Celecoxib Alter 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Celecoxib Alter 200 mg hard capsules EFG

Read all of 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, 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.

Contents of the leaflet

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

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

Celecoxib Alter is indicated in adults for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

Celecoxib Alter belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), and 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 Alter works by reducing the production of prostaglandins, thereby decreasing pain and inflammation.

You should expect this medicine to start working within a few hours of taking the first dose, although a full effect may not be felt for several days.

2. What you need to know before taking Celecoxib Alter

Your doctor has prescribed Celecoxib Alter. The following information will help you get the best results from Celecoxib Alter. If you have any further questions, please ask your doctor or pharmacist.

Do not take Celecoxib Alter

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

• 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 pectoris, or blockage of blood vessels to the heart or brain
• if you have or have had circulation problems (peripheral arterial disease) or if you have undergone surgery on the arteries in your legs.

Warnings and precautions

Talk to your doctor before starting to take Celecoxib Alter:

• if you have previously had an ulcer or bleeding in your stomach or intestine (Do not take Celecoxib Alter if you currently have 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 receiving medications to reduce blood clotting (e.g., warfarin/warfarin-like anticoagulants or newer oral anticoagulants, e.g., apixaban)
• if you are receiving corticosteroid medicines (e.g., prednisone)
• if you are taking Celecoxib Alter at the same time as other non-acetylsalicylic NSAIDs such as ibuprofen or diclofenac. The combined use of these medicines should be avoided
• if you are a smoker, 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, diarrhea, or due to the use of diuretics (used to treat excess fluid in the body)
• if you have experienced a serious 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 Alter 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
• alcohol consumption and NSAIDs can increase the risk of gastrointestinal problems.

Like other anti-inflammatory drugs (e.g., ibuprofen or diclofenac), this medicine may increase your blood pressure, so your doctor may monitor it periodically.

Serious liver reactions have been reported with celecoxib, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation). Among cases where the onset date was reported, most serious liver reactions occurred within the first month of treatment.

Celecoxib Alter 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, breastfeeding and fertility).

Other medicines and Celecoxib Alter

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines:

• Dextromethorphan (used to treat cough)
• ACE inhibitors or 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-like agents (medicines 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 transplants)

Celecoxib Alter may be taken with low-dose acetylsalicylic acid (75 mg daily or less). Seek advice from your doctor before taking both medicines together.

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 Alter must 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 being treated with Celecoxib Alter, you must stop treatment and contact your doctor for alternative treatment.

Breastfeeding

Celecoxib Alter must not be used during breastfeeding.

Fertility

NSAIDs, including Celecoxib Alter, may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are experiencing difficulties becoming pregnant.

Driving and using machines

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

Celecoxib Alter contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Celecoxib Alter

Follow exactly the instructions for using this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again. If you think or believe that the effect of Celecoxib Alter 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 effective dose that controls your pain and not to take Celecoxib Alter longer than necessary to control symptoms.

Method of administration:

Celecoxib Alter is taken orally. Capsules may be taken at any time of day, with or without food. However, try to take each dose of Celecoxib Alter at the same time each day.

If you have difficulty swallowing the capsules: you may sprinkle the entire contents of the capsule onto a teaspoon of soft, semi-solid food (such as applesauce, rice, yogurt, or mashed cold or room temperature banana) and swallow it immediately with a glass of water of approximately 240 ml.

To open the capsule, hold it vertically to keep the granules at the bottom; then squeeze the top and twist it off, taking care not to spill the contents. Do not chew or crush the granules.

Contact your doctor if you do not experience improvement within two weeks of starting treatment.

Recommended dose:

The usual dose for the treatment of osteoarthritis is 200 mg daily. If necessary, your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

• one 200 mg capsule taken once daily
• .

The usual dose for the treatment of rheumatoid arthritis is 200 mg daily (administered in two divided doses). If necessary, your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

• one 100 mg capsule taken twice daily (this dose of 100 mg of celecoxib twice daily cannot be administered with this medicine. Other medicinal products containing 100 mg of celecoxib are available for this dosing regimen. Please consult your doctor).

The usual dose for the treatment of ankylosing spondylitis is 200 mg daily. If necessary, your doctor may increase it up to a maximum of 400 mg.

The dose is usually:

• one 200 mg capsule taken 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 wish to monitor you more closely if you are over 65 years of age, particularly if you weigh less than 50 kg.

Do not take more than 400 mg per day.

Use in children

Celecoxib Alter is for adults only and is not indicated for use in children.

If you take more Celecoxib Alter than you should

Do not take more capsules than prescribed by your doctor. If you take more capsules than directed, 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 (telephone 91 562 04 20), indicating the medicine and the amount taken.

If you forget to take Celecoxib Alter

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 Celecoxib Alter

Abruptly stopping treatment with Celecoxib Alter may cause worsening of symptoms. Do not stop taking Celecoxib Alter unless instructed by your doctor. Your doctor will advise you to gradually reduce the dose over several days before completely stopping treatment.

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. The 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 Alter 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 blood-stained stools, or blood in vomit.
• a skin reaction such as rash, blisters or peeling of the skin.
• liver failure (symptoms may include nausea (feeling unwell), diarrhoea, jaundice (your skin or the whites of your eyes appear yellow)).

Very common adverse effects: may affect more than 1 in 10 people:

• Increase in blood pressure, including worsening of existing high blood pressure*

Common adverse effects: may affect up to 1 in 10 people:

• Heart attack*
• Fluid retention with swelling of ankles, legs and/or hands
• Urinary tract infection
• 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, diarrhoea, 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 people:

• 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
• Anaemia (changes in red blood cells which 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 discolouration (bruising)
• Chest pain (generalised pain not related to the heart)
• Swelling of the face

Rare adverse effects: may affect up to 1 in 1,000 people:

• Ulcers (bleeding) in the stomach, throat or intestines; or intestinal perforation (may cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the pancreas (may cause stomach pain), inflammation of the throat (may cause difficulty swallowing)
• 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 with 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 from the stomach or intestine (may result in bloody stools or vomit), inflammation of the intestine or colon
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or 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 people:

• 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 redness of the skin with swollen areas and numerous small pustules)
• A delayed-type 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 transplantation). Symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, easy bruising or 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 tiredness, easy bruising, frequent nosebleeds and increased risk of infections)
• Muscle pain and weakness
• Disturbance of taste
• Loss of taste

Adverse effects with unknown frequency: frequency cannot be estimated from the available data:

• Decrease in female fertility, which is usually reversible if treatment is discontinued

Adverse effects reported in clinical trials where celecoxib was administered at a dose of 400 mg per day for a period of 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 people:

• Heart problems: angina (chest pain)
• Stomach problems: irritable bowel syndrome (may include abdominal pain, diarrhoea, indigestion and 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 people:

• Deep vein thrombosis (blood clotting usually in the leg, which may cause pain, swelling or redness of the calf or breathing problems)
• Stomach problems: infection in the stomach (which may cause irritation or ulcers in the stomach and intestine)
• Fracture of lower limbs
• Herpes, skin infection, eczema (dry itchy rash), pneumonia (infection in the chest (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, haemorrhage from haemorrhoids/anal fissures, frequent bowel movements
• Fatty lumps under the skin or elsewhere, ganglion cyst (non-painful swelling in or around joints or tendons, 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, talk to 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Celecoxib Alter

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Celecoxib Alter

• The active substance is celecoxib. Each capsule contains 200 mg of celecoxib.
• The other components are: monohydrate lactose, sodium lauryl sulfate, povidone K30, sodium croscarmellose, magnesium stearate (see section 2, Celecoxib Alter contains lactose).

The capsule shell contains gelatin and titanium dioxide (E171).

Nature of the product and pack contents

Celecoxib Alter is available as hard capsules.

The capsules are opaque and white in colour.

The capsules are supplied in PVC-aluminum blisters.

Celecoxib Alter is available in packs containing 30 hard capsules.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Date of the most recent revision of this leaflet: August 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/