AXATAL 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Axatal 200 mg Hard Capsules EFG

Celecoxib

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

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

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

? This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

? If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Axatal and what is it used for
2. What you need to know before you take Axatal
3. How to take Axatal
4. Possible side effects
5. Storing Axatal
6. Contents of the pack and other information

1. What is Axatal and what is it used for

Axatal contains the active substance celecoxib.

This medicine is used in adults to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Celecoxib belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), and more 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 more of them. Celecoxib works by reducing the production of prostaglandins, thus reducing pain and inflammation.

2. What you need to know before you take Axatal

Do not take Axatal

• if you are allergic to celecoxib or any of the other ingredients of this medicine (listed in section 6)
• if you have had any allergic reaction to any medicine belonging to 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 after taking acetylsalicylic acid or any other anti-inflammatory medicine: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such 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 disease such as ulcerative colitis or Crohn's disease
• if you have heart failure, diagnosed ischaemic heart disease, or cerebrovascular disease, e.g. you have been diagnosed with a heart attack, stroke, or transient ischaemic attack (temporary reduction in blood flow to the brain; also known as a "mini-stroke"), angina, or obstruction of the blood vessels to the heart or brain
• if you have or have had problems with blood circulation (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 Axatal:

• if you have previously had a stomach or intestinal ulcer or bleeding
• if you are taking acetylsalicylic acid (even at low doses as a heart protector)
• if you are taking medicines to reduce blood clotting (e.g. warfarin/other warfarin-like anticoagulants or new oral anticoagulants, e.g. apixaban)
• if you are taking corticosteroid medicines (e.g. prednisone)
• if you are taking celecoxib at the same time as other non-acetylsalicylic NSAIDs such as ibuprofen or diclofenac. The use of these medicines 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 working 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 due to 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 medicine
• 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

As with other anti-inflammatory medicines (e.g. ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may perform regular blood pressure checks.

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

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

Other medicines and Axatal

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines:

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

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

Using Axatal and alcohol

Consuming alcohol and NSAIDs can 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 medicine.

Pregnancy

This medicine should not be used by pregnant women or women who may become pregnant (i.e. women of childbearing age who do not use an adequate contraceptive method) during treatment. If you become pregnant during treatment with celecoxib, you should stop treatment and contact your doctor for alternative treatment.

Breastfeeding

This medicine should not be used during breastfeeding.

Fertility

NSAIDs, including celecoxib, may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are having difficulty becoming pregnant (see section Pregnancy and breastfeeding).

Driving and using machines

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

Axatal contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Axatal contains sodium

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

3. How to take Axatal

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again. If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

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

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

The recommended dose is:

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

The dose is usually:

• one 200 mg capsule once a day.

The recommended dose for the treatment of rheumatoid arthritisis 200 mg per day. If necessary, your doctor may increase it to a maximum of 400 mg.

The dose is usually:

• one 100 mg capsule twice a day.

The recommended dose for the treatment of ankylosing spondylitisis 200 mg per day. If necessary, your doctor may increase it to a maximum of 400 mg.

The dose is usually:

• one 200 mg capsule once a day.

Kidney or liver problems

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

Patient over 65 years, especially those weighing less than 50 kg

Your doctor may want to monitor you more closely if you are over 65 years old, 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.

Method of administration:

This medicine should be taken orally. 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 each day.

If you take more Axatal than you should

Do not take more capsules than your doctor has told you. If you take more medicine than you should, talk to a doctor, pharmacist, or hospital immediately and take the medicine with you.

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

If you forget to take Axatal

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 Axatal

Stopping treatment suddenly may cause your symptoms to worsen. Do not stop taking the medicine unless your doctor tells you to. Your doctor will tell you to reduce the dose over a few days before stopping treatment completely.

If you have any further questions about the use of this medicine, 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 taking celecoxib. The adverse effects marked with an asterisk (*) occurred in patients taking 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 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 skin peeling.
• Liver failure [symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (your skin or the whites of your eyes appear yellow)].

Very Common Adverse Effects: may affect more than 1 in 10 patients:

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

Common Adverse Effects: may affect up to 1 in 10 patients:

• Heart attack*
• Fluid retention with swelling of ankles, legs and/or hands
• Urinary tract infections
• 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)
• Pain in the joints
• 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 [can cause nausea (feeling of discomfort), fatigue, muscle weakness or palpitations]
• Blurred or altered vision, 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 habon)
• 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 intestinal rupture (can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (can cause stomach pain), esophagitis (inflammation of the esophagus)
• Low sodium levels in the blood (a disease known as hyponatremia)
• Decreased number of white blood cells and platelets (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 pulmonary inflammation
• Irregular heartbeat
• Flush
• 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 (can 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 (yellow discoloration 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 disorders such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blistering or skin peeling) and generalized acute pustular exanthema (symptoms include redness of the skin with swollen areas and numerous small pustules)
• A late-onset 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)]

Brain bleeding 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 (yellow discoloration of the skin and eyes), dark urine, pale stools, ease of bleeding, itching or chills

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

The adverse 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 diseases unrelated to arthritis or other arthritic conditions, were:

Common Adverse Effects: 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, gas)
• Kidney stones (which can lead to stomach or back pain, blood in the urine), difficulty urinating
• Weight gain

Uncommon Adverse Effects: may affect up to 1 in 100 patients:

• Deep vein thrombosis (blood clots 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 intestines)
• 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 movements
• 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 very heavy vaginal bleeding, chest pain

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

5. Storage of Axatal

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

Do not use this medicine 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 above 30 ºC.

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

6. Package Contents and Additional Information

Axatal Composition

The active ingredient 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).

Axatal Appearance and Package Contents

It is presented in the form of hard capsules.

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

The capsules are presented in PVC/PVdC-Al blisters.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

Date of the Last Revision of this Prospectus:December 2020

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/