Patient Leaflet Updated 25-Mar-2020 | Dexcel Pharma Ltd
PACKAGE LEAFLET: INFORMATION FOR THE USER
FENACTOL® TABLETS 50MG
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 TABLETS 50MG are and what they are used for
2. What you need to know before you take FENACTOL TABLETS 50MG
3. How to take FENACTOL TABLETS 50MG
4. Possible side effects
5. How to store FENACTOL TABLETS 50MG
6. Contents of the pack and other information
1. WHAT FENACTOL TABLETS 50MG ARE AND WHAT THEY ARE USED FOR
Diclofenac sodium, the active ingredient in FENACTOL TABLETS 50MG, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation.
FENACTOL 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FENACTOL TABLETS 50MG
Do not take FENACTOL TABLETS 50MG 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 TABLETS 50mg 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 TABLETS 50MG might not be the right medicine for you.
These tablets are not suitable for children aged under 12.
Other medicines and FENACTOL TABLETS 50mg
Some medicines can interfere with your treatment. Please tell your doctor or pharmacist if you are taking any 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 TABLETS 50MG 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 TABLETS 50MG contains
FENACTOL TABLETS 50MG contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
FENACTOL TABLETS 50MG contain a colouring agent, sunset yellow (E110), which may cause allergic reactions.
3. HOW TO TAKE FENACTOL TABLETS 50MG
The doctor will tell you how many FENACTOL TABLETS 50MG 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. Check with your doctor or pharmacist if you are not sure.
Take the tablets with or after food.
Swallow the tablets whole with a glass of water. DO NOT crush or chew the tablets.
The recommended dose is:
75 to 150 mg daily divided into two or three doses. The number of tablets which you take will depend on the strength the doctor has given you.
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. Your doctor may also want to check closely that the FENACTOL TABLETS are not affecting your stomach.
These tablets are not suitable for children aged under 12.
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 TABLETS 50MG than you should
If you, or anyone else, accidentally take too much FENACTOL, 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 TABLETS 50MG
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 TABLETS 50MG can cause side effects, although not everybody gets them.
Some side effects can be serious
STOP TAKING FENACTOL TABLETS 50MG 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 pancrease.
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 TABLETS 50MG
Keep out of the sight and reach of children.
Do not use FENACTOL 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 TABLETS 50MG contain
The name of your medicine is FENACTOL TABLETS 50MG.
FENACTOL TABLETS 50MG: Each gastro-resistant tablet contains 50 mg of the active ingredient diclofenac sodium, and also contains the following inactive ingredients: tablet core: copolyvidone, microcrystalline cellulose, colloidal anhydrous silica, lactose, maize starch, magnesium stearate, crospovidone. Tablet enteric coat: triethyl citrate, methacrylic acid-ethylacrylate copolymer (1:1) dispersion 30%, talc. Tablet film coat: hydroxypropylmethylcellulose, polyethylene glycol, iron oxide yellow (E172), iron oxide red (E172), sunset yellow (E110), titanium dioxide (E171). Polish: carnauba wax.
What FENACTOL TABLETS 50MG look like and contents of the pack
FENACTOL TABLETS 50MG gastro-resistant tablets are marked DICL50 on one side and are reddish-brown in colour. FENACTOL TABLETS 50MG gastro-resistant tablets are packed in cartons containing 28, 84 or 100 tablets in foil blister strips.
Not all pack sizes may be marketed.
Marketing Authorisation Holder/Manufacturer:
This leaflet was last revised in February 2020.
7, Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
+44 (0)1327 312 266
+44 (0)1327 312 262
+44 (0) 1748 828 784
+44 (0) 1748 828 784