PIROXICAM 20 MG CAPSULES - patient leaflet, side effects, dosage

llllllllll

ifyou get any side effects, talktoyour doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.

What is in this leaflet

• 1. What Piroxicam Capsules are and what they are used for

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

• 3. How to take Piroxicam Capsules

• 4. Possible side effects

• 5. Howtostore­PiroxicamCapsu­les

• 6. Contents of the pack and other information

• 1. What Piroxicam Capsules are and what they are 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 rheumatoid arthritis, osteoarthritis (joint disease) 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 and tell your doctor 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), Stevens-Johnson syndrome (a rash, blistering and peeling of skin) 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 oracetylsalicylic 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.

Potentially life-threatening skin rashes (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 ofthe skin. The highest riskfor 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 doctorthatyou are taking this medicine.

Warnings and precautions

Before prescribing Piroxicam capsules, your doctor will assess the benefits this medicine may giveyou againstyour riskof 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.

Talktoyour doctoror pharmacist beforetaking Piroxicam capsules ifyou::

• Sufferfromasthma
• Are elderly. Your doctor may prescribe another medicine to protect your stomach and intestines from side effects, particularly if you are over 70 years old or are taking other medication. You should nottake this medicine ifyou are over 80 years of age.
• Sufferfrom liver or kidney disease.
• Have diabetes.
• High blood pressure, heart problems or stroke
• High cholesterol or hardening of the arteries
• Have unusual abdominal symptoms.

Piroxicam Capsules may be associated with a small risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you have heart problems, previous stroke orthinkyou may be at risk ofthese 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.

Other medicines and Piroxicam capsules

Tell your doctor or pharmacist if you are taking or 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 if you are taking any of the following medicines:

• Corticosteroids, which are drugs given to treat a variety of conditions such as allergies and hormone imbalances
• Certain medicines used to treat heart conditions known as cardiac glycosides such as digoxin
• Certain medicines for depression such as lithium
• 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, which is given to help prevent rejection of transplanted organs can increase the risk of kidney problems when used with Piroxicam
• Quinolone antibiotics, 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 with food and drink

Piroxicam Capsules should be taken with or after food.

Pregnancy and breast-feeding

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. 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 talkto 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 contain 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 tablet, 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. Yourdoctorwill adjustyourtreatment 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 is 20mg.

Elderly:

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

200 × 300 mm

ARTWORK DETAIL LABEL

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 many Piroxicam Capsules, tell your doctor at once or go to the nearest casualty department. Always take the labelled medicine package with you, whether there is any Piroxicam capsules medicine left or not.

If you forget to take Piroxicam Capsules

If you forget to take a dose, takeit 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 ofthe following symptoms after taking this medicine:

• any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements orvomiting blood
• sudden wheeziness, difficulty in breathing, fever, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body)
• yellowing of the skin and the whites of your eyes (jaundice) which may be a sign of hepatitis or other liver problems
• increased risk of heart attack (myocardial infarction)
• increased risk of stroke
• potentially life-threatening skin rashes including peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) orextensive peeling of the skin (toxic epidermal necrolysis) (see section 2).

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
• Lowering of blood platelet count (thrombocytopenia)
• Anorexia
• Increase in blood sugar levels
• Dizziness
• Headache
• Vertigo (a spinning sensation)
• Sleepiness
• Ringing in ears (tinnitus)
• Abdominal pain/discomfort
• Constipation
• Diarrhoea
• Wind
• Feeling sick (nausea)
• Being sick (vomiting)
• Indigestion
• Itching
• Skin rash
• Swelling of the feet, hands or other parts of the body (oedema)
• Weight increased serum transaminase levels

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
• Kidneyfailure
• Kidney damage
• Change in urine output or appearance

Not known: frequency cannot be estimated from the available data

• an allergic reaction to an injection of serum which can include fever, rash and joint pain.
• Abnormalities in the blood e.g. decreased haemoglobin
• Fluid retention
• Depression
• Dream abnormalities
• Hallucinations
• Changes in sleep patterns
• Mental confusion
• Mood alterations
• Nervousness
• Pins and needles
• Eye irritations
• Swollen eyes
• Hearing impairment
• High blood pressure
• Inflammation of the blood vessels
• Shortness of breath
• Constriction of the muscles lining the airways of lungs (bronchial)
• Nose bleeds
• Inflammation of the stomach lining (gastritis)
• Gastrointestinal bleeding including vomiting of blood and black, tarry stools
• Inflamed pancreas (which may lead to severe pain in the upper abdomen or back)
• Stomach (peptic) ulcers
• Hair loss
• Allergic reaction involving purple spots on the skin, joint pain, abdominal pain and kidney dysfunction (Henoch-Schoenlein purpura)
• Swelling of the lower layer of skin and tissue which can affect the eyes, lips, hands and feet
• Skin rashes including peeling skin, particularly around the mouth, nose, eyes and genitals (Erythema multiforme)
• Hives
• Itchy red rash, blisters which might be painful and filled with pus (Vesiculo bullous reactions)
• Skin allergic reactions such as exfoliative dermatitis (reddening of skin). See section 2.
• Fixed drug eruption (may look like round or oval patches of redness and swelling ofthe skin), blistering (hives), itching
• Loosening or splitting of fingernails
• Increased sensitivity of the skin to sunlight
• Decreased fertility in females
• Feeling unwell, general aches and pains
• Weight decrease
• Glomerulonephritis (group of diseases that injure the part of the kidney that filters blood (called glomeruli)).

Decreases in hemoglobin and hematocrit unassociated with obvious gastro-intestinal bleeding

• Aplastic anaemia (reduce in production of new blood cells).
• Severe stomach pain due to a hole in the stomach, large bowel or small intestine. If you get any side effects, talktoyour doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 afterthe expiry date which is stated on the 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 protect the environment.

6. contents of the pack and other information what piroxicam capsules contain

The active substance is 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

Description:

Piroxicam Capsules 10mg: A white powder encapsulated within a Size “3” Hard Gelatin Capsule with a violet body and turquoise cap, printed “CX45” both on body and cap in white.

Piroxicam Capsules 20 mg: A white powder encapsulated within a Size “3” Hard Gelatin Capsule with a maroon body and cap, printed “CX46” both on body and cap in white.

Contents of pack: Blister pack.

Piroxicam Capsules 10mg&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, Metro Centre,

Tolpits Lane, Watford, Herts,

WD18 9SS, UK

Tel: 01923 255580

Fax: 01923255581 g

This leaflet was last revised 01/2022. °

ARTWORK DETAIL LABEL

RD/PD/003/F-08/R0