Diclac 75 duo

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Diclac 75 Duo (Diclo 75 SL - 1 A Pharma)
75 mg, prolonged-release tablets
Diclofenacum natricum
Diclac 75 Duo and Diclo 75 SL - 1 A Pharma are different trade names for the same medicine.
Please read this leaflet carefully before using 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, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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 those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Diclac 75 Duo is and what it is used for
2. Important information before taking Diclac 75 Duo
3. How to take Diclac 75 Duo
4. Possible side effects
5. How to store Diclac 75 Duo
6. Contents of the pack and other information

1. What Diclac 75 Duo is and what it is 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 primarily involves inhibition of prostaglandin biosynthesis, which plays 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 joint inflammation, painful conditions associated with spinal changes, extra-articular rheumatism;
• pain caused by inflammatory and edematous post-traumatic and postoperative conditions, e.g., following dental or orthopedic procedures;
• painful and (or) inflammatory conditions in gynecology, e.g., primary dysmenorrhea or salpingitis.

Monitoring tests during treatment with Diclac 75 Duo
In patients diagnosed with heart disease or significant risk factors for cardiovascular disease, the treating physician will periodically assess the patient's need for symptomatic treatment and response to the medicine, especially if treatment lasts longer than 4 weeks.
During treatment, the physician may 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 physician will decide whether to discontinue treatment with Diclac 75 Duo or adjust the dosage.

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 pain-relieving medicines (e.g., acetylsalicylic acid, diclofenac, or ibuprofen). Reactions may include asthma, rhinitis, skin rash, urticaria, facial swelling, swelling of the lips, tongue, throat, and (or) limbs (symptoms of angioedema). If you suspect 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 ischemic attack (TIA), or arterial embolism in the heart or brain, or after revascularization or bypass surgery;
• if you have current or past circulatory disorders (peripheral vascular disease).

Inform your doctor if any of these conditions apply.
Warnings and precautions
Before taking Diclac 75 Duo, discuss with your doctor if:

• you have diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormally elevated blood lipid levels (cholesterol, triglycerides), or if you are a smoker, as in such cases the daily dose should not exceed 100 mg 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 risk is particularly high when high doses are used. If any unusual abdominal symptoms occur during treatment with Diclac 75 Duo (especially gastrointestinal bleeding), discontinue the medicine immediately and contact your doctor;
• you have ulcerative colitis or Crohn’s disease, as diclofenac may worsen the disease;
• you have asthma, allergic rhinitis, nasal mucosal swelling (e.g., due to nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory infections, as you may be more prone to allergic reactions to diclofenac (worsening of asthma, Quincke’s edema, or urticaria). This warning also applies to patients allergic to other substances (e.g., those with skin reactions, itching, or hives). The medicine should be taken with particular caution (preferably under medical supervision);
• you have impaired liver function, as diclofenac may worsen liver disease. Strictly follow your doctor’s recommendations regarding liver function monitoring;
• you have hepatic porphyria, as diclofenac may trigger an acute porphyria attack.

Before taking diclofenac, inform your doctor 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 minimize the risk of adverse effects.
If at any time during treatment with Diclac 75 Duo you experience symptoms suggesting heart or blood vessel problems, such as chest pain, shortness of breath, weakness, or slurred speech, contact your doctor or emergency department immediately.
Diclofenac may, very rarely (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 signs of infection (e.g., headache, elevated body temperature), making correct diagnosis more difficult. Inform your doctor about using this medicine during medical examinations.
Do not take 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 about any of the above-mentioned conditions.
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 use higher doses or longer treatment durations than recommended.
If you have heart problems, have had a stroke, or suspect you are at risk of such 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 dosage strength.
Elderly patients (aged 65 years and older)
Elderly individuals may be more sensitive to the effects of the medicine than younger 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
Inform 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 - SSRIs)
• digoxin – used in the treatment of heart disease
• diuretics – medicines that increase urine output
• angiotensin-converting enzyme (ACE) inhibitors, beta-blockers – used in the treatment of hypertension and heart failure
• non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen) and corticosteroids – used to relieve inflammatory conditions
• anticoagulants and antiplatelet agents
• antidiabetic medicines, except insulin
• methotrexate – used in the treatment of certain cancers or arthritis
• cyclosporine and tacrolimus – used in organ transplant patients
• trimethoprim – used to prevent and treat urinary tract infections
• antibacterial quinolones – used to treat infections
• colestipol and cholestyramine – used to lower blood cholesterol levels
• voriconazole – used to treat fungal infections
• phenytoin – 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, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Diclac 75 Duo should not be used during the first two trimesters unless absolutely necessary.
As with other anti-inflammatory medicines, Diclac 75 Duo must not be used during the last three months of pregnancy, as it may seriously harm the unborn child or adversely affect delivery.
Do not use Diclac 75 Duo while breastfeeding, as it may harm the infant.
Your doctor will discuss the potential risks of using Diclac 75 Duo during pregnancy and breastfeeding.
Taking Diclac 75 Duo may make it more difficult to become pregnant. If you are planning pregnancy 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 previously been 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 exactly as recommended by your doctor. If in doubt, consult your doctor or pharmacist.
Do not exceed the recommended doses. If Diclac 75 Duo is used for longer than several weeks, regular medical check-ups should be performed to rule out any undetected adverse effects.
The dosage is determined individually by the doctor for each patient. The 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). The daily dose should not exceed 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, the lowest effective dose should be used.

Diagnosed cardiovascular disease or significant cardiovascular risk factors
Patients with diagnosed cardiovascular disease or significant cardiovascular risk factors should take diclofenac only after a doctor has assessed their condition 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 established. 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 established. 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. Tablets should be swallowed whole with water, preferably during a meal. Tablets must not be divided or chewed.

How long to use Diclac 75 Duo
Diclac 75 Duo should always be used as recommended by your doctor.
If Diclac 75 Duo is taken long-term, regular contact with your doctor 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.

Overdose 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 seizures. In cases of severe poisoning, acute renal failure and liver damage may occur.
If an overdose is accidentally taken, contact your doctor, pharmacist, or go immediately to the nearest hospital emergency department.

Missed dose of Diclac 75 Duo
If a dose of medicine 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, the next tablet should be taken 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 and to diclofenac in other pharmaceutical forms, used either short-term or long-term.

Adverse effects

Common (may occur in fewer than 1 in 10 people taking the medicine):

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

Uncommon (may occur in fewer than 1 in 100 people taking the medicine):

• myocardial infarction, heart failure, palpitations, chest pain.

Rare (may occur in fewer than 1 in 1000 people taking the medicine):

• 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 (with or without bleeding or perforation),
• hepatitis, jaundice, liver function disorders,
• urticaria,
• oedema.

Very rare (may occur in fewer than 1 in 10,000 people taking the medicine):

• thrombocytopenia (reduced number of platelets), leukopenia (reduced number of white blood cells), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (reduced number or absence of granulocytes),
• angioedema (including facial swelling),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
• paraesthesia, memory disturbances, 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 intestinal stricture, 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.

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

• simultaneous occurrence of chest pain and allergic reaction (symptoms of Kounis syndrome).

Taking medicines such as Diclac 75 Duo may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Other adverse effects may occur in some people during treatment with Diclac 75 Duo. If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.

If any of the following adverse effects occur, stop taking Diclac 75 Duo immediately and contact your doctor:

• stomach discomfort, heartburn or upper abdominal pain,
• vomiting blood, blood in stool, blood in urine,
• skin reactions such as rash or itching,
• wheezing or shortness of breath,
• yellowing of the skin or whites of the eyes,
• persistent sore throat or high body temperature,
• swelling of the face, feet or legs,
• severe migraine,
• chest pain associated with cough,
• mild painful abdominal cramps and tenderness occurring soon after starting Diclac 75 Duo, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain (frequency unknown).

Some adverse effects may be serious
These uncommon adverse effects may occur in 1 to 10 patients per 1000, especially when high daily doses (150 mg) are used for a prolonged period:

• sudden, constricting 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 any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of 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 this medicine.

5. How to store Diclac 75 Duo

• Keep the medicine out of the sight and reach of children.
• No special storage instructions apply.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated 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 pack and other information

What Diclac 75 Duo contains

• The active substance is sodium diclofenac. One prolonged-release tablet contains 75 mg of sodium diclofenac.
• Other ingredients are: lactose monohydrate, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, sodium carboxymethyl starch (type A), 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 or PVC/PVDC/Aluminium blisters in cardboard boxes.
Pack sizes contain 10 or 20 prolonged-release tablets.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Germany, country of export:
1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany
Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Germany, country of export: 48728.00.00
Parallel Import Authorisation Number: 69/22