Preservex 100 mg film-coated tablets

• 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 section 4.

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

• 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 causing tightness in the chest wheezing and difficulty breathing.
  • runny nose, itching and/or sneezing (irritation of the nose).
  • raised red circular patchy rash on the skin which may have felt itchy or like a sting or burn .
  • a severe allergic reaction known as anaphylactic shock. The symptoms may be life threatening and include difficulty breathing, wheezing, abdominal pain and vomiting.
• if you have a history of, suffer from, or suspect that you have a stomach ulcer or have vomited blood or passed blood in your faeces (black tarry stools).
• if you have severe kidney disease.
• if you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages.
• if you have or have had problems with your blood circulation (peripheral arterial disease).
• if you suffer from, or suspect that you have severe liver failure.
• if you suffer from bleeding or any type of blood clotting disorders.
• if you are pregnant (unless your doctor considers it essential for you to continue to take this medicine)

Preservex is not recommended for use in children.

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:
  • Disorders of the stomach or gut/bowel
  • inflammatory bowel disease (ulcerative colitis)
  • chronic inflammatory bowel disease (Crohn’s disease)
  • ulceration, bleeding or perforation of the stomach or bowel
• 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 a rare inherited disorder known as porphyria.
• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, raised cholesterol or or other raised body fats such as triglycerides
• if you suffer from an autoimmune condition known as systemic lupus erythematosus or other connective tissue disorders.
• if you are infected with chicken pox, the use of this medicine should be avoided because a rare serious infection of the skin may develop.
• 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 stopped immediately at the first onset of symptoms such as tightness of the chest, breathing difficulties, fever, skin rashes , soreness of the skin lining the mouth and other mucous membranes causing ulcers, or any signs of hypersensitivity.

Medicines such as Preservex may be associated with a small increased risk of heart attack (”myocardial infarction”). Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

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 mental health problems like depression (selective serotonin-reuptake inhibitors (SSRIs) such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) 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: ACE inhibitors such as enalopril, lisinopril; angiotensin II receptor antagonists such as losartan, candesartan; also hydralazine, methyldopa, clonidine, moxonidine, propranalol)
• medicines to treat infection (quinolone antibiotics such as ciprofloxacin, ofloxacin, levofloxacin moxifloxacin)
• drugs used to increase the rate of urine excretion (diuretics such as thiazides,furosemide amiloride hydrochloride)
• medicines that stop blood clotting (anticoagulants) such as warfarin, heparin
• methotrexate which is used to treat cancer and autoimmune disorders such as arthritis and skin conditions
• mifepristone
• any steroids for the treatment of swelling and inflammation (glucocorticoids such as hydrocortisone, prednisolone,)
• medicines used to suppress the immune system after organ transplant (cyclosporin or tacrolimus)
• medicines used to treat HIV (zidovudine)
• medicines used to lower blood sugar levels in diabetes (antidiabetics such as glibenclamide, glicazide, tolbutamide)
• any other painkiller NSAID drugs (aspirin, ibuprofen, naproxen, COX-2 inhibitors such as celecoxib and etoricoxib)
• antiplatelet drugs such as clopidogrel.

Preservex must be taken preferably with or after food.

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 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 is not known. It is not recommended for use in pregnancy unless considered essential by your doctor.

Do not take Preservex if you are in the last 3 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 Preservex 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, Preservex 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.

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 breast-feeding unless considered essential by your doctor.

If you are taking Preservex and you experience dizziness, drowsiness, vertigo, tiredness or any difficulty with your eyesight, you must not drive or use machinery.

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

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 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.

Do not stop taking Preservex unless your doctor advises you.

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 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.

The active substance is aceclofenac 100mg.

The other ingredients (excipients) are:

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 100 mg film-coated tablets are white, round tablets.

Preservex tablets are available in boxes of either 10 or 60 tablets.

Not all pack sizes may be marketed.

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