Slofenac 75mg Sr
Effects on the nervous system:
Tingling or numbness in the fingers, tremor, blurred or double vision, hearing loss or impairment, tinnitus ringing in the ears), sleeplessness, nightmares, mood changes, depression, anxiety, mental disorders, disorientation and loss of memory, fits, headaches together with a dislike of bright lights, fever and a stiff neck, disturbances in sensation.
Effects on the stomach and digestive system:
Constipation, inflammation of the tongue, mouth ulcers, inflammation of the inside of the mouth or lips, taste changes, lower gut disorders (including inflammation of the colon or worsening of ulcerative colitis or Crohn’s disease).
Effects on the heart, chest or blood:
Palpitations (fast or irregular heart beat), chest pain, hypertension (high blood pressure), inflammation of blood vessels (vasculitis), inflammation of the lung (pneumonitis), heart disorders, including congestive heart failure or heart attack, 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:
Serious skin rashes including Stevens-Johnson syndrome, Lyell’s syndrome and other skin rashes which may be made worse by exposure to sunlight. Hair loss.
Other side effects that have also been reported include:
Inflammation ofthe pancreas, impotence. Facial swelling, inflammation ofthe lining ofthe brain (meningitis), stroke, throat disorders, confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves in the eye.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at 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 Slofenac SR
• Do not store above 25°C. The blister strips should be kept in the outer carton to protect the tablets from light.
• Do not put them into another container as they might get mixed up.
• Keep out of the reach and sight of children.
• Do not use Slofenac SR after the expiry date which is stated on the blister and the carton after EXP or EXP. DATE
• 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.
This leaflet does not contain all the information about your medicine. If you have any questions or are not
sure about anything ask your doctor or pharmacist._
6. Contents of the pack and other information
What Slofenac SR contains
The active substance is Diclofenac sodium 75mg or 10Omg. The other ingredients are: talc, ethylcellulose, povidone, stearic acid, magnesium stearate, diethyl phthalate, hypromellose, titanium dioxide (E171) and macrogol 4000. Slofenac 100mg SR tablet also contains red and yellow iron oxides (E172).
What Slofenac SR looks like and contents ofthe pack
The 75mg tablets are white, triangular and are marked ‘S56’ on one side.
The 100mg tablets are pale red, round and are marked ‘S58’ on one side.
The 75mg and 100mg tablets are supplied in packs of 28, 30, 50, 56, 60, 84, 100, 250, 500, 1000 . Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Product Licence holder for your tablets is: Rl Pharma Ltd, 6 St. John’s Court, First Floor, Upper Forest Way, Swansea Enterprise Park, Swansea SA6 8QQ.
The manufacturer for your tablets is Rl Pharma Ltd, Old Police Station, Church Street, Swadlincote, DE1 1 8LN.
If you would like this leaflet in a different format please contact the licence holder at the following address: Rl Pharma Ltd, 6 St. John’s Court, First Floor, Upper Forest Way, Swansea Enterprise Park, Swansea SA6 8QQ or e-mail at info@ri-pharma.com.
If you would like to have any further information or want to report any side effects, please email at info@ri-pharma.com
This leaflet was last updated in December 2014 POM
G2014092167/4825/1
Package Leaflet: Information for the User
SLOFENAC 75 MG AND 100MG SR
Diclofenac sodium
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 or pharmacist.
• This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (See section 4).
What is in this leaflet:
1. What Slofenac SR is and what it is used for
2. What you need to know before you take Slofenac SR
3. How to take Slofenac SR
4. Possible side effects
5. How to store Slofenac SR
6. Contents of the pack and other information
1. What Slofenac SR is and what it is used for
These tablets contain Diclofenac sodium. Diclofenac belongs to a group of medicines known as ‘Non-Steroidal Anti-Inflammatory Drugs’ (NSAID).
They are used to relieve pain and inflammation in a variety of conditions including:
1. Rheumatoid arthritis, osteoarthritis and arthritis of the spine (ankylosing spondylitis).
2. Gout.
3. Lower back pain.
4. Tendon and joint pain.
5. Bone or muscle pain (particularly frozen shoulder).
6. Dislocations, fractures, sprains and strains.
7. Minor surgery (including dental surgery)._
2. What you need to know before you take Slofenac SR
Do not take Slofenac SR:
1. If you are allergic (hypersensitive) to Diclofenac or any of the other ingredients of this medicine (listed in section 6).
2. If you have previously experienced an allergic reaction to ibuprofen, aspirin or any other NSAIDs. The symptoms of an allergic reaction include itching, nettle rash, wheezing or swelling of the hands, throat, mouth or eyelids.
3. If you suffer from severe liver, kidney or heart failure.
4. If you are more than 6 months pregnant because Slofenac may affect the unborn baby.
5. If you have now, or have ever had, a stomach (gastric) or duodenal (peptic) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels).
6. If you have had stomach or bowel problems after you have taken other NSAIDs.
7. 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.
8. If you have or have had problems with your blood circulation (peripheral arterial disease).
Warning and Precautions
Talk to your doctor or pharmacist before taking Slofenac SR:
1. If you are elderly - as you are more at risk from suffering serious side effects such as bleeding from the stomach.
2. If you have, or have ever had, a type of asthma (wheezing) known as bronchial asthma.
3. If you have any problems with your liver including hepatic porphyria (a type of liver disease).
4. If you have problems with your kidneys or are taking diuretics (water tablets).
5. If you are recovering from major surgery.
6. If you have problems with your heart, have ever had high blood pressure or experienced heart failure.
7. If you have stomach ulcers, blood in you vomit, passed black tarry stools, experienced bleeding from
the stomach, have ulcerative colitis or Crohn’s disease (a type of stomach disease).
8. If you have any bleeding problems.
9. If you are taking corticosteroids, anticoagulants such as warfarin or aspirin (an NSAID).
10. If you have systemic lupus erthematosus (SLE) or a mixed connective tissue disorder, as you have a high risk of suffering from meningitis.
11. If you have difficulties conceiving or are undergoing investigation of infertility.
12. If you smoke.
13. If you have diabetes.
14. If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides.
Risk of heart attack and stroke
Medicines such as Slofenac SR 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.
If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
Tests while taking this medicine
Your doctor will monitor your liver and kidneys during your treatment with Slofenac SR, in order to make sure that they are working properly.
Other medicines and Slofenac SR:
Tell your doctor before taking this medicine if you are already taking any of the following:
• Aspirin or any other painkillers called NSAIDS e.g. Ibuprofen.
• Medicines used to treat high blood pressure (anti-hypertensives) e.g. Atenolol.
• Diuretics (water tablets).
• Medicines used to treat heart failure (cardiac glycosides) e.g. Digoxin.
• Lithium - used to treat depression.
• Methotrexate - used to treat cancer.
• Ciclosporin or tacrolimus - medicines used to help prevent rejection of transplants.
• Mifepristone - a medicine used for abortion.
• Corticosteroids e.g. Methylprednisolone - used to treat allergic disorders.
• Anticoagulants such as warfarin.
• Quinolone antibiotics - used to treat bacterial infections.
• Antidiabetic drugs e.g. Metformin- used to treat diabetes.
• Trimethoprim (a medicine used to prevent or treat urinary tract infections).
• Medicines known as SSRIs used to treat depression.
• Voriconazole (a medicine used to treat fungal infections).
• Phenytoin (a medicine used to treat seizures).
• Colestipol/cholestyramine (used to lower cholesterol).
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding Pregnancy:
Taking Slofenac may make it more difficult to become pregnant and may affect your unborn baby. Therefore, you should not take this medicine if you are planning a pregnancy, or if you are pregnant unless your doctor tells you to.
Breast feeding:
A small amount of Diclofenac sodium passes into breast milk. Speak to your doctor or pharmacist before taking this medicine if you are planning to breast feed or if you are breastfeeding.
Fertility:
The use of Slofenac may impair female fertility and is not recommended in women attempting to conceive. In women who may have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Slofenac should be considered.
Driving and using machines
Do not drive or operate machinery if you experience any dizziness, drowsiness, fatigue, vertigo, somnolence, central nervous system disturbances, or visual disturbances while taking this medicine.
3. How to take Slofenac SR
Always take Slofenac SR exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults
The normal daily dose in adults and healthy elderly patients is one 100 mg tablet a day or one 75 mg tablet once or twice a day.
The duration of treatment will depend on the condition being treated. Your doctor may decide to change your
dose and it is always important to follow your doctor's advice about when and how to take your medicine. The elderly
Your doctor will prescribe you a much lower starting dose and he/she may then increase your dose gradually until the lowest dose required to effectively treat your condition is reached. You may be monitored more closely during your treatment for any serious side effects.
Children
These tablets are not suitable for children.
Taking your tablets
Swallow the tablets whole, with liquid, with or after food.
These tablets have a special coating that slows the release of the active ingredient. Do not break or chew the tablets. If you notice any defects or if the tablets are broken or chipped you must take them to your pharmacist for advice before taking them.
If you take more Slofenac SR than you should
As with all medicines an overdose could be dangerous. If you or someone else has taken too many tablets tell your doctor or go to the nearest hospital casualty department immediately. Take the tablet pack with you. The symptoms of Slofenac SR tablets overdose are headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting or convulsions. If you forget to take Slofenac SR
If you have forgotten to take a dose do not make up for this by taking an extra tablet. Continue with your usual routine and take your next tablet at the next prescribed time, take care not to take 2 doses close together. Do not take more than 150 mg in 24 hours. If you are at all concerned about this consult your doctor or pharmacist.
If you stop taking Slofenac SR
Do not stop taking your Slofenac SR without talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, these tablets can cause side effects, although not everybody gets them.
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
Some side effects can be serious
Stop taking Slofenac SR and tell your doctor straight away if you notice:
1. Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick).
2. Any sign of bleeding in the stomach or intestine, for example, when emptying your bowels, blood in vomit or black, tarry faeces.
3. Allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering.
4. Wheezing or shortness of breath (bronchospasm).
5. Swollen face, lips, hands or fingers.
6. Yellowing of your skin or the whites of your eyes.
7. Persistent sore throat or high temperature.
8. An unexpected change in the amount of urine produced and/or its appearance.
If you notice that you are bruising more easily than usual or have frequent sore throats or infections, tell your doctor.
The side effects listed below have also been reported:
Common side effects (These may affect between 1 and 10 in every 100 patients):
• Stomach pain, heartburn, nausea, vomiting, diarrhoea, indigestion, wind, loss of appetite
• Headache, dizziness, vertigo
• Skin rash or spots
• Raised levels of liver enzymes in the blood.
Rare side effects (These may affect between 1 in every 1000 to 1 in every 10,000 patients):
• Stomach ulcers or bleeding (there have been very rare reported cases resulting in death, particularly in the elderly).
• Gastritis (inflammation, irritation or swelling of the stomach lining).
• Vomiting blood.
• Diarrhoea with blood in it or bleeding from the back passage.
• Black, tarry faeces or stools.
• Drowsiness, tiredness.
• Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness).
• Skin rash and itching.
• Fluid retention, symptoms of which include swollen ankles.
• Liver function disorders, including hepatitis and jaundice.
Very rare side effects (These may affect less than 1 in every 10,000 patients):