Diclac 75 Duo

Leaflet attached to the packaging: information for the user

Diclac 75 Duo, 75 mg, modified-release tablets

Diclofenac sodium

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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 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 is Diclac 75 Duo and what is it used for

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

• inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, psoriatic arthritis, spondyloarthritis, and 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 treatment with 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 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 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 medicine.

2. Important information before taking Diclac 75 Duo

When not to take Diclac 75 Duo

• if the patient is hypersensitive to diclofenac or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ever had an allergic reaction after taking anti-inflammatory or analgesic drugs (i.e. acetylsalicylic acid, diclofenac, or ibuprofen). Reactions may include asthma, rhinitis, skin rash, urticaria, facial edema, lip edema, tongue edema, and/or limb edema (symptoms of angioedema). If the patient thinks they may be allergic, they should consult a doctor.
• if the patient has active or past peptic ulcer disease of the stomach and/or duodenum, 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 ischemic attack (TIA), or vascular surgery, or angioplasty or bypass grafting of closed vessels, or
• 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 taking 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 levels of lipids (cholesterol, triglycerides) in the blood, or if the patient is a smoker, as in such cases the dose of the medicine should not be increased above 100 mg per day if treatment lasts longer than 4 weeks;
• the patient has had a gastrointestinal ulcer or is elderly. Taking diclofenac may cause gastrointestinal bleeding, ulceration, or perforation (with possible fatal outcome). Such effects may be particularly dangerous in cases of high doses of the medicine. If any unusual abdominal symptoms occur during treatment with Diclac 75 Duo (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the doctor consulted;
• 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 medicine should be taken with special 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,
• 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 at any time during treatment with Diclac 75 Duo the patient experiences 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.
Taking diclofenac may 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, and toxic epidermal necrolysis with skin and mucous membrane lesions, high fever, and severe general condition). After the first signs of rash, mucous membrane lesions, or other symptoms of an allergic reaction, the medicine should be discontinued and the doctor consulted.
The medicine 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 taking the medicine.
The patient should not take Diclac 75 Duo at the same time as other systemic NSAIDs, including selective cyclooxygenase-2 inhibitors.
Before taking the medicine, the patient should inform their doctor or pharmacist about the presence of the above-mentioned diseases.
Taking such medicines 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 medicine.
The patient should not take higher doses or use the medicine for longer 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 their treatment with their doctor or pharmacist.
The medicine may temporarily inhibit platelet aggregation.

Children and adolescents

The medicine 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 effects of the medicine than other adults. They should follow the recommendations in the leaflet, take the medicine according to the doctor's instructions, use the smallest effective dose, and report all side effects that occur during treatment to their doctor.

Diclac 75 Duo and other medicines

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

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

• lithium or antidepressant medicines (selective serotonin reuptake inhibitors)
• digoxin - a medicine used to treat heart diseases
• diuretics - medicines that increase urine production
• angiotensin-converting enzyme (ACE) inhibitors, beta-blockers - a group of medicines used to treat hypertension and heart failure
• non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid or ibuprofen) and corticosteroids (a group of medicines used to alleviate inflammatory conditions)
• anticoagulant and antiplatelet medicines
• antidiabetic medicines (except insulin)
• methotrexate - a medicine used to treat certain cancers or arthritis
• cyclosporine and tacrolimus - medicines used in patients with organ transplants
• trimethoprim - a medicine used to prevent and treat urinary tract infections
• quinolone antibacterials - medicines used to treat infections
• cholestyramine and colestipol - medicines that lower cholesterol levels in the blood
• voriconazole - a medicine used to treat fungal infections
• phenytoin - a medicine used to treat epileptic seizures

Taking 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 baby, they should consult their doctor before taking this medicine.
Pregnancy
The patient should not take Diclac 75 Duo if they are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Diclac 75 Duo may cause kidney and heart disorders in the unborn baby. It may also increase the risk of bleeding in the patient and the baby and prolong or delay delivery. During the first 6 months of pregnancy, the patient should not take Diclac 75 Duo unless their doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the patient should use the smallest possible dose for the shortest possible time.
From the 20th week of pregnancy, Diclac 75 Duo may cause kidney disorders in the unborn baby if taken for more than a few days. This may lead to a low level of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
The patient should not take Diclac 75 Duo while breastfeeding, as it may harm the baby.
The doctor will discuss the potential risks of taking Diclac 75 Duo during pregnancy and breastfeeding with the patient.
Fertility
Taking Diclac 75 Duo may make it more difficult to conceive. If the patient plans to conceive or is having trouble 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 and sodium

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

3. How to take Diclac 75 Duo

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor or pharmacist.
The patient should not exceed the recommended dose. If Diclac 75 Duo is taken for more than a few weeks, the patient should have regular medical check-ups to rule out any unnoticed side effects.
The dose of the medicine 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 medicine 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 take 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 medicine should be used with caution in elderly patients. In elderly patients and those 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 their doctor has assessed their situation and only at a dose of ≤100 mg per day if treatment lasts longer than 4 weeks.
Kidney function disorders
Taking 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
Taking 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 take Diclac 75 Duo

Diclac 75 Duo should always be taken exactly as prescribed by the doctor.
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.
If the patient is unsure how long to take the medicine, they should consult their doctor or pharmacist.

Taking a higher dose of Diclac 75 Duo than recommended

Overdose of Diclac 75 Duo does not cause characteristic symptoms, but may cause: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In case of significant poisoning, acute kidney failure and liver damage may occur.
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.
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 medicines, Diclac 75 Duo can cause side effects, although not everybody gets them.
The following side effects are described below for diclofenac in the form of modified-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 medicine):

• 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 medicine)

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

Rare(may occur in less than 1 in 1,000 people taking the medicine):

• hypersensitivity, anaphylactic and pseudoanaphylactic reactions (including sudden decrease in blood pressure and shock),
• drowsiness,
• asthma (including shortness of breath),
• gastritis, gastrointestinal bleeding, hematemesis, melena,
• peptic ulcer disease 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 medicine):

• thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), anemia (including hemolytic and aplastic anemia), agranulocytosis (decreased or absent granulocytes),
• angioedema (including facial edema),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
• paresthesia, memory disorders, seizures, anxiety, tremors, aseptic meningitis, taste disorders, cerebrovascular accident,
• visual disturbances, blurred vision, diplopia,
• tinnitus, hearing disorders,
• hypertension, vasculitis,
• pneumonitis,
• ulcerative colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal disorders, intestinal obstruction, pancreatitis,
• 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 (symptoms of Kounis syndrome).

Taking such medicines as Diclac 75 Duo may be associated with a small increased risk of heart attack or stroke.
In some people, during treatment with 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 stop taking Diclac 75 Duo and inform their doctor:

• discomfort in the stomach, heartburn, or abdominal pain
• hematemesis, melena, or hematuria
• skin disorders such as rash or pruritus
• shortness of breath or dyspnea
• jaundice or yellowing of the eyes
• prolonged sore throat or high fever
• facial edema, peripheral edema, or generalized edema
• severe migraine
• chest pain accompanied by cough
• mild painful abdominal cramps and tenderness, starting soon after the initiation of Diclac 75 Duo, followed by gastrointestinal bleeding or melena, usually within 24 hours of the onset of abdominal pain (frequency not known).

Some side effects may be serious

These uncommon side effects may occur in 1 to 10 patients per 1,000, especially when taking 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 ankles (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 side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. 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
tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Diclac 75 Duo

The medicine should be stored out of the sight and reach of children.
No special precautions for storage are necessary.
The patient should not take the medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month stated.
The batch number on the packaging is marked as "Lot".
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Diclac 75 Duo contains

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

What Diclac 75 Duo looks like and contents of the pack

Diclac 75 Duo tablets consist of two layers: pink and white.
They are packaged in aluminum/polypropylene or aluminum/polyvinyl chloride blisters in a cardboard box. The packs contain 10 or 20 modified-release tablets.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
Domaniewska 50 C
02-672 Warsaw
To obtain more detailed information, the patient should contact:
Sandoz Polska Sp. z o.o.
Domaniewska 50 C
02-672 Warsaw
tel. +48 22 209 70 00

Date of last revision of the leaflet:

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