Package Leaflet: Information for the User

Axatal 200 mg Hard Capsules EFG

Celecoxib

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

?Keep this leaflet, as you may need to read it again.

?If you have any questions, ask your doctor or pharmacist.

?This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

?If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

1.What Axatal is and what it is used for

2.What you need to know before you start taking Axatal

3.How to take Axatal

4.Possible side effects

5.Storage of Axatal

6.Contents of the pack and additional information

Axatal contains the active ingredient celecoxib.

This medication is used in adults to relieve the symptoms and signs ofrheumatoid arthritis, osteoarthritis, and ankylosing spondylitis..

Celecoxib belongs 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. Celecoxib acts by reducing the production of prostaglandins, thereby reducing pain and inflammation.

Do not take Axatal

- if you are allergic to celecoxib or any of the other ingredients of this medication (listed in section 6)

- if you have had any allergic reaction to any medication in the group called “sulfamides” (e.g. some antibiotics used to treat infections)

- if you have currently an ulcer or bleeding in your 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 medication: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as itchy skin rash, facial swelling, lip, tongue, or throat swelling, 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 your child

- if you have severe liver disease

- if you have severe kidney disease

- if you have inflammatory bowel disease such as ulcerative colitis or Crohn's disease

- if you have heart failure, diagnosed coronary artery 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, or obstruction of blood vessels to the heart or brain

- if you have or have had circulation problems (peripheral arterial disease) or if you have been operated on your leg arteries.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Axatal:

- if you have previously had an ulcer or bleeding in your stomach or intestine

- if you are taking acetylsalicylic acid (even at low doses as a heart protector)

- 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 at the same time as other non-acetylsalicylic acid anti-inflammatory drugs such as ibuprofen or diclofenac. The use of these medications together should be avoided

- if you are a smoker, have diabetes, high blood pressure, or high cholesterol

- if your heart, liver, or kidneys are not functioning well, your doctor may want to monitor you regularly

- if you have fluid retention (e.g. swollen feet or ankles)

- if you are dehydrated, for example, due to a disease with vomiting, diarrhea, or the use of diuretics (used to treat excess fluid in the body)

- if you have had a severe allergic reaction or a severe skin reaction to any medication

- if you feel unwell due to an infection or think you have an infection, as taking celecoxib 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

Like other anti-inflammatory medications (e.g. ibuprofen or diclofenac), this medication may increase your blood pressure, so your doctor will be able to perform regular checks.

There have been reports of severe liver reactions with celecoxib that included severe liver inflammation, liver damage, and liver failure (some with fatal outcome or requiring liver transplant). In cases where the onset of the event was reported, most severe liver reactions occurred in the first month of treatment.

This medication may make it difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you have difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Other medications and Axatal

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)

- inhibitors of the ECA, angiotensin II receptor antagonists, beta-blockers, and diuretics (medications used to treat hypertension and heart failure)

- fluconazole and rifampicin (used to treat infections caused by bacteria and fungi)

- warfarin or other analogs of warfarin (agents that reduce blood clotting), including newer medications such as apixaban

- lithium (used to treat some types of depression)

- other medications used 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 forms of pain or depression)

- barbiturates (used to treat epilepsy/convulsions and some sleep disorders)

- cyclosporine and tacrolimus (used to treat immunosuppression, e.g. after transplants).

This medication can be taken with low doses of acetylsalicylic acid (75 mg daily or less). Consult your doctor before taking both medications together.

Use of Axatal and alcohol

The consumption of alcohol and NSAIDs may increase the risk of gastrointestinal problems.

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 medication.

Pregnancy

This medication 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, you should discontinue treatment and contact your doctor for alternative treatment.

Breastfeeding

This medication should not be used during breastfeeding.

Fertility

NSAIDs, including celecoxib, 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 machinery

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

Axatal contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Axatal contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. If you think or believe that the action of this medication is too strong or 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. Do not take this medication for longer than necessary to control your symptoms.

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

The recommended dose is:

The recommended dosefor the treatment of arthritisis 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.

The recommended dosefor the treatment of rheumatoid arthritisis 200 mg per day, if necessary, your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

-two 100 mg capsules per day.

The recommended dosefor the treatment of ankylosing spondylitisis 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 per day.

Problems with the kidney or liver

Make sure your doctor knows if you have problems with the liver or kidney since you may need a lower dose.

Patients over 65 years, especially those with a weight of 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, it is not indicated for children.

Administration form:

This medication should be taken orally.The capsules should 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 take more Axatal than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Axatal

If you forgot to take a capsule, take it as soon as you remember. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Axatal

Stopping treatment abruptly may cause a worsening of symptoms. Do not stop taking the medication 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 medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

If you have:

-an allergic reaction such as skin rash, facial swelling, sneezing, 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 with blood, or blood in the vomit.

-a skin reaction such as rash, blisters, or skin peeling.

-liver insufficiency [symptoms may include nausea (feeling unwell), diarrhea, jaundice (your skin or the white of your eyes appears yellow)].

Very common side effects: may affect more than 1 in 10 patients:

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

Common side effects: may affect up to 1 in 10 patients:

-Myocardial infarction*

-Fluid retention with swelling of ankles, legs, and/or hands

-Urinary tract infections

-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

Rare side effects: 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), esophagitis (inflammation of the esophagus)

-Low sodium levels in the blood (a condition known as hyponatremia)

-Decreased white blood cell count and platelet count (may cause increased risk of bleeding and petechiae)

-Difficulty in coordinating muscle movements

-Confusion, altered sense of taste

-Increased sensitivity to light

-Hair loss

-Hallucinations

-Eye hemorrhage

-Acute reaction that may lead to pulmonary inflammation

-Irregular heartbeat

-Rubefaction

-Thrombi in the pulmonary blood vessels. Symptoms may include sudden difficulty breathing, acute chest pain, or collapse

-Gastrointestinal hemorrhage (may cause stools or vomit with blood), intestinal or colon inflammation

-Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellow discoloration of the skin and eyes), dark urine, pale stools, easy bruising, itching, or chills

-Acute kidney injury

-Menstrual disorders

-Swelling in the face, lips, mouth, tongue, or throat, or difficulty swallowing

Very rare side effects: may affect up to 1 in 10,000 patients:

-Severe allergic reactions (including potential 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 redness of the skin with swollen and numerous small pustules)

-Late-onset 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)

-Severe liver insufficiency, liver damage, and severe liver inflammation (hepatitis fulminans) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellow discoloration of the skin and eyes), dark urine, pale stools, easy bruising, itching, or chills

-Renal 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, purple spots on the skin)

-Decreased red and white blood cell count and platelet count (may cause fatigue, easy bruising, frequent nosebleeds, and increased risk of infections)

-Muscle pain and weakness

-Altered sense of taste

-Loss of taste

Side effects of unknown frequency: their frequency cannot be estimated from available data:

-Decreased female fertility, which is usually reversible if the medication is discontinued

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

Common side effects: 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, gas)

-Kidney stones (which may cause stomach or back pain, blood in the urine), difficulty urinating

-Weight gain

Rare side effects: may affect up to 1 in 100 patients:

-Deep vein thrombosis (blood clots usually 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)

-Fracture of lower limbs

-Herpes, skin infection, eczema (dry, itchy rash), pneumonia [lung 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, heavy menstrual bleeding, 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 vaginal bleeding, chest pain

-High 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Axatal

The active principle is celecoxib.

Each hard capsule contains 200 mg of celecoxib.

The other components (excipients) are: lactose monohydrate, sodium croscarmellose, povidone K30, sodium lauryl sulfate, magnesium stearate, titanium dioxide (E-171), gelatin, yellow iron oxide (E172).

Appearance of Axatal and contents of the packaging

It is presented in the form of hard capsules.

The capsules are hard gelatin capsules with a white body and a yellow cap, filled with a white or almost white crystalline powder.

The capsules are presented in a PVC/PVdC-Al blister.

Available in packaging of 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 160, 180 hard capsules.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for Manufacturing

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

Last review date of this leaflet:December 2020

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