Dopergin Consumer Medicine Information

lisuride 0.2mg tablets

What is in this leaflet

Please read this leaflet carefully before starting to use DOPERGIN. It will advise you about how to use DOPERGIN properly and when to tell your doctor about health-related conditions. If you have any questions or need more advice, ask your doctor, professional health care provider or pharmacist.

What is DOPERGIN used for and how does it work

Brain cells communicate by neurotransmitters with other parts of the body. DOPERGIN is a preparation that improves the way these neurotransmitters communicate.

Special nerve cells (neurons) in the brain use the neurotransmitter dopamine, which essentially is responsible for controlling movement. People with Parkinson's Disease have a deficiency of this type of neurotransmitter. By improving the effect of dopamine DOPERGIN can be used in the treatment of Parkinson's Disease.

DOPERGIN also acts as an inhibitor of the hormone prolactin which is involved in controlling lactation.

How does DOPERGIN work?

The active substance in DOPERGIN tablets is lisuride hydrogen maleate. Each tablet contains 0.2mg of this active substance which has a pronounced affinity (attraction) for dopamine receptors in the brain.

Parkinsonism

Parkinsonism (a classified group of neurological disorders) is a dopamine deficiency disease. By replacing the effect of the missing dopamine DOPERGIN improves or eliminates the reduced body movement, rigor and tremor symptoms which are common in Parkinsonism patients.

The combination of DOPERGIN with L-dopa-containing preparations is particularly effective and allows low dosages of both active substances. The two substances complement each other in the way they work, since L-dopa requires intact dopamine neurons to be effective, while DOPERGIN directly stimulates postsynaptic dopamine receptors. Combining L-dopa containing preparations with DOPERGIN may influence fluctuations of locomotion and dyskinesia in a favourable manner and may even retard their occurrence.

Endocrine indications

The function of the mammary gland is essentially controlled by prolactin, a hormone produced by the pituitary. DOPERGIN acts to suppress the normal production and flow of milk (primary ablactation). DOPERGIN may also improve pathological states of the mammary gland (galactorrhea).

Elevated prolactin levels also inhibit the function of the gonads. Amenorrhea (absence or abnormal stoppage of menstruation), cycle disturbances and infertility resulting from these conditions can therefore be treated with DOPERGIN if they are based on an elevated prolactin level.

In addition the above-mentioned disorders can also be caused by prolactin-producing pituitary tumors. In macroadenomas (large benign tumors), DOPERGIN not only leads to an improvement of clinical symptoms, but frequently also to a marked reduction in the size of the tumor.

In acromegaly, the over-production of growth hormone can be favorably influenced. Consequently, in this instance, DOPERGIN can be used when other forms of therapy are not feasible or are inadequate.

What is DOPERGIN used for?

DOPERGIN is indicated for use in Parkinson's Disease and related neurological disorders (postencephalitic Parkinsonism, Parkinsonism of other genesis (with the exception of the drug-induced form)).

It is also indicated for use in primary ablactation (where medically indicated); galactorrhea, prolactin-induced amenorrhea, prolactin-induced infertility of the woman, prolactinomas and acromegaly.

Before you use DOPERGIN

You must not use DOPERGIN if:

  • You have a severe disorder effecting the circulation of blood in your arteries of the outer body and/or heart e.g. heart failure
  • You have or have had past or present psychosis. Your doctor will assess your condition and weigh the benefits against the risks, since deterioration or recurrence of psychosis is possible

What else you should know

It is important to tell your doctor about any other medications you are taking.

DOPERGIN and other medicines

Neuroleptics and other dopamine antagonists (e.g. haloperidol, sulpiride, metoclopramide, chlorpromazine) may attenuate the effect of DOPERGIN resulting in a less effective treatment of the symptoms of Parkinson's Disease. Domperidone inhibits only the peripheral but not the central effects of DOPERGIN and thus has no influence on the symptoms of Parkinsonism.

As a precaution, DOPERGIN should not be used together with other ergot alkaloids (e.g. methylergometrin) after delivery and in the puerperal period, although no interactions between them and lisuride have so far been observed. Special caution should be exercised when prescribing DOPERGIN for women who have taken or are taking drugs for controlling the blood pressure. Check with your doctor if DOPERGIN is suitable for you.

DOPERGIN and Breast-feeding

In ablactation, the baby should not be put to the breast nor should the milk be pumped off in order to avoid stimulating lactation. In its early stage, mastitis can usually be managed simply by restricting the production of milk by means of DOPERGIN, after which the baby can often be breast-fed again. Additional therapeutic measures (e.g. administration of antibiotics etc.) are required in pre-existing bacterial superinfection, persistent fever or abscess formation.

DOPERGIN and Pregnancy

If you have a pituitary adenoma (prolactinoma) and you become pregnant, you should look for any signs of renewed tumor growth (severe and sustained headaches, disturbed vision). If these present themselves contact your doctor immediately.

DOPERGIN and the ability to drive or operate machinery

DOPERGIN can very occasionally lead to a sudden fall in blood pressure that may affect your reactions to such an extent that the ability to drive or to operate machinery is impaired.

You may experience excessive drowsiness during the day that could affect your ability to drive and use machines.

How to use DOPERGIN properly

Remember that DOPERGIN has been prescribed for you personally. Do not share it with others, even if they have the same symptoms. This may prove harmful.

When and how to take the tablets

DOPERGIN tablets must always be taken with a meal or snack. To avoid side effects, DOPERGIN should be started gradually and, if possible in the evening particularly for higher doses.

To halve a 0.2mg DOPERGIN tablet, place the tablet on a hard surface with the scored side facing down, then press with one finger.

Unless otherwise instructed by your doctor, the following dosage guidelines apply:

Parkinsonism

Your doctor will tailor the dose for your individual requirement.

Treatment begins with one half a DOPERGIN tablet in the evening, increasing by half a tablet weekly until the desired clinical affect is achieved. Your doctor will determine this.

The daily dose will depend on the tolerance and effectiveness and on the severity of the disease but generally lies between 0.6 mg and 2 mg, although higher doses may be necessary in individual cases. The dosage is usually divided into 3 to 4 smaller doses which can be taken together with levodopa and or other antiparkinsonism drugs. In cases of marked fluctuation, it is advisable to divide the daily dose into even smaller portions.

The dose should be low in the early phases of Parkinsonism and should be only increased slowly. The dose of the levodopa preparation can be reduced as the dose of DOPERGIN is increased. This merits particular attention in cases where the MAO-B inhibitor selegiline, which increases and prolongs the availability of dopamine at the receptors, is administered at the same time with levodopa. Monotherapy with DOPERGIN is also possible in individual cases.

After every increase of the dose, the effect and tolerance should be observed for at least one week before the dose is increased again.

Under no circumstances should the dose be increased any further if side effects occur. Tolerance usually develops towards some of the side effects (nausea, headaches, tiredness, dizziness), so that the dose can, if necessary, be increased further after the side effects have disappeared. The more the total daily dose is divided into smaller doses, the better the tolerance of DOPERGIN.

In advanced cases of Parkinsonism, the dose may sometimes be increased more quickly depending on the tolerance and effectiveness.

If your symptoms improve remarkably your doctor may administer domperidone simultaneously, which can eliminate the side effects mentioned above allowing the dosage of DOPERGIN to be increased further as required. This should, however, be the exception. The need for continued domperidone medication should be checked after 4 weeks at the most by withdrawing it. A temporary reduction of the dose of DOPERGIN is recommended in the case of pronounced side effects.

Treatment week Number of Dopergin 0.2 mg tablets
Morning Midday Evening
1 - -
2 -
3
4 1
5 1 1
6 1 1 1
7 Your doctor will decide whether further weekly increases by tablet are necessary

 

Endocrine indications

primary ablactation( where medically indicated)

Treatment with DOPERGIN should begin if possible immediately after or within the first 24 hours of delivery or abortion

1 DOPERGIN tablet should be taken 2 to 3 times daily for 14 days.

In rare cases slight milk secretion may occur after you stop taking DOPERGIN. However milk secretion will arrest once weekly DOPERGIN treatment is resumed.

Galactorrhea, prolactin-induced amenorrhea, prolactin-induced infertility

The treatment of galactorrhea (excessive/spontaneous milk flow) must be continued until the milk flow has been completely arrested. In the case of amenorrhea you must continue taking DOPERGIN (frequently over several months) until normal cycles with regular menstrual periods are restored.

Depending on the height or effect of the prolactin level, your daily dose may need to be increased. For better tolerance the daily dose should be increased at the earliest after 3 - 4 days and divided into several single doses (as seen below).

Day of treatment Number of tablets (0.2 mg)
Morning Midday Evening
1st - -
2nd -
from 3rd

 

As soon as the complaints have subsided in post- partum galactostasis, DOPERGIN can be discontinued and breast-feeding can usually be resumed immediately afterwards.

DOPERGIN can also be used to treat Prolactin-induced infertility. However if pregnancy is undesired, some form of contraception must be used. As a general rule, drugs should not be used during pregnancy or only when absolutely necessary. Therefore, DOPERGIN should be discontinued as soon as pregnancy is suspected.

Acromegaly

Dosage follows the same regime as for galactorrhea, prolactin-induced amenorrhea, prolactin-induced infertility (see above). Depending on the tolerance and effect on the growth hormone level, the dose may also be increased further to a maximum of 2 mg per day.

Special Circumstances

The following describe situations, which may be adversely affected by using DOPERGIN. Caution should be taken in these instances.

  • If you are taking DOPERGIN for the treatment of ablactation and signs such as high blood pressure, persistent headaches or other signs of a disturbance (e.g. heart attack, convulsive fits and stroke) occur DOPERGIN treatment should be discontinued immediately to avoid blood vessel problems of the brain after childbirth.
  • In patients with impaired kidney function especially dialysis patients treatment with DOPERGIN should always be initiated with the lowest possible dose and the dose then increased slowly.
  • In patients with severe disturbances of liver function, particular care must be taken with the dosage of DOPERGIN. In these circumstances the dosage should be kept low.

Overdosage

DOPERGIN may be slightly toxic if the therapeutic dose is taken into consideration. Inadvertent large single doses (e.g. 30 tablets of DOPERGIN) may evoke nausea, vomiting and vertigo.

If overdosage occurs, metoclopramide oral drops may, if necessary, be given in milder cases (in parkinsonism: domperidone) and up to 100mg sulpiride intra-muscularly in severe cases as antidotes.

You should not take more tablets than your doctor tells you to.

Contact your doctor immediately if you suspect an overdosage.

Adverse effects

Tell your doctor if you notice any unwanted effect, especially if severe or persistent, or if there is any change in your health that you think might be caused by DOPERGIN.

The following side effects may occur whilst taking DOPERGIN:

  • Nausea, headaches, tiredness, dizziness, dopiness, sweating, dry mouth and, in rare cases vomiting may occur particularly at the start of treatment, if the dose is increased too quickly or if the dosage is too high, and if the tablets are not taken together with a meal or snack.
  • Sudden decreases in blood pressure (which may cause fainting upon standing) and violent vomiting have been observed in particularly sensitive people.
  • Temporary deterioration of the symptoms of Parkinsonism
  • Nightmares, hallucinations, paranoid reactions and states of confusion may occur, but almost only in patients with Parkinsonism. These effects are more common in the elderly who also have dementia (cerebro-organic psychosyndrome). This can also occur with acute infections, dehydration and a high dosage of DOPERGIN and other dopaminergic medicines. Symptoms can usually be managed by reducing the dose. However caution should be taken when using other antiparkinsonism drugs which can also induce psychosis-like symptoms.
  • Weight gain has been reported in some patients with Parkinsonism. Usually it is considered a positive treatment effect.
  • The development of fibrosis (inflammation) or effusion (fluid discharge/emission) within the chest wall or retroperitoneal fibrosis (inflammation behind the membrane surrounding the abdominal organs) has been observed in isolated cases after long-term use of DOPERGIN. The doctor should be consulted if symptoms indicative of these conditions occur (e.g. shortness of breath, persistent urge to cough).
  • Abnormal involuntary movements (dyskinesia) may also occur in Parkinson patients due both to the disease and to the simultaneous use of other anti-parkinson agents (particularly levodopa).
  • There have been occasional reports of sleep disorders, excessive daytime drowsiness and very rare reports of allergic reactions of the skin or mucosal tissue and swelling.

These side effects do not usually necessitate termination of the treatment and can be controlled by reducing the dose. In the course of treatment, side effects generally cease to occur even with markedly higher doses.

Storage

Store below 30C.

Please note the expiry date on the bottle. Do not use after this date or if the contents do not look right.

Store all drugs properly and keep them out of the reach of children.

Further information

DOPERGIN (30 tablets per glass bottle):

Active substances (per tablet) - lisuride hydrogen maleate 0.2mg

Other substances - lactose monohydrate, microcrystalline cellulose, magnesium stearate, tartaric acid, sodium calcium edetate.

If you have any further questions, please consult your doctor or pharmacist.

This leaflet was last revised on November 24th 2003