Dicuno

PATIENT INFORMATION LEAFLET: USER INFORMATION

Dicuno, 50 mg, coated tablets

Diclofenac potassium

Read the leaflet carefully before using the medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

• 1. What is Dicuno and what is it used for
• 2. Important information before using Dicuno
• 3. How to use Dicuno
• 4. Possible side effects
• 5. How to store Dicuno
• 6. Contents of the pack and other information

1. What is Dicuno and what is it used for

Dicuno belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). It has anti-inflammatory, analgesic, and antipyretic properties.
Dicuno is used for the symptomatic treatment of mild to moderate acute pain, including acute migraine pain.

2. Important information before using Dicuno

When not to use Dicuno

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• if you have or have had stomach or duodenal ulcers.
• if you have or have had bleeding or perforation of the gastrointestinal tract or if you have had previous bleeding or perforation with other NSAIDs.
• if you have a tendency to bleed.
• if you have severe liver dysfunction.
• if you have porphyria (a metabolic disorder).
• if you have heart or cerebrovascular disease, e.g. after a heart attack, stroke, transient ischemic attack (mini-stroke), or after angioplasty or bypass surgery.
• if you have circulatory disorders (peripheral arterial disease).
• if you have severe kidney disease.
• in the last 3 months of pregnancy.
• if you think you may be allergic to diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID, or any of the other ingredients of Dicuno.

(listed at the end of this leaflet.) Hypersensitivity symptoms include facial and lip swelling (angioedema), difficulty breathing, chest pain, rash, or any other allergic reactions.

Warnings and precautions

The risk of side effects can be minimized by using the lowest effective dose for the shortest duration necessary.
Taking higher doses than recommended increases the risk of side effects. This also applies to taking different NSAIDs at the same time.
Tell your doctor if you have or have had any of the following conditions:

• inflammatory bowel disease (ulcerative colitis, Crohn's disease).
• asthma, heart disease, liver or kidney disease.
• chronic obstructive pulmonary disease or chronic respiratory disease (diseases that lead to narrowing of the airways and restriction of oxygen flow, causing shortness of breath).
• nasal polyps.
• systemic lupus erythematosus (SLE) (a connective tissue disease).
• urticaria or angioedema (a localized swelling that occurs periodically).
• diseases that increase the risk of bleeding.
• hepatic porphyria (a metabolic disorder).

Before taking diclofenac, tell your doctor

• if you smoke.
• if you have diabetes.
• if you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

Elderly patients are at increased risk of side effects related to increasing age.
Severe skin reactions associated with the use of NSAIDs are very rare. You should stop taking Dicuno if you develop any skin rash or mucosal lesions and contact your doctor.
You should avoid taking this medicine during chickenpox.
You should stop taking Dicuno and consult your doctor immediately if you experience any of the following symptoms (angioedema): facial swelling, tongue or throat swelling, difficulty swallowing, urticaria, and difficulty breathing.
Taking medicines like Dicuno may increase the risk of heart attack or stroke. This increased risk is more likely during long-term treatment with high doses. Do not exceed the recommended dose or duration of treatment.
Gastrointestinal bleeding may occur at any time during treatment, with or without warning symptoms. These can have more serious consequences in elderly patients. If you experience gastrointestinal problems or signs of gastrointestinal bleeding, such as blood in your stool, black stools, or vomiting blood, stop taking Dicuno and contact your doctor.
Before taking Dicuno, tell your doctor if you have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Dicuno may sometimes impair the healing of gastrointestinal ulcers after surgery.
Long-term use of different types of painkillers for headaches may lead to worsening of headaches. If this occurs or is suspected, treatment should be discontinued.
Like other anti-inflammatory drugs, Dicuno may mask the symptoms and signs of infection.
Dicuno may reduce the number of white blood cells, reducing the body's resistance to infections. If you develop infections with symptoms such as fever and severe deterioration of general health or fever with symptoms of local infection, such as throat ulcers or oral cavity problems or urinary tract problems, you should consult your doctor immediately. Your doctor will recommend blood tests to check for possible reduction in white blood cell count (agranulocytosis).
It is essential to inform your doctor about taking Dicuno.

Dicuno and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
The following medicines may interact with Dicuno, for example:

• blood-thinning medicines (warfarin, ticlopidine, acetylsalicylic acid, heparin, etc.).
• methotrexate (an anticancer and immunosuppressive medicine).
• medicines used to treat diabetes, except insulin.
• lithium (used to treat manic-depressive psychosis).
• selective serotonin reuptake inhibitors (used in depression).
• digoxin (used to treat heart conditions).
• tacrolimus (used in transplantation and treatment of eczema).
• cyclosporin (used during the transplantation process, in the treatment of acute psoriasis, and rheumatism).
• medicines for high blood pressure (beta-blockers, angiotensin II receptor antagonists, ACE inhibitors).
• diuretics (medicines that stimulate urine production and are used to lower blood pressure).
• quinolone antibiotics (used to treat urinary tract infections).
• zidovudine (used to treat HIV infections).
• corticosteroids (used to treat inflammatory diseases).
• colestipol and cholestyramine (used to lower high levels of fats in the blood). These medicines can be taken with Dicuno, provided they are taken with a few hours' interval.
• fluconazole (used to treat fungal infections).
• rifampicin (antibiotics used in tuberculosis).
• carbamazepine (used in epilepsy).
• barbiturates (sleeping pills).
• diazepam (a sedative).
• pentoxifylline (a vasodilator).
• phenytoin (used in the treatment of epilepsy).

Do not take different pain-relieving medicines at the same time without consulting your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Dicuno if you are in the last 3 months of pregnancy, as it may harm your unborn baby or cause problems during delivery. Dicuno may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in you and your baby and cause prolongation or delay of labor.
In the first 6 months of pregnancy, do not take Dicuno unless your doctor advises you to. If treatment is necessary during this period or during attempts to conceive, use the lowest possible dose for the shortest possible time.
If you are taking Dicuno after the 20th week of pregnancy, for more than a few days, it may cause kidney problems in the unborn baby, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the ductus arteriosus in the baby's heart. If you need treatment for more than a few days, your doctor will recommend additional monitoring of fetal function.
Breastfeeding
Diclofenac passes into breast milk. Therefore, Dicuno should not be taken during breastfeeding to avoid side effects in the newborn.
Fertility
Diclofenac may make it more difficult to become pregnant. You should tell your doctor if you are planning to become pregnant or if you are having problems becoming pregnant.

Driving and using machines

If you experience dizziness, drowsiness, fatigue, or vision disturbances while taking Dicuno, you should not drive or operate machinery.

Dicuno contains the colorant E 124 (Ponceau 4R)

Dicuno 50 mg tablets contain the colorant E 124 (Ponceau 4R), which may cause allergic reactions.

3. How to use Dicuno

Always use Dicuno exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Mild and moderate pain
Adults (over 18 years and elderly): the usual dose is 25-50 mg taken up to 3 times a day. The maximum recommended daily dose is 150 mg.
Migraine attacks
Adults (over 18 years and elderly): 50 mg at the first signs of a migraine headache. If, after 2 hours of taking the first dose, the pain relief is not sufficient, a second dose of 50 mg may be taken. If necessary, further doses of 50 mg may be taken at 4-6 hour intervals, not exceeding a total dose of 150 mg per day.
Tablets should be taken with a drink of water. Tablets should not be taken during meals or immediately after meals. Tablets can be divided into equal doses.
Dicuno should not be used in children and adolescents under 18 years.

Overdose of Dicuno

If you have taken more than the recommended dose of Dicuno, or if a child has taken Dicuno by mistake, you should contact your doctor or go to the hospital immediately to get advice on the risk and the necessary actions to be taken.
Symptoms of overdose are nausea, vomiting, abdominal pain, gastrointestinal bleeding, diarrhea, dizziness, drowsiness, headache, tinnitus, restlessness, hallucinations, seizures in children (including myoclonic seizures), loss of consciousness, effects on the kidneys and liver, and possible metabolic acidosis and tendency to edema.
Additionally, you may experience low blood pressure, respiratory depression, and blue discoloration of the skin and lips.

Missed dose of Dicuno

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Dicuno can cause side effects, although not everybody gets them.

Some side effects can be serious

You should stop taking Dicuno and tell your doctor immediately if you experience any of the following side effects:

• agranulocytosis (symptoms: fever, sore throat, painful mouth ulcers, anal ulcers, reduced immune response, tendency to bacterial infections).
• Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening skin diseases that cause rash, blistering, and peeling of the skin and mucous membranes).
• Hypersensitivity reactions (narrowing and obstruction of the airways, urticaria, anaphylactic shock with a drop in blood pressure).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
• You should stop taking Dicuno and consult your doctor immediately if you experience symptoms of angioedema, such as facial swelling, tongue or throat swelling, difficulty swallowing, urticaria, and difficulty breathing.
• mild painful abdominal cramps and tenderness, starting soon after the start of treatment with Dicuno, followed by gastrointestinal bleeding or bloody diarrhea, usually within 24 hours of the onset of abdominal pain (frequency not known - cannot be estimated from the available data).

Other side effects that may occur:

• abdominal pain.
• nausea.
• vomiting.
• diarrhea.
• gastrointestinal problems.
• loss of appetite.
• excess gas.
• headache.
• dizziness.
• rash.
• increased liver enzymes.
• dizziness.

Rarely (may affect up to 1 in 1,000 people):

• eczema, erythema.
• hypersensitivity reactions (narrowing and obstruction of the airways, urticaria, anaphylactic shock with a drop in blood pressure).
• gastritis, gastrointestinal bleeding or ulcers (may cause blood in the stool or vomit).
• liver dysfunction (including hepatitis with or without jaundice).
• fatigue.
• asthma (with shortness of breath, difficulty breathing).
• fluid retention.

Very rarely (may affect up to 1 in 10,000 people):

• blisters on the skin.
• reduction in the number of certain blood cells (red blood cells, platelets, and neutrophils).
• sudden severe swelling of the skin and mucous membranes (angioedema).
• disorientation, depression, insomnia, nightmares, irritability, disturbances of perception.
• burning or tingling sensation on the skin without visible physical effects (paresthesia), memory disturbances, seizures, restlessness, uncontrolled muscle movements (tremor), taste disturbances, stroke.
• vision and hearing disturbances (blurred vision, double vision) and (reduced hearing, tinnitus).
• effects on the heart and blood vessels (such as palpitations, chest pain, heart failure, myocardial infarction).
• high blood pressure.
• vasculitis.
• pneumonitis.
• colitis, constipation, inflammation of the tongue, mouth, or esophagus.
• pancreatitis.
• meningitis (inflammation of the meninges).
• acute liver failure.
• hair loss.
• photosensitivity.
• acute kidney failure.
• effects on the kidneys (which may lead to decreased or stopped urine production and blood in the urine).

Severe skin infections may occur in the case of chickenpox.

Reporting of side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the
Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dicuno

Do not store above 25°C. Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and blister after EXP.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Dicuno contains

The active substance is 50 mg of diclofenac potassium.
Other ingredients are microcrystalline cellulose, calcium hydrogen phosphate dihydrate, maize starch, sodium carmellose, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, macrogol, talc, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172).
Dicuno 50 mg also contains the colorant E 124 (Ponceau 4R).

What Dicuno looks like and contents of the pack

What Dicuno tablets look like:
Dicuno 50 mg: The tablets are reddish-brown, round, biconvex, with a dividing line on one side.
Diameter: 10 mm.
Pack sizes:
Dicuno 50 mg: 30, 50, or 100 tablets.

Marketing authorization holder and manufacturer

Vitabalans Oy
Varastokatu 8
FI-13500 Hämeenlinna
FINLAND
Phone: +358 3 615 600
Fax: +358 3 618 3130

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Dicuno 50 mg (CZ, DK, EE, FI, LT, LV, NO, PL, SE, SI, SK)
Diclotin 50 mg (DE)

Date of revision of the leaflet

2023-01-30