Package leaflet: Information for the patient

Diclofenac Hexal 75 mg/3 ml solution for injection for intramuscular use

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

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

Contents of this leaflet:

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

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

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

inflammation of muscles, joints and bones
smooth muscle spasms

2. What you should know before taking Diclofenac Hexal

Do not take Diclofenac Hexal

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Diclofenac Hexal.
Tell your doctor before taking Diclofenac Hexal:

if you smoke
if you have diabetes
if you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides
if you have asthma or bronchial asthma
if you have seasonal allergic rhinitis, nasal mucosa swelling (e.g. nasal polyps)
if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
if you have liver problems (e.g. hepatic insufficiency, hepatitis)
if you have hepatic porphyria
if you have ulcerative colitis or Crohn’s disease, as these conditions may worsen
if you have kidney problems (e.g. renal insufficiency)
if you are using medicines that increase urine production (diuretics) or other medicines that may affect kidney function
if you have reduced body fluid volume (e.g. before or after major surgery)
if you are undergoing or have recently undergone major surgery
if you have blood clotting disorders (coagulation defects)
if you have or have had high blood pressure, heart or brain problems (e.g. congestive heart failure, established heart disease, peripheral arterial disease, and/or stroke)
if you have or have ever had stomach or intestinal problems (e.g. ulcer), or if you have had gastric or intestinal ulceration, bleeding, or perforation
if you are taking medicines that may increase the risk of bleeding, ulceration, and perforation, such as acetylsalicylic acid (e.g. aspirin), orally, injected, or rectally administered corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Diclofenac Hexal”).
Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before receiving/taking/using [product name], as [product name] may sometimes impair wound healing in the intestine following surgery.

Inform your doctor if, during treatment with Diclofenac Hexal, you develop:

skin reactions, even severe ones, as very rare serious skin reactions, which may even be fatal, have been reported (see section 4 “Possible side effects”)
fluid retention and swelling due to fluid accumulation (edema)
any signs of allergic reaction
signs and symptoms of liver problems or if liver function parameters are abnormal (visible from blood tests)
unusual stomach or intestinal symptoms, especially at the beginning of treatment with Diclofenac Hexal
signs and symptoms typical of serious atherothrombotic events such as chest pain, shortness of breath, weakness, and difficulty speaking.

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

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

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

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

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

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

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
Diclofenac Hexal must not be used during the first and second trimesters of pregnancy except in cases of clear necessity.
If you wish to become pregnant or are in the first or second trimester of pregnancy and need to use diclofenac, your doctor will prescribe the lowest dose for the shortest possible time.
Diclofenac must not be used during the third trimester of pregnancy as it may cause serious harm to the mother and the unborn child.
Breastfeeding
Diclofenac Hexal must not be used during breastfeeding to avoid adverse effects on the newborn.
Fertility
As with other NSAIDs, Diclofenac Hexal must not be used in women planning pregnancy, as this medicine may impair female fertility. Your doctor will assess whether treatment with Diclofenac Hexal should be discontinued if you have difficulty becoming pregnant or are undergoing fertility investigations.
Driving and using machines
Diclofenac Hexal may cause visual disturbances, dizziness, vertigo, drowsiness, or other disturbances that may affect the ability to drive or operate machinery.
If you experience these symptoms, avoid driving or operating machinery.
Diclofenac Hexal contains benzyl alcohol and propylene glycol
The injectable solution contains 120 mg of benzyl alcohol, which may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant or have liver or kidney disease.
Large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis).
This medicine contains 600 mg of propylene glycol per vial. If you are pregnant or suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. Your doctor may perform additional monitoring during treatment.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is practically ‘sodium-free’.

3. How to take Diclofenac Hexal

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
How to inject Diclofenac Hexal
Injections of Diclofenac Hexal must be administered following standard sterilization and aseptic techniques.
Diclofenac Hexal must be injected into the muscle.
Inject the contents of one vial deeply into the upper outer quadrant of the buttock.
If you need to use two vials of Diclofenac Hexal, do not inject both into the same buttock (inject one vial into each buttock).
Use in adults
Diclofenac Hexal injectable solution for intramuscular use should not be used for more than two
days. If necessary, treatment may be continued with Diclofenac Hexal tablets or suppositories.
The recommended initial dose is 1 vial of 75 mg per day, administered by intramuscular injection.
In exceptional cases, in severe conditions, 2 vials of 75 mg per day may be given. The contents of the two
vials must not be injected into the same buttock (inject one vial into each buttock).
Your doctor will advise you on how much Diclofenac Hexal to take and for how long.
Diclofenac Hexal is also available as tablets and suppositories. In addition to Diclofenac Hexal vials, you may
use Diclofenac Hexal tablets or suppositories, up to a maximum daily dose of 150 mg.
How to open the Diclofenac Hexal vial:

Hold the vial as shown in the picture,

Technical drawing showing a medical device on the left and two hands gripping it to rotate it to the right following a curved arrow

with the coloured mark facing upwards.

Break the vial with a sharp, firm motion.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.
Stop taking Diclofenac Hexal and contact your doctor immediately if you experience:
Mild abdominal cramps and tenderness occurring shortly after starting treatment with Diclofenac Hexal, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of onset of abdominal pain (frequency not known, cannot be estimated from available data).

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

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

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

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

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

Allergic reactions, severe and rapidly occurring allergic reactions (anaphylaxis), including hypotension and collapse (shock)
Drowsiness
Asthma, difficulty breathing (dyspnoea)
Inflammation of the stomach (gastritis), bleeding from the stomach or intestine, vomiting blood, stomach or intestinal ulcer with or without bleeding and perforation
Blood in the stools
Inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders
Hives (urticaria)
Oedema (fluid retention and swelling)
Tissue damage at the injection site. If you experience any of these side effects, inform your doctor immediately.

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

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

Side effects with unknown frequency

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
Nicolau syndrome, characterised by an immediate, intense pain sensation at the injection site, followed by redness, swelling, and nodule formation, possibly involving blockage of blood vessels leading to damage of the skin and underlying tissue.

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 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 Hexal

Store below 30°C. Keep the ampoules in the outer packaging to protect the medicine from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.. The expiry date refers to the last day of that month.
Do not 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Diclofenac Hexal contains

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

Description of the appearance of Diclofenac Hexal and contents of the pack
Each pack contains 5 vials of Diclofenac Hexal 75 mg/3 ml solution for injection for intramuscular use.
Marketing Authorization Holder
Sandoz S.p.A.
Largo Umberto Boccioni 1
21040 Origgio (VA)
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee, 1
D-39179 Barleben (Germany)

Patient Information Leaflet

Diclofenac Hexal 25 mg gastro-resistant tablets, 50 mg gastro-resistant tablets

sodium diclofenac
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 side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

joint diseases such as rheumatoid arthritis, ankylosing spondylitis and osteoarthritis
muscle, tendon and bone disorders
pain due to non-rheumatic inflammation or trauma
pain associated with menstruation

2. What you should know before taking Diclofenac Hexal

Do not take Diclofenac Hexal

if you are allergic (hypersensitive) to sodium diclofenac or to any of the other ingredients of this medicine (listed in section 6)
if you have ever had an allergic reaction after taking medicines used to treat inflammation or pain, such as acetylsalicylic acid (aspirin), diclofenac, or ibuprofen. Reactions may include: asthma, runny nose, skin redness, swelling of the face, lips, tongue, throat and/or extremities (signs of angioedema), chest pain. If you think you may be allergic, consult your doctor
if you have a stomach or intestinal ulcer, bleeding, or perforation
if you currently have bleeding or are prone to bleeding
if you have previously experienced bleeding (haemorrhage) or perforation of the stomach or intestine after prior treatment with NSAIDs
if you have had recurrent bleeding (haemorrhage) or ulceration of the stomach or duodenum (two or more distinct episodes of proven ulceration or bleeding)
if you have had liver problems
if you have severe liver problems (hepatic failure)
if you have severe kidney problems (renal failure)
if you have confirmed heart disease (established cardiopathy and/or cerebrovascular disease, e.g. you have had a heart attack, stroke, mini-stroke (TIA)) or 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 circulatory problems in the arteries (peripheral arterial disease)
if you have a blood cell production disorder
if you are taking high doses of medicines that increase urine production (diuretics) (see "Other medicines and Diclofenac Hexal")
if you are in the third trimester of pregnancy (see section "Pregnancy, breastfeeding and fertility")
if you are breastfeeding (see section "Pregnancy, breastfeeding and fertility")
if the patient is under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Diclofenac Hexal.
Inform your doctor before taking Diclofenac Hexal:

if you smoke
if you have diabetes
if you have angina, blood clots, high blood pressure, high cholesterol or high triglycerides
if you have asthma
if you have seasonal allergic rhinitis, nasal mucosa swelling (e.g. nasal polyps)
if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
if you have liver problems (e.g. hepatic failure, hepatitis)
if you have hepatic porphyria
if you have ulcerative colitis or Crohn's disease, as these conditions may worsen
if you have kidney problems (e.g. renal failure)
if you are taking medicines that increase urine production (diuretics) or other medicines that may affect kidney function
if you have reduced body fluid volume (e.g. before or after major surgery)
if you are undergoing or have recently undergone major surgery
if you have blood clotting disorders (coagulation defects)
if you have or have had high blood pressure, heart or brain problems (e.g. congestive heart failure, established heart disease, peripheral arterial disease and/or stroke)
if you have or have had stomach or intestinal problems (e.g. ulcer), or if you have experienced stomach or intestinal ulcers, bleeding, or perforation
if you are taking medicines that may increase the risk of bleeding, ulceration, and perforation such as acetylsalicylic acid (e.g. aspirin), 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 Diclofenac Hexal”).
Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/taking/using [product name], as [product name] may occasionally impair wound healing in the intestine following surgery.

Inform your doctor if, during treatment with Diclofenac Hexal, you develop:

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

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

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

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

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

The effect of some medicines used to lower blood pressure, such as:
o medicines that increase urine production (diuretics)
o beta-blockers
o angiotensin-converting enzyme inhibitors (ACE inhibitors)
may decrease when used together with Diclofenac Hexal.
Your doctor will monitor you closely and carefully evaluate the co-administration of these medicines with Diclofenac Hexal, especially if you are elderly.
Exercise particular caution and inform your doctor if you need to take Diclofenac Hexal while already taking one or more of the following medicines:

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

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
Diclofenac Hexal must not be used during the first and second trimesters of pregnancy unless strictly necessary.
If you are planning pregnancy or are in the first or second trimester and need to use diclofenac, your doctor will prescribe the lowest dose for the shortest possible duration.
Diclofenac must not be used during the third trimester of pregnancy because it may cause serious harm to the mother and baby.
Breastfeeding
Diclofenac Hexal must not be used during breastfeeding to avoid adverse effects on the newborn.
Fertility
As with other NSAIDs, Diclofenac Hexal must not be used in women who are planning pregnancy, as this medicine may impair female fertility. Your doctor will assess whether discontinuation of Diclofenac Hexal treatment is necessary if you experience difficulty becoming pregnant or require fertility testing.
Driving and use of machinery
Diclofenac Hexal 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.
Diclofenac Hexal contains lactose and sodium
The gastro-resistant tablets contain lactose. If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Diclofenac Hexal

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Diclofenac Hexal 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 100–150 mg per day.
For mild conditions and long-term treatment, the recommended dose is 75–100 mg per day.
The dose should be divided into 2–3 administrations throughout the day.
Your doctor will tell you how much Diclofenac Hexal to take and for how long.
Treatment of pain associated with menstrual cycle (dysmenorrhea)
The recommended dose is 50–150 mg per day, but it should be adjusted individually for each patient.
Your doctor will initially prescribe 50–100 mg per day and, if necessary, may instruct you to increase the dose
during subsequent menstrual cycles, up to a maximum of 150 mg per day.
Start treatment when the first symptoms appear and continue for a few days depending on your
symptoms.
Treatment of night-time pain and morning stiffness
Diclofenac Hexal is also available as suppositories. In addition to Diclofenac Hexal tablets taken during the
day, you may use a suppository before going to bed.
Do not exceed the maximum daily dose of 150 mg.
Use in children and adolescents
Diclofenac Hexal must not be used in children and adolescents under 14 years of age.
Use in the elderly
In elderly patients, a dose reduction of diclofenac may be necessary. Your doctor will tell you how much Diclofenac Hexal
you should take.
If you take more Diclofenac Hexal than you should
If you accidentally ingest an excessive dose of Diclofenac Hexal, 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 more severe cases, serious kidney and liver damage may occur.
Your doctor will treat acute poisoning from non-steroidal anti-inflammatory drugs, including diclofenac, based on the symptoms you present.
If you forget to take Diclofenac Hexal
Do not take a double dose to make up for a forgotten dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some side effects can be serious.
Stop taking Diclofenac Hexal and inform your doctor immediately if you notice:
Mild abdominal cramps and tenderness occurring shortly after starting treatment with Diclofenac Hexal, 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).

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

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

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

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

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

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

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

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

Side effects with unknown frequency

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

5. How to store Diclofenac Hexal

Diclofenac Hexal 25 mg gastro-resistant tablets
This medicinal product requires no special storage conditions.

Diclofenac Hexal 50 mg gastro-resistant tablets
Do not store above 25°C.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging after Exp.. 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 Diclofenac Hexal contains
Diclofenac Hexal 25 mg gastro-resistant tablets

The active substance is sodium diclofenac. Each tablet contains 25 mg of sodium diclofenac.
The other components are monohydrate lactose, dibasic calcium phosphate, microcrystalline cellulose, maize starch, sodium carboxymethyl starch, magnesium stearate, colloidal silicon dioxide.
The coating contains "Eudragit L" 30D, triethyl citrate, talc, titanium dioxide, yellow iron oxide (E 172).

Diclofenac Hexal 50 mg gastro-resistant tablets

The active substance is sodium diclofenac. Each tablet contains 50 mg of sodium diclofenac.
The other components are monohydrate lactose, dibasic calcium phosphate, microcrystalline cellulose, maize starch, sodium carboxymethyl starch, magnesium stearate, colloidal silicon dioxide.
The coating contains "Eudragit L" 30D, triethyl citrate, talc, titanium dioxide, yellow iron oxide (E 172).

Description of the appearance of Diclofenac Hexal and contents of the pack
Diclofenac Hexal 25 mg gastro-resistant tablets
Each pack contains 60 gastro-resistant tablets for oral use.
Diclofenac Hexal 50 mg gastro-resistant tablets
Each pack contains 30 gastro-resistant tablets for oral use.
Marketing Authorization Holder
Sandoz S.p.A.
Largo Umberto Boccioni 1
21040 Origgio (VA)
Manufacturer
Lek Pharmaceuticals d.d. – Verovškova 57 – 1526 Ljubljana (Slovenia)

Patient Information Leaflet

Diclofenac Hexal 100 mg suppositories

sodium diclofenac
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 other people, 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 Diclofenac Hexal is and what it is used for
What you need to know before taking Diclofenac Hexal
How to take Diclofenac Hexal
Possible side effects
How to store Diclofenac Hexal
Contents of the pack and other information

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

Diclofenac Hexal 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.
Diclofenac Hexal is used to treat:

joint diseases such as rheumatoid arthritis, ankylosing spondylitis and osteoarthritis
conditions affecting muscles, tendons and bones
pain caused by non-rheumatic inflammation or trauma
pain associated with menstruation

2. What you should know before taking Diclofenac Hexal

Do not take Diclofenac Hexal

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Diclofenac Hexal.
Tell your doctor before taking Diclofenac Hexal:

if you smoke
if you have diabetes
if you suffer from angina, blood clots, high blood pressure, high cholesterol, or high triglycerides
if you have asthma
if you have seasonal allergic rhinitis, swelling of the nasal mucosa (e.g. nasal polyps)
if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
if you have liver problems (e.g. hepatic insufficiency, hepatitis)
if you have hepatic porphyria
if you have ulcerative colitis or Crohn’s disease, as these conditions may worsen
if you have kidney problems (e.g. renal insufficiency)
if you are taking medicines that increase urine production (diuretics) or other medicines that may affect kidney function
if you have reduced body fluid volume (e.g. before or after major surgery)
if you are undergoing or have recently undergone major surgery
if you have blood clotting disorders (coagulation defects)
if you have or have had high blood pressure, heart or brain problems (e.g. congestive heart failure, established heart disease, peripheral arterial disease and/or stroke)
if you have or have had stomach or intestinal problems (e.g. ulcer), or if you have had stomach or intestinal ulcers, bleeding, or perforation
if you are taking medicines that may increase the risk of bleeding, ulcers, and perforation, such as acetylsalicylic acid (e.g. aspirin), corticosteroids taken by mouth, by injection, or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Diclofenac Hexal”).
Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/taking/using [product name], as [product name] may occasionally impair wound healing in the intestine following surgery.

Inform your doctor if, during treatment with Diclofenac Hexal, you develop:

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

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

Do not swallow the suppositories.
At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulceration, or perforation may occur, which can be fatal. Your doctor will prescribe the lowest effective dose of diclofenac to reduce the risk of gastrointestinal toxicity and may also prescribe medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
If you are elderly, especially if you are frail and underweight, your doctor will prescribe a low dose of Diclofenac Hexal.
Side effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 “How to take Diclofenac Hexal”).
Avoid using diclofenac during treatment with other NSAIDs taken orally, by injection, or rectally, including selective COX-2 inhibitors, as this increases the likelihood of side effects.
Diclofenac Hexal may mask the signs and symptoms of infection.
Medicines such as Diclofenac Hexal may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is greater with higher doses or prolonged treatment.

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

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

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

medicines to lower blood pressure or ACE inhibitors and angiotensin II antagonists, if you have kidney problems, or medicines known as potassium-sparing agents (e.g. spironolactone)
other anti-inflammatory medicines (non-steroidal anti-inflammatory drugs and corticosteroids)
medicines to thin the blood (anticoagulants or antiplatelet agents)
serotonin reuptake inhibitors (antidepressants)
medicines for diabetes
cyclosporine (an immunosuppressant used to modify the body's immune response)
trimethoprim (an antibiotic)
medicines for bacterial infections of the quinolone class
colestipol and cholestyramine, as they may delay or reduce 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 colestipol and cholestyramine
rifampicin (an antibiotic used to treat bacterial infections), as it may reduce diclofenac absorption
other medicines that may increase blood levels of diclofenac, e.g. sulfinpyrazone and voriconazole. Your doctor will monitor you and arrange tests as needed.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Diclofenac Hexal must not be used during the first and second trimesters of pregnancy unless strictly necessary. If you plan to become pregnant or are in the first or second trimester and need to use diclofenac, your doctor will prescribe the lowest dose for the shortest possible time.
Diclofenac Hexal must not be used during the third trimester of pregnancy because it may cause serious harm to the mother and unborn child.
Breastfeeding
Diclofenac Hexal must not be used during breastfeeding to avoid potential adverse effects on the newborn.
Fertility
As with other NSAIDs, Diclofenac Hexal must not be used in women who are trying to conceive, as this medicine may impair female fertility. Your doctor will assess whether treatment with Diclofenac Hexal should be discontinued if you experience difficulty conceiving or require fertility testing.
Driving and using machines
Diclofenac Hexal 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.
Diclofenac Hexal suppositories contain sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per suppository, i.e. essentially “sodium-free”.

3. How to take Diclofenac Hexal

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use the suppositories after having passed a bowel movement and insert them properly into the rectum. The suppositories must not
be crushed or divided.
Do not swallow the suppositories; they are for rectal use only.

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

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

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

Use in children and adolescents
Diclofenac Hexal must not be used in children and adolescents.

Use in the elderly
In elderly patients, a dose reduction of diclofenac may be necessary. Your doctor will advise you on how much Diclofenac Hexal to take.

If you take more Diclofenac Hexal than you should
If you accidentally take too much Diclofenac Hexal, 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 more severe cases, serious kidney and liver damage may also occur.
Your doctor will treat acute poisoning with non-steroidal anti-inflammatory drugs, including diclofenac, based on the symptoms you present.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some side effects may be serious.
Stop taking Diclofenac Hexal and inform your doctor immediately if you notice:
Mild abdominal cramps and tenderness occurring shortly after starting treatment with Diclofenac Hexal, 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).

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

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

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

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

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

Allergic reactions, severe and sudden allergic reactions (anaphylaxis) including hypotension and collapse (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
Blood in the stools
Inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders
Urticaria
Oedema (swelling due to fluid accumulation)
If you experience any of these side effects, inform your doctor immediately.

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

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

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

Inflammation of the rectum (proctitis)
Haemorrhoids
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome
Burning sensation at the application site
Dry skin

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 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 Hexal

Store below 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.. The expiry date refers to the last day of that month.
Do not 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 Diclofenac Hexal contains

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

Description of the appearance of Diclofenac Hexal and package contents
Each package contains 10 rectal suppositories of 100 mg.
Marketing Authorization Holder
Sandoz S.p.A.
Largo Umberto Boccioni 1
21040 Origgio (VA)
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee, 1
D-39179 Barleben (Germany)