Misofen 50mg/200microgram Modified Release Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Misofen 50mg/200microgram modified release Tablets
Diclofenac sodium/misoprostol
Read all of this leaflet carefully before you start taking
this medicine.
• 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 on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Misofen Tablets are and what they are used for
2. Before you take Misofen Tablets
3. How to take Misofen Tablets
4. Possible side effects
5. How to store Misofen Tablets
6. Further information
Misofen Tablets help to relieve the pain and swelling of rheumatoid arthritis and osteoarthritis, and may help to protect patients at risk of irritation or ulceration of the stomach or intestines.
Misofen Tablets contain diclofenac and misoprostol. Diclofenac belongs to a group of medicinal products called Non-Steroidal Anti-Inflammatory drugs (NSAIDs).
Although NSAIDs relieve the pain, they can reduce the amount of natural protective substances called prostaglandins in the stomach lining.
This means that NSAIDs can lead to stomach upsets or stomach ulcers. Misofen Tablets also contain misoprostol which is very similar to these prostaglandins and may help protect your stomach.
Do not take Misofen Tablets
• if you have had an allergic reaction such as a skin rash, swelling or itchiness of the skin, severe nasal congestion, asthma or wheezing after taking diclofenac or other NSAIDs such as aspirin (acetylsalicylic acid), misoprostol or another prostaglandin medicine, or any of the other ingredients in Misofen Tablets (see Further Information section 6)
• if you currently have an ulcer or perforation (hole) in your stomach or intestines
• if you currently suffer from bleeding in your stomach, intestines or brain
• if you are undergoing or you have just had coronary artery bypass graft (CABG) surgery
• if you have severe kidney or liver failure
• 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
• if you have or have had problems with your blood circulation (peripheral arterial disease)
• if you are pregnant, or trying to become pregnant, because it may cause a miscarriage. Women who have not reached the menopause should use reliable contraception while they are taking Misofen Tablets.
Take special care with Misofen Tablets
Check with your doctor if any of the following applies to
you:
• if you have any heart problems, previous stroke or think you might be at risk of these conditions
• If you smoke
• If you have diabetes
• If you have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides
• if you have other health problems such as a disease of the liver or kidneys. Do not take Misofen Tablets if you have severe kidney or liverfailure
• if you have previously had an ulcer or bleeding in your stomach or intestines. Do not take Misofen Tablets if you currently have an ulcer or bleeding in your stomach or intestines
• if you bleed or bruise easily
• if you have inflammation of the intestines (ulcerative colitis or Crohn's disease)
• if you have, or have ever had asthma or an allergic disease
• if you have an infection, as Misofen Tablets may mask a fever or other signs of infection
• if you are dehydrated
• if you are over the age of 65 as your doctor may want to keep a regular check on you.
NSAID medicines such as Misofen Tablets can cause bleeding or ulceration. If this occurs, treatment should be stopped.
Medicines such as Misofen Tablets 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.
As with other NSAIDs (e.g. ibuprofen) Misofen Tablets may lead to an increase in blood pressure, and so your doctor may ask to monitor your blood pressure on a regular basis.
If you have heart, liver or kidney problems, your doctor will want to monitoryou regularly.
Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following:
• Aspirin (acetylsalicylic acid) or other NSAIDs (e.g. ibuprofen)
• Medicines used to treat osteoarthritis or rheumatoid arthritis known as cyclo-oxygenase-2 (COX-2) inhibitors
• Diuretics (used to treat excess fluid in the body)
• Ciclosporin or tacrolimus (used for immune system suppression e.g. after transplants)
• Lithium (used to treat some types of depression)
• Digoxin (a medicine for an irregular heart beat and/or heart failure)
• Warfarin or other oral anticoagulants (blood-thinning agents that reduce blood clotting)
• Medicines used to treat anxiety and depression known as Serotonin Selective Re-uptake Inhibitors (SSRIs)
• Medicines used to control your blood sugar (oral hypoglycaemics for diabetes)
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
• Steroid medications (e.g. corticosteroids, which are often used as anti-inflammatory medicines)
• Medicines for high blood pressure (anti-hypertensives)
• Magnesium containing antacids (used to treat heartburn, indigestion)
• Quinolone antibiotics (used to treat some infections)
• Ketoconazole (used to treat some fungal infections)
• If you have taken a medicine called mifepristone (used to terminate pregnancy) within the last 12 days. Misofen Tablets should not be taken within 8-12 days of taking mifepristone.
Pregnancy and breast-feeding
Pregnancy
Do not use Misofen Tablets if you are pregnant or trying to become pregnant. Women who have not reached the menopause should use reliable contraception while they are taking Misofen Tablets.
Breastfeeding
Do not use Misofen Tablets while you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
If you feel dizzy or drowsy after taking Misofen Tablets, do not drive and do not use any tools or machines until these effects have worn off.
Important information about some of the ingredients of Misofen Tablets
Misofen Tablets contain lactose. If your doctor has told you that you are intolerant of some sugars, discuss it with them before taking this medicine.
Always take Misofen Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
One tablet two or three times a day, or as directed by your doctor.
Misofen Tablets should be swallowed whole with a drink of water (not chewed), taken during or after mealtimes. Do not take if the tablet is broken or damaged.
In the elderly and patients with liver or kidney disorders, your doctor may want to monitor you more closely. No change in dose is needed.
Children: Misofen Tablets are for adults only, they are not for use in children (under 18 years).
If you take more Misofen Tablets than you should
You should not take more tablets than your doctor tells you to. If you take too many tablets contact your doctor, pharmacist or hospital as soon as possible, and take your medicine with you.
If you forget to take Misofen Tablets
If you forget to take a tablet, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.
If you stop taking Misofen Tablets
Do not stop taking Misofen Tablets unless your doctor tells you to. If you have any questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Misofen Tablets can have side effects, although not everybody gets them.
If you are worried about side effects, ask your doctor. It is important that you know what can happen, so that you can take action if Misofen Tablets does have a side effect. Misofen Tablets sometimes cause side effects but these usually go away during treatment as your body gets used to the medicine.
If any of the following happen, stop taking Misofen Tablets and tell your doctor immediately:
If you have
• severe stomach pain or any sign of bleeding or rupture in the stomach or intestines, such as passing black or bloodstained stools, or vomiting blood - this occurs very rarely
• a serious skin reaction such as rash, blistering or peeling of the skin (Stevens-Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis) - this occurs very rarely
• a serious allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing (anaphylactic shock) - this occurs rarely)
• jaundice (your skin or the whites of your eyes look yellow) - this occurs rarely
Additionally, if any of the following side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Very common side effects
(affecting more than 1 in every 10):
• Stomach ache, diarrhoea, nausea (feeling sick), indigestion
Diarrhoea is the most common problem and is occasionally severe. You have less chance of getting diarrhoea if you take Misofen Tablets with food. If you use an antacid (something to reduce acid in the stomach) you should avoid antacids with magnesium in them as these may make diarrhoea worse. Your pharmacist can help you choose a suitable antacid. If this diarrhoea continues and is severe tell your doctor.
Common side effects
(affecting less than 1 person in every 10, but more than 1 in every 100):
• Rash, itching
• Vomiting, wind, constipation, burping, gastritis (indigestion, stomach ache, vomiting)
• Ulcers in the stomach or intestines
• Headache, dizziness
• Difficulty sleeping
• Changes in blood tests relating to the liver Uncommon side-effects
(affecting less than 1 person in every 100, but more than 1 in every 1000):
• Swelling of the mouth
• Abnormal or unexpected bleeding from the vagina, menstrual disturbances
• Reduction in the number of blood platelets (increased chance of bleeding or bruising)
• Purpura (purple spots on the skin)
• Urticaria (raised itchy rash)
Rare side-effects
(affecting less than 1 person in every 1,000, but more than 1 in every 10,000):
• Inflammation of the liver (possible yellow discoloration of skin, headache, fever, chills, general weakness)
Additional side effects experienced in actual use
(post-marketing experience, frequency unknown):
• Heart failure, chest pain, palpitations (awareness of your heartbeat)
• Damage to the gullet
• Worsening of ulcerative colitis or Crohn's disease (inflammation of the intestines)
• Kidney or liver problems
• Shortness of breath
• Seizures
• Allergic reaction, [including asthma, breathing problems, itching, hair loss, inflamed blood vessels (can cause fever, aches, purple blotches)]
• Symptoms of meningitis (stiff neck, headache, nausea (feeling sick), vomiting, fever or loss of consciousness)
• Fluid build-up in the body that can cause swollen ankles and legs
• Vomiting blood
• Psychotic reactions (mental disorder that features loss of contact with reality)
• Swelling of the tongue, mouth ulcers, dry mouth
• Depression, feeling anxious, mood swings, irritability, memory problems, feeling confused, feeling shaky, nightmares, drowsiness, tiredness
• Difficulty seeing, impaired or blurred vision, ringing in the ears, changes in the way things taste
• Chills, fever, increased sensitivity to light, inflammation
• Loss of appetite
• Abnormal contractions of the womb, rupture in the womb, retained placenta after giving birth, clotting in the amniotic fluid (fluid covering the foetus), bleeding in the womb, miscarriage, death of the unborn baby, birth defects, premature birth
• Low blood pressure, high blood pressure
• Reduction in the number of white blood cells (these help protect the body from infection and disease)
• Anaemia (low number of red blood cells) which can lead to pale skin and cause weakness or breathlessness.
Medicines such as Misofen Tablets may be associated with
a small increased risk of heart attack or stroke.
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOWTO STORE MISOFEN TABLETS
Keep out of the reach and sight of children. This medicine does not require any special storage conditions.
Do not use Misofen Tablets after the expiry date which is stated on the blister and carton, after the EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. These measures will help protect the environment. Return any leftover Misofen Tablets to your pharmacist.
6. FURTHER INFORMATION
What Misofen Tablets contain
The active substances are Diclofenac sodium and misoprostol, each tablet contains 50 mg diclofenac sodium and 200 micrograms misoprostol.
Other ingredients:
Core:
lactose monohydrate, microcrystalline cellulose, maize starch, povidone K-30, magnesium stearate, purified talc
Mantle/Coat:
Hypromellose, methylacrylic acid copolymer type C, purified talc, triethylcitrate, sodium starch glycolate, hydrogenated castor oil, microcrystalline cellulose
What Misofen Tablets look like and contents of the pack
White circular, uncoated tablets plain on one side and embossed with “DM2” on the other side.
Misofen Tablets are available in blister packs of 6,7,56,60, 84,100,120 and 140
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Morningside Healthcare Ltd.
115 Narborough Road Leicester, LE3 0PA, UK
Manufacturer:
Morningside Pharmaceuticals Ltd 5 Pavilion Way,
Loughborough, LE11 5GW, UK.
This medicinal product is authorised in the Member States of the EEA under the following names:
Ireland: Diclofenac/Misoprostol modified release tablets UK: Misofen
This leaflet was last revised in October 2013