Diclac 50

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Diclac 50, 50 mg, enteric-coated tablets

Diclofenac sodium

You should carefully read the contents of the leaflet before using the medicine, 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 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.
• 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 50 and what is it used for
• 2. Important information before using Diclac 50
• 3. How to use Diclac 50
• 4. Possible side effects
• 5. How to store Diclac 50
• 6. Contents of the packaging and other information

1. What is Diclac 50 and what is it used for

Diclac 50 contains diclofenac sodium, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which have anti-rheumatic, anti-inflammatory, analgesic, and antipyretic effects. The mechanism of action of Diclac 50 involves the inhibition of prostaglandin biosynthesis, which plays a fundamental role in the pathogenesis of inflammation, pain, and fever.

Diclac 50 is used to treat:

• inflammatory or degenerative forms of rheumatic disease: rheumatoid arthritis, juvenile rheumatoid arthritis (Still's disease), ankylosing spondylitis, osteoarthritis, psoriatic arthritis, spinal arthritis, pain syndromes associated with spinal changes, extra-articular rheumatism;
• acute attacks of gout;
• pain caused by post-traumatic and post-operative inflammatory conditions and swelling, e.g. after dental or orthopedic procedures;
• painful and inflammatory conditions in gynecology, e.g. primary dysmenorrhea or adnexitis;
• supportive treatment in severe, painful infections of the ear, nose, or throat, such as pharyngitis and tonsillitis. According to general therapeutic principles, in the case of the above-mentioned diseases, causal treatment should be used first. Fever, as the only symptom, is not an indication for use.

Control tests during the use of Diclac 50

In patients with diagnosed heart disease or significant risk factors for cardiovascular disease, the attending 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 levels), and blood cell count (white blood cell count, red blood cell count, and platelet count). Based on the test results, the doctor will decide whether to discontinue treatment with Diclac 50 or change the dose of the medicine.

2. Important information before using Diclac 50

When not to use Diclac 50:

• 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 using 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, pharyngeal 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 a history of stomach or duodenal ulcer, 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 third 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), thrombosis of the coronary or cerebral vessels, or after a procedure to open or bypass blocked vessels;
• 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 50, 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 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. The use of diclofenac may cause gastrointestinal bleeding, ulceration, or perforation (with possible fatal outcome). Such effects may be particularly dangerous in the case of high doses of the medicine;
• if any unusual abdominal symptoms occur during the use of Diclac 50 (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the doctor consulted;
• the patient has ulcerative colitis or Crohn's disease; diclofenac may exacerbate the course of 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 (exacerbation of asthma symptoms, angioedema, 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 used with caution (preferably under medical supervision);
• the patient has liver function disorders; 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,
• if they have diabetes,
• if they have angina pectoris, thrombosis, hypertension, elevated cholesterol levels, or elevated triglyceride levels.

The patient should use the smallest dose of Diclac 50 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 the use of Diclac 50 the patient experiences symptoms indicating 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 (such as 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 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 correctly. During medical examinations, the patient should inform their doctor about the use of the medicine.

The patient should not use Diclac 50 at the same time as other systemic non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors.

Before using the medicine, the patient should inform their doctor or pharmacist about the presence of the above-mentioned diseases.

Taking such medicines as Diclac 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. The patient should not use higher doses or longer treatment than recommended.

In the 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 medicine may temporarily inhibit platelet aggregation.

Children and adolescents

The medicine should not be used in children and adolescents under the age of 14.

Elderly patients (65 years and older)

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

Diclac 50 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 the use of the following medicines:

• lithium or antidepressant drugs (selective serotonin reuptake inhibitors)
• digoxin - a medicine used to treat heart diseases
• diuretics - medicines that increase the amount of urine excreted
• angiotensin-converting enzyme (ACE) inhibitors, beta-blockers - a group of medicines used to treat high blood pressure and heart failure
• non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid, ibuprofen, selective cyclooxygenase-2 inhibitors) and corticosteroids (groups of medicines used to alleviate certain inflammatory conditions)
• anticoagulant and antiplatelet drugs
• antidiabetic drugs (except insulin)
• methotrexate - a medicine used to treat certain cancers or arthritis
• cyclosporine and tacrolimus - medicines used in organ transplant patients
• trimethoprim - a medicine used to prevent and treat urinary tract infections
• quinolone antibacterial agents - 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

Using Diclac 50 with food and drink

The tablets should be swallowed whole, with a glass of water, preferably before 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 medicine.

Pregnancy

The patient should not take Diclac 50 if they are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Diclac 50 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 50 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 possible dose for the shortest possible time. From the 20th week of pregnancy, Diclac 50 may cause kidney problems in the unborn child if used for more than a few days. This may lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

The patient should not use Diclac 50 while breastfeeding, as it may have a harmful effect on the baby.

The doctor will discuss the potential risks of using Diclac 50 during pregnancy and breastfeeding with the patient.

Fertility

Taking Diclac 50 may make it more 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 50 on the ability to drive and use machines is unlikely.

Diclac 50 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 medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to use Diclac 50

This medicine 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 doses. If Diclac 50 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 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

The recommended initial daily dose is 100 mg to 150 mg.

In milder cases and in chronic treatment, a dose of up to 100 mg per day is considered sufficient.

The total daily dose should be taken in 2 to 3 divided doses.

To alleviate nocturnal pain and morning stiffness, treatment with tablets during the day can be supplemented with a suppository before bedtime (without exceeding the maximum daily dose of 150 mg).

In primary dysmenorrhea, the daily dose is determined by the doctor individually for each patient. It usually ranges from 50 mg to 150 mg. Initially, 50 mg to 100 mg should be administered, and if necessary, the dose can be increased over several menstrual cycles to a maximum of 200 mg per day. Treatment should be started when the first symptoms appear and continued for several days, depending on their severity.

Other indications for use

The use of Diclac 50 is not recommended in children and adolescents.

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 the situation and only at a dose of ≤100 mg per day if treatment lasts longer than 4 weeks.

Kidney function disorders

The use of Diclac 50 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

The use of Diclac 50 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

The tablets should be swallowed whole, with a glass of water, preferably before a meal. The tablets should not be divided or chewed.

How long to use Diclac 50

Diclac 50 should always be used according to the doctor's recommendations.

If the patient is taking Diclac 50 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 medicine, the patient should consult their doctor or pharmacist.

Using a higher dose of Diclac 50 than recommended

Overdose of Diclac 50 does not cause characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In the case of significant poisoning, acute kidney failure and liver damage may occur.

In the event of accidental ingestion of a larger amount of tablets than recommended, the patient should immediately consult their doctor, pharmacist, or go to the hospital emergency department.

Missing a dose of Diclac 50

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 50 can cause side effects, although not everybody gets them.

The following side effects are presented below, which apply to diclofenac in the form of enteric-coated 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 using 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 using the medicine):

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

Rare(may occur in less than 1 in 1000 people using the medicine):

• 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 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 using 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, stroke,
• visual disturbances, 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 ulcerative stomatitis), glossitis, esophageal disorders, membranous intestinal stenosis, pancreatitis,
• fulminant hepatitis, liver necrosis, liver failure,
• bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome,
• toxic epidermal necrolysis, 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):

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

Taking such medicines as Diclac 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

In some people, during the use of Diclac 50, other side effects may occur.

If any side effects worsen or any side effects not listed in this leaflet occur, the patient should tell their doctor or pharmacist.

Some side effects can be serious.

In the event of any of the following side effects, the patient should immediately stop taking Diclac 50 and inform their doctor:

• discomfort in the stomach, heartburn, or abdominal pain
• bloody vomiting, blood in the stool, blood in the urine
• skin problems, 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 ankles
• severe migraine
• chest pain accompanied by coughing
• mild painful abdominal cramps and tenderness, starting soon after the start of Diclac 50 treatment, followed by gastrointestinal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain onset (frequency not known - cannot be estimated from the available data).

Some side effects can be serious

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

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

In the event of taking Diclac 50 for more than a few weeks, the patient should regularly consult their doctor to ensure that no side effects have occurred.

Reporting 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 Adverse Reaction Monitoring 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.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Diclac 50

• Keep out of the sight and reach of children.
• Do not store above 25°C. Store in the original packaging to protect from moisture.
• Translation of some information on the immediate packaging: Ch.-B./verwendbar bis: siehe Prägung- batch number/expiration date - see embossing.
• Do not use after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
• 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 packaging and other information

What Diclac 50 contains

• The active substance of the medicine is diclofenac sodium. One enteric-coated tablet contains 50 mg of diclofenac sodium.
• The other ingredients are: lactose monohydrate, corn starch, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), magnesium stearate, anhydrous colloidal silica, methacrylic acid and ethyl acrylate copolymer (1:1), triethyl citrate, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

What Diclac 50 looks like and contents of the pack

The tablets are packaged in blisters in a cardboard box.

The packaging contains 30 or 50 enteric-coated tablets.

For more detailed information about the medicine, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

Hexal AG

Industriestraße 25

83607 Holzkirchen

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 authorization number in Germany, the country of export:6360.01.03

Parallel import authorization number: 74/23 Date of leaflet approval: 13.04.2023

[Information about the trademark]