dicloreum
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 Dicloreum:

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

The blood pressure-lowering effect of the following medicines may decrease when used together with Dicloreum:

medicines used to lower blood pressure, diuretics (medicines that increase urine production), beta-blockers, or angiotensin-converting enzyme (ACE) inhibitors
Your doctor will monitor you closely and carefully evaluate the use of these medicines with Dicloreum, especially if you are elderly. Your doctor will monitor you and may order tests if you need to take one or more of the following medicines together with Dicloreum:
blood pressure-lowering medicines or ACE inhibitors and angiotensin II antagonists, and if you have kidney problems or potassium-sparing agents (e.g. spironolactone)
other non-steroidal anti-inflammatory drugs
corticosteroids (hormone-like medicines used, for example, to reduce inflammation)
blood-thinning medicines (anticoagulants or antiplatelets)
serotonin reuptake inhibitors (antidepressants)
diabetes medicines
cyclosporine (an immunosuppressant used to modify the body’s immune response)
antibiotics of the quinolone class
colestipol and cholestyramine, as they may delay or reduce the absorption of diclofenac. Your doctor will advise you when to take these medicines; generally, diclofenac should be taken 1 hour before or 4–6 hours after taking colestipol or cholestyramine
strong CYP2C9 inhibitors, e.g. sulfinpyrazone and voriconazole.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
DO NOT take Dicloreum during the last three months of pregnancy (during the third trimester), as it may harm the fetus or cause problems during delivery. It may cause heart, lung, or kidney problems in the fetus. It may affect your and your baby’s tendency to bleed and delay or prolong labor beyond normal.
Do not take Dicloreum during the first and second trimesters of pregnancy unless strictly necessary and under medical advice, as it may increase the risk of miscarriage and birth defects. The risk increases with higher doses and longer duration of diclofenac therapy. 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 week 20 of pregnancy, diclofenac may cause kidney problems in the fetus if taken for more than a few days, leading to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.
Breastfeeding
Diclofenac passes into breast milk in small amounts; therefore, do not use Dicloreum during breastfeeding to avoid potential adverse effects on the infant.
Fertility
As with other NSAIDs, do not use Dicloreum if you are planning a pregnancy, as this medicine may impair fertility. Your doctor will assess whether treatment with Dicloreum should be discontinued if you experience difficulty conceiving or require fertility testing.
Driving and using machines
Diclofenac 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.
Dicloreum contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially ‘sodium-free’.

3. How to take Dicloreum

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dicloreum tablets must be taken whole with some liquid and must not be crushed, split, or chewed.

Use in adults
The recommended dose is 1 tablet daily, taken after breakfast.

Use in the elderly
In elderly patients, a reduced dose of diclofenac may be necessary. Your doctor will tell you how much Dicloreum you should take.

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

If you take more Dicloreum than you should
If you accidentally take too much Dicloreum, contact your doctor immediately or go to the nearest hospital.
If you take an excessive dose of diclofenac, you may experience vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus (ringing in the ears), or seizures. In severe cases, serious kidney and 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 present.

If you forget to take Dicloreum
Do not take a double dose to make up for the missed dose.

If you stop taking Dicloreum
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 Dicloreum and contact your doctor immediately if you notice any of the following serious side effects. You may require urgent medical treatment:

severe skin allergic reaction which may include extensive red and/or dark patches, swelling of the skin, blisters, and itching sensation (Fixed generalized bullous drug eruption)
mild abdominal cramps and tenderness occurring shortly after starting Dicloreum treatment, 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)
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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 or reduction of appetite (anorexia)
abnormal blood test results (increased levels of certain liver enzymes: transaminases)
skin rash

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

allergic reactions, severe allergic reactions (anaphylaxis), including hypotension and shock
drowsiness
asthma, breathing difficulties (dyspnoea)
inflammation of the stomach (gastritis), bleeding from the stomach or intestine, vomiting blood, stomach or intestinal ulcer with or without bleeding and perforation
diarrhoea accompanied by bleeding, 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)

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

abnormal blood test results: low platelet count (thrombocytopenia), reduced white blood cell count (leucopenia), reduced red blood cell count (anaemia, including haemolytic and aplastic anaemia), reduced granulocyte count (agranulocytosis)
abnormal urine test results: presence of blood in urine (haematuria), presence of protein in 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 (delirium, hallucinations)
memory impairment, excitement, convulsions, anxiety, tremors
tingling sensations (paraesthesia)
taste disturbances
inflammation of the membranes covering the brain (aseptic meningitis), damage to blood vessels in the brain
vision disturbances, blurred vision, double vision
ringing or buzzing in the ears (tinnitus), worsening of hearing
awareness of your heartbeat (palpitations), chest pain, heart problems (heart failure), heart attack
high blood pressure, inflammation of blood vessels (vasculitis)
pneumonia
inflammation of the colon (colitis), including colitis with bleeding, worsening of ulcerative proctocolitis or Crohn's disease
constipation
inflammation of the mouth mucosa (stomatitis), including stomatitis with ulcers, inflammation of the tongue (glossitis)
oesophageal problems, intestinal narrowing
inflammation of the pancreas (pancreatitis)
very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (liver failure)
various types of skin reactions (redness, blistering, peeling, etc.), ranging from mild to potentially fatal
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
fatigue

Frequency not known (frequency cannot be estimated from available data)

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 (Drug-induced fixed eruption). Darkening of the skin in the 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.

Reporting of side effects
If you experience any side effects, 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 Dicloreum

6. Package contents and other information

What Dicloreum contains

The active substance is sodium diclofenac. Each tablet contains 100 mg of sodium diclofenac.
The other components are talc, ethylcellulose, magnesium stearate, povidone, hydroxypropylcellulose, diethyl phthalate, titanium dioxide.

Description of the appearance of Dicloreum and package contents
Each package contains 20 tablets for oral use.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Alfasigma S.p.A. – Via Ragazzi del ‘99, n. 5 - 40133 Bologna (BO)
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)

Package leaflet: Information for the patient

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

diclofenac sodium
Equivalent medicinal product
Please read this leaflet carefully before using this medicine as 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:

What Dicloreum is and what it is used for
What you need to know before using Dicloreum
How to use Dicloreum
Possible side effects
How to store Dicloreum
Contents of the pack and other information

1. What Dicloreum is and what it is used for

severe pain due to inflammation of the joints, muscles and bones
muscle spasms.

If you do not feel better or if you feel worse after the prescribed treatment period, consult your doctor.

2. What you need to know before using Dicloreum

DO NOT use Dicloreum

if you are allergic to sodium diclofenac, or to other non-steroidal anti-inflammatory drugs (NSAIDs), and in particular to acetylsalicylic acid, or to painkillers (analgesics), fever-reducing medicines (antipyretics), sodium metabisulfite, or to any of the other ingredients of this medicine (listed in section 6)
if you have had liver problems (e.g. severe hepatic insufficiency)
if you have a stomach or intestinal ulcer, bleeding, or perforation
if you have previously experienced gastrointestinal bleeding or perforation after taking NSAIDs
if you have had recurrent stomach or duodenal bleeding/ulceration (two or more distinct episodes of proven ulceration or bleeding)
if you are in the last trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”)
if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”)
if you have severe kidney problems (severe renal insufficiency)
if you have confirmed heart or cerebral blood vessel problems (cerebrovascular disease), for example if you have had a heart attack, stroke, or mini-stroke (also known as transient ischemic attack, TIA)
if you have obstruction of blood vessels supplying the heart or brain, or have undergone a procedure to remove or prevent such blockages
if you have current or past problems with arterial blood circulation (peripheral arterial disease)
if you currently have bleeding or a tendency to bleed
if you have experienced asthma attacks, chest pain, hives, or acute rhinitis after taking acetylsalicylic acid or other NSAIDs
if you have a blood cell production disorder
if you are taking high doses of medicines that increase urine production (diuretics) (see section “Other medicines and Dicloreum”)

Do not administer Dicloreum to children under 14 years of age
Warnings and precautions
Talk to your doctor or pharmacist before using Dicloreum.
Inform your doctor before using Dicloreum:

if you have ever developed severe skin rash, skin peeling, or blistering rash and/or mouth ulcers after taking Dicloreum or other analgesics
if you have or have had high blood pressure
if you have heart, brain, or blood vessel problems (e.g. congestive heart failure, confirmed cardiomyopathy, peripheral arterial disease, and/or stroke)
if you have risk factors for adverse events affecting the heart, brain, or blood vessels (e.g. high blood pressure, diabetes, smoking, high cholesterol or triglycerides, etc.)
if you have chest pain (angina), blood clots
if you have had thrombosis or embolism
if you have blood clotting disorders (hemostasis defects)
if you have kidney problems (e.g. renal hypoperfusion, renal insufficiency), except in cases of severe kidney problems (severe renal insufficiency), as you must not use Dicloreum (see section “Do not use Dicloreum”)
if you are taking medicines that increase urine production (diuretics) or other medicines that may affect kidney function
if you are taking medicines that may increase the risk of bleeding, ulceration, and perforation, such as acetylsalicylic acid (e.g. aspirin), corticosteroids taken orally, by injection, or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), or selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Dicloreum”)
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, as Dicloreum may not be suitable for you
if you have ulcerative colitis or Crohn’s disease, as these conditions may worsen
if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract, as Dicloreum may sometimes impair wound healing in the intestine after surgery
if you have asthma or are prone to it, as this medicine may cause respiratory distress (bronchospasm attacks) and, in some cases, shock or other allergic reactions
if you have seasonal allergic rhinitis, or nasal mucosa swelling (e.g. nasal polyps)
if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
if you have or have had liver problems (e.g. hepatic insufficiency), except in cases of severe liver problems (severe hepatic insufficiency), as you must not use Dicloreum (see section “Do not use Dicloreum”)
if you have hepatic porphyria
if you have undergone major surgical procedures
if you have reduced body fluid volume (e.g. before or after major surgery)
if you are underweight, as you will be prescribed a low dose of Dicloreum
if you are elderly, particularly if frail and underweight, as you will be prescribed a low dose of Dicloreum (see section “Elderly patients”)

skin reactions, even severe ones, as serious, potentially life-threatening skin reactions have very rarely been reported
fluid retention and swelling due to fluid accumulation (edema)
signs and symptoms of liver problems or if liver function tests are abnormal (blood test results)
unusual stomach or intestinal symptoms, especially at the beginning of treatment with Dicloreum. In such cases, your doctor will evaluate whether to continue or discontinue treatment with Dicloreum.

Also, 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 minimize the risk of gastrointestinal toxicity and may also prescribe medicines to protect the gastrointestinal mucosa (e.g. misoprostol or proton pump inhibitors).
Side effects can be minimized by using the lowest effective dose for the shortest possible duration (see section 3 “How to use Dicloreum”).
Avoid using diclofenac during treatment with other NSAIDs taken orally, by injection, or rectally, including selective COX-2 inhibitors, as this increases the risk of adverse effects.
Dicloreum may mask signs and symptoms of infection.

Elderly patients
Elderly patients have a higher risk of adverse reactions, particularly gastrointestinal bleeding and perforation, which are generally more severe and may be fatal. Inform your doctor of any unusual stomach or intestinal symptoms, especially at the beginning of treatment with this medicine.
If you are elderly, particularly if frail and underweight, your doctor will prescribe a low dose of Dicloreum.
Other medicines and Dicloreum
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 Dicloreum:

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

The blood pressure-lowering effect of the following medicines may decrease when used together with Dicloreum:

medicines used to lower blood pressure, diuretics (medicines that increase urine production), beta-blockers, or angiotensin-converting enzyme inhibitors (ACE inhibitors)
Your doctor will monitor you closely and carefully consider co-administration of these medicines with Dicloreum, especially if you are elderly. Your doctor will monitor you and may order tests if you need to take one or more of the following medicines together with Dicloreum:
blood pressure-lowering medicines or ACE inhibitors and angiotensin II receptor antagonists, especially if you have kidney problems or potassium-sparing agents (e.g. spironolactone)
other non-steroidal anti-inflammatory drugs (NSAIDs)
corticosteroids (hormone-type medicines used, for example, to reduce inflammation)
blood-thinning medicines (anticoagulants or antiplatelet agents)
serotonin reuptake inhibitors (antidepressants)
diabetes medicines
cyclosporine (an immunosuppressant used to modify the body's immune response)
antibiotics of the quinolone class
colestipol and cholestyramine, as they may delay or reduce diclofenac absorption. Your doctor will advise you when to take these medicines; generally, diclofenac should be taken 1 hour before or 4–6 hours after colestipol or cholestyramine
strong CYP2C9 inhibitors, e.g. sulfinpyrazone and voriconazole.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Dicloreum during the last three months of pregnancy (during the third trimester), as it may harm the fetus or cause complications during delivery. It may cause problems with the baby’s heart, lungs, and kidneys. It may affect your and your baby’s tendency to bleed and may delay or prolong labor beyond the expected duration.
Do not use Dicloreum during the first and second trimesters of pregnancy unless strictly necessary and under medical advice, as it may increase the risk of miscarriage and birth defects. The risk increases with higher doses and longer duration of diclofenac therapy. 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 week 20 of pregnancy, diclofenac 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 is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Diclofenac passes into breast milk in small amounts; therefore, do not use Dicloreum during breastfeeding to avoid adverse effects on the infant.
Fertility
As with other NSAIDs, do not use Dicloreum if you are planning a pregnancy, as this medicine may affect fertility. Your doctor will assess whether treatment with Dicloreum should be discontinued if you experience difficulty conceiving or require fertility testing.
Driving and using machines
Diclofenac may cause visual disturbances, dizziness, vertigo, drowsiness, or other disturbances that may impair your ability to drive or operate machinery.
If you experience these symptoms, avoid driving or operating machinery.
Dicloreum contains benzyl alcohol, propylene glycol, sodium metabisulfite, sodium
This medicine contains 119 mg of benzyl alcohol per vial. Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
This medicine contains 581 mg of propylene glycol per vial.
Dicloreum contains sodium metabisulfite. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is essentially ‘sodium-free’.

3. How to use Dicloreum

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Use in adults
The recommended dose is 1 injection (1 vial of 75 mg) per day, administered into the upper part of the buttock. Change side each time you give the injection and strictly follow hygiene procedures when preparing and administering the injection.
In more severe cases, your doctor may prescribe 2 injections per day.
As soon as possible, your doctor will tell you to stop the injections and will prescribe diclofenac in tablet form.

Use in the elderly
In elderly patients, a reduced dose of diclofenac may be necessary. Your doctor will advise you on how much Dicloreum to use.

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

If you use more Dicloreum than you should
If you accidentally ingest or use an excessive dose of Dicloreum, contact your doctor immediately or go to the nearest hospital.
If you use an excessive dose of diclofenac, you may experience vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus (ringing or buzzing in the ears), or seizures. In 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 use Dicloreum
Do not use a double dose to make up for a forgotten dose.

If you stop using Dicloreum
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Some side effects may be serious.
Stop taking Dicloreum and contact your doctor immediately if you notice any of the following serious side effects. You may need urgent medical care:

a severe allergic skin reaction which may include widespread red and/or dark patches, swelling of the skin, blisters, and itching sensation (Generalized fixed bullous eruption due to drugs)
mild cramps and abdominal pain occurring shortly after starting treatment with Dicloreum, 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)
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome. Contact your doctor immediately if you notice: Reactions at the injection site, including pain, redness, swelling, hard nodule, ulcers, and bruising. These reactions may worsen with skin and underlying tissue surrounding the injection site turning dark and dying, eventually healing with scarring; this condition is known as Nicolau syndrome.

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 or reduction of appetite (anorexia)
abnormal results in blood tests (increase in certain liver enzymes: transaminases)
skin rash
reactions, pain, and hardening at the injection site

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

allergic reactions, severe allergic reactions (anaphylaxis) including hypotension and 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
diarrhoea accompanied by bleeding, blood in the stool
inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes, and eyes (jaundice), liver disorders
urticaria
oedema (swelling due to fluid accumulation)

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

abnormal blood test results: low platelet count (thrombocytopenia), reduced white blood cell count (leucopenia), reduced red blood cell count (anaemia, including haemolytic and aplastic anaemia), reduced granulocyte count (agranulocytosis)
abnormal urine test results: presence of blood in urine (haematuria), presence of protein in 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 (delirium, hallucinations)
memory impairment, excitement, seizures, anxiety, tremors
tingling sensations
taste disturbances
inflammation of the membranes covering the brain (aseptic meningitis), damage to blood vessels in the brain
vision disorders, blurred vision, double vision
ringing or buzzing in the ears, worsening of hearing
awareness of your heartbeat (palpitations), chest pain, heart problems (heart failure), heart attack
high blood pressure, inflammation of blood vessels (vasculitis)
pneumonia
inflammation of the colon (colitis), including colitis with bleeding, worsening of ulcerative proctocolitis or Crohn’s disease
constipation
inflammation of the mouth lining (stomatitis), including stomatitis with ulcers, inflammation of the tongue (glossitis)
problems with the oesophagus, intestinal narrowing
inflammation of the pancreas (pancreatitis)
a very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (liver failure)
various types of skin reactions (redness, blistering, peeling, etc.), ranging from mild to potentially fatal
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
fatigue
accumulation of pus (abscess) at the injection site.

Frequency not known (frequency cannot be estimated from available data)

A skin allergic reaction, which may include round or oval patches with redness and swelling of the skin, skin rash with blisters, and itching (Drug-induced fixed eruption). Darkening of the skin in the 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
tissue damage at the injection site.

Reporting of side effects
If you get any side effects, including ones 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 Dicloreum

Keep the medicine away from light and heat.
This medicine does not require any special storage temperature.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not use this medicine if the packaging has been opened or damaged.
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 Dicloreum contains

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

Description of the appearance of Dicloreum and contents of the pack
Each pack contains 6 vials of solution for intramuscular injection.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Alfasigma S.p.A. – Via Ragazzi del ‘99, n. 5 - 40133 Bologna (BO)
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)

Patient Information Leaflet

Dicloreum 150 mg prolonged-release hard capsules

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 any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Dicloreum is and what it is used for
What you need to know before taking Dicloreum
How to take Dicloreum
Possible side effects
How to store Dicloreum
Contents of the pack and other information

1. What Dicloreum is and what it is used for

joint diseases such as rheumatoid arthritis and osteoarthritis
muscle, tendon and bone disorders such as periarthritis, bursitis, tendinitis, myositis, lumbosciatica
inflammation and swelling following trauma.

Consult your doctor if you do not feel better or if you feel worse after the prescribed treatment period.

2. What you should know before taking Dicloreum

DO NOT take Dicloreum

if you are allergic to sodium diclofenac, or to other non-steroidal anti-inflammatory drugs (NSAIDs), particularly acetylsalicylic acid, or to medicines used to relieve pain (analgesics), reduce fever (antipyretics), or to any of the other ingredients of this medicine (listed in section 6)
if you have liver problems (e.g. severe hepatic insufficiency)
if you have a stomach or intestinal ulcer, bleeding, or perforation
if you have had gastrointestinal bleeding or perforation following previous treatment with NSAIDs
if you have had recurrent bleeding/ulceration of the stomach or duodenum (two or more distinct episodes of confirmed ulceration or bleeding)
if you are in the last trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”)
if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”)
if you have severe kidney problems (severe renal insufficiency)
if you have confirmed heart problems or cerebrovascular disease, for example if you have had a heart attack, stroke, or mini-stroke (also known as transient ischemic attack, TIA)
if you have a blockage in the blood vessels supplying the heart or brain, or have undergone a procedure to remove or prevent such blockages
if you have or have had peripheral arterial disease (poor blood circulation in the arteries)
if you currently have bleeding or a tendency to bleed
if you have previously experienced asthma attacks, chest pain, hives, or acute rhinitis after taking acetylsalicylic acid or other NSAIDs
if you have a blood cell production disorder
if you are taking high doses of medicines that increase urine production (diuretics) (see section “Other medicines and Dicloreum”)

Do not administer Dicloreum to children under 14 years of age
Warnings and precautions
Talk to your doctor or pharmacist before taking Dicloreum.
Tell your doctor before taking Dicloreum:

if you have ever developed severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking Dicloreum or other analgesics
if you have or have had high blood pressure
if you have or have had heart, brain, or blood vessel problems (e.g. congestive heart failure, confirmed cardiomyopathy, peripheral arterial disease, and/or stroke)
if you have risk factors for adverse cardiovascular, cerebrovascular, or vascular events (e.g. high blood pressure, diabetes, smoking, high cholesterol or triglycerides, etc.)
if you have chest pain (angina), blood clots
if you have had blood clots (thrombosis) or embolism
if you have blood clotting disorders (hemostatic defects)
if you have kidney problems (e.g. renal hypoperfusion, renal insufficiency), except if you have severe kidney problems (severe renal insufficiency), in which case you must not take Dicloreum (see section “DO NOT take Dicloreum”)
if you are taking medicines that increase urine production (diuretics) or other medicines that may affect kidney function
if you are taking medicines that may increase the risk of bleeding, ulceration, and perforation, such as acetylsalicylic acid (e.g. aspirin), corticosteroids taken orally, by injection, or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), or selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Dicloreum”)
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, as Dicloreum may not be suitable for you
if you have ulcerative colitis or Crohn’s disease, as these conditions may worsen
if you have recently undergone or are about to undergo stomach or intestinal surgery, as Dicloreum may sometimes impair wound healing in the intestine after surgery
if you have asthma or are predisposed to it, as this medicine may cause respiratory distress (bronchospasm attacks) and, in some cases, shock or other allergic reactions
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 or have had liver problems (e.g. hepatic insufficiency), except if you have had severe liver problems (severe hepatic insufficiency), in which case you must not take Dicloreum (see section “DO NOT take Dicloreum”)
if you have hepatic porphyria
if you have undergone major surgery
if you have reduced body fluid volume (e.g. before or after major surgery)
if you are underweight, as you will be prescribed a low dose of Dicloreum
if you are elderly, particularly if frail and underweight, as you will be prescribed a low dose of Dicloreum (see section “Elderly patients”)

skin reactions, even severe ones, as serious, potentially fatal skin reactions have very rarely been reported
fluid retention and swelling due to fluid accumulation (edema)
signs and symptoms of liver problems or if liver function test results are abnormal
unusual stomach or intestinal symptoms, especially at the beginning of treatment with Dicloreum. In such cases, your doctor will assess whether to continue or discontinue Dicloreum treatment.

Additionally, take special care:

At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulceration, or perforation may occur, which can also be fatal. Your doctor will prescribe the lowest effective dose of diclofenac to minimize gastrointestinal toxicity and may also prescribe medicines to protect the gastrointestinal mucosa (e.g. misoprostol or proton pump inhibitors).
Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration (see section 3 “How to take Dicloreum”).
Avoid using diclofenac during treatment with other NSAIDs taken orally, by injection, or rectally, including selective COX-2 inhibitors, as this increases the risk of adverse effects.
Dicloreum may mask signs and symptoms of infection.

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

The blood pressure-lowering effect of the following medicines may decrease when used together with Dicloreum:

medicines used to lower blood pressure or diuretics (medicines that increase urine production), beta-blockers, or angiotensin-converting enzyme inhibitors (ACE inhibitors)
Your doctor will monitor you closely and carefully evaluate the concurrent use of these medicines with Dicloreum, especially if you are elderly. Your doctor will monitor you and may order tests if you need to take one or more of the following medicines together with Dicloreum:
blood pressure-lowering medicines or ACE inhibitors and angiotensin II receptor antagonists, especially if you have kidney problems or are taking potassium-sparing agents (e.g. spironolactone)
other non-steroidal anti-inflammatory drugs
corticosteroids (hormone-like medicines used, for example, to reduce inflammation)
blood-thinning medicines (anticoagulants or antiplatelet agents)
serotonin reuptake inhibitors (antidepressants)
diabetes medicines
cyclosporine (an immunosuppressant used to modify the body’s immune response)
antibiotics of the quinolone class
colestipol and cholestyramine, as they may delay or reduce diclofenac absorption. Your doctor will advise you when to take these medicines; generally, diclofenac should be taken 1 hour before or 4–6 hours after colestipol or cholestyramine
strong CYP2C9 inhibitors, e.g. sulfinpyrazone and voriconazole.

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
Do not take Dicloreum during the last three months of pregnancy (third trimester), as it may harm the fetus or cause complications during delivery. It may cause problems with the baby’s heart, lungs, and kidneys. It may affect your and your baby’s tendency to bleed and may delay or prolong labor.
Do not take Dicloreum during the first and second trimesters of pregnancy unless absolutely necessary and under medical advice, as it may increase the risk of miscarriage and birth defects. The risk increases with higher doses and longer duration of diclofenac treatment. 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 week 20 of pregnancy, diclofenac may cause fetal kidney problems if taken for more than a few days, leading to reduced amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Diclofenac passes into breast milk in small amounts; therefore, do not use Dicloreum during breastfeeding to avoid potential adverse effects on the infant.
Fertility
As with other NSAIDs, do not use Dicloreum if you are planning a pregnancy, as this medicine may impair fertility. Your doctor will assess whether treatment with Dicloreum should be discontinued if you experience difficulty conceiving or require fertility testing.
Driving and using machines
Diclofenac 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.
Dicloreum contains sucrose, sodium
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially ‘sodium-free’.

3. How to take Dicloreum

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.
Use in adults
The recommended dose is 1 capsule per day, taken after breakfast.
Use in the elderly
In elderly patients, a reduced dose of diclofenac may be necessary. Your doctor will tell you how much Dicloreum you should take.
Use in children and adolescents
Dicloreum must not be used in children and adolescents under 14 years of age.
If you take more Dicloreum than you should
If you accidentally take too much Dicloreum, contact your doctor immediately or go to the nearest hospital.
If you take an excessive dose of diclofenac, you may experience vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus (ringing or buzzing in the ears), or seizures. In 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 Dicloreum
Do not take a double dose to make up for a forgotten dose.
If you stop taking Dicloreum
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some side effects may be serious.
Stop taking Dicloreum and inform your doctor immediately if you notice any of the following serious side effects. You may require urgent medical treatment:

a severe skin allergic reaction which may include widespread red and/or dark patches, skin swelling, blisters, and itching sensation (Fixed generalized bullous eruption due to drugs)
mild cramps and abdominal tenderness occurring shortly after starting treatment with Dicloreum, 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)
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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

headache, dizziness
vertigo
nausea, vomiting
diarrhoea, gas (flatulence)
digestive problems (dyspepsia), abdominal pain
loss or reduced appetite (anorexia)
abnormal results in blood tests (increase in certain liver enzymes: transaminases)
skin rash

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

allergic reactions, severe allergic reactions (anaphylaxis) including hypotension and shock
somnolence
asthma, breathing difficulties (dyspnoea)
inflammation of the stomach (gastritis), bleeding from the stomach or intestines, vomiting blood, stomach or intestinal ulcer with or without bleeding and perforation
diarrhoea accompanied by bleeding, blood in the stool
inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders
urticaria
oedema (swelling due to fluid accumulation)

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

abnormal blood test results: low platelet count (thrombocytopenia), reduced white blood cell count (leucopenia), reduced red blood cell count (anaemia, including haemolytic and aplastic anaemia), reduced granulocyte count (agranulocytosis)
abnormal urine test results: presence of blood in urine (haematuria), presence of protein in 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 (delirium, hallucinations)
memory disturbances, excitement, seizures, anxiety, tremors
tingling sensations
taste disturbances
inflammation of the membranes covering the brain (aseptic meningitis), damage to blood vessels in the brain
vision disturbances, blurred vision, double vision
ringing or buzzing in the ears, worsening of hearing
awareness of your heartbeat (palpitations), chest pain, heart problems (heart failure), heart attack
high blood pressure, inflammation of blood vessels (vasculitis)
pneumonia
inflammation of the colon (colitis), including colitis with bleeding, worsening of ulcerative proctocolitis or Crohn's disease
constipation
inflammation of the mouth mucosa (stomatitis), including stomatitis with ulcers, inflammation of the tongue (glossitis)
oesophageal problems, intestinal narrowing
inflammation of the pancreas (pancreatitis)
very severe and sudden onset hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (hepatic failure)
various skin reactions (redness, blistering, peeling, etc.), ranging from mild to potentially fatal
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
fatigue.

Frequency not known (frequency cannot be estimated from the available data)

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 (Drug-induced fixed eruption). Darkening of the skin in the 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.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Dicloreum

Do not store above 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. The expiry date refers to the last day of that month.
Do not use this medicine if the packaging is open or damaged.
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 Dicloreum contains

The active substance is sodium diclofenac. Each capsule contains 150 mg of sodium diclofenac.
The other components are sugar spheres (containing sucrose and maize starch), macrogol 4000, solid paraffin, methacrylic acid copolymers, talc, gelatin, indigotine (E132).

Description of the appearance of Dicloreum and contents of the pack
Each pack contains 20 capsules for oral use.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Alfasigma S.p.A. – Via Ragazzi del ‘99, n. 5 - 40133 Bologna (BO)
Manufacturer:
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)
Alfasigma S.p.A. – Via Pontina Km 30,400 – 00071 Pomezia (RM)