NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
NORTRITABS
Nortriptyline hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about NortriTABS. It does not contain all the available information.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 you taking NortriTABS against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What NortriTABS is used for
NortriTABS is used to treat depression.
There are many different types of medicines used to treat depression. NortriTABS belongs to a group of medicines called tricyclic antidepressants (TCAs). TCAs are thought to work by their action on brain chemicals called amines, which are involved in controlling mood.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor’s prescription.
There is not enough information to recommend the use of this medicine for children or adolescents under the age of 18 years.
Before you take NortriTABS
When you must not take it
Do not take NortriTABS if you have an allergy to:
any medicine containing nortriptyline
any of the ingredients listed at the end of this leaflet.
any other similar medicines such as other tricyclic antidepressants.
Some of the 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.
Do not take this medicine if:
you are taking another medicine for depression called a monoamine oxidase inhibitor (MAOI), or have been taking a MAOI within the last 14 days. Check with your doctor or pharmacist if you are unsure as to whether or not you are taking a MAOI.
you are taking another medicine for sedation or anxiety. If you take both medicines together, you may have an allergic reaction.
you have an irregular heartbeat or have had a heart attack within the previous 8 weeks.
It may affect your developing baby if you take it during pregnancy.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, including other medicines used to treat your current condition, or to other substances foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
heart disease
diabetes
glaucoma (increased pressure in the eye)
difficulty in urinating
thyroid problems
epilepsy or seizures
mental illnesses such as mania or schizophrenia.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you plan to have surgery.
If you have not told your doctor about any of the above, tell him/her before you start taking NortriTABS.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and NortriTABS may interfere with each other. These include:
cimetidine, a medicine used to treat ulcers and gastric reflux
fluoxetine, a medicine used to treat depression
quinidine, a medicine used to treat heart disease
chlorpropamide, a medicine used to treat diabetes
carbamazepine, a medicine used to treat epilepsy
medicines used to treat high blood pressure
medicines used to treat thyroid problems.
These medicines may be affected by NortriTABS or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How to take NortriTABS
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How much to take
Your doctor will tell you how much NortriTABS you need to take each day.
The usual adult dose for NortriTABS is 75 to 100 mg daily, in 3 or 4 divided doses. For elderly patients, 25 to 50 mg daily in divided doses is recommended.
Your doctor may increase or decrease your dose depending on your condition.
How to take it
Swallow the tablets whole with a full glass of water.
When to take it
Take your medicine at about the same time(s) each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
For depression, the length of treatment will depend on how quickly your symptoms improve. Most antidepressants take time to work so don’t be discouraged if you do not feel better right away. While some symptoms may be relieved sooner than others, NortriTABS commonly takes 2 to 4 weeks before you feel much better.
If you do not start to feel better in about 4 weeks, check with your doctor.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much NortriTABS.Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include confusion, blurred vision, dizziness, body temperature changes (low and high), difficulty in breathing and increased heartbeat.
While you are taking NortriTABS
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking NortriTABS.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
Watch carefully for signs that your depression or anxiety is getting worse, especially in the first few weeks of treatment.
Tell your doctor immediately if you experience any of the following symptoms, especially if they are severe, you have not had these symptoms before, or they happen very suddenly:
anxiety or agitation
panic attacks
difficulty sleeping
hostility or impulsiveness
restlessness
overactivity or uninhibited behaviour.
Tell your doctor immediately if you have any thoughts about suicide or doing harm to yourself.
Warning signs of suicide:
All thoughts or talk about suicide or violence are serious. If you or someone you know is showing the following warning signs, either contact your doctor or a mental health advisor right away, or go to the nearest hospital for treatment:
thoughts or talk about death or suicide
thoughts or talk about self-harm or doing harm to others
any recent attempts of self-harm
an increase in aggressive behaviour, or irritability or agitation.
Tell your doctor if your mouth feels dry and this lasts for more than 2 weeks.
NortriTABS can cause dry mouth.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor’s appointments so that your progress can be checked.
Things you must not do
Do not take NortriTABS to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Stopping NortriTABS suddenly may cause unwanted side effects, such as nausea, headache or generally feeling unwell. Your doctor may decide to reduce your dose, or the interval of your dose over 1 or 2 weeks.
Things to be careful of
Be careful driving or operating machinery until you know how NortriTABS affects you.
NortriTABS may cause drowsiness in some people. If you feel drowsy, do not drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking this medicine.
Combining NortriTABS and alcohol can make you more sleepy, dizzy or light-headed.
Your doctor may suggest that you avoid alcohol while you are being treated with NortriTABS.
Be careful to avoid exposure to sunlight while you are taking NortriTABS, as symptoms of sunburn may occur more quickly than normal.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking NortriTABS.
This medicine helps most people with depression, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Side effects may be related to the dose of NortriTABS, so it is important that you do not exceed the dose your doctor has told you to take.
It is important that you tell your doctor as soon as possible about any unwanted effects. Your doctor may then decide to adjust to the dose of NortriTABS you are taking.
Do not be alarmed by the following lists of side effects.You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
drowsiness
blurred vision
constipation
diarrhoea and stomach pain
nausea or vomiting
dizziness or light-headedness (especially on standing rapidly)
difficulty passing urine
dry mouth
weight gain or loss.
These are common side effects of tricyclic antidepressants.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
body temperature changes (low and high)
difficulty in breathing
increased heartbeat (palpitations)
The above list includes very serious side effects. These side effects are uncommon but may be serious and need urgent medical attention or hospitalisation.
There are other rare side effects.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After taking NortriTABS
Storage
Keep your tablet in the blister pack until it is time to take them.
If you take the tablets out of the blister pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store NortriTABS or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
NortriTABS tablets are available in 2 strengths, 10 mg and 25 mg.
NortriTABS tablets are available in packs of 50.
The 10 mg tablets are white to off-white, round, biconvex, uncoated tablets, debossed ‘NM’ on one side and ’10’ on the other side.
The 25 mg tablets are white to off-white, bound, biconvex, uncoated tablets, debossed ‘NM’ on one side and ’25’ on the other side.
Ingredients
Active ingredient:
10 mg or 25 mg nortriptyline (as hydrochloride)
Inactive ingredients:
maize starch
magnesium stearate
lactose monohydrate.
Sponsor details
Distributed in Australia by:
Amdipharm Mercury (Australia) Pty Ltd
Level 9, 76 Berry Street
North Sydney NSW 2060
Australia Registration Numbers:
10 mg: AUST R 220998
25 mg: AUST R 220997
Date of preparation
This leaflet was prepared on 7 November 2016.
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