NORCAPTO 10 mg Hard Capsule

Зміст інструкції

1. Norcapto 10 mg hard capsules, 25 mg hard capsules
   1. What is Norcapto hard capsules and what is it used for
   2. What you need to know before you take Norcapto hard capsules
   3. How to take Norcapto hard capsules
   4. Possible side effects
   5. How to store Norcapto hard capsules
   6. Package Contents and Other Information
   7. What is Norcapto oral solution and what is it used for?
   8. What you need to know before you take Norcapto oral solution
   9. How to take Norcapto oral solution
   10. Possible side effects
   11. How to store Norcapto oral solution
   12. Contents of the pack and other information

Norcapto 10 mg hard capsules, 25 mg hard capsules

nortriptyline

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 Norcapto hard capsules is and what it is used for
• 2. What you need to know before you take 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 is Norcapto hard capsules and what is it used for

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

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

Do not take Norcapto hard capsules if:

• you are allergicto 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 had a recent heart attackor if you have heart problems;
• you suffer from severe liver disorders;
• you are affected by mania(excessive euphoria);
• you are breast-feeding;
• the child is under 6 years of age;
• you are taking or have taken in the last two weeks monoamine oxidase inhibitors(another type of antidepressant);
• you are taking adrenalin-like pharmaceutical substances, including ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine. These substances are often contained in pharmaceutical products for coughs and colds.

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

• you experience suicidal or aggressive feelings- inform your doctor;
• you feel agitated, hyperactiveor suffer from schizophrenia;
• you suffer from heart disease;
• you suffer from thyroid problems;
• you have had epileptic seizures;
• you suffer from high pressure in the eye (glaucoma);
• you suffer from prostatic hypertrophy;
• your child takinghard capsules shows a change inbehavior;
• you will have to undergo electroconvulsive therapy(electroshock);
• you suffer from diabetes;
• you are to be given anaesthetics, for example if you are to undergo surgery - inform your doctor;
• you have had an allergic reaction to another tricyclic antidepressantin the past;
• you are pregnant, think you may be pregnant or are planning a pregnancy, or are breast-feeding. Taking Norcapto hard capsules is not recommended unless indicated by your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder.
If you suffer from depression or anxiety disorder, you may sometimes think about harming yourself or committing suicide. These thoughts
may become more frequent in the early stages of taking antidepressants, because these
medicines take time to take effect, usually about two weeks or sometimes even longer.
You may be more prone to such thoughts if:

• You have previously had thoughts of suicide or self-harm;
• You are a young person. Information from clinical trials shows an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders and treated with antidepressants. If you continuously think about committing suicide or harming yourself, contact your doctor or goimmediately to hospital.It may be helpful to inform a relative or close friendthat you are suffering from depression or an

think that your depression or anxiety is getting worse or if they are concerned about any
change in your behavior.
If you recognize yourself in any of the situations described above, 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 medicine.
The following medicines can interact with Norcapto Hard Capsules:

• guanethidine, debrisoquine, betanidine, clonidineand reserpine(used to treat high blood pressure);
• barbiturates(used for anxiety or to help sleep);
• alcohol(you should not drink alcohol);
• 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 is not excluded that you may not be able to take Norcapto hard capsules. Your doctor will
decide what is best for you.

Driving and using machines
Norcapto hard capsules can alter the level of attention. Therefore, do not drive or use
machinery until you know how this medicine affects your body. If you feel that Norcapto hard capsules affect your ability to drive or use machinery,
seek immediate advice from your doctor.

Norcapto hard capsules contains lactose
Norcapto hard capsules contains lactose. If your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.

3. How to take Norcapto hard capsules

Take this medicine following exactly the instructions of 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 a day. Alternatively, the dose may be
administered once a day, usually in the evening. The dose should start at a low level,
for example 10 mg, 3-4 times a day, 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 3 times a day.

Adolescents:
The recommended dose is 30-50 mg per day in divided doses.
Treatment may start with 10 mg 3 times a day.
Lower dosages are recommended for outpatients compared to hospital patients who
are under strict medical supervision.
After remission, maintenance treatment may require a longer period.
During this period, the minimum dose capable of preventing the recurrence of depressive symptoms should be administered.

If you take more Norcapto than you should
Go to the nearest emergency room or contact your doctor immediately.
Bring the cardboard box 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 forgotten 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 suddenly stop treatment with this medicine, nausea, headache or general malaise may occur.
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.
If the side effects get worse or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.
All medicines can cause allergic reactions, although serious allergic reactions are very rare.

Tell your doctor immediately if you experience sudden wheezing, difficulty in
breathing, swelling of the eyelids, face or lips, skin rash or itching,
especially if it spreads all over the body.
The following side effects have been reported:

• high or low blood pressure
• increased or irregular heartbeats
• palpitations
• heart attack (myocardial infarction)
• stroke
• edema (swelling of the ankles)
• confusion (especially in the elderly) with altered vision or hearing (hallucinations)
• feeling of not knowing where you are (disorientation)
• false beliefs (delusions)
• anxiety, restlessness, agitation
• difficulty sleeping (insomnia)
• nightmares
• panic
• prolonged abnormal mood
• worsening of mental disorder
• numbness, tingling, pins and needles sensation in the hands or feet
• problems with coordination
• tremors
• abnormal movements
• convulsions (seizures)
• altered brain activity (EEG)
• ringing in the ears (tinnitus)
• dry mouth
• more rarely, inflamed glands under the tongue or inflammation of the gums (gingivitis)
• blurred vision, difficulty focusing, dilated pupils
• constipation, blockage of the digestive tract
• difficulty or delay in urination
• skin rash
• itching
• sensitivity to light
• swelling (edema)
• fever
• reaction to other similar drugs
• blood disorders that can cause easy bruising, anemia or inability to fight infections
• feeling sick and vomiting
• loss of appetite (anorexia)
• indigestion
• diarrhea
• constipation
• altered taste
• inflamed mouth
• abdominal cramps
• black tongue
• development of breasts in men, enlargement of the breasts and milk production in women
• increased or decreased libido
• erectile dysfunction (impotence)
• enlargement of the testicles
• altered blood sugar levels
• yellowing of the skin and eyes (jaundice)
• altered 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 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 national reporting system 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 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 particular storage conditions.
Do not use this medicine if you notice signs of deterioration (for example, a change in colour).
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. Package Contents and Other Information

What Norcapto hard capsules contain

• The active ingredient is nortriptyline. Each capsule contains nortriptyline hydrochloride equivalent to 10 mg or 25 mg of nortriptyline base
• The other ingredients are: corn starch, lactose monohydrate and talc.
• The external coating of Norcapto 10 mg hard capsules contains: gelatin, titanium dioxide and printing ink.
• The external 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, size 3 hard gelatin capsules
marked with the abbreviation 'NT 10'.
The 25 mg hard capsules are opaque red, size 1 hard gelatin capsules,
marked with the abbreviation '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 of 30 hard capsules.

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
United KingdomNortriptyline 10mg, 25 mg Hard Capsules

ItalyNorcapto 10 mg, 25 mg hard capsules

This leaflet was last updated on:
Norcapto 5 mg/ml oral solution
nortriptyline

Read all of this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it may 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 Norcapto oral solution is and what it is used for
• 2. What you need to know before you take Norcapto oral solution
• 3. How to take Norcapto oral solution
• 4. Possible side effects
• 5. How to store Norcapto oral solution
• 6. Contents of the pack and other information

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

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

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

Do not take Norcapto oral solution if:

• you are allergicto nortriptyline or 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 attackor if you have heart problems;
• you suffer from severe liver disorders;
• you are affected by mania(excessive euphoria);
• you are breastfeeding;
• the child is less than 6 years old;
• you are taking or have taken in the last two weeks monoamine oxidase inhibitors(another type of antidepressant);
• you are taking adrenalin-like substances, including ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine. These substances are often contained in pharmaceutical products for coughs and colds.

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

• you have suicidal or aggressive feelings- inform your doctor;
• you feel agitated, hyperactiveor suffer from schizophrenia;
• you suffer from heart disease;
• you suffer from thyroid problems;
• you have had epileptic seizures;
• you suffer from high pressure in the eye (glaucoma);
• you suffer from prostatic hypertrophy;
• your child takingoral solution shows a change inbehavior;
• you will undergo electroconvulsive therapy(electroshock);
• you suffer from diabetes;
• you are to be administered anesthetics, e.g. if you are to undergo surgery - inform your doctor;
• you have had an allergic reaction to another tricyclic antidepressantin the past;
• you are pregnant, think you may be pregnant or are planning a pregnancy, or are breastfeeding. Taking Norcapto oral solution is not recommended unless indicated by your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder.
If you suffer from depression or anxiety disorder, you may sometimes think about harming yourself or committing suicide. These thoughts
may become more frequent in the early stages of taking antidepressants, because these
medicines take time to have an effect, usually about two weeks or sometimes even longer.
You may be more prone to such thoughts if:

• You have previously had thoughts of suicide or self-harm;
• You are a young person. Information from clinical trials shows an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders and treated with antidepressants. If you think about suicide or harming yourself constantly, contact your doctor or goimmediately to the hospital.It may help to inform a relative or close friendthat you are suffering from depression or a

think that your depression or anxiety is getting worse or if they are worried about any
change in your behavior.
If you recognize yourself in any of the above situations, inform your doctor or pharmacist.

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

• guanethidine, debrisochine, betanidine, clonidineand reserpine(used to treat hypertension);
• barbiturates(used for anxiety or to promote sleep);
• alcohol(you should not drink alcohol);
• 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 is not excluded that you may not be able to take Norcapto oral solution. Your doctor will
decide what is best for you.

Driving and using machines
Norcapto oral solution can alter the level of attention. Therefore, do not drive or
use machines until you know the effects of this medicine on your body. If
you feel that Norcapto oral solution affects your ability to drive or use
machines, consult your doctor immediately.

Norcapto oral solution contains sodium benzoate and sodium
This medicine contains 0.50 mg of sodium benzoate E211 in each ml.
This medicine contains 0.08 mg of sodium in each ml.

3. How to take Norcapto oral solution

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Dosage
Adults:
The recommended dose in adults is 25 mg, 3-4 times a day. Alternatively, the dose may be
administered once a day, usually in the evening. The dose should start at a low level, such as
10 mg, 3-4 times a day, 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 3 times a day.

Adolescents:
The recommended dose is 30-50 mg per day in divided doses.
Treatment may start with 10 mg 3 times a day.
Lower dosages are recommended for outpatients compared to hospital patients who
are under close medical supervision.
After remission, maintenance treatment may require a longer period.
During this period, the minimum dose capable of preventing the recurrence of symptoms of
depression 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 firmly 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, pulling the plunger slightly (Fig. 3A). Then, reinsert the plunger to remove any air bubbles (Fig. 3B). Subsequently, pull the plunger up to the mark in milliliters (ml) corresponding to the dose prescribed by the doctor (Fig. 3C).

• Return the bottle to the vertical position. Remove the oral syringe from the adapter.
• Empty the contents of the oral syringe onto a spoon or into a glass of water, pushing the plunger all the way 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 package 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 forgotten several doses, consult
your doctor. Do not take a double dose to make up for a forgotten one.

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 suddenly stop treatment with this medicine, nausea, headache or general malaise may occur.
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.
If the side effects get worse or if you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
All medicines can cause allergic reactions, although serious allergic reactions are very rare.

Immediately inform your doctor 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 heartbeats
• palpitations
• heart attack (myocardial infarction)
• stroke
• edema (swelling of the ankles)
• confusion (especially in the elderly) with altered vision or hearing (hallucinations)
• feeling of not knowing where you are (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 the hands or feet
• problems with coordination
• tremors
• abnormal movements
• convulsions (seizures)
• altered brain activity (EEG)
• ringing in the ears (tinnitus)
• dry mouth
• more rarely, inflamed glands under the tongue or inflammation of the gums (gingivitis)
• blurred vision, difficulty focusing, dilated pupils
• constipation, blockage of the digestive tract
• difficulty or delay in urination
• skin rash
• itching
• sensitivity to light
• swelling (edema)
• fever
• reaction to other similar drugs
• blood disorders that can cause easy bruising, anemia or inability to fight infections
• feeling of nausea and vomiting
• loss of appetite (anorexia)
• indigestion
• diarrhea
• constipation
• altered taste
• inflamed mouth
• abdominal cramps
• black tongue
• development of breasts in men, enlargement of the breasts and milk production in women
• increased or decreased libido
• erectile dysfunction (impotence)
• enlargement of the testicles
• altered blood sugar levels
• yellowing of the skin and eyes (jaundice)
• altered 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 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 national reporting system 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 packaging after the abbreviation “Exp.”.
The expiry date refers to the last day of the month indicated.
This medicine does not require any particular storage conditions.
Use within 3 months after first opening
Do not use this medicine if you notice signs of deterioration (for example, a change in colour).
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What Norcapto oral solution contains

• The active ingredient is nortriptyline. Each ml contains nortriptyline hydrochloride equivalent to 5 mg of nortriptyline base
• The other ingredients 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 colorless and odorless solution, in an amber glass bottle of type
III with a nominal capacity of 250 ml, suitable for pharmaceutical use, securely closed with a child-resistant screw cap with a tamper-evident closure.
The secondary packaging includes a folded cardboard box containing a bottle and a leaflet.
Also provided are a 10 ml graduated oral syringe in LDPE, CE marked with intermediate graduations of
0.5 ml and an appropriate syringe/bottle adapter in LDPE, 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: