Dicloduo

Patient Information Leaflet: User Information

DicloDuo, 75 mg, Modified Release Capsules

Diclofenac Sodium

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is DicloDuo and what is it used for

Diclofenac belongs to a group of non-steroidal anti-inflammatory drugs, it is a derivative of aminophenylacetic acid. In addition to its anti-inflammatory effect, it has analgesic and antipyretic properties and inhibits platelet aggregation. Diclofenac does not affect glucose metabolism. The mechanism of action of diclofenac, like other non-steroidal anti-inflammatory drugs, is based on the inhibition of prostaglandin cyclooxygenase synthesis, which conditions the occurrence of inflammation.
DicloDuo is used:
For symptomatic treatment:

• inflammatory forms of rheumatic diseases (e.g. rheumatoid arthritis, ankylosing spondylitis, degenerative joint diseases);
• rheumatic and post-traumatic inflammatory conditions of tendons, ligaments, and periarticular soft tissues. Analgesically:
• after surgical procedures;
• in painful menstruation.

2. Important information before taking DicloDuo

When not to take DicloDuo

• If the patient thinks they may be allergic to diclofenac sodium, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other ingredients of DicloDuo (listed at the end of this leaflet). Hypersensitivity symptoms include facial and lip edema (angioedema), difficulty breathing, chest pain, runny nose, rash, or any other allergic reactions.
• In patients with active or recurrent gastric and/or duodenal ulcers, bleeding, or perforation.
• In women in the third trimester of pregnancy.
• If the patient has severe liver, kidney, or heart failure.
• Similarly, as with other non-steroidal anti-inflammatory drugs (NSAIDs), it should not be used in people who may experience an asthma attack, hives, or acute rhinitis after taking acetylsalicylic acid or other prostaglandin synthesis inhibitors.
• If the patient has ever had bleeding or perforation in the gastrointestinal tract after taking NSAIDs.
• If the patient has cerebral bleeding or other active bleeding.
• If the patient has unexplained blood disorders.
• 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 or has had circulatory disorders (peripheral vascular disease).

Before taking diclofenac, the patient should inform their doctor

• if they smoke
• if they have diabetes
• if they have angina pectoris, thrombosis, hypertension, high cholesterol, or high triglycerides.

Before taking DicloDuo, the patient should tell their doctor if they have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as DicloDuo may sometimes cause impaired wound healing in the gut after surgery.
The occurrence of side effects can be reduced by using the lowest effective dose for the shortest possible time.

Warnings and precautions

• Before starting DicloDuo, the patient should discuss it with their doctor or pharmacist.
• Taking the medicine in the lowest effective dose for the shortest possible time reduces the risk of side effects.
• Bleeding, ulcers, or perforation of the gastrointestinal tract, which can cause life-threatening side effects (sometimes fatal), have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms, and regardless of previous gastrointestinal disorders. These complications are more dangerous in the elderly. If bleeding or ulcers occur in patients taking DicloDuo, the doctor will advise discontinuing the medicine.
• Rarely, very serious skin reactions have been reported with NSAIDs, including diclofenac, which can cause life-threatening side effects (sometimes fatal), including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (see section 4). In patients at high risk of these reactions, they usually occurred within the first month of treatment. DicloDuo should be discontinued immediately if a rash, mucosal lesions, or any other signs of hypersensitivity occur.
• Like other non-steroidal anti-inflammatory drugs (NSAIDs), rare allergic reactions, including anaphylactic and pseudo-anaphylactic reactions, can occur, even if the medicine has not been taken before.
• Like other non-steroidal anti-inflammatory drugs (NSAIDs), DicloDuo may mask symptoms of infection.
• Diclofenac may make it harder to get pregnant. If the patient is planning to get pregnant or is having trouble getting pregnant, they should tell their doctor.
• The patient should avoid taking DicloDuo with other systemic NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the lack of evidence of benefits from combined use and the potential for increased side effects.

The patient should take the medicine with caution if they have a history of bronchial asthma, seasonal allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease, or chronic respiratory infections (especially if they have symptoms similar to those of allergic rhinitis), as they are more likely to experience asthma exacerbations after taking NSAIDs (aspirin-induced asthma), Quincke's edema, or urticaria. Therefore, special caution is advised in these patients (they should have quick access to medical help). Particular caution is advised in patients allergic to other substances, e.g. with skin reactions, itching, or urticaria.

During long-term use of diclofenac, the doctor will recommend regular monitoring of kidney function and blood morphology indicators.
During long-term use of painkillers, headaches may occur, which should not be treated with a higher dose of the medicine.
Too frequent use of painkillers, especially concurrent use of several medicines with different active substances, may lead to permanent kidney damage and an increased risk of kidney failure.

Children and adolescents

Due to the dose size, the medicine is not recommended for use in children and adolescents under 18 years of age.

DicloDuo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Concurrent use of DicloDuo may change the effect of the following medicines or the use of the following medicines may change the effect of DicloDuo:

• Lithium;
• Digoxin;
• Phenytoin;
• Corticosteroids;
• Probenecid;
• Colestyramine;
• Cholestyramine;
• CYP2C9 inhibitors, e.g. sulfinpyrazone and voriconazole
• Diuretics and blood pressure-lowering medicines (e.g. beta-blockers, ACE inhibitors);
• Non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids: concurrent administration of diclofenac and other NSAIDs or corticosteroids may increase the frequency of gastrointestinal side effects;
• Anticoagulant and antiplatelet agents: caution is advised when used concurrently with diclofenac, as they may increase the risk of bleeding;
• Selective serotonin reuptake inhibitors: concurrent use of NSAIDs and selective serotonin reuptake inhibitors may increase the risk of gastrointestinal bleeding;
• Antidiabetic agents: blood glucose monitoring is necessary during combined therapy;
• Methotrexate: caution is advised when using NSAIDs during or within 24 hours of methotrexate administration, as it may increase methotrexate plasma levels and increase the risk of toxicity;
• Cyclosporin and tacrolimus: diclofenac should be administered at lower doses in patients receiving cyclosporin and tacrolimus;
• Quinolone antibacterials;
• Mifepristone: diclofenac and other NSAIDs should not be used for 8-12 days after mifepristone administration.

DicloDuo with food, drinks, or alcohol

The capsules should be taken preferably with meals, with a drink. Do not chew or crush.
Concurrent use of DicloDuo and alcohol may increase the risk of side effects, especially those affecting the gastrointestinal system or the central nervous system.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or is planning to have a baby, they should consult their doctor or pharmacist before taking this medicine.
DicloDuo should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the patient and child and cause delayed or prolonged labor.
In the first 6 months of pregnancy, DicloDuo should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, DicloDuo may cause kidney problems in the unborn child if taken for more than a few days. This may lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the ductus arteriosus in the child's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Diclofenac passes into breast milk in small amounts, so it should not be given to breastfeeding women.

Driving and using machines

If the patient experiences dizziness or fatigue, blurred vision, they should not drive or operate machinery.

DicloDuo contains sodium and propylene glycol

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".
The medicine contains 1 mg of propylene glycol per capsule.

3. How to take DicloDuo

This medicine should always be taken as directed by the doctor. If the patient is unsure, they should ask their doctor or pharmacist.
The patient should not exceed the recommended dose or treatment duration.

Adults

The dose should be determined individually, depending on the indication and the patient's condition. The recommended daily dose is up to 150 mg of diclofenac sodium (2 capsules). Adults are usually given 1 capsule of DicloDuo 75 mg per day. If necessary, the dose can be increased to 2 capsules per day (2 x 75 mg of diclofenac sodium). In severe cases, 2 capsules of DicloDuo 75 mg can be given once a day for a short period (1 x 150 mg of diclofenac sodium). The capsules should be taken preferably with meals. The capsules should not be chewed or crushed.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.
The doctor will adjust the dose individually for each patient and will use the lowest effective dose for the shortest possible time.

Use in children and adolescents

Due to the dose size, the medicine is not recommended for use in children and adolescents under 18 years of age.

Use of DicloDuo in patients with kidney and/or liver function disorders

There is no need to reduce the dose in patients with mild or moderate kidney and/or liver function disorders (see section 2 for recommendations for patients with severe kidney and/or liver failure).

Use of DicloDuo in elderly patients

There are no contraindications. No dose adjustment is necessary. The medicine should be used with caution in elderly patients.
In elderly patients and patients with low body weight, the lowest effective dose is recommended.

Overdose of DicloDuo

In case of overdose or accidental ingestion of the medicine by a child, the patient should immediately contact their doctor or pharmacist.
Overdose may cause vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In case of significant poisoning, acute kidney failure and liver damage may occur.
There is no specific antidote for diclofenac. Treatment is symptomatic.

Missed dose of DicloDuo

The patient should not take a double dose to make up for a missed dose.

Stopping DicloDuo treatment

If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, DicloDuo can cause side effects, although not everybody gets them.
Some side effects can be serious.
The patient should stop taking DicloDuo and contact their doctor immediately if they notice:

• mild painful abdominal cramps and tenderness, starting soon after taking DicloDuo, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain onset (frequency not known - cannot be estimated from available data).
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

The following side effects have been reported during the use of diclofenac formulations, used for a short or long period:
Common (occurring in less than 1 in 10 but more than 1 in 100 treated patients): abdominal pain, other gastrointestinal disorders (e.g. nausea, vomiting, diarrhea, abdominal cramps, indigestion, bloating, lack of appetite), headaches, dizziness, drowsiness, skin rashes and eruptions, increased liver enzyme activity in the blood (ALT, AST).
Rare (occurring in less than 1 in 1,000 but more than 1 in 10,000 treated patients):
gastritis, gastrointestinal bleeding (vomiting blood, black stools, bloody diarrhea), gastrointestinal ulcers with bleeding or perforation or without, drowsiness, fatigue, urticaria, edema, liver function disorders with hepatitis, including jaundice or without, hypersensitivity reactions (e.g. asthma exacerbation, bronchospasm, or dyspnea, systemic anaphylactic or anaphylactoid reactions, including sudden hypotension and shock), angioedema.
Very rare (occurring in less than 1 in 10,000 treated patients): aphthous stomatitis, glossitis, changes in the oral mucosa, disorders of the lower gastrointestinal tract (e.g. non-specific hemorrhagic colitis, exacerbation of ulcerative colitis or proctitis in Crohn's disease, colon damage, and stricture formation), pancreatitis, constipation, paresthesia, memory disorders, seizures, anxiety states, tremors, aseptic meningitis (especially in patients with autoimmune diseases, such as systemic lupus erythematosus and mixed connective tissue disease) with fever, neck stiffness, headache, nausea, and vomiting, taste disorders, stroke, vision disturbances (blurred or double vision), tinnitus, hearing disorders, bullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (acute toxic epidermal necrolysis), exfoliative dermatitis (exfoliative dermatitis), hair loss, photosensitivity reactions, purpura, including allergic purpura, rash, itching, acute kidney failure, urine abnormalities (e.g. hematuria, proteinuria), interstitial nephritis, nephrotic syndrome, renal papillary necrosis, thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), agranulocytosis (very low count of a certain type of white blood cell), hemolytic anemia, aplastic anemia, impotence, angioedema (including facial and lip edema), vasculitis, pneumonia, palpitations, chest pain, heart failure, myocardial infarction, hypotension, disorientation, depression, insomnia, nightmares, irritability, psychotic disorders.
Taking such medicines as DicloDuo 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 take higher doses or use the medicine for longer than recommended.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they 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
Al. Jerozolimskie 181 C,
02-222 Warsaw,
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store DicloDuo

Store below 25°C. Store in the original packaging to protect from light and moisture.
The medicine should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after {EXP}. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What DicloDuo contains

• The active substance is diclofenac sodium, with 25 mg in the enteric pellets and 50 mg in the prolonged-release pellets.
• The other ingredients (excipients) are:
• in the enteric pellets: microcrystalline cellulose, povidone K 25, colloidal anhydrous silica, methacrylic acid-ethyl acrylate copolymer (1:1) with 0.28 mg of sodium hydroxide (1N), propylene glycol, talc.
• in the prolonged-release pellets: microcrystalline cellulose, povidone K 25, colloidal anhydrous silica, ammonio methacrylate copolymer (type B) - Eudragit RS 100, ammonio methacrylate copolymer (type A) - Eudragit RL 100, triethyl citrate, talc.
• in the capsule shell: titanium dioxide (E 171), indigo carmine (E 132), purified water, gelatin.
• in the capsule shell ink: shellac, propylene glycol, titanium dioxide (E 171).

What DicloDuo looks like and contents of the pack

PVC/PVDC/Aluminum blisters in a cardboard box.
30 capsules in blisters of 10.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Phone: +48 17 865 51 00

Manufacturer

Swiss Caps GmbH
Grassingerstraße 9
83043 Bad Aibling,
Germany

Importer

Bausch Health Poland sp. z o.o.
ul. Kosztowska 21
41-409 Mysłowice
Poland
Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów
Poland

Date of last revision of the leaflet: