Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Diclac 75 Duo (Diclac ID 75 mg), 75 mg, modified-release tablets
Diclofenacum natricum
Diclac 75 Duo and Diclac ID 75 mg are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What is Diclac 75 Duo and what is it used for
Important information before taking Diclac 75 Duo
How to take Diclac 75 Duo
Possible side effects
How to store Diclac 75 Duo
Contents of the pack and other information

1. What is Diclac 75 Duo and what is it used for
Diclac 75 Duo contains sodium diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), with anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of Diclac 75 Duo involves inhibition of prostaglandin biosynthesis, which play a key role in the pathogenesis of inflammation, pain, and fever.
Diclac 75 Duo is used in the treatment of:

Inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spinal arthritis, painful syndromes associated with spinal changes, and extra-articular rheumatism;
Pain caused by inflammatory and oedematous post-traumatic and postoperative conditions, e.g. after dental or orthopaedic procedures;
Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis.

Monitoring during treatment with Diclac 75 Duo
In patients diagnosed with heart disease or significant risk factors for heart disease, the treating physician will periodically assess the patient's need for symptomatic treatment and their response to the medicine, especially if treatment lasts longer than 4 weeks.
During treatment, the doctor will order regular blood tests to monitor liver function (aminotransferase activity), kidney function (creatinine concentration), and blood cell counts (white and red blood cells and platelets). Based on test results, the doctor will decide whether to discontinue treatment with Diclac 75 Duo or adjust the dose.

2. Important information before taking Diclac 75 Duo

When not to use Diclac 75 Duo:

if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6),
if you have ever experienced an allergic reaction after taking anti-inflammatory or analgesic medicines (e.g. acetylsalicylic acid, diclofenac, or ibuprofen). Reactions may include asthma, rhinitis, skin rash, urticaria, or swelling of the face, lips, tongue, throat, and/or limbs (symptoms of angioedema). If you think you may be allergic, consult your doctor.
if you have active or a history of peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding, or perforation; if you have previously experienced stomach discomfort or heartburn after taking anti-inflammatory medicines,
if you are in the third trimester of pregnancy,
if you have liver failure,
if you have kidney failure,
if you have been diagnosed with heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischaemic attack (TIA), or arterial embolism in the heart or brain, or after a procedure to open blocked vessels or bypass surgery,
if you have current or previous circulatory disorders (peripheral vascular disease).

You should inform your doctor if you have any of the above conditions.
Warnings and precautions
Talk to your doctor before taking Diclac 75 Duo if:

you have diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormal increases in blood lipid levels (cholesterol, triglycerides), or if you are a smoker, as in such cases the dose of the medicine should not exceed 100 mg per day if treatment lasts longer than 4 weeks;
you have a history of gastrointestinal ulceration or are elderly. Use of diclofenac may cause gastrointestinal bleeding, ulceration, or perforation (which may be fatal). This effect may be particularly dangerous when high doses of the medicine are used. If you experience any unusual abdominal symptoms during treatment with Diclac 75 Duo (especially gastrointestinal bleeding), stop taking the medicine immediately and contact your doctor;
you have ulcerative colitis or Crohn's disease, as diclofenac may worsen the course of the disease;
you have asthma, allergic rhinitis, nasal mucosal oedema (e.g. due to nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory tract infections, as you may be more susceptible to allergic reactions to diclofenac (worsening of asthma symptoms, Quincke's oedema, or urticaria). This warning also applies to patients allergic to other substances (e.g. those with skin reactions, itching, or urticaria). The medicine should be taken with particular caution (preferably under medical supervision);
you have impaired liver function, as diclofenac may worsen the course of the disease. You must strictly follow your doctor's recommendations regarding regular monitoring of liver function tests;
you have hepatic porphyria, as diclofenac may trigger an attack of porphyria;
you have previously experienced severe skin rash, skin peeling, blistering, and/or oral mucosal ulcers after taking Diclac 75 Duo or other analgesic medicines.

Inform your doctor before taking diclofenac if:

you smoke,
you have diabetes,
you have angina pectoris, thrombosis, hypertension, elevated cholesterol, or elevated triglycerides.

Use the lowest effective dose of Diclac 75 Duo that relieves pain and/or swelling, and use it for the shortest possible duration to minimise the risk of adverse effects.
If at any time during treatment with Diclac 75 Duo you experience symptoms indicating heart or blood vessel problems, such as chest pain, shortness of breath, weakness, or slurred speech, contact your doctor or emergency department immediately.
Use of diclofenac may, in very rare cases (especially at the beginning of treatment), cause life-threatening skin reactions (e.g. exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever, and joint pain, or toxic epidermal necrolysis with skin and mucosal lesions, high fever, and severe general condition). At the first signs of rash, mucosal changes, or other symptoms of allergic reaction, discontinue the medicine and contact your doctor.
The medicine may mask symptoms of infection (e.g. headache, elevated body temperature) and make correct diagnosis more difficult. Inform your doctor during medical examinations that you are taking this medicine.
Do not use Diclac 75 Duo simultaneously with other systemic non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors.
Before taking the medicine, inform your doctor or pharmacist if you have any of the conditions listed above.
Taking medicines such as Diclac 75 Duo may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of high doses. Do not take higher doses or for longer than recommended.
If you have heart problems, have had a stroke, or suspect you are at risk of these conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss the treatment approach with your doctor or pharmacist.
The medicine may transiently inhibit platelet aggregation.
Children and adolescents
Diclac 75 Duo should not be used in children and adolescents due to the dose size.
Elderly patients (aged 65 years and older)
Elderly individuals may react more strongly to the medicine than other adults. Follow the instructions in this leaflet, use the lowest effective dose as recommended by your doctor, and report any adverse effects to your doctor.
Diclac 75 Duo and other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Especially inform your doctor if you are taking the following medicines:

lithium or antidepressants (selective serotonin reuptake inhibitors)
digoxin – a medicine used in the treatment of heart disease
diuretics – medicines that increase urine output
angiotensin-converting enzyme (ACE) inhibitors, beta-blockers – a group of medicines used in the treatment of hypertension and heart failure
non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid or ibuprofen) and corticosteroids (a group of medicines used to relieve inflammatory conditions)
anticoagulants and antiplatelet medicines
antidiabetic medicines, except insulin
methotrexate – a medicine used in the treatment of certain cancers or arthritis
cyclosporine and tacrolimus – medicines used in organ transplant recipients
trimethoprim – a medicine used to prevent and treat urinary tract infections
antibacterial quinolones – medicines used to treat infections
colestipol and cholestyramine – medicines that lower blood cholesterol levels
voriconazole – a medicine used to treat fungal infections
phenytoin – a medicine used to treat epileptic seizures

Taking Diclac 75 Duo with food and drink
Swallow the tablets whole with water, preferably during a meal.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.
Pregnancy
Do not take Diclac 75 Duo if you are in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Diclac 75 Duo may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labour. Do not use Diclac 75 Duo during the first six months of pregnancy unless your doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time.
From week 20 of pregnancy, Diclac 75 Duo may cause kidney problems in the unborn child if used for more than a few days, potentially leading to low levels of amniotic fluid (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Do not use Diclac 75 Duo in breastfeeding women, as it may harm the infant.
Your doctor will discuss with you the potential risks of using Diclac 75 Duo during pregnancy and breastfeeding.
Fertility
Taking Diclac 75 Duo may make it more difficult to become pregnant. If you are planning to become pregnant or have difficulty conceiving, inform your doctor.
Driving and operating machinery
The effect of Diclac 75 Duo on the ability to drive, operate machinery, or perform other tasks requiring special attention is unlikely.
Diclac 75 Duo contains lactose monohydrate and sodium
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Diclac 75 Duo

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Do not exceed the recommended doses. If Diclac 75 Duo is used for longer than a few weeks, regular medical check-ups should be performed to rule out undetected adverse effects.
The dosage is determined individually by the physician for each patient. The general principle is to use the lowest effective dose for the shortest possible duration.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Adults
1 tablet of Diclac 75 Duo (75 mg of sodium diclofenac) once daily. If necessary, the doctor may increase the dose to 2 tablets of Diclac 75 Duo (150 mg per day). Do not use a daily dose exceeding 150 mg.

Use in children and adolescents
Due to the dosage strength, Diclac 75 Duo should not be used in children and adolescents under 18 years of age.

Elderly patients (aged 65 years and older)
This medicine should be used with caution in elderly patients. In elderly patients and in patients with low body weight, it is recommended to use the lowest effective dose.

Diagnosed cardiovascular disease or significant cardiovascular risk factors
Patients with diagnosed cardiovascular disease or significant cardiovascular risk factors should take diclofenac only after a physician has assessed the individual situation, and only at a dose ≤100 mg per day if treatment lasts longer than 4 weeks.

Renal function disorders
The use of Diclac 75 Duo is contraindicated in patients with renal insufficiency.
No specific studies have been conducted in patients with renal function disorders; therefore, appropriate dosage recommendations cannot be provided. Caution is advised in patients with mild to moderate renal function impairment.

Hepatic function disorders
The use of Diclac 75 Duo is contraindicated in patients with hepatic insufficiency.
No specific studies have been conducted in patients with hepatic function disorders; therefore, appropriate dosage recommendations cannot be provided. Caution is advised in patients with mild to moderate hepatic function impairment.

Method of administration
If symptoms are most pronounced at night or in the early morning, Diclac 75 Duo should be taken in the evening hours. The tablets should be swallowed whole with water, preferably during a meal. The tablets must not be divided or chewed.

How long to use Diclac 75 Duo
Diclac 75 Duo should always be used as directed by the physician.
If Diclac 75 Duo is used long-term, regular contact with the physician is necessary to ensure that no adverse effects have occurred.
If in doubt about how long to use the medicine, consult your doctor or pharmacist.

Use of a higher than recommended dose of Diclac 75 Duo
Overdose with Diclac 75 Duo does not produce characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus, or convulsions. In cases of severe poisoning, acute renal failure and liver damage may occur.
If an overdose is accidentally taken, contact a doctor, pharmacist, or go immediately to a hospital emergency department.

Missed dose of Diclac 75 Duo
If a dose is missed, it should be taken as soon as remembered. However, if more than half of the time between two doses has passed, the missed dose should not be taken; instead, take the next tablet according to the previous dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects listed below relate to diclofenac in modified-release tablets as well as diclofenac in other pharmaceutical forms, used short- or long-term.

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

headache, dizziness,
nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, bloating, decreased appetite,
increased aminotransferase activity,
rash.

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

myocardial infarction, heart failure, palpitations, chest pain.

Rare (may occur in up to 1 in 1,000 patients):

hypersensitivity, anaphylactic and anaphylactoid reactions (including sudden drop in blood pressure and shock),
somnolence,
asthma (including breathlessness),
gastric mucosal inflammation, gastrointestinal bleeding, vomiting of blood, bloody diarrhoea, melaena,
gastric and/or duodenal ulcer disease (with or without bleeding or perforation),
hepatitis, jaundice, liver function disorders,
urticaria,
oedema.

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

thrombocytopenia (reduced number of blood platelets), leukopenia (reduced number of white blood cells), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (reduced number or absence of neutrophil granulocytes),
angioedema (including facial swelling),
disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
paraesthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, stroke,
visual disturbances, blurred vision, double vision,
tinnitus, hearing disturbances,
hypertension, vasculitis,
pneumonia,
colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, oral mucosal inflammation (including ulcerative stomatitis), glossitis, oesophageal disorders, membranous stricture of the intestine, pancreatitis,
fulminant hepatitis, hepatic necrosis, liver failure,
bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, Schönlein-Henoch disease, pruritus,
acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

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

simultaneous occurrence of chest pain and allergic reaction (symptoms of Kounis syndrome);
allergic skin reaction, which may manifest as round or oval redness and swelling of the skin, blisters and itching (persistent erythema). The skin in areas affected by the lesions may also become darker, and this discoloration may persist after the lesions have healed. Upon re-administration of the medicine, persistent erythema usually appears in the same locations.

Taking medicines such as Diclac 75 Duo may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Some people may experience other adverse effects while taking Diclac 75 Duo. If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, tell your doctor or pharmacist.

Stop taking Diclac 75 and seek immediate medical attention if any of the following adverse effects occur – urgent treatment may be required:

stomach discomfort, heartburn or upper abdominal pain,
vomiting blood, blood in stool, blood in urine,
skin reactions such as rash or itching,
severe allergic skin reaction, which may manifest as extensive red and/or dark patches, skin swelling, blisters and itching (generalized bullous fixed drug eruption),
wheezing or shortness of breath,
yellowing of the skin or whites of the eyes,
persistent sore throat or high fever,
swelling of the face, feet or legs,
severe migraine,
chest pain associated with cough,
mild but painful abdominal cramps and tenderness beginning shortly after starting Diclac 75 Duo, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency not known).

Some adverse effects may be serious
These uncommon adverse effects may occur in up to 1 in 100 patients, especially when high daily doses (150 mg) are used for prolonged periods:

sudden, crushing chest pain (symptoms of myocardial infarction),
breathlessness, difficulty breathing when lying down, swelling of feet or legs (symptoms of heart failure).

If you are taking Diclac 75 Duo for longer than a few weeks, you should regularly consult your doctor to ensure that no adverse effects have occurred.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Diclac 75 Duo

Keep this medicine out of the sight and reach of children.
No special storage conditions required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Diclac 75 Duo contains

The active substance is sodium diclofenac. One modified-release tablet contains 75 mg of sodium diclofenac.
The other ingredients are: lactose monohydrate, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, sodium carboxymethyl starch, colloidal anhydrous silica, maize starch, iron oxide red (E 172), hypromellose.

What Diclac 75 Duo looks like and contents of the pack
Diclac 75 Duo tablets consist of two layers: pink and white.
They are packed in PP/Aluminium blisters in cardboard boxes. The packs contain 10 or 20
modified-release tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
Sandoz d.d.
Verovškova 57
SI-1000 Ljubljana
Slovenia
Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179 Barleben
Germany
LEK S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Poland
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Latvia, country of export: 99-0827
Parallel Import Authorisation Number: 370/25