Traulen

Package leaflet: Information for the patient

Traulen 100 mg prolonged-release tablets

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

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

Contents of this leaflet:

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

1. What Traulen is and what it is used for

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

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

2. What you need to know before taking Traulen

Do not take Traulen

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you have ever had an allergic reaction after taking medicines used to treat inflammation, pain or fever, such as acetylsalicylic acid (aspirin), ibuprofen, or any other NSAID. Reactions may include: asthma, runny nose, skin redness, swelling of the face, lips, tongue, throat and/or extremities (signs of angioedema), chest pain. If you think you may be allergic, consult your doctor.
• if you have a stomach or intestinal ulcer, bleeding or perforation;
• if you currently have bleeding or are prone to bleeding;
• if you have previously experienced bleeding (haemorrhage) or perforation of the stomach or intestine during previous treatment with NSAIDs;
• if you have had recurrent stomach or duodenal bleeding/ulcer (two or more distinct episodes of proven ulceration or bleeding);
• if you have severe gastrointestinal disorders;
• if you have severe liver problems (hepatic insufficiency);
• if you have severe kidney problems (renal insufficiency);
• if you have severe heart problems (heart failure);
• if you have established heart disease 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 undergone surgery to remove or prevent such obstructions;
• 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 Traulen");
• if you are taking medicines to thin the blood (anticoagulants);
• 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 are under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Traulen:

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

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

• skin reactions, even severe ones, because very rare serious skin reactions, which may be fatal, have been reported (see section 4 “Undesired effects”);
• fluid retention and swelling due to fluid accumulation (oedema);
• any signs of an allergic reaction;
• signs and symptoms of liver problems or if liver function tests are abnormal (evident from blood tests);
• unusual stomach or intestinal symptoms, especially at the beginning of treatment with Traulen, as they may indicate gastrointestinal bleeding or ulceration;

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

• At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulceration or perforation may occur, which can be fatal. Your doctor will prescribe the lowest effective dose of diclofenac to reduce the risk of gastrointestinal toxicity and may also prescribe medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
• If you are elderly, especially if you are frail and underweight, your doctor will prescribe a low dose of Traulen.
• Undesired effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 “How to take Traulen”).
• Avoid using diclofenac during treatment with other NSAIDs taken orally, by injection or rectally, including selective cyclooxygenase-2 inhibitors, as this increases the likelihood of adverse effects.
• Traulen may mask signs and symptoms of infection.
• Medicines like Traulen 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 Traulen.
Additionally, your doctor may arrange periodic tests to monitor your condition during treatment with Traulen.
Children and adolescents
Traulen 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, especially stomach or intestinal bleeding and perforation, which are generally more severe and may be fatal.
If you are elderly, especially if you are frail and underweight, your doctor will prescribe a low dose of Traulen.
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 Traulen
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
The blood concentration of the following medicines may increase when used together with Traulen:

• lithium,
• digoxin,
• methotrexate – caution is recommended when taking diclofenac 24 hours before or after methotrexate treatment,
• phenytoin.

Your doctor will perform checks to monitor blood levels of these medicines.
The effect of some medicines used to lower blood pressure, such as:

• medicines that increase urine production (diuretics),
• beta-blockers,
• angiotensin-converting enzyme inhibitors (ACE inhibitors),

may decrease when used together with Traulen.
Your doctor will monitor you and carefully evaluate the use of these medicines together with Traulen, especially if you are elderly.
Pay special attention and inform your doctor if you need to take Traulen while already taking one or more of the following medicines.
Your doctor will monitor you and arrange tests.

• blood pressure-lowering medicines:
  o ACE inhibitors and angiotensin II antagonists, if you have kidney problems;
  o potassium-sparing diuretics (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);
• antibiotics of the quinolone class;
• colestipol and cholestyramine, as they may delay or reduce absorption of diclofenac. Your doctor will advise when to take these medicines; generally, diclofenac should be taken 1 hour before or 4–6 hours after colestipol or cholestyramine;
• 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, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Traulen must not be used during the first and second trimesters of pregnancy unless strictly necessary. If you wish to become pregnant or are in the first or second trimester and need to use Traulen, your doctor will prescribe the lowest dose of diclofenac for the shortest possible time.
Do not take Traulen 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 Traulen during the first six months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From the 20th week of pregnancy, Traulen may cause kidney problems in the fetus if taken for more than a few days, thereby reducing amniotic fluid levels surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Traulen must not be used during breastfeeding to avoid adverse effects on the newborn.
Fertility
As with other NSAIDs, Traulen is not recommended for women planning pregnancy, as this medicine may affect female fertility. Your doctor will assess whether treatment with Traulen should be discontinued if you have difficulty becoming pregnant or require fertility testing.
Driving and using machines
Traulen 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.
Traulen contains lactose and sodium
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Traulen

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 Traulen must be taken whole with some liquid,
preferably during meals. The prolonged-release tablets must not be crushed, divided or
chewed.
Use in adults
The recommended starting dose is 1 tablet of 100 mg per day.
If necessary, the daily dose may be increased to 150 mg. For doses not achievable with this
strength, other medicinal products containing sodium diclofenac are available.
Your doctor will tell you how much Traulen to take and for how long.
If symptoms are worse at night or in the morning, take Traulen tablets preferably in the evening.
Use in children and adolescents
Traulen must not be used in children and adolescents under 14 years of age.
Use in the elderly
A reduced dose of diclofenac may be necessary in the elderly. Your doctor will tell you how much Traulen you should take.
If you take more Traulen than you should
If you accidentally take an excessive dose of Traulen, inform your doctor immediately or go to the nearest hospital.
If you take an excessive dose of Traulen, you may experience vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus or convulsions. In more severe cases, serious kidney and liver damage may also occur.
Your doctor will treat acute poisoning from non-steroidal anti-inflammatory drugs, including diclofenac, based on the symptoms you present.
If you forget to take Traulen
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Traulen
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• Mild cramps and abdominal tenderness occurring soon after starting treatment with Traulen, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (ischaemic colitis; frequency not known, cannot be estimated based on available data).
• A severe skin allergic reaction which may include widespread red and/or dark patches, skin swelling, blisters, and itching sensation (generalized fixed drug eruption; frequency not known, cannot be estimated based on available data).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome (frequency not known, cannot be estimated based on 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;
• persistent loss of appetite (anorexia);
• abnormal blood test results (increase in certain liver enzymes: transaminases);
• skin rash.

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;
• 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 blood test results: either 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 urine test results: either presence of blood in urine (haematuria), or presence of protein in urine (proteinuria);
• allergic reaction with rapid swelling of the skin and mucous membranes (angioedema), including facial swelling;
• disorientation, depression, insomnia, nightmares, irritability, severe mental disturbances (psychotic reactions);
• memory impairment, seizures, anxiety, tremors;
• tingling sensations (paraesthesia);
• taste disturbances;
• inflammation of the membranes covering the brain (aseptic meningitis), stroke;
• visual disturbances, blurred vision, double vision;
• ringing or buzzing in the ears, worsening of hearing;
• high blood pressure, inflammation of blood vessels (vasculitis);
• awareness of your own heartbeat (palpitations), chest pain, heart problems (heart failure), heart attack;
• pneumonia;
• inflammation of the colon (colitis), including colitis with bleeding, worsening of ulcerative colitis or Crohn’s disease;
• constipation;
• inflammation of the mouth lining (stomatitis), including stomatitis with ulcers, inflammation of the tongue (glossitis);
• oesophageal problems, intestinal narrowing;
• inflammation of the pancreas (pancreatitis);
• very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (liver failure);
• skin reactions ranging from mild (bullous eruptions, eczema, erythema) to potentially fatal (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), exfoliative dermatitis);
• appearance of red-brown spots on the skin (purpura), also as an allergic reaction;
• itching;
• hair loss;
• skin sensitivity to sunlight;
• kidney problems such as acute kidney failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• A skin allergic reaction, which may include round or oval-shaped red and swollen patches on the skin, skin rash with blisters, and itching (fixed drug eruption). Darkening of the skin in the affected areas may also occur, which could persist after healing. A fixed drug eruption usually recurs at the same site (or sites) if the medicine is taken again.

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

5. How to store Traulen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
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 Traulen contains

• The active substance is sodium diclofenac. Each tablet contains 100 mg of sodium diclofenac.
• The other components are: microcrystalline cellulose, lactose, starch, polyvinylpyrrolidone, magnesium stearate, hydroxypropylcellulose, cellulose acetate phthalate, diethyl phthalate, titanium dioxide.

Description of the appearance of Traulen and pack contents
Pack of 20 tablets in PVC/Al blisters.
Marketing Authorization Holder
OP Pharma S.r.l., Via Monte Rosa, 61 - 20149 Milan
Manufacturer
Farmaceutici FORMENTI S.p.A. - Via G. Di Vittorio, 2 - Origgio (VA)

Patient Information Leaflet

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

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, 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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Traulen is and what it is used for
2. What you need to know before using Traulen
3. How to use Traulen
4. Possible side effects
5. How to store Traulen
6. Package contents and other information

1. What Traulen is and what it is used for

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

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

2. What you should know before taking Traulen

Do not take Traulen

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you have ever had an allergic reaction after taking medicines used to treat inflammation, pain or fever, such as acetylsalicylic acid (aspirin), ibuprofen, or any other NSAID. 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 previously experienced bleeding (haemorrhage) or perforation of the stomach or intestine during prior treatment with NSAIDs;
• if you have had recurrent bleeding/ulceration of the stomach or duodenum (two or more distinct episodes of proven ulceration or bleeding);
• if you have severe gastrointestinal disorders;
• if you have severe liver problems (hepatic insufficiency);
• if you have severe kidney problems (renal insufficiency);
• if you have severe heart problems (heart failure);
• if you have established cardiovascular disease 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 undergone surgery to remove or prevent such obstructions;
• 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 Traulen");
• if you are taking blood-thinning medicines (anticoagulants);
• 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 are a child or adolescent.

Warnings and precautions
Talk to your doctor or pharmacist before taking Traulen:

• if you have ever developed severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking Traulen or other painkillers.
• if you smoke;
• if you have diabetes;
• if you have angina, blood clots, high blood pressure, high cholesterol or high triglycerides;
• if you have asthma;
• if you have seasonal allergic rhinitis, nasal mucosa swelling (e.g. nasal polyps);
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections;
• if you have liver problems (e.g. hepatic insufficiency, hepatitis);
• if you have hepatic porphyria;
• if you have ulcerative colitis or Crohn’s disease, as these conditions may worsen;
• if you have kidney problems (e.g. renal insufficiency);
• if you are using medicines that increase urine production (diuretics) or other medicines that may affect kidney function;
• if you have reduced body fluid volume (e.g. before or after major surgery);
• if you are undergoing or have recently undergone major surgery;
• if you have blood clotting disorders (hemostasis 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 ulceration, bleeding or perforation;
• if you are taking medicines that may increase the risk of bleeding, ulceration and perforation such as acetylsalicylic acid (e.g. aspirin) or other NSAIDs, corticosteroids taken orally, by injection or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) (see section "Other medicines and Traulen");
• inform your doctor if you have recently undergone or are about to undergo surgery on the stomach or intestinal tract before taking Traulen, as Traulen may sometimes impair wound healing in the intestine after surgery.

Inform your doctor if you develop the following during treatment with Traulen:

• skin reactions, even severe ones, as very rare but potentially life-threatening skin reactions have been reported (see section 4 "Undesirable 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 tests are abnormal (visible from blood tests);
• unusual stomach or intestinal symptoms, especially at the beginning of treatment with Traulen, as they may indicate gastrointestinal bleeding or ulceration;

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

• At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulceration or perforation may occur, which can be fatal. Your doctor will prescribe the lowest effective dose of diclofenac to minimize 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 Traulen.
• Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration (see section 3 "How to take Traulen").
• Avoid using diclofenac during treatment with other NSAIDs taken orally, by injection or rectally, including selective COX-2 inhibitors, as this increases the risk of adverse effects.
• Traulen may mask signs and symptoms of infection.
• Medicines like Traulen 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 Traulen, including pain at the injection site, redness, swelling/induration, ulceration, sometimes with hematoma or pus collection, and damage to the skin and subcutaneous tissue (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 continued treatment with Traulen.
Additionally, your doctor may perform periodic tests to evaluate your condition during treatment with Traulen.
Children and adolescents
Traulen must not be used in children and adolescents.
Elderly patients
Elderly patients are more likely to experience 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 Traulen.
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 Traulen
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 Traulen:

• lithium,
• digoxin,
• methotrexate – caution is recommended when taking diclofenac 24 hours before or after methotrexate treatment,
• phenytoin.

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

• blood pressure-lowering medicines:
  o ACE inhibitors and angiotensin II antagonists, if you have kidney problems;
  o potassium-sparing diuretics (e.g. spironolactone);
• other anti-inflammatory medicines (non-steroidal anti-inflammatory drugs and corticosteroids);
• blood-thinning medicines (anticoagulants or antiplatelet agents);
• serotonin reuptake inhibitors (antidepressants);
• medicines for diabetes;
• cyclosporine (an immunosuppressant used to modify the body's immune response);
• antibacterial medicines of the quinolone class;
• colestipol and cholestyramine, as they may delay or reduce diclofenac absorption. Your doctor will advise you when to take these medicines; generally, diclofenac should be taken 1 hour before or 4–6 hours after colestipol or cholestyramine;
• 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, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Traulen must not be used during the first and second trimesters of pregnancy unless strictly necessary. If you are trying to become pregnant or are in the first or second trimester and need to use Traulen, your doctor will prescribe the lowest dose of diclofenac for the shortest possible time.
Do not take Traulen during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labour beyond expected duration. You should not take Traulen during the first six months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From the 20th week of pregnancy, Traulen may cause kidney problems in the fetus if taken for more than a few days, thereby reducing amniotic fluid levels surrounding the baby (oligohydramnios) or causing constriction 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
Traulen must not be used during breastfeeding to avoid adverse effects on the newborn.
Fertility
As with other NSAIDs, Traulen is not recommended for women who are trying to conceive, as this medicine may impair female fertility. Your doctor will assess whether treatment with Traulen should be discontinued if you have difficulty becoming pregnant or are undergoing fertility testing.
Driving and using machines
Traulen 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.
Traulen contains benzyl alcohol, propylene glycol and sodium
This medicine contains 119 mg of benzyl alcohol per vial.
Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant, breastfeeding, or have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
This medicine contains 581 mg of propylene glycol per vial.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially 'sodium-free'.

3. How to use Traulen

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
How to inject Traulen
Traulen injections must be administered following proper sterilization and aseptic techniques.
Traulen must be injected into the muscle.
The contents of one vial should be injected deeply into the upper outer part of the buttock.
An appropriate injection technique must be used, and a needle of adequate length must be selected (considering the thickness of fat in the patient's buttock) to avoid unintentional subcutaneous administration of the drug.
If you need to use two vials of Traulen, do not inject the contents of both vials into the same buttock (inject one vial into each buttock).
Use in adults
Traulen injectable solution for intramuscular use should not be used for more than two days. If necessary, treatment may be continued with Traulen tablets.
The recommended dose is 1 vial of 75 mg per day.
Exceptionally, in severe cases (e.g. colic), 2 vials of 75 mg per day may be administered.
The maximum daily dose is 150 mg. Your doctor will tell you how much Traulen to take and for how long.
Use in children and adolescents
Traulen must not be used in children and adolescents.
Use in the elderly
In elderly patients, a reduced dose of diclofenac may be necessary. Your doctor will advise you on the appropriate dose of Traulen.
If you take more Traulen than you should
If you accidentally take an excessive dose of Traulen, inform your doctor immediately or go to the nearest hospital.
If you take an excessive dose of Traulen, you may experience vomiting, stomach or intestinal bleeding, diarrhoea, dizziness, tinnitus 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 the symptoms you present.
If you forget to take Traulen
Do not take a double dose to make up for the missed dose.
If you stop treatment with Traulen
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 may be serious.
Stop taking Traulen and contact your doctor immediately if you experience any of the following serious side effects. You may require urgent medical treatment:

• Reactions at the injection site, including pain, redness, swelling, hard nodule, ulcers, and bruising. These reactions may worsen with darkening and death of the skin and underlying tissues surrounding the injection site, which then heal with scarring. This condition is known as Nicolau syndrome (frequency not known, cannot be estimated from available data).
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome (frequency not known, cannot be estimated from available data).
• Mild cramps and abdominal tenderness occurring shortly after starting treatment with Traulen, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (ischaemic colitis; frequency not known, cannot be estimated from available data).
• A severe skin allergic reaction that may include widespread red and/or dark patches, skin swelling, blisters, and itching sensation (Generalised fixed drug eruption; 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;
• persistent loss of appetite (anorexia);
• abnormal blood test results (increased liver enzymes: transaminases);
• skin rash;
• reactions, pain or hardening at the injection site.

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

• allergic reactions, severe and rapidly occurring allergic reactions (anaphylaxis) including low blood pressure and collapse (shock);
• drowsiness;
• asthma, difficulty breathing (dyspnoea);
• inflammation of the stomach (gastritis), bleeding from the stomach or intestine, vomiting blood, stomach or intestinal ulcer with or without bleeding and perforation;
• blood in the stools;
• inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders;
• urticaria;
• oedema (swelling due to fluid accumulation);
• 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: either 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: either 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 sensation (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);
• awareness of your heartbeat (palpitations), chest pain, heart problems (heart failure), heart attack;
• 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);
• oesophageal problems, intestinal narrowing;
• inflammation of the pancreas (pancreatitis);
• very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (hepatic failure);
• skin reactions ranging from mild (bullous eruptions, eczema, erythema) to potentially fatal (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), exfoliative dermatitis);
• appearance of red-brown spots on the skin (purpura), also as an allergic reaction;
• itching;
• hair loss;
• skin sensitivity to sunlight;
• kidney problems such as acute kidney failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis;
• pus formation in the tissue (abscess) at the injection site.

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

• A skin allergic reaction, which may include round or oval patches with redness and swelling of the skin, skin rash with blisters, and itching sensation (Fixed drug eruption). Darkening of the skin in the affected areas may also occur, which could persist after healing. A fixed drug eruption usually recurs at the same site (or same sites) if the medicine is taken again.

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

5. How to store Traulen

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.
Store in the original packaging to protect the medicine from light, and keep away from sources of heat.
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 Traulen contains

• The active substance is sodium diclofenac. Each vial contains 75 mg of sodium diclofenac.
• The other components are: propylene glycol (E1520), benzyl alcohol, water for injections.

Description of the appearance of Traulen and pack contents
Pack of 5 glass vials.
Marketing Authorization Holder
OP Pharma S.r.l., Via Monte Rosa, 61 - 20149 Milan
Manufacturer
BIOLOGICI ITALIA LABORATORIES S.r.l. - Via Cavour 41/43 - Novate Milanese (MI)

Package leaflet: Information for the user

TRAULEN 4% Gel
Diclofenac sodium
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement, or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What Traulen is and what it is used for

Traulen contains the active substance diclofenac and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), used to relieve pain and inflammation.
Traulen is used for the local treatment of pain and inflammation of rheumatic or traumatic origin in joints, muscles, tendons and ligaments.
Consult your doctor if you do not feel better or feel worse after 7 days.

2. What you need to know before using Traulen

Do not use Traulen

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6).
• if you have experienced asthma attacks, hives, or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• after the sixth month of pregnancy (see section “Pregnancy and breastfeeding”).
• in children and adolescents under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Traulen.
If the medicine is used over large areas of skin and for prolonged periods, the possibility of systemic adverse effects (which may affect various parts of the body) cannot be ruled out (see section 4 “Possible side effects”).
Stop treatment immediately and consult your doctor if a skin rash occurs after applying the gel.

Children and adolescents
There is insufficient data on efficacy and safety in children and adolescents under 14 years of age. Therefore, do not use Traulen in children under 14 years of age.

Other medicines and Traulen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Since the absorption of diclofenac after topical application is very low, interactions with other medicines are highly unlikely.

Pregnancy and breastfeeding
Do not use Traulen after the sixth month of pregnancy. It is also advisable to avoid using Traulen during the early stages of pregnancy.
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
Topical application of diclofenac does not affect the ability to drive vehicles or operate machinery.

Traulen contains propylene glycol (E1520) and ethanol (ethyl alcohol)
This medicine contains 3.75 g of propylene glycol per bottle.
This medicine contains 6.7 mg of alcohol (ethanol) in each spray. It may cause a burning sensation on damaged skin.

3. How to use Traulen

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults (over 18 years of age)
The recommended dose is three or four applications, depending on the size of the area to be treated, three times daily.
Use in children and adolescents (from 14 to 18 years of age)
Three to four applications, depending on the size of the area to be treated, three times daily.
Warning: Use Traulen only for short treatment periods.
If you need to use Traulen for more than 7 days to relieve pain, or if symptoms worsen, consult your doctor.
Elderly:
The usual adult dosage may be used.
Children under 14 years of age
There is insufficient data on efficacy and safety in children and adolescents under 14 years of age. Therefore, do not use Traulen in children under 14 years of age.
Instructions for use:

Wash and dry the Apply to the affected area Massage gently to
painful area promote absorption

• After application, wash your hands thoroughly; otherwise, they will also be exposed to the gel.
• DO NOT USE on diseased skin, skin wounds, or open lesions.
• Avoid contact with eyes or mucous membranes.
• Do not ingest.
• Do not use an occlusive dressing that does not allow air permeability.

If you use more Traulen than you should
In case of accidental ingestion/overdose of Traulen, inform your doctor immediately or go to the Emergency Room of the nearest hospital.
If you forget to use Traulen
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
If the medicine is used on extensive skin areas and for a prolonged period, systemic side effects (which may affect various parts of the body) cannot be ruled out, such as nausea, indigestion, heartburn, excitement, altered taste sensation, conjunctivitis; if you notice any of these symptoms, stop treatment and consult your doctor.

Common side effects (may occur in up to 1 in 10 patients):

• Rash
• Itching

Uncommon side effects (may occur in up to 1 in 100 patients):

• Skin redness and burning
• Blistering rash
• Skin peeling
• Tingling
• Involuntary muscle contractions

Very rare side effects (may occur in up to 1 in 10,000 patients):

• Allergic reactions (hypersensitivity, including urticaria)
• Rapid swelling of the skin and mucous membranes
• Increased sensitivity of the skin to sunlight
• Asthma

Side effects with unknown frequency (cannot be estimated from the available data):

• 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 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 Traulen

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 carton and container after Exp. The
expiry date refers to the last day of that month.
The shelf life after first opening the container is 6 months.
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. Contents of the pack and other information

What Traulen contains

• The active substance is sodium diclofenac. Each 100 g of gel contains 4 g of sodium diclofenac.
• The other components are: propylene glycol (E1520), isopropyl alcohol, ethyl alcohol, soybean lecithin, disodium phosphate dihydrate, disodium phosphate dodecahydrate, edetate disodium, ascorbyl palmitate, peppermint flavor, purified water.

Description of the appearance of Traulen and contents of the pack
Traulen is a topical gel, available in packs containing a 25 g bottle with dispenser.
Marketing Authorization Holder
OP Pharma S.r.l., Via Monte Rosa, 61 - 20149 Milan
Manufacturer
Pharbil Waltrop GmbH, Im Wirrigen, 25 - Waltrop (Germany)
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)
By scanning the QR Code on the carton, in the leaflet, or visiting the website https://oppharma-products.com/traulen, you can access detailed and up-to-date information about this product.