NORPRESS

Nortriptyline 10mg & 25mg Tablets

What is in this leaflet

This leaflet answers some common questions about NORPRESS. It does not
contain all the information available on this medicine. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks and
benefits. Your doctor has weighed the risks of using NORPRESS against the
benefits expected it will have for you. If you have any concerns about using
this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may want to read it again.

What NORPRESS is used for and how it works

Your NORPRESS tablets contain nortriptyline hydrochloride. It belongs to a
group of medicines known as tricyclic antidepressants (TCAs).

NORPRESS is used to treat depression. NORPRESS is also used as an aid to
smoking cessation and may help you stop smoking. Its exact mechanism of action
is not fully understood, but it is believed that it interacts with chemicals in
the brain called neurotransmitters (i.e. noradrenaline) and helps develop their
action in the brain, which appears to be associated with antidepressant activity
and an aid in smoking cessation. Studies have shown that a significant number of
people managed to remain smoke-free for at least 6 months while taking
nortriptyline.

Your doctor may, however, prescribe NORPRESS for another reason. Ask your
doctor if you have any questions about why NORPRESS has been prescribed for you.

NORPRESS is not recommended for use in children 12 years of age and under.

NORPRESS is not recommended for use in adolescents (13-18 years of age)
for the treatment of depression, unless under the supervision of a specialist.

NORPRESS is not recommended for use in adolescents (under 18 years of age)
as a aid in smoking cessation.

NORPRESS is available on prescription from your doctor.

Before you take NORPRESS

When you must not take it

Do not take NORPRESS if:

  • You are allergic to nortriptyline, other tricyclic antidepressants or
    any other ingredients listed at the end of this leaflet
  • You are taking another medicine for depression called a monoamine
    oxidase inhibitor (MAOI) or have been taking a MAOI within the last 14 days.
    Ask your doctor or pharmacist if you are unsure as to whether or not you are
    taking a MAOI
  • You have recently had a heart attack.

Symptoms of an allergic reaction may include shortness of breath, wheezing or
difficulty breathing; swelling of the face, lips, tongue or other parts of the
body; rash, itching or hives on the skin.

Before you take it

Tell your doctor if:

  • You have had an allergic reaction to any medicine that you have taken
    previously to treat your current condition
  • You have heart, kidney or liver problems
  • You have difficulty passing urine
  • You have epilepsy, fits or convulsions (or a condition such as alcoholism,
    brain damage or a head injury which might make fits more likely to occur)
  • You take medications which are known to lower the seizure threshold (e.g.
    antipsychotics, antidepressants, tramadol, theophylline, systemic steroids,
    quinolones and sedating antihistamines)
  • You have diabetes
  • You are a heavy drinker
  • You take sedatives or stimulants
  • You are having electrical shock treatment
  • You are pregnant, plan to become pregnant or are breastfeeding
  • You suffer from an overactive thyroid gland (hyperthyroidism) or are
    receiving thyroid medication
  • You suffer from raised pressure in the eye (glaucoma)
  • You have suicidal thoughts or have attempted suicide in the past
  • You suffer from mania (mood of excitement, over-activity and uninhibited
    behaviour) or bipolar disorder
  • You have allergies to any other medicines, foods, preservatives or dyes.

Taking other medicines

If you are taking any other medicines, including any you get without a
prescription from a pharmacy, supermarket or health food shop, tell your doctor
or pharmacist.

Medicines that may interfere with NORPRESS include:

  • Monoamine Oxidase Inhibitors (e.g. moclobemide, phenelzine,
    tranylcypromine)
  • Other antidepressants (e.g. SSRIs and tricyclic antidepressants)
  • Guanethidine and similar agents (used to lower blood pressure)
  • Sympathomimetics, such as nasal decongestants (used for colds or
    hay fever) and anticholinergic medicines
  • Cimetidine (used to treat ulcers and other stomach complaints)
  • Reserpine
  • Thyroid Hormone Medication
  • Quinidine.

These medicines may be affected by NORPRESS or may affect how well NORPRESS
works. You may need different amounts of your medicines or you may need to take
different medicines.

Your doctor or pharmacist has more information on medicines to be careful
with or avoid while taking NORPRESS.

How to take NORPRESS properly

How much to take

Your doctor will tell you how much NORPRESS you need to take each day. It is
important that you take NORPRESS as directed by your doctor. Do not take more
than the recommended dose.

For the Relief of Symptoms of Depression

It may take several weeks before any response to NORPRESS is noticeable.

The usual dose for an adult is 25mg of nortriptyline 3 or 4 times daily. If
necessary, your doctor may increase the dose up to a maximum of 100mg daily.

If you are elderly you may be started on a lower dose of 25 to 50mg per day,
in divided doses.

Your doctor may tell you to take different doses to these. If so, follow
their instructions.

As an Aid in Smoking Cessation

The recommended starting time is 10-28 days prior to the quit date.

The recommended starting dose is 25mg per day, increased gradually over a
period of ten days to five weeks, to achieve a maintenance dose of 75 to 100mg
per day for a total of up to 12 weeks.

Your doctor may tell you to take different doses to these. If so, follow
their instructions.

NORPRESS and nicotine patches should only be used together under the
supervision of your doctor.

The tablets should be swallowed whole with a glass of water.

How long to take it

For depression, the treatment is usually continued for at least six months to
prevent potential recurrence. You may not feel better immediately as most
antidepressants take time to work. Keep taking the tablets every day. Do not
stop taking NORPRESS even if you begin to feel better, unless your doctor tells
you to do so. Make sure you do not run out of tablets.

For smoking cessation, 12 weeks is the usual treatment duration. However,
your doctor has the discretion to use the medication for up to 6 months.

If you forget a dose

If you forget a dose, just take the next dose when it is due. Do not take
additional tablets to make up for missed doses.

Taking your medicine at the same time each day may help you to remember to
take it regularly. If you have trouble remembering to take your medicine, ask
your pharmacist for some hints.

While you are taking NORPRESS

Tell all doctors, dentists and pharmacists who are treating you that you are
taking NORPRESS.

Tell your doctor or pharmacist that you are taking NORPRESS before you start
any new medicine.

Tell your doctor if you develop a skin rash or hives, or you become pregnant
while taking NORPRESS.

If you are going to have surgery, tell the surgeon or anaesthetist that you
are taking NORPRESS.

If you are going to have any blood tests, tell your doctor that you are
taking NORPRESS.

Keep all appointments you and your doctor have scheduled so that your
progress can be followed.

Tell your doctor if you notice any of the following, especially if they
are severe, abrupt in onset, or were not part of your presenting symptoms:
anxiety, agitation, panic attacks, insomnia (difficulty sleeping), irritability,
hostility (aggressiveness), impulsivity, akathisia (restlessness or difficulty
sitting still), hypomania, mania (mood of excitement, over-activity and
uninhibited behaviour), worsening of depression.

Tell your doctor immediately if you have any distressing thoughts (thought
of suicide or self-harm) or experiences during this initial period or at any
other time.

Do not take NORPRESS to treat any other complaints unless your doctor tells
you to.

Do not stop taking NORPRESS or lower the dose without first checking with
your doctor.

Do not give this medicine to anyone else, even if their symptoms seem similar
to yours.

NORPRESS may cause drowsiness in some people. Be careful when driving,
operating machinery or performing jobs that need you to be alert, until you are
certain that NORPRESS does not affect your performance.

Your doctor may suggest avoiding alcohol while you are being treated for
depression.

Side effects

Tell your pharmacist or doctor as soon as possible if you do not feel well
while you are taking NORPRESS.

All medicines can have some unwanted effects. Sometimes they are serious,
most of the time they are not. You may need medical treatment if you get some of
the side effects.

Tell your doctor or pharmacist if you notice any of the following and they
worry you:

  • Stomach or bowel problems (e.g. nausea, diarrhoea, constipation)
  • Drowsiness
  • Dry mouth or taste change
  • Loss of appetite
  • Shakiness or tremor
  • Ejaculation disorders or changes in your sex drive
  • Dizziness
  • Headache
  • Weakness
  • Impaired concentration or thought processes
  • Vision problems
  • Irregular heart beats, also called palpitations.

These are the more common side effects of NORPRESS.

Tell your doctor immediately if you:

  • Develop a rash or hives while taking NORPRESS.

This side effect is rare but serious. You may need urgent medical
attention.

See your doctor if you experience any of the following when you stop NORPRESS
treatment:

  • Nausea
  • Headache
  • Malaise (a general feeling of being unwell).

These symptoms are generally not serious and disappear within a few days.

The list of side effects mentioned above is not complete. If you should
suffer from any of these side effects or any other undesired effect please tell
your doctor or pharmacist.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

In case of overdose

You should only take the number of tablets that you have been told.

Immediately contact your doctor or the National Poisons Information Centre
(0800 POISON or 0800 764 766) or go to the Emergency department at your nearest
hospital, if you think that you may have taken too much, or if anyone else has
taken any NORPRESS by mistake. Do this even if there are no signs of discomfort
or poisoning. You may need urgent medical attention.
Take the pack of
NORPRESS with you if you can.

Keep telephone numbers for these places handy.

Storage conditions

Do not take this medicine after the expiry date shown on the pack/blister
strip or if the packaging shows signs of tampering.

Keep your NORPRESS tablets in the blister pack until it is time to take them.

Store below 25°C and out of reach of children. Avoid exposure to heat, light
and moisture.

Do not store NORPRESS, or any other medicine, in the bathroom or near a sink.

Disposal

If your doctor tells you to stop taking NORPRESS or if the tablets have
passed the expiry date, ask your pharmacist what to do with the remaining
medicine.

Product Description

What NORPRESS tablets look like

NORPRESS 10mg tablets are yellow, film coated biconvex tablets.

NORPRESS 25mg tablets are orange, film coated biconvex tablets.

NORPRESS 10mg tablets are available in blister packs of 100 tablets.

NORPRESS 25mg tablets are available in blister packs of 500 tablets.

Ingredients

Each NORPRESS 10mg tablet contains 11.385mg of the active ingredient,
nortriptyline hydrochloride, equivalent to 10mg nortriptyline.

Each NORPRESS 25mg tablet contains 28.463mg of the active ingredient,
nortriptyline hydrochloride, equivalent to 25mg nortriptyline.

Each tablet also contains lactose, maize starch, magnesium stearate, and
contents of an organic film coat (ethanol, chloroform, diethyl phthalate,
hydroxypropylmethylcellulose, and opaspray yellow/orange).


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