Allegron 25mg Tablets
Out of date information, search anotherPATIENT INFORMATION LEAFLET
ALLEGRON® 25MG TABLETS
Revision Date: 09.12.2014
(nortriptyline hydrochloride) Leaflet reference: ALLE25
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Allegron® 25mg Tablets are and what they are used for
2. Before you take Allegron® 25mg Tablets
3. How to take Allegron® 25mg Tablets
4. Possible side effects
5. How to store Allegron® 25mg Tablets
6. Further information
1. What Allegron® 25mg Tablets are and what they are used for
Allegron® 25mg Tablets contain the active ingredient nortriptyline hydrochloride, which is a tricyclic antidepressant. Allegron® 25mg Tablets relieve the symptoms of depression.
Allegron® 25mg Tablets may also be is used for the treatment of bedwetting in children 6 years and older.
2. Before you take Allegron® 25mg Tablets Do not take Allegron® 25mg Tablets if
• you are allergic (hypersensitive) to nortriptyline hydrochloride or any of the other ingredients of Allegron® 25mg Tablets (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue;
• you have had a recent heart attack or heartbeat disorder;
• you have severe liver disease;
• you suffer from mania (abnormally raised mood);
• 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 adrenaline-like drugs including ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine. These drugs are often contained in cough and cold remedies.
Take special care with Allegron® 25mg Tablets if
• you feel suicidal or aggressive - tell your doctor;
• you are agitated, overactive, or suffer from schizophrenia;
• you have heart disease;
• you have a thyroid condition;
• you have a history of epilepsy;
• you have high pressure in the eyes (glaucoma);
• you have an enlarged prostate;
• your child taking Allegron® 25mg Tablets has a change in behaviour;
• you are going to have electroconvulsive therapy (electric shock);
• you are diabetic;
• you are going to receive an anaesthetic, e.g. for an operation - tell your doctor;
• you have had an allergic reaction to another tricyclic antidepressant in the past;
• you are pregnant, think you might be pregnant or planning to become pregnant or breast-feeding you should not take Allegron® 25mg Tablets unless your doctor tells you to.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing or harming yourself;
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
If any of the above apply to you, tell your doctor or pharmacist.
Taking other medicines
You should tell your doctor if you are taking or have taken any medicines, including medicines obtained without a prescription.
The following medicines may interact with your Allegron® 25mg Tablets:
• guanethidine, debrisoquine, bethanidine, clonidine (used to treat high blood pressure);
• barbiturates (used for anxiety or to make you feel sleepy);
• alcohol (you should not drink alcohol);
• fluoxetine (another antidepressant);
• cimetidine (for heartburn and ulcers);
• phenothiazines (for mental illness);
• carbamazepine (for epilepsy);
• propafenone, flecainide, encainide, quinidine (for heartbeat disorders).
It may still be all right for you to be given Allegron® 25mg Tablets. Your doctor will be able to decide what is suitable for you.
Driving and using machines
Allegron® 25mg Tablets may affect alertness. Use caution when driving or operating heavy machinery until you're aware of how this drug affects you. If you feel Allegron® 25mg Tablets affect your ability to drive or use machines, tell your doctor immediately.
Important information about some of the ingredients of Allegron® 25mg Tablets
Allegron® 25mg Tablets contain lactose. If you are lactose intolerant, contact your doctor before taking this medicine. Allegron® 25mg Tablets contain sunset yellow (E110), which may cause allergic reactions.
3. How to take Allegron® 25mg Tablets
Always take Allegron® 25mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure
Dosage
Adults:
The usual adult dose is 25mg three or four times daily or the dose may be given once a day, usually at night.
The dose should begin at a low level, 10mg, 3-4 times daily, for example and be increased gradually as required. The maximum dose is 150mg per day.
The elderly:
The usual dose is 30 to 50mg/day in divided doses.
Treatment may start with 10mg three times a day.
Adolescent patients:
The usual dose is 30 to 50mg/day in divided doses.
Treatment may start with 10mg three times a day.
Lower dosages are recommended for outpatients than for patients in hospital who will be under close supervision.
Following remission maintenance treatment may be needed longer term. This should be at the lowest dose that stops the symptoms of depression coming back.
Children (for bed-wetting only)
|
Age (years) |
Weight Kg |
lb |
Dose (mg) |
|
6-7 |
20-25 |
44-55 |
10 |
|
8-11 |
25-35 |
55-77 |
10-20 |
|
Over 11 |
35-54 |
77-119 |
25-35 |
The dose should be given thirty minutes before bedtime.
The maximum length of treatment should be three months. Another course of treatment should not be started until a full physical examination has been made.
If you take more Allegron® 25mg Tablets than you should
Go to the nearest casualty department or contact your doctor immediately. Take the tablet carton with you.
If you forget to take Allegron® 25mg Tablets
If you miss a dose, take one as soon as you can. If you have missed several doses, tell your doctor. Do not take a double dose to make up for a forgotten dose.
If you stop taking Allegron® 25mg Tablets
Do not stop taking the tablets or reduce the dose without telling your doctor first.
If you suddenly stop taking the tablets you may feel sick (nausea), have a headache or feel generally unwell.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Allegron® 25mg Tablets can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
All medicines can cause allergic reactions, although serious allergic reactions are very rare.
Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching, especially affecting your whole body.
The following side effects have been reported:
• low or high blood pressure
• fast or irregular heartbeat
• palpitations
• heart attack (myocardial infarction)
• stroke
• oedema (swelling of the ankles)
• confusion (especially in the elderly) with seeing or hearing things (hallucinations)
• not knowing where you are (disorientation)
• false beliefs (delusions)
• anxiety, restlessness, agitation
• not sleeping (insomnia)
• nightmares
• panic
• long-lasting abnormal mood
• worsening of mental illness
• numbness, tingling, pins and needles in the hands or feet
• coordination problems
• tremors
• abnormal movements
• fits (seizures)
• altered brainwave (EEG) patterns
• ringing in the ears (tinnitus)
• dry mouth
• rarely, inflamed glands under the tongue or inflammation of the gums (gingivitis)
• blurred vision, difficulty in focusing, dilated pupils
• constipation, blockage of the digestive tract
• unable to urinate or delayed urination
• rash
• itching
• light sensitivity
• swelling (oedema)
• fever
• reaction to other similar drugs
• altered blood sugar levels
• yellow eyes and skin (jaundice)
• altered liver function
• inflamed liver (hepatitis) and liver damage
• weight gain or loss
• sweating
• flushing
• urinating often and at night
• sleepiness
• dizziness
• weakness
• tiredness
• headache
• swollen glands
• hair loss (alopecia)
• An increased risk of bone fractures has been observed in patients taking this type of medicine.
Reporting of side effects:
If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Allegron® 25mg Tablets
• Do not store above 25°C. Store in a dry place.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is printed on the carton label. The expiry date refers to the last day of the month.
• If your doctor stops treatment return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
• If your tablets show signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
Your medicine is called Allegron® 25mg Tablets. Each round, orange film-coated tablet has a breakline on one side and is plain on the reverse. Allegron® 25mg Tablets are available as blister packs of 25 tablets.
What is in your medicine
Each film-coated tablet contains 25mg of the active ingredient nortriptyline (as the hydrochloride).
Each tablet also contains lactose, starch, magnesium stearate, hypromellose, calcium phosphate, glycerine, ethylcellulose and sunset yellow FCF (E110).
Who manufactured your medicine Allegron® 25mg Tablets are manufactured by Laboratorios Biomed S.L., C/Licorers, 169-170 Nave 14, Poligono Ca'n Robiols, E-07141 Marratxi (Balearic Isles), Spain and is procured from within the EU and repackaged by Product Licence Holder:
BEACHCOURSE LIMITED 20 ALLIANCE COURT ALLIANCE ROAD LONDON W3 0RB
PL 16378/0451 |POM|
blood disorders which may cause you to bruise easily, become Leaflet reference and date: 09.12.2014 ALLE25
anaemic or be unable to fight off infections
feeling sick (nausea) and vomiting
not eating (anorexia)
indigestion
diarrhoea
constipation
peculiar taste
inflamed mouth
abdominal cramps
black tongue
development of breasts in men, breast enlargement and milk
production in women
increased or decreased sex drive
failure to have an erection (impotence)
swollen testicles
PATIENT INFORMATION LEAFLET
NORTRIPTYLINE 25mg TABLETS
Revision Date: 09.12.2014
(nortriptyline hydrochloride) Leaflet reference: NORT25
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Nortriptyline 25mg Tablets are and what they are used for
2. Before you take Nortriptyline 25mg Tablets
3. How to take Nortriptyline 25mg Tablets
4. Possible side effects
5. How to store Nortriptyline 25mg Tablets
6. Further information
1. What Nortriptyline 25mg Tablets are and what they are used for
Nortriptyline 25mg Tablets contain the active ingredient nortriptyline hydrochloride, which is a tricyclic antidepressant. Nortriptyline 25mg Tablets relieve the symptoms of depression.
Nortriptyline 25mg T ablets may also be is used for the treatment of bedwetting in children 6 years and older.
2. Before you take Nortriptyline 25mg Tablets Do not take Nortriptyline 25mg Tablets if
• you are allergic (hypersensitive) to nortriptyline hydrochloride or any of the other ingredients of Nortriptyline 25mg Tablets (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue;
• you have had a recent heart attack or heartbeat disorder;
• you have severe liver disease;
• you suffer from mania (abnormally raised mood);
• 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 adrenaline-like drugs including ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine. These drugs are often contained in cough and cold remedies.
Take special care with Nortriptyline 25mg Tablets if
• you feel suicidal or aggressive - tell your doctor;
• you are agitated, overactive, or suffer from schizophrenia;
• you have heart disease;
• you have a thyroid condition;
• you have a history of epilepsy;
• you have high pressure in the eyes (glaucoma);
• you have an enlarged prostate;
• your child taking Nortriptyline 25mg Tablets has a change in behaviour;
• you are going to have electroconvulsive therapy (electric shock);
• you are diabetic;
• you are going to receive an anaesthetic, e.g. for an operation - tell your doctor;
• you have had an allergic reaction to another tricyclic antidepressant in the past;
• you are pregnant, think you might be pregnant or planning to become pregnant or breast-feeding you should not take Nortriptyline 25mg Tablets unless your doctor tells you to.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing or harming yourself;
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
If any of the above apply to you, tell your doctor or pharmacist.
Taking other medicines
You should tell your doctor if you are taking or have taken any medicines, including medicines obtained without a prescription.
The following medicines may interact with your Nortriptyline 25mg Tablets:
• guanethidine, debrisoquine, bethanidine, clonidine (used to treat high blood pressure);
• barbiturates (used for anxiety or to make you feel sleepy);
• alcohol (you should not drink alcohol);
• fluoxetine (another antidepressant);
• cimetidine (for heartburn and ulcers);
• phenothiazines (for mental illness);
• carbamazepine (for epilepsy);
• propafenone, flecainide, encainide, quinidine (for heartbeat disorders).
It may still be all right for you to be given Nortriptyline 25mg Tablets. Your doctor will be able to decide what is suitable for you.
Driving and using machines
Nortriptyline 25mg Tablets may affect alertness. Use caution when driving or operating heavy machinery until you're aware of how this drug affects you. If you feel Nortriptyline 25mg Tablets affect your ability to drive or use machines, tell your doctor immediately.
Important information about some of the ingredients of Nortriptyline 25mg Tablets
Nortriptyline 25mg Tablets contain lactose. If you are lactose intolerant, contact your doctor before taking this medicine. Nortriptyline 25mg Tablets contain sunset yellow (E110), which may cause allergic reactions.
3. How to take Nortriptyline 25mg Tablets
Always take Nortriptyline 25mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure
Dosage
Adults:
The usual adult dose is 25mg three or four times daily or the dose may be given once a day, usually at night.
The dose should begin at a low level, 10mg, 3-4 times daily, for example and be increased gradually as required. The maximum dose is 150mg per day.
The elderly:
The usual dose is 30 to 50mg/day in divided doses.
Treatment may start with 10mg three times a day.
Adolescent patients:
The usual dose is 30 to 50mg/day in divided doses.
Treatment may start with 10mg three times a day.
Lower dosages are recommended for outpatients than for patients in hospital who will be under close supervision.
Following remission maintenance treatment may be needed longer term. This should be at the lowest dose that stops the symptoms of depression coming back.
Children (for bed-wetting only)
|
Age (years) |
Weight Kg |
lb |
Dose (mg) |
|
6-7 |
20-25 |
44-55 |
10 |
|
8-11 |
25-35 |
55-77 |
10-20 |
|
Over 11 |
35-54 |
77-119 |
25-35 |
The dose should be given thirty minutes before bedtime.
The maximum length of treatment should be three months. Another course of treatment should not be started until a full physical examination has been made.
If you take more Nortriptyline 25mg Tablets than you should
Go to the nearest casualty department or contact your doctor immediately. Take the tablet carton with you.
If you forget to take Nortriptyline 25mg Tablets
If you miss a dose, take one as soon as you can. If you have missed several doses, tell your doctor. Do not take a double dose to make up for a forgotten dose.
If you stop taking Nortriptyline 25mg Tablets
Do not stop taking the tablets or reduce the dose without telling your doctor first.
If you suddenly stop taking the tablets you may feel sick (nausea), have a headache or feel generally unwell.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Nortriptyline 25mg Tablets can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
All medicines can cause allergic reactions, although serious allergic reactions are very rare.
Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching, especially affecting your whole body.
The following side effects have been reported:
• low or high blood pressure
• fast or irregular heartbeat
• palpitations
• heart attack (myocardial infarction)
• stroke
• oedema (swelling of the ankles)
• confusion (especially in the elderly) with seeing or hearing things (hallucinations)
• not knowing where you are (disorientation)
• false beliefs (delusions)
• anxiety, restlessness, agitation
• not sleeping (insomnia)
• nightmares
• panic
• long-lasting abnormal mood
• worsening of mental illness
• numbness, tingling, pins and needles in the hands or feet
• coordination problems
• tremors
• abnormal movements
• fits (seizures)
• altered brainwave (EEG) patterns
• ringing in the ears (tinnitus)
• dry mouth
• rarely, inflamed glands under the tongue or inflammation of the gums (gingivitis)
• blurred vision, difficulty in focusing, dilated pupils
• constipation, blockage of the digestive tract
• unable to urinate or delayed urination
• rash
• itching
• light sensitivity
• swelling (oedema)
• fever
• reaction to other similar drugs
• blood disorders which may cause you to bruise easily, become anaemic or be unable to fight off infections
• feeling sick (nausea) and vomiting
• not eating (anorexia)
• indigestion
• diarrhoea
• constipation
• peculiar taste
• inflamed mouth
• abdominal cramps
• black tongue
• development of breasts in men, breast enlargement and milk production in women
• increased or decreased sex drive
• failure to have an erection (impotence)
• swollen testicles
• altered blood sugar levels
• yellow eyes and skin (jaundice)
• altered liver function
• inflamed liver (hepatitis) and liver damage
• weight gain or loss
• sweating
• flushing
• urinating often and at night
• sleepiness
• dizziness
• weakness
• tiredness
• headache
• swollen glands
• hair loss (alopecia)
• An increased risk of bone fractures has been observed in patients taking this type of medicine.
Reporting of side effects:
If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Nortriptyline 25mg Tablets
• Do not store above 25°C. Store in a dry place.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is printed on the carton label. The expiry date refers to the last day of the month.
• If your doctor stops treatment return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
• If your tablets show signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
Your medicine is called Nortriptyline 25mg Tablets. Each round, orange film-coated tablet has a breakline on one side and is plain on the reverse.
Nortriptyline 25mg Tablets are available as blister packs of 25 tablets. What is in your medicine
Each film-coated tablet contains 25mg of the active ingredient nortriptyline (as the hydrochloride).
Each tablet also contains lactose, starch, magnesium stearate, hypromellose, calcium phosphate, glycerine, ethylcellulose and sunset yellow FCF (E110).
Who manufactured your medicine Nortriptyline 25mg Tablets are manufactured by Laboratorios Biomed S.L., C/Licorers, 169-170 Nave 14, Poligono Ca'n Robiols, E-07141 Marratxi (Balearic Isles), Spain and is procured from within the EU and repackaged by Product Licence Holder:
BEACHCOURSE LIMITED 20 ALLIANCE COURT ALLIANCE ROAD LONDON W3 0RB
PL 16378/0451 |POM|
Leaflet reference and date: 09.12.2014 NORT25