Preservex 100mg Tablets
Patient Information Leaflet
Preservex® 100mg tablets
(aceclofenac)
This product is called Preservex 100mg tablets, but will be referred to as Preservex throughout the remainder of the leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See also section 4.
What is in this leaflet:
1. What Preservex is and what it is used for
2. What you need to know before you take Preservex
3. How to take Preservex
4. Possible side effects
5. How to store Preservex
6. Contents of the pack and other information
1. What Preservex is and what it is used for
Preservex belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs). These drugs have anti-inflammatory and painkiller properties. The active ingredient of Preservex is aceclofenac.
Preservex works by blocking the production of hormone-like substances called prostaglandins. Prostaglandins are released at the sites of injury, tissue damage and immune reactions. Prostaglandins play an important role in both the inflammatory response of the body and stimulating the reabsorption of bone in diseases.
Preservex is used to relieve pain and inflammation in patients suffering from:
• arthritis of the joints (osteoarthritis). This commonly occurs in patients over the age of 50 and causes the loss of the cartilage and bone tissue next to the joint.
• autoimmune disease that causes chronic inflammation of the joints (rheumatoid arthritis).
• arthritis of the spine which can lead to the fusion of the vertebrae (ankylosing spondylitis).
2. What you need to know before you take Preservex Do not take Preservex:
• if you are allergic to aceclofenac or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to aspirin or any other NSAIDs (such as ibuprofen, naproxen or diclofenac).
• if you have taken aspirin or any other NSAIDs and experienced one of the following:
- asthma attack
- runny nose, itching and/or sneezing (irritation of the nose)
- raised red circular patchy rash on the skin which may have been itchy, stung or had a burning sensation
- severe allergic reaction (anaphylactic shock). Symptoms include difficulty breathing, wheezing, abnormal pain and vomiting
• if you have a history of, suffer from, or suspect that you have a stomach ulcer or intestinal bleeding.
• if you have severe kidney disease.
• if you have or have ever had a severe heart failure (heart attack).
• if you suffer from, or suspect that you have severe liver failure.
• If you suffer from bleeding or bleeding disorders.
• if you are pregnant (unless considered essential by your doctor)
Preservex is not recommended for use in children.
Warnings and precautions
Before you start taking Preservex, tell your doctor:
• if you suffer from any other form of kidney or liver disease.
• if you have any of the following disorders, as they may worsen:
- gastrointestinal disorders of the upper or lower tract
- inflammatory bowel disease (ulcerative colitis)
- chronic inflammatory bowel disease (Crohn's disease)
- ulceration, bleeding or perforation
- blood disorders
• if you have, or have ever had problems with the circulation of the blood to your brain.
• If you suffer from asthma or any other breathing problems.
• if you suffer from porphyria.
• if you have heart problems, previous stroke or think that you might be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
• If chicken pox occurs, the use of this medicine should be avoided because of rare serious infections of the skin related to this use.
• If you are recovering from major surgery.
• If you are elderly (your doctor will prescribe you the lowest effective dose over the shortest duration).
Hypersensitivity reactions can occur and very rarely, very serious allergic reactions are appearing (see section 4. Possible side effects).
The risk is higher in the first month of treatment. Preservex should be discontinued at the first onset of a skin rash, injuries of mucous membrane or any signs of hypersensitivity.
Medicines such as Preservex 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. Do not exceed the recommended dose or duration of treatment.
Other medicines and Preservex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Please tell your doctor if you are taking:
• medicines used to treat depression (selective serotonin-reuptake inhibitors) or manic depression (lithium)
• medicines used to treat heart failure and irregular heart beats (cardiac glycosides such as digoxin)
• medicines used to treat high blood pressure (antihypertensives)
• quinolone antibiotics
• drugs used to increase the rate of urine excretion (diuretics)
• medicines that stop blood clotting (anticoagulants) such as warfarin, heparin
• methotrexate which is used to treat cancer and autoimmune disorders
• mifepristone
• any steroids (oestrogens, androgens, or glucocorticoids)
• medicines used to supress the immune system (ciclosporin or tacrolimus)
• medicines used to treat HIV (zidovudine)
• medicines used to lower blood sugar levels (antidiabetics)
• any other NSAID drugs (aspirin, ibuprofen, naproxen), including COX-2 inhibitors
Preservex with food and drink
Preservex must be taken preferably 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.
You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. NSAIDs may make it more difficult to become pregnant.
Do not take Preservex if you are pregnant or think you are pregnant. The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor.
Preservex should not be used if you are breast-feeding. It is not known if this medicine passes into breast milk. It is not recommended for use during breastfeeding unless considered essential by your doctor.
Driving and using machines
If you are taking Preservex and you experience dizziness, drowsiness, vertigo, tiredness or any visual disturbances, you must not drive or use machinery.
3. How to take Preservex
Always take this medicine exactly as your doctor or pharmacist has told you. You will be prescribed the lowest effective dose over the shortest duration to reduce side effects. Check with your doctor or pharmacist if you are not sure.
The recommended dose in adults is 200 mg (two Preservex tablets). One 100 mg tablet should be taken in the morning and one in the evening.
Tablets should be swallowed whole with plenty of water and should be taken with or after food. Do not crush or chew the tablets.
Do not exceed the stated daily dose.
Elderly
If you are elderly, you are more likely to experience serious side-effects (listed in section 4 ‘Possible Side Effects'). If your doctor prescribes Preservex for you, you will be given the lowest effective dose over the shortest duration.
If you take more Preservex than you should
If you accidentally take too many Preservex tablets, contact your doctor immediately or go to your nearest hospital casualty department. Please take this leaflet or the box the Preservex tablets came in, with you to the hospital so that they will know what you have taken.
If you forget to take Preservex
If you miss a dose, do not worry, just take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet dose.
If you stop taking Preservex
Do not stop taking Preservex unless your doctor advises you. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
POM
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the medicine and seek medical advice IMMEDIATELY, if you experience any of the following side effects:
• severe allergic reaction (anaphylactic shock). Symptoms may develop quickly and can be life-threatening if not immediately treated and include fever, difficulty breathing, wheezing, abdominal pain, vomiting, swelling of the face and throat.
• severe skin rashes such as Stevens-Johnnson Syndrome and Toxic Epidermal Necrolysis. These are potentially life-threatening and develop quickly forming large blisters and the skin to peel away. The rash can also appear in the mouth, throat or eyes. Fever, headache and aching of the joints usually occur at the same time.
• meningitis. The symptoms include high fever, headache, vomiting, blotchy red rashes, neck stiffness, sensitivity and intolerance to light.
• passing blood in your faeces (stools/motions).
• passing black tarry stools. Vomit any blood or dark particles that look like coffee grounds.
• medicines such as Preservex may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.
• kidney failure.
STOP TAKING the medicine and seek medical advice if you experience:
• indigestion or heartburn.
• abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
• blood disorders such as reduced production of blood cells, abnormal breakdown of red blood cells known as haemolytic anaemia, low content of iron in the blood, low level of white blood cells, low number of platelet cells, increased blood potassium levels which can irritate the blood vessels causing inflammation known as vasculitis. These disorders can cause you to feel extremely tired, breathless, aching of the joints and be prone to repeated infections and bruising.
If any of the below side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Common (may affect up to 1 in 10 people):
• dizziness
• nausea (feeling sick)
• diarrhoea
• increased liver enzymes in the blood
Uncommon (may affect up to 1 in 100 people):
• wind (flatulence)
• inflammation or irritation of the lining of the stomach (gastritis)
• constipation
• vomiting
• mouth ulcers
• itching
• rash
• inflammation of the skin (dermatitis)
• raised circular red itchy, stinging or burning patches on the skin (hives)
• increase in blood urea levels
• increase in blood creatinine levels
Rare (may affect up to 1 in 1,000 people):
• hypersensitivity (allergic reaction)
• visual disturbance
• cardiac failure
• hypertension
• shortness of breath
• gastrointestinal haemorrhage
• gastrointestinal ulceration
Very Rare (may affect up to 1 in 10,000 people):
• depression
• strange dreams
• inability to sleep
• tingling, pricking or numbness of skin
• uncontrollable shaking (tremor)
• drowsiness
• headaches
• abnormal taste in the mouth
• sensation of spinning when standing still
• ringing in the ears (tinnitus)
• heart pounding or racing (palpitations)
• hot flushes
• difficulty breathing
• high pitched noise when breathing
• inflammation of the mouth
• perforation of either the stomach, large intestine or bowel wall
• exacerbation of colitis and Crohn's disease
• inflammation of the pancreas (pancreatitis)
• injury of the liver (including hepatitis)
• yellowing of the skin (jaundice)
• spontaneous bleeding into the skin (appears as a rash)
• nephrotic syndrome
• water retention and swelling
• tiredness
• leg cramps
• increased blood alkaline phosphatase levels
• weight gain
Other side effects that have been reported with this type of drug (NSAIDs) are:
• hallucinations
• confusion
• blurred, partial or complete loss of vision
• painful movement of the eye
• aggravated asthma
• skin reaction to sunlight
• inflammation of the kidneys
• generally feeling unwell
Exceptionally, serious skin infections occur in association with chickenpox
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, Website: www.mhra.gov.uk/yellowcard.
By reporting side-effects you can help provide more information on the safety of this medicine
5. How to store Preservex
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the outer 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 throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
Preservex are white round, tablets with no markings.
Each Film coated tablet contains 100 mg of the active ingredient aceclofenac.
Also contains:
Tablet core: microcrystalline cellulose, sodium croscarmellose, povidone and glyceryl palmitostearate.
Coating Material - partially substituted hydroxypropyl methylcellulose, microcrystalline cellulose, polyoxyethylene 40 stearate and titanium dioxide E171.
Preservex tablets are available in packs of 60 tablets.
Manufactured by: Industrias Farmaceuticas Almirall, S.A., Ctra. Nacionall II, Km. 593 08740 Sant Andreu de la Barca, Barcelona, Spain. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton BL6 4SA. Repackaged by Maxearn Ltd, Bolton, BL6 4SA.
PL 20774/1434 Preservex 100mg tablets Preservex is a registered trademark of Almirall, S.A. Date of preparation 21st May 2015