Meticel 200 mg hard capsules EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Meticel 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 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 must not be given to other people, even if they have the same symptoms as you, since 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

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

1. What Meticel is and what it is used for

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

Meticel 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 them in higher amounts. Meticel 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 starting to take Meticel

Your doctor has prescribed Meticel. The following information will help you achieve better results with Meticel. If you have any further questions, please ask your doctor or pharmacist.

Do not take Meticel

Inform your doctor if any of the following circumstances apply to you, as patients with these conditions should not take Meticel.

• if you are allergic to celecoxib or to any of the other components 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 have undergone surgery on the arteries in your legs

Warnings and precautions

Consult your doctor before starting to take Meticel:

• if you have previously had a stomach or intestinal ulcer or bleeding (Do not take Meticel if you currently have a stomach or intestinal ulcer or bleeding)
• if you are taking acetylsalicylic acid (even at low doses such as for cardiovascular protection)
• if you are taking medications to reduce blood clotting (e.g., warfarin/warfarin-like anticoagulants or newer oral anticoagulants, e.g., apixaban)
• if you are taking corticosteroid medicines (e.g., prednisone)
• if you are taking Meticel 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 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 or diarrhea, or due to the use of diuretics (used to treat excess fluid in the body)
• if you have previously experienced 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 Meticel 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 may 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 periodically monitor it.

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

Meticel 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, lactation and fertility).

Other medicines and Meticel

Inform 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 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)

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

Pregnancy, lactation 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 Meticel 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 Meticel, you must stop treatment and contact your doctor for alternative treatment.

Lactation

Meticel should not be used during breastfeeding.

Fertility

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

Driving and use of machines

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

Meticel contains lactose

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

3. How to take Meticel

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again. If you think or believe that the effect of Meticel 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 and not to take Meticel longer than necessary to control symptoms.

Method of administration

Meticel must be administered orally. The capsules may be taken at any time of day, with or without food. However, try to take each dose of Meticel at the same time every day.

If you have difficulty swallowing the capsules: you may sprinkle the entire contents of the capsule onto a spoonful of semisolid food (such as applesauce, rice, yogurt, or mashed banana at room temperature or cold) 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 after two weeks of starting treatment.

Recommended dose:

The usual 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 dose is usually:

• one 200 mg capsule once daily.

The usual dose for the treatment of rheumatoid arthritis is 200 mg per day (administered in two doses); if necessary, your doctor may increase it up to a maximum of 400 mg:

The dose is usually:

• one 100 mg capsule twice daily (this dosage of 100 mg celecoxib twice daily cannot be administered with this medicine. Other medicines containing 100 mg celecoxib are available for this treatment regimen. Please consult your doctor).

The usual 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 dose is usually:

• one 200 mg capsule once daily.

Kidney or liver problems: ensure 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 of celecoxib per day.

Use in children

Meticel is for adults only and is not indicated for use in children.

If you take more Meticel 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 Meticel

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 Meticel

Stopping treatment with Meticel abruptly may cause worsening of symptoms. Do not stop taking Meticel 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 experiences them.

The adverse effects listed below were observed in patients with arthritis who took celecoxib. The adverse effects marked with an asterisk (*) occurred in patients who took 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 Meticel 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), diarrhea, jaundice (your skin or the whites of your eyes appear yellow)).

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

• Increased blood pressure, including worsening of pre-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, 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 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
• Anemia (changes in red blood cells which may cause fatigue and difficulty breathing)
• Anxiety, depression, tiredness, numbness, tingling sensation
• Elevated 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 rash)
• 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 people:

• 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), throat inflammation (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 hemorrhage
• Acute reaction that may lead to lung inflammation
• Irregular heartbeat
• Flushing
• Blood clots in blood vessels of the lungs. Symptoms may include sudden shortness of breath, sharp pain when breathing, or collapse.
• Stomach or intestinal bleeding (may result in bloody stools or vomit), intestinal or colon inflammation
• 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 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 skin redness with swollen areas and numerous small pustules)
• 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))
• Brain 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 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 per day 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 people:

• Heart problems: angina (chest pain)
• Stomach problems: irritable bowel syndrome (may include abdominal pain, diarrhea, 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 in 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))
• Eye floaters 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, hemorrhoid/anal bleeding, 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
• Elevated levels of sodium in blood test results.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Meticel

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

Do not use this medicine after the expiry date stated on the packaging 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 or household waste. Unused medicines and packaging should be taken to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Meticel

• 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, Meticel contains lactose).

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

Nature and content of the container

Meticel is presented as hard capsules.

The capsules are opaque and white in colour.

The capsules are contained in PVC-aluminum blisters.

Meticel is available in packs containing 30 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/