Celecoxib Maxmind: detailed information

Patient Information Leaflet

Celecoxib Maxmind 100 mg capsules, 200 mg capsules

Celecoxib
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Celecoxib Maxmind is and what it is used for
What you need to know before taking Celecoxib Maxmind
How to take Celecoxib Maxmind
Possible side effects
How to store Celecoxib Maxmind
Contents of the pack and other information

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

Celecoxib Maxmind belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), and more specifically to a subgroup known as "COX-2 inhibitors". Your body produces prostaglandins, which can cause pain and inflammation. In certain conditions such as rheumatoid arthritis and osteoarthritis, your body produces higher amounts of prostaglandins. Celecoxib Maxmind works by reducing the production of prostaglandins, thereby reducing pain and inflammation.
Celecoxib Maxmind is used in adults for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

2. What you need to know before taking Celecoxib Maxmind

Celecoxib Maxmind has been prescribed by your doctor. The information below will help you achieve the best results with Celecoxib Maxmind. If you have further questions, please consult your doctor or pharmacist.
Do not take Celecoxib Maxmind
Inform your doctor if any of the following apply to you, as patients with these conditions must not take Celecoxib Maxmind:

if you are allergic to celecoxib or to 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 "sulfonamides" (e.g. certain antibiotics used to treat infections);
if you currently have a stomach or intestinal ulcer, or bleeding in the stomach or intestines;
if, after taking acetylsalicylic acid (aspirin) or any other anti-inflammatory or pain-relieving medicine (NSAIDs), you have experienced asthma, nasal polyps, severe nasal congestion, or an allergic reaction such as skin rash with itching, swelling of the face, lips, tongue or throat, difficulty breathing or shortness of breath;
if you are pregnant. If you could become pregnant during treatment, discuss possible contraceptive methods with your doctor;
if you are breastfeeding;
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, confirmed ischemic heart disease, or cerebrovascular disease, e.g. if you have been diagnosed with a heart attack, stroke or transient ischemic attack (a temporary reduction in blood flow to the brain; also known as "mini-stroke"), angina, or blockage of blood vessels supplying 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
Talk to your doctor before taking Celecoxib Maxmind:

if you have previously had a stomach or intestinal ulcer or gastrointestinal bleeding. (Do not take Celecoxib Maxmind if you have a current stomach or intestinal ulcer or bleeding);
if you are taking acetylsalicylic acid (even at low doses for heart protection);
if you are taking medicines to reduce blood clotting (e.g. warfarin);
if you are using Celecoxib Maxmind together with other NSAIDs other than acetylsalicylic acid, such as ibuprofen or diclofenac. Concurrent use of these medicines should be avoided;
if you smoke, have diabetes, high blood pressure, or high cholesterol levels;
if your heart, liver or kidneys do not function properly, your doctor may carry out regular checks;
if you suffer from fluid retention (such as swelling of the ankles and feet);
if you are dehydrated, for example due to vomiting, diarrhea, or use of diuretics (used to treat excess fluid in the body);
if you have had a severe allergic reaction or a serious skin reaction to any medicine;
if you are unwell due to an infection or suspect you have an infection, as Celecoxib Maxmind may mask fever or other signs of infection and inflammation;
if you are over 65 years of age, your doctor may carry out regular checks.

Like other NSAIDs (e.g. ibuprofen or diclofenac), this medicine may cause an increase in blood pressure, and your doctor may therefore ask you to monitor your blood pressure at regular intervals.
Serious liver reactions, including severe hepatitis, liver damage, and liver failure (some fatal or requiring liver transplantation), have been reported with celecoxib. In cases where onset time was reported, the most severe liver reactions occurred within one month of starting treatment.
Taking Celecoxib Maxmind may make it more difficult to become pregnant. Inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant (see section Pregnancy and breastfeeding).
Other medicines and Celecoxib Maxmind
Inform 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 to treat excess fluid in the body)
fluconazole and rifampicin (used to treat fungal and bacterial infections)
warfarin and other oral anticoagulants (blood-thinning agents that reduce blood clotting)
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 to treat 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 Maxmind may be taken with low-dose acetylsalicylic acid (75 mg or less per day).
Ask your doctor for advice before taking both medicines together.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Celecoxib Maxmind must not be used in women who are pregnant or who may become pregnant (e.g. women of childbearing age not using adequate contraception) during treatment.
If you become pregnant while being treated with Celecoxib Maxmind, you must stop treatment and contact your doctor for alternative treatment.
Breastfeeding
Celecoxib Maxmind must not be used during breastfeeding.
Fertility
NSAIDs, including Celecoxib Maxmind, may make it more difficult to conceive. Inform your doctor if you are planning a pregnancy or if you have difficulty conceiving.
Driving and using machines
Before driving or operating machinery, assess how you react to Celecoxib Maxmind. If you experience dizziness or drowsiness after taking Celecoxib Maxmind, do not drive or operate machinery until these effects have disappeared.
Celecoxib Maxmind contains lactose
Celecoxib Maxmind contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Celecoxib Maxmind

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. If you think or feel that the effect of Celecoxib Maxmind is too strong or too weak, talk to your doctor or pharmacist.
Your doctor will tell you what dose to take. Since the risk of unwanted side effects related to heart problems may increase with dose and duration of use, it is important to use the lowest effective dose needed to control your pain. Do not take Celecoxib Maxmind for longer than necessary to control your symptoms.
Celecoxib Maxmind capsules must be swallowed whole with a glass of water.
The capsules can be taken at any time of day, with or without food. However, always try to take each dose of Celecoxib Maxmind at the same time every day.
If you do not experience any benefit, contact your doctor within two weeks of starting treatment.

For osteoarthritis: the usual dose is 200 mg per day, which your doctor may increase if necessary to a maximum of 400 mg per day.
The dose is usually:

one 200 mg capsule per day; or
one 100 mg capsule twice daily.

For rheumatoid arthritis: the recommended starting dose is 200 mg per day, taken in two divided doses. The dose may then be increased if necessary to a maximum of 200 mg twice daily.
The dose is usually:

one 100 mg capsule twice daily.

For ankylosing spondylitis: the usual dose is 200 mg per day, which your doctor may increase if necessary to a maximum of 400 mg per day.
The dose is usually:

one 200 mg capsule per day; or
one 100 mg capsule twice daily.

Liver or kidney problems: make sure your doctor knows if you have liver or kidney problems, as you may require a lower dose.
Elderly patients, especially those weighing less than 50 kg: if you are over 65 years of age, and particularly if you weigh less than 50 kg, your doctor may decide to monitor you more closely.
Do not take more than 400 mg per day.
Use in children: Celecoxib Maxmind should only be used in adults; it must not be used in children.

If you take more Celecoxib Maxmind than you should
Do not take more capsules than your doctor has prescribed. If you take too many capsules, contact your doctor, pharmacist, or hospital immediately and bring the medicine with you.

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

If you stop taking Celecoxib Maxmind
Stopping treatment with Celecoxib Maxmind suddenly may lead to a worsening of your symptoms. Do not stop taking Celecoxib Maxmind unless your doctor tells you to. Your doctor may advise you to gradually reduce the dose over several days before stopping treatment completely.

If you have any doubts about how to use this medicine, talk to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The side effects listed below were observed in patients with arthritis treated with Celecoxib Maxmind. The side effects marked with an asterisk (*) are listed below under the most frequent occurrence in patients treated with Celecoxib Maxmind for the prevention of colon polyps. Patients in these studies took Celecoxib Maxmind at high doses and for a long period.
Stop taking Celecoxib Maxmind immediately and contact your doctor immediately if you experience any of the following side effects:
If you have:

an allergic reaction such as skin rash, swelling of the face, shortness of breath 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 or bloody stools, or vomiting blood;
a skin reaction such as rash, blisters or skin peeling;
liver failure (symptoms may include nausea (feeling unwell), diarrhoea, jaundice (yellowing of the skin or whites of the eyes)).

Very common: may affect more than 1 in 10 people

high blood pressure, including worsening of pre-existing high blood pressure*

Common: may affect up to 1 in 10 people

heart attack*
fluid retention with swelling of ankles, legs and/or hands
urinary tract infections
shortness of breath*, sinusitis (inflammation of the sinuses, sinus infection, blocked or painful sinuses), nasal congestion or runny nose, sore throat, cough, cold, flu-like symptoms
dizziness, difficulty sleeping
vomiting*, stomach pain, diarrhoea, indigestion, flatulence
rash, itching
muscle stiffness
difficulty swallowing*
headache
nausea (feeling unwell)
painful joints
worsening of pre-existing allergies
accidental injury

Uncommon: may affect up to 1 in 100 people

stroke*
heart failure, palpitations (awareness of heartbeat), rapid heartbeat
abnormal liver blood test results
abnormal kidney blood test results
anaemia (changes in red blood cells which may cause tiredness and shortness of breath)
anxiety, depression, fatigue, dizziness, tingling sensations
elevated potassium levels in blood tests (may cause nausea (feeling unwell), tiredness, muscle weakness or palpitations)
blurred or impaired vision, ringing in the ears, mouth pain and sores, hearing difficulties*
constipation, belching, inflammation of the stomach (indigestion, stomach pain or vomiting), worsening of stomach or intestinal inflammation
leg cramps
itchy raised rash (urticaria)
eye inflammation
difficulty breathing
changes in skin colour (bruising)
chest pain (generalised pain not related to the heart)

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

ulcers (bleeding) in the stomach, oesophagus or intestine; or intestinal injury (may cause pain, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of the pancreas (may lead to stomach pain), inflammation of the oesophagus
low sodium levels in the blood (a condition known as hyponatraemia)
reduced number of white blood cells (which help protect the body from infections) and platelets in the blood (increased risk of bleeding or bruising)
difficulty coordinating muscle movements
confusion, altered taste
increased sensitivity to light
hair loss
hallucinations
bleeding from the eye
irregular heartbeat
hot flushes
blood clots in the blood vessels of the lungs. Symptoms may include shortness of breath, sharp pain when breathing or collapse
bleeding from the stomach or intestine (may result in blood in 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 or eyes), dark urine, pale stools, easy bleeding, itching and 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

severe allergic reactions (including potentially fatal anaphylactic shock)
serious skin conditions such as Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (may cause rash, blisters or skin peeling) and acute generalised exanthematous pustulosis (symptoms include redness of the skin with swollen areas covered with numerous small pustules)
delayed allergic reaction with possible symptoms such as rash, facial swelling, fever, swollen glands and abnormal test results (e.g. liver, blood cells (eosinophilia, a type of increase in white blood cells))
bleeding within the brain causing death
meningitis (inflammation of the membrane around 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), diarrhoea, jaundice (yellowing of the skin or 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 or other kidney problems (such as nephrotic syndrome, minimal change glomerulopathy which may be accompanied by symptoms such as fluid retention (oedema), foamy urine, fatigue and loss of appetite)
worsening of epilepsy (possibly more frequent and/or more severe seizures)
blockage of an artery or vein in the eye which may lead to partial or complete loss of vision
inflamed blood vessels (may cause fever, pain, red spots on the skin)
reduction in the number of white and red blood cells and platelets (may cause tiredness, easier bruising, frequent nosebleeds and increased risk of infections)
muscle pain and weakness
impaired sense of smell

Frequency not known: frequency cannot be estimated from the available data

Reduced fertility in women, usually reversible upon discontinuation of the drug.

In clinical studies not related to arthritis or other arthritic conditions, in which Celecoxib Maxmind was taken at doses of 400 mg daily for up to 3 years, the following side effects were observed:
Common: may affect up to 1 in 100 people

heart problems: angina (chest pain)
stomach problems: irritable bowel syndrome (may include stomach pain, diarrhoea, indigestion, flatulence)
kidney stones (may cause stomach or back pain, blood in urine), difficulty passing urine
weight gain

Uncommon: may affect up to 1 in 100 people

deep vein thrombosis (blood clots, usually in the legs, which may cause calf pain or redness or breathing problems)
stomach problems: stomach infection (which may cause irritation and ulcers in the stomach and intestine)
lower limb fractures
herpes, skin infection, eczema (rash with dry, itchy skin), pneumonia (inflammation of the lungs (possible cough, fever, difficulty breathing))
eye deposits causing blurred or impaired vision, dizziness due to inner ear problems, injury, inflamed or bleeding gums, mouth sores
excessive urination at night, bleeding from haemorrhoids, frequent bowel movements
fatty lumps under the skin or elsewhere, ganglion cysts (harmless swellings on or around joints and tendons of the hands and feet), difficulty speaking, abnormal or heavy vaginal bleeding, breast pain
elevated sodium levels in blood test results

Reporting of side effects
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Celecoxib Maxmind

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Celecoxib Maxmind contains

The active substance is celecoxib. Each capsule contains 100 mg or 200 mg of celecoxib.
The other components are: Anhydrous lactose, hydroxypropylcellulose, crospovidone, povidone, sodium lauryl sulfate, magnesium stearate. The capsule shell contains: titanium dioxide E171, gelatin, sodium lauryl sulfate. The printing ink contains: shellac, propylene glycol, strong ammonia solution, indigo carmine aluminium lake E132 (100 mg capsules) and yellow iron oxide E172 (200 mg capsules).

Description of the appearance of Celecoxib Maxmind and pack contents
Celecoxib Maxmind 100 mg: size “4” capsules containing white to almost white powder, with an opaque white cap and an opaque white body, printed with “C5” on a blue band on the cap and “100mg” on a blue band on the body.
Celecoxib Maxmind 200 mg: size “2” capsules containing white to almost white powder, with an opaque white cap and an opaque white body, printed with “C6” on a yellow band on the cap and “200mg” on a yellow band on the body.
The capsules are packaged in transparent PVC/PVdC and aluminium blisters and are available in packs of 20, 40, 50, 60, 100 capsules (100 mg strength) and 10, 20, 30, 50, 100 capsules (200 mg strength).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Maxmind Pharmaceutical S.L.
Calle Copenhague 12, Oficina 205, Edificio Tifán,
28232 Las Rozas,
Madrid,
Spain

Manufacturer
Mawdsleys Brooks and Co Ltd
Unit 22, Quest Park,
Wheatley Hall Road,
Doncaster,
DN2 4LT, United Kingdom.