CELECOXIB ALMUS 200 mg HARD CAPSULES

Introduction

Leaflet:Informationfortheuser

CelecoxibAlmus200 mg hard capsules EFG

Read the entire leaflet carefully before starting to take the medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

Contents of the leaflet

1. What is Celecoxib Almusand what is it used for
2. What you need to know before taking Celecoxib Almus
3. How to take Celecoxib Almus
4. Possible side effects
5. Storage of Celecoxib Almus
6. Package contents and additional information

1. What is Celecoxib Almus and what is it used for

Celecoxib belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), and specifically to the subgroup known as selective cyclooxygenase-2 (COX-2) inhibitors. Your body produces prostaglandins that can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces them in greater quantities. Celecoxib acts by reducing the production of prostaglandins, thus reducing pain and inflammation.

Celecoxib Almusis indicated in adultsto relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

The medicine will start to take effect a few hours after taking the first dose, but you may not experience a complete effect until several days have passed.

2. What you need to know before taking Celecoxib Almus

Your doctor has prescribed this medicine. The following information will help you get better results with this medicine. If you have any other doubts, please ask your doctor or pharmacist.

Do not take CelecoxibAlmus

Tell your doctor if any of the following circumstances apply to you, as patients with these conditions should not take Celecoxib Almus:

• if you are allergic to celecoxib or any of the other componentsof celecoxib (see section 6),
• if you have had an allergic reactionto any medicine in the group called "sulfonamides" (e.g., some antibiotics used to treat infections),
• if you currently have a stomach or intestinal ulcer or bleeding,
• if you have previously experienced any of the following symptoms as a result of taking acetylsalicylic acid or any other anti-inflammatory medication: asthma, nasal polyps, severe nasal congestion, or allergic symptomssuch as skin rash with itching, swelling of the face, lips, tongue, or throat, difficulty breathing or wheezing,
• if you are pregnant. If you can become pregnant during treatment, you should discuss the use of contraceptive methods with your doctor.
• if you are breastfeeding,
• if you have severe liver disease,
• if you have severe kidney disease,
• if you have inflammatory bowel diseasesuch as ulcerative colitisor Crohn's disease,
• if you have heart failure, diagnosed ischemic heart disease, or cerebrovascular disease, e.g., you have been diagnosed with a heart attack, stroke, or transient ischemic attack (temporary reduction in blood flow to the brain; also known as "mini-stroke"), angina pectoris, or obstruction of the blood vessels to the heart or brain,
• if you have or have had circulatory problems(peripheral arterial disease) or if you have undergone surgery on the arteries in your legs.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Celecoxib Almus:

• if you have previously had a stomach or intestinal ulcer or bleeding(Do not take CelecoxibAlmusif you currently have a stomach or intestinal ulcer or bleeding),
• if you are taking acetylsalicylic acid(even at low doses as a cardiac protector),
• if you are taking antiplatelet therapies,

• if you are receiving medications to reduce blood coagulation (e.g., warfarin/warfarin-like anticoagulants or new oral anticoagulants, e.g., apixaban),
• if you are receiving medications called corticosteroids (e.g., prednisone),

• if you are taking Celecoxib Almus at the same time as other non-acetylsalicylic NSAIDssuch as ibuprofen or diclofenac. The concomitant use of these medications should be avoided,

• if you are a smoker, have diabetes, high blood pressure, or high cholesterol,
• if your heart, liver, or kidneysare not functioning properly, your doctor may want to monitor you regularly,
• if you have fluid retention(such as swollen feet or ankles),
• if you are dehydrated, for example, due to an illness with vomiting, diarrhea, or the use of diuretics (used to treat excess fluid in the body),
• if you have had a severe allergic reactionor a severe skin reaction to any medication,
• if you feel unwell due to an infectionor think you have an infection, as taking Celecoxib Almus may mask fever or other signs of infection and inflammation,
• if you are over 65 years old, your doctor will want to monitor you regularly,
• the consumption of alcohol and NSAIDs can increase the risk of gastrointestinal problems.

As with other NSAIDs(e.g., ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may perform periodic blood pressure checks.

Some cases of severe liver reactionshave been reported with celecoxib, including severe liver inflammation, liver damage, liver failure (some with a fatal outcome or requiring liver transplantation). Of the cases in which it was reported when the event started, most severe liver reactions occurred within the first month of treatment.

Celecoxib Almus may make it difficult to become pregnant. You should inform your doctor if you plan to become pregnant or are having trouble becoming pregnant (see section Pregnancy and breastfeeding).

Use of CelecoxibAlmuswith other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine:

• Dextromethorphan(used to treat cough).
• ACE inhibitors, angiotensin II receptor antagonists, beta blockers, and diuretics(medicines used to treat hypertension and heart failure).
• Fluconazoleand rifampicin(used to treat bacterial and fungal infections).
• Warfarinor other warfarin-like anticoagulants(agents that reduce blood clot formation), including newer medications such as apixaban.
• Lithium(used to treat certain types of depression).
• Other medicinesused to treat depression, sleep disorders, high blood pressure, or irregular heartbeat.
• Neuroleptics(used to treat certain mental disorders).
• Methotrexate(used in rheumatoid arthritis, psoriasis, and leukemia).
• Carbamazepine(used to treat epilepsy/seizures and certain types of pain or depression).
• Barbiturates(used to treat epilepsy/seizures and certain sleep disorders).
• Cyclosporinand tacrolimus(used to suppress the immune system, e.g., after transplants).

Celecoxib Almus can be taken with low doses of acetylsalicylic acid(75 mg daily or less). Ask your doctor for advice before taking both medications together.

Taking CelecoxibAlmuswith food and drinks

Food and drink do not affect the effect of Celecoxib Almus.

Pregnancy,breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Celecoxib Almus should not be used by pregnant women or women who may become pregnant (i.e., women of childbearing age who do not use adequate contraception) during treatment. If you become pregnant during treatment with Celecoxib Almus, you should stop treatment and contact your doctor for alternative treatment.

Breastfeeding

Celecoxib Almus should not be used during breastfeeding.

Fertility

NSAIDs, including Celecoxib Almus, may make it difficult to become pregnant. You should inform your doctor if you plan to become pregnant or are having trouble becoming pregnant.

Driving and using machines

You should know how you react to Celecoxib Almus before driving or using machinery. If you feel dizzy or drowsy after taking Celecoxib Almus, do not drive or operate machinery until these effects have passed.

CelecoxibAlmuscontains lactose

Celecoxib Almuscontains lactose(a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

CelecoxibAlmuscontains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule, which is essentially "sodium-free".

3. How to take Celecoxib Almus

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. If you think or believe that the effect of celecoxib is too strong or too weak, inform your doctor or pharmacist.

Your doctor will indicate the dose you should take. Since the risk of side effects associated with heart problems may increase with the dose and duration of treatment, it is important to use the lowest dose that controls your pain and not to take celecoxib for longer than necessary to control the symptoms.

Method of administration

CelecoxibAlmusistakenorally.The capsules can be taken at any time of day, with or without food. However, try to take each dose of celecoxib at the same time every day.

If you have difficulty swallowing the capsules: you can sprinkle the entire contents of the capsule into a level teaspoon of some semi-solid food (cold or at room temperature, such as apple sauce, rice porridge, yogurt, or mashed banana) and swallow it immediately with a glass of water of approximately 240 ml.

To open the capsule, hold it in a vertical position to keep the granules at the bottom; then, press the top and twist it to remove it, being careful not to spill the contents. Do not chew or crush the granules.

Contact your doctor if, after two weeks of treatment, you do not experience an improvement.

The recommended doseis:

The recommended dose for the treatment of osteoarthritisis 200 mg per day, if necessary, your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

• one 200 mg capsule once a day.
• or 100 mg twice a day

The recommended dose for the treatment of rheumatoid arthritisis 200 mg per day (taken in two divided doses), which may be increased by your doctor up to a maximum of 400 mg (taken in two divided doses per day), if necessary.

The recommended dose for the treatment of ankylosing spondylitisis 200 mg per day, which may be increased by your doctor up to a maximum of 400 mg, if necessary.

The dose is usually:

• one 200 mg capsule once a day.
• 100 mg twice a day

The initial recommended dose of 200 mg (taken as one 100 mg capsule twice a day) cannot be administered with Celecoxib Almus 200 mg hard capsules. Please consult your doctor.

Patientswithkidney or liver problems:make sure your doctor knows if you have liver or kidney problems, as you may need a lower dose.

Patientsover 65 years old, especially those weighing less than 50 kg: your doctor may want to monitor you more closely if you are over 65 years old and especially if you weigh less than 50 kg.

Do not take more than 400 mg per day.

Use in children:celecoxib is only for adults, it is not indicated in children.

If you take more CelecoxibAlmusthan you should

Do not take more capsules than indicated by your doctor. If you take more celecoxib than indicated, consult your doctor, pharmacist, or hospital immediately and bring the medicine with you.

You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take CelecoxibAlmus

If you forget to take a capsule, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking CelecoxibAlmus

Stopping treatment with celecoxib abruptly may cause a worsening of symptoms. Do not stop taking celecoxib unless your doctor tells you to. Your doctor will indicate that you should reduce the dose over a few days before stopping treatment completely.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The adverse effects mentioned below were observed in patients with arthritis who took Celecoxib Almus. The adverse effects marked with an asterisk (*) occurred in patients who took celecoxib for the prevention of colon polyps and have been classified taking into account the highest frequency of occurrence. The patients included in these studies took celecoxib at high doses and for a prolonged period.

If you experience any of the following adverse effects, discontinue treatment with Celecoxib Almus and inform your doctor immediately:

If you have:

• An allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing.
• Heart problems such as chest pain.
• Severe stomach pain or any sign of bleeding in the stomach or intestines, such as dark urine or stools stained with blood, or blood in vomit.
• A skin reaction such as rash, blisters or peeling of the skin.
• Liver failure [symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellowing of the skin and eyes)].

Very frequent adverse effects (may affect more than 1 in 10 patients)

• Increased blood pressure, including worsening of existing high blood pressure*

Frequent adverse effects (may affect up to 1 in 10 patients)

• Heart attack*
• Fluid retention with swelling of ankles, legs and/or hands
• Urinary tract infection
• Difficult breathing*, sinusitis (inflammation and infection of the paranasal sinuses, obstruction or pain of the paranasal sinuses), stuffy nose or runny nose, sore throat, cough, cold, flu-like symptoms
• Dizziness, difficulty sleeping
• Vomiting*, stomach pain, diarrhea, indigestion, gas
• Rash, itching
• Muscle stiffness
• Difficulty swallowing*
• Headache
• Nausea (feeling of discomfort)
• Joint pain
• Worsening of existing allergies
• Accidental injury

Uncommon adverse effects (may affect up to 1 in 100 patients)

• Stroke*
• Heart failure, palpitations (perception of heartbeat), rapid heartbeat
• Abnormalities in blood tests related to the liver
• Abnormalities in blood tests related to the kidneys
• Anemia (changes in red blood cells that can cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling sensation
• High levels of potassium in blood test results [may cause nausea (feeling of discomfort), fatigue, muscle weakness or palpitations]
• Blurred or altered vision, ringing in the ears, mouth pain or ulcers, difficulty hearing*
• Constipation, belching, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
• Leg cramps
• Rash with itching and relief (urticarial wheal)
• Eye inflammation
• Difficulty breathing
• Discoloration of the skin (bruises)
• Chest pain (generalized pain not related to the heart)
• Swelling of the face

Rare adverse effects (may affect up to 1 in 1,000 patients)

• Ulcers (bleeding) in the stomach, throat or intestines; or rupture of the intestine (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (may cause stomach pain), esophagitis (inflammation of the esophagus)
• Low sodium levels in the blood (a disease known as hyponatremia)
• Decrease in the number of white blood cells and platelets in the blood (increases the possibility of bleeding and bruising)
• Difficulty in muscular coordination of movements
• Feeling of confusion, taste disturbances
• Increased sensitivity to light
• Hair loss
• Hallucinations
• Eye bleeding
• Acute reaction that can lead to lung inflammation
• Irregular heartbeat
• Redness
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp chest pain or collapse
• Bleeding in the stomach or intestine (may cause stools or vomit with blood), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, ease of bleeding, itching or chills
• Acute kidney failure
• Menstrual disorders
• Swelling in the face, lips, mouth, tongue or throat, or difficulty swallowing

Very rare adverse effects (may affect up to 1 in 10,000 patients)

• Severe allergic reactions (including potentially fatal anaphylactic shock)
• Severe skin reactions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blistering or peeling of the skin) and acute generalized exanthematous pustulosis (symptoms include redness of the skin with swollen areas and numerous small pustules)
• A late allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands and abnormalities in clinical test results [e.g. liver, blood cells (eosinophilia, a type of increase in blood cell count]
• Bleeding in the brain that causes death
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
• Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, ease of bleeding, itching or chills
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as discolored stools, nausea and yellowing of the skin or eyes)
• Kidney inflammation and other kidney problems (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as fluid retention (edema), foamy urine, fatigue and loss of appetite)
• Worsening of epilepsy (possibly more frequent and/or severe seizures).
• Obstruction of an artery or vein in the eye that leads to partial or complete loss of vision
• Inflammation of the blood vessels (may cause fever, pain, purple spots on the skin)
• Reduction in the number of red and white blood cells and platelets (may cause fatigue, ease of bruising, frequent nosebleeds and increased risk of infections)
• Muscle pain and weakness
• Taste disturbance
• Loss of taste

Adverse effects of unknown frequency(their frequency cannot be estimated from the available data)

• Decreased fertility in women, which is normally reversible if the medication is discontinued

Adverse effects reported in clinical trials in which celecoxib was administered at doses of 400 mg per day for more than 3 years, in patients with diseases unrelated to arthritis or other arthritic conditions, were:

Frequent(may affect up to 1 in 10 patients)

• Heart problems: angina pectoris (chest pain)
• Stomach problems: irritable bowel syndrome (may include abdominal pain, diarrhea, indigestion and gas)
• Kidney stones (which can lead to stomach or back pain, blood in the urine), difficulty urinating
• Weight gain

Uncommon(may affect up to 1 in 100 patients)

• Deep vein thrombosis (blood clotting usually in the leg, which can cause pain, swelling or redness of the calf or breathing problems)
• Stomach problems: stomach infection (which can cause irritation or ulcers in the stomach and intestine)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry rash with itching), pneumonia [infection in the chest (possibility of cough, fever, difficulty breathing)]
• Floaters in the eye that cause vision disturbance or blurred vision, vertigo due to problems in the inner ear, ulcers, inflammation or bleeding of the gums, mouth ulcers
• Excessive urination at night, bleeding from hemorrhoids, frequent bowel movement
• Fat lumps on the skin or other areas, ganglion cyst (painless inflammation in the joints or tendons or around them, in the hand or foot) difficulty speaking, abnormal or heavy vaginal bleeding, chest pain
• High levels of sodium in blood test results

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Celecoxib Almus

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging, after "CAD". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines that you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Celecoxib Almus

The active ingredient is celecoxib. Each hard capsule contains 200 mg of celecoxib.

The other ingredients (excipients) are:

Lactose monohydrate, sodium lauryl sulfate, povidone, sodium croscarmellose, magnesium stearate (E572) (granule)

Gelatin (E441), titanium dioxide (E171), yellow iron oxide (172) (capsule shell)

Shellac lacquer (E904), propylene glycol (E1520), yellow iron oxide (172) (ink)

Appearance of the product and package contents

Hard gelatin capsules, white and opaque. The body of the capsule has a yellow band and on the body is printed "C90X-200" in white.

The capsules are presented in PVC/Aluminum blisters.

Packaging with 1, 10, 20, 30, 40, 50, 60 and 100 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer

Synthon Hispania S.L.

Castelló, 1,

08830 Sant Boi de Llobregat,

Spain

Synthon BV

Microweg 22

6545 CM, Nijmegen

Netherlands

EGIS PHARMACEUTICALS PLC.

Bökenyföldi ut 118-120

H-1165 Budapest, Hungary

Lek Pharmaceuticals d.d.

Verovfkova 57

SI – 1526 Ljubljana

Slovenia

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179, Barleben, Sachsen-Anhalt

Germany

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

Netherlands: Bixocel 200 mg, capsules, hard

Germany: Celecox-HEXAL 200 mg hard capsules

France: Celecoxib Sandoz 200 mg, capsule

Spain: Celecoxib Almus 200 mg hard capsules EFG

Portugal: Celecoxib Sandoz

Date of the last revision of this prospectus:July 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/