Label:InformationfortheUser

CelecoxibAlmus200 mg hard capsules EFG

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

• Keep this label 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4

Celecoxibbelongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), and specifically to the subgroup known as cyclooxygenase-2 (COX-2) inhibitors. The body produces prostaglandins that can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, the body produces them in greater quantities. Celecoxibacts by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

CelecoxibAlmusis indicated inadultsfor alleviating the symptoms ofrheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

The medication 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.

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

Do not take CelecoxibAlmus

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

• if you areallergic to celecoxib or any of the other componentsof celecoxib (see section 6),
• if you have had anyallergic reactionto any medication in the group called “sulfonamides” (e.g.: some are antibiotics used to treat infections),
• if you havecurrentlyanulcerorhemorrhageof the stomach or intestine,
• if you have previously experienced any of the following symptoms as a result of taking acetylsalicylic acid or any other anti-inflammatory drug:asthma, nasal polyps, severe nasal congestion, or allergic symptomssuch as skin rash with itching, facial swelling, lip, tongue, or throat swelling, difficulty breathing, or wheezing,
• if you arepregnant. If you can become pregnant during treatment, you should discuss the use of contraceptive methods with your doctor.
• if you arebreastfeeding your child,
• if you have aserious liver disease,
• if you have aserious kidney disease,
• if you haveinflammatory bowel diseasesuch asulcerative colitisorCrohn's disease,
• if you haveheart failure, diagnosed ischemic heart disease, or cerebrovascular disease, e.g. you have been diagnosed with a heart attack, stroke, or transient ischemic attack (temporary decrease in blood flow to the brain; also known as “mini-stroke”), angina pectoris, or obstruction of the heart or brain blood vessels,
• if you have or have hadcirculatory problems(peripheral arterial disease) or if you have beenoperatedon the arteries of your legs.

Warnings and precautions

Consult your doctor or pharmacist before starting to take CelecoxibAlmus:

• if you have hadpreviouslyan ulcer or hemorrhage in your stomach or intestine (Do not take CelecoxibAlmusif you currently have an ulcer or hemorrhage in your stomach or intestine),
• if you are takingacetylsalicylic acid(even low doses as a heart protector),
• if you are taking antiplatelet therapies,

• if you are receiving medications to reduce blood clotting (e.g.: warfarin/anticoagulant analogs of warfarin or new oral anticoagulants, e.g.: apixaban),
• if you are receiving corticosteroids (e.g.: prednisone),

• if you are taking Celecoxib Almus at the same time as othernon-acetylsalicylic acid NSAIDssuch as ibuprofen or diclofenac. You should avoid using these medications together,

• if you area smoker, have diabetes, high blood pressure, or high cholesterol,
• if yourheart, liver, or kidneysdo not function well, your doctor may want to monitor you regularly,
• if you havefluid retention(such as swollen feet or ankles),
• if you aredehydrated, 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 asevere allergic reactionor a severe skin reaction to any medication,
• if you feel unwell due to aninfectionor think you have an infection, as taking Celecoxib Almus may mask fever or other signs of infection and inflammation,
• if you are over65 years old, your doctor will want to monitor you regularly,
• the consumption of alcohol and NSAIDs may increase the risk of gastrointestinal problems.

Like otherNSAIDs(e.g.: ibuprofen or diclofenac), this medication may increase your blood pressure, so your doctor may perform regular checks on it.

There have beenreportedcases ofsevere liver reactionswith celecoxib that included severe liver inflammation, liver damage, liver failure (some with fatal outcome or requiring liver transplant).Of the cases in which it wasreportedwhen the event began, most of the severe liver reactions occurred in the first month of treatment.

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

Use of CelecoxibAlmuswith other medications

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

• Dextromethorphan(used to treat cough).
• ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics(medications used to treat hypertension and heart failure).
• Fluconazoleandrifampicin(used to treat infections caused by bacteria and fungi).
• Warfarinor other warfarin analogs(agents that reduce blood clotting), including newer medications such as apixaban.
• Lithium(used to treat some types of depression).
• Other medicationsused to treat depression, sleep disorders, high blood pressure, or irregular heartbeat.
• Neuroleptics(used to treat some mental disorders).
• Methotrexate(used in rheumatoid arthritis, psoriasis, and leukemia).
• Carbamazepine(used to treat epilepsy/convulsions and some types of pain or depression).
• Barbiturates(used to treat epilepsy/convulsions and some sleep disorders).
• Ciclosporinand tacrolimus(used to treat immunosuppression, e.g.: after transplants).

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

Taking CelecoxibAlmuswith food and drinks

Foods and drinks do not affect the effect of CelecoxibAlmus.

Pregnancy,lactation, 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 medication.

Pregnancy

Celecoxib Almus should not be used by pregnant women or women who may become pregnant (i.e.: women of childbearing age and not using an adequate contraceptive method) during treatment. If you become pregnant during treatment with Celecoxib Almus, you should interrupt treatment and contact your doctor for an alternative treatment.

Lactation

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 if you are having difficulty becoming pregnant.

Driving and operating machines

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

CelecoxibAlmuscontains lactose

CelecoxibAlmuscontainslactose(a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

CelecoxibAlmuscontains sodium

This medication contains less than 23 mgof sodium (1 mmol) per capsule, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. If you think or believe that the action 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 adverse effects associated with heart problems may increase with the dose and duration of treatment, it is essential to use the lowest dose that controls your pain and do not take celecoxib for longer than necessary to control your symptoms.

Administration Form

CelecoxibAlmusistakenbyoralroute.The capsules can be taken at any time of the 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 spread the entire contents of the capsule on a teaspoon of some semi-solid food (cold or at room temperature such as apple sauce, oatmeal, yogurt, or mashed banana) and swallow it immediately with a glass of water 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 turn it to extract it, being careful not to spill the contents.Do not chew or crush the granules.

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

TheRecommendedDose

The recommended dosefor 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 dosefor the treatment of rheumatoid arthritisis 200 mg per day (taken in twotimes),whichmaybeincreasedbyyour doctor up to a maximum of 400 mg (taken in twotimesperday),ifnecessary.

The recommended dosefor the treatment of ankylosing spondylitisis 200 mg per day,whichmaybeincreasedbyyour doctor up to a maximum of 400 mg,ifnecessary.

The dose is usually:

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

The initialrecommendeddoseof200 mg (taken as a 100 mg capsule twice a day) cannotbeadministeredwith CelecoxibAlmus200 mg hard capsules. Please consult your doctor.

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

Patients over 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.

You should not take more than 400 mg per day.

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

If you take more CelecoxibAlmusthan you should

You should not take more capsules than indicated by your doctor. If you take more celecoxib than you have been told, consult your doctor, pharmacist, or hospital immediately and bring the medication with you.

You can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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 the missed dose.

If you interrupt treatment with CelecoxibAlmus

Stopping treatment abruptly with celecoxib 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.

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

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

If you have:

• A hypersensitivity reaction such as skin rash, facial swelling, 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 the vomit.
• A skin reaction such as rash, blisters, or skin peeling.
• Liver failure [symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin or eyes)].

Side effectsVery common(may affect more than 1 in 10 patients)

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

Side effectsCommon(may affect up to 1 in 10 patients)

• Myocardial infarction*
• Fluid retention with swelling of ankles, legs, and/or hands
• Urinary tract infection
• Difficulty breathing*, sinusitis (inflammation and infection of the paranasal sinuses, obstruction or pain of the paranasal sinuses), nasal congestion or discharge, 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 unwell)
• Joint pain
• Worsening of existing allergies
• Accidental injury

Side effectsRare(may affect up to 1 in 1,000 patients)

• Ulcers (bleeding) in the stomach, esophagus, or intestines; or intestinal rupture (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (may cause stomach pain), esophageal inflammation (may cause difficulty swallowing)
• Low sodium levels in the blood (a condition known as hyponatremia)
• Abnormalities in blood tests related to the liver
• Abnormalities in blood tests related to the kidneys
• Anemia (changes in red blood cells that may cause fatigue and difficulty breathing)
• Anxiety, depression, fatigue, numbness, tingling
• Elevated potassium levels in blood test results [may cause nausea (feeling unwell), fatigue, muscle weakness, or palpitations]
• Blurred or altered vision, tinnitus (ringing in the ears), mouth pain and 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 hives)
• Eye inflammation
• Difficulty breathing
• Decoloration of the skin (cardenales)
• Chest pain (generalized pain not related to the heart)
• Facial swelling

Side effectsVery rare(may affect up to 1 in 10,000 patients)

• Severe allergic reactions (including potentially fatal anaphylactic shock)
• Severe skin changes such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (may cause rash, blistering, or skin peeling) and acute generalized pustular psoriasis(symptoms include skin redness with swollen areas and numerous small pustules)
• A delayed allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen lymph nodes, and abnormalities in clinical test results [e.g., liver, blood cells (eosinophilia, a type of increased white blood cell count]
• Cerebral hemorrhage leading to 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 unwell), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising, itching, or chills
• Severe liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as dark 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 (seizures possibly more frequent and/or severe).
• Obstruction of an artery or vein in the eye leading to partial or complete loss of vision
• Inflammation of blood vessels (may cause fever, pain, and purple spots on the skin)
• Reduction in the number of red and white blood cells and platelets (may cause fatigue, easy bruising, frequent nosebleeds, and increased risk of infections)
• Muscle pain and weakness
• Alteration of taste
• Loss of taste

Side effects ofUnknown frequency(their frequency cannot be estimated from available data)

The side effects reported in clinical trials in which celecoxib was administered at a dose of 400 mg per day for more than 3 years in patients with non-arthritis-related diseases or other arthritic conditions were:

Common(may affect up to 1 in 10 patients)

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

Rare(may affect up to 1 in 100 patients)

• Deep vein thrombosis (blood clotting generally in the leg, which may cause pain, swelling, or redness of the calf or problems breathing)
• Gastrointestinal problems: stomach infection (which may cause irritation or ulcers in the stomach and intestines)
• Lower limb fractures
• Herpes, skin infection, eczema (dry, itchy rash), pneumonia [chest infection (possibility of cough, fever, difficulty breathing)]
• Flies in the eye causing visual disturbance or blurred vision, vertigo due to inner ear problems, ulcers, inflammation, or bleeding of the gums, mouth ulcers
• Excessive nighttime urination, vaginal bleeding or hemorrhoids, frequent bowel movements
• Fatty lumps in the skin or other areas, ganglion cyst (non-painful inflammation in the joints or tendons or around them, in the hand or foot) difficulty speaking, abnormal or severe vaginal bleeding, chest pain
• Elevated sodium levels in blood test results

Reporting of side effects

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

Keepthismedicationout of the sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Celecoxib Almus Composition

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

The other components (excipients) are:

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

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

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

Product appearance and packaging contents

Hard gelatin capsules, white and opaque. The capsule body contains a yellow band and on the body is printed “C90X-200” in white.

The capsules are presented in PVC/Aluminium blisters.

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

Only some packaging 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]

Responsible for manufacturing

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, Saxony-Anhalt

Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Netherlands:Bixocel 200 mg, capsules,hard

Germany:Celecox-HEXAL 200 mg Hartkapseln

France:Celecoxib Sandoz 200 mg, gélule

Spain:Celecoxib Almus 200 mg hard capsules EFG

Portugal:CelecoxibSandoz

Last review date of this leaflet:July 2023

The detailed and updated information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/