Norcapto

Norcapto 10 mg hard capsules
Norcapto 25 mg hard capsules
nortriptyline

Please read this entire leaflet carefully before 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Norcapto hard capsules are and what they are used for
2. What you need to know before taking Norcapto hard capsules
3. How to take Norcapto hard capsules
4. Possible side effects
5. How to store Norcapto hard capsules
6. Contents of the pack and other information

1. What Norcapto hard capsules are and what they are used for

Norcapto hard capsules contain the active substance nortriptyline, which belongs to a group of medicines called tricyclic antidepressants. This medicine is indicated for the treatment of depressive episodes.

2. What you need to know before taking Norcapto hard capsules

Do not take Norcapto hard capsules if:

• you are allergic to nortriptyline or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue;
• you have recently had a heart attack or if you have heart problems;
• you have severe liver disease;
• you have mania (excessive euphoria);
• you are breastfeeding;
• the child is under 6 years of age;
• you are taking or have taken within the last two weeks monoamine oxidase inhibitors (another type of antidepressant);
• you are taking adrenergic-like pharmaceutical substances, including ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine. These substances are often contained in cough and cold medicines.

Warnings and precautions
Take Norcapto hard capsules with particular caution if:

• you experience suicidal thoughts or aggressive feelings – inform your doctor;
• you feel agitated, hyperactive, or suffer from schizophrenia;
• you have heart disease;
• you have thyroid problems;
• you have had epileptic seizures;
• you have high pressure in the eye ( glaucoma );
• you have prostatic hypertrophy;
• your child taking hard capsules shows a change in behaviour;
• you are due to undergo electroconvulsive therapy (electroshock);
• you have diabetes;
• you are to be given anaesthetics, for example if undergoing surgery – inform your doctor;
• you have previously had an allergic reaction to another tricyclic antidepressant;
• you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding. Taking Norcapto hard capsules is not recommended unless advised by your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder.
If you suffer from depression or an anxiety disorder, you may sometimes think about harming yourself or committing suicide. These thoughts may become more frequent at the beginning of antidepressant treatment, as these medicines take time to work, usually about two weeks or sometimes longer.
You may be more likely to have such thoughts if:

• You have previously had thoughts of suicide or self-harm;
• You are young. Evidence from clinical trials shows an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressants. If you continually think about suicide or harming yourself, contact your doctor or go to hospital immediately. It may be 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 ask them to tell you if they think your depression or anxiety is getting worse or if they are concerned about any change in your behaviour. If any of the above situations apply to you, inform your doctor or pharmacist.

Other medicines and Norcapto hard capsules
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following medicines may interact with Norcapto hard capsules:

• guanethidine, bretylium, betanidine, clonidine, and reserpine (used to treat hypertension);
• barbiturates (used for anxiety or to aid sleep);
• alcohol (you must not drink alcoholic beverages);
• fluoxetine (another antidepressant);
• cimetidine (for heartburn and ulcers);
• phenothiazines (for mental disorders);
• carbamazepine (for epilepsy);
• propafenone, flecainide, encainide, quinidine (for heart rhythm disorders).

However, this does not necessarily mean you cannot take Norcapto hard capsules. Your doctor will decide what is best for you.

Driving and using machines
Norcapto hard capsules may affect your level of alertness. Therefore, do not drive or operate machinery until you know how this medicine affects you. If you feel that Norcapto hard capsules impair your ability to drive or operate machinery, contact your doctor immediately.

Norcapto hard capsules contain lactose
Norcapto hard capsules contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Norcapto hard capsules

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Dosage
Adults:
The recommended dose in adults is 25 mg, 3-4 times daily. Alternatively, the dose may be
administered once daily, usually in the evening. The dose should start at a low level,
for example 10 mg, 3-4 times daily, and then be gradually increased as needed. The
maximum dose is 150 mg per day.
Elderly:
The recommended dose is 30-50 mg per day in divided doses.
Treatment may start with 10 mg three times daily.
Adolescents:
The recommended dose is 30-50 mg per day in divided doses.
Treatment may start with 10 mg three times daily.
Lower doses are recommended for outpatients compared to hospitalized patients who
are under close medical supervision.
After remission, maintenance treatment may require a longer period.
During this period, the lowest effective dose preventing the recurrence of depressive symptoms should be administered.
If you take more Norcapto than you should
Go immediately to the nearest emergency department or contact your doctor immediately.
Take the carton with you.
If you forget to take Norcapto hard capsules
If you forget to take a dose, take it as soon as possible. If you have missed several doses, contact your
doctor. Do not take a double dose to make up for a forgotten dose.
If you stop taking Norcapto hard capsules
Do not stop taking the hard capsules or reduce the dose without first consulting your doctor.
If you stop treatment with this medicine abruptly, you may experience nausea,
headache (cephalalgia), or general malaise.
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.
If side effects worsen or you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
All medicines can cause allergic reactions, although serious allergic reactions are very rare.
Contact your doctor immediately if you experience sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially if it affects the whole body.

The following side effects have been reported:

• high or low blood pressure
• increased or irregular heartbeat
• palpitations
• heart attack (myocardial infarction)
• stroke
• oedema (swelling of the ankles)
• confusion (especially in the elderly), with visual or auditory disturbances (hallucinations)
• feeling of disorientation
• false beliefs (delusions)
• anxiety, restlessness, agitation
• lack of sleep (insomnia)
• nightmares
• panic
• prolonged abnormal mood
• worsening of mental disorder
• numbness, tingling, pins and needles sensation in hands or feet
• coordination problems
• tremors
• abnormal movements
• seizures (fits)
• altered brain activity (EEG)
• ringing in the ears (tinnitus)
• dry mouth
• less commonly, inflamed glands under the tongue or inflammation of the gums (gingivitis)
• blurred vision, difficulty focusing, dilated pupils
• constipation, intestinal blockage
• difficulty or delay in urination
• skin rash
• itching
• light sensitivity
• swelling (oedema)
• fever
• reaction to other similar medicines
• blood disorders that may cause easy bruising, anaemia, or inability to fight infections
• nausea and vomiting
• loss of appetite (anorexia)
• indigestion
• diarrhoea
• constipation
• altered taste
• mouth inflammation
• abdominal cramps
• black tongue
• breast development in men, breast enlargement and milk production in women
• increased or decreased libido
• erectile dysfunction (impotence)
• enlarged testicles
• altered blood sugar levels
• yellowing of the skin and eyes (jaundice)
• changes in liver function
• inflammation of the liver (hepatitis) and liver damage
• weight gain or loss
• sweating
• flushing
• frequent and nocturnal urination
• insomnia
• dizziness
• weakness
• fatigue
• headache
• swollen glands
• hair loss (alopecia)
• An increased risk of bone fractures has been observed in patients undergoing this treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Norcapto hard capsules

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation “Exp.”.
The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any signs of deterioration (for example, a change in colour).
Do not dispose of any medicine 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 Norcapto hard capsules contain

• The active substance is nortriptyline. Each capsule contains nortriptyline hydrochloride equivalent to 10 mg or 25 mg of nortriptyline base.
• The other components are: maize starch, monohydrate lactose and talc.
• The outer coating of Norcapto 10 mg hard capsules contains: gelatin, titanium dioxide and printing ink.
• The outer coating of Norcapto 25 mg hard capsules contains: gelatin, titanium dioxide, red iron oxide (E172) and printing ink.
• The printing ink contains: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.

Description of the appearance of Norcapto hard capsules and package contents
The 10 mg hard capsules are opaque white, hard gelatin capsules of size 3,
marked with the code 'NT 10'.
The 25 mg hard capsules are opaque red, hard gelatin capsules of size 1,
marked with the code 'NT 25'.
The blisters are made of PVC/PVDC sealed with an aluminum foil.
Each blister contains 10 hard capsules.
Norcapto hard capsules are available in packs containing 30 hard capsules.

Marketing Authorization Holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 – Ascoli Piceno (AP)
Italy

Manufacturer
Anfarm Hellas S.A.
Sximatari Viotias,
32009, Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
United Kingdom Nortriptyline 10mg, 25 mg Hard Capsules
Italy Norcapto 10 mg, 25 mg hard capsules

This patient information leaflet was last updated on:

Norcapto 5 mg/ml oral solution
nortriptyline

Please read 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 to them.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Norcapto oral solution is and what it is used for
2. What you need to know before taking Norcapto oral solution
3. How to take Norcapto oral solution
4. Possible side effects
5. How to store Norcapto oral solution
6. Package contents and other information

1. What Norcapto oral solution is and what it is used for

Norcapto oral solution contains the active substance nortriptyline, which belongs to a group of
medicines called tricyclic antidepressants. This medicine is indicated for the treatment of
depressive episodes.

2. What you need to know before taking Norcapto oral solution

Do not take Norcapto oral solution if:

• you are allergic to nortriptyline or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing, or swelling of the face, lips, throat or tongue;
• you have recently had a heart attack or you have heart problems;
• you have severe liver disease;
• you suffer from mania (excessive euphoria);
• you are breastfeeding;
• the child is under 6 years of age;
• you are taking or have taken monoamine oxidase inhibitors (another type of antidepressant) within the last two weeks;
• you are taking adrenergic-like pharmaceutical substances, including ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine. These substances are often contained in cough and cold medicines.

Warnings and precautions
Take Norcapto oral solution with particular caution if:

• you experience suicidal or aggressive feelings – inform your doctor;
• you feel agitated, hyperactive or suffer from schizophrenia;
• you suffer from heart disease;
• you suffer from thyroid problems;
• you have had epileptic seizures;
• you suffer from high eye pressure ( glaucoma );
• you suffer from prostatic hypertrophy;
• your child taking the oral solution shows a change in behaviour;
• you are due to undergo electroconvulsive therapy (electroshock);
• you suffer from diabetes;
• you are due to be given anaesthetics, for example if undergoing surgery – inform your doctor;
• you have previously had an allergic reaction to another tricyclic antidepressant;
• you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding. Taking Norcapto oral solution is not recommended unless specifically advised by your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder.
If you suffer from depression or an anxiety disorder, you may sometimes have thoughts about harming yourself or committing suicide. These thoughts may become more frequent during the initial phase of antidepressant treatment, as these medicines take time to become effective, usually about two weeks or sometimes even longer.
You may be more likely to have such thoughts if:

• You have previously had suicidal or self-harming thoughts;
• You are young. Clinical trial data show an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with antidepressants. If you have persistent thoughts about suicide or harming yourself, contact your doctor or go immediately to hospital. It may be 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 ask them to tell you if they think your depression or anxiety is worsening or if they are concerned about any change in your behaviour. If you recognise yourself in any of the situations described above, inform your doctor or pharmacist.

Other medicines and Norcapto Oral Solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicines may interact with Norcapto Oral Solution:

• guanethidine, bretylium, betanidine, clonidine and reserpine (used to treat hypertension);
• barbiturates (used for anxiety or to aid sleep);
• alcohol (you must not drink alcoholic beverages);
• fluoxetine (another antidepressant);
• cimetidine (for heartburn and ulcers);
• phenothiazines (for mental disorders);
• carbamazepine (for epilepsy);
• propafenone, flecainide, encainide, quinidine (for heart rhythm disorders).

However, it may still be possible for you to take Norcapto oral solution. Your doctor will decide what is best for you.
Driving and using machines
Norcapto oral solution may affect your level of alertness. Therefore, do not drive or operate machinery until you know how this medicine affects you. If you feel that Norcapto oral solution affects your ability to drive or operate machinery, contact your doctor immediately.
Norcapto oral solution contains sodium benzoate and sodium
This medicine contains 0.50 mg of sodium benzoate E211 per ml.
This medicine contains 0.08 mg of sodium per ml.

3. How to take Norcapto oral solution

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Dosage
Adults:
The recommended dose for adults is 25 mg, 3–4 times daily. Alternatively, the dose may be
administered once daily, usually in the evening. The dose should start at a low level, for
example 10 mg, 3–4 times daily, and then be gradually increased as needed. The maximum
dose is 150 mg per day.
Elderly:
The recommended dose is 30–50 mg per day in divided doses.
Treatment may start with 10 mg three times daily.
Adolescents:
The recommended dose is 30–50 mg per day in divided doses.
Treatment may start with 10 mg three times daily.
Lower doses are recommended for outpatients compared to hospitalized patients who
are under close medical supervision.
After remission, maintenance treatment may require a longer period.
During this period, the lowest effective dose that prevents the recurrence of depressive symptoms should be administered.
Instructions for correct use:

• Open the bottle.
• Insert the oral syringe adapter into the neck of the bottle (Fig. 1). Make sure the adapter is securely inserted.
• Take the oral syringe and insert it into the opening of the adapter (Fig. 1).

• Turn the bottle upside down (Fig. 2).

• Fill the oral syringe with a small amount of solution by gently pulling back the plunger (Fig. 3A). Then, push the plunger back slightly to remove any air bubbles (Fig. 3B). Next, pull the plunger to the mark in millilitres (ml) corresponding to the dose prescribed by your doctor (Fig. 3C).

• Return the bottle to an upright position. Remove the oral syringe from the adapter.
• Empty the contents of the oral syringe onto a spoon or into a glass of water by pushing the plunger fully into the oral syringe (Fig. 4).

• Drink the entire contents of the glass or spoon.
• Rinse the oral syringe with water only (Fig. 5).
• Close the bottle with the screw cap.

If you take more Norcapto than you should
Go to the nearest emergency room or contact your doctor immediately.
Bring the packaging or bottle with you.
If you forget to take Norcapto oral solution
If you forget to take a dose, take it as soon as possible. If you have missed several doses, consult your doctor. Do not take a double dose to make up for a forgotten dose.
If you stop taking Norcapto oral solution
Do not stop taking the oral solution or reduce the dose without first consulting your doctor.
If you stop treatment with this medicine abruptly, symptoms such as nausea, headache (cephalalgia), or general malaise may occur.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects worsen or you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
All medicines can cause allergic reactions, although serious allergic reactions are very rare.
Contact your doctor immediately if you experience sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching, especially if it involves the whole body.

The following side effects have been reported:

• high or low blood pressure
• increased or irregular heartbeat
• palpitations
• heart attack (myocardial infarction)
• stroke
• oedema (swelling of the ankles)
• confusion (especially in the elderly), with visual or auditory disturbances (hallucinations)
• feeling of disorientation
• false beliefs (delusions)
• anxiety, restlessness, agitation
• lack of sleep (insomnia)
• nightmares
• panic
• prolonged abnormal mood
• worsening of mental disorder
• numbness, tingling, pins and needles sensation in hands or feet
• coordination problems
• tremors
• abnormal movements
• seizures (fits)
• altered brain activity (EEG)
• ringing in the ear (tinnitus)
• dry mouth
• less commonly, inflamed glands under the tongue or gum inflammation (gingivitis)
• blurred vision, difficulty focusing, dilated pupils
• constipation, intestinal obstruction
• difficulty or delay in urinating
• skin rash
• itching
• light sensitivity
• swelling (oedema)
• fever
• reaction to other similar medicines
• blood disorders that may cause easy bruising, anaemia or inability to fight infections
• nausea and vomiting
• loss of appetite (anorexia)
• indigestion
• diarrhoea
• constipation
• altered taste
• inflamed mouth
• abdominal cramps
• black tongue
• breast development in men, breast enlargement and milk production in women
• increased or decreased libido
• erectile dysfunction (impotence)
• testicular enlargement
• altered blood sugar levels
• yellowing of the skin and eyes (jaundice)
• changes in liver function
• liver inflammation (hepatitis) and liver damage
• weight gain or weight loss
• sweating
• flushing
• frequent and nocturnal urination
• insomnia
• dizziness
• weakness
• fatigue
• headache
• swollen glands
• hair loss (alopecia)
• An increased risk of bone fractures has been observed in patients undergoing this treatment.

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 national reporting system at: 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 Norcapto oral solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after the abbreviation "Exp.".
The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
After first opening, use within 3 months.
Do not use this medicine if you notice signs of deterioration (for example, a change in colour).
Do not dispose of any medicine 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 Norcapto oral solution contains

• The active substance is nortriptyline. Each ml contains nortriptyline hydrochloride equivalent to 5 mg of nortriptyline base.
• The other components are: Concentrated hydrochloric acid, Sodium benzoate, Sucralose, Purified water.

Description of the appearance of Norcapto oral solution and contents of the pack
Norcapto 5 mg/ml oral solution is a colourless and odourless solution, supplied in a 250 ml amber glass bottle of type III, with nominal capacity suitable for pharmaceutical use, securely closed with a child-resistant screw cap and a tamper-evident closure.
The secondary packaging consists of a folded cardboard box containing one bottle and a leaflet.
Also supplied are a 10 ml graduated oral syringe made of LDPE, CE marked, with intermediate graduations of 0.5 ml, and a suitable LDPE syringe-to-bottle adapter, CE marked.
Each bottle is filled with 250 ml of solution.

Marketing Authorisation Holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 – Ascoli Piceno (AP)
Italy

Manufacturer
Anfarm Hellas S.A.
Sximatari Viotias,
32009, Greece
or
CANA AE FARMAKEFTIKA ERGASTIRIA
Irakliou Ave. 446,
14122 Iraklio, Attiki, Greece

This leaflet was last updated on: