PIROXICAM CAPSULES 10 mg & 20 mg – patient leaflet, side effects, dosage

1. What Piroxicam Capsules and what it is used for

Piroxicam is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). This means it will help to relieve pain and reduce swelling affecting joints. Piroxicam is used to relieve some symptoms caused by osteoarthritis (joint disease), rheumatoid arthritis, and ankylosing spondylitis (rheumatism of the spine) such as swelling, stiffness and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it.

Your doctor will only prescribe piroxicam capsules to you when you have had unsatisfactory relief of symptoms with other NSAIDs.

2. What you need to know before you take Piroxicam Capsules

Do not take Piroxicam Capsules

• if you are allergic to piroxicam or any of the other ingredients of this

  medicine (listed in Section 6).

• Have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your

  stomach.

• Have a history or stomach bleeding of perforation which may be related to

  the use of NSAIDs (naproxen, ibuprofen, diclofenac) or aspirin.

• Have a history of skin hypersensitive (allergic) reactions such as exfoliative

  dermatitis (reddening of skin, with skin peeling off in scales or layers), Stevens-Johnson syndrome (a rash, blistering and peeling of skin, mouth, eyes or genitals) or toxic epidermal necrolysis (blistering and peeling of the top layer of skin).

• Have a history of allergy to aspirin, ibuprofen or NSAIDs, which includes

  attacks of asthma, swelling of the nose and throat, skin rashes or a runny nose.

• Have a history of, or active disorders of the stomach or intestines such as

  ulcerative colitis, Crohn’s disease, gastrointestinal cancers or diverticulitis (inflamed or infected pouches/pockets in the colon).

• Have severe heart failure.

• Are taking other non-steroidal anti-inflammatory drugs (NSAIDs) such as

  ibuprofen, naproxen, diclofenac or acetylsalicylic acid (aspirin).

• Are taking anticoagulants, such as warfarin, to prevent blood clots.
• Are in the last three months of pregnancy.

If any of the above applies to you, tell your doctor immediately and do not take piroxicam capsules.

Warnings and precautions

Potentially life-threatening skin rashes (DRESS syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of piroxicam, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.

Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).

These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first weeks of treatment.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of piroxicam, you must not be re-started on piroxicam at any time. If you develop a rash or skin symptoms, you should stop taking Piroxicam capsules immediately, seek prompt medical advice and tell your doctor that you are taking this medicine.

Take special care with Piroxicam capsules

Before prescribing piroxicam capsules, your doctor will assess the benefits this medicine may give you against your risk of developing side effects. Your doctor may need to give you check-ups and will tell you how often you need to be checked during treatment with this medicine.

Piroxicam capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment or if you are a smoker. Do not exceed the recommended dose or duration of treatment. If you have heart problems, previous stroke or think you may be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

Talk to your doctor or pharmacist before taking piroxicam capsules if you:

• Suffer from asthma
• Suffer from liver or kidney disease.
• Have diabetes.
• High blood pressure, heart problems or stroke

• High cholesterol or hardening of the arteries

  • Have unusual abdominal symptoms.

If you have or had any other medical problems or any allergies or if you are not sure as to whether you can use piroxicam tell your doctor before taking this medicine. You should stop taking piroxicam capsule immediately and tell your doctor if you have any allergic reaction such as a skin rash, swelling of the face, wheezing or difficulty breathing

Take special care with piroxicam capsules as like all NSAIDs Piroxicam capsules can cause serious reactions in the stomach and intestines, such as pain, bleeding, ulceration and perforation.

You should stop taking piroxicam immediately and tell your doctor if you have stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements or vomiting blood.

Your doctor may prescribe piroxicam capsules together with another medicine to protect your stomach and intestines from side effects, particularly if you are over 70 years old, or you are taking other medicines like corticosteroids (medicines given to treat a variety of conditions such as allergies and hormone imbalances), certain medicines for depression called selective serotonin reuptake inhibitors (SSRIs) or low dose acetylsalicylic acid (aspirin) to help prevent heart attacks or stroke. Piroxicam capsules may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Patients over 70 years of age

If you are over 70 years old, your doctor may wish to minimise the length of your treatment and to see you more often while you are taking Feldene. You should not take this medicine if you are over 80 years of age. Other medicines and Piroxicam capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. , including medicines obtained without a prescription. The following medicines must not be taken with Piroxicam capsules:

• Aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief e.g. naproxen, diclofenac
• Anticoagulants such as warfarin to prevent blood clots

Tell your doctor before you take piroxicam capsules if you are taking any of the following medicines:

• Corticosteroids, which are medicines given to treat a variety of conditions such as allergies and hormone imbalances
• Low dose aspirin (75 mg) to help prevent heart attack or stroke
• Certain medicines used to treat heart conditions known as cardiac glycosides, such as digoxin
• Certain medicines for depression such as lithium or selective serotonin re-uptake inhibitors (SSRIs) used to treat depression, as these can increase the risk of gastro-intestinal bleeding e.g. Fluoxetine, paroxetine, citalopram
• Antihypertensives to treat high blood pressure
• Methotrexate which can be given to treat various conditions such as cancers, psoriasis and rheumatoid arthritis
• Cyclosporin or tacrolimus, which are given to help prevent rejection of transplanted organs can increase the risk of kidney problems when used with piroxicam
• Quinolone antibiotics e.g. ciprofloxacin, which are used to treat various infections
• Mifepristone which is used to medically terminate pregnancies as NSAIDS can reduce the effects of mifepristone and so should not be used for 8-12 days after mifepristone
• Diuretics such as hydrochlorothiazide to treat high blood pressure or kidney problems (water tablets) can increase the risk of kidney problems when used with piroxicam
• Anti-platelet agents (used to prevent blood clots from forming that can lead to heart attack or stroke) e.g. aspirin, clopidogrel, ticlopidine, dipyridamole
• Tacrolimus which is used to suppress the immune system after organ transplant can increase the risk of kidney problems when used with piroxicam
• Cimetidine, used in the treatment of heartburn and peptic ulcers. Taking Piroxicam capsules with food and drink

Piroxicam capsules should be taken with or after food.

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. Do not take Piroxicam if you are in the last three months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take piroxicam during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, piroxicam can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring. It is not usually recommended at other stages of pregnancy, but you may be able to take it if your doctor advises that it is necessary for you. Impaired female fertility

The use of piroxicam may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, should talk to doctor and stop taking this medicine. Driving and using machines

Piroxicam capsules may cause dizziness, drowsiness, fatigue or affect your vision. If affected, do not drive or operate machinery.

Piroxicam capsules contains lactose

Piroxicam capsules contains lactose a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking piroxicam capsules.

Piroxicam capsules contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. How to take Piroxicam Capsules

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will give you a regular check-up to make sure you are taking the optimal dose of piroxicam. Your doctor will adjust your treatment to the lowest dose. If continued treatment is considered necessary, this should be accompanied by frequent review.

Swallow your capsules whole with a glass of water. It is advisable to take your capsules at the same time each day with food or soon after eating. Adults:

The maximum daily dose of piroxicam capsules is 20mg.

Elderly:

If you are older than 70 years your doctor may prescribe a lower daily dose and reduce the duration of treatment.

If you feel that the medicine is not very effective, always talk to your doctor. Do not increase the dose.

If you take more Piroxicam Capsules than you should

If you accidentally take too much piroxicam capsules, tell your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there is any Piroxicam capsules left or not.

If you forget to take Piroxicam Capsules

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Piroxicam Capsules

Continue to take the capsules for as long as your doctor tells you to. Talk to your doctor if you have any concerns.

4. Possible side effects

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

Tell your doctor immediately and stop taking this medicine if you experience any of the following symptoms after taking this medicine:

• any sign of bleeding in the stomach or intestines, such as passing black or

  bloodstained bowel movements or vomiting blood

• sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips,

  rash or itching (especially affecting the whole body)

• a rash, blistering or peeling of the skin, mouth, eyes or genitals

• yellowing of the skin and the whites of your eyes (jaundice) which may be a sign

  of hepatitis or other liver problems

Common: may affect up to 1 in 10 people

• Changes in the red blood cells which may result in unusual bruising or bleeding
• Changes in the white blood cells which may result in increased risk of infection
• Anorexia
• Increase in blood sugar levels
• Headache
• Dizziness
• Drowsiness
• Vertigo (a spinning sensation)
• Ringing in ears (tinnitus)
• Abdominal pain/discomfort
• Feeling sick (nausea)
• Constipation
• Wind
• Diarrhoea
• Being sick (vomiting)
• Indigestion
• Skin rash
• Itching
• Swelling of the feet, hands or other parts of the body (oedema)
• Abnormalities in the blood e.g. decreased haemoglobin
• Weight increase

Uncommon: may affect up to 1 in 100 people

• Blurred vision
• Fast or pounding heartbeat
• Sore mouth and/or lips
• Decreased/low blood sugar level

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

• Kidney inflammation
• Kidney failure
• Kidney damage
• Change in urine output or appearance
• Kidney pain or pain in abdomen

Very rare: may affect up to 1 in 10,000 people

• Potentially life-threatening skin rashes including peeling skin, particularly around

  the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) or extensive peeling of the skin (toxic epidermal necrolysis) (see section 2) Not known: frequency cannot be estimated from the available data

• Reduction in red blood cells which can make the skin pale and cause weakness

  or breathlessness

• Fluid retention

• Sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips,

  rash or itching (especially affecting the whole body)

• Depression
• Hallucinations
• Mental confusion

• Mood alterations

  • Changes in sleep patterns
  • Nervousness
  • Dream abnormalities
  • Pins and needles
  • Eye irritations
  • Swollen eyes
  • Hearing impairment
  • Increased risk of heart attack (myocardial infarction)
  • Increased risk of stroke
  • Inflammation of the blood vessels
  • High blood pressure
  • Constriction of the muscles lining the airways of lungs (bronchial)
  • Shortness of breath
  • Nose bleeds
  • Upset stomach
  • Stomach (peptic) ulcers
  • Inflamed pancreas (which may lead to severe pain in the upper abdomen or back)
  • Gastrointestinal bleeding including vomiting of blood and black, tarry stools
  • Inflammation of the stomach lining (gastritis)
  • Inflammation of the liver (hepatitis)
  • Yellowing of the skin and the whites of your eyes (jaundice)

  • Serious allergic reaction which causes swelling of the face or the throat

    (angioedema)

  • Rashes, blistering, peeling, itching, redness, tenderness, thickening or scaling of skin
  • Increased sensitivity of the skin to sunlight
  • Fixed drug eruption (may look like round or oval patches of redness and swelling of the skin), blistering (hives), itching
  • Allergic reaction involving purple spots on the skin, joint pain, abdominal pain and kidney dysfunction (Henoch-Schoenlein purpura)
  • Loosening or splitting of fingernails
  • Hair loss
  • Decreased fertility
  • Feeling unwell, general aches and pains
  • Weight decrease

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Piroxicam Capsules

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

Keep the capsules in a dry place at normal room temperature (below 30°C) in the packaging they come in.

Do not use Piroxicam Capsules 10 mg and 20 mg after the expiry date which is stated on the carton and the bottle label. 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 throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Piroxicam Capsules contain

The active substance Piroxicam BP/Ph.Eur.

The other ingredients are:

10mg: Lactose monohydrate, Maize Starch, Sodium Lauryl Sulphate, Crospovidone NF, Magnesium Stearate, indigotine (E132). Titanium Dioxide (E171), Erythrosin (E127), black iron oxide (E172) and Gelatin and Opacode white containing titanium dioxide (E171), shellac, soya lecithin and Antifoam DC 1510.

20mg: Lactose monohydrate, Maize Starch, Sodium Lauryl Sulphate, Crospovidone NF, Magnesium Stearate, indigotine (E132). Titanium Dioxide (E171), Erythrosin (E127), black iron oxide (E172) and Gelatin and Opacode white containing titanium dioxide (E171), shellac, soya lecithin and Antifoam DC 1510.

What Piroxicam Capsules look like and contents of the pack

Piroxicam Capsules 10 mg: Turquoise cap and violet body, size “3” hard gelatin capsule shells printed “CX45” on body and cap in white and filled with white powder. Approximately 16 mm in length.

Piroxicam Capsules 20 mg: Maroon cap and body, size “3” hard gelatin capsule shells printed “CX46” on body and cap in white and filled with white powder. Approximately 16 mm in length.

Contents of pack: Blister pack.

Piroxicam Capsules 10 mg & 20 mg: Polypropylene tubes with low density polyethylene caps. Blister packs consisting of clear PVC and hard temper aluminium foil contained in a carton.

Tracer Packs: Child resistant containers consisting of polypropylene tubes with high density polyethylene caps.

Pack sizes: 28, 30, 56, 60, 100, 250 and 500 capsules.

Marketing Authorisation Holder and Manufacturer

Strides Pharma UK Ltd.

Unit 4, The Metro Centre,

Dwight Road,, Watford,

WD18 9SS

United Kingdom

Tel: 01923 255580

Fax: 01923 255581

This leaflet was last revised 08/2024