contains the active ingredient bromocriptine (mesylate)
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about Kripton.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking Kripton against the benefits expected for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What Kripton is used for
Kripton contains the active ingredient bromocriptine which belongs to a group of medicines called ergot alkaloids. Bromocriptine has an effect on the body similar to that of a chemical messenger occurring naturally in the body called dopamine.
Kripton has several uses that have been outlined below.
Prevention of breast milk production (lactation) in women who cannot breastfeed for medical reasons. If breast milk production has already begun, your doctor can advise you about other methods of stopping lactation.
Treatment of abnormally high blood levels of a hormone called prolactin. This condition is sometimes caused by a tumour called prolactinoma. Kripton can be used alone or in combination with surgery to treat this tumour.
Treatment of acromegaly, a disease in which the body produces too much growth hormone. Kripton treats this disease by reducing the excessive amounts of growth hormone in the blood.
Treatment of Parkinson's disease, a condition where people experience shaking (tremor), muscle stiffness and slow and unsteady body movements. Kripton is often used in combination with other medicines such as levodopa to treat Parkinson's disease.
Ask your doctor if you have any questions about why Kripton has been prescribed for you.
Your doctor may have prescribed Kripton for another reason.
There is not enough information available to recommend the use of Kripton in children.
Kripton is available only with a doctor's prescription.
There is no evidence that Kripton is addictive.
Before you take Kripton
When you must not take it
Do not take Kripton if you are allergic to:
medicines containing bromocriptine
ergot alkaloids, such as ergotamine or dihydroergotamine, which are medicines usually used to treat migraine headaches
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath.
Do not take Kripton if you have or have had any of the following medical conditions:
severe heart disease
mental illness
high blood pressure that is not controlled
toxaemia (a condition where women experience high blood pressure, fluid build up or convulsions during pregnancy, immediately after giving birth or within several weeks of child birth).
Do not take this medicine if you are lactose or galactose intolerant.
This medicine contains lactose.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
This medicine contains lactose and allura red AC (an azo dye).
Tell your doctor if you are pregnant or plan to become pregnant.
Your doctor will discuss the risks and benefits of taking Kripton during pregnancy.
Tell your doctor if you are breastfeeding or wish to breastfeed.
Kripton is not recommended in women who wish to breastfeed as it stops breast milk production.
Tell your doctor if you have or have had, any of the following medical conditions:
diabetes
stomach and/or duodenal ulcers
liver problems
underactive thyroid gland
excessive drowsiness, or if you unexpectedly fall asleep
poor blood circulation.
Your doctor may want to take special care if you have any of these conditions.
If you have not told your doctor about any of the above, tell them before you start taking Kripton.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may be affected by Kripton, or may affect how well it works. These include:
other medicines containing ergot alkaloids, such as medicines used to treat migraine headaches and post-delivery bleeding
levodopa, a medicine used to treat Parkinson's disease
medicines used to treat high blood pressure (the combination may cause a sudden and excessive drop in blood pressure)
other medicines that may raise or lower blood pressure such as ergometrine, adrenaline and ephedrine
some medicines used to treat fungal infections (e.g. fluconazole, ketoconazole and voriconazole)
macrolide antibiotics (e.g. erythromycin, clarithromycin, roxithromycin)
some medicines used to treat HIV virus infections, such as ritonavir, nelfinavir, indinavir, and delavirdine
octreotide, an injection used in the treatment of acromegaly and certain tumours
dopamine antagonists, such as phenothiazines, butyrophenones, thioxanthenes, metoclopramide and domperidone; medicines used to treat nausea
sumatriptan, a medicine used to treat migraine
certain medicines used to treat mental illnesses, depression and psychotic conditions.
Your doctor can tell you what to do if you are taking any of these medicines.
If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Kripton.
How to take Kripton
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the bottle, ask your doctor or pharmacist.
How much to take
The dose varies from patient to patient.
A different dose may be required for patients with liver problems.
Prevention of breast milk production
One tablet (2.5 mg) is taken twice daily for 2 weeks. Some patients may require a further 1 week course of Kripton to bring the breast milk production under control.
Reducing prolactin levels
The usual starting dose is half a tablet (1.25 mg) two to three times a day. This dose may be gradually increased, if necessary, to one tablet three times each day. If the high prolactin levels are caused by a prolactinoma, the dose may be increased up to 15 mg daily, usually divided into 2 to 4 doses per day.
Acromegaly
The usual starting dose is half a tablet (1.25 mg) each night. The dose is then slowly increased over a period of 1 to 2 weeks, to one tablet (5 mg) four times a day. The dose can be further increased if needed. Most patients need between 10 mg and 30 mg per day. The maximum dose is not usually more than 40 mg per day.
Parkinson's disease
The usually starting dose is half a tablet (1.25 mg) once or twice a day for the first week. The dose may then be increased by half a tablet (1.25 mg) per week until the best effect is achieved. Most patients need between 5 mg and 40 mg per day in 3 or 4 divided doses.
How to take it
Swallow the tablets or capsules with a glass of water.
When to take it
Take Kripton during or immediately after food.
This will lessen the chance of nausea or stomach upset.
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
How long to take it
Keep taking Kripton for as long as your doctor recommends.
The length of treatment with Kripton will depend on the condition you are being treated for.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you are not sure what to do or have any questions, ask your doctor or pharmacist.
If you take too much (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Kripton. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much Kripton, you may vomit, feel sick, sleepy, dizzy or faint. You may also have hallucinations (see or hear things that are not there).
While you are taking Kripton
Things you must do
Do not use Kripton if you are breast feeding.
Women who have taken Kripton after childbirth or abortion have experienced some rare, serious side effects. These include fits, high blood pressure, stroke, heart attack and mental disorders.
If you are taking Kripton to prevent breast milk production or to lower prolactin levels and you do not wish to become pregnant, talk to your doctor about the need to use a reliable method of contraception.
Breastfeeding and high prolactin levels tend to reduce a woman's ability to fall pregnant. Taking Kripton may restore this ability.
If you become pregnant while taking Kripton, tell your doctor.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking Kripton.
Before starting any new medicine, tell your doctor or pharmacist that you are taking Kripton.
Visit your doctor regularly so that they can check on your progress, especially if you are taking Kripton for a long time.
Your doctor may want to check your blood, lungs, heart, blood pressure and womb from time to time. This helps to make sure the treatment is working and to prevent unwanted side effects.
Things you must not do
Do not use Kripton to treat any other complaints unless your doctor tells you to.
Do not give this medicine to anyone else, even if they have the same condition as you.
Things to be careful of
Be careful driving or operating machinery or doing jobs that require you to be alert until you know how Kripton affects you.
Kripton may make you feel dizzy, lightheaded or faint, especially when first starting to take it. It may also cause confusion and mental changes such as hallucinations in a few people. Very rarely it can cause extreme sleepiness and sudden onset of sleep in the middle of daytime activities, sometimes without warning.
If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.
Be careful getting up from a sitting or lying position.
Dizziness, lightheadedness or fainting may occur, especially when you get up quickly. Getting up slowly may help. Be especially careful when you first start to take Kripton.
Be careful when drinking alcohol while taking Kripton.
Your tolerance for alcohol may be lower than usual when taking Kripton. Combining Kripton and alcohol may cause unwanted side effects.
Tell your doctor or caregiver if you notice any unusual behavioural changes.
Some impulse control disorders have been reported in patients treated with high doses of this medicine. These may include in increased sexual drive, a failure to control gambling, or failure to resist a temptation, urge, or impulse.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Kripton.
Like all other medicines, Kripton may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Tell your doctor if you notice any of the following and they worry you:
feeling sick (nausea), vomiting
dizziness, lightheadedness or fainting, especially on standing up
drowsiness or sleepiness (if you have extreme sleepiness or sudden onset of sleep in the middle of daytime activities, tell your doctor immediately)
unexplained shortness of breath or difficulty breathing
severe, progressive, or persistent headaches
tiredness
blocked or stuffy nose (sinus congestion)
constipation, stomach pain
diarrhoea
nervousness
difficulty sleeping or restlessness
physical excitement or muscular activity associated with anxiety or mental tension (such as pacing, tapping of feet, or another repeated action)
feeling unsteady on your feet
depression (sad mood)
loss of appetite
dry mouth, metallic taste
sore eyes, blurred vision
hair loss
burning sensation in the breasts
leg cramps or burning feeling in the feet
pain, numbness, tingling or colour change in the fingers and toes when exposed to cold
buzzing, hissing, whistling, ringing or other persistent noise in the ears
uncontrollable twitching, jerking or writhing movements of the body
an irregular, slow, or fast heart beat
heartburn, recurrent stomach pain
swelling of the arms or feet due to fluid build up
sudden watery discharge from your nose
skin rash or itchiness
lower back pain, swollen legs and pain when passing urine
behavioural changes such as self-harm, urge to gamble, failure to resist a temptation or impulse, or increased sexual drive
strange or disturbing thoughts or moods
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you develop:
severe persistent headaches or vision problems. Some women who have taken Kripton to prevent breast milk production have had seizures (fits), high blood pressure, stroke, heart attack, or mental disorders. It is not known whether these problems are caused by Kripton or are complications of giving birth
any signs of stomach bleeding such as red or black bowl motions, bloody diarrhoea, bleeding from the back passage or vomiting blood. Some people being treated with high doses of Kripton for acromegaly have had serious stomach bleeding
confusion, hallucinations (seeing or hearing things that are not there) or sudden sleep attacks. Some people being treated with Kripton for Parkinson's disease, especially with high doses, have experienced mental changes
muscle stiffness, agitation, very high fever, or heart problems
wheezing, cough or other breathing problems, chest pain, back pain, swelling of the feet or kidney problems while taking Kripton.
When Kripton is used for a long time to treat Parkinson's disease, it can affect the lungs, heart or abdomen. Your doctor may ask you to have regular chest x-rays to see if you are developing any problems.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some patients.
After taking Kripton
Storage
Keep Kripton where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Keep your tablets or capsules in the pack until it is time to take them.
If you take the tablets or capsules out of the pack they will not keep well.
Keep Kripton tablets in a cool dry place where the temperature stays below 25°C. Keep the tablets away from light.
Keep Kripton capsules in a cool dry place where the temperature stays below 30°C.
Do not store Kripton or any other medicine in the bathroom or near a sink.
Do not leave Kripton in the car or on window sills.
Heat and dampness can destroy some medicines.
Disposal
If your doctor tells you to stop taking Kripton, or your medicine has passed its expiry date, ask your pharmacist what to do with any that is left over.
Product description
What it looks like
Kripton is available in 3 strengths and comes as tablets or capsules:
Kripton 2.5 - round, white, scored tablet marked BE/2.5 on one side and a Greek Alpha symbol on the reverse
Kripton 5 - grey and red capsule with "BE 5" printed on the grey half and a Greek Alpha symbol on the red half
Kripton 10 - yellow and red capsule with "BE 10" printed on the yellow half and a Greek Alpha symbol on the red half.
Kripton 2.5 is available in bottles of 30 and 60 tablets.
Kripton 5 is available in bottles of 60 capsules.
Kripton 10 is available in bottles of 100 capsules.
Ingredients
The active ingredient in Kripton tablets and capsules is bromocriptine (as bromocriptine mesylate):
each Kripton 2.5 tablet contains 2.5 mg of bromocriptine
each Kripton 5 capsule contains 5 mg of bromocriptine
each Kripton 10 capsule contains 10 mg of bromocriptine.
Kripton 2.5 tablets also contain the following inactive ingredients:
lactose
maize starch
colloidal anhydrous silica
maleic acid
magnesium stearate
disodium edetate.
Kripton 5 and 10 capsules also contain the following inactive ingredients:
lactose
maize starch
colloidal anhydrous silica
maleic acid
magnesium stearate
sodium lauryl sulfate
gelatin
shellac
propylene glycol
ammonium hydroxide
potassium hydroxide
titanium dioxide CI 77891 (E171)
iron oxide black CI 77499 (E172)
allura red AC CI 16035 (E129)
iron oxide yellow CI 77499 (E172) (10 mg only).
Kripton tablets and capsules are gluten free.
