DOSTINEX 0.5MG TABLETS

Active substance: CABERGOLINE

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What is in this leaflet
1. What Dostinex is and what it is used for
2. What you need to know before you take Dostinex
3. How to take Dostinex
4. Possible side effects
5 How to store Dostinex
6. Contents of the pack and other information

Package leaflet: Information for the patient

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.

1. What Dostinex is and what it is used for
- Dostinex is used to stop breast milk production
(lactation) soon after childbirth, stillbirth, abortion
or miscarriage. It can also be used if you do not
want to continue to breastfeed your baby once you
have started.
- Dostinex can also be used to treat other conditions
caused by hormonal disturbance which can result in
high levels of prolactin being produced. This includes
high levels of prolactin caused by tumours of the
pituitary gland in both men and women.
- This medicine contains cabergoline and belongs to
a class of medicines called ‘dopamine agonists’.
Dopamine is produced naturally in the body and
helps to transmit messages to the brain.
- Cabergoline mimics the action of dopamine to
reduce the production of prolactin in the blood.
Prolactin is the hormone which stimulates the breast
to produce milk.
- Dostinex should only be used in adults. It is not
suitable for children under the age of 16 years.
- You must talk to a doctor or pharmacist if you do
not feel better or if you feel worse.

2. What you need to know before you take Dostinex
Do not take Dostinex
- If you are hypersensitive (allergic) to cabergoline, to
other medicines called ergot alkaloids, (e.g. pergolide,
bromocriptine, lisuride, ergotamine or ergometrine)
or to any of the other ingredients of this medicine
(listed in section 6);
- If you have severe liver disease;
- If you have high blood pressure in pregnancy
associated with swelling and protein in the urine
(toxaemia of pregnancy);
- If you are being treated with anti-psychotics or have
a history of mental illness associated with child-birth
(puerperal psychosis);
- If you are pregnant or breastfeeding;
- If you will be treated with Dostinex for a long period
and have or had fibrotic reactions (scar tissue) affecting
your heart.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dostinex
if you have or had any of the following conditions:
- Disease that involves the heart and blood vessels
(cardiovascular disease);
- Cold hands and feet (Raynaud’s syndrome);
- Gnawing pain in the abdomen when hungry (peptic
ulcer) or bleeding from the stomach and intestines
(gastrointestinal bleeding);
- History of serious mental disease, particularly
psychotic disorders;
- Liver or kidney disease;
- Kidney function abnormality;

- Increased blood pressure after giving birth;
- Fibrotic reactions (scar tissue) affecting your heart,
lungs or abdomen. In case you are treated with
Dostinex for a long period, your physician will check
before starting treatment whether your heart, lungs
and kidneys are in good condition. He/she will also
have an echocardiogram (an ultrasound test of the
heart) taken before treatment is started and at regular
intervals during treatment. If fibrotic reactions occur
treatment will have to be discontinued;
- Low blood pressure (postural hypotension) or you are
taking any medicines to lower your blood pressure.
Tell your doctor if you or your family/carer notices
that you are developing urges or cravings to behave
in ways that are unusual for you and you cannot resist
the impulse, drive or temptation to carry out certain
activities that could harm yourself or others. These
are called impulse control disorders and can include
behaviours such as addictive gambling, excessive
eating or spending, an abnormally high sex drive or
an increase in sexual thoughts or feelings.
Your doctor may need to adjust or stop your dose.
It is recommended that women on long term treatment
with Dostinex for hormonal disorders should have regular
gynaecological exams including smear tests. Your
doctor will continue to monitor your medical condition
while you are taking Dostinex tablets.

Other medicines and Dostinex
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
Some medicines can reduce the effectiveness of
Dostinex, these include:
- Medicines to lower your blood pressure;
- Medicines used to treat mental illness (e.g. antipsychotic
medicines like chlorpromazine, haloperidol);
- Medicines for nausea and vomiting (e.g. domperidone,
metoclopramide).
Some medicines can increase the amount of Dostinex
in your blood and so could increase the side effects,
these include:
- Medicines for Parkinson’s disease;
- Medicines for severe migraine headaches (e.g.
pergolide, bromocriptine, lisuride, ergotamine,
dihydroergotamine, ergometrine or methysergide);
- Antibiotics (e.g. erythromycin).
Dostinex with food and drink
Please see section 3 for details.
Pregnancy
If you are pregnant, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist
for advice before taking this medicine. You should also
take care not to become pregnant for at least one
month once you have stopped taking this medicine.
Dostinex can result in congenital abnormalities if you
use it during pregnancy.

Breast-feeding
As Dostinex will stop you producing milk for your
baby, you should not take this medicine if you plan to
breast-feed. If you need to take Dostinex you should
use another method of feeding your baby.
Driving and using machines
Dostinex can cause drowsiness (somnolence) and
sudden sleepy episodes, in some cases without any
warning signs or awareness. You are advised not to drive
or operate machines or engage in activities requiring
mental alertness or coordination during treatment with
this medine. Your doctor will decide if you can continue
treatment on Dostinex if this occurs.
Dostinex contains lactose
Lactose is a type of sugar, if you have been told you
have an intolerance to sugars, consult your doctor
before you take this medicine.
3. How to take Dostinex
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
It is recommended you take Dostinex with or after
food to help reduce feelings of nausea or vomiting.
• To prevent milk production (lactation): You should
take 1 mg (two 0.5 mg tablets) on the first day after
delivery.

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• To stop lactation once you have started to breastfeed: You should take 0.25 mg (one half of Dostinex
0.5 mg tablet) every 12 hours for two days.
• To reduce prolactin levels in other conditions:
You should initially take one 0.5 mg tablet (to be
taken in two doses) spread out over a week (e.g.
half a tablet on Monday and the other half of the
tablet on Thursday). Your dose will be increased
up to a maximum dose of 4.5 mg or until you have
responded fully to treatment.
When you first start taking the tablet, it is recommended
you slowly change position when trying to sit, stand
or lie down, this is because this medicine may cause
a drop in blood pressure that could make you dizzy
when you move from a position. It is also recommended
that you avoid alcohol and other medicines that cause
drowsiness as this could increase the risk of dizziness.
During treatment your doctor may need to check your
blood pressure, particularly in the first few days of
treatment. A gynaecological assessment may also be
carried out on the cells of your cervix or womb lining.
If you take more Dostinex than you should
If you take too many Dostinex tablets, contact your
doctor immediately or go to the nearest hospital
casualty department. Symptoms of overdose may
include nausea, vomiting, gastric complaints, low
blood pressure when standing, confusion/psychosis
or hallucinations.

If you forget to take Dostinex
If you forget to take a dose take the next one as normal
and tell your doctor if you have trouble remembering
to take your tablets. Do not take a double dose to
make up for a forgotten dose.

breathing with or without wheezing, feeling faint,
unexplained swelling of the body or tongue or any
other symptoms which appear to come on rapidly
after taking this medication and make you feel unwell.
These may be indicative of an allergic reaction.

If you stop taking Dostinex
Your doctor will advise you how long to take Dostinex.
You should not stop until your doctor tells you.

You may experience the following side effects:
• Inability to resist the impulse, drive or temptation
to perform an action that could be harmful to you
or others, which may include:
• Strong impulse to gamble excessively despite
serious personal or family consequences.
• Aggression and altered or increased sexual interest
and behaviour of significant concern to you or to
others, for example, an increased sexual drive.
• Uncontrollable excessive shopping or spending.
• Binge eating (eating large amounts of food in a
short time period) or compulsive eating (eating
more food than normal and more than is needed
to satisfy your hunger).

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.
Tell your doctor immediately if you experience any of
the following symptoms after taking this medicine.
These symptoms can be severe:
• Abnormal or unusual thoughts.
• Heart valve and related disorders e.g. inflammation
(pericarditis) or leaking of fluid in the pericardium
(pericardial effusion). This is a very common side
effect (may affect more than 1 in 10 people). The
early symptoms may be one or more of the following:
difficulty breathing, shortness of breath, pounding
heart, feeling faint, chest pain, back pain, pelvic
pain or swollen legs. These may be the first signs
of a condition called pulmonary fibrosis, which can
affect the lungs, heart/heart valves or lower back.
• Development of a widespread itchy rash, difficulty

Tell your doctor if you experience any of these
behaviours; they will discuss ways of managing
or reducing the symptoms.
During treatment you may also notice the following
effects:
• Very common (may affect more than 1 in 10 people)
drowsiness, nausea, headache, dizziness, vertigo,
stomach pain, indigestion, inflamed stomach lining,
fatigue, lack of bodily strength, weakness.
• Common (may affect up to 1 in 10 people) constipation,

blurred vision, low blood pressure after childbirth
which may not have any symptoms, breast pain,
depression, sleep disturbances, excessive daytime
drowsiness/sleepiness, vomiting, low blood pressure,
hot flushes.
• Uncommon (may affect up to 1 in 100 people)
loss of hair, severe itching, shortness of breath,
fainting, nosebleed, leg cramps, swelling due to
accumulation of fluid in the tissues (oedema), rash,
irregular or strong heartbeat (palpitations), pins and
needles sensation, decrease in haemoglobin in women
whose periods had stopped and then re-started,
temporary partial vision loss.
• Rare (may affect up to 1 in 1000 people) allergic skin
reactions, muscle weakness, cold hands and feet.
• Not known (frequency cannot be estimated from
the available data) abnormal liver and abnormal
blood tests of liver function, breathing problems
with inadequate intake of oxygen, an increase in
the level of some enzymes in the blood, abnormal
vision, episodes of sudden sleep onset, seeing or
hearing things that are not really there (hallucinations),
delusions, psychotic disorder.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Dostinex
• Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date which
is stated on the carton and on the bottle label after
EXP. The expiry date refers to the last day of that
month.
• Do not store above 25°C. Keep the bottle tightly
closed in order to protect from moisture.
• The bottle caps contain desiccant granules. Do not
remove desiccant granules from cap or transfer tablets
to another container.

Marketing Authorisation Holder and Manufacturer

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.

Company Contact Address
For any further information about this medicine, please
contact Medical Information at: Pfizer Limited, Walton
Oaks, Tadworth, Surrey, KT20 7NS. Tel: 01304 616161

6. Contents of the pack and other information
What Dostinex contains
The active substance is 0.5 mg cabergoline.
The other ingredients are lactose and leucine.

This leaflet was last revised in 11/2013

Marketing Authorisation Holder

Pfizer Ltd
Ramsgate Road
Sandwich, Kent
CT13 9NJ

Manufacturer

Pharmacia Italia
Marino Del Tronto
Ascoli, Piceno
Italy

Ref: DX 12_4

What Dostinex looks like and contents of the pack
Dostinex is a flat capsule-shaped, scored, white tablet.
The tablets are contained in an amber glass bottle
with tamper resistant screw cap containing desiccant
silica gel. Each bottle contains 2, 4 or 8 tablets and
is enclosed in an outer cardboard carton.
Not all pack sizes may be marketed.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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