Dicloduo combi

Package leaflet: Information for the user

DicloDuo Combi, 75 mg + 20 mg, modified-release hard capsules
Diclofenacum natricum + Omeprazolum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What DicloDuo Combi is and what it is 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 pack and other information

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

DicloDuo Combi contains two active substances in one capsule: sodium diclofenac (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 joint pain and inflammation.
Omeprazole belongs to a group of medicines known as "proton pump inhibitors", which reduce the amount of acid produced by the stomach. Omeprazole reduces the risk of developing gastrointestinal ulcers (stomach or duodenal ulcers) caused by non-steroidal anti-inflammatory drugs (NSAIDs).
DicloDuo Combi is prescribed for individuals with symptoms caused by joint disorders, such as osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis. When taking NSAIDs, patients may be at risk of developing gastrointestinal ulcers.

2. Important information before taking DicloDuo Combi

When not to take DicloDuo Combi

• if the patient thinks they may be allergic or are allergic to sodium diclofenac, acetylsalicylic acid, ibuprofen, or any medicine in the NSAID group, 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, nasal congestion, rash, or any other allergic-type reactions.
• if the patient is allergic to medicines containing 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 in the treatment of HIV infection),
• if the patient has or has ever had stomach or duodenal ulcers or intestinal perforation,
• if the patient has or has ever had gastrointestinal bleeding (this may include vomiting blood, bleeding during bowel movements, presence of fresh blood in stool, or tarry stools),
• if the patient has been diagnosed with heart disease and/or conditions related to impaired cerebral circulation, e.g. if the patient has had a heart attack, stroke, mini-stroke (transient ischaemic attack), or blood vessel blockage (thrombosis) in the heart or brain, or has undergone surgery to unblock or bypass blocked blood vessels,
• if the patient has or has had circulatory disorders (peripheral arterial disease).

Before using diclofenac, it is essential to inform the doctor if the patient

• smokes,
• has diabetes,
• suffers from angina pectoris, has a tendency to form blood clots, high blood pressure, elevated cholesterol levels, or elevated triglyceride levels.

If any of these statements apply to the patient or if the patient is uncertain, they
should not take the capsules. The patient should first consult a doctor and follow
their advice.
Before taking DicloDuo Combi, tell the doctor if the patient has recently undergone or has planned surgery on the stomach or gastrointestinal tract, as DicloDuo Combi may sometimes impair wound healing in the intestines after surgical procedures.

Warnings and precautions

If the patient is taking other NSAIDs, they should consult a doctor before starting DicloDuo Combi, as DicloDuo Combi should not be used simultaneously with other NSAIDs.

DicloDuo Combi may mask symptoms of other diseases or contribute to their worsening. Therefore, if the patient has experienced any of the following conditions before starting DicloDuo Combi, they should inform their doctor immediately:

• asthma, hay fever or other allergies, nasal polyps, breathing difficulties (chronic obstructive pulmonary disease, COPD), long-term respiratory infections,
• Crohn's disease or ulcerative colitis,
• systemic lupus erythematosus, connective tissue disease,
• heart, kidney, or liver dysfunction (the doctor may order tests during treatment with the capsules),
• high blood pressure,
• blood clotting disorders,
• unexplained significant weight loss, swallowing difficulties,
• abdominal pain or indigestion,
• vomiting of food or blood,
• passing black stools (blood in stool),
• severe or persistent diarrhoea, as omeprazole use is associated with a slight increase in the risk of infectious diarrhoea.

The patient should inform their doctor about any planned major surgical procedures.
Because DicloDuo Combi contains an NSAID, it may reduce the visibility of infection symptoms (such as fever or pain).
Use of medicines such as DicloDuo Combi may be associated with a small increased risk of heart attack or stroke. The risk increases with higher doses and longer duration of treatment. Do not exceed the recommended dose or duration of treatment.
If the patient has heart function disorders, has had a stroke in the past, or suspects they may be at risk of these conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), they should discuss treatment with their doctor or pharmacist.
Patients taking DicloDuo Combi long-term (for over 1 year) will likely undergo regular medical check-ups. Any new or unusual symptoms should be reported at every doctor’s visit.
Long-term use of proton pump inhibitors such as DicloDuo Combi, particularly 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 inform their doctor.
Kidney inflammation may occur during omeprazole treatment. Symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. The patient should report such symptoms to their doctor.
Talk to a doctor before starting DicloDuo Combi: if the patient has ever developed a severe skin rash, skin peeling, blistering, or mouth ulcers after taking DicloDuo Combi or other pain-relieving medicines.
Before starting DicloDuo Combi, consult a doctor: if the patient has ever had a skin reaction after using a medicine similar to DicloDuo Combi that reduces stomach acid secretion.
If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as it may be necessary to discontinue DicloDuo Combi. Also report any other adverse effects such as joint pain.
Before taking DicloDuo Combi, inform the doctor about a planned specific blood test (chromogranin A levels).

DicloDuo Combi and other medicines

Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This is necessary because DicloDuo Combi may affect the action of certain medicines, and some medicines may affect the action of DicloDuo Combi.

Do not take DicloDuo Combi if you are taking medicines containing nelfinavir (used in the treatment of HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Other painkillers or anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, or other medicines used to prevent platelet aggregation
• Medicines that lower blood pressure (antihypertensives)
• Antidiabetic tablets
• Certain antibiotics, e.g. ciprofloxacin
• Cyclosporine or tacrolimus (immunosuppressive medicines used to suppress immune reactions)
• Corticosteroids
• Mifepristone (used as an early abortion agent)
• Heart medicines, such as digoxin
• Medicines used to treat heart conditions or high blood pressure, e.g. beta-blockers or angiotensin-converting enzyme (ACE) inhibitors
• Diuretics (water tablets), including potassium-sparing diuretics
• 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)
• Colestipol or cholestyramine (medicines used to lower cholesterol levels)
• Sulfinpyrazone (a medicine used to treat gout)
• Diazepam (a medicine used to treat anxiety, muscle relaxation, or epilepsy)
• Phenytoin (a medicine used in epilepsy). If the patient is taking phenytoin, they will be monitored medically when starting or stopping DicloDuo Combi
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. The patient may be monitored medically when starting or stopping DicloDuo Combi
• 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 leg pain or fatigue)
• 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)
• Clarithromycin (a medicine used to treat bacterial infections)

Children

These capsules are not suitable for use in children.

Elderly patients

If the patient is elderly, they may be closely monitored during treatment with DicloDuo Combi.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to become pregnant, they should consult a doctor or pharmacist before using this medicine.

Like other non-steroidal anti-inflammatory drugs, DicloDuo Combi may impair fertility. The patient should inform their doctor if they plan to become pregnant or have difficulty conceiving.

Do not take DicloDuo Combi if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. DicloDuo may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labour. DicloDuo should not be used during the first 6 months of pregnancy unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, DicloDuo may cause kidney function disturbances in the unborn child if taken for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

DicloDuo Combi should be avoided during breastfeeding, as small amounts may pass into breast milk.

Driving and operating machinery

These capsules may cause dizziness, drowsiness, fatigue, or visual disturbances in some people. If these occur, DO 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 per capsule, meaning the medicine is considered "sodium-free".

3. How to take DicloDuo Combi

This medicine should always be taken as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
The recommended dose of DicloDuo Combi is one capsule per day. If symptoms are not relieved
with one capsule per day, consult your doctor. Do not take more than one capsule per day without
consulting your doctor, as this may increase the risk of adverse effects.
DicloDuo Combi capsules should be swallowed whole with water (about half a glass). Do not chew
or crush the capsules. It is best to take the capsules during or after a meal. It is easier to remember
to take the capsules if they are taken at the same time each day, for example with breakfast or dinner.
If you have any doubts about your treatment, inform your doctor.
Taking more DicloDuo Combi than recommended
If you take more capsules than recommended or if a child accidentally swallows several capsules,
seek immediate medical attention at the nearest emergency department and bring the medicine
packaging with you.
Missing a dose of DicloDuo Combi
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Taking this medicine for the shortest possible duration will help minimize adverse reactions.
Some adverse reactions may be serious.
The patient should discontinue taking DicloDuo Combi and seek immediate medical advice if any of the following adverse reactions occur, as urgent treatment may be required:

Adverse reactions caused by diclofenac

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• blood appearing in the stool;
• bleeding from the stomach or intestines (e.g. black, tarry stools);
• vomiting blood or presence of dark particles resembling coffee grounds in vomit;
• stomach pain or other abnormal symptoms related to the stomach;
• mild abdominal cramps and tenderness starting shortly after initiation of DicloDuo Combi treatment, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain (frequency not known – cannot be estimated from available data);
• indigestion or heartburn;
• allergic reactions which may include sudden onset of wheezing, difficulty breathing, swelling of the face, lips, mouth, hands or fingers, skin rash, itching, bruising, red painful patches, skin peeling or blistering.
• severe allergic skin reaction, which may present as widespread red and (or) dark patches, skin swelling, blisters and itching (generalized bullous fixed drug eruption).

Symptoms caused by omeprazole

• sudden onset of wheezing, swelling of lips, tongue and throat or trunk, skin rash, fainting or difficulty swallowing (severe allergic reaction);
• skin redness accompanied by painful red lesions, blisters or skin peeling. Blisters and bleeding may also occur in the lips, eyes, oral cavity, nose and genital area. This may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis;
• yellowing of the skin, dark urine and fatigue, which may be symptoms of liver dysfunction.

The doctor may recommend periodic examinations during treatment with DicloDuo Combi.
Adverse reactions may occur with a defined frequency, categorized as follows:

Other adverse reactions that may be caused by diclofenac:
Common adverse reactions:

• Headache, dizziness.
• Nausea, vomiting, bloating, diarrhoea, loss of appetite.
• Stomach pain or other abnormal symptoms related to the stomach, indigestion or heartburn.
• Changes in blood test results used to assess liver function.
• Rash.

Uncommon adverse reactions:

• 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 of the skin.
• Difficulty swallowing.
• Fatigue, drowsiness.
• Blood in stool, gastrointestinal bleeding (e.g. passing black, tarry stools).
• Vomiting blood or dark particles resembling "coffee grounds".
• Stomach ulcer or duodenal ulcer.
• Liver disorders, jaundice (yellowing of the skin or whites of the eyes).
• Rash and small blisters (urticaria).
• Perforation of the stomach or intestines (gastrointestinal perforation).

Very rare adverse reactions:

• Anaemia.
• Depression, disorientation, insomnia, irritability, mood changes, nightmares.
• Memory disturbances, prickling and tingling sensations.
• Neck stiffness, which may be a sign of meningitis.
• Confusion, hallucinations, malaise.
• Changes in taste sensation, tremors, seizures, anxiety.
• Blurred vision, double vision.
• Hearing disturbances, tinnitus (ringing in the ears).
• Worsening of Crohn's disease or ulcerative colitis.
• Constipation (including intestinal obstruction).
• Oesophageal disorders.
• Pancreatitis.
• Photosensitivity, skin rashes, blisters on the skin and pain in mouth/eyes, skin peeling, eruption and unusual bruising, hair loss.
• Kidney disorders, disturbances in urination (e.g. change in usual volume or colour of urine).
• Decrease in white blood cell count (leukopenia).
• Inflammation of lung tissue (pneumonitis).

Frequency not known:

• Allergic skin reaction, which may present as round or oval red patches and swelling of the skin, blisters and itching (erythema multiforme). The skin in affected areas may also appear darker, and this discoloration may persist after healing. Upon re-administration of the drug, erythema multiforme usually reappears in the same locations.

Other disorders:
Diclofenac may slightly increase the risk of heart attack (i.e. myocardial infarction) or stroke.
Other adverse reactions reported with the use of non-steroidal anti-inflammatory drugs include fluid retention causing oedema, increased blood pressure, palpitations, chest pain and heart failure.

Other adverse reactions that may be caused by omeprazole:
Common adverse reactions:

• Headache.
• Effects on stomach or intestines: diarrhoea, stomach pain, constipation, flatulence (bloating).
• Nausea or vomiting.
• Benign gastric polyps.

Uncommon adverse reactions:

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, prickling and numbness sensations, drowsiness.
• Sensation of spinning (dizziness).
• Skin rash, small blisters on the skin (urticaria) and itchy skin.
• General malaise and lack of energy.
• Abnormal blood test results assessing liver function.
• Fracture of the hip, wrist or spine.

Rare adverse reactions:

• Blood disorders, such as decreased number of white blood cells or platelets. This may increase the likelihood of experiencing weakness, bruising or infections.
• Allergic reactions, sometimes very severe, including swelling of lips, tongue and throat, fever, wheezing.
• Low sodium levels in blood. This may cause weakness, nausea and cramps.
• Feeling of restlessness, confusion or depression.
• Changes in taste sensation.
• Vision disturbances, such as blurred vision.
• Sudden feeling of breathing difficulty or shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Infection called "thrush", which may also affect the intestines and is caused by a fungus.
• Liver disorders, including jaundice, which may cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin rash after exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney disorders (interstitial nephritis).
• Excessive sweating.

Very rare adverse reactions:

• Changes in blood cell counts, including absence of white blood cells (agranulocytosis).
• Aggression.
• Seeing, feeling or hearing things that do not exist (hallucinations).
• Severe liver disorders leading to liver failure and encephalopathy.
• Sudden onset of severe rash or blistering or peeling of the skin. This may be associated with high fever or joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Breast enlargement in men.

Frequency not known:

• Inflammation of the intestine (leading to diarrhoea).
• Rash which may be accompanied by joint pain.
• If a patient takes DicloDuo Combi for more than three months, it is possible that their blood magnesium levels may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or rapid heartbeat. If any of these symptoms occur, the doctor should be informed immediately. The doctor will decide whether routine blood tests to determine magnesium levels should be performed.

Other adverse reactions:

• In very rare cases, omeprazole may affect white blood cells, leading to immune system deficiency. If an infection occurs with symptoms such as fever and severe deterioration in general condition, or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, it is essential to consult a doctor as quickly as possible. Absence of white blood cells (agranulocytosis) can only be ruled out based on blood test results. It is important to inform the doctor about the medication being taken in such a situation.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Medical Devices and Biocidal Products at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store DicloDuo Combi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister.
The expiry date refers to the last day of the stated month.
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. Keep the bottle tightly closed to protect from moisture.

Blister:
Store in the original packaging to protect from moisture.

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

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

What DicloDuo Combi looks like and contents of the pack
DicloDuo Combi capsules have a matt pink cap and a matt yellow body, and contain white to pale yellow pellets.

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Manufacturers:
Haupt Pharma Amareg GmbH
Donaustauf Straße 378
93055 Regensburg
Germany

Swiss Caps GmbH
Grassingerstrasse 9
83043 Bad Aibling
Germany

This medicinal product is authorised for marketing in 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