Diclofenac Hexal AG: detailed information

Package leaflet: information for the patient

Diclofenac Hexal AG 100 mg prolonged-release 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Diclofenac Hexal AG 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 AG is used to treat:

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 need to know before taking Diclofenac Hexal AG

Do not take Diclofenac Hexal AG

if you are allergic (hypersensitive) to diclofenac or to any of the other ingredients of this medicine (listed in section 6)
if you have ever had an allergic reaction after taking medicines used to treat inflammation or pain or to reduce fever, such as acetylsalicylic acid (aspirin), diclofenac or ibuprofen. Reactions may include: asthma, runny nose, skin redness, swelling of the face, lips, tongue, throat and/or extremities (signs of angioedema), chest pain. If you think you may be allergic, consult your doctor
if you have had liver problems
if you have a stomach or intestinal ulcer, bleeding or perforation
if you currently have bleeding or are prone to bleeding
if you have had bleeding (haemorrhage) or perforation of the stomach or intestine after previous treatment with NSAIDs
if you have had recurrent stomach or duodenal bleeding/ulceration (two or more distinct episodes of proven ulceration or bleeding)
if you 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 to the heart or brain, or surgery to remove or prevent such blockages
if you have or have had problems with blood circulation (peripheral arterial disease)
if you have a disorder in blood cell production
if you are taking high doses of medicines that increase urine production (diuretics) (see "Other medicines and Diclofenac Hexal AG")
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 AG.
Tell your doctor before taking Diclofenac Hexal AG:

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 allergic seasonal 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 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), oral, injectable or rectal corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Diclofenac Hexal AG”).

Inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before receiving/taking/using Diclofenac Hexal AG, as Diclofenac Hexal AG may sometimes impair wound healing in the intestine following surgery.

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

skin reactions, even severe ones, as very rare but 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 (oedema)
any signs of allergic reaction
signs and symptoms of liver problems or if liver function tests are abnormal (as shown by blood tests)
unusual stomach or intestinal symptoms, especially at the beginning of treatment with Diclofenac Hexal AG, as they may indicate gastrointestinal bleeding or ulceration
signs and symptoms typical of serious atherothrombotic events such as chest pain, shortness of breath, weakness and difficulty speaking.

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

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

Your doctor will monitor you closely and periodically reassess the need for treatment with Diclofenac Hexal AG. In addition, your doctor may carry out periodic tests to evaluate your condition during treatment with Diclofenac Hexal AG.
Children and adolescents
Diclofenac Hexal AG must not be used in children and adolescents under 14 years of age.
Elderly patients
Elderly patients have a higher likelihood of experiencing adverse reactions, particularly stomach or intestinal bleeding and perforation, which are usually more severe and may be fatal.
If you are elderly, especially if you are frail and underweight, your doctor will prescribe a low dose of Diclofenac Hexal AG.
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 AG
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 AG:

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 AG. Your doctor will monitor you closely and carefully evaluate the use of these medicines with Diclofenac Hexal AG, especially if you are elderly.
Be particularly careful and inform your doctor if you need to take Diclofenac Hexal AG while already taking one or more of the following medicines.
Your doctor will monitor you and may carry out tests.

ACE inhibitors and angiotensin II antagonists, if you have kidney problems
potassium-sparing diuretics (e.g. spironolactone)
other anti-inflammatory medicines (non-steroidal anti-inflammatory drugs and corticosteroids)
blood-thinning medicines (anticoagulants or antiplatelets)
serotonin reuptake inhibitors (antidepressants)
medicines for diabetes
cyclosporine and tacrolimus (immunosuppressants 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 or cholestyramine
rifampicin (an antibiotic used to treat bacterial infections) as it may reduce diclofenac absorption
other medicines that may increase blood levels of diclofenac, e.g. sulfinpyrazone (a medicine used to treat gout) and voriconazole (a medicine used to treat fungal infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Diclofenac Hexal AG must not be used during the first and second trimesters of pregnancy unless clearly necessary.
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.
Do not take Diclofenac Hexal AG during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labour more than expected. You should not take Diclofenac Hexal AG during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the minimum dose for the shortest possible time should be used. From week 20 of pregnancy, Diclofenac Hexal AG may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Diclofenac Hexal AG must not be used during breastfeeding to avoid adverse effects on the newborn.
Fertility
As with other NSAIDs, Diclofenac Hexal AG is not recommended for women who are trying to become pregnant, as this medicine may affect female fertility. Your doctor will assess whether treatment with Diclofenac Hexal AG should be discontinued if you have difficulty becoming pregnant or need fertility tests.
Driving and using machines
Diclofenac Hexal AG 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 AG contains lactose and sodium
The prolonged-release tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him 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 AG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The prolonged-release tablets of Diclofenac Hexal AG must be taken whole with some liquid,
preferably during meals. Prolonged-release tablets must not be crushed, divided or
chewed.
Use in adults
The recommended initial dose is 100 mg daily (1 prolonged-release tablet of 100 mg).
In mild cases and for long-term treatment, the recommended dose is 100 mg daily.
Your doctor will tell you how much Diclofenac Hexal AG to take and for how long.
If symptoms are more severe at night or in the morning, take the prolonged-release tablets of Diclofenac
Hexal AG preferably in the evening.
Use in children and adolescents
Diclofenac Hexal AG 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
AG you should take.
If you take more Diclofenac Hexal AG than you should
If you accidentally ingest an excessive dose of Diclofenac Hexal AG, contact your doctor immediately or go to the nearest hospital.
If you take an excessive dose of Diclofenac Hexal AG, you may experience vomiting, gastrointestinal bleeding,
diarrhea, dizziness, tinnitus (ringing or buzzing in the ears), or seizures. In more severe cases, serious kidney and liver damage may also occur.
Your doctor will treat acute poisoning from non-steroidal anti-inflammatory drugs, including diclofenac, according to the symptoms you present.
If you forget to take Diclofenac Hexal AG
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.
Stop taking Diclofenac Hexal AG and contact your doctor immediately if you notice:
Mild abdominal cramps and tenderness occurring shortly after starting treatment with Diclofenac Hexal AG, 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 (anorexia)
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 sudden allergic reactions (anaphylaxis) including low blood pressure and collapse (shock)
Drowsiness
Asthma, difficulty breathing (dyspnoea)
Inflammation of the stomach (gastritis), bleeding from the stomach or intestine, vomiting blood, stomach or intestinal ulcer with or without bleeding and perforation
Blood in the stools
Inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders
Hives (urticaria)
Oedema (swelling due to fluid accumulation)
If you experience any of these side effects, contact your doctor immediately.

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

Abnormal results in blood tests or low platelet count (thrombocytopenia) or reduced white blood cell count (leucopenia) or reduced red blood cell count (anaemia, including haemolytic and aplastic anaemia) or low granulocyte count (agranulocytosis)
Abnormal results in urine tests

o presence of blood in the urine (haematuria)
o presence of protein in the urine (proteinuria)

Allergic reaction with rapid swelling of the skin and mucous membranes (angioneurotic oedema), including facial oedema
Disorientation, depression, insomnia, nightmares, irritability, severe mental disturbances (psychotic reactions)
Memory impairment, seizures, anxiety, tremors
Tingling sensations (paraesthesia)
Taste disturbances
Inflammation of the membranes covering the brain (aseptic meningitis), stroke, vision disorders, blurred vision, double vision
Ringing or buzzing in the ears, worsening of hearing
High blood pressure, inflammation of blood vessels (vasculitis)
Pneumonitis
Inflammation of the colon (colitis), including colitis associated 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)
Very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (hepatic 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
Increased skin sensitivity to sunlight
Kidney problems such as acute renal 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

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

5. How to store Diclofenac Hexal AG

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.
This medicine does not require any special storage conditions.
Do not use this medicine if the packaging is opened or damaged.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Diclofenac Hexal AG contains

The active substance is sodium diclofenac. Each prolonged-release tablet contains 100 mg of sodium diclofenac.
The other ingredients are monohydrate lactose, magnesium stearate, methylhydroxypropylcellulose.

Description of the appearance of Diclofenac Hexal AG and contents of the pack
Each pack contains 21 prolonged-release tablets for oral use, 100 mg.
Marketing Authorization Holder
Hexal AG S.p.A.
Industriestrasse, 25
83607 Holzkirchen - Germany
Representative in Italy
Sandoz S.p.A.
Largo Umberto Boccioni 1
21040 Origgio (VA) - Italy
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee, 1
D-39179 Barleben - Germany