NORITREN 10 mg Tabletki Powlekane

Treść ulotki

1. Noritren 10 mg film-coated tablets, 25 mg film-coated tablets
   1. What is Noritren and what is it used for
   2. What you need to know before you take Noritren
   3. How to take Noritren
   4. Possible side effects
   5. How to store Noritren
   6. Contents of the pack and other information

Noritren 10 mg film-coated tablets, 25 mg film-coated tablets

nortriptyline (as hydrochloride)

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Noritren and what is it used for

Noritren belongs to a group of medicines called tricyclic antidepressants. These medicines
help to correct certain chemical imbalances in the brain that cause the symptoms of your
illness.
Noritren is used for the treatment of depression.

2. What you need to know before you take Noritren

Do not take Noritren

• if you are allergic to nortriptyline or any of the other ingredients of this medicine (listed in section 6).
• if you have recently had a heart attack (myocardial infarction) or if you suffer from heart block/irregular heartbeat or coronary heart disease.
• if you are taking medicines known as monoamine oxidase inhibitors (MAOIs) at the same time.

MAOIs include medicines such as phenelzine, iproniazide, isocarboxazide, nialamide, tranylcypromine
and moclobemide, which are also used to treat depression, and selegiline which is
used to treat Parkinson's disease.
You will need to wait 2 weeks before starting to take Noritren tablets, even if you have stopped treatment with one of the following MAOIs: phenelzine, iproniazide, isocarboxazide, nialamide or tranylcypromine
for depression or selegiline for Parkinson's disease.
You will need to spend at least one day after stopping treatment with moclobemide.

Warnings and precautions
Talk to your doctor or pharmacist before taking Noritren, especially if you suffer from:

• epilepsy or if you have a history of seizures or convulsions
• difficulty urinating
• enlarged prostate
• hyperactivity of the thyroid gland
• a liver or heart disorder
• glaucoma (increased pressure in the eye)
• diabetes (it may be necessary to adjust your antidiabetic therapy)
• mental illnesses other than depression

Talk to your doctor, even if these events have affected you in the past.
Suicidal thoughts and worsening of depression and anxiety disorder
If you suffer from depression and/or anxiety disorders, you may sometimes have thoughts of self-harm or suicide.
These thoughts may increase at the beginning of treatment with antidepressants, as these
medicines need time to work, usually about two weeks but sometimes even longer.
The risk of you experiencing these thoughts may increase if:

• you have previously had thoughts of self-harm or suicide.
• you are a young adult. Information from clinical studies has shown an increase in the risk of suicidal behavior in adults under 25 years of age with psychiatric illnesses who were treated with antidepressants. If you experience thoughts of self-harm or suicide, contact your doctor or go to a hospital immediately.

It may be helpful to tell a relative or close friend that you are suffering from depression or have a
your depressive or anxious state is getting worse or if they are concerned about changes in your
behavior.
Episodes of mania
Some patients with manic-depressive illness may enter the manic phase. This phase is
characterized by numerous and rapid changes in ideas, exaggerated cheerfulness and excessive physical activity.
In these cases it is important to contact your doctor, who will probably modify your therapy.
Children and adolescents
Noritren should not be used to treat depression in children and adolescents under the age of
18 years. In studies on the treatment of depression in this age group, tricyclic antidepressants
have not shown any therapeutic benefit. Tricyclic antidepressants should not be
given to patients under the age of 18 as, with the intake of antidepressants, the risk of suicide attempts, suicidal thoughts and hostility (especially
aggression, oppositional behavior and anger) may increase in this age group. In addition, treatment with Noritren is associated with the risk of
cardiovascular side effects in all age groups.

Other medicines and Noritren
Some medicines can change the action of other medicines and this can, sometimes, cause serious adverse
reactions.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
Be particularly careful if you take Noritren with the following medicines:

• ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (present in some cold remedies)
• anticholinergic medicines (e.g. atropine or hyoscyamine)
• medicines for the thyroid
• cimetidine (used in the treatment of stomach ulcers)
• medicines that lower blood pressure
• medicines that cause drowsiness
• medicines for epilepsy
• other medicines used for mental illnesses, such as antipsychotics
• antifungal medicines, such as fluconazole and terbinafine
• some antihistamines, such as astemizole and terfenadine
• valproic acid (medicine used to treat epilepsy and bipolar disorder)
• Buprenorphine (strong painkillers) The use of these medicines together with Noritren can lead to serotonin syndrome, a potentially life-threatening condition (see section 4 Possible side effects)

If you are awaiting surgery and will be given general or local anesthesia, tell them
that you are taking Noritren.
Similarly, tell your dentist that you are taking Noritren if you are to have local anesthesia.

Noritren with food and drink
Noritren can be taken with or without food.
Noritren may enhance the sedative effects of alcohol, increasing feelings of drowsiness. It is advisable to
avoid drinking alcohol during treatment with Noritren.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor for advice before taking this medicine.
The use of this group of medicines (antidepressants) may affect the general condition of
the newborn.
The doctor will advise you whether to start/continue/stop breastfeeding or to stop using this
medicine, taking into account the benefit of breastfeeding for the baby and the benefit of
therapy for you.

Driving and using machines
Generally Noritren does not cause drowsiness. However, if you feel sleepy when you start taking these tablets,
experience dizziness or blurred vision, do not drive or use any tools or machinery,
until these effects have disappeared.

Noritren contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

3. How to take Noritren

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
If you feel that the effect of Noritren is too strong or too weak, talk to your doctor or
pharmacist.
Adults
The recommended initial dose is generally 25 mg two to three times a day. This dose may be
gradually increased by the doctor up to 50 mg three times a day (total daily dose of 150 mg).
Elderly patients (over 65 years of age)
The recommended initial dose is 10 mg two to three times a day. This dose may be gradually
increased by the doctor, up to a total daily dose of 100‑150 mg.
Patients with particular risks
Patients with liver disorders generally receive lower doses.
The doctor may take blood samples to determine the level of nortriptyline in the blood.
Swallow the tablets with a sip of water. Do not chew them.
At the beginning of treatment, Noritren is generally taken in 2 or 3 separate doses during the day.
In maintenance treatment, Noritren can be taken in a single daily dose in the
morning.
Children and adolescents (<18 years)
Noritren should not be given to children or adolescents. For further information, see
section 2.

Duration of treatment
As with other medicines for the treatment of depression, it may take several
weeks before an improvement is noticed.
The duration of treatment varies on an individual basis and is generally at least 6 months. The duration of treatment
is established by the doctor. Continue to take the tablets for the entire time recommended by the doctor. Do not
interrupt the treatment even if you start to feel better, unless your doctor tells you to. Because
the underlying disease may persist for a long time, if you interrupt the treatment too early, the symptoms
may reappear.
Never change the dose of the medicine without first consulting your doctor.

If you take more Noritren than you should
If you think that you or someone else has taken too many Noritren tablets, contact your
doctor or the emergency room of the nearest hospital immediately, even if there are no disturbances or signs of poisoning.
If you go to the doctor or hospital, bring the Noritren packaging with you.
Symptoms of overdose may include:

• drowsiness or excitement
• loss of consciousness
• difficulty breathing, bluish discoloration of the skin
• pupil dilation
• convulsions
• increased heart rate
• lowering of blood pressure, weak pulse, pallor
• fever

If you forget to take Noritren
If you forget to take a dose, take the next one at the usual time. Do not take a double dose
to make up for the missed dose.

If you stop taking Noritren
The doctor will decide when and how to stop the treatment to avoid unpleasant symptoms that may
occur in case of sudden interruption (e.g. headache, feeling unwell, insomnia and
irritability).
If you have any doubts about 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.
Stop taking this medicine immediately and see your doctor if you notice any of the
following symptoms:

• an increase in intraocular pressure usually does not cause any signs or symptoms, but represents a significant risk factor for glaucoma. If you notice attacks of intermittent blurred vision, see rainbow-colored halos, and complain of eye pain, have your eyes examined immediately before continuing treatment with this medicine, as these symptoms may be signs of glaucoma. Uncommon side effect, may affect up to 1 in 100 people.
• severe constipation, abdominal bloating, fever and vomiting; these symptoms may be due to a part of the intestine becoming paralyzed. Rare side effect, may affect up to 1 in
• 1,000.
• yellowing of the skin and the whites of the eyes (jaundice); there may be problems with the liver. Rare side effect, may affect up to 1 in 1,000 people.
• bruising, bleeding, paleness or persistent sore throat and fever; these symptoms may be early signs of blood problems. Effects on the blood may consist of a reduction in the number of red blood cells (which carry oxygen throughout the body), white blood cells (which help fight infections), and platelets (which help with blood clotting). Rare side effect, may affect up to 1 in 1,000 people.
• suicidal behavior or thoughts. Frequency not known, the frequency cannot be estimated based on the available data.
• involuntary rhythmic contractions of the muscles, including the muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C (signs of serotonin syndrome, a potentially life-threatening condition). Frequency not known, the frequency cannot be estimated based on the available data.

The following side effects are often mild and may disappear after a few days of
treatment.

See your doctor if they are bothersome or if their duration lasts more than a few days.

• Dry mouth increases the risk of tooth decay, so you should brush your teeth more frequently than usual.

Very common side effects (may affect more than 1 in 10 people):
Sweating
Hand tremor, headache; dizziness which may be due to low blood pressure (it is
advisable to get up slowly).
Blurred vision (objects appear blurry and hazy).
Dry mouth, constipation, nausea (feeling sick).
Palpitations (heartbeats that feel strong or irregular), increased heart rate.
Common side effects (may affect up to 1 in 10 people):
Numbness or tingling in the arms or legs, coordination problems.
Pupil dilation.
Confusion (especially in elderly patients), attention disorder, decreased sexual desire.
Changes in taste.
Weight gain.
Heart abnormalities, found in the form of changes in the electrocardiogram (ECG).
Feeling dizzy when getting up due to a rapid drop in
pressure (orthostatic hypotension).
Men may experience problems with erection.
Fatigue.
Uncommon side effects (may affect up to 1 in 100 people):
Skin rash, itching, swelling of the face and tongue.
Tinnitus (ringing in the ears).
Convulsions.
Mood changes, including increased anxiety or agitation.
Insomnia, nightmares.
Diarrhea, vomiting.
Increased blood pressure.
Difficulty urinating (especially in elderly men).
Rare side effects (may affect up to 1 in 1,000 people):
Hair loss, increased skin sensitivity to sunlight.
Loss of appetite, delirium (especially in elderly patients), hallucinations.
Swelling of the salivary glands.
Weight loss.
Breast enlargement.
Abnormal heart rhythm or sequence of heartbeat.
An increased risk of bone fractures has been observed in patients taking tricyclic antidepressants
like Noritren.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the Italian
Medicines Agency. Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Noritren

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Noritren contains
The active ingredient is nortriptyline as hydrochloride.
The other ingredients are corn starch, lactose monohydrate, copovidone, glycerol 85%, microcrystalline
cellulose, talc, magnesium stearate.
Coating: hypromellose 5, macrogol 6000.
Colorant: titanium dioxide (E 171).

Description of the appearance of Noritren and contents of the pack
The 10 mg tablets are round, slightly biconvex, white in color, film-coated with a
flat upper part and imprinted with “NL” on one side.
The 25 mg tablets are round, slightly biconvex, white in color, film-coated with a
flat upper part and imprinted with “NO” on one side.
This medicinal product is available in the following pack sizes:
10 mg: blister packs of 28 tablets
25 mg: blister packs of 28 tablets

Marketing Authorisation Holder
Lundbeck Italia S.p.A.
Via Joe Colombo 2
20124 Milano
Italy

Manufacturer

• H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark