- diclofenac sodium
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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 14017/0009.
Fenactol 75mg SR and Fenactol Retard 100mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
FENACTOL 75 MG SR® and FENACTOL® RETARD 100MG Prolonged-release tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
In this leaflet
1. What FENACTOL 75MG SR and FENACTOL RETARD 100MG are and what they are used for
2. What you need to know before you take FENACTOL 75MG SR or FENACTOL RETARD 100MG
3. How to take FENACTOL 75MG SR or FENACTOL RETARD 100MG
4. Possible side effects
5. How to store FENACTOL 75MG SR and FENACTOL RETARD 100MG
6. Contents of the pack and other information
1. WHAT FENACTOL 75MG SR and FENACTOL RETARD 100MG ARE AND WHAT THEY ARE USED FOR
Diclofenac sodium, the active ingredient in FENACTOL 75MG SR and FENACTOL RETARD 100MG tablets, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. FENACTOL 75MG SR and FENACTOL RETARD 100MG tablets are especially formulated to release the diclofenac sodium slowly.
FENACTOL 75MG SR and FENACTOL RETARD 100MG tablets relieve pain, reduce swelling and ease inflammation in conditions affecting the joints, muscles and tendons including:
They are also used to treat pain and inflammation associated with dental and minor surgery.
FENACTOL 75MG SR and FENACTOL RETARD 100MG tablets are not suitable for children.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENACTOL 75MG SR OR FENACTOL RETARD 100MG
Do not take FENACTOL 75MG SR or FENACTOL RETARD 100MG if
Warnings and precautions
Talk to your doctor or pharmacist before taking Diclofenac if:
Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before taking FENACTOL 75MG SR or FENACTOL RETARD 100MG as FENACTOL can sometimes worsen wound healing in your gut after surgery.
Tell your doctor or pharmacist if you have any of these conditions because FENACTOL 75MG SRor FENACTOL RETARD 100MG might not be the right medicine for you.
FENACTOL 75MG SR and FENACTOL RETARD 100MG tablets are not suitable for children.
Other medicines and Fenactol 75mg SR and Fenactol Retard 100mg
Some medicines can interfere with your treatment. Please tell your doctor or pharmacist if you are takingany of the following:
Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.
FENACTOL 75MG SR or FENACTOL RETARD 100MG with food and drink
Take this medicine with or after food
Pregnancy and breast-feeding
Driving and using machines
Very occasionally people have reported that diclofenac sodium tablets have made them feel dizzy, tired or sleepy. Problems with eyesight have also been reported. If you are affected in this way, you should not drive or operate machinery.
Other special warnings
FENACTOL 75MG SR and FENACTOL RETARD 100MG contains
FENACTOL 75MG SR and FENACTOL RETARD 100MG contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE FENACTOL 75MG SR or FENACTOL RETARD 100MG
The doctor will tell you how many FENACTOL 75MG SR or FENACTOL RETARD 100MG to take and when to take them. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
Take the tables with or after food.
Swallow the tablets whole with a glass of water. DO NOT crush or chew the tablets as this will affect the special “slow release” system.
The recommended dose is:
Adults: 100-150mg daily divided into two or three doses. The number of tablets which you take will depend on the strength the doctor has given you.
Your doctor may wish to increase your daily dose if required to 150mg.
Elderly: The lowest effective dose should be used. Your doctor may advise you to take a dose that is lower than the usual adult dose if you are elderly. Close surveillance is advisable.
Children: These tablets are not suitable for children.
The doctor may also prescribe another drug to protect the stomach to be taken at the same time, particularly if you have had stomach problems before, or if you are elderly, or taking certain other drugs as well.
If you take more FENACTOL 75MG SR or FENACTOL RETARD 100MG than you should
If you, or anyone else, accidentally takes too much FENACTOL 75MG SR or FENACTOL RETARD 100MG, tell your doctor or go to your nearest hospital casualty department immediately. Take your medicine pack with you so that people can see what you have taken.
Symptoms of an overdose can include: headache, nausea (feeling sick), vomiting, abdominal pain, stomach or intestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, ringing in the ears, fainting, or occasionally convulsions (seizures, uncontrolled fits).
If you forget to take FENACTOL 75MG SR or FENACTOL RETARD 100MG
It is important that you do not miss a dose. If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose, just take the next dose and forget about the one you missed. Do NOT take a double dose to make up for a forgotten tablet. Do not take more than 150 mg in 24 hours. If you have trouble remembering to take the tablets, tell your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, FENACTOL 75MG SR or FENACTOL RETARD 100MG can cause side effects, although not everybody gets them.
Some side effects can be serious
STOP TAKING FENACTOL 75MG SR or FENACTOL RETARD 100MG and tell your doctor straight away if you notice:
If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.
Tell your doctor immediately if you notice the following:
The side effects listed below have also been reported.
Common side effects (These may affect between 1 and 1 in 10 in every 100 patients):
Uncommon side effects (These may affect between 1 and 10 in every 1000 patients):
Rare side effects (These may affect between 1 in every 1,000 to 1 in every 10,000 patients):
Very rare side effects (These may affect less than 1 in every 10,000 patients):
Effects on the nervous system:
Inflammation of the lining of the brain (meningitis), tingling or numbness in the fingers, tremor, visual disturbances such as blurred or double vision, taste changes, hearing loss or impairment, tinnitus (ringing in the ears), sleeplessness, nightmares, mood changes, depression, anxiety, irritability, mental disorders, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the inside of the mouth or lips, , lower gut disorders (including inflammation of the colon or worsening of ulcerative colitis or Crohn’s disease), inflammation of the pancreas.
Effects on the chest or blood:
Hypertension (high blood pressure), hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), blood disorders (including anaemia).
Effects on the liver or kidneys:
Kidney or severe liver disorders including liver failure, presence of blood or protein in the urine
Effects on skin or hair:
Facial swelling, serious skin rashes including Stevens-Johnson syndrome, Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight.
Effects on the reproductive system:
Other side effects that have also been reported with unknown frequency include:
Throat disorders, confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves in the eye, disturbances of sensation.
Medicines such as diclofenac may be associated with a small increased risk of heart attack or stroke.
Do not be alarmed by this list - most people take Diclofenac Sodium Tablets without any problems.
If any of the side effects becomes serious, or if you notice side effects not listed in this leaflet, please tell your doctor. He/she may want to give you a different medicine.
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 at: 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 FENACTOL 75MG SR and FENACTOL RETARD 100MG
Keep out of the sight and reach of children.
Do not use FENACTOL 75MG SR or FENACTOL RETARD 100MG tablets after the expiry date which is printed after ‘Exp’on the carton.
Do not store above 25°C. Keep the tablets in their original pack.
Medicines should not be disposed of via waste water 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 FENACTOL 75MG SR and FENACTOL RETARD 100MG contain
The name of your medicine is FENACTOL 75MG SR or FENACTOL RETARD 100MG.
FENACTOL 75MG SR: Each prolonged-release tablet contains 75mg of the active ingredient diclofenac sodium, and also contains the following inactive ingredients: tablet core: cetostearyl alcohol, colloidal anhydrous silica, compressible sugar, talc, povidone and magnesium stearate. Subcoat: copovidone and sucrose. Tablet film coat: hydroxypropylmethylcellulose, polyethylene glycol, iron oxide red (E172), titanium dioxide (E171) and gum acasia. Polish: carnauba wax.
FENACTOL RETARD 100MG: Each prolonged-release tablet contains 100mg of the active ingredient diclofenac sodium, and also contains the following inactive ingredients: tablet core: cetostearyl alcohol, colloidal anhydrous silica, compressible sugar, talc, povidone, magnesium stearate. Subcoat: copovidone and sucrose. Tablet film coat: hydroxypropylmethylcellulose, polyethylene glycol, iron oxide red (E172), titanium dioxide (E171) and gum acasia. Polish: carnauba wax.
What FENACTOL 75MG SR and FENACTOL RETARD 100MG look like and contents of the pack
FENACTOL 75MG SR prolonged-release tablets are marked DICL75 on one side and are pink in colour. FENACTOL 75MG SR prolonged-release tablets are packed in cartons containing 28 tablets or 56 tablets in foil blister strips.
FENACTOL RETARD 100MG prolonged-release tablets are marked DICL100 on one side and are pink in colour. FENACTOL RETARD 100MG prolonged-release tablets are packed in cartons containing 28 tablets in foil blister strips.
Not all pack sizes may be marketed.
Marketing Authorisation Holder / Manufacturer:
This leaflet was last revised in December 2019
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+44 (0) 1748 828 784