Noritren

Package leaflet: Information for the patient

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

nortriptyline (as hydrochloride)
Please read all of this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 taking 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 Noritren is and what it is used for

Noritren belongs to a group of medicines called tricyclic antidepressants. These medicines help 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 taking Noritren

Do not take Noritren

• if you are allergic to nortriptyline or to 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 have heart block/heart rhythm disorders or coronary heart disease.
• if you are currently taking medicines known as monoamine oxidase inhibitors (MAOIs).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Noritren, especially if you have:

• epilepsy or a history of seizures or convulsions
• difficulty passing urine
• enlarged prostate
• overactive thyroid gland
• a liver or heart disorder
• glaucoma (increased eye pressure)
• diabetes (your antidiabetic treatment may need adjusting)
• mental illnesses other than depression
• a heart condition called Brugada syndrome

Talk to your doctor even if these conditions affected you in the past.

Suicidal thoughts and worsening of depression and anxiety disorders

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 take time to work, usually about two weeks but sometimes longer.

The risk that you experience such thoughts may be higher if:

• you have previously had thoughts of self-harm or suicide.
• you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with antidepressants. If you experience thoughts of self-harm or suicide, contact your doctor or go immediately to a hospital.

You may find it helpful to inform a relative or close friend that you suffer from depression or an anxiety disorder, and ask them to read this leaflet. You may wish to ask them to alert you if they think your depression or anxiety is worsening or if they are concerned about any changes in your behaviour.

Manic episodes

Some patients with bipolar disorder may enter a manic phase. This phase is characterised by numerous and sudden changes of mind, excessive cheerfulness and excessive physical activity. In such cases, it is important to contact your doctor, who will likely adjust your treatment.

Children and adolescents

Noritren must not be used to treat depression in children and adolescents under 18 years of age. In studies on the treatment of depression in this age group, tricyclic antidepressants have shown no therapeutic benefit. Tricyclic antidepressants must not be administered to patients under 18 years of age, as the use of antidepressants in this age group may increase the risk of suicide attempts, suicidal thoughts and hostility (particularly aggression, oppositional behaviour and anger). In addition, treatment with Noritren is associated with a risk of cardiovascular adverse effects in all age groups.

Other medicines and Noritren

Some medicines can alter the effects of other medicines, and this may 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 without a prescription.

Pay particular attention if you are taking Noritren with the following medicines:

• ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (present in some cold remedies)
• anticholinergic medicines (e.g. atropine or hyoscine)
• thyroid medicines
• cimetidine (used to treat 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
• certain antihistamines, such as astemizole and terfenadine
• valproic acid (a medicine used to treat epilepsy and bipolar disorder)
• buprenorphine (strong painkillers)

Taking these medicines together with Noritren may lead to serotonin syndrome, a potentially life-threatening condition (see section 4 Possible side effects).

If you are scheduled for surgery and will receive general or local anaesthesia, inform your doctor that you are taking Noritren.

Likewise, inform your dentist that you are taking Noritren if you are to receive local anaesthesia.

Noritren with food and drink

Noritren can be taken with or without food.

Noritren may enhance the sedative effects of alcohol, increasing drowsiness. It is advisable not to drink alcoholic beverages during treatment with Noritren.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor before taking this medicine.

Using this group of medicines (antidepressants) may affect the newborn's general condition.

Your doctor will advise you whether to start/continue/stop breastfeeding or whether to stop using this medicine, taking into account the benefits of breastfeeding for the child and the benefits of treatment for you.

Driving and using machines

Noritren generally does not cause drowsiness. However, if when you start taking these tablets you feel drowsy, dizzy or have blurred vision, do not drive or use any tools or machinery until these effects have disappeared.

Noritren contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Noritren

Take this medicine exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
If you think that the effect of Noritren is too strong or too weak, discuss this with your doctor or pharmacist.

Adults
The recommended starting dose is generally 25 mg two to three times daily. This dose may be gradually increased by your doctor up to 50 mg three times a day (total daily dose of 150 mg).

Elderly patients (over 65 years of age)
The recommended starting dose is 10 mg two to three times daily. This dose may be gradually increased by your doctor, up to a total daily dose of 100–150 mg.

Patients at particular risk
Patients with liver disorders are generally given lower doses.
Your doctor may take blood samples to determine the level of nortriptyline in your blood.

Swallow the tablets with a glass of water. Do not chew them.
At the beginning of treatment, Noritren is usually taken in 2 or 3 divided doses during the day.
For maintenance treatment, Noritren may be taken as a single daily dose in the morning.

Children and adolescents (<18 years)
Noritren must not be given to children or adolescents. For further information, see section 2.

Duration of treatment
As with other medicines used to treat depression, it may take several weeks before improvement is noticed.
The duration of treatment varies individually and is usually at least 6 months. The duration of treatment is determined by your doctor. Continue taking the tablets for the entire time recommended by your doctor. Do not stop treatment even if you start to feel better, unless your doctor tells you to do so. Since the underlying illness may persist for a long time, stopping treatment too early may cause symptoms to return.
Never change the dose of this 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 nearest hospital emergency department immediately, even if there are no symptoms or signs of poisoning. If you go to the doctor or hospital, take the Noritren packaging with you.
Symptoms of overdose may include:

• drowsiness or agitation
• loss of consciousness
• breathing difficulties, bluish discoloration of the skin
• dilated pupils
• seizures
• increased heart rate
• low blood pressure, weak pulse, paleness
• fever

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

If you stop taking Noritren
Your doctor will decide when and how to stop treatment to avoid unpleasant symptoms that could occur if treatment is stopped abruptly (e.g. headache, feeling unwell, insomnia, and irritability).

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking this medicine immediately and see your doctor if you notice any of the following symptoms:

• Increased intraocular pressure generally does not cause signs or symptoms, but represents a significant risk factor for glaucoma. If you experience episodes of intermittent blurred vision, see rainbow-coloured halos, or have eye pain, seek immediate eye examination before continuing treatment with this medicine, as these symptoms could indicate glaucoma. Uncommon side effect: may affect up to 1 in 100 people.
• Severe constipation, stomach swelling, fever, and vomiting; these symptoms could be due to intestinal paralysis. Rare side effect: may affect up to 1 in 1,000 people.
• Yellowing of the skin and whites of the eyes (jaundice); this may indicate liver problems. 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 disorders. Blood-related effects may include a reduced number of red blood cells (which carry oxygen throughout the body), white blood cells (which help fight infections), and platelets (which aid blood clotting). Rare side effect: may affect up to 1 in 1,000 people.
• Suicidal thoughts or behaviour. Frequency not known – frequency cannot be estimated based on available data.
• Involuntary rhythmic muscle contractions, including muscles controlling 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 – frequency cannot be estimated based on available data.
• Brugada syndrome (identification) (symptoms may include very rapid heartbeat, dizziness, fainting, seizures). Frequency not known – frequency cannot be estimated based on available data.

The following side effects are often mild in severity and may disappear after a few days of treatment.
Consult your doctor if they are bothersome or persist for more than a few days.

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

Very common side effects (may affect more than 1 in 10 people):
Sweating
Hand tremors, headache; dizziness which may be due to low blood pressure (it is advisable to stand up slowly)
Blurred vision (objects appear blurry and hazy)
Dry mouth, constipation, nausea (feeling unwell)
Palpitations (pounding heartbeat), rapid heart rate

Common side effects (may affect up to 1 in 10 people):
Numbness or tingling in arms or legs, coordination disturbances
Pupil dilation
Confusional state (especially in elderly patients), attention disturbance, decreased sexual desire
Taste disturbances
Weight gain
Heart abnormalities, detected as changes in the electrocardiogram (ECG)
Dizziness upon standing due to a rapid drop in blood 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)
Seizures
Mood changes, including increased anxiety or agitation
Insomnia, nightmares
Diarrhoea, 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 sensitivity of the skin to sunlight
Loss of appetite, delirium (especially in elderly patients), hallucinations
Swelling of the salivary glands
Weight loss
Breast enlargement

Frequency not known (frequency cannot be estimated based on available data):
Low sodium concentration in the blood
An increased risk of bone fractures has been observed in patients taking tricyclic antidepressants such as Noritren.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco). 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 stated on the pack after Exp. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Noritren and pack contents
The 10 mg tablets are round, slightly biconvex, white, film-coated tablets with a flat top surface, marked “NL” on one side.
The 25 mg tablets are round, slightly biconvex, white, film-coated tablets with a flat top surface, marked “NO” on one side.

This medicinal product is available in the following pack sizes:
10 mg: blister packs containing 28 tablets
bottle containing 100 tablets.
25 mg: blister packs containing 28 tablets
bottle containing 100 tablets.

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

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