Preservex 100 MG Film-Coated Tablets: (Aceclofenac)
Preservex 100 MG Film-Coated Tablets: (Aceclofenac)
Preservex 100 MG Film-Coated Tablets: (Aceclofenac)
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 (cyclosporin 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.
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 30C.
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.
If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
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) CONTENTS OF THE PACK AND OTHER INFORMATION
What Preservex contains
Each film-coated tablet contains 100 mg aceclofenac.
The other ingredients are:
Microcrystalline cellulose, croscarmellose sodium, glyceryl
palmitostearate, povidone, hypromellose, polyoxyethylene 40 stearate
and titanium dioxide (E 171).
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 40 and 60 tablets.
Manufacturer
Industrias Farmacuticas Almirall, S.L., Ctra. Nacional II, Km. 593 08740,
Sant Andreu de la Barca, Barcelona, Spain
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER, UK
Repackaged by MPT Pharma Ltd.
PL: 33532/0533
POM
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. Aceclofenac should be
discontinued at the first onset of a skin rash, injuries of mucous
membrane or any signs of hypersensitivity.
Medicines such as Aceclofenac 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 Aceclofenac
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 (cyclosporin 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
Aceclofenac with food and drink
Aceclofenac 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 Aceclofenac 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.
Aceclofenac 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 Aceclofenac and you experience dizziness, drowsiness,
vertigo, tiredness or any visual disturbances, you must not drive or use
machinery.
3) HOW TO TAKE ACECLOFENAC
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 Aceclofenac 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
Aceclofenac for you, you will be given the lowest effective dose over the
shortest duration.
If you take more Aceclofenac than you should
If you accidentally take too many Aceclofenac tablets, contact your
doctor immediately or go to your nearest hospital casualty department.
Please take this leaflet or the box the Aceclofenac tablets came in, with
you to the hospital so that they will know what you have taken.
If you forget to take Aceclofenac
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 Aceclofenac
Do not stop taking Aceclofenac unless your doctor advises you.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.
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 ACECLOFENAC
Keep out of the sight and reach of children.
Do not store above 30C.
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 Aceclofenac in the original box.
If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
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) CONTENTS OF THE PACK AND OTHER INFORMATION
What Aceclofenac contains
Each film-coated tablet contains 100 mg aceclofenac.
The other ingredients are:
Microcrystalline cellulose, croscarmellose sodium, glyceryl
palmitostearate, povidone, hypromellose, polyoxyethylene 40 stearate
and titanium dioxide (E 171).
What Aceclofenac looks like and contents of the pack
Aceclofenac 100 mg film-coated tablets are white, round tablets.
Aceclofenac tablets are available in boxes of 40 and 60 tablets.
Manufacturer
Industrias Farmacuticas Almirall, S.L., Ctra. Nacional II, Km. 593 08740,
Sant Andreu de la Barca, Barcelona, Spain
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER, UK
Repackaged by MPT Pharma Ltd.
PL: 33532/0533
POM