Diclac 75 Duo

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Diclac 75 Duo (Diclo 75 SL - 1 A Pharma)

75 mg, prolonged-release tablets

Diclofenac sodium
Diclac 75 Duo and Diclo 75 SL - 1 A Pharma are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Diclac 75 Duo and what is it used for
• 2. Important information before using Diclac 75 Duo
• 3. How to use Diclac 75 Duo
• 4. Possible side effects
• 5. How to store Diclac 75 Duo
• 6. Package contents and other information

1. What is Diclac 75 Duo and what is it used for

Diclac 75 Duo contains diclofenac sodium, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), acting as anti-rheumatic, anti-inflammatory, analgesic, and antipyretic agents. The mechanism of action of Diclac 75 Duo involves the inhibition of prostaglandin biosynthesis, which plays a crucial role in the pathogenesis of inflammation, pain, and fever.
Diclac 75 Duo is used to treat:

• inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, pain syndromes associated with spinal changes, extra-articular rheumatism;
• pains caused by post-traumatic and post-operative inflammatory conditions and swelling, e.g., after dental or orthopedic procedures;
• painful and/or inflammatory conditions in gynecology, e.g., primary dysmenorrhea or adnexitis.

Control tests during the use of Diclac 75 Duo

In patients with diagnosed heart disease or significant risk factors for cardiovascular disease, the doctor will periodically assess the patient's need for symptomatic treatment and their response to the drug, especially if the treatment lasts longer than 4 weeks.
During treatment, the doctor will order regular blood tests to monitor liver function (aminotransferase activity), kidney function (creatinine levels), and blood cell count (white and red blood cells and platelets). Based on the test results, the doctor will decide whether to discontinue treatment with Diclac 75 Duo or change the dose of the drug.
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2. Important information before using Diclac 75 Duo

When not to use Diclac 75 Duo

• if the patient is allergic to diclofenac or any of the other ingredients of this drug (listed in section 6),
• if the patient has ever had an allergic reaction after using anti-inflammatory or analgesic drugs (i.e., acetylsalicylic acid, diclofenac, or ibuprofen). Reactions may include asthma, rhinitis, skin rash, urticaria, facial swelling, lip swelling, tongue swelling, throat swelling, and/or limb swelling (symptoms of angioedema). If the patient thinks they may be allergic, they should consult a doctor.
• if the patient has active or past stomach or duodenal ulcers, bleeding, or perforation; if the patient has experienced discomfort in the stomach area or heartburn after taking anti-inflammatory drugs,
• if the patient is in the last trimester of pregnancy,
• if the patient has liver failure,
• if the patient has kidney failure,
• if the patient has heart disease and/or cerebrovascular disease, e.g., after a heart attack, stroke, transient cerebral ischemia (mini-stroke), or vascular occlusion of the heart or brain, or after a revascularization or bypass procedure,
• if the patient has circulatory disorders (peripheral vascular disease).

The patient should inform their doctor about the presence of these diseases.

Warnings and precautions

Before using Diclac 75 Duo, the patient should discuss it with their doctor if:

• the patient has diagnosed cardiovascular disease (see above) or significant risk factors, such as high blood pressure, elevated lipid levels (cholesterol, triglycerides), or if the patient is a smoker, as in such cases, the dose of the drug should not be increased above 100 mg per day if the treatment lasts longer than 4 weeks;
• the patient has undergone gastrointestinal ulceration or is elderly. The use of diclofenac may cause gastrointestinal bleeding, ulceration, or perforation (with possible fatal outcome). This effect may be particularly dangerous in the case of high doses of the drug. If any unusual abdominal symptoms occur during the use of Diclac 75 Duo (especially gastrointestinal bleeding), the drug should be discontinued immediately and the patient should consult a doctor;
• the patient has ulcerative colitis or Crohn's disease, as diclofenac may exacerbate the disease;
• the patient has asthma, allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease, or chronic respiratory infections, as they are more likely to experience an allergic reaction to diclofenac (asthma exacerbation, angioedema, or urticaria). This warning also applies to patients allergic to other substances (e.g., those who experience skin reactions, itching, or urticaria). The drug should be used with caution (preferably under medical supervision);
• the patient has liver function disorders, as diclofenac may worsen the course of the disease. The patient should strictly follow the doctor's recommendations regarding liver function tests;
• the patient has porphyria, as diclofenac may trigger a porphyria attack.

Before taking diclofenac, the patient should inform their doctor if:

• they smoke,

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• they have diabetes,
• they have angina pectoris, thrombosis, hypertension, elevated cholesterol levels, or elevated triglyceride levels.

The patient should use the smallest dose of Diclac 75 Duo that provides relief from pain and/or swelling and use it for the shortest possible time to minimize the risk of side effects.
If the patient experiences any symptoms suggesting heart or vascular problems, such as chest pain, shortness of breath, weakness, or slurred speech, they should immediately contact their doctor or hospital emergency department.
The 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, and toxic epidermal necrolysis with skin and mucous membrane changes, high fever, and severe general condition). After the first signs of rash, mucous membrane changes, or other symptoms of an allergic reaction, the drug should be discontinued and the patient should consult a doctor.
The drug may mask the symptoms of infection (e.g., headache, elevated body temperature) and make it difficult to diagnose. During medical examinations, the patient should inform their doctor about the use of the drug.
The patient should not use Diclac 75 Duo with other systemic NSAIDs, including selective cyclooxygenase-2 inhibitors.
Before using the drug, the patient should inform their doctor or pharmacist about the presence of the above-mentioned diseases.
Taking such drugs 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 of the drug.
The patient should not use higher doses or longer treatment than recommended.
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, elevated cholesterol levels, smoking), the patient should discuss the treatment with their doctor or pharmacist.
The drug may temporarily inhibit platelet aggregation.

Children and adolescents

The drug should not be used in children and adolescents due to the dose size.

Elderly patients (65 years and older)

Elderly patients may react more strongly to the drug than other adult patients. The patient should follow the recommendations in the leaflet, use the smallest effective dose according to the doctor's recommendations, and report all side effects that occur during treatment to their doctor.

Diclac 75 Duo and other drugs

The patient should tell their doctor about all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take.

The patient should especially inform their doctor about taking the following drugs

• lithium or antidepressant drugs (selective serotonin reuptake inhibitors)
• digoxin - a drug used to treat heart diseases
• diuretics - drugs that increase urine production
• angiotensin-converting enzyme (ACE) inhibitors, beta-blockers - a group of drugs used to treat hypertension and heart failure

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• non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen) and corticosteroids (a group of drugs used to alleviate inflammatory conditions)
• anticoagulant and antiplatelet drugs
• antidiabetic drugs (except insulin)
• methotrexate - a drug used to treat certain cancers or arthritis
• cyclosporine and tacrolimus - drugs used in organ transplant patients
• trimethoprim - a drug used to prevent and treat urinary tract infections
• quinolone antibacterials - drugs used to treat infections
• cholestyramine and colestipol - drugs that lower cholesterol levels in the blood
• voriconazole - a drug used to treat fungal infections
• phenytoin - a drug used to treat epileptic seizures

Using Diclac 75 Duo with food and drink

The tablets should be swallowed whole, with a glass of water, preferably during a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this drug.
Pregnancy
The patient should not use Diclac 75 Duo if they are in the last 3 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 also increase the risk of bleeding in the patient and the child and cause delayed or prolonged labor. During the first 6 months of pregnancy, the patient should not use Diclac 75 Duo unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the patient should use the smallest dose for the shortest possible time.
From the 20th week of pregnancy, Diclac 75 Duo may cause kidney problems in the unborn child if used for more than a few days. This may lead to low amniotic fluid levels around the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
The patient should not use Diclac 75 Duo while breastfeeding, as it may harm the baby.
The doctor will discuss the potential risks of using Diclac 75 Duo during pregnancy and breastfeeding with the patient.
Fertility
Taking Diclac 75 Duo may make it difficult to conceive. If the patient plans to conceive or has problems conceiving, they should inform their doctor.

Driving and using machines

The effect of Diclac 75 Duo on the ability to drive and use machines is unlikely.

Diclac 75 Duo contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the drug.
The drug contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to use Diclac 75 Duo

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This drug should always be used according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The patient should not exceed the recommended dose. If Diclac 75 Duo is used for more than a few weeks, the patient should regularly undergo medical check-ups to rule out any unnoticed side effects.
The dose of the drug is determined by the doctor individually for each patient. The rule is to use the smallest effective dose for the shortest possible time.
If the patient feels that the effect of the drug is too strong or too weak, they should consult their doctor.
Adults
1 tablet of Diclac 75 Duo (75 mg of diclofenac sodium) once a day. If necessary, the doctor may increase the dose to 2 tablets of Diclac 75 Duo (150 mg per day). The patient should not use a daily dose higher than 150 mg.
Use in children and adolescents
Due to the dose size, Diclac 75 Duo should not be used in children and adolescents under 18 years of age.
Elderly patients (65 years and older)
The drug should be used with caution in elderly patients. In elderly patients and patients with low body weight, the smallest effective dose is recommended.
Diagnosed cardiovascular disease or significant cardiovascular risk factors
Patients with diagnosed cardiovascular disease or significant risk factors for cardiovascular events should take diclofenac only after the doctor has assessed their situation and only at a dose of ≤100 mg per day if the treatment lasts longer than 4 weeks.
Kidney function disorders
Using Diclac 75 Duo in patients with kidney failure is contraindicated.
No special studies have been conducted in patients with kidney function disorders, so no specific dosage recommendations can be made. In patients with mild to moderate kidney function disorders, caution is recommended.
Liver function disorders
Using Diclac 75 Duo in patients with liver failure is contraindicated. No special studies have been conducted in patients with liver function disorders, so no specific dosage recommendations can be made. In patients with mild to moderate liver function disorders, caution is recommended.

Method of administration

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

How long to use Diclac 75 Duo

Diclac 75 Duo should always be used according to the doctor's recommendations.
If the patient is taking Diclac 75 Duo for a long time, they should regularly consult their doctor to ensure that no side effects have occurred.
In case of doubts about how long to use the drug, the patient should consult their doctor or pharmacist.

Using a higher dose of Diclac 75 Duo than recommended

Overdosing on Diclac 75 Duo does not cause characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In case of significant poisoning, acute kidney failure and liver damage may occur.
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If the patient has accidentally taken more tablets than recommended, they should immediately consult their doctor, pharmacist, or go to the hospital emergency department.

Missing a dose of Diclac 75 Duo

If the patient misses a dose, they should take it as soon as they remember. However, if more than half of the time between two doses has passed, the patient should not take the missed dose but take the next tablet according to the previous dosing schedule. The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all drugs, Diclac 75 Duo can cause side effects, although not everyone will experience them.
The following side effects are related to diclofenac in the form of prolonged-release tablets and diclofenac in other pharmaceutical forms, used for short or long periods.

Side effects

Common( may occur in less than 1 in 10 people taking the drug):

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

Uncommon( may occur in less than 1 in 100 people taking the drug):

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

Rare( may occur in less than 1 in 1000 people taking the drug):

• hypersensitivity, anaphylactic and pseudo-anaphylactic reactions (including sudden drop in blood pressure and shock),
• drowsiness,
• asthma (including shortness of breath),
• gastritis, gastrointestinal bleeding, bloody vomiting, bloody diarrhea, melena,
• peptic ulcer of the stomach and/or duodenum (with or without bleeding and perforation),
• hepatitis, jaundice, liver function disorders,
• urticaria,
• edema.

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

• thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), anemia (including hemolytic and aplastic anemia), agranulocytosis (decreased or absent granulocytes),
• angioedema (including facial swelling),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
• paresthesia, memory disorders, seizures, anxiety, tremors, aseptic meningitis, taste disorders, cerebral stroke,
• vision disorders, blurred vision, double vision,
• tinnitus, hearing disorders,
• hypertension, vasculitis,
• pneumonitis,
• ulcerative colitis (including bloody colitis and exacerbation of ulcerative colitis and Crohn's disease), constipation, oral mucositis (including aphthous stomatitis), glossitis, esophageal disorders, intestinal stricture, pancreatitis,

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• fulminant hepatitis, liver necrosis, liver failure,
• bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, Henoch-Schönlein purpura, pruritus,
• acute kidney failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

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

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

Taking such drugs as Diclac 75 Duo may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
In some patients, during the use of Diclac 75 Duo, other side effects may occur. If any of the side effects worsen or any side effects not listed in this leaflet occur, the patient should tell their doctor or pharmacist.

If any of the following side effects occur, the patient should immediately stop taking Diclac 75 Duo and inform their doctor:

• discomfort in the stomach, heartburn, or abdominal pain
• bloody vomiting, blood in the stool, blood in the urine
• skin disorders such as rash or itching
• shortness of breath or difficulty breathing
• jaundice or yellowing of the eyes
• prolonged sore throat or high fever
• swelling of the face, feet, or legs
• severe migraine
• chest pain accompanied by coughing
• mild painful abdominal cramps and tenderness, starting soon after the use of Diclac 75 Duo, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain onset (frequency not known).

Some side effects can be serious

These uncommon side effects may occur in 1 to 10 patients out of 1000, especially when using high daily doses (150 mg) for a long time

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

If the patient is taking Diclac 75 Duo for more than a few weeks, they should regularly consult their doctor to ensure that no side effects have occurred.

Reporting suspected side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the drug.

5. How to store Diclac 75 Duo

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• The drug should be stored out of sight and reach of children.
• There are no special storage recommendations.
• The drug should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.

Translation of some blister pack inscriptions:

Ch.-B./verwendbar bis: see embossing - Batch number and expiration date: see embossing

• Drugs should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Diclac 75 Duo contains

• The active substance of the drug is diclofenac sodium. One prolonged-release tablet contains 75 mg of diclofenac sodium.
• The other ingredients are: lactose monohydrate, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, sodium carboxymethylcellulose (type A), anhydrous colloidal silica, cornstarch, red iron oxide (E 172) ,hypromellose.

What Diclac 75 Duo looks like and what the package contains

Diclac 75 Duo tablets consist of two layers: pink and white.
They are packaged in PP/Aluminum or PVC/PVDC/Aluminum blisters in a cardboard box.
The packages contain 10 or 20 prolonged-release tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

1 A Pharma GmbH, Industriestraße 18, 83607 Holzkirchen, Germany

Manufacturer:

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German marketing authorization number: 48728.00.00

Parallel import authorization number: 140/23

Date of leaflet approval: 14.07.2023

[Information about the trademark]
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