Coxi 200 mg. 10 capsules

1. What Coxy is and what it is used for
Coxy is used to relieve the signs and symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

Coxy belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and in particular a subgroup known as cyclooxygenase-2 (COX-2) inhibitors. Your body produces prostaglandins that can cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis, your body produces more of them. Coxy works by reducing the production of prostaglandins, thereby reducing pain and inflammation.

2. What you need to know before you take Coxy
Coxy has been prescribed for you by your doctor. The following information will help you get the best results from Coxy. If you have any further questions, please ask your doctor or pharmacist.

Do not take Coxi
Talk to your doctor if any of the following apply to you, as patients with these conditions should not take Coxi:

if you are allergic (hypersensitive) to celecoxib or any of the other ingredients of this medicine (listed in section 6);
if you have had an allergic reaction to a group of medicines called "sulphonamides" (e.g. some antibiotics used to treat infections);
if you currently have a stomach or intestinal ulcer, or bleeding in the stomach or intestines;
if you have had asthma, nasal polyps, severe swelling of the lining of the nose or an allergic reaction such as an itchy skin rash, swelling of the face, lips, tongue or throat, difficulty breathing or wheezing after taking acetylsalicylic acid (aspirin) or another anti-inflammatory and painkiller (NSAID);
if you are pregnant. If there is a possibility of becoming pregnant during treatment, you should discuss contraceptive methods with your doctor;
if you are breast-feeding;
if you have severe liver disease;
if you have severe kidney disease;
if you have an inflammatory bowel disease such as ulcerative colitis or Crohn's disease;
if you have heart failure, established ischaemic heart disease or cerebrovascular disease, e.g. you have had a heart attack, stroke or transient ischaemic attack (temporary reduction of blood flow to the brain, also known as a 'microstroke'), angina or blockage of blood vessels to the heart or brain;
if you have or have had problems with your blood circulation (peripheral arterial disease) or if you have had surgery on the arteries of your lower limbs.
Warnings and precautions
Talk to your doctor or pharmacist before taking Coxy:
if you have previously had an ulcer or bleeding in your stomach or intestines (Do not take Coxy,
if you currently have an ulcer or bleeding in your stomach or intestines.);
if you are taking acetylsalicylic acid (aspirin) (even at low doses for heart prevention);
if you are taking medicines to reduce blood clotting (e.g. warfarin);
if you are using Coxy together with other non-aspirin MCIs, e.g. ibuprofen or diclofenac. Taking these medicines together should be avoided;
if you smoke, have diabetes, high blood pressure or high cholesterol levels;
if your heart, brain, liver or kidneys are not working properly, your doctor may want to check you regularly;
if you have fluid retention (such as swollen ankles or feet);
if you are dehydrated, for example due to vomiting, diarrhoea or the use of diuretics (used to lose weight);
if you have had a serious allergic reaction or a serious skin reaction to certain medicines;
if you feel unwell due to an infection or think you may have an infection, as Coxi may mask fever or other signs of infection and inflammation;
if you are over 65 years of age, your doctor may want to check you periodically.
Like other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may cause an increase in blood pressure and your doctor may want to monitor your blood pressure periodically.

Some cases of acute liver reactions, including acute liver inflammation, liver injury, liver failure (some fatal or requiring liver transplantation) have been reported with celecoxib. Among cases where the time of onset was reported, most acute liver reactions occurred within one month of starting treatment.

Coxib may make it more difficult to become pregnant. You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant (see section “Pregnancy, breast-feeding and fertility”).

Other medicines and Coxib
You should tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:

Dextromethorphan (used to treat cough);

ACE inhibitors or angiotensin II antagonists (used for high blood pressure and heart failure);

Diuretics (used for water loss);

Fluconazole and rifampicin (used to treat fungal infections)
and bacterial infections);
Warfarin or other oral anticoagulants (medicines that reduce blood clotting);
Lithium (used to treat some types of depression);
Other medicines to treat depression, sleep disorders, high blood pressure or irregular heartbeat;
Neuroleptics (used to treat some mental illnesses);
Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia); Carbamazepine (used to treat epilepsy/seizures and some forms of pain or depression);
Barbiturates (used to treat epilepsy/seizures and some sleep disorders).
Ciclosporin and tacrolimus (used to suppress the immune system, for example after transplantation).
Coxi can be taken with low doses of acetylsalicylic acid (75 mg or less per day). Consult your doctor before using the two medicines together.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Coxib should not be taken by women who are pregnant or who may become pregnant (i.e. women of childbearing potential who are not using adequate contraception) during treatment. If you become pregnant while taking Coxib, you should stop taking it and contact your doctor for alternative treatment.

Breast-feeding
Coxib should not be used during breast-feeding.
Fertility
NSAIDs, including Coxs, may make it more difficult to get pregnant. You should talk to your doctor if you are planning to get pregnant, or if you have problems getting pregnant.

Driving and using machines
You should know how you react to Coxs before you drive or use machines. If you feel dizzy or tired after taking Coxs, do not drive or use machines until these reactions have stopped.

Coxs contains
Coxs contains lactose (a type of sugar). If your doctor has told you that you have some sugars, contact your doctor before taking
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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

Coxi capsules should be swallowed whole with water. The capsules can be taken at any time of the day, with or without food. However, try to take each dose of Coxi at the same time each day.

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

For osteoarthritis the usual dose is 200 mg each day, which may be increased by your doctor to a maximum of 400 mg if necessary.

The dose is usually:

one 200 mg capsule once a day;

one 100 mg capsule twice a day.

For rheumatoid arthritis the usual dose is 200 mg each day, which may be increased by your doctor to a maximum of 400 mg if necessary.

The dose is usually:

one 100 mg capsule twice a day.

For ankylosing spondylitis the usual dose is 200 mg each day, which may be increased by your doctor to a maximum of 400 mg if necessary.

The dose is usually:

one 200 mg capsule once a day;

one 100 mg capsule twice 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.

Elderly patients, especially those weighing less than 50 kg: if you are over 65 years of age and especially if you weigh less than 50 kg. Your doctor may want to monitor you closely.

You should not take more than 400 mg of Coxsackie a day.

Children
Coxsackie is for adults only, it should not be used by children.

If you take more Coxsackie than you should
You should not take more capsules than your doctor has told you to. If you take too many capsules, contact your doctor, pharmacist or hospital and take your medicine with you.

If you forget to take Coxsackie
If you forget to take a capsule, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

If you stop taking Coxsackie
Stopping your treatment with Coxsackie may cause your symptoms to get worse. Do not stop taking Coxsackie unless your doctor tells you to. Your doctor may tell you to reduce your dose over a few days before stopping completely.
If you have any further questions on the use of this medicine, please ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects listed below have been seen in patients with arthritis who took Coxib. Side effects marked with an asterisk (*) occurred at a higher frequency than those in patients who took Coxib to prevent colon polyps. The patients in these studies took Coxib in high doses and for a long time.
If any of the following happen, stop taking Coxib and tell your doctor immediately if you have:
An allergic reaction such as skin rash, swelling of the face, difficulty breathing or wheezing;
Heart problems such as chest pain;
Severe stomach pain or signs of bleeding from the stomach or intestines such as passing black or bloody stools or vomiting blood;
A skin reaction such as rash, blistering or peeling skin;
Liver failure (symptoms may include nausea (feeling sick), diarrhoea, jaundice (your skin and the whites of your eyes look yellow).
Very common: may affect more than 1 in 10 people:
High blood pressure, including worsening of existing high blood pressure*.
Common: may affect up to 1 in 10 people:
Heart attack*;
Fluid retention with swelling of the ankles, legs and/or hands. Urinary tract infections;
Breathlessness*, sinusitis, sinus infection, blocked or painful sinuses (sinusitis), blocked or runny nose, sore throat
, cough, cold, flu-like symptoms;
Dizziness, sleep problems;
Vomiting*, stomach pain, diarrhoea, indigestion, flatulence; Rash, itching;
Muscle stiffness;
Difficulty swallowing*;
Headache;
Nausea (feeling sick);
Joint pain;
Worsening of existing allergies;
Accidental injury.
Uncommon: may affect up to 1 in 100 people:
Bleeding in the brain (stroke)*;
Heart failure, palpitations (feeling your heart beating), increased heart rate;
Changes in laboratory tests reflecting liver function;
Changes in laboratory tests reflecting kidney function;
Changes in red blood cells which can cause tiredness and shortness of breath (anaemia); Anxiety, depression, tiredness, drowsiness, pins and needles;
High levels of potassium in blood tests (may cause nausea, tiredness, muscle weakness or palpitations);
Blurred or blurred vision, ringing in the ears, mouth pain and sores, hearing loss*;
Constipation, belching, stomach inflammation (indigestion, stomach pain or vomiting), worsening of inflammation of the stomach or intestines;
Muscle spasms (cramps) in the lower limbs;
Raised itchy rash (urticaria);
Inflammation of the eyes;
Difficulty breathing;
Change in skin colour (bruising);
Chest pain (not related to the heart).
Rare: may affect up to 1 in 1,000 people:
Ulcers (bleeding) in the stomach, gullet or intestines; rupture of the small intestine (may cause stomach pain, fever, nausea, vomiting, retention of food in the intestine), dark or black stools, inflammation of the pancreas (pancreatitis) - may cause stomach pain, inflammation of the gullet (esophagitis);
Low levels of sodium in the blood (a condition known as hyponatremia); Reduced number of white blood cells (which help protect the body from infection) or platelets (increased risk of bleeding or bruising);
Difficulty coordinating muscle movements;
Feeling confused, changes in taste;
Increased sensitivity to light;
Hair loss;
Hallucinations;
Bleeding in the eye;
Irregular heartbeat;
Flushing;
A clot in a blood vessel in the lung. Symptoms may include sudden shortness of breath, severe pain when breathing or collapse;
Bleeding from the stomach or small intestine (may cause bloody stools or vomiting), inflammation of the small intestine or colon;
Severe inflammation of the liver (hepatitis). Symptoms may include nausea (feeling sick), diarrhoea, jaundice (yellowing of the skin or whites of the 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: may affect up to 1 in 10,000 people:
Serious allergic reactions (including potentially life-threatening anaphylactic shock);
Serious skin reactions such as one affecting the whole body with rashes on the skin and mucous membranes and blisters on the skin (Stevens-Johnson syndrome), inflammation of the skin
with redness and peeling (exfoliative dermatitis) and detachment of the top layer of the skin (toxic epidermal necrolysis) and a red swollen area of ​​the skin with many small pus-filled bumps (acute generalised exanthematous pustulosis);
Delayed allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen glands and abnormal laboratory tests (liver, blood,
increased number of a certain type of white blood cell (eosinophilia));
Bleeding in the brain (stroke) which causes death;
Inflammation of the lining of the brain and spinal cord (meningitis); Liver failure, liver damage and severe liver inflammation (fulminant hepatitis) (sometimes fatal or requiring liver transplantation). Symptoms may include nausea (feeling sick), diarrhoea, jaundice (yellowing of the skin or whites of the eyes), dark urine, pale stools, easy bleeding, itching or chills;
Liver complications such as bile leakage from the gallbladder into the intestines (cholestasis) and liver damage (cholestatic hepatitis), which may be accompanied by symptoms such as pale stools, nausea and yellowing of the skin or eyes);
Inflammation of the kidneys and other kidney complications (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as fluid retention (oedema), foamy urine, tiredness and loss of appetite);
Worsening of epilepsy (possible more frequent and/or severe seizures);
Blockage of an artery or vein in the eye, leading to partial or complete loss of vision;
Inflamed blood vessels (may cause fever, pain, purple spots on the skin);
Reduced 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
ost;
Impaired sense of smell.
Not known: frequency cannot be estimated from the available data:
Reduced fertility in women, which is usually reversible when the medicine is stopped.
In clinical studies not related to arthritis or other arthritic conditions, where Coxi was taken at doses of 400 mg daily for up to 3 years, the following additional side effects were observed:
Common: may affect up to 1 in 10 people
Heart problems: chest pain (angina);
Gastrointestinal problems: irritable bowel syndrome (may include stomach pain, diarrhoea, indigestion, wind);
Kidney stones (which may cause abdominal or back pain, blood in the urine), difficulty urinating;
Weight gain.
Uncommon: may affect up to 1 in 100 people
Blood clot usually in the leg which may cause pain, swelling or redness in the calf or trouble breathing (deep vein thrombosis);
Stomach problems: stomach infection (which may cause inflammation or ulcers in the stomach and intestines);
Fracture of a lower limb;
Herpes zoster, skin infection, dry itchy rash (eczema), chest infection with possible cough, fever, difficulty breathing (pneumonia);
Floating particles in the eye causing blurred or distorted vision, dizziness due to inner ear problems, painful, inflamed or bleeding mouth sores;
Excessive urination at night, bleeding from piles, frequent bowel movements;
Fatty lumps on the skin or elsewhere, harmless swelling in or around the joints and tendons of the hands or feet (ganglions), difficulty speaking, unusual or very heavy vaginal bleeding, chest pain;
High levels of sodium in blood tests.
5. How to store Coxi
Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.

6. Contents of the pack and other information
What Coxi contains
The active substance is: celecoxib.
One capsule contains 200 mg of celecoxib.
The other ingredients are:
lactose monohydrate, hydroxypropylcellulose, crospovidone, povidone, sodium lauryl sulphate, magnesium stearate.

The capsule shells contain:
titanium dioxide 1:171, gelatin, sodium lauryl sulphate.

The ink contains:
shellac, anhydrous alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution, yellow iron oxide P172.

What Coxy looks like and contents of the pack
Coxy is available in the form of hard capsules.

White, hard gelatin capsules, size 2, containing white to off-white powder, with white, opaque body and cap. Marked “C6” on a yellow stripe on the cap and “200 mg” on a yellow stripe on the body of the capsule.

PVC/PVdC-AI blisters of 10 capsules, placed in a cardboard box.

 

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