Preservex 100mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Aceclofenac
Available from:
CST Pharma Ltd
ATC code:
M01AB16
INN (International Name):
Aceclofenac
Dosage:
100mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 10010100; GTIN: 5055946801100

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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 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 effect

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 anti-inflammatory drugs

(NSAIDs). They have anti-inflammatory and

painkiller properties causing a lowering of

swelling, redness (inflammation) and pain.

The medicine/active ingredient of Preservex

is aceclofenac.

Preservex works by blocking the production

of hormone-like substances called

prostaglandins. Prostaglandins have many

functions in the body including an

important role in both the way the body

responds to inflammation and also the

reabsorption of calcium in some diseases of

the bone

Preservex is used to relieve pain and reduce

redness and swelling (inflammation) in

patients suffering from:

Osteoarthritis - inflammation of the joints.

This is a common condition in patients

over the age of 50 and causes damage to

the tissues and bones in the joints.

Rheumatoid arthritis - long term

inflammation of the joints caused by the

body’s own immune system (autoimmune

response).

Ankylosing spondylitis - inflammation of

the spine/backbone which can lead to the

joints fusing together.

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 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.

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:

- 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.

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 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 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 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.

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.

Driving and using machines

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.

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 200mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Preservex

100 mg

film-coated Tablets

Aceclofenac

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Date:

Manufacturer’s Technical check:

Manufacturer confirms the printability and

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for correct use during packaging process.

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00000000

(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 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 of treatment.

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.

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 immedia-

tely 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.

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

inflammation or irritation of the lining of

the stomach

constipation

vomiting

mouth ulcers

itching

rash

inflammation of the skin 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)

problems with eyesight

heart failure

high blood pressureshortness of breath

bleeding from the stomach or bowel

stomach or bowel 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

drowsiness

headaches

abnormal taste in the mouth

sensation of spinning when standing still

ringing in the ears

heart pounding or racing

hot flushes

difficulty breathing

high pitched noise when breathing

inflammation of the mouth

perforation of either the stomach, large

intestine or bowel wall

worsening of colitis and Crohn’s disease

inflammation of the pancreas

injury of the liver (including hepatitis)

yellowing of the skin

spontaneous bleeding into the skin

(appears as a rash)

nephrotic syndrome: a condition which

indicates kidney damage and includes

large amounts of protein in the urine, low

blood albumin levels, high blood cholesterol

levels and swelling of the legs, feet or ankles

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

worsening of 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 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 Preservex

Keep this medicine out of the sight and

reach of children.

Store below 30

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. It is recommended that you store

Preservex in the original box.

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 Preservex contains

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, microcrysta-

lline cellulose, polyoxyethylene 40 stearate

and titanium dioxide (E171).

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 November

2018.

ADHESIVE

ADHESIVE

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

PRESERVEX® 100 mg film-coated tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 100 mg of aceclofenac.

3

PHARMACEUTICAL FORM

Preservex film-coated tablets 100 mg are presented as white round film-coated

tablets, 8 mm in diameter.

4.1

Therapeutic indications

Preservex is indicated for the relief of pain and inflammation in osteoarthritis,

rheumatoid arthritis and ankylosing spondylitis.

4.2

Posology and method of administration

Preservex film-coated tablets are supplied for oral administration.

Posology

When Preservex was administered to fasting and fed healthy volunteers only the rate and not

the extent of aceclofenac absorption was affected.

Undesirable effects may be minimised by using the lowest effective dose for the shortest

duration necessary to control symptoms (see section 4.4

Special warnings and precautions for

use).

Adults

The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the

morning and one in the evening.

Paediatric population

There are no clinical data on the use of Preservex in children and therefore it is not

recommended for use in children.

Elderly

The elderly, who are more likely to be suffering from impaired renal, cardiovascular or

hepatic function and receiving concomitant medication, are at increased risk of the serious

consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective

dose should be used and for the shortest possible duration. The patient should be monitored

regularly for GI bleeding during NSAID therapy.

The pharmacokinetics of Preservex are not altered in elderly patients, therefore it is not

considered necessary to modify the dose or dose frequency.

Renal insufficiency

There is no evidence that the dosage of Preservex needs to be modified in patients with mild

renal impairment, but as with other NSAIDs caution should be exercised (see also

Precautions).

Hepatic insufficiency

There is some evidence that the dose of Preservex should be reduced in patients with hepatic

impairment and it is suggested that an initial daily dose of 100 mg be used.

Method of administration

To be taken preferably with or after food. The tablets should be swallowed whole with a

sufficient quantity of liquid.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of

proven ulceration or bleeding).

NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions

(e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-

steroidal anti-inflammatory drugs.

Hepatic failure and renal failure (see section 4.4).

Patients with established congestive heart failure (NYHA II-IV), ischemic heart disease,

peripheral arterial disease and/or cerebrovascular disease.

History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Active bleedings or bleeding disorders.

Preservex should not be prescribed during pregnancy, especially during the last trimester of

pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage

should be used (see section 4.6).

4.4

Special warnings and precautions for use

Undesirable effects may be minimised by using the lowest effective dose for the

shortest duration necessary to control symptoms (see section 4.2, and GI and

cardiovascular risks below).

The use of Preservex with concomitant NSAIDs including cyclooxygenase-2 selective

inhibitors should be avoided (see section 4.5).

Elderly:

The elderly have an increased frequency of adverse reactions to NSAIDs especially

gastrointestinal bleeding and perforation which may be fatal (see section 4.2).

Respiratory disorders:

Caution is required if administered to patients suffering from, or with a previous

history of, bronchial asthma since NSAIDs have been reported to precipitate

bronchospasm in such patients.

Cardiovascular, Renal and Hepatic Impairment:

The administration of an NSAID may cause a dose dependent reduction in

prostaglandin formation and precipitate renal failure. Patients at greatest risk of this

reaction are those with impaired renal function, cardiac impairment, liver dysfunction,

those taking diuretics or recovering from major surgery, and the elderly. The

importance of prostaglandins in maintaining renal blood flow should be taken into

account in these patients.

Renal function should be monitored in these patients (see also section 4.3).

Renal:

Patients with mild to moderate renal impairment should be kept under surveillance,

since the use of NSAIDs may result in deterioration of renal function. The lowest

effective dose should be used and renal function monitored regularly. Effects on renal

function are usually reversible on withdrawal of Preservex.

Hepatic:

If abnormal liver function tests persist or worsen, clinical signs or symptoms

consistent with liver disease develop or if other manifestations occur (eosinophilia,

rash), Preservex should be discontinued. Close medical surveillance is necessary in

patients suffering from mild to moderate impairment of hepatic function. Hepatitis

may occur without prodromal symptoms.

Use of Preservex in patients with hepatic porphyria may trigger an attack.

Cardiovascular and cerebrovascular effects:

Appropriate monitoring and advice are required for patients with a history of hypertension

and/or mild to moderate congestive heart failure as fluid retention and oedema have been

reported in association with NSAID therapy.

Patients with congestive heart failure ( NYHA-I) and patients with significant risk

factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes

mellitus, smoking) should only be treated with aceclofenac after careful consideration.

As the cardiovascular risks of aceclofenac may increase with dose and duration of

exposure, the shortest duration possible and the lowest effective daily dose should be

used. The patient's need for symptomatic relief and response to therapy should be re-

evaluated periodically.

Aceclofenac should also be administered with caution and under close medical

surveillance to patients with a history of cerebrovascular bleeding.

Gastrointestinal bleeding, ulceration and perforation:

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all

NSAIDs at any time during treatment, with or without warning symptoms or a

previous history of serious GI events.

Close medical surveillance is imperative in patients with symptoms indicative of

gastro-intestinal disorders involving either the upper or lower gastrointestinal tract,

with a history suggestive of gastro-intestinal ulceration, bleeding or perforation, with

ulcerative colitis or with Crohn's disease, or haematological abnormalities, as these

conditions may be exacerbated (see section 4.8)

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID

doses, in patients with a history of ulcer, particularly if complicated with haemorrhage

or perforation (see section 4.3), and in the elderly. These patients should commence

treatment on the lowest dose available. Combination therapy with protective agents

(e.g. misoprostol or proton pump inhibitors) should be considered for these patients,

and also

for patients requiring concomitant low dose aspirin, or other drugs

likely to increase gastrointestinal risk (see below and section 4.5).

Patients with a history of GI toxicity, particularly when elderly, should report any unusual

abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could

increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants

such as warfarin, selective serotonin-reuptake inhibitors or antiplatelet agents such as

aspirin (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving aceclofenac, the treatment

should be withdrawn.

SLE and mixed connective tissue disease:

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue

disorders there may be an increased risk of aseptic meningitis (see section 4.8).

Dermatological:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-

Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in

association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk

for these reactions early in the course of therapy: the onset of the reaction occurring in the

majority of cases within the first month of treatment. Preservex should be discontinued at

the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Exceptionally, varicella can trigger serious cutaneous and soft tissues infections

complications. To date, the contributing role of NSAIDs in the worsening of these

infections cannot be ruled out. Thus, it is advisable to avoid use of aceclofenac in case of

varicella.

Hypersensitivity reactions:

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions,

can also occur without earlier exposure to the drug.

Haematological:

Preservex may reversibly inhibit platelet aggregation (see section 4.5 anticoagulants under

'Interactions').

Long-term treatment:

All patients who are receiving NSAIDs should be monitored as a precautionary measure

e.g. renal, hepatic function (elevation of liver enzymes may occur) and blood counts.

4.5

Interaction with other medicaments and other forms of interaction

Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of

two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects,

including GI bleeding (see section 4.4).

Anti-hypertensives: NSAID’s may reduce the effect of antihypertensives. The risk of acute

renal insufficiency, which is usually reversible, may be increased in some patients with

compromised renal function (e.g. dehydrated patients or elderly patients) when ACE-

inhibitors or angiotensin II receptor antagonists are combined with NSAIDs. Therefore, the

combination should be administered with caution, especially in the elderly. Patients should be

adequately hydrated and consideration should be given to monitoring of renal function after

initiation of concomitant therapy, and periodically thereafter.

Diuretics: Aceclofenac, like other NSAIDs, may inhibit the activity of diuretics. Diuretics can

increase the risk of nephrotoxicity of NSAIDs. Although it was not shown to affect blood

pressure control when co-administered with bendrofluazide, interactions with other diuretics

cannot be ruled out. When concomitant administration with potassium-sparing diuretics is

employed, serum potassium should be monitored.

Cardiac glycosides, like digoxin: NSAIDs may exacerbate cardiac failure, reduce GFR

(glomerular filtration rate) and inhibit the renal clearance of glycosides, resulting in increased

plasma glycoside levels. The combination should be avoided unless frequent monitoring of

glycoside levels can be performed.

Lithium: Several NSAID drugs inhibit the renal clearance of lithium, resulting in increased

serum concentrations of lithium. The combination should be avoided unless frequent

monitoring of lithium can be performed.

Methotrexate: The possible interaction between NSAIDs and methotrexate should be born in

mind also when low doses of methotrexate are used, especially in patients with decreased

renal function. When combination therapy has to be used, the renal function should be

monitored. Caution should be exercised if both an NSAID and methotrexate are administered

within 24 hours of each other, since NSAIDs may increase plasma levels of methotrexate,

resulting in increased toxicity.

Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as

NSAIDs can reduce the effect of mifepristone.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see

section 4.4). Close monitoring of patients on combined anti-coagulants and Preservex therapy

should be undertaken.

Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions

associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an

increased risk of developing convulsions.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of

gastrointestinal bleeding (see section 4.4).

Ciclosporin, tacrolimus: Administration of NSAID drugs together with cyclosporin or

tacrolimus is thought to increase the risk of nephrotoxicity due to decreased synthesis of

prostacyclin in the kidney. During combination therapy it is therefore important to carefully

monitor renal function.

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with

zidovudine. There are indications of an increased risk of haemarthroses and haematoma in

HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Antidiabetic agents: Clinical studies have shown that diclofenac can be given together with

oral antidiabetic agents with influencing their clinical effect. However, there have been

isolated reports of hypoglycaemic and hyperglycaemic effects. Thus with Preservex,

consideration should be given to adjustment of the dosage of hypoglycaemic agents.

4.6

Fertility, pregnancy and lactation

Pregnancy:

There is no information on the use of aceclofenac during pregnancy. Inhibition of

prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal

development. Data from epidemiological studies suggest an increased risk of miscarriage,

cardiac malformation or gastroschisis after use of prostaglandin synthesis inhibitor in early

pregnancy. The absolute risk for cardiovascular malformation was increased from less than

1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of

therapy.

In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in

increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased

incidences of various malformations, including cardiovascular, have been reported in animals

given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and

second trimester of pregnancy, aceclofenac should not be given unless clearly necessary. If

aceclofenac is used by a woman attempting to conceive, or during the first and second

trimester of pregnancy, the dose should be kept as low and duration of treatment as short as

possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the

foetus to:

cardiopulmonary toxicity (with premature closure of the ductus arteriosus and

pulmonary hypertension);

renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

possible prolongation of bleeding time, an anti-aggregating effect which may occur

even at very low doses.

inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, aceclofenac is contraindicated during the third trimester of pregnancy (see

section 4.3).

Breastfeeding:

There is no information on the secretion of aceclofenac to breast milk; there was however no

notable transfer of radio labelled (14C) aceclofenac to the milk of lactating rats.

The use of Preservex should therefore be avoided in pregnancy and lactation unless the

potential benefits to the other outweigh the possible risks to the foetus.

Fertility:

The use of Preservex 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, withdrawal of Preservex should be considered.

4.7

Effects on ability to drive and use machines

Undesirable effects such as dizziness, drowsiness, vertigo, fatigue, visual disturbances

or other central nervous system disorders are possible after taking NSAIDs. If

affected, patients should not drive or operate machinery.

4.8

Undesirable effects

Gastrointestinal: The most commonly-observed adverse events are gastrointestinal in nature.

Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may

occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia,

abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and

Crohn’s disease (See section 4.4) have been reported following administration. Less

frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

Hypersensitivity: Hypersensitivity reactions have been reported following treatment with

NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b)

respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or

dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria,

purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal

necrolysis and erythema multiforme).

Cardiovascular and cerebrovascular: Oedema, hypertension and cardiac failure have been

reported in association with NSAID treatment

Aceclofenac is both structurally related and metabolised to diclofenac for which a greater

amount of clinical and epidemiological data consistently point towards an increased risk of

general arterial thrombotic events (for example myocardial infarction or stroke, particularly at

high doses or in long treatment). Epidemiological data has also found an increased risk of

acute coronary syndrome and myocardial infarction associated with the use of aceclofenac

(see section 4.3 and 4.4 for Contraindications and Special warnings and special precautions

for use).

Exceptionally, occurrence of serious cutaneous and soft tissues infections complications

during varicella has been reported in association with NSAID treatment

Other adverse reactions reported less commonly include:

Renal: interstitial nephritis.

Neurological and special senses: optic neuritis, reports of aseptic meningitis (especially in

patients with existing auto immune disorders, such as systemic lupus erythematosus, mixed

connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting,

fever or disorientation (See section 4.4), confusion, hallucinations, malaise and drowsiness.

Haematological: agranulocytosis, aplastic anaemia .

Dermatological: Bullous reactions including Stevens Johnson Syndrome and Toxic

Epidermal Necrolysis (very rare). Photosensitivity.

If serious adverse reactions occur, Preservex should be withdrawn.

The following is a table of adverse reactions reported during clinical studies and after

authorization, grouped by System-Organ Class and estimated frequencies. Very common

1/10); common (

1/100 to <1/10); uncommon (

1/1,000 to <1/100), rare (

1/10,000 to

<1/1,000), very rare (<1/10,000).

MedDRa SOC

Common

1/100 to

<1/10

Uncommon

1/1,000 to

<1/100

Rare <

1/10,000 to

<1/1,000

Very rare/

<1/10,000

Blood and

lymphatic system

disorders

Anaemia

Bone Marrow

depression

Granulocytopenia

Thrombocytopenia

Neutropenia

Haemolytic anaemia

Immune system

disorders

Anaphylactic

reaction (including

shock)

Hypersensitivity

Metabolism and

nutrition

disorders

Hyperkalemia

Psychiatric

disorders

Depression

Abnormal dreams

Insomnia

Nervous system

disorders

Dizziness

Paraesthesia

Tremor

Somnolence

Headache

Dysgeusia (abnormal

taste)

Eye disorders

Visual disturbance

Ear and labyrinth

disorders

Vertigo

Tinnitus

Cardiac disorders

Cardiac failure

Palpitations

Vascular

disorders

Hypertension

Flushing

Hot flush

Vasculitis

Respiratory,

thoracic and

mediastinal

disorders

Dyspnoea

Bronchospasm

Stridor

Gastrointestinal

disorders

Dyspepsia

Abdominal

pain

Nausea

Diarrhoea

Flatulence

Gastritis

Constipation

Vomiting

Mouth

ulceration

Melaena

Gastrointestinal

haemorrhage

Gastrointestinal

ulceration

Stomatitis

Intestinal perforation

Exacerbation of Crohn’s

disease and Colitis

Ulcerative

Haematemesis

Pancreatitis

MedDRa SOC

Common

1/100 to

<1/10

Uncommon

1/1,000 to

<1/100

Rare <

1/10,000 to

<1/1,000

Very rare/

<1/10,000

Hepatobiliary

disorders

Hepatic

enzyme

increased

Hepatic injury

(including hepatitis )

Jaundice

Blood alkaline

phosphatase increased

Skin and

subcutaneous

tissue disorders

Pruritus Rash

Dermatitis

Urticaria

Angioedema

Purpura

Severe mucocutaneous

skin reaction (including

Stevens Johnson

Syndrome and Toxic

Epidermal Necrolysis

Renal and urinary

disorders

Blood urea

increased

Blood

creatinine

increased

Renal failure Nephrotic

syndrome

General disorders

administration

site conditions

Oedema

Fatigue

Cramps in legs

Investigations

Weight increase

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions 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.

4.9

Overdose

a) Symptoms

Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal

irritation, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma,

drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting,

occasionally convulsions. In cases of significant poisoning acute renal failure and

liver damage are possible.

b) Therapeutic measure

Patients should be treated symptomatically as required.

Within one hour of ingestion of a potentially toxic amount, activated charcoal should

be considered. Alternatively, in adults, gastric lavage should be considered within one

hour of ingestion of a potentially life-threatening overdose.

Specific therapies such as dialysis or haemoperfusion are probable of no help in

eliminating NSAIDs due to their high rate of protein binding and extensive

metabolism.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Patients should be observed for at least four hours after ingestion of potentially toxic

amounts.

In case of frequent or prolonged convulsions, patients should be treated with

intravenous diazepam.

Other measures may be indicated by the patient's clinical condition.

Management of acute poisoning with oral aceclofenac essentially consists of supportive

and symptomatic measures for complications such as hypotension, renal failure,

convulsions, gastro-intestinal irritation, and respiratory depression.

5.1

Pharmacodynamic properties

Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic

properties.

The mode of action of aceclofenac is largely based on the inhibition to prostaglandin

synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclo-oxygenase, which is

involved in the production of prostaglandins.

5.2

Pharmacokinetic properties

After oral administration, aceclofenac is rapidly and completely absorbed as unchanged

drug. Peak plasma concentrations are reached approximately 1.25 to 3.00 hours

following ingestion. Aceclofenac penetrates into the synovial fluid, where the

concentrations reach approximately 57% of those in plasma. The volume of distribution

is approximately 25 L.

The mean plasma elimination half-life is around 4 hours. Aceclofenac is highly protein-

bound (>99%). Aceclofenac circulates mainly as unchanged drug. 4'-

Hydroxyaceclofenac is the main metabolite detected in plasma. Approximately two-

thirds of the administered dose is excreted via the urine, mainly as hydroxymetabolites.

No changes in the pharmacokinetics of aceclofenac have been detected in the elderly.

5.3

Preclinical safety data

The results from preclinical studies conducted with aceclofenac are consistent with those

expected for NSAIDs. The principal target organ was the gastro-intestinal tract. No

unexpected findings were recorded.

Aceclofenac was not considered to have any mutagenic activity in three in vitro studies

and an in vivo study in the mouse.

Aceclofenac was not found to be carcinogenic in either the mouse or rat.

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