Axatal 200 mg hard capsules EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Axatal 200 mg hard capsules EFG
Celecoxib
Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
? If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Axatal is and what it is used for
- What you need to know before taking Axatal
- How to take Axatal
- Possible side effects
- How to store Axatal
- Contents of the pack and other information
1. What Axatal is and what it is 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 class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), and more specifically to the subgroup known as selective cyclooxygenase-2 (COX-2) inhibitors. Your body produces prostaglandins, which can cause pain and inflammation. In conditions such as rheumatoid arthritis or osteoarthritis, your body produces higher levels of prostaglandins. Celecoxib works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.
2. What you need to know before taking Axatal
Do not take Axatal
- if you are allergic to celecoxib or to any of the other ingredients of this medicine (listed in section 6)
- if you have previously had an allergic reaction to 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 after taking acetylsalicylic acid or any other anti-inflammatory drug: asthma, nasal polyps, severe nasal congestion, or allergic symptoms such as itchy rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing
- if you are pregnant. If you could 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 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, or blockage of blood vessels to the heart or brain
- if you have or have had circulation problems (peripheral arterial disease) or 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 such as for heart protection)
- if you are taking medicines to reduce blood clotting (e.g., warfarin/warfarin analogues or newer oral anticoagulants, e.g., apixaban)
- if you are taking corticosteroids (e.g., prednisone)
- if you are taking celecoxib at the same time as other non-acetylsalicylic acid NSAIDs such as ibuprofen or diclofenac. The combined use of these medicines should be avoided
- if you smoke, or have diabetes, high blood pressure, or high cholesterol
- if your heart, liver, or kidneys do not function 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 or diarrhea, or due to the use of diuretics (used to treat excess fluid in the body)
- if you have previously had a severe allergic reaction or a serious skin reaction to any medicine
- if you feel unwell due to an infection or suspect 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 may want to monitor you regularly
Like other anti-inflammatory drugs (e.g., ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may periodically monitor it.
There have been reports of serious liver reactions with celecoxib, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation). Among cases where the onset was reported, most serious liver reactions occurred within the first month of treatment.
This medicine may make it harder to get 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 medicines and Axatal
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines:
- Dextromethorphan (used to treat cough)
- ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, and diuretics (medicines used to treat hypertension and heart failure)
- Fluconazole and rifampicin (used to treat infections caused by bacteria and fungi)
- Warfarin or other warfarin analogues (agents that reduce blood clot formation), including newer agents such as apixaban
- Lithium (used to treat certain types of depression)
- Other medicines used 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)
- Cyclosporine and tacrolimus (used for immunosuppression, e.g., after organ transplants)
This medicine may be taken with low-dose acetylsalicylic acid (75 mg daily or less). Seek advice from your doctor before taking both medicines together.
Use of Axatal and alcohol
Consuming alcohol while taking NSAIDs may increase the risk of gastrointestinal problems.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 potential who are not using an adequate contraceptive method) during treatment. If you become pregnant while taking celecoxib, you must 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 harder to become pregnant. You should inform your doctor if you plan to become pregnant or if you are having difficulty becoming pregnant.
Driving and using machines
You should be aware of how you react to celecoxib before driving or operating 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 informed you that you have an intolerance to certain sugars, consult with 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 instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again. If you think or believe that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
Your doctor will determine the dose you should take. Since the risk of adverse effects related to heart problems may increase with dose and duration of treatment, it is important to use the lowest dose that controls your pain. You should not take this medicine for longer than necessary to control your symptoms.
Contact your doctor if you do not experience improvement within two weeks after starting treatment.
The recommended dose is:
The recommended dose for the treatment of osteoarthritis is 200 mg per day; if necessary, your doctor may increase it up to a maximum of 400 mg.
The usual dose is:
- one 200 mg capsule once daily.
The recommended dose for the treatment of rheumatoid arthritis is 200 mg per day; if necessary, your doctor may increase it up to a maximum of 400 mg.
The usual dose is:
- one 100 mg capsule twice daily.
The recommended dose for the treatment of ankylosing spondylitis is 200 mg per day; if necessary, your doctor may increase it up to a maximum of 400 mg.
The usual dose is:
- one 200 mg capsule once daily.
Kidney or liver problems
Make sure your doctor knows if you have liver or kidney problems, as you may require a lower dose.
Patients over 65 years of age, especially those weighing less than 50 kg
Your doctor may want to monitor you more closely if you are over 65 years of age, particularly if you weigh less than 50 kg.
You must not take more than 400 mg per day.
Use in children
Celecoxib is for adults only and is not indicated for use in children.
Method of administration:
This medicine is for oral use. 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 prescribed by your doctor. If you take more medicine than instructed, contact your doctor, pharmacist, or hospital immediately and bring the medicine with you.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.
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 missed doses.
If you stop taking Axatal
Stopping treatment abruptly may cause worsening of symptoms. Do not stop taking the medicine unless instructed by your doctor. Your doctor will advise you to gradually reduce the dose over several 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 everyone will experience them.
The adverse effects listed below were observed in patients with arthritis who were taking celecoxib. Adverse 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. The patients included in these studies took celecoxib at high doses and for a prolonged period of time.
If you experience any of the following adverse effects, stop treatment with celecoxib and contact 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 signs of bleeding in the stomach or intestines, such as dark urine or blood in the stool, or blood in the vomit.
- a skin reaction such as rash, blistering or peeling of the skin.
- liver failure [symptoms may include nausea (feeling unwell), diarrhea, jaundice (your skin or the whites of your eyes appear yellow)].
Very common adverse effects: may affect more than 1 in 10 patients:
- Increase in blood pressure, including worsening of pre-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
- Difficulty breathing*, sinusitis (inflammation and infection of the sinuses, sinus blockage or pain), stuffy 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 unwell)
- Joint pain
- Worsening of existing allergies
- Accidental injury
Uncommon adverse effects: may affect up to 1 in 100 patients:
- Stroke*
- Heart failure, palpitations (awareness of heartbeat), rapid heartbeat
- Abnormalities in blood tests related to the liver
- Abnormalities in blood tests related to the kidney
- Anemia (changes in red blood cells that may cause fatigue and difficulty breathing)
- Anxiety, depression, tiredness, numbness, tingling sensation
- High levels of potassium in blood test results [may cause nausea (feeling unwell), fatigue, muscle weakness or palpitations]
- Blurred or altered vision, ringing in the ears, mouth pain and ulcers, hearing difficulty*
- Constipation, burping, stomach inflammation (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
- Leg cramps
- Itchy, raised rash (urticarial wheals)
- Eye inflammation
- Difficulty breathing
- Skin discoloration (bruising)
- 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 (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, pancreatitis (may cause stomach pain), inflammation of the throat (esophagus)
- Low levels of sodium in the blood (a condition known as hyponatremia)
- Decrease in the number of white blood cells (which help protect the body from infections) and platelets (increased risk of bleeding and bruising)
- Difficulty in muscular coordination of movements
- Feeling confused, taste disturbances
- Increased sensitivity to light
- Hair loss
- Hallucinations
- Eye bleeding
- Acute reaction that may lead to lung inflammation
- Irregular heartbeat
- Flushing
- Blood clots in the blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing or collapse
- Bleeding of the stomach or intestines (may result in blood in stool or vomit), inflammation of the intestine or colon
- Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bleeding, itching or chills
- Acute kidney failure
- Menstrual disorders
- Swelling of 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 life-threatening 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 reddening of the skin with swollen areas and numerous small pustules)
- A delayed allergic reaction with possible symptoms such as rashes, facial swelling, 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 causing death
- Meningitis (inflammation of the membrane surrounding the brain and spinal cord)
- Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplant). Symptoms may include
nausea (feeling unwell), diarrhea, jaundice (yellowing of the skin and eyes), dark urine,
pale stools, easy bleeding, itching or chills
- Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as pale 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)
- Blockage of an artery or vein in the eye leading to partial or complete vision loss
- Inflammation of 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, easy bruising, frequent nosebleeds, and increased risk of infections)
- Muscle pain and weakness
- Disturbance of taste sensation
- Loss of taste
Adverse effects with unknown frequency: frequency cannot be estimated from the available data:
- Decreased fertility in women, which is usually reversible if the medication is discontinued
Adverse effects reported in clinical trials where celecoxib was administered at a dose of 400 mg daily for up to 3 years in patients with conditions unrelated to arthritis or other arthritic conditions were:
Common adverse effects: may affect up to 1 in 10 patients:
- Heart problems: angina (chest pain)
- Stomach problems: irritable bowel syndrome (may include abdominal pain, diarrhea, indigestion, gas)
- Kidney stones (may lead to stomach or back pain, blood in 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 may cause pain, swelling or redness of the calf or breathing problems)
- Stomach problems: stomach infection (may cause irritation or ulcers in the stomach and intestine)
- Fracture of lower limbs
- Herpes, skin infection, eczema (dry, itchy rash), pneumonia [chest infection (possible cough, fever, difficulty breathing)]
- Floaters 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 urination at night, bleeding from hemorrhoids, frequent bowel movements
- Fatty lumps in the skin or other areas, ganglion cyst (non-painful swelling in joints or tendons or around them, in the hand or foot), difficulty speaking,
abnormal or very 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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the blister pack and container after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 30 °C.
Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Axatal
The active substance is celecoxib.
Each hard capsule contains 200 mg of celecoxib.
The other components (excipients) are: monohydrate lactose, 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 pack
It is presented as hard capsules.
The capsules are hard gelatin capsules with a white body and yellow cap, filled with white or almost white crystalline powder.
The capsules are supplied 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 certain pack sizes may be marketed.
Marketing Authorization Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
Manufacturer
STADA Arzneimittel AG
Stadastrasse 2 – 18
61118 Bad Vilbel
Germany
Date of the most recent review of this leaflet: December 2020
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/