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. Itmay harm them, even if theirsymptoms are the same as yours.

In this leaflet:1.What Eudemine is for2.Before you take Eudemine3.How to take Eudemine4.Possible side effects5.How to store Eudemine6.Further information.

1. What Eudemine is forEudemine belongs to a group ofmedicines called thiazides. These workby increasing levels of sugar in theblood.Eudemine is used to treat a conditioncalled ‘intractable hypoglycaemia’. Thisis when the sugar level in your bloodhas been very low for a long time. Alow sugar level in the blood is causedby an increase in the amount of thehormone insulin, being produced by thepancreas.It is important to take this medicine asvery low blood sugar can result inunusual behaviour, (such as aggression),sweating, a fast pulse and can lead to acoma, which may occur quite suddenly.

2. Before you take EudemineDo not take Eudemine if:• You are allergic to diazoxide• You are allergic to any of the other

ingredients of Eudemine (see section 6)• You are allergic to any other thiazide

drugs such as bendrofluazide• This is the first treatment you have

been given for your low blood sugar.If any of the above applies to you talkto your doctor or pharmacist.

Check with your doctor before takingEudemine if:• You have heart problems• You have kidney problems• You have high levels of uric acid in

your blood or have a history of gout• You have been told you have low

plasma proteins in your blood.

Tell your doctor if you are taking anyof the following medicines:Eudemine can increase the effect ofthese medicines:• Drugs to relieve water retention such

as frusemide• Drugs to lower your blood pressure

such as propranolol, methyldopa orcaptopril

• Drugs to thin your blood such aswarfarin.

Eudemine can cause high blood sugarlevels with these medicines:• Any drugs known as steroids or

corticosteroids, such as prednisoloneor betamethasone

• An oral contraceptive (the ‘Pill’)containing oestrogen and progesterone.

Eudemine can reduce the effect of thismedicine:

• A drug for epilepsy called phenytoin.Your doctor will regularly check thelevels of phenytoin in your blood andmay increase your dose.

Pregnancy and breast-feedingIf you are pregnant or trying to becomepregnant ask your doctor or pharmacistfor advice before taking Eudemine.Your doctor will tell you if you need totake Eudemine.If you take Eudemine for a long timewhilst you are pregnant it may causeyour newborn baby to lose its hair.Do not take Eudemine if you arebreastfeeding.

Driving and using machinesEudemine may cause you to feel faint,have difficulty moving, blurred visionand temporary cataracts. If any of thesehappens to you, do not drive or usemachinery.

Warnings about the ingredients inEudemineIf you have been told by your doctorthat you have intolerance to somesugars such as lactose or milk sugar,contact your doctor before takingEudemine.

3. How to take EudemineAlways take Eudemine exactly as yourdoctor has told you.

Important:Your doctor will choose the dose that isright for you. Your dose will be shownclearly on the label that yourpharmacist puts on your medicine. If itdoes not, or you are not sure, ask yourdoctor or pharmacist.

How much to take

Adults and children• The usual daily starting dose is 5 mg

for every kilogram of body weight.The total amount is divided into 2 or3 doses that are taken throughout theday

• Your doctor may increase your doseuntil it is right for you

• The usual daily maintenance dose isbetween 3 and 8 mg for everykilogram of body weight. This total isthen divided into two or three dosestaken throughout the day.

People with Kidney problemsIf you have kidney problems your doctormay choose a lower dose for you.

Children with leucine-sensitivehypoglycaemiaFor children with a certain type of hypo-glycaemia known as ‘leucine-sensitivehypoglycaemia’, the usual dose is between15 and 20 mg per kilogram per day.

Adults with tumours of the pancreasIf you are an adult with tumours of thepancreas which produce large amountsof the hormone insulin you may requirehigh doses of up to 1000 mg per day.

Medical check-upsWhile you are taking this medicine,your doctor may ask you to have check-ups. These are to make sure that yourmedicine is working properly and thatthe dose you are taking is right for you.• Your doctor will check your blood

sugar levels regularly in the first fewdays of treatment to see how the drugis working

• Your doctor will regularly check yourblood pressure

• Eudemine causes the body to retainwater so you may need to takeanother medicine called a diuretic tohelp your body get rid of this water.If you have to take a diurectic, yourdoctor may reduce your dose ofEudeminePa

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• Your doctor may prescribe a potassiumsupplement for you to stop yourpotassium levels going too low

• Your doctor may check the level of uricacid in your blood if you have a historyof high uric acid levels or gout

• If you take Eudemine for a long timeyour doctor will monitor the levels ofyour blood cells

• In children the doctor will check therate they are growing and developing.

If you take more Eudemine than you shouldIf you accidentally take too much,immediately go to the nearest hospitalcasualty department or your doctor.Too much Eudemine can cause very highlevels of sugar in your blood. This will betreated with other drugs to bring yourblood sugar back to normal. Too muchEudemine may also cause your bloodpressure to fall and again, you may begiven other medicines to bring this backto normal.

If you forget to take EudemineDo not take a double dose to make up fora missed dose. Simply take the next doseas planned.

If you stop taking EudemineDo not stop taking Eudemine withoutfirst talking to your doctor.If you have any further questions aboutthe use of this medicine, ask your doctoror pharmacist.

4. Possible side effectsLike all medicines Eudemine can causeside effects, although not everybody getsthem.

Seek immediate medical help if you feelfaint or dizzy, especially when you standup.

Effects on your heart and circulation• Fast or irregular heart beat (palpitations)• Chest pains• Collapse• Anaemia (which may make you feel

tired)• Reduced blood platelets (which increases

the chances of bleeding or bruising)• Changes to white blood cells (which

may cause a sore throat and fever).

Effects on the nervous system• Coma

• Symptoms similar to those seen inParkinson’s disease, such as shaking ofthe hands, difficulty moving and rollingof the eyes. Your doctor may treat thesewith an anti-Parkinson’s drug

• Headache

Effects on liver or kidneys• Weight gain• Feeling bloated and swollen• Changes in the way the liver and

kidney’s work, seen from blood orurine test results.

Effects on stomach and bowels• Feeling and being sick, especially during

the first 2-3 weeks of taking Eudemine.Your doctor may give you anothermedicine to stop this.

• Stomach pain• Loss of appetite• Diarrhoea• Constipation.

Effects on the eyes and skin• Sensitivity reactions such as rash or fever• Blurred vision• Cataracts which are temporary

• Increased growth of body hair.

Other effects• Breathlessness• Muscle pain• High levels of uric acid in the blood

(which may cause joint pain)• Changes to voice and abnormal facial

features in children• Hyperglycaemia (high sugar levels in

the blood) which may cause you to passlarge amounts of urine and/or makeyou thirsty.

Reporting of side effectsIf you get any side effects, talk to yourdoctor or pharmacist. This includes anypossible side effects not listed in thisleaflet. You can also report side effectsdirectly via Yellow Card Scheme on theMHRA website(www.mhra.gov.uk/yellowcard). Byreporting side effects you can helpprovide more information on the safety ofthis medicine.

5. How to store Eudemine TabletsKeep this medicine out of the sight andreach of children.Do not use Eudemine after the expirydate on the label. The expiry date refers

to the last day of that month.Medicines should not be disposed of viawastewater or household waste. Returnany medicine you no longer need to yourpharmacist.

6. Further informationWhat Eudemine containsThe active substance is diazoxide 50 mg.The other ingredients are lactose, maizestarch, pre-gelatinised magnesiumstearate, purified water.The tablet coating consists of sugar,gelatin coarse powder 200 bloom,purified water, carnauba wax (E903),beeswax, white (E901), polysorbate 20(E432) and sorbic acid (E200).

What Eudemine looks like?Eudemine tablets are white, sugar-coatedtablets. Eudemine comes in plasticcontainers containing 100 tablets.

Marketing Authorisation holderRPH Pharmaceuticals ABLagervägen 7,136 50 Haninge,Sweden

ManufacturerRecipharm LimitedVale of BardsleyAshton-under-LyneOL7 9RRUK

This leaflet was last updated December 2017

If this leaflet is difficult tosee or read or you wouldlike it in a differentformat, please contactRPH Pharmaceuticals ABLagervägen 7,136 50 Haninge,Sweden

11001731