NORTRIPTYLINE 10MG & 25MG TABLETS

PATIENT INFORMATION LEAFLET

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START

USING 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.

THE LEAFLET CONTAINS INFORMATION ON:

1.    What Nortriptyline Tablets are and what are they used for?

2.    Before you take Nortriptyline Tablets

3.    How to take Nortriptyline Tablets

4.    Possible side effects

5.    How to store Nortriptyline Tablets

6.    Further information

1.    WHAT NORTRIPTYLINE TABLETS ARE AND WHAT ARE

THEY USED FOR?_

Nortriptyline belongs to a class of medicines called tricyclic antidepressants. Nortriptyline tablets are used:

•    to treat major depression.

2.    BEFORE YOU TAKE NORTRIPTYLINE TABLETS_

You should not take Nortriptyline Tablets until you are sure it is safe for you to do so. Nortriptyline Tablets are for adults only.

Do not take Nortriptyline Tablets if you:

•    have had a rash or any other allergic reaction to Nortriptyline.

•    have recently had a heart attack or if you have other heart problems such as palpitations or irregular heartbeats?

•    are taking, or have stopped taking within the last 14 days, a monoamine oxidase inhibitor (e.g. phenelzine, isocarboxazid or tranylcypromine). If you are taking moclobemide you must stop this at least 24 hours before starting nortriptyline.

Take special care with Nortriptyline Tablets

Do not take Nortriptryline Tablets without first discussing your condition with your doctor or pharmacist if you:

•    are having an operation under general anaesthetic, discuss this with your GP. You may need to stop taking Nortriptyline Tablets several days before the operation. If your GP tells you to carry on taking Nortriptyline Tablets, make sure the doctors treating you in hospital know that you are on Nortriptyline.

•    are pregnant or may be pregnant

•    have thyroid problem

•    have suffered from an allergic type reaction with another tricyclic antidepressant, as cross sensitivity may occur

•    ever had epilepsy

•    are diabetic

•    are breast feeding

•    have an enlarged prostate

•    have glaucoma or raised intra-ocular pressure

•    are agitated or suffer from schizophrenia

•    have low blood pressure or heart failure

•    have severe liver disease

•    have suffered from urinary retention

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.

Taking other medicines

You should not take Nortriptyline Tablets without discussing with your doctor if you:

•    are taking, or you have recently been taking, any medicines known as monoamine oxidase inhibitors ('MAOIs')? MAOls include phenelzine such as Nardil, tranylcypromine such as Parnate or Parstelin and isocarboxazid such as Marplan. Tell your doctor or pharmacist if you are taking them now or have taken them in the last 2 weeks

•    are taking moclobemide you must stop this at least 24 hours before starting nortriptyline.

•    are taking any medicine for your heart or for high blood pressure?

•    are taking adrenaline-like drugs including ephedrine, isoprenaline, phenylepherine and phenylpropanolamine - these drugs may be in cold remedies?

•    are taking cimetidine, such as Tagamet?

•    are taking any other medicines including other antidepressants or medicine for bowel complaints, breathing difficulties, bronchitis, glaucoma or prostate trouble?

•    are taking levothyroxine?

•    are taking antifungal medicines such as fluconazole and terbinafine?

•    are taking the antihistamines astemizole or terfenadine

•    are taking the pain killer tramadol?

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained with out a prescription.

Taking Nortriptyline Tablets with food and drink

You should not drink alcohol while you are being treated with Nortriptyline Tablets. You may find that you get more drunk or feel more depressed.

Use by pregnant or breast feeding women

The safety of nortriptyline for use during pregnancy has not been established. Hence, it should be taken only if your doctor advises to do so. Please ask your doctor or pharmacist for advice before taking any medicine.

The amount of Nortriptyline in breast milk is low, and no adverse effects on breast fed infants of mothers taking nortriptyline have been reported. However you should discuss the fact that you are breast-feeding with your doctor if you are prescribed nortriptyline.

Driving and using machines

Do not drive or use machinery when you are on Nortriptyline Tablets unless you are sure your judgement and co-ordination are not affected. Antidepressants may affect your ability to drive or to operate machinery safely.

Nortriptyline Tablets contains lactose monohydrate

Nortriptyline Tablets contain Lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    HOW TO TAKE NORTRIPTYLINE TABLETS_

Always take Nortriptyline Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

•    The usual dose an adult will start on is 25mg two to three times daily. You will usually be told to increase your dose gradually (no more rapidly than by 25mg every other day) until you are taking the usual maintenance dose of 75 to I00mg a day. Once you feel better, you will be told to carry on taking Nortriptyline Tablets at the same dose. Do not take more than six 25mg tablets a day (150mg).

•    If your doctor tells you to take more than four 25mg tablets a day, he or she may arrange for you to have regular blood tests.

•    If you are elderly you will usually be told to start on one I0mg tablet three times a day. Dose increases should also be gradual by no more than I0mg every other day. If you require a dose of 50mg or over, your doctor will arrange for you to have a recording of your heart (ECG) and blood tests.

•    Antidepressants may not make you feel better for the first two weeks or more of treatment, so keep taking Nortriptyline Tablets until your doctor tells you to stop. Do not stop these tablets without discussing it with your doctor first.

•    Do not suddenly stop taking the tablets. Your doctor will tell you how to cut them down gradually.

If you take more Nortriptyline Tablets than you should

Do not take more tablets than your doctor tells you to. If you ever take too many, or if a child has taken any nortriptyline, go to the nearest hospital casualty department or tell your doctor at once. An overdose can be very dangerous.

If you forget to take Nortriptyline Tablets

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose do not take a double dose to make up for a forgotten dose, just carry on as before. If you have missed several doses, discuss this with your doctor.

If you stop using Nortriptyline Tablets

If you stop using Nortriptyline Tablets abruptly after prolong therapy you may have withdrawal symptoms, including not being able to sleep, headache, nausea, irritability and sweating.

4.    POSSIBLE SIDE EFFECTS_

Like all medicines Nortriptyline Tablets can cause side effects although not everybody gets them.

Tell your doctor or pharmacist immediately if you experience any of the following:

•    serious heart problems along with ringing in the ears, stomach cramps and clumsiness

•    swelling of ankles and in severe cases of the face & tongue

•    alterations in brain function (including perhaps seizures)

•    blood disorders along with changes in blood sugar level

•    swelling of breasts & testicles in men and increase in breast size and spontaneous lactation in women

•    swelling & damage to liver cells

•    flu like symptoms including sore throat if occurring during the first 10 weeks of treatment

The following side effects have also been reported:

Very common: More than 1 out of 10 patients.

Dry mouth, sweating, constipation, blurred vision, and irregular or heavy heart beats.

Common: More than 1 but less than 10 out of 100 patients. Strange body movements and headaches, sweating, flushing, weakness, fatigue, headache, low blood pressure, tremors, decreases in libido and erectile dysfunction.

Uncommon: More than 1 but less than 10 out of 1,000 patients. Dizziness, changes in sleep patterns (including nightmares), numbness, nausea (feeling sick) & vomiting, problems urinating (increased or decreased), high blood pressure are all uncommon side effects.

Tingling in arms & legs, anxiety, loss of appetite, diarrhoea, liver problems including jaundice, weight gain or loss & changes in sexual performance may also occur.

Rare: More than 1 but less than 10 out of 10,000 patients.

Peculiar taste, mouth or gum problems, confusional states (especially in the elderly) perhaps with anxiety & restlessness are rare side effects. More serious heart problems along with ringing in the ears, stomach cramps and clumsiness can also occasionally occur. Rarely increases in libido have been reported. Some patients have had a rash, which may be itchy or get worse in sunlight. If you suddenly stop taking the tablets, you may not be able to sleep and may feel irritable or sweaty.

Very rare: Less than 1 out of 10,000 patients.

Alterations in brain function (including perhaps seizures), swelling of ankles and in severe cases of the face & tongue. Blood disorders may also very rarely occur along with changes in blood sugar level. In severe cases men may suffer from swelling of breasts & testicles whilst women may also notice an increase in breast size and spontaneous lactation. In extreme cases there may be swelling & damage to liver cells.

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 TABLETS_

•    Keep out of the sight and reach of children.

•    Do not use Nortriptyline Tablets after the expiry date, which is stated on the label and carton. The expiry date refers to the last day of the month.

•    Do not store above 25°C. Store in the original container. Keep the container tightly closed.

• 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_

What Nortriptyline Tablets contain?

The name of this medicine is Nortriptyline 10mg or 25mg Tablets. The active substance in your tablet is nortriptyline hydrochloride. Each tablet contains 10mg or 25mg of nortriptyline (as the hydrochloride) respectively. Other ingredients include lactose monohydrate, maize starch and magnesium stearate.

What Nortriptyline Tablets look like and contents of the pack

Nortriptyline 10 mg Tablets are white to off white, round, biconvex, uncoated tablets, debossed 'NO' on one side and '10' on other side.

Nortriptyline 25 mg Tablets are white to off white, round, biconvex, uncoated tablets, debossed 'NO' on one side and '25' on other side.

Nortriptyline 10mg & 25mg Tablets are packed in a white HDPE bottle, with a white polypropylene child resistant cap and tamper evident film, containing 100 tablets.

Marketing Authorisation Holder:

The Marketing Authorisation Holder of these tablets is Lime Pharma Ltd., Mckenzie House, Bury Street, Ruislip,

Middlesex HA4 7TL, U.K.

Manufacturer:

Actavis UK Limited

Whiddon Valley, Barnstaple, North Devon, EX32 8NS, UK

This leaflet was prepared in April 2016

AAAI9306

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START

USING 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.

THE LEAFLET CONTAINS INFORMATION ON:

1.    What Nortriptyline Tablets are and what are they used for?

2.    Before you take Nortriptyline Tablets

3.    How to take Nortriptyline Tablets

4.    Possible side effects

5.    How to store Nortriptyline Tablets

6.    Further information

1.    WHAT NORTRIPTYLINE TABLETS ARE AND WHAT ARE

THEY USED FOR?_

Nortriptyline belongs to a class of medicines called tricyclic antidepressants. Nortriptyline tablets are used:

•    to treat major depression.

2.    BEFORE YOU TAKE NORTRIPTYLINE TABLETS_

You should not take Nortriptyline Tablets until you are sure it is safe for you to do so. Nortriptyline Tablets are for adults only.

Do not take Nortriptyline Tablets if you:

•    have had a rash or any other allergic reaction to Nortriptyline.

•    have recently had a heart attack or if you have other heart problems such as palpitations or irregular heartbeats?

•    are taking, or have stopped taking within the last 14 days, a monoamine oxidase inhibitor (e.g. phenelzine, isocarboxazid or tranylcypromine). If you are taking moclobemide you must stop this at least 24 hours before starting nortriptyline.

Take special care with Nortriptyline Tablets

Do not take Nortriptryline Tablets without first discussing your condition with your doctor or pharmacist if you:

•    are having an operation under general anaesthetic, discuss this with your GP. You may need to stop taking Nortriptyline Tablets several days before the operation. If your GP tells you to carry on taking Nortriptyline Tablets, make sure the doctors treating you in hospital know that you are on Nortriptyline.

•    are pregnant or may be pregnant

•    have thyroid problem

•    have suffered from an allergic type reaction with another tricyclic antidepressant, as cross sensitivity may occur

•    ever had epilepsy

•    are diabetic

•    are breast feeding

•    have an enlarged prostate

•    have glaucoma or raised intra-ocular pressure

•    are agitated or suffer from schizophrenia

•    have low blood pressure or heart failure

•    have severe liver disease

•    have suffered from urinary retention

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.

Taking other medicines

You should not take Nortriptyline Tablets without discussing with your doctor if you:

•    are taking, or you have recently been taking, any medicines known as monoamine oxidase inhibitors ('MAOIs')? MAOls include phenelzine such as Nardil, tranylcypromine such as Parnate or Parstelin and isocarboxazid such as Marplan. Tell your doctor or pharmacist if you are taking them now or have taken them in the last 2 weeks

•    are taking moclobemide you must stop this at least 24 hours before starting nortriptyline.

•    are taking any medicine for your heart or for high blood pressure?

•    are taking adrenaline-like drugs including ephedrine, isoprenaline, phenylepherine and phenylpropanolamine - these drugs may be in cold remedies?

•    are taking cimetidine, such as Tagamet?

•    are taking any other medicines including other antidepressants or medicine for bowel complaints, breathing difficulties, bronchitis, glaucoma or prostate trouble?

•    are taking levothyroxine?

•    are taking antifungal medicines such as fluconazole and terbinafine?

•    are taking the antihistamines astemizole or terfenadine

•    are taking the pain killer tramadol?

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained with out a prescription.

Taking Nortriptyline Tablets with food and drink

You should not drink alcohol while you are being treated with Nortriptyline Tablets. You may find that you get more drunk or fee more depressed.

Use by pregnant or breast feeding women

The safety of nortriptyline for use during pregnancy has not been established. Hence, it should be taken only if your doctor advises to do so. Please ask your doctor or pharmacist for advice before taking any medicine.

The amount of Nortriptyline in breast milk is low, and no adverse effects on breast fed infants of mothers taking nortriptyline have been reported. However you should discuss the fact that you are breast-feeding with your doctor if you are prescribed nortriptyline

Driving and using machines

Do not drive or use machinery when you are on Nortriptyline Tablets unless you are sure your judgement and co-ordination are not affected. Antidepressants may affect your ability to drive or to operate machinery safely.

Nortriptyline Tablets contains lactose monohydrate

Nortriptyline Tablets contain Lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    HOW TO TAKE NORTRIPTYLINE TABLETS

Always take Nortriptyline Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

•    The usual dose an adult will start on is 25mg two to three times daily. You will usually be told to increase your dose gradually (no more rapidly than by 25mg every other day) until you are taking the usual maintenance dose of 75 to I00mg a day. Once you feel better, you will be told to carry on taking Nortriptyline Tablets at the same dose. Do not take more than six 25mg tablets a day (I50mg).

•    If your doctor tells you to take more than four 25mg tablets a day, he or she may arrange for you to have regular blood tests.

•    If you are elderly you will usually be told to start on one I0mg tablet three times a day. Dose increases should also be gradual by no more than I0mg every other day. If you require a dose of 50mg or over, your doctor will arrange for you to have a recording of your heart (ECG) and blood tests.

•    Antidepressants may not make you feel better for the first two weeks or more of treatment, so keep taking Nortriptyline Tablets until your doctor tells you to stop. Do not stop these tablets without discussing it with your doctor first.

•    Do not suddenly stop taking the tablets. Your doctor will tell you how to cut them down gradually.

If you take more Nortriptyline Tablets than you should

Do not take more tablets than your doctor tells you to. If you ever take too many, or if a child has taken any nortriptyline, go to the nearest hospital casualty department or tell your doctor at once. An overdose can be very dangerous.

If you forget to take Nortriptyline Tablets

f you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose do not take a double dose to make up for a forgotten dose, just carry on as before. If you have missed several doses, discuss this with your doctor.

If you stop using Nortriptyline Tablets

f you stop using Nortriptyline Tablets abruptly after prolong therapy you may have withdrawal symptoms, including not being able to sleep, headache, nausea, irritability and sweating.

4.    POSSIBLE SIDE EFFECTS_

Like all medicines Nortriptyline Tablets can cause side effects although not everybody gets them.

Tell your doctor or pharmacist immediately if you experience any of the following:

•    serious heart problems along with ringing in the ears, stomach cramps and clumsiness

•    swelling of ankles and in severe cases of the face & tongue

•    alterations in brain function (including perhaps seizures)

•    blood disorders along with changes in blood sugar level

•    swelling of breasts & testicles in men and increase in breast size and spontaneous lactation in women

•    swelling & damage to liver cells

•    flu like symptoms including sore throat if occurring during the first 10 weeks of treatment

The following side effects have also been reported:

Very common: More than 1 out of 10 patients.

Dry mouth, sweating, constipation, blurred vision, and irregular or heavy heart beats.

Common: More than 1 but less than 10 out of 100 patients. Strange body movements and headaches, sweating, flushing, weakness, fatigue, headache, low blood pressure, tremors, decreases in libido and erectile dysfunction.

Uncommon: More than 1 but less than 10 out of 1,000 patients. Dizziness, changes in sleep patterns (including nightmares), numbness, nausea (feeling sick) & vomiting, problems urinating (increased or decreased), high blood pressure are all uncommon side effects.

Tingling in arms & legs, anxiety, loss of appetite, diarrhoea, liver problems including jaundice, weight gain or loss & changes in sexual performance may also occur.

Rare: More than 1 but less than 10 out of 10,000 patients.

Peculiar taste, mouth or gum problems, confusional states (especially in the elderly) perhaps with anxiety & restlessness are rare side effects. More serious heart problems along with ringing in the ears, stomach cramps and clumsiness can also occasionally occur. Rarely increases in libido have been reported. Some patients have had a rash, which may be itchy or get worse in sunlight. If you suddenly stop taking the tablets, you may not be able to sleep and may feel irritable or sweaty.

Very rare: Less than 1 out of 10,000 patients.

Alterations in brain function (including perhaps seizures), swelling of ankles and in severe cases of the face & tongue. Blood disorders may also very rarely occur along with changes in blood sugar level. In severe cases men may suffer from swelling of breasts & testicles whilst women may also notice an increase in breast size and spontaneous lactation. In extreme cases there may be swelling & damage to liver cells.

Reporting of side effects:

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 TABLETS_

•    Keep out of the sight and reach of children.

•    Do not use Nortriptyline Tablets after the expiry date, which is stated on the label and carton. The expiry date refers to the last day of the month.

•    Do not store above 25°C. Store in the original container. Keep the container tightly closed.

• 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_

What Nortriptyline Tablets contain?

The name of this medicine is Nortriptyline 10mg or 25mg Tablets. The active substance in your tablet is nortriptyline hydrochloride Each tablet contains 10mg or 25mg of nortriptyline (as the hydrochloride) respectively. Other ingredients include lactose monohydrate, maize starch and magnesium stearate.

What Nortriptyline Tablets look like and contents of the pack

Nortriptyline 10 mg Tablets are white to off white, round, biconvex, uncoated tablets, debossed 'NO' on one side and '10' on other side.

Nortriptyline 25 mg Tablets are white to off white, round, biconvex, uncoated tablets, debossed 'NO' on one side and '25' on other side.

Nortriptyline 10mg & 25mg Tablets are packed in a white HDPE bottle, with a white polypropylene child resistant cap and tamper evident film, containing 100 tablets.

Marketing Authorisation Holder:

The Marketing Authorisation Holder of these tablets is Lime Pharma Ltd., Mckenzie House, Bury Street, Ruislip,

Middlesex HA4 7TL, U.K.

Manufacturer:

Auden Mckenzie (Pharma Division) Ltd.,

Mckenzie House, Bury Street, Ruislip, Middlesex HA4 7TL, U.K.

This leaflet was prepared in May 2015