What You Should Know About Parlodel (Bromocriptine)
Please read this leaflet carefully before you start to take this medicine, even if you have taken PARLODEL before.
If you have any questions or are unsure about anything, ask your doctor or pharmacist (chemist) for advice.
What’S In Your Medicine
The active ingredient contained in PARLODEL is bromocriptine mesilate. Tablets are available in two strengths. They contain bromocriptine mesilate equivalent to:-
- 1 mg bromocriptine PARLODEL 1 mg tablets
- 2.5 mg bromocriptine PARLODEL 2.5 mg tablets.
The tablets also contain lactose, maize starch, disodium EDTA, maleic acid, colloidal anhydrous silica and magnesium stearate.
The 1 mg tablets are white, round and flat, with a breakline and ‘1 MG’ inscribed on the upper side. They come in amber glass bottles of 30 or 100 tablets.
The 2.5 mg tablets are whitish, round and flat, with a groove and ‘2.5 MG’ inscribed on the upper side. They come in amber glass bottles of 100 or 500 tablets, or in a blister strip containing 30 tablets.
Capsules are available in two strengths.
They contain bromocriptine mesilate equivalent to:-
- 5 mg bromocriptine PARLODEL 5 mg capsules
- 10 mg bromocriptine PARLODEL 10 mg capsules.
The capsules also contain colloidal anhydrous silica, lactose, maize starch, maleic acid and magnesium stearate. The capsule shell consists of gelatin and titanium dioxide (E171). The 5 mg capsule shell also contains indigo carmine (E132). The capsules are imprinted using the printing inks shellac (E904) and black iron oxide (E172).
The 5 mg capsules are blue and white with ‘5mg’ imprinted. They come in either blister strips containing 30 capsules or amber glass bottles containing 100 capsules.
The 10 mg capsules are plain white with ‘10mg’ imprinted. They come in amber glass bottles containing 100 capsules.
PARLODEL is a medicine used to reduce secretion of the hormone prolactin. It also stimulates certain nerve pathways in the brain causing more dopamine to be produced. (See “WHY DOES YOUR DOCTOR WANT YOU TO USE PARLODEL?”).
Product licence holder:
Bishop’s Stortford
Manufactured by:
Why Does Your Doctor Want You To Use Parlodel?
PARLODEL is used to treat patients with conditions which result from having high levels of the hormone prolactin in the blood. Prolactin is a hormone produced by the pituitary gland which is a small gland in the base of the brain. High prolactin levels may occur without any apparent cause, due to the effects of a drug or a disorder in the pituitary gland or surrounding area in the brain.
PARLODEL may be used for the following situations:
- In cases where it is considered essential for preventing or holding back milk production in the mother for medical reasons following childbirth, miscarriage or abortion.
- Men and women with high prolactin levels which has caused suppression of the sexual glands (leading to infertility) and/or excess milk production.
- Infertility resulting from high prolactin levels. PARLODEL has also been used to treat patients with infertility where prolactin levels are not raised.
- In patients with certain non-malignant tumours which release prolactin, including patients with prolactinomas and acromegaly. Acromegaly is a condition in which there is an excess of growth hormone in the blood which, in childhood can lead to gigantism due to increased skeletal growth and in adulthood can lead to an increase in the lower jaw bone, increase in size of hands and feet and a general coarseness of facial features. In acromegaly, PARLODEL reduces the amount of growth hormone in the blood.
Parkinson’s Disease
Because PARLODEL stimulates certain nerve pathways in the brain causing more dopamine to be produced, it can be used to treat Parkinson’s Disease where there is a lack of dopamine. Dopamine is a substance in the brain important for the co-ordination of movement.
Before Taking Your Medicine
Tell your doctor before you start using PARLODEL if the answer to any of the following questions is yes:
- Do you suspect that you have had an allergic reaction to, or have been upset by any of the ingredients in PARLODEL (listed in “WHAT’S IN YOUR MEDICINE”)?
- Do you have:-
- raised blood pressure or has your blood pressure been too high during pregnancy?
- heart disease, stroke or other cardiovascular disease
- any symptoms or history of serious psychiatric problems
- a history of peptic ulcers or stomach bleeds
- any type of liver disease
- Excessive drowsiness or if you are unexpectedly falling asleep?
- Intolerance to some sugars (e.g. lactose)?
- Are you under 15 years of age?
- Have you ever been diagnosed in the past with a problem known as fibrosis affecting the lungs, lower back and kidneys, or heart?
- Are you pregnant or planning to become pregnant? If so, tell your doctor immediately. If you are taking PARLODEL for a fertility disorder caused by high prolactin, PARLODEL may result in release of an egg from the female reproductive organs. Women of childbearing age who do not wish to become pregnant should use a barrier method of contraception.
- Are you taking PARLODEL following childbirth, miscarriage or abortion.
- Are you breast feeding?
- It is especially important that your doctor knows if you are taking any of the following medicines:
- Any drugs that can alter blood pressure e.g. diuretics, beta blockers, calcium channel blockers, and ACE inhibitors
- Protease inhibitors used to treat HIV/AIDS
- Any drugs of the ergot alkaloid type e.g. ergotamine tartrate
- Azole antifungals, medicines used to treat fungal infections
- The antibiotic erythromycin or any other macrolide antibiotics used to treat infection
- Antipsychotics such as phenothiazines, butyrophenones, thioxanthenes
- Metoclopramide, domperidone (medicines used to treat vomiting)
- Octreotide (a medicine used to treat growth disorder)
For women after childbirth or abortion: the use of medicines that constrict blood vessels after birth, including medicines containing ergot alkaloids such as ergometrine together with Parlodel is not recommended.
Effects on driving or operating machinery:
PARLODEL can cause somnolence (excessive drowsiness) and sudden sleep onset episodes.
During treatment with PARLODEL, take special care when you drive or operate a machine.
If you experience excessive drowsiness or even a sudden sleep onset episode, you must not drive or operate machinery, and contact your doctor.
Care is also needed especially during the first few days of treatment when driving or operating machinery as PARLODEL can also cause a drop in blood pressure.
Effect of alcohol:
Drinking alcohol may increase the side-effects of this medicine. Therefore, you are advised to avoid drinking alcohol whilst taking the medicine.
During treatment with PARLODEL your doctor may carry out some monitoring procedures:
- Some patients on PARLODEL maybe asked to have regular blood pressure monitoring, especially in the first few days of treatment.
- If you are a woman receiving PARLODEL for a prolonged length of time, your doctor will periodically examine you and do a cervical “smear test”.
- If your are taking PARLODEL for a tumour of the pituitary, you may be required to have your visual fields monitored.
- If you are taking PARLODEL for a condition involving a tumour, the tumour maybe monitored to determine if there is a change in its type or shape.
Taking Your Medicine
PARLODEL tablets or capsules should always be taken with food.
Therapy is usually started gradually to keep any side-effects to a minimum. This is achieved by taking PARLODEL in the following manner:
Prevention/Suppression of Lactation Gradual introduction is not necessary in these cases.
Women receiving PARLODEL for prevention or suppression of lactation should have their blood pressure carefully monitored especially during the first few days of treatment.
For prevention of lactation 2.5 mg is given on the day of delivery followed by 2.5 mg twice daily for 14 days.
For the stopping of lactation 2.5 mg is given on day 1, and increased after 2–3 days to 2.5 mg twice daily for 14 days.
Following the prevention or suppression of lactation, slight milk secretions may still occur for 2 to 3 days after treatment has stopped. If this occurs speak to your doctor.
Other treatment conditions.
In other treatments PARLODEL should be introduced gradually, an example of a gradually increasing scheme is given below:
Initially 1 mg to 1.25 mg at bedtime, increasing after 2 to 3 days to 2 mg to 2.5 mg at bedtime. The dose may then be increased by 1 mg to 2.5 mg at 2 to 3 day intervals, until a dosage of 2.5 mg twice daily is reached. If the dose is to be increased, it will be done in a similar way.
The dose of PARLODEL that you take after this gradual start will depend on the condition that the doctor is treating you for, in some conditions the start of treatment may depend on your menstrual cycle, so always follow the doctor’s instructions carefully. The label on your medicine should tell you how much medicine to take and when to take it. If it does not, or you are not sure, ask your doctor or pharmacist.
The tablets or capsules you receive will be dispensed loose in a child-resistant medicine container. Sometimes they may be dispensed in foil strips contained in a carton.
Swallow tablet or capsule with water.
Missed Dose
If you forget to take a dose, take another as soon as you remember, unless it is almost time for your next dose. Then go on as before.
Overdose
If you accidentally take too much of your medicine tell your doctor immediately or go to your nearest casualty department.
After Taking Your Medicine
Like all medicines after taking your medication you may experience some side effects. Taking PARLODEL with food and starting therapy gradually should help keep side-effects to a minimum. Nausea (the feeling of sickness) is the most common side-effect.
The following side-effects have also been reported occasionally:
- A fall in blood pressure on standing, dizziness
- Headache, nasal congestion
- Vomiting, abdominal pain, constipation or diarrhoea
- Fatigue, drowsiness, somnolence (excessive drowsiness), sudden sleep onset episodes
- Confusion, hallucinations, visual disturbances
- Tinnitus
- Loss of co-ordinated movement or abnormal movements
- Leg cramps
- Paraesthesia (tingling or numbness of the hands or feet)
- Arrhythmia (irregular heartbeat)
- Dry mouth or blocked nose
- Allergic skin reactions
- Hair loss
- Psychiatric disorders
- Insomnia (sleeping difficulties)
- Swelling of the ankles
On prolonged treatment, you may occasionally experience pale or white fingers and toes, induced by cold temperatures. This is reversible and has occurred particularly in patients who are prone to this type of condition.
Bleeding and ulcers in the alimentary tract has occurred with patients taking PARLODEL, although the connection with treatment is not proven. If you are taking PARLODEL and have any side effects like nausea, indigestion or vomiting during therapy, tell your doctor as soon as possible. In extremely rare cases, in some women where PARLODEL has been taken within six weeks of birth/miscarriage or abortion to prevent milk production, serious side effects including very high blood pressure (symptoms of which include dizziness, flushed face), heart attack, fits, stroke , or mental disorders have been reported although it is not certain whether this is due to PARLODEL. In some patients fits and strokes followed severe headache and/or disturbances with eye-sight. Tell your doctor immediately and stop taking PARLODEL if you get increased blood pressure, constant headache or any other unusual symptoms.
In some patients with prolactin-secreting adenomas, sudden watery discharge from the nose is a known effect. Speak to your doctor who may check you for evidence of tumour shrinkage.
In patients with pituitary gland tumours visual impairment is a known effect of their condition.
Some patients may experience visual disturbances when taking PARLODEL, speak to your doctor if this occurs.
On very rare occasions upon stopping therapy, there have been reports of a condition similar to Neuroleptic Malignant Syndrome (NMS). This is a rare condition which usually occurs in patients taking another type of medication known as antipsychotics. The typical symptoms include rigidity, altered mental status, and hyperthermia. Speak to your doctor at once if you experience any symptoms or feel unwell once PARLODEL treatment has been stopped.
A few patients treated with PARLODEL may develop a fibrous thickening of the body’s lining which covers most of the internal organs (peritoneum). Symptoms of this problem may include difficulty in breathing, shortness of breath, chest, back or pelvic pain, increased swelling of the lower limbs or kidney problems. If you have any of the symptoms described, stop taking PARLODEL and tell your doctor straight away.
Especially during the first few days of treatment some patients experience low blood pressure, this can reduce their alertness, you are therefore advised to take particular care when driving vehicles or operating machinery.
Some patients have experienced sudden sleep episodes this can increase the risk of serious injuries to themselves or others if they are operating machines. These patients maybe advised not to drive and should consult their doctor.
Failure to resist gambling impulses despite serious personal or family consequences, increased sex drive, and altered sexual interest and behaviour of significant concern to the individual or to others have been reported in patients treated with PARLODEL for Parkinson’s disease. These side-effects appear to be related to the dose of PARLODEL and occur mainly in patients treated with high doses of the medicine. They are usually reversible if the dose of the medicine is reduced or stopped. Patients should seek help from their doctor if they, or their family/carer, notice that their behaviour is unusual.
Tell your doctor or pharmacist if you suffer from any of the side-effects mentioned above or from any other side-effects not mentioned in this leaflet.
Storing Your Medicine
Store the tablets or capsules in the original package in order to protect from light.
1 mg and 2.5 mg Tablets - Store below 25°C
5 mg and 10 mg Capsules - Store below 30°C
Keep your medicine in a safe place where children cannot reach it. Your medicine could harm them. Do not use this medicine after the expiry date shown on the container or carton.
LEAFLET REVISED
May 2010
FURTHER INFORMATION
Remember: This medicine is only for you. Only a doctor can prescribe it for you. Never give it to anyone else. It may harm them, even if their symptoms appear to be the same as yours.
If you have any questions or are unsure about anything regarding your medicine ask your doctor or pharmacist.
Product Licence Numbers
1 mg Tablets: PL 19166/0052
2.5 mg Tablets: PL 19166/0053
5 mg Capsules: PL 19166/0054
10 mg Capsules: PL 19166/0055
PARLODEL is a registered Trade Mark.
T5004063
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