MISOFEN 50 MG / 200MICROGRAMSMODIFIED RELEASE TABLETS - patient leaflet, side effects, dosage

Misofen

50mg/200microgram modified-release Tablets

Diclofenac sodium, misoprostol

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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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 Misofen Tablets are and what they are used for

• 2. What you need to know before you take Misofen Tablets

• 3. Howto take Misofen Tablets

• 4. Possible side effects

• 5. How to store Misofen Tablets

• 6. Contents of the pack and other information

• 1. What Misofen Tablets are and what they are used for

Misofen Tablets helps 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 contains 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 contains misoprostol which is very similar to these prostaglandins and may help protect your stomach.

2. what you need to know before you take misofen tablets

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 section 6),
• currently have an ulcer or perforation (hole) in your stomach or intestines,
• currently suffer from bleeding in your stomach, intestines or brain,
• are undergoing or you have just had coronary artery bypass graft (CABG) surgery,
• have severe kidney or liver failure,
• have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, ministroke (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 a woman of childbearing age and you are not using an effective contraceptive method to avoid becoming pregnant (see Section on ‘Pregnancy’ for further information).
• 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
• are allergic to diclofenac sodium and/or misoprostol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Misofen:

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 liver failure,
• 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,
• bleed or bruise easily,
• have inflammation of the intestines (ulcerative colitis or Crohn’s disease),
• have, or have ever had asthma or an allergic disease,
• have an infection, as Misofen Tablets may mask a fever or other signs of infection,
• are dehydrated,
• are over the age of 65 as your doctor may want to monitor you regularly.
• are pregnant or plan to become pregnant (see section on “pregnancy”). Due to the risk for the foetus, your treatment with Misofen must be discontinued immediately.
• are a woman of childbearing age (see also section on “pregnancy” ). It is important to use effective contraception while you are taking this medicine.
• recently had or you are going to have a surgery of the stomach or intestinal tract before receiving/takin­g/using Misofen, as Misofen can sometimes worsen wound healing in your gut after surgery.

NSAID medicines such as Misofen Tablets can cause bleeding or ulceration. If this occurs, treatment should be stopped.

Use of Misofen Tablets with another NSAID other than aspirin (e.g. ibuprofen) may also increase frequency of ulcers or bleeding in your stomach or intestines. Misofen Tablets may cause serious side effects, especially stomach and intestinal complications, if you are using a corticosteroid (e.g. prednisone), an oral anticoagulant, or a Selective Serotonin Re-uptake Inhibitor (e.g. sertraline) or if you drink alcohol.

Make sure your doctor knows, before you are given Misofen Tablets

If you:

• smoke
• have diabetes
• have angina, blood clots, high blood pressure, raised cholesterol or raised triglycerides

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 monitor you regularly.

Side effects may be minimised by using the lowest effective dose for the shortest duration necessary.

Other medicines and Misofen Tablets

Some medicines can affect the way other medicines work. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription or herbal medicines, including:

• 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 e.g. aspirin),
• 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) except insulin,
• 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, fluconazole, miconazole and voriconazole (used to treat some fungal infections),
• Amiodarone (used to treat an abnormal heart beat)
• Sulfinpyrazole (used to treat gout)
• 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 take Misofen Tablets if you are pregnant, think you may be pregnant or trying to become pregnant. You should tell your doctor if you are planning to become pregnant. Due to the possible risk of damage to the foetus, you must make sure you are not pregnant beforestarting treatment. Women who have not reached the menopause must use reliable contraception while they are taking Misofen Tablets.

Your doctor will make you aware of the risks if you do become pregnant while taking Misofen as it may cause a miscarriage, premature birth abnormal formation of the foetus (birth defects).

You should NEVER take this medicine if you are pregnant, as it can also have severe consequences on your child, especially on the heart, lungs and/or kidneys, including death. If you have received treatment with this medicine during pregnancy, talk with your doctor. If you decide to continue with the pregnancy, careful ultrasound scan monitoring of the pregnancy, with special attention to the limbs and head must be carried out.

Breast-feeding

Ask your doctor or pharmacist for advice before taking this medicine if you are breast-feeding.

Do not use Misofen Tablets while you are breast-feeding.

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.

Misofen Tablets contain lactose

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.

Important information about Misofen Tablets

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take misofen tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet twice 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.

Use in 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 a forgotten dose.

If you stop taking Misofen Tablets

Do not stop taking Misofen Tablets unless your doctor tells you to.

If you have any further questions on the use of this medicine ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause 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 do 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

• Weakness of or inability to move one side of body, slurred speech (stroke) or chest pain (heart attack) or heart failure or palpitations (awareness of your heartbeat) – the occurrence is uncommon
• Shortness of breath – the occurrence is uncommon
• Misofen Tablets can cause a decrease in a type of white blood cell (these help protect the body from infection and disease) and lead to infections with symptoms like chills, sudden fever, sore throat or flu-like symptoms -the occurrence is uncommon
• Severe stomach pain or any sign of bleeding or rupture in the stomach or intestines, such as passing black or bloodstained stools – the occurrence is uncommon, or vomiting blood – this occurs 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
• Reduction in the number of blood platelets (increased chance of bleeding or bruising)
• Symptoms of meningitis (stiff neck, headache, nausea (feeling sick), vomiting, fever or loss of consciousness) – it is not known how often this occurs
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome – it is not known how often this occurs

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Very common (may affect more than 1 in 10 people)

• 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 (may affect up to 1 in 10 people)

• Rash, itching,
• Vomiting, wind, constipation, burping, gastritis (indigestion, stomach ache, vomiting), farting,
• Ulcers in the stomach or intestines,
• Headache, dizziness,
• Difficulty sleeping,
• Changes in blood tests relating to the liver.
• Inflammation of the digestive tract, including the intestines, such as nausea, diarrhoea, abdominal pain
• Abnormal formation of foetus
• Inflammation of the duodenum
• Inflammation of the lining of the gullet (oesophagus)

Uncommon (may affect up to 1 in 100 people)

• Fluid build-up in the body that can cause swollen ankles and legs
• Abnormal or unexpected bleeding from the vagina, menstrual disturbances,
• Hypersensitivity
• Purpura (purple spots on the skin),
• Urticaria (raised itchy rash).
• Infection of the vagina (itching, burning, soreness, pain especially during intercourse and/or urination)
• Blurred vision
• High blood pressure
• Loss of appetite
• Menstrual disorders such as usually heavy or light bleeding, or delayed periods
• Chills or fever
• Drowsiness, tiredness, feeling shaky
• Ringing in the ears
• Depression and feeling anxious
• Tingling or pricking (pins and needles)
• Mouth ulcers and dry mouth
• Gastrointestinal bleeding
• Blood bilirubin increased, aspartate aminotransferase increased
• Sore or inflammation inside of the mouth
• Swelling of the mouth

Rare (may affect up to 1 in 1,000 people)

• Inflammation of the liver (possible yellow discoloration of skin, headache, fever, chills, general weakness)
• Inflammation of the pancreas, which causes severe pain in the abdomen and back
• Inflammation of the lung such as coughing, increased sputum
• Breastpain
• Vomiting blood
• Worsening of ulcerative colitis (inflammation of lower intestine)
• Damage to the gullet
• Low blood pressure
• Hair loss
• Increased sensitivity to light
• Nightmares
• Swelling underneath the skin
• Inflammation of the skin
• Painful menstrual/period cramps
• Oesophageal disorder

Very rare: may affect up to 1 in 10,000 people

• Severe liver disorders including liver failure

Not known: frequency cannot be estimated from the available data

• Worsening of ulcerative colitis or Crohn’s disease (inflammation of the intestines),
• Kidney or liver problems,
• Seizures,
• Inflamed blood vessels (can cause fever, aches, purple blotches),
• Psychotic reactions (mental disorder that features loss of contact with reality),
• Mood swings, irritability, memory problems, feeling confused
• Difficulty seeing, changes in the way things taste,
• Inflammation,
• Abnormal contractions of 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, premature birth,
• Anaemia (low number of red blood cells) which can lead to pale skin and cause weakness or breathlessness.
• Uterine haemorrhage, uterine spasm, decreased fertility in females
• Swelling in the feet, ankles and legs, Swelling of tongue
• Skin reaction, rash

5. how to store misofen tablets

Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions.

Do not use this medicine 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Misofen Tablets contain

The active substances are Diclofenac sodium and misoprostol, each tablet contains 50 mg diclofenac sodium and 200 micrograms misoprostol.

The other ingredients are:

Core:

lactose monohydrate, microcrystalline cellulose, maize starch, povidone K-30, magnesium stearate and purified talc.

Mantle/Coat:

hypromellose, methylacrylic acid copolymer type C, purified talc, triethylcitrate, sodium starch glycolate, hydrogenated castor oil and 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 leaflet was last revised in February 2021