10 mg, 25 mg film-coated tablets 
amitriptyline

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Amitriptyline Orifarm is and what it is used for 
2. What you need to know before you use Amitriptyline Orifarm 
3. How to use Amitriptyline Orifarm 
4. Possible side effects 
5. How to store Amitriptyline Orifarm 
6. Contents of the pack and other information 

What Amitriptyline Orifarm is and what it is used for

Amitriptyline Orifarm belongs to the group of tricyclic antidepressant drugs. 
This medicine is used for:

  • Treatment of depression in adults (actual depression).
  • Treatment of neuropathic pain in adults.
  • Preventive treatment of chronic tension-type headaches in adults.
  • Preventive treatment of migraine in adults.
  • Nocturnal bedwetting in children from 6 years. Prior to treatment, physical (anatomical) causes of nocturnal bedwetting must have been ruled out. All other treatments, with and without medication, must also have been without effect. This medicine should only be prescribed by a doctor who has experience in the treatment of patients with persistent bedwetting.


Amitriptyline contained in Amitriptyline Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Amitriptyline Orifarm

Do not take Amitriptyline Orifarm

  • if you are allergic to amitriptyline or any of the other ingredients of this medicine (listed in section 6)
  • if you have recently had a heart attack (heart attack)
  • if you have heart problems e.g. cardiac arrhythmias as seen with ECG, cardiac arrhythmia ( AV block ), or coronary heart disease
  • if you are taking antidepressants called monoamine oxidase inhibitors ( MAOIs )
  • if you have been taking MAOIs for the last 14 days
  • if you have taken moclobemide the day before
  • if you have severe liver disease.
  • If you are being treated with Amitriptyline Orifarm, you must stop taking this medicine and wait 14 days before you can start treatment with an MAOI.


This medicine should not be used to treat children younger than 6 years.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Amitriptyline Orifarm. 

Heart rhythm disturbances and low blood pressure may occur if you receive a high dose of amitriptyline. This can also happen with regular doses if you already have pre-existing heart disease.


Extended QT interval

A heart problem called “prolonged QT interval” (which can be seen on your ECG ) and heart rhythm disturbances (fast or irregular heartbeat) have been reported with Amitriptyline Orifarm. Tell your doctor if you:

  • has a slow heart rate
  • have or have had problems with your heart not being able to pump blood around the body as well as it should (a condition called heart failure )
  • taking any other medicine that may cause heart problems
  • have problems that cause low levels of potassium or magnesium or high levels of potassium in the blood
  • have an operation booked, as treatment with amitriptyline may need to be stopped before you receive anesthesia. In acute surgery, the anesthetist should be informed about the treatment with amitriptyline
  • have an overactive thyroid gland or receive treatment with thyroid hormone.


Suicidal thoughts and worsening depression

You who are depressed can sometimes have thoughts of harming yourself or committing suicide. These thoughts can get worse when you start using antidepressants, as it takes time for drugs of this type to take effect, usually about two weeks but sometimes longer.

These thoughts may be more common:

  • if you have previously had thoughts of harming yourself or committing suicide.
  • if you are a young adult. Data from clinical trials have shown an increased risk of suicidal behavior in young adults (younger than 25 years) with mental illness who were treated with antidepressant drugs.


Contact a doctor as soon as possible or go to the nearest hospital if you have thoughts of injuring yourself or committing suicide.


It can be helpful to tell a relative or close friend that you are depressed. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.


Manic episodes

Some patients with bipolar disorder may end up in a manic phase. This is characterized by intense and rapidly changing thinking activity, strong elation, and excessive physical activity. If this happens, it is important that you contact your doctor who is likely to change your medication.


Tell your doctor if you have, or have had any medical problems in the past, especially if you have:

  • visual impairment due to increased pressure in the eye ( glaucoma with narrow ventricular angle )
  • epilepsy, previous seizures
  • difficulty urinating
  • enlarged prostate
  • thyroid disease
  • bipolar disease
  • schizophrenia
  • severe liver disease
  • severe heart disease
  • narrowing of the lower gastrointestinal tract (pyloric narrowing) and blocked intestine (paralytic ileus )
  • diabetes, as your diabetes treatment may need to be adjusted.


If you use antidepressant drugs such as SSRIs, your doctor may consider changing the dose of one of your medicines (see also section 2 “Other medicines and Amitriptyline Orifarm” and section 3)


The elderly have an increased risk of certain side effects such as dizziness when getting up which is caused by a drop in blood pressure (see also section 4 “Possible side effects”).

Children and young people

Depression, neuropathic pain, preventive treatment of tension-type chronic headaches and migraines

Do not give this medicine to children and adolescents under 18 years of age for these diseases as safety and efficacy have not been established for this age group.


Nocturnal bedwetting

  • An ECG should be performed before starting treatment with amitriptyline to rule out long QT syndrome (prolonged QT interval )
  • This medicine should not be taken with anticholinergic medicines (see also section 2 “Other medicines and Amitriptyline Orifarm”)
  • Suicidal ideation and suicidal ideation may also occur in the early stages of treatment with antidepressants for diseases other than depression. The same precautions to be taken when treating patients with depression should therefore be taken when treating patients with bedwetting.

Other medicines and Amitriptyline Orifarm

Some medicines can affect the way some other medicines work and this can sometimes cause serious side effects.


Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines such as:

  • MAO inhibitors, e.g. phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine (used to treat depression) or selegiline (used to treat Parkinson’s disease ). These should not be taken concomitantly with Amitriptyline Orifarm (see section 2 “Do not take Amitriptyline Orifarm”)
  • adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine (these can be found in cough medicines, certain cold medicines, and certain anesthetics)
  • medicines for high blood pressure such as calcium channel blockers (eg diltiazem and verapamil), guanethidine, betanidine, clonidine, reserpine, and methyldopa
  • anticholinergic drugs such as certain drugs for Parkinson’s disease and gastrointestinal diseases (eg atropine, hyoscyamine)
  • thioridazine (used to treat schizophrenia)
  • tramadol (painkiller)
  • medicines for fungal infections (eg fluconazole, terbinafine, ketoconazole, and itraconazole)
  • sedatives (eg barbiturates )
  • antidepressants (eg SSRIs ( fluoxetine, paroxetine, fluvoxamine, and bupropion))
  • medicines for certain heart diseases (eg beta-blockers and antiarrhythmics )
  • cimetidine (used to treat stomach ulcers )
  • methylphenidate (used to treat ADHD )
  • ritonavir (used to treat HIV )
  • birth control pills
  • rifampicin (used to treat infections )
  • phenytoin and carbamazepine (used to treat epilepsy )
  • St. John’s wort ( Hypericum perforatum ) – a (traditional) herbal medicine used for mild depression and mild anxiety
  • thyroid hormone.
  • valproic acid ( valproate ).


You should also tell your doctor if you are taking or have recently taken medicines that may affect your heart rhythm, for example:

  • medicines for irregular heartbeats (eg quinidine and sotalol)
  • astemizole and terfenadine (used to treat allergies and hay fever)
  • medicines used to treat mental illness (eg pimozide and sertindole)
  • cisapride (used to treat certain types of indigestion)
  • halofantrine (used against malaria )
  • methadone (used for pain and detoxification)
  • diuretics ( diuretics such as furosemide ).


If you are going to have an operation and receive general or local anesthesia, tell your doctor that you are taking this medicine.


In the same way, you should tell your dentist that you are taking this medicine if you are to receive local anesthesia.

Amitriptyline Orifarm with alcohol

You should not drink alcohol during treatment with this medicine as the sedative effects (such as drowsiness and lethargy) may worsen.

Pregnancy and breastfeeding

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.


Amitriptyline is not recommended during pregnancy, unless your doctor considers it absolutely necessary, and only after careful analysis of the risks and benefits of treatment. If you have taken the medicine during the latter part of the pregnancy, the newborn baby may experience withdrawal symptoms (withdrawal symptoms) such as anxiety/irritability, muscle tension, tremors, irregular breathing, difficulty eating, loud crying, difficulty urinating, and constipation.


Your doctor will tell you if you should start, continue or stop breast-feeding or if you should stop using the medicine. This is after the doctor has assessed the benefit of breastfeeding for the baby and the benefit of treatment for you.

Driving and using machines

This medicine may cause drowsiness and dizziness, especially at the beginning of treatment. Do not drive or use any tools or machines if this happens. 

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Amitriptyline Orifarm contains lactose

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

How to use Amitriptyline Orifarm

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.


Depression

Adults

The recommended starting dose is 25 mg twice daily.


Depending on the effect you get from the medicine, your doctor may gradually increase the dose to one to 150 mg per day, divided into two doses.


Elderly (over 65 years) and patients with cardiovascular disease

The recommended starting dose is 10-25 mg daily.


Depending on the effect of the medicine, your doctor may gradually increase your dose to a total daily dose of 100 mg, divided into two doses. If you are given a dose in the range of 100-150 mg, your doctor may need to follow up your treatment more often.


Use for children and adolescents

This medicine should not be given to children or adolescents for the treatment of depression. For more information, see section 2.


Neuropathic pain, preventive treatment of chronic tension headaches and migraines

Your doctor will adjust the treatment according to your symptoms and your treatment response.


Adults

The recommended starting dose is 10-25 mg in the evening.

The recommended daily dose is 25-75 mg.


Depending on the effect you get from the medicine, your doctor may gradually increase the dose. If you are given a dose of more than 100 mg daily, your doctor may need to monitor your treatment more often. Your doctor will tell you if you should take a dose once a day or divided it into two doses.


Elderly (over 65 years) and patients with cardiovascular disease

The recommended initial dose is 10-25 mg in the evening.


Depending on the effect of the medicine, your doctor may increase the dose gradually. If you are given a dose of more than 75 mg daily, your doctor may need to monitor your treatment more often.


Use for children and adolescents

It should not be given to children and adolescents for the treatment of neuropathic pain, for the treatment of chronic headache, or for the treatment of migraine. For more information, see section 2.


Nocturnal bedwetting

Use for children and adolescents

The recommended dose for children:

  • For 6 years: see section 2 “Do not take Amitriptyline Orifarm”.
  • At the age of 6 to 10 years: 10-20 mg daily. A suitable dosage form should be used for this age group.
  • From 11 years: 25-50 mg.


The dose should be increased gradually according to the doctor’s prescription.


Take this medicine 1–1½ hours before bedtime.


Before starting treatment, your doctor will examine your heart with an ECG to see if there are any signs of an unusual heartbeat.


Your doctor will re-evaluate the treatment after 3 months and if necessary take a new ECG.


Do not stop treatment without first consulting your doctor.


Patients at particular risk

Patients with liver disease or people who are known to be “slow metabolizers” of certain drugs usually receive lower doses. Your doctor may take blood samples to check the concentration of amitriptyline in your blood (see also section 2). 


How and when to take Amitriptyline Orifarm

This medicine can be taken with or without food.


Swallow the tablets with a little water. Do not chew them.


Treatment time

Do not change the dose of the medicine and do not stop taking the medicine without first consulting your doctor.


Depression

As with other antidepressants, it may take a few weeks before you feel any improvement.


In the treatment of depression, the treatment period is individually adapted and is usually at least 6 months. The treatment time is determined by your doctor.


Continue to take this medicine for the time your doctor recommends it.


The underlying disease can persist for a long time. If you stop your treatment too soon, your symptoms may return.


Neuropathic pain, chronic tension-type headache, and preventive treatment of migraine

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


Talk to your doctor about the duration of treatment and continue to take the medicine for the time your doctor recommends.


Nocturnal bedwetting

The doctor will evaluate whether the treatment should continue after 3 months.


Do this even if you do not feel discomfort or show signs of poisoning. Take the medicine pack with you if you see a doctor or hospital.


Symptoms of overdose include:

  • large pupils are
  • fast or irregular heartbeat
  • difficulty urinating
  • dry mouth and dry tongue
  • intestinal obstruction (constipation)
  • seizures
  • fever
  • anxiety or physical restlessness
  • confusion
  • hallucinations
  • uncontrolled movements
  • low blood pressure, weak pulse, pallor
  • breathing difficulties
  • bluish discoloration of the skin
  • decreased heart rate
  • somnolence
  • unconsciousness that can turn into a coma
  • various heart symptoms such as cardiac arrhythmia ( AV block ), heart failure, low blood pressure, cardiogenic shock (the heart does not pump around enough blood), metabolic acidosis (too low pH in the blood), too low levels of potassium in the blood.

If you forget to use Amitriptyline Orifarm

Take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop using Amitriptyline Orifarm

Your doctor will decide when and how to stop your treatment to avoid unpleasant symptoms that may occur during a sudden interruption (eg headache, malaise, insomnia, and irritability).
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.


Stop taking Amitriptyline Orifarm and see a doctor immediately if you get any of the following symptoms:

Common side effect: may affect up to 1 in 10 people

  • A heart problem called an “extended QT interval” (which can be seen on your ECG).


The rare side effect may affect up to 1 in 1,000 people

  • Severe constipation, bloated stomach, fever, and vomiting. These symptoms may be due to parts of the intestinal muscles stopping functioning.
  • Yellow skin or yellow whites of the eyes (jaundice). Your liver may be affected.
  • Bruising, bleeding, pallor, or persistent sore throat and fever. These symptoms may be the first signs of an effect on the blood or bone marrow. Effects on the blood can be a reduced number of red blood cells (which carry oxygen in the body), white blood cells (which fight infections ), and platelets (which help the blood to clot).
  • Suicidal ideation or suicidal ideation.


The very rare side effect may affect up to 1 in 10,000 people

  • Recurrent blurred vision, rainbow vision, and eye pain. Your eyes should be examined immediately before treatment with this medicine can continue. This may be a sign of acute glaucoma.


Other side effects:

Adverse reactions listed below have been reported with the following frequencies:


Very common: may affect more than 1 user in 10

  • drowsiness/drowsiness
  • tremors in the hands or other parts of the body
  • dizziness
  • headache
  • irregular, strong, or rapid heartbeat
  • dizziness due to a drop in blood pressure when you get up ( orthostatic hypotension )
  • dry mouth
  • constipation
  • nausea
  • heavy sweating
  • weight gain
  • slurred or slow speech
  • aggression
  • nasal congestion.


Common: may affect up to 1 in 10 users

  • confusion
  • sexual changes (decreased sexual drive, erection problems )
  • attention deficit disorder
  • taste changes
  • numbness and tingling in the arms and legs
  • coordination difficulties
  • large pupils are
  • heart rhythm disorder ( AV block )
  • fatigue
  • low sodium content in the blood
  • anxiety, physical restlessness
  • various problems with the urinary tract
  • thirst.


Uncommon: may affect up to 1 in 100 people

  • arousal, anxiety, difficulty sleeping, nightmares
  • cramps
  • tinnitus (ringing in the ears)
  • high blood pressure
  • diarrhea, vomiting
  • skin rash, hives (hives), swelling of the face and tongue
  • difficulty urinating
  • increased production of breast milk or excretion of breast milk (without breastfeeding)
  • elevated pressure in the eye
  • dizziness and fainting
  • worsening heart failure
  • hepatic impairment (eg cholestatic liver disease).


Rare: may affect up to 1 in 1,000 people

  • decreased appetite
  • delirium, which is a condition with e.g. decreased consciousness, confusion or loss of reality (in elderly patients), or hallucinations
  • abnormal heart rhythm or irregular heartbeat
  • swollen salivary glands
  • hair loss
  • increased sensitivity to sunlight
  • mammary gland enlargement in men
  • fever
  • weight loss
  • abnormal liver function values.


Very rare: may affect up to 1 in 10,000 people

  • heart muscle disease
  • the feeling of inner restlessness and a strong need to be in constant motion
  • a condition called peripheral nerve disease, which involves e.g. numbness and tingling in the legs and feet, sensitivity to touch, or deterioration of sensation
  • acute elevated pressure in the eye
  • special forms of abnormal heart rhythm (so-called torsades de pointes )
  • allergic inflammation in the alveoli and in the lung tissue.


Has been reported: occurs in an unknown number of users

  • decreased appetite
  • increase or decrease in blood sugar
  • paranoia (delusions)
  • motion sickness (involuntary movements or reduced movements)
  • myocarditis due to hypersensitivity reaction
  • inflammation of the liver
  • hot flashes
  • dry eyes.


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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Amitriptyline Orifarm

Keep this medicine out of the sight and reach of children.

No special storage instructions. 

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month. 

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. Contents of the packaging and other information

Content declaration

  • The active substance is amitriptyline hydrochloride equivalent to amitriptyline 10 mg or 25 mg.
  • Other ingredients are:Tablet core:anhydrous lactose; microcrystalline cellulose (E460); sodium starch glycolate; talc (E553b); colloidal anhydrous silica; magnesium stearate (E470b).Film coating:10 mg: Hypromellose (E464); titanium dioxide (E171); yellow iron oxide (E172); talc (E553b).25 mg: Hypromellose (E464); titanium dioxide (E171); yellow ionic oxide (E172); red iron oxide (E172); talc (553b).

What the medicine looks like and the contents of the pack

Appearance

10 mg: yellow, round, biconvex, film-coated tablet without embossing, diameter 6 mm.

25 mg: light brown, round, biconvex, film-coated tablet without embossing, diameter 8 mm.


Pack sizes

Amitriptyline Orifarm 10 mg

PVC / Al / PE / PVdC blisters: 90 and 100 tablets.


Amitriptyline Orifarm 25 mg 
PVC / Al / PE / PVdC blisters: 50, 90 and 100 tablets.


Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark 

Local representative:

Orifarm Generics AB,

Box 56048

102 17 Stockholm 

info@orifarm.com

This medicinal product is authorized under the European Economic Area under the names:

, Norway: Amitriptyline Orifarm

Muhammad Nadeem

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