PRESERVEX TABLETS 100MG

Active substance: ACECLOFENAC

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Preservex

Film Coated Tablets 100 mg
Aceclofenac

Read all of this leaflet carefully before you start
taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on

to others. It may harm them, even if their symptoms are the
same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Preservex is and what it is used for
2. Before you take Preservex
3. How to take Preservex
4. Possible side effects
5. How to store Preservex
6. Further information

1. WHAT PRESERVEX IS AND WHAT IT IS USED FOR

Preservex belongs to a group of medicines called non-steroidal
anti-inflammatory 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 re-absorption 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. BEFORE YOU TAKE PRESERVEX
Do not take Preservex

• if you are allergic (hypersensitive) to aceclofenac or any of the

other ingredients of Preservex.

• if you are allergic (hypersensitive) 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 moderate to 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 liver failure.
• if you are pregnant (unless considered essential by your doctor).
Preservex is not recommended for use in children

Take special care with Preservex

Before you start taking Preservex, tell your doctor:
• if you suffer from any other form of liver disease.
• if you have any of the following gastro-intestinal disorders:
- inflammatory bowel disease (ulcerative colitis)
- chronic inflammatory bowel disease (Crohn’s disease)
- bleeding
- vomiting of blood
• 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 blood disorder known as 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 you are elderly (your doctor will prescribe you the lowest
effective dose over the shortest duration).

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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Please tell your doctor if you are taking:
• medicines used to treat depression or manic depression (lithium)
• medicines used to treat heart failure and irregular heart beats
(cardiac glycosides)
• 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 which is used as an emergency contraceptive
or to induce abortions
• any steroids (oestrogens, androgens, or glucocorticoids)
• medicines used to supress the immune system (cyclosporin
or tacrolimus)
• medicines used to treat HIV (zidovudine)
• medicines used to lower blood sugar levels (antidiabetics)
• any other NSAID drugs (aspirin, ibuprofen, naproxen)

Taking Preservex with food and drink

Preservex must be taken preferably with or after food.

Pregnancy and breast-feeding

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 estblished. 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 breast-feeding unless considered
essential by your doctor.
Consult your doctor or pharmacist for advice before taking
any medicine.

Driving and using machines

If you are taking Preservex and you experience dizziness,
drowsiness, tiredness or any visual disturbances, you must not
drive or use machinery.

3. HOW TO TAKE PRESERVEX

Always take Preservex exactly as your doctor has told you. You
will be prescribed the lowest effective dose over the shortest
duration to reduce side effects. You should check with your
doctor or pharmacist if you are not sure.
The recommended dose in adults is 200mg (two Preservex
tablets). One 100mg 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 sideeffects (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 product, ask
your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

• blisters
• water retention and swelling
• tiredness
• leg cramps
• increased blood alkaline phosphatase levels
• weight gain

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

If any of the below side effects get serious, please tell your
doctor or pharmacist.

If you experience any of the following side effects, tell your
doctor IMMEDIATELY:
• medicines such as Preservex may be associated with a small
increased risk of heart attack, (”myocardial infarction”) or stroke
• severe allergic reaction (anaphylactic shock). Symptoms may
include difficulty breathing, wheezing, abnormal pain and vomiting
• swelling of the face
• kidney failure

Other side effects that have been reported with this type of
drug (NSAIDs) are:
• bone marrow failure
• hallucinations
• confusion
• blurred, partial or complete loss of vision
• painful movement of the eye
• ringing in the ears
• aggravated asthma
• ulcers
• perforation of either the stomach, large intestine or bowel wall
• blistering and peeling of the top layer of skin
• mild, itchy pink/redness of the skin
• reddening or scaling of skin
• skin irritation (eczema)
• skin reaction to sunlight
• inflammation of the kidneys
• generally feeling unwell
• aseptic meningitis
• exacerbation of colitis and Crohn’s disease
• hypertension (high blood pressure)
• cardiac failure
• bone marrow depression

f you suffer from any of the following at any time during your
treatment STOP TAKING the medicine and seek immediate
medical help:
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds.
STOP TAKING the medicine and tell your doctor if you experience:
• Indigestion or heartburn
• Abdominal pain (pains in your stomach) or other abnormal
stomach symptoms.
If any of the below side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.

Common (occur in more than 1 in 100 patients but
in less than 1 in 10 patients):
• dizziness
• nausea (feeling sick)
• diarrhoea
• increased liver enzymes in the blood

Uncommon (occur in more than 1 in 1,000 patients
but in less than 1 in 100 patients):

• 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 (occur in more than 1 in 10,000 patients but in
less than 1 in 1,000 patients):
• low levels of iron in the blood
• hypersensitivity (allergic reaction)
• visual disturbance
• shortness of breath

Very Rare (occur in less than 1 in 10,000 patients):
• low white blood cells levels
• low platelets levels in the blood
• abnormal breakdown of red blood cells (anemia)
• high potassium levels in the blood
• 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
• heart pounding or racing (palpitations)
• hot flushes
• difficulty breathing
• high pitched noise when breathing
• inflammation of the mouth
• stomach ulcer
• inflammation of the pancreas (pancreatitis)
• inflammation of the liver (hepatitis)
• yellowing of the skin (jaundice)
• spontaneous bleeding into the skin (appears as a rash)

5. HOW TO STORE PRESERVEX

Keep out of the reach and sight of children.
Do not store above 30ºC.
Do not use Preservex after the expiry date which is stated on
the outer carton. The expiry date refers to the last day of that
month. It is recommended that you store Preservex in the
original box.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Preservex contains

The active substance is aceclofenac 100mg.
The other ingredients 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.

What Preservex looks like and contents of the pack
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.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Almirall, S.A.
General Mitre 151
08022 Barcelona
Spain

Manufacturer:

Industrias Farmacéuticas Almirall, S.L.
Ctra. Nacional II, km 593
08740 Sant Andreu de la Barca
Barcelona
Spain

This leaflet was last approved in January 2011

80001203

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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