DICLOFENAC 50 mg Tablet

Зміст інструкції

1. Diclofenac Alfasigma 75 mg/3 ml injectable solution for intramuscular use
   1. What is Diclofenac Alfasigma and what is it used for
   2. What you need to know before using Diclofenac Alfasigma
   3. How to use Diclofenac Alfasigma
   4. Possible side effects
   5. How to store Diclofenac Alfasigma
   6. Contents of the pack and other information
2. Diclofenac Alfasigma 150 mg prolonged-release capsules
   1. What is Diclofenac Alfasigma and what is it used for
   2. What you need to know before taking Diclofenac Alfasigma
   3. How to take Diclofenac Alfasigma
   4. Possible side effects
   5. How to store Diclofenac Alfasigma
   6. Package Contents and Other Information
3. Diclofenac Alfasigma 50 mg tablets
   1. What is Diclofenac Alfasigma and what is it used for
   2. What you need to know before taking Diclofenac Alfasigma
   3. How to take Diclofenac Alfasigma
   4. Possible side effects
   5. How to store Diclofenac Alfasigma
   6. Contents of the pack and other information

Diclofenac Alfasigma 75 mg/3 ml injectable solution for intramuscular use

diclofenac sodium

Generic medicine
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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Diclofenac Alfasigma and what is it used for

Diclofenac Alfasigma contains the active ingredient diclofenac sodium, which belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs). Diclofenac sodium is used to reduce pain and inflammation.
Diclofenac Alfasigma is used to treat the symptoms:

• of severe pain in case of inflammation of the joints, muscles and bones
• of muscle contractions.

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 using Diclofenac Alfasigma

DO NOT use Diclofenac Alfasigma

• if you are allergic to diclofenac sodium, sodium metabisulfite or any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver problems (severe hepatic insufficiency)
• if you have an ulcer, bleeding or perforation of the stomach or intestine
• if you have had bleeding (hemorrhage) of the stomach or intestine or perforation after previous treatments with NSAIDs
• if you have had recurrent bleeding/ulcer in the stomach or duodenum (two or more distinct episodes of demonstrated ulceration or bleeding)
• if you have any serious problems with the stomach or intestine
• 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 blood vessels of the brain (cerebrovascular disease), for example if you have had a heart attack, stroke, mini-stroke (also called transient ischemic attack, TIA)
• if you have an obstruction of the blood vessels leading to the heart or brain or have undergone surgery to eliminate or prevent the formation of these obstructions
• if you have or have had problems with the arterial blood circulation (peripheral arteriopathy)
• if you have ongoing bleeding or if you have a predisposition to bleeding
• if you have had asthma attacks, chest pain, hives or acute rhinitis after taking acetylsalicylic acid or other NSAIDs
• if you have an alteration in the production of blood cells
• if you are taking high doses of medicines that increase urine production (diuretics) or medicines to thin the blood (anticoagulants) (see section “Other medicines and Diclofenac Alfasigma”)
• if you are under 14 years of age

Warnings and precautions
Consult your doctor or pharmacist before using Diclofenac Alfasigma.

Tell your doctor before using Diclofenac Alfasigma:

• if you suffer from high blood pressure
• if you suffer from heart, brain or blood vessel problems (e.g. congestive heart failure)
• 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 triglyceride levels, etc.)
• if you have had thrombosis or embolisms
• if you suffer from blood coagulation defects (hemostasis disorders)
• if you have kidney problems (e.g. renal hypoperfusion, renal insufficiency), unless you have had severe kidney problems (severe renal insufficiency) because you should not use Diclofenac Alfasigma (see section “DO NOT use Diclofenac Alfasigma”)
• if you have or have had problems with the stomach or intestine (for example ulcer) or if you have had ulcers of the stomach or intestine, bleeding or perforation, because Diclofenac Alfasigma may not be suitable for you
• if you suffer from ulcerative colitis or Crohn's disease
• if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract, as Diclofenac Alfasigma may sometimes worsen wound healing in the intestine following surgery
• if you suffer from asthma or are prone to it, as this medicine can cause crises with narrowing of the airways (bronchospasm) and in some cases shock and other allergic reactions
• if you suffer from seasonal allergic rhinitis (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps)
• if you suffer from chronic obstructive pulmonary diseases or chronic respiratory tract infections.
• if you suffer from or have suffered from liver problems (e.g. hepatic insufficiency) unless you have had severe liver problems (severe hepatic insufficiency) because you should not use Diclofenac Alfasigma (see section “DO NOT use Diclofenac Alfasigma”)
• if you suffer from hepatic porphyria
• if you have undergone major surgery
• if you have a reduced volume of body fluids (for example before or after major surgery)
• if you are underweight because you will be prescribed a low dose of Diclofenac Alfasigma
• if you are elderly, especially if you are frail and underweight, because you will be prescribed a low dose of Diclofenac Alfasigma. Elderly patients are more likely to experience adverse reactions, especially bleeding in the stomach or intestine and perforation which are generally more severe and can be fatal. Tell your doctor of any unusual symptoms in the stomach and intestine.

In these cases, your doctor will keep you under strict control and may re-evaluate the need for treatment
with Diclofenac Alfasigma. In addition, your doctor may prescribe periodic tests to assess your
condition during treatment with Diclofenac Alfasigma.

Tell your doctor if you develop during treatment with Diclofenac Alfasigma:

• skin reactions even severe, because even if very rarely and especially at the beginning of therapy, severe skin reactions have been reported that can also be fatal
• fluid retention and swelling from fluid accumulation (edema)
• signs and symptoms of liver problems or if liver function parameters are not normal (blood test results)
• unusual symptoms in the stomach and intestine. In these cases, the doctor will evaluate whether to continue or stop treatment with Diclofenac Alfasigma.

Also, be particularly careful:

• At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulcers or perforations may occur, which can also be fatal. The doctor will prescribe the lowest effective dose of diclofenac to reduce the risk of gastrointestinal toxicity and may also prescribe you medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
• Adverse effects can be minimized by using the lowest effective dose for the shortest possible time (see section 3 “How to use Diclofenac Alfasigma”).
• Avoid using diclofenac during treatment with other NSAIDs, including selective cyclooxygenase-2 inhibitors, as this increases the possibility of you having adverse effects.
• Diclofenac Alfasigma can mask the signs and symptoms of an infection.

Children and adolescents
Do not administer Diclofenac Alfasigma to children and adolescents under 14 years of age.

Other medicines and Diclofenac Alfasigma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The concentration in the blood of the following medicines may increase when they are used together with Diclofenac
Alfasigma:

• lithium
• digoxin
• methotrexate
• phenytoin The doctor will have you undergo tests to assess the concentrations of these medicines in the blood.

The effect on blood pressure of the medicines listed below may decrease when they are used
together with Diclofenac Alfasigma:

• medicines used to lower blood pressure or medicines that increase urine production (diuretics) or beta-blockers or angiotensin-converting enzyme (ACE) inhibitors The doctor will monitor you and carefully evaluate the administration of these medicines with Diclofenac Alfasigma, especially if you are elderly.

The doctor will monitor you and have you undergo tests if you need to take one or more of the medicines listed
below together with Diclofenac Alfasigma:

• medicines to lower blood pressure (potassium-sparing)
• other non-steroidal anti-inflammatory drugs
• corticosteroids (hormone-like medicines used, for example, to reduce inflammation)
• medicines to thin the blood (anticoagulants or antiplatelet agents)
• selective serotonin reuptake inhibitors (antidepressants)
• medicines for diabetes
• cyclosporine (immunosuppressant to modify the response of the body's immune system)
• medicines to fight bacterial infections of the quinolone class
• cholestyramine and colestipol, because they can delay or reduce the absorption of diclofenac. The doctor will tell you when to take these medicines, generally diclofenac should be taken 1 hour before or 4-6 hours after taking cholestyramine and colestipol
• potent inhibitors of a protein in the body called CYP2C9 e.g. sulfinpyrazone and voriconazole.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy

Do not useDiclofenac Alfasigma in the last 3 months of pregnancy (during the third trimester of pregnancy)
as it may harm the fetus or cause problems during childbirth. It can cause problems with the heart, the
lungs, the kidneys of the fetus. It may affect the tendency of you and the baby to bleed and delay or
prolong labor more than expected.

Do not useDiclofenac Alfasigma during the first and second trimester of pregnancy unless absolutely
necessary and under the advice of a doctor because it can increase the risk of abortion and malformations in the newborn.
The risk increases with increasing dose and duration of therapy with diclofenac. If you need
treatment during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, diclofenac can cause kidney problems in the fetus, if taken for more than a few days, reducing the levels of amniotic fluid surrounding
the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
If you need treatment for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding

Diclofenac passes into breast milk in small amounts, so do not take Diclofenac Alfasigma during
breastfeeding to avoid adverse effects on the newborn.
Fertility

As with other NSAIDs, if you are planning a pregnancy, you should not take Diclofenac Alfasigma because
this medicine can alter fertility. The doctor will assess the need to stop treatment with
Diclofenac Alfasigma if you have difficulty getting pregnant or need to have fertility tests.

Driving and using machines
Diclofenac can cause visual disturbances, dizziness, vertigo, drowsiness or other disturbances that can
affect the ability to drive vehicles and use machines.
If you experience these symptoms, avoid driving a vehicle or using machinery.

Diclofenac Alfasigmacontains benzyl alcohol, propylene glycol, sodium metabisulfite, sodium
This medicine contains 119 mg of benzyl alcohol per vial. Benzyl alcohol can cause allergic
reactions.
Ask your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts
of benzyl alcohol can accumulate in the body and cause adverse effects (such as metabolic acidosis).
Ask your doctor or pharmacist if you have a liver or kidney disease. This is because large
amounts of benzyl alcohol can accumulate in the body and cause adverse effects (such as acidosis
metabolic).
This medicine contains 581 mg of propylene glycol per vial.
Diclofenac Alfasigma contains sodium metabisulfite. Rarely it can 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 Diclofenac Alfasigma

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.

Use in adults
The recommended dose is 1 injection (1 ampoule of 75 mg) per day, administered in the upper part of the buttock. Change
sides each time you administer the injection and strictly adhere to hygiene rules while preparing and administering
the injection.
In more severe cases, your doctor may prescribe 2 injections per day, spaced several hours apart.
Each injection must be administered in a different buttock. Alternatively, your doctor may prescribe 1 injection per
day in combination with other pharmaceutical forms of diclofenac (e.g. tablets or suppositories) up to a maximum
dose of 150 mg per day.
Ampoules of diclofenac should not be administered for more than 2 days; therefore, as soon as possible, your
doctor will tell you to stop the injections and will prescribe diclofenac in tablet or suppository form.

Use in the elderly
In the elderly, it may be necessary to reduce the dose of diclofenac. Your doctor will tell you how much Diclofenac
Alfasigma you should use.

If you use more Diclofenac Alfasigmathan you should
In case of accidental ingestion or use of an excessive dose of Diclofenac Alfasigma, immediately inform
your doctor or go to the nearest hospital.
If you use an excessive dose of diclofenac, you may experience vomiting, bleeding from the stomach and intestines,
diarrhea, dizziness, ringing or buzzing in the ears, or convulsions. In more severe cases, serious damage to the
kidneys and liver may also occur.
The doctor will treat acute poisoning from non-steroidal anti-inflammatory drugs, including diclofenac, based on
the symptoms you present.

If you forget to use Diclofenac Alfasigma
Do not use a double dose to make up for a missed dose.

If you stop using Diclofenac Alfasigma
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.
Stop taking Diclofenac Alfasigma and tell your doctor immediately if you notice:

• mild abdominal cramps and tenderness that occur shortly after starting treatment with Diclofenac Alfasigma, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the abdominal pain appearing (frequency not known, cannot be estimated from the available data)
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome. Tell your doctor immediately if you notice:

Reactions at the injection site, including pain, redness, swelling, hard lump, ulcers and bruising. These
reactions may worsen with blackening and death of the skin and underlying tissues surrounding the
injection site, which then heal with scarring; this condition is called Nicolau syndrome.

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

• headache, dizziness
• vertigo
• nausea, vomiting
• diarrhoea, passing gas (flatulence)
• problems with digestion (dyspepsia), abdominal pain
• loss or reduction of appetite (anorexia)
• abnormal values in blood tests (increased levels of some liver enzymes: transaminases)
• skin rash
• reactions, pain and hardening in the area where the injection is given

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

• allergic reactions, severe allergic reactions (anaphylaxis) including low blood pressure 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 stools
• inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders
• urticaria
• oedema (swelling from fluid retention)

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

• abnormal values in blood tests: low number of platelets (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 values in urine tests: presence of blood in the urine (haematuria), presence of protein in the urine (proteinuria)
• allergic reaction with rapid swelling of the skin and mucous membranes (angioedema) including swelling of the face
• disorientation, depression, insomnia, nightmares, irritability, severe mental changes (delirium, hallucinations)
• memory impairment, convulsions, anxiety, tremors
• tingling
• altered taste
• inflammation of the membranes lining the brain (aseptic meningitis), damage to blood vessels in the brain
• visual disturbances, blurred vision, double vision
• ringing or buzzing in the ears, worsening of hearing
• perception 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 accompanied by bleeding and worsening of ulcerative colitis or Crohn's disease
• constipation
• inflammation of the mouth lining (stomatitis) including stomatitis with ulcers, inflammation of the tongue (glossitis)
• problems with the oesophagus, narrowing of the intestine
• inflammation of the pancreas (pancreatitis)
• very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (liver failure)
• skin reactions of various types (redness, blistering, scaling etc.) from mild to potentially fatal
• appearance of reddish-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
• accumulation of pus (abscess) at the injection site

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

• tissue damage at the injection site.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through 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 Diclofenac Alfasigma

Store the medicine protected from light and heat. This medicine does not require any particular storage
temperature.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported 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 in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Diclofenac Alfasigma contains

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

Description of the appearance of Diclofenac Alfasigmaand contents of the pack
Each pack contains 6 vials of injectable solution for intramuscular use.

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)

Diclofenac Alfasigma 150 mg prolonged-release capsules

diclofenac sodium

Generic medicine
Read this leaflet carefully before taking 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Diclofenac Alfasigma and what is it used for

Diclofenac Alfasigma contains the active ingredient diclofenac sodium, which belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs). Diclofenac sodium is used to reduce pain and inflammation.
Diclofenac Alfasigma is used to treat:

• inflammatory and degenerative rheumatic diseases, such as: o rheumatoid arthritis (chronic disease of the membrane lining the joints that manifests in subjects of all ages, in which inflammation causes an increase in the volume of the membrane with consequent damage to the joints) o ankylosing spondylitis (inflammatory disease of the spine that generally affects young people and causes pain and stiffness) o osteoarthritis (chronic disease of the joints that mainly manifests in old age) o rheumatism (disorders characterized by inflammation, degeneration and alterations of the affected structures) in sites other than the joints
• painful conditions caused by an inflammatory state of non-rheumatic nature or due to trauma
• pain due to the menstrual cycle (primary dysmenorrhea).

See 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 Diclofenac Alfasigma

DO NOT take Diclofenac Alfasigma

• if you are allergic to diclofenac sodium or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver problems (severe hepatic insufficiency)
• if you have an ulcer, bleeding or perforation of the stomach or intestine
• if you have had bleeding (haemorrhage) of the stomach or intestine or perforation after previous treatments with NSAIDs
• if you have had recurrent bleeding/ulcer in the stomach or duodenum (two or more distinct episodes of proven ulceration or bleeding)
• if you have any serious problems with your stomach or intestine
• 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 blood vessels of the brain (cerebrovascular disease), for example if you have had a heart attack, stroke, mini-stroke (also called a transient ischaemic attack, TIA)
• if you have an obstruction of the blood vessels leading to the heart or brain or have undergone surgery to eliminate or prevent the formation of these obstructions
• if you have or have had problems with the arterial circulation of blood (peripheral arteriopathy)
• if you have ongoing bleeding or if you have a predisposition to bleeding
• if you have had asthma attacks, chest pain, hives or acute rhinitis after taking acetylsalicylic acid or other NSAIDs
• if you have an alteration in the production of blood cells
• if you are taking high doses of medicines that increase urine production (diuretics) or medicines to thin the blood (anticoagulants) (see section “Other medicines and Diclofenac Alfasigma”)
• if you are under 14 years of age

Warnings and precautions
Talk to your doctor or pharmacist before taking Diclofenac Alfasigma.

Tell your doctor before taking Diclofenac Alfasigma:

• if you suffer from or have suffered from high blood pressure
• if you suffer from heart, brain or blood vessel problems
• 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 triglyceride levels, etc.)
• if you have had thrombosis or embolisms
• if you suffer from blood coagulation defects (haemostatic disorders)
• if you have kidney problems (e.g. renal hypoperfusion, renal insufficiency), unless you have had severe kidney problems (severe renal insufficiency) because you should not take Diclofenac Alfasigma (see section “DO NOT take Diclofenac Alfasigma”)
• if you have or have had problems with your stomach or intestine (e.g. ulcer) or if you have had ulcers of the stomach or intestine, bleeding or perforation, because Diclofenac Alfasigma may not be suitable for you
• if you suffer from ulcerative colitis or Crohn's disease
• if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract, as Diclofenac Alfasigma may sometimes worsen wound healing in the intestine following surgery
• if you suffer from asthma or are prone to it, as this medicine can cause crises with reduction of the airways (bronchospasm) and in some cases shock and other allergic phenomena
• if you suffer from seasonal allergic rhinitis (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps)
• if you suffer from chronic obstructive pulmonary diseases or chronic respiratory tract infections.
• if you suffer from or have suffered from liver problems (e.g. hepatic insufficiency) unless you have had severe liver problems (severe hepatic insufficiency) because you should not take Diclofenac Alfasigma (see section “DO NOT take Diclofenac Alfasigma”)
• if you suffer from hepatic porphyria
• if you have undergone major surgery
• if you have a reduced volume of body fluids (e.g. before or after major surgery)
• if you are underweight because you will be prescribed a low dose of Diclofenac Alfasigma
• if you are elderly, especially if you are frail and underweight, because you will be prescribed a low dose of Diclofenac Alfasigma. Elderly patients are more likely to experience adverse reactions, especially bleeding in the stomach or intestine and perforation which are generally more serious and can be fatal. Tell your doctor of any unusual symptoms in the stomach and intestine.

In these cases, your doctor will monitor you closely and may re-evaluate the need for treatment
with Diclofenac Alfasigma. In addition, your doctor may prescribe periodic tests to assess your
condition during treatment with Diclofenac Alfasigma.

Tell your doctor if you develop during treatment with Diclofenac Alfasigma:

• skin reactions, even severe ones, because even if very rarely and especially at the beginning of therapy, severe skin reactions have been reported that can also be fatal
• fluid retention and swelling from fluid accumulation (edema)
• signs and symptoms of liver problems or if liver function parameters are not normal (blood test results)
• unusual symptoms in the stomach and intestine. In these cases, the doctor will assess whether to continue or stop treatment with Diclofenac Alfasigma.

In addition, pay particular attention:

• At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulcers or perforations 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 you medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
• Adverse effects can be minimized by using the lowest effective dose for the shortest possible time (see section 3 “How to take Diclofenac Alfasigma”).
• Avoid using diclofenac during treatment with other NSAIDs, including selective cyclooxygenase-2 inhibitors, as this increases the possibility of you having adverse effects.
• Diclofenac Alfasigma can mask the signs and symptoms of an infection.

Children and adolescents
Do not give Diclofenac Alfasigma to children and adolescents under 14 years of age.

Other medicines and Diclofenac Alfasigma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The concentration in the blood of the following medicines may increase when used together with Diclofenac
Alfasigma:

• lithium
• digoxin
• methotrexate
• phenytoin Your doctor will have you undergo checks to assess the concentrations in the blood of these medicines.

The effect on blood pressure of the medicines listed below may decrease when used
together with Diclofenac Alfasigma:

• medicines used to lower blood pressure or medicines that increase urine production (diuretics)

or betablockers
or angiotensin-converting enzyme (ACE) inhibitors
Your doctor will monitor you and carefully assess the administration of these medicines with
Diclofenac Alfasigma, especially if you are elderly.
Your doctor will monitor you and have you undergo tests if you need to take one or more of the medicines listed
below together with Diclofenac Alfasigma:

• medicines to lower blood pressure (potassium-sparing)
• other non-steroidal anti-inflammatory drugs
• corticosteroids (hormone-like medicines used, for example, to reduce inflammation)
• medicines to thin the blood (anticoagulants or antiplatelet agents)
• selective serotonin reuptake inhibitors (antidepressants)
• medicines for diabetes
• cyclosporine (immunosuppressant to modify the body's immune response)
• medicines to fight bacterial infections of the quinolone class
• cholestyramine and colestipol, because they can delay or reduce the absorption of diclofenac. Your doctor will tell you when to take these medicines, generally diclofenac should be taken 1 hour before or 4-6 hours after taking cholestyramine and colestipol
• potent inhibitors of a protein in the body called CYP2C9 e.g. sulfinpyrazone and voriconazole.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy

Do not takeDiclofenac Alfasigma in the last 3 months of pregnancy (during the third trimester of
pregnancy) as it may harm the fetus or cause problems during childbirth. It can cause problems with the
heart, lungs, kidneys of the fetus. It may affect your and the baby's tendency to bleed and
delay or prolong labor longer than expected.
Do not takeDiclofenac Alfasigma during the first and second trimesters of pregnancy unless in cases of
actual necessity and under the advice of a doctor because it can increase the risk of abortion and malformations in
the newborn. The risk increases with increasing dose and duration of therapy with diclofenac. Where
treatment is necessary in this period or during attempts to conceive, the
lowest dose should be used for the shortest possible time. From the 20th week of pregnancy, diclofenac can cause
kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid that
surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
Where treatment is needed for more than a few days, your doctor may advise
additional monitoring.
Breastfeeding

Diclofenac passes into breast milk in small amounts, so do not take Diclofenac Alfasigma during
breastfeeding to avoid adverse effects on the infant.
Fertility

As with other NSAIDs, if you are planning a pregnancy, you should not take Diclofenac Alfasigma because
this medicine can alter fertility. Your doctor will assess the need to discontinue treatment with
Diclofenac Alfasigma if you have difficulty getting pregnant or need to have fertility tests.

Driving and using machines
Diclofenac can cause visual disturbances, dizziness, vertigo, drowsiness or other disturbances that can
affect the ability to drive vehicles and use machinery.
If you experience these symptoms, avoid driving a vehicle or using machinery.

Diclofenac Alfasigmacontains sucrose, sodium
If your doctor has diagnosed you with intolerance to certain sugars, contact him 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 Diclofenac Alfasigma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Use in adults
The recommended dose is 150 mg per day, preferably before meals.
Treatment of pain due to menstrual cycle (primary dysmenorrhea)
The recommended dose is 50-150 mg per day, but must be adjusted to each patient.
Start treatment when the first symptoms appear and continue for a few days according to your
symptoms.

Use in the elderly
In the elderly, it may be necessary to reduce the dose of diclofenac. Your doctor will tell you how much Diclofenac
Alfasigma you should take.

If you take more Diclofenac Alfasigmathan you should
In case of accidental ingestion of an excessive dose of Diclofenac Alfasigma, immediately inform your
doctor or go to the nearest hospital.
If you take an excessive dose of diclofenac, you may experience vomiting, bleeding from the stomach and intestines,
diarrhea, dizziness, ringing or buzzing in the ears, or convulsions. In the most severe cases, it may also manifest
serious damage to the kidneys and liver.
The doctor will treat acute poisoning from non-steroidal anti-inflammatory drugs, including diclofenac, based on
the symptoms you present.

If you forget to take Diclofenac Alfasigma
Do not take a double dose to make up for a missed dose.

If you stop taking Diclofenac Alfasigma
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.
Stop taking Diclofenac Alfasigma and tell your doctor immediately if you notice:

• mild abdominal cramps and tenderness that occur shortly after starting treatment with Diclofenac Alfasigma, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the abdominal pain appearing (frequency not known, cannot be estimated from the 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)
• problems with digestion (dyspepsia), abdominal pain
• loss or reduction of appetite (anorexia)
• abnormal values in blood tests (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, 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 the stool
• inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders
• urticaria
• oedema (swelling due to fluid retention)

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

• abnormal values in blood tests: low number of platelets (thrombocytopenia), reduction in the number of white blood cells (leucopenia), reduction in the number of red blood cells (anaemia, including haemolytic and aplastic anaemia), reduction in the number of granulocytes (agranulocytosis)
• abnormal values in urine tests: presence of blood in the urine (haematuria), presence of protein in the urine (proteinuria)
• allergic reaction with rapid swelling of the skin and mucous membranes (angioedema) including facial swelling
• disorientation, depression, insomnia, nightmares, irritability, severe mental changes (delirium, hallucinations)
• memory impairment, convulsions, anxiety, tremors
• tingling
• altered sense of taste
• inflammation of the membranes surrounding the brain (aseptic meningitis), damage to blood vessels in the brain
• visual disturbances, blurred vision, double vision
• ringing or buzzing in the ears, worsening of hearing
• perception 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 accompanied by bleeding and worsening of ulcerative rectocolitis or Crohn's disease
• constipation
• inflammation of the oral mucosa (stomatitis) including stomatitis with ulcers, inflammation of the tongue (glossitis)
• problems with the oesophagus, narrowing of the intestine
• inflammation of the pancreas (pancreatitis)
• very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (liver failure)
• skin reactions of various types (redness, blistering, scaling etc.) from mild to potentially life-threatening
• appearance of reddish-brown spots on the skin (purpura), also as an allergic reaction
• itching
• hair loss
• skin sensitivity to sunlight
• kidney problems such as acute renal failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 Diclofenac Alfasigma

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 which is stated on the pack. The expiry date refers to the last day of that month.
Do not use this medicine if the pack is opened or damaged.
Do not dispose of any medicine in 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 Diclofenac Alfasigma contains

• The active ingredient is diclofenac sodium. Each prolonged-release capsule contains 150 mg of diclofenac sodium.
• The other ingredients are sugar spheres (containing sucrose and corn starch), macrogol 4000, solid paraffin, methacrylic acid polymers, talc, gelatin, indigotine (E132).

Description of the appearance of Diclofenac Alfasigma and package contents
Each pack contains 20 prolonged-release capsules.

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)

Diclofenac Alfasigma 50 mg tablets

diclofenac sodium

Generic medicine
Read this leaflet carefully before taking 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Diclofenac Alfasigma and what is it used for

Diclofenac Alfasigma contains the active ingredient diclofenac sodium, which belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs). Diclofenac sodium is used to reduce pain and inflammation.
Diclofenac Alfasigma is used to treat:

• rheumatic and degenerative inflammatory diseases, such as: o rheumatoid arthritis (chronic disease of the membrane lining the joints that manifests in subjects of all ages, in which inflammation causes an increase in the volume of the membrane with consequent damage to the joints) o ankylosing spondylitis (inflammatory disease of the spine that generally affects young people and causes pain and stiffness) o osteoarthritis (chronic disease of the joints that mainly manifests in old age) o rheumatism (disorders characterized by inflammation, degeneration and alterations of the affected structures) in sites other than the joints
• painful conditions caused by an inflammatory state of non-rheumatic nature or due to trauma
• pain due to the menstrual cycle (primary dysmenorrhea).

See 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 Diclofenac Alfasigma

DO NOT take Diclofenac Alfasigma

• if you are allergic to diclofenac sodium or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver problems (severe hepatic insufficiency)
• if you have an ulcer, bleeding or perforation of the stomach or intestine
• if you have had bleeding (haemorrhage) of the stomach or intestine or perforation after previous treatments with NSAIDs
• if you have had recurrent bleeding/ulcer in the stomach or duodenum (two or more distinct episodes of proven ulceration or bleeding)
• if you have any serious problems with your stomach or intestine
• 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 blood vessels of the brain (cerebrovascular disease), for example if you have had a heart attack, stroke, mini-stroke (also called a transient ischaemic attack, TIA)
• if you have an obstruction of the blood vessels leading to the heart or brain or have undergone surgery to eliminate or prevent the formation of these obstructions
• if you have or have had problems with the arterial blood circulation (peripheral arteriopathy)
• if you have ongoing bleeding or if you have a predisposition to bleeding
• if you have had asthma attacks, chest pain, urticaria or acute rhinitis after taking acetylsalicylic acid or other NSAIDs
• if you have an alteration in the production of blood cells
• if you are taking high doses of medicines that increase urine production (diuretics) or medicines to thin the blood (anticoagulants) (see section “Other medicines and Diclofenac Alfasigma”)
• if you are under 14 years of age

Warnings and precautions
Talk to your doctor or pharmacist before taking Diclofenac Alfasigma.

Tell your doctor before taking Diclofenac Alfasigma:

• if you suffer from or have suffered from high blood pressure
• if you suffer from heart, brain or blood vessel problems
• 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 triglyceride levels, etc.)
• if you have had thrombosis or embolisms
• if you suffer from blood coagulation defects (haemostatic disorders)
• if you have kidney problems (e.g. renal hypoperfusion, renal insufficiency), except if you have had severe kidney problems (severe renal insufficiency) because you should not take Diclofenac Alfasigma (see section “DO NOT take Diclofenac Alfasigma”)
• if you have or have had problems with your stomach or intestine (e.g. ulcer) or if you have had ulcers of the stomach or intestine, bleeding or perforation, because Diclofenac Alfasigma may not be suitable for you
• if you suffer from ulcerative colitis or Crohn's disease
• if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract, as Diclofenac Alfasigma may sometimes worsen wound healing in the intestine following surgery
• if you suffer from asthma or are prone to it, as this medicine can cause crises with narrowing of the airways (bronchospasm) and in some cases shock and other allergic reactions
• if you suffer from seasonal allergic rhinitis (allergic rhinitis), swelling of the nasal mucosa (e.g. nasal polyps)
• if you suffer from chronic obstructive pulmonary diseases or chronic respiratory tract infections.
• if you suffer from or have suffered from liver problems (e.g. hepatic insufficiency) except if you have had severe liver problems (severe hepatic insufficiency) because you should not take Diclofenac Alfasigma (see section “DO NOT take Diclofenac Alfasigma”)
• if you suffer from hepatic porphyria
• if you have undergone major surgery
• if you have a reduced volume of body fluids (e.g. before or after major surgery)
• if you are underweight because you will be prescribed a low dose of Diclofenac Alfasigma
• if you are elderly, especially if you are frail and underweight, because you will be prescribed a low dose of Diclofenac Alfasigma. Elderly patients are more likely to experience adverse reactions, especially bleeding in the stomach or intestine and perforation which are generally more severe and can be fatal. Tell your doctor of any unusual symptoms in the stomach and intestine. In these cases, the doctor will keep you under close control and may re-evaluate the need for treatment with Diclofenac Alfasigma. In addition, the doctor may prescribe periodic tests to assess your condition during treatment with Diclofenac Alfasigma.

Tell your doctor if you develop during treatment with Diclofenac Alfasigma:

• skin reactions, even severe, because even if very rare and especially at the beginning of therapy, severe skin reactions have been reported that can also be fatal
• fluid retention and swelling from fluid accumulation (edema)
• signs and symptoms of liver problems or if liver function parameters are not normal (blood test results)
• unusual symptoms in the stomach and intestine. In these cases, the doctor will assess whether to continue or discontinue treatment with Diclofenac Alfasigma.

In addition, be particularly careful:

• At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulcers or perforations can occur, which can also be fatal. The doctor will prescribe the most effective dose of diclofenac to reduce the risk of gastrointestinal toxicity and may also prescribe medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
• Adverse effects can be minimized by using the lowest effective dose for the shortest possible time (see section 3 “How to take Diclofenac Alfasigma”).
• Avoid the use of diclofenac during treatment with other NSAIDs, including selective cyclooxygenase-2 inhibitors, as this increases the likelihood of you experiencing adverse effects.
• Diclofenac Alfasigma can mask the signs and symptoms of an infection.

Children and adolescents
Do not give Diclofenac Alfasigma to children and adolescents under 14 years of age.

Other medicines and Diclofenac Alfasigma
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
The blood concentration of the following medicines may increase when used together with Diclofenac
Alfasigma:

• lithium
• digoxin
• methotrexate
• phenytoin The doctor will check your levels to assess the concentrations of these medicines in your blood.

The effect on blood pressure of the medicines listed below may decrease when used
together with Diclofenac Alfasigma:

• medicines used to lower blood pressure or medicines that increase urine production (diuretics) or beta-blockers

or angiotensin-converting enzyme (ACE) inhibitors
The doctor will monitor you and carefully assess the administration of these medicines with
Diclofenac Alfasigma, especially if you are elderly.
The doctor will monitor you and have tests done if you need to take one or more of the medicines listed
below together with Diclofenac Alfasigma:

• medicines to lower blood pressure (potassium-sparing)
• other non-steroidal anti-inflammatory drugs
• corticosteroids (hormone-like medicines used, for example, to reduce inflammation)
• medicines to thin the blood (anticoagulants or antiplatelet agents)
• selective serotonin reuptake inhibitors (antidepressants)
• medicines for diabetes
• cyclosporine (immunosuppressant to modify the body's immune response)
• medicines to fight bacterial infections of the quinolone class
• cholestyramine and colestipol, because they can delay or reduce the absorption of diclofenac. The doctor will tell you when to take these medicines, usually diclofenac should be taken 1 hour before or 4-6 hours after taking cholestyramine and colestipol
• potent inhibitors of a protein in the body called CYP2C9 e.g. sulfinpyrazone and voriconazole.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy

Do not takeDiclofenac Alfasigma in the last 3 months of pregnancy (during the third trimester of
pregnancy) as it may harm the fetus or cause problems during delivery. It can cause problems with the
heart, lungs, kidneys of the fetus. It may affect your and the baby's tendency to bleed and
delay or prolong labour more than expected.
Do not takeDiclofenac Alfasigma during the first and second trimester of pregnancy unless in cases of
real need and under medical advice because it can increase the risk of abortion and malformations in the
newborn. The risk increases with increasing dose and duration of diclofenac therapy. Where
treatment is necessary in this period or during attempts to conceive, the
lowest dose should be used for the shortest possible time. From the 20th week of pregnancy, diclofenac can cause
kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid that
surrounds the baby (oligohydramnios) or narrowing a blood vessel (ductus arteriosus) in the baby's heart.
Where treatment is needed for more than a few days, the doctor may advise
additional monitoring.
Breastfeeding
Diclofenac passes into breast milk in small amounts, so do not take Diclofenac Alfasigma during
breastfeeding to avoid adverse effects on the infant.
Fertility
As with other NSAIDs, if you are planning a pregnancy, you should not take Diclofenac Alfasigma because
this medicine can alter fertility. The doctor will assess the need to stop treatment with
Diclofenac Alfasigma if you have difficulty getting pregnant or need to have fertility tests.

Driving and using machines
Diclofenac can cause visual disturbances, dizziness, vertigo, drowsiness or other disturbances that can
affect your ability to drive vehicles and use machines.
If you experience these symptoms, avoid driving a vehicle or using machinery.

Diclofenac Alfasigmacontains lactose, sodium
If your doctor has diagnosed you with intolerance to certain sugars, contact him 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 Diclofenac Alfasigma

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Diclofenac Alfasigma tablets must be taken whole with a little liquid, preferably before
meals.

Use in adults
Initial therapy: the recommended dose is 100-150 mg per day.
In milder cases: the recommended dose may be reduced to 75-100 mg per day.
Prolonged therapy: the recommended dose is 75-100 mg per day.
You should take the daily dose in 2 or 3 separate administrations.
The maximum dose is 150 mg per day.
Your doctor will tell you if you can further reduce the dosage.
Diclofenac is also available in suppositories. To eliminate nighttime pain and morning stiffness, the
oral administration can be combined with rectal therapy: 1 suppository, in the evening before bedtime and 1
50 mg tablet in the morning.
Treatment of pain due to the menstrual cycle (primary dysmenorrhea)
The recommended dose is 50-150 mg per day, but it must be adjusted to each patient.
Your doctor will initially prescribe 50-100 mg per day and, if necessary, will tell you to increase the dose
during subsequent menstrual cycles, up to a maximum of 150 mg per day. You should take the daily dose
in 2 or 3 separate administrations.
Start treatment when the first symptoms appear and continue for a few days according to your
symptoms.

Use in the elderly
In the elderly, it may be necessary to reduce the dose of diclofenac. Your doctor will tell you how much Diclofenac
Alfasigma you should take.

If you take more Diclofenac Alfasigmathan you should
In case of accidental ingestion of an excessive dose of Diclofenac Alfasigma, immediately inform your
doctor or go to the nearest hospital.
If you take an excessive dose of diclofenac, you may experience vomiting, bleeding from the stomach and intestines,
diarrhea, dizziness, ringing or buzzing in the ears, or convulsions. In more severe cases, serious damage to the
kidneys and liver may also occur.
The doctor will treat acute poisoning from non-steroidal anti-inflammatory drugs, including diclofenac, based on
the symptoms you present.

If you forget to take Diclofenac Alfasigma
Do not take a double dose to make up for a missed dose.

If you stop taking Diclofenac Alfasigma
If you have any doubts about the use of this medicine, ask 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 Diclofenac Alfasigma and tell your doctor immediately if you notice:

• mild abdominal cramps and tenderness that occur shortly after starting treatment with Diclofenac Alfasigma, followed by rectal bleeding or bloody diarrhea usually within 24 hours of the 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
• diarrhea, passing gas (flatulence)
• problems with digestion (dyspepsia), abdominal pain
• loss or decrease of appetite (anorexia)
• abnormal values in blood tests (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, difficulty breathing (dyspnea)
• inflammation of the stomach (gastritis), bleeding from the stomach or intestines, vomiting blood, stomach or intestinal ulcer with or without bleeding and perforation
• diarrhea accompanied by bleeding, blood in the stool
• inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders
• urticaria
• edema (swelling from fluid retention)

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

• abnormal values in blood tests: low number of platelets (thrombocytopenia), decreased number of white blood cells (leukopenia), decreased number of red blood cells (anemia, including hemolytic and aplastic anemia), decreased number of granulocytes (agranulocytosis)
• abnormal values in urine tests: presence of blood in the urine (hematuria), presence of protein in the urine (proteinuria)
• allergic reaction with rapid swelling of the skin and mucous membranes (angioedema) including facial edema
• disorientation, depression, insomnia, nightmares, irritability, severe mental changes (delirium, hallucinations)
• memory impairment, convulsions, anxiety, tremors
• tingling
• altered taste
• inflammation of the membranes lining the brain (aseptic meningitis), damage to blood vessels in the brain
• vision disorders, blurred vision, double vision
• whistling or ringing in the ears, worsening of hearing
• perception 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 accompanied by bleeding and worsening of ulcerative rectocolitis or Crohn's disease
• constipation
• inflammation of the oral mucosa (stomatitis) including stomatitis with ulcers, inflammation of the tongue (glossitis)
• problems with the esophagus, narrowing of the intestine
• inflammation of the pancreas (pancreatitis)
• very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (liver failure)
• skin reactions of various types (redness, blistering, peeling, etc.) from mild to potentially fatal
• appearance of reddish-brown spots on the skin (purpura), also as an allergic reaction
• itching
• hair loss
• skin sensitivity to sunlight
• kidney problems such as acute renal failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Diclofenac Alfasigma

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 which is 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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Diclofenac Alfasigma contains

• The active ingredient is sodium diclofenac. Each tablet contains 50 mg of sodium diclofenac.
• The other ingredients are microcrystalline cellulose, lactose, corn starch, magnesium stearate, cellulose acetate phthalate, diethyl phthalate, titanium dioxide, polyvinylpyrrolidone.

Description of the appearance of Diclofenac Alfasigmaand contents of the pack
Each pack contains 30 tablets for oral use.

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)