The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 16973/0001.
PRESERVEX film-coated tablets
Preservex 100 mg film-coated Tablets
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
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:
if you are allergic to aspirin or any other NSAIDs (such as ibuprofen, naproxen or diclofenac).
Preservex is not recommended for use in children.
Before you start taking Preservex, tell your doctor:
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:
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’.
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 (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.
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 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 have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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:
STOP TAKING the medicine and seek medical advice if you experience:
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):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Very Rare (may affect up to 1 in 10,000 people):
Other side effects that have been reported with this type of drug (NSAIDs) are:
Exceptionally, serious skin infections occur in association with chickenpox
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.
Keep this medicine out of the sight and reach of children.
Store below 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. 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.
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.
Marketing Authorisation Holder:
This leaflet was last approved in October 2022.