Nortriptyline 50mg film-coated tablets

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Nortriptyline film-coated tablets are and what they are used for
2. What you need to know before you take Nortriptyline film-coated tablets
3. How to take Nortriptyline film-coated tablets
4. Possible side effects
5. How to store Nortriptyline film-coated tablets
6. Contents of the pack and other information

• If you are allergic to Nortriptyline hydrochloride or any of the other ingredients of this medicine (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;
• If you have had a recent heart attack or heartbeat disorder;
• If you are taking, or have taken in the last two weeks, monoamine oxidase inhibitors (another type of antidepressant e.g. phenelzine, isocarboxazid or tranylcypromine);
• you have to stop treatment with Nortriptyline tablets and wait for 14 days before you start treatment with a monoamine oxidase inhibitor.

Talk to your doctor or pharmacist before taking Nortriptyline Film-coated Tablets:

• If you feel suicidal or aggressive – tell your doctor;
• If you are agitated, overactive, or suffer from schizophrenia or another mental illness;
• If you have heart disease or low blood pressure;
• If you have severe liver disease;
• If you have a thyroid condition;
• If you have a history of epilepsy;
• If you have high pressure in the eyes (glaucoma);
• If you have an enlarged prostate or difficult in passing urine;
• If you are going to have electroconvulsive therapy (electric shock);
• If you are diabetic; It may be necessary to adjust your diabetes therapy when you start Nortriptyline Tablets If you are going to receive an anaesthetic, e.g. for an operation -tell your doctor; You may need to stop taking Nortriptyline Tablets several days before the operation. If your doctor tells you to carry on taking Nortriptyline Tablets, make sure the doctors treating you in the hospital know that you are on Nortriptyline Tablets
• If you have had an allergic reaction to another tricyclic anti-depressant in the past;
• if you have a cardiac condition called Brugada syndrome
• The use of buprenorphine together with Nortriptyline tablets can lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Nortriptyline film-coated tablets").

A heart problem called “prolonged QT interval” (which is shown on your electrocardiogram, ECG) and heart rhythm disorders (rapid or irregular heart beat) have been reported with Nortriptyline

Tell your doctor if you:

• have slow heart rate,
• have or had a problem where your heart cannot pump the blood round your body as well as it should (a condition called heart failure),
• are taking any other medication that may cause heart problems, or
• have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood.

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 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 these points apply to you, tell your doctor or pharmacist.

Do not give this medicine to children and adolescents aged below 18 years for these treatments as safety and efficacy have not been established in this age group.

Tell your doctor or pharmacist if you are taking, have recently taken or might take, any other medicines, including medicines obtained without a prescription.

The following medicines may interact with your Nortriptyline film-coated tablets:

• monoamine oxidase inhibitors (MAOIs)
  e.g. moclobemide, phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine (used to treat depression) or selegiline (used to treat Parkinson's disease). Tell your doctor or pharmacist if you are taking them now or have taken them in the last 2 weeks. These should not be taken at the same time as Nortriptyline tablets (see section 2 Do not take nortritptyline tablets)
• adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (these may be present in cough or cold medicine, and in some anaesthetics)
• medicine to treat high blood pressure for example calcium-channel blockers (e.g. diltiazem and verapamil), guanethidine, debrisoquine, bethanidine, clonidine reserpine and methyldopa
• Anticholinergic drugs such as certain medicines to treat Parkinsons disease and gastrointerstinal disorders (e.g. atropine, hyoscyamine)
• thioridazine (used to treat schizophrenia)
• tramadol (painkiller)
• medicines to treat fungal infections (e.g. fluconazole, terbinafine, ketoconazole, and itraconazole)
• sedatives (e.g. babiturates)
• antidepressants (e.g SSRIs (fluoxetine, paroxetine, fluvoxamine), and bupropion)
• medicines for certain heart conditions (e.g. beta blockers and antiarrhythmics)
• cimetidine (used to treat stomach ulcers)
• methylphenidate (used to treat ADHD)
• rifampicin (to treat infections)
• phenytoin and carbamazepine (used to treat epilepsy)
• St. John´s Wort (hypericum perforatum) – a herbal remedy used for depression
• thyroid medication
• valproic acid (medicine used for the treatment of epilepsy and bipolar disorder).
• buprenorphine/opioids-These medicines may interact with Nortriptyline and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.

You should also tell your doctor if you take or have recently taken medicine that may affect the heart´s rhythm. e.g.:

• medicines to treat irregular heartbeats (e.g. quinidine and sotalol)
• astemizole and terfenadine (used to treat allergies and hay fever)
• medicines used to treat some mental illnesses (e.g. pimozide and sertindole)
• cisapride (used to treat certain types of indigestion)
• halofantrine (used to treat malaria)
• methadone (used to treat pain and for detoxification)
• diuretics (“water tablets” e.g. furosemide)

If you are going to have an operation and receive general or local anaesthetics, you should tell your doctor that you are taking this medicine. Likewise, you should tell your dentist that you take this medicine if you are to receive a local anaesthetic.

You should not drink alcohol while you are being treated with Nortriptyline film-coated tablets as alcohol might increase the sedative effect.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Nortriptyline should not be used during pregnancy unless your doctor considers it clearly necessary and only after careful consideration of the benefit and risk. If you have taken this medicine during the last part of the pregnancy, the newborn may have withdrawal symptoms such as irritability, increased muscle tension, tremor, irregular breathing, poor drinking, loud crying, urinary retention, and constipation.

If you are breast-feeding, ask your doctor or pharmacist for advice before taking Nortriptyline film-coated tablets.

Nortriptyline hydrochloride 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 film-coated tablets affect your ability to drive or use machines, tell your doctor immediately.

If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.

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 at a low level (10-20 mg daily) and may be increased as required to the maximum dose of 50mg.

Lower dosages are recommended for outpatients than for patients in hospital who will be under close supervision.

In case of renal impairment, your doctor will increase or decrease the dose carefully and gradually. In most cases, however, the usual dosage will be given.

Patients with liver diseases or people known as “poor metabolisers” usually receive lower doses.

Your doctor may take blood samples to determine the level of nortriptyline in the blood.

Nortriptyline tablets should not be used in children and adolescents aged less than 18 years, as safety and efficacy have not been established. Patients under 18 have an increased risk of suicide attempts, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they are treated with drugs of this class.

It may take a few weeks before you feel any improvement.

Following remission, maintenance treatment may be needed longer term. This should be at the lowest dose that stops the symptoms of depression coming back.

Nortriptyline film-coated tablets are for oral use.

Go to the nearest casualty department or contact your doctor immediately. Take the tablet carton with you. An overdose can be very dangerous.

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.

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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is nortriptyline (as hydrochloride). Each film-coated tablet contains 50mg of nortriptyline (as hydrochloride).

The other ingredients are cellulose microcrystalline, lactose monohydrate, maize starch, silica colloidal anhydrous (E551), magnesium stearate (E572), isopropyl alcohol, dichloromethane, Instamoistshield A21E01392 (peach) which contains hypromellose (E464), diethyl phthalate, ethyl cellulose (E462), talc (E553b), titanium dioxide (E171) red iron oxide (E172) and yellow iron oxide (E172).

Nortriptyline 50 mg film-coated tablets are peach coloured, circular, biconvex film-coated tablets plain on both sides.

Nortriptyline 50 mg film-coated tablets are available in aluminium-PVC/PVDC blister pack of 30 tablets.