Norprolac: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

Your doctor may begin your treatment with the NORPROLAC^® STARTER PACK. The NORPROLAC^® STARTER PACK is specifically designed to allow your body to gradually adjust to the medicine and lessen the chance of unwanted effects.

What the medication is used for:

NORPROLAC® (quinagolide hydrochloride) belongs to the group of medicines known as prolactin inhibitors. NORPROLAC® is used for the treatment of hyperprolactinemia.

Remember:

• This medicine has been prescribed for your current medical problem only. It must not be given to other people or be used for other problems unless you are otherwise directed by your doctor

What it does:

NORPROLAC^® is a medicine used to block the release of a hormone called prolactin. Prolactin is released by a part of the brain called the pituitary gland. NORPROLAC® acts to stimulate dopamine D2 receptors. Stimulation of these receptors results in a decreased level of prolactin in the body. NORPROLAC® is used in the treatment of conditions where there is an excessive level of prolactin in the body (hyperprolactinaemia).

Excess prolactin can result if the pituitary secretes more prolactin than it should or due to the presence of pituitary tumours. Excess prolactin can cause a range of problems such as infertility, menstrual irregularities, loss of sexual function and breast-milk production. With regard to pregnancy, normal ovulation is a complex process that requires many things to happen properly and at the correct time with the proper hormone levels. Often subtle hormonal imbalances or ovulation abnormalities result in decreased fertility (i.e. excessive prolactin levels or hyperprolactinemia). Norprolac can lower prolactin levels and thus restore fertility.

It may take several weeks for NORPROLAC® to work.

When it should not be used:

Do not take Norprolac if you have an allergy to:

* quinagolide (the active ingredient) or any of the other ingredients.

Do not take this medicine if you have problems with your kidneys or liver.

There is no experience with the use of this medicine in people whose kidney or liver function is impaired.

What the medicinal ingredient is:

quinagolide hydrochloride

What the nonmedicinal ingredients are:

Silica (colloidal anhydrous), magnesium stearate, methylhydroxy-propylcellulose, maize starch, cellulose (microcrystalline), lactose.

What dosage forms it comes in:

0.025 mg, 0.050 mg, 0.075 mg and 0.150 mg Tablets

WARNINGS AND PRECAUTIONS

NORPROLAC^® has been associated with somnolence, and episodes of sudden sleep onset. Do not drive or operate machines if you experience any episodes of sudden sleep onset or drowsiness. Contact your doctor if sudden onset of sleep occurs as a reduction of dosage or termination or therapy may be necessary.

Hypotensive reactions or dizziness may occur during the first few days of treatment with NORPROLAC^® (quinagolide hydrochloride) and patients should be cautious when driving a vehicle or operating machinery.

Talk to your doctor if you have any of the following behavioural change:

• abnormal gambling habits,
• increase sexual drive or desire,
• extremely frequent or suddenly increased sexual urges or sexual activity,
• obsession with shopping and buying behaviour
• eating muchmore rapidly than normal until feeling uncomfortably full and/or not feeling physically hungry, a sense of being out of control

Pregnancy: Women of childbearing age who do not wish to conceive should practice a reliable method of contraception.

In patients wishing to conceive, NORPROLAC^® should be discontinued when pregnancy is confirmed, unless there is a medical reason for continuing therapy.

BEFORE you use NORPROLAC^® talk to your doctor or pharmacist if:

• if you intend to breast-feed an infant since this medication stops milk from being produced
• if you have any of the following medical problems:

liver disease, severe renal disease, mental problems (history of)

INTERACTIONS WITH THIS MEDICATION

Let your doctor or pharmacist know about your alcohol consumption and any medication you take including the medications you have bought without prescription.

If you are now taking any of the following medicines or types of medicines let your doctor or pharmacist know.

• Blood pressure-lowering medication

  • Birth control pills
  • Drugs intended to treat mood disorders and generally prescribed by psychiatrists
  • Drugs intended to treat Parkinson's disease and generally prescribed by neurologists

PROPER USE OF THIS MEDICATION

Unless otherwise directed by your doctor take this medicine at bedtime, you can have a snack or a full glass of milk to reduce stomach irritation. If stomach upset continues, check with your doctor. In order for this medicine to work it should be taken as directed.

It is important that your doctor checks your progress at regular visits to make sure that this medicine is working and check for unwanted effects.

Usual dose:

The amount of NORPROLAC^® you will need depends on your body's needs and individual tolerance. Your doctor will advise you on the correct dosage regimen for you. The usual starting dosage prescribed is 0.025 mg (pink tablets) once-a-day for the first three days, followed by the higher dosage 0.050 mg (blue tablets) once-a-day for a further three days. From Day 7 onwards the usual maintenance dosage is 0.075 to 0.150 mg/day with a snack at bedtime.

Should you experience any intolerance at any of these dose levels, discuss it with your doctor before proceeding to the following dose level. During treatment your doctor may decide to adjust the dosage according to the response to the medication.

Overdose:

There is no information on overdosage in humans with NORPROLAC (quinagolide hydrochloride). However based on the knowledge of this type of drug, symptoms such as nausea, vomiting, headache, dizziness, drowsiness, hallucinations and hypotension might possibly occur. In the event of overdosage go to your emergency room and bring the medication bottle with you or contact you local Poison Control Centre.

Missed dose:

If you miss a dose of this medicine take it as soon as possible. If it is almost time for your next dose, do not take the missed dose and do not double the next one. Instead go back to your regular dosing schedule. If you miss more than 2 or 3 doses in a row or if you have any questions about this, check with your doctor.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The adverse reactions reported with the use of NORPROLAC^® (quinagolide hydrochloride) are characteristic of this group of medicines. The most commonly observed adverse events (more than10%) reported during clinical trials with NORPROLAC^® were: nausea, vomiting, headache, dizziness and fatigue. Most of these adverse events occur predominantly during the first few days of the initial treatment or, as a mostly transient event.

You may also experience anorexia, abdominal pain, constipation or diarrhoea, insomnia, oedema, palpitations, flushing, nasal congestion, hypotension on standing and hypotension.

In rare cases NORPROLAC^® has been associated with sudden onset of sleep or drowsiness.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

* Percentages reported represent the expected occurrence in 100 people

This is not a complete list of side effects. For any unexpected effects while taking NORPROLAC^® _, contact your doctor or pharmacist.

HOW TO STORE IT

Store between 15^o to 30^oC. Protect from light and humidity. Keep all medicines out of the reach of children.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Ferring Inc., at:

1-800-263-4057

Last revised: October 29, 2013