Dicloduo Combi

Leaflet accompanying the packaging: information for the user

DicloDuo Combi, 75 mg + 20 mg, modified-release hard capsules

Diclofenac sodium/ Omeprazole

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.
• In case of any doubts, 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is DicloDuo Combi and what is it used for

DicloDuo Combi contains two active substances in one capsule. These active substances are diclofenac sodium (75 mg) and omeprazole (20 mg). Diclofenac belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and is used to reduce pain and inflammation of the joints. Omeprazole belongs to a group of medicines called proton pump inhibitors, which reduce the amount of acid produced by the stomach. Omeprazole reduces the risk of developing stomach ulcers (stomach or duodenal ulcers) caused by non-steroidal anti-inflammatory drugs (NSAIDs). DicloDuo Combi is prescribed for people with symptoms caused by joint disorders, such as osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis. When taking NSAIDs, the patient may be at risk of developing stomach ulcers.

2. Important information before taking DicloDuo Combi

When not to take DicloDuo Combi

• if the patient thinks they may be allergic or is allergic to diclofenac sodium, acetylsalicylic acid, ibuprofen, or any other NSAID, omeprazole, or any of the other ingredients of DicloDuo Combi (listed at the end of this leaflet). Symptoms of hypersensitivity include swelling of the face and lips (angioedema), difficulty breathing, chest pain, runny nose, rash, or any other allergic reaction.
• if the patient is allergic to other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole),
• if the patient has severe liver, kidney, or heart failure,
• if the patient is in the last three months of pregnancy,
• if the patient is taking a medicine containing nelfinavir (used to treat HIV infection),
• if the patient has or has ever had stomach or duodenal ulcers or perforation of the intestine,
• if the patient has or has ever had bleeding from the digestive tract (this may include bloody vomiting, bleeding during bowel movements, presence of fresh blood in the stool, black stools),
• if the patient has established heart disease and/or cerebrovascular disease, e.g., if the patient has had a heart attack, stroke, transient ischemic attack (TIA), or has had an artery blocked or has undergone bypass grafting or angioplasty of blocked arteries,
• if the patient has or has had circulatory problems (peripheral arterial disease). Before taking diclofenac, the patient must inform their doctor if they
• smoke,
• have diabetes,
• have angina or have a tendency to form blood clots, high blood pressure, elevated cholesterol, or elevated triglycerides. If any of these statements apply to the patient or if the patient is unsure, they should not take the capsules. They should consult their doctor and follow their advice. Before taking DicloDuo Combi, the patient should tell their doctor if they have recently undergone or are scheduled to undergo stomach or intestinal surgery, as DicloDuo Combi may sometimes cause delayed healing of intestinal wounds after surgery.

Warnings and precautions

If the patient is taking other NSAIDs, they should consult their doctor before starting DicloDuo Combi, as DicloDuo Combi should not be used at the same time as other NSAIDs. DicloDuo Combi may mask the symptoms of other diseases or contribute to their worsening. Therefore, if before starting DicloDuo Combi, the patient has experienced any of the following conditions, they should immediately inform their doctor:

• asthma, hay fever, or other allergies, nasal polyps, difficulty breathing (chronic obstructive pulmonary disease, COPD), prolonged respiratory infections,
• Crohn's disease or ulcerative colitis,
• systemic lupus erythematosus, connective tissue disease,
• heart, kidney, or liver problems (the doctor may order tests during the patient's treatment with the capsules).
• high blood pressure,
• bleeding disorders,
• unexplained significant weight loss, swallowing disorders,
• abdominal pain or indigestion,
• vomiting blood or coffee grounds,
• passing black stools (stool discolored with blood),
• severe or persistent diarrhea, as omeprazole may be associated with a slight increase in infectious diarrhea. The patient should inform their doctor about planned major surgery.

As DicloDuo Combi contains an NSAID, it may cause the symptoms of infection (such as fever or pain) to be less pronounced. Taking medicines like DicloDuo Combi may be associated with a small increased risk of heart attack or stroke. The risk increases with higher doses and longer treatment. The patient should not exceed the recommended dose or treatment duration. If the patient has heart problems, has had a stroke, or suspects they may be at risk of these conditions (e.g., high blood pressure, diabetes, high cholesterol, smoking), they should discuss their treatment with their doctor or pharmacist. Patients taking DicloDuo Combi for a long time (more than 1 year) will likely be regularly monitored by their doctor. They should report any new or unusual symptoms and circumstances during each visit to the doctor. Taking proton pump inhibitors like DicloDuo Combi, especially for more than 1 year, may slightly increase the risk of hip, wrist, or spine fractures. If the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis), they should tell their doctor. During omeprazole treatment, kidney inflammation may occur. Symptoms may include decreased urine output or blood in the urine and/or hypersensitivity reactions, such as fever, rash, and stiffness. The patient should report such symptoms to their doctor. Before starting DicloDuo Combi, the patient should consult their doctor: if they have ever had a skin reaction after taking a medicine similar to DicloDuo Combi that reduces stomach acid production. If the patient develops a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking DicloDuo Combi. They should also report any other adverse reactions, such as joint pain. Before taking DicloDuo Combi, the patient should inform their doctor about planned specific blood tests (chromogranin A levels).

DicloDuo Combi and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is necessary because DicloDuo Combi may affect the action of some medicines, and some medicines may affect the action of DicloDuo Combi. The patient should not take DicloDuo Combi if they are taking medicines containing nelfinavir (used to treat HIV infection). The patient should inform their doctor or pharmacist about taking any of the following medicines:

• Other painkillers or anti-inflammatory medicines (NSAIDs), including acetylsalicylic acid, or other medicines used to prevent blood clots from forming
• Blood pressure-lowering medicines (antihypertensives)
• Anti-diabetic tablets
• Certain antibiotics, e.g., ciprofloxacin
• Cyclosporine or tacrolimus (immunosuppressive medicines used to suppress the body's immune response)
• Corticosteroids
• Mifepristone (used as an early abortion pill)
• Heart medicines, such as digoxin
• Medicines used to treat heart problems or high blood pressure, e.g., beta-blockers or angiotensin-converting enzyme (ACE) inhibitors
• Diuretics (water pills), including those that spare potassium
• Lithium (a medicine used to treat sudden mood changes and certain types of depression)
• Selective serotonin reuptake inhibitors (SSRIs) (medicines used to treat certain types of depression)
• Methotrexate (a medicine used to treat arthritis and certain types of cancer)
• Zidovudine (a medicine used to treat HIV infection)
• Colestyramine or cholestyipol (medicines used to lower cholesterol levels)
• Sulfinpyrazone (a medicine used to treat gout)
• Diazepam (a medicine used to treat anxiety, to relax muscles, or in epilepsy)
• Phenytoin (a medicine used in epilepsy). If the patient is taking phenytoin, they will be monitored by their doctor when starting or stopping DicloDuo Combi
• Medicines used to thin the blood, such as warfarin or other vitamin K blockers. When starting or stopping DicloDuo Combi, the patient may be monitored by their doctor
• Rifampicin (a medicine used to treat tuberculosis)
• Atazanavir (a medicine used to treat HIV infection)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)
• Cilostazol (a medicine used to treat intermittent pain or fatigue in the legs)
• Saquinavir (a medicine used to treat HIV infection)
• Clopidogrel (a medicine used to prevent blood clots)
• Erlotinib (a medicine used to treat cancer)
• Ketoconazole, itraconazole, posaconazole, or voriconazole (medicines used to treat fungal infections)
• Clarithmetic (a medicine used to treat bacterial infections)

Children

These capsules are not suitable for use in children.

Elderly

If the patient is elderly, they may be closely monitored by their doctor while taking DicloDuo Combi.

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 or pharmacist before taking this medicine. Like other non-steroidal anti-inflammatory drugs, DicloDuo Combi may make it more difficult to become pregnant. Female patients should tell their doctor if they are planning to become pregnant or are having trouble becoming pregnant. The patient should not take DicloDuo Combi if they are in the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. DicloDuo Combi may cause kidney or heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and baby and prolong labor. During the first six months of pregnancy, DicloDuo Combi should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to become pregnant, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, DicloDuo Combi may cause kidney problems in the unborn baby if taken for more than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is required for more than a few days, the doctor may recommend additional monitoring. The patient should avoid taking DicloDuo Combi while breastfeeding, as small amounts may pass into breast milk.

Driving and using machines

These capsules may cause dizziness, drowsiness, fatigue, or vision disturbances in some people. If these occur, the patient should not drive or operate machinery.

DicloDuo Combi contains propylene glycol and sodium

The medicine contains 1 mg of propylene glycol in each capsule. The medicine contains less than 1 mmol (23 mg) of sodium in one capsule, which means the medicine is considered "sodium-free".

3. How to take DicloDuo Combi

This medicine should always be taken exactly as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist. The recommended dose of DicloDuo Combi is one capsule per day. If the symptoms are not relieved with one capsule per day, the patient should talk to their doctor. The patient should not take a higher dose than one capsule per day without consulting their doctor, as this may increase the risk of side effects. DicloDuo Combi should be swallowed whole with water (about half a glass). The capsules should not be chewed or crushed. It is best to take the capsules with a meal or after a meal. It is easier to remember to take the capsules when taken at the same time every day, e.g., during breakfast or dinner. In case of any doubts about treatment, the patient should tell their doctor.

Taking a higher dose of DicloDuo Combi than recommended

In case of taking more capsules than recommended or accidental ingestion of several capsules by a child, the patient should immediately go to the nearest emergency department and take the packaging of the medicine with them.

Missing a dose of DicloDuo Combi

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

4. Possible side effects

Like all medicines, DicloDuo Combi can cause side effects, although not everybody gets them. Taking this medicine for the shortest possible time will help minimize side effects. Some side effects may be serious. The patient should stop taking DicloDuo Combi and consult their doctor immediately if they notice any of the following symptoms:

Symptoms caused by diclofenac

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• blood in the stool;
• bleeding from the stomach or intestines (e.g., black, tarry stools);
• bloody vomiting or the presence of dark coffee grounds in the vomit;
• stomach pain or other abnormal stomach symptoms;
• mild painful cramps and abdominal tenderness, starting soon after starting DicloDuo Combi, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain (frequency not known - cannot be estimated from available data);
• indigestion or heartburn;
• allergic reactions, which may include sudden wheezing, difficulty breathing, swelling of the face, lips, tongue, hands, or fingers, skin rash, bruising, painful red areas, peeling, or blistering.

Symptoms caused by omeprazole

• sudden wheezing, swelling of the lips, tongue, and throat, or hands and feet, rash, fainting, or difficulty swallowing (severe allergic reaction);
• redness of the skin with painful red spots, blisters, or peeling. Blisters and bleeding in the mouth, eyes, nose, and genitals may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis;
• yellowing of the skin, dark urine, and fatigue, which may be signs of liver problems. The doctor may order periodic tests during DicloDuo Combi treatment. Side effects may occur with the following frequency, which is defined as follows:

Other side effects that may be caused by diclofenac:
Common side effects:

• headache, dizziness.
• nausea, vomiting, bloating, diarrhea, loss of appetite.
• stomach pain or other abnormal stomach symptoms, indigestion, or heartburn.
• changes in blood test results that evaluate liver function.
• skin rash. Rare side effects:
• allergic reactions, including sudden wheezing, difficulty breathing, swelling of the face, lips, tongue, hands, or fingers, skin rash, bruising, painful red areas, peeling, or blistering.
• swallowing disorders.
• fatigue, drowsiness.
• blood in the stool, bleeding from the stomach or intestines (e.g., black, tarry stools).
• bloody vomiting or the presence of dark coffee grounds in the vomit.
• stomach or duodenal ulcers.
• liver problems, jaundice (yellowing of the skin or whites of the eyes).
• skin rash and small blisters (hives).
• perforation of the stomach or intestines (perforation of the digestive tract). Very rare side effects:

• Anemia.
• Depression, disorientation, insomnia, irritability, mood changes, nightmares.
• Memory disorders, feeling of tingling and numbness.
• Stiffness of the neck, which may be a sign of meningitis.
• Confusion, hallucinations, malaise.
• Changes in taste, tremors, seizures, anxiety.
• Blurred vision, double vision.
• Hearing disorders, ringing in the ears (tinnitus).
• Worsening of Crohn's disease or ulcerative colitis.
• Constipation (including obstruction).
• Esophageal disorders.
• Pancreatitis.
• Sensitivity to light, skin rashes, blisters on the skin and pain in the mouth/eyes, peeling, and bruising.
• Kidney problems, urinary disorders (e.g., change in normal urine volume or color).
• Decreased white blood cell count (leukopenia).
• Pneumonia (pneumonitis). Other disorders: Diclofenac may slightly increase the risk of heart attack (i.e., myocardial infarction) or stroke. Other side effects reported with non-steroidal anti-inflammatory drugs include fluid retention (edema), high blood pressure, palpitations, and heart failure. Other side effects that may be caused by omeprazole: Common side effects:
• headache.
• effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating).
• nausea or vomiting.
• mild stomach polyps.

Other side effects may occur. Please refer to the full list of side effects in the original leaflet.

Reporting side effects

If side effects occur, including any 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 Biocides, Al. Jerozolimskie 181 C, 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. Reporting side effects will help gather more information on the safety of the medicine.

5. How to store DicloDuo Combi

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month stated. The term "Lot" on the packaging and blister means "Batch number". The term "EXP" on the packaging and blister means "Expiry date". Do not store above 30°C. HDPE bottle: Shelf life after first opening: 1 month. Store in the original packaging. Store the bottle tightly closed to protect from moisture. Blister: Store in the original packaging to protect from moisture.

6. Contents of the packaging and other information

What DicloDuo Combi contains

The active substances of DicloDuo Combi are diclofenac sodium and omeprazole. Each hard gelatin capsule contains 75 mg of diclofenac sodium and 20 mg of omeprazole. The other ingredients of the medicine are: Capsule: microcrystalline cellulose, povidone K 25, anhydrous colloidal silica, methacrylic acid - ethyl acrylate copolymer (1:1) type A, neutralized (6 mol%) with sodium hydroxide, propylene glycol, ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, mannitol, heavy magnesium carbonate, hydroxypropyl cellulose (75-150 mPa x s / 5% solution), sodium lauryl sulfate, hypromellose (6 mPa x s), methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30% (dry matter), polysorbate 80, triethyl citrate, talc. Coating: titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), gelatin.

What DicloDuo Combi looks like and contents of the pack

DicloDuo Combi capsules consist of a pink matte cap and a yellow matte body and contain white to light yellow pellets.

Pack sizes

HDPE bottles: 30 capsules Blister: 10, 20, 30, 50, 60, 100 capsules Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bausch Health Ireland Limited 3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT3 Ireland

Manufacturer:

Haupt Pharma Amareg GmbH Donaustauf Straße 378 93055 Regensburg Germany Swiss Caps GmbH Grassingerstrasse 9 83043 Bad Aibling Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Bulgaria ДИКЛОПРАМ 75 mg / 20 mg твърди капсули с изменено освобождаване Cyprus DICLODUO COMBI 75 mg / 20 mg, καψάκιο ελεγχόμενης αποδέσμευσης σκληρό Estonia DICLOPRAM Greece DICLODUO COMBI 75 mg / 20 mg, καψάκιο ελεγχόμενης αποδέσμευσης σκληρό Hungary DICLOPRAM 75 mg / 20 mg módosított hatóanyagleadású kemény kapszula Latvia DIOMPRAZ 75 mg / 20 mg ilgstošās darbības cietās kapsulas Lithuania DIOMPRAZ 75/20 mg modifikuoto atpalaidavimo kietosios kapsulės Malta DICLODUO COMBI 75 mg / 20 mg, modified-release hard capsules Poland DICLODUO COMBI Slovakia DIOMPRAZ 75 mg /20 mg tvrdé kapsuly s riadeným uvoľňovaním

Date of last revision of the leaflet: 10.04.2023