Patient leaflet - Flamatak MR tablets 75 mg
1. What Flamatak MR Tablets are and what it is used for
Diclofenac sodium, the active ingredient in Flamatak MR Tablets, is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce pain and inflammation. Flamatak MR Tablets are specially formulated to release the diclofenac sodium slowly.
Flamatak MR Tablets relieve pain, reduce swelling and ease inflammation in conditions
affecting the joints, muscles and tendons including:
- Rheumatoid arthritis, osteoarthritis, acute gout, ankylosing spondylitis
- Backache, sprains and strains, soft tissue sports injuries, frozen shoulder,
- dislocations and fractures
- Tendonitis, tenosynovitis, bursitis.
They are also used to treat pain and inflammation associated with dental and minor
surgery.
2. What you need to know before you take Flamatak MR Tablets
Do not take if you:
- are allergic to diclofenac sodium, aspirin, ibuprofen or any other NSAID, or to any of the other ingredients of Flamatak MR Tablets (listed in section 6). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash or any other allergic type reaction you have now, or have ever had, a stomach (gastric) or small intestine (duodenal) ulcer, or bleeding in the digestive tract (this can include blood in vomit, bleeding when emptying bowels, fresh blood in faeces or black, tarry faeces)
- have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Flamatak or other pain medications
- have had stomach or bowel problems after you have taken other NSAIDs
- have severe heart, kidney or liver failure
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
have or have had problems with your blood circulation (peripheral arterial
disease)
- are more than six months pregnant.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Flamatak MR Tablets if you:
- suffer from any stomach or bowel disorders including ulcerative colitis or Crohn's disease
- have kidney or liver problems, or are you elderly
- have a condition called porphyria
- suffer from any blood or bleeding disorder. If you do, your doctor may ask you to go for regular check-ups while you are taking these tablets.
- have ever had asthma, hay fever, nasal swelling (polyps), breathing problems or chest infections.
- are breast-feeding
- have heart problems, or have you had a stroke, or do you think you might be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or are a smoker)
- have Lupus (SLE) or any similar condition
Other special warnings
You should take the lowest dose of Flamatak MR Tablets for the shortest possible time, particularly if you are underweight or elderly.
There is a small increased risk of heart attack or stroke when you are taking any medicine like Flamatak MR Tablets. The risk is higher if you are taking high doses for a long time.
Always follow the doctor’s instructions on how much to take and how long to take it for.
Whilst you are taking these medicines your doctor may want to give you a check-up from time to time.
If you have a history of stomach problems when you are taking NSAIDs, particularly if you are elderly, you must tell your doctor straight away if you notice any unusual symptoms.
Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before taking Flamatak MR Tablets, as Flamatak MR Tablets can sometimes worsen wound healing in your gut after surgery.
Because it is an anti-inflammatory medicine, Flamatak MR Tablets may reduce the symptoms of infection, for example, headache and high temperature. If you feel unwell and need to see a doctor, remember to tell him or her that you are taking Flamatak MR Tablets.
Other medicines and Flamatak MR Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
- Medicines to treat diabetes
- Anticoagulants (blood thinning tablets like warfarin)
- Diuretics (water tablets)
- Lithium (used to treat some mental problems)
- Methotrexate (for some inflammatory diseases and some cancers)
Ciclosporin and tacrolimus (used to treat some inflammatory diseases and after
transplants)
- Trimethoprim (a medicine used to prevent or treat urinary tract infections)
- Quinolone antibiotics (for infections)
Any other NSAID or COX-2 (cyclo-oxgenase-2) inhibitor, for example aspirin or
ibuprofen
- Mifepristone (a medicine used to terminate pregnancy)
- Cardiac glycosides (for example digoxin), used to treat heart problems
- Medicines known as SSRIs used to treat depression
- Oral steroids (an anti-inflammatory drug)
Medicines used to treat heart conditions or high blood pressure, for example betablockers
or ACE inhibitors.
- Voriconazole (a medicine used to treat fungal infections).
- Phenytoin (a medicine used to treat seizures)
- Colestipol/cholestyramine (used to lower cholesterol), take Flamatak MR tablets 1 hour before or 4-6 hours after taking these.
- Zidovudine (a medicine for viral infections)
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.
Pregnancy
Do not take Flamatak MR Tablets 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 Flamatak MR Tablets 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, Flamatak MR Tablets 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.
Taking Flamatak MR Tablets may make it more difficult to conceive. You should talk to your doctor if you are planning to become pregnant, or if you have problems getting pregnant.
Driving or using machines
Very occasionally people have reported that Flamatak MR Tablets have made them feel dizzy, tired or sleepy. Problems with eyesight and vertigo have also been reported. If you are affected in this way, you should not drive or operate machinery.
Flamatak MR Tablets contains Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Flamatak MR Tablets
Always take this medicine exactly as your doctor or pharmacist 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 them as this will affect the special 'slow release' system.
The recommended dose is:
Adults
75-150 mg daily divided into one to two doses. Do not take more than 150 mg in
24 hours.
Elderly
Your doctor may advise you to take a dose that is lower than the usual adult dose if you are elderly. Your doctor may also want to check closely that the Flamatak MR Tablets are not affecting your stomach.
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.
These tablets are not suitable for children.
If you take more Flamatak MR Tablets than you should
If you, or anyone else, accidentally takes too much, 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.
If you forget to take Flamatak MR Tablets
If you forget to take a dose, take one as soon as you remember. If it is nearly time for your next dose, though, just take the next dose and forget about the one you missed. Do not double up on the next dose to make up for the one missed.
If you have any further questions on the use of this medicine, as your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Flamatak MR Tablets and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
- Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome
- Stomach pain, indigestion, heartburn, wind, nausea (feeling sick) or vomiting (being sick)
- Any sign of bleeding in the stomach or intestine, for example, when emptying your bowels, blood in vomit or black, tarry faeces
Allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling
or blistering
- Wheezing or shortness of breath (bronchospasm)
- Swollen face, lips, hands or fingers
- A serious allergic skin reaction which may include large widespread red and/or dark patches, swelling of the skin, blisters, and itching (Generalised bullous fixed drug eruption)
- Liver function disorders, including hepatitis and jaundice (yellowing of your skin or the whites of your eyes).
- Blood disorders, including anaemia, which can include unexplained bleeding or bruising, frequent infections with sore throats, mouth ulcers or high temperatures, paleness and tiredness.
- An unexpected change in the amount of urine produced and/or its appearance
- Mild cramping and tenderness of the abdomen, starting shortly after the start of the treatment with Flamatak MR Tablets and followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from the available data).
Other side effects
Common side effects (may affect up to 1 in 10 people):
- Diarrhoea, loss of appetite
- Headache, dizziness, vertigo
- Skin rash or spots
- Raised levels of liver enzymes in the blood.
Rare side effects (may affect up to 1 in 100 people):
- Gastritis (inflammation, irritation or swelling of the stomach lining)
- Drowsiness, tiredness
- Hives (Urticaria)
- Fluid retention, symptoms of which include swollen ankles
- Liver function disorders, including hepatitis and jaundice.
Very rare side effects (may affect up to 1 in 10,000 people):
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, headaches together with a dislike of bright lights, fever and a stiff neck, disturbances in sensation. Impotence, irritability.
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 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, stroke. Hypotension (low blood pressure, symptoms of which may include faintness, giddiness or light headedness)
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:
Hair loss, skin itching.
Not known (frequency cannot be estimated from the available data):
Confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the nerves in the eye, taste changes.
An allergic skin reaction, that may include round or oval patches of redness and swelling of the skin, blistering, and itching (Fixed drug eruption). Darkening of the skin in affected areas, which might persist after healing, may also occur. Fixed drug eruption usually reoccurs at the same site(s) if the medication is taken again.
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 Flamatak MR Tablets
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister after EXP. The expiry date refers to the last day of that month.
Do not store above 25oC.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicine you no longer use. These measures will help protect the environment.
- 6. Content of the pack and other information
What Flamatak MR Tablets contains
The active substance is Diclofenac Sodium, Each tablet contains 75mg of diclofenac sodium.
The other ingredients are lactose monohydrate, magnesium stearate (E572), methylhydroxypropylcellulose (E464), microcrystalline cellulose (E460), povidone, talc (E553) and Iron Oxide Red (E172).
Contents of the pack
Pack size:
28 or 56 blisters
Marketing Authorisation Holder
Accord, Barnstaple, EX32 8NS, UK
Manufacture
Actavis hf,
Reykjavikurvegur 78
IS-220 Hafnarfjordur,
Iceland.