What do you think of amitriptyline

Amitriptyline neuraxpharm

neuraxpharm Arzneimittel GmbH

Addictive drugPsychotropic
NoNo
Pharmacological groupAntidepressants

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Brief information

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neuraxpharm Arzneimittel GmbH

What is it and what is it used for?

Amitriptyline-neuraxpharm is a drug from the group of tricyclic antidepressants. Amitriptyline-neuraxpharm is used for the treatment of depression and for the long-term treatment of pain in connection with other therapeutic measures.

What do you need to consider before use?

If any of the above apply to you, do not take this medicine.

How is it used?

If the effect is sufficient, the dose should be as small as possible. If necessary, however, the available dosage range should be used.

How should it be stored?

Keep this medicine out of the reach and sight of children! Store in the original packaging in order to protect the contents from light!

What is it and what is it used for?

Amitriptyline-neuraxpharm is a drug from the group of tricyclic antidepressants.

Amitriptyline-neuraxpharm is used for the treatment of depression (illnesses with pathologically sad moods) and for the long-term treatment of pain in connection with other therapeutic measures.

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What do you need to consider before use?

Amitriptyline-neuraxpharm must not be taken:

  • if you are allergic to amitriptyline, methyl 4-hydroxybenzoate (Paraben E 218), propyl 4-hydroxybenzoate (Paraben E 216) or any of the other ingredients of this medicine (listed in section 6).
  • in acute poisoning with alcohol, sleeping pills, painkillers or psychotropic drugs.
  • if you have urinary behaviors (inability to empty the bladder).
  • with confusion and excitement with hallucinations and z. Sometimes severe physical disorders (delirium).
  • with untreated increased intraocular pressure (glaucoma, narrow-angle glaucoma).
  • if you have an enlarged prostate gland (prostatic hyperplasia) with residual urine.
  • if the stomach outlet is narrowed (pyloric stenosis).
  • in cases of intestinal paralysis or obstruction (paralytic ileus).
  • if there is a lack of potassium (hypokalaemia).
  • if you have a slow heartbeat (bradycardia).
  • if you suffer from certain heart diseases (e.g. congenital QT syndrome, other clinically important heart problems, especially coronary artery disease, conduction disorders, cardiac arrhythmias).
  • if you are being treated at the same time with medicinal products that can also prolong the so-called QT interval in the ECG or cause a potassium deficiency (see also "Other medicines and Amitriptyline").
  • if you are being treated concomitantly with MAOIs (medicines used to treat depression).

Warnings and Precautions
Talk to your doctor or pharmacist before taking Amitriptyline neuraxpharm.
Particular caution is required

  • if you have an enlarged prostate gland (prostatic hyperplasia) with no residual urine.
  • if you have severe liver or kidney damage.
  • if you are prone to seizures.
  • with disorders of blood formation.
  • if you are taking other antidepressants (selective serotonin reuptake inhibitors / SSRIs) at the same time.

Thoughts of suicide and worsening of your depression
When you are depressed you can sometimes have thoughts of harming or killing yourself. Such thoughts can occur when the first time

Use of antidepressants should be increased because all of these medicines take some time to work, usually about two weeks, sometimes longer.

Such thoughts are more likely to occur

  • if you have had thoughts of killing or harming yourself in the past
  • if you are a young adult. Results from clinical trials have shown an increased risk of suicidal behavior in young adults aged 25 and under with a psychiatric illness who were treated with an antidepressant.


Contact your doctor or go to a hospital straight away if you have thoughts of harming or killing yourself at any time.
It can be helpful if you tell a friend or relative that you are depressed. Ask them to read this leaflet. Ask them to tell you if they think your depression is getting worse or if they are worried about changes in your behavior.
Amitriptyline can lower the seizure threshold, which is why seizures may occur more frequently if there is an increased readiness for seizures (e.g. withdrawal syndrome after discontinuation of benzodiazepines or barbiturates).


A heart problem called "QT prolongation" (which can be seen on your electrocardiogram, EKG) and abnormal heart rhythm (fast or irregular heartbeat) have been reported with amitriptyline. Tell your doctor if you:

  • have a slow heart rate
  • have or have had a disease where your heart cannot pump blood around your body properly (a disease called heart failure)
  • are receiving other medicines that can cause heart problems, or
  • have a condition that causes you to have low levels of potassium or magnesium, or high levels of potassium in your blood.


Depending on your clinical picture and the risk of side effects, your doctor will carry out regular examinations such as: B. of blood pressure, EKG, blood count and liver values.

When occurring

  • a pathological elation (mania) or
  • of so-called acute productive symptoms in the treatment of depressive syndromes in the course of schizophrenic illnesses, please inform your doctor immediately, who will then stop Amitriptyline-neuraxpharm immediately.

In patients with an organic brain psychosyndrome, the possible generation of pharmacogenic delirium should be considered.


Amitriptyline should be used with caution in patients with hyperthyroidism and patients treated with thyroid preparations and in patients with paranoid symptoms.


As described for other psychotropic drugs, amitriptyline could also influence the response of insulin and glucose in diabetics, so that an adjustment of the antidiabetic therapy is necessary. The depressive illness itself can also have an impact on the patient's glucose level.

Children and adolescents
Amitriptyline should not be used to treat depression in children and adolescents under 18 years of age. In studies of the treatment of depression in this age group, tricyclic antidepressants showed no therapeutic benefit. Studies of other antidepressants (SSRIs, SNRIs) have shown an increased risk of suicidal behavior, self-harm, and hostile behavior associated with the use of these agents. These risks cannot be ruled out for amitriptyline either.


In addition, amitriptyline is associated with a risk of cardiovascular side effects in all age groups (see also section 4. “What side effects are possible?”). In addition, no data are available on the safety of long-term use in children and adolescents with regard to growth, maturation or intellectual and behavioral development.


However, if Amitriptyline-neuraxpharm is prescribed for children and adolescents under 18 years of age, paying particular attention to the risk-benefit ratio, it is recommended that greater attention be paid to daily dental care due to the increased risk of caries in children.

Elderly or debilitated patients
Care should be taken in elderly or debilitated patients as well as patients with organic brain changes, circulatory and respiratory weaknesses (chronic obstructive respiratory insufficiency) and impaired kidney or liver function (follow dosage instructions!)


Other medicines and Amitriptyline-Neuraxpharm
Tell your doctor or pharmacist if you are taking / using, have recently taken / used or may take / use any other medicines.

The following medicines can affect the way Amitriptyline-Neuraxpharm works or the way it works:

  • Sleeping, sedative or pain relievers: the effect of the mentioned agents is enhanced.
  • Other drugs, some of which have the same effect as Amitriptyline-neuraxpharm (anticholinergic effect): intensification of the "side effects" mentioned in section 4, especially states of confusion (delirium).
  • The effect of certain drugs that affect the involuntary nervous system (sympathomimetics) can be significantly increased by simultaneous administration of Amitriptyline-neuraxpharm, e.g. B. in agents for local anesthesia in dentistry (vasoconstricting additives in local anesthetics).
  • Certain drugs used to treat depression (MAO inhibitors): irreversible MAO inhibitors should always be discontinued at least 14 days, reversible MAO inhibitors at least 1 day before starting treatment with Amitriptyline-neuraxpharm. Otherwise, severe side effects such as agitation, states of confusion (delirium), coma, very high fever, seizures and severe fluctuations in blood pressure must be expected (see section 2).
  • Fluoxetine, fluvoxamine or paroxetine (medicines used to treat depressive disorders): If these medicines are used at the same time or before, the concentration of amitriptyline in the blood may increase. It may therefore be necessary to reduce the dose of Amitriptyline neuraxpharm, fluoxetine, fluvoxamine or paroxetine.
  • St. John's wort (Hypericum): If medicinal products containing active substances from St. John's wort are used at the same time, the concentration of amitriptyline in the blood can be reduced, thereby weakening the effectiveness of amitriptyline.
  • Certain drugs for lowering blood pressure of the guanethidine or clonidine type: Decreases the antihypertensive effect. Clonidine-treated patients are at risk of dangerous increases in blood pressure.
  • Simultaneous use of drugs
    - which also extend the so-called QT interval in the EKG, e.g. B. Agents against cardiac arrhythmias (antiarrhythmics class IA or III), certain antibiotics (e.g. erythromycin), cisapride, antimalarials, agents against allergies or gastrointestinal ulcers (antihistamines) or agents for the treatment of special mental and emotional diseases (Neuroleptics),
    - which lead to a potassium deficiency (e.g. certain diuretics),
    - which can inhibit the breakdown of amitriptyline in the liver, e.g. B. MAOIs or antifungal agents (imidazole antifungal agents)
    must not be done (see Section 2).
  • Medicines for the treatment of certain mental and emotional disorders (neuroleptics) and certain medicines for the treatment of stomach / intestinal ulcers (cimetidine): an increase in the concentration of amitriptyline in the blood is possible.
  • Certain medicines to prevent blood clotting (coumarin derivatives, e.g. phenprocoumon): Amitriptyline can affect the way these medicines work. If Amitriptyline-neuraxpharm and coumarins are taken at the same time, the blood coagulation values ​​must be monitored continuously.
  • During concomitant use of fluconazole, increased amitriptyline plasma concentrations have been observed, which may lead to toxic effects affecting the central nervous system and the cardiovascular system.
  • There have also been reports of possible interactions between amitriptyline and mirtazapine.
  • Valproic acid

Amitriptyline-Neuraxpharm with food, drink and alcohol
Do not consume alcohol during treatment with Amitriptyline-Neuraxpharm.



Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant or planning to become pregnant.

pregnancy
Amitriptyline neuraxpharm should only be taken during pregnancy, especially in the first and last trimester of pregnancy, if absolutely necessary and after carefully weighing the risk and benefit.


There is insufficient experience with the use of amitriptyline during pregnancy. When higher doses of antidepressants were given before birth, withdrawal symptoms in the form of cardiac and respiratory disorders, urinary and stool evacuation, and restlessness were observed in the newborn.

Breastfeeding
Amitriptyline-neuraxpharm should not be used during breast-feeding, as amitriptyline and its breakdown products are excreted in breast milk. If necessary, breastfeeding should be discontinued before treatment with Amitriptyline-neuraxpharm.

Driving and using machines
Amitriptyline-neuraxpharm affects the ability to drive actively or use machines to different degrees.
This applies in particular at the start of treatment, when changing preparations and in conjunction with other centrally acting drugs (pain relievers, sleeping pills, psychotropic drugs). This applies to a greater extent at the same time

Consumption of alcohol.
Therefore, driving vehicles, operating machines or other dangerous activities should be avoided at all, at least during the first days of treatment. The decision is to be made on a case-by-case basis by the attending physician, taking into account the individual reaction and the respective dosage.

How is it used?

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


Unless otherwise directed by your doctor, the following dosage guidelines apply
If the effect is sufficient, the dose should be as small as possible. If necessary, however, the available dosage range should be used.


The dose should be increased gradually at the start of treatment and decreased gradually when the treatment is stopped.


For outpatient treatment of depressive illnesses (outside the hospital), a starting dose of 25 to 37 drops of Amitriptyline-neuraxpharm (corresponding to 50 to 75 mg amitriptyline / day) is recommended.

The dose should then be increased daily until it takes effect. The maximum daily dose must not exceed 150 mg in an outpatient setting and 300 mg in an inpatient setting (in a hospital).

If necessary, preparations with a more suitable active ingredient content are available.
If a sleep-inducing effect is particularly desired, a larger part of the daily dose can be given at night.
Children and adolescents under 18 years of age receive amitriptyline in a dose between 25 and 150 mg per day or up to a maximum dose of 4 - 5 mg / kg body weight. Accordingly, 3 times 4 drops to 3 times 25 drops of Amitriptyline-neuraxpharm can be given per day. Here, however, the risk-benefit ratio must be carefully weighed (see Section 2 under “Warnings and precautionary measures”).


The treatment of chronic pain should begin with an evening dose of 12 drops of amitriptyline neuraxpharm (equivalent to 24 mg of amitriptyline), which the doctor can gradually increase to an evening dose of 75 to 100 mg (in individual cases up to 150 mg) of amitriptyline.

Note
Older patients often require a significantly lower dose; even half the usual daily dose often shows a satisfactory effect.
A dose reduction of Amitriptyline-neuraxpharm is also indicated in weakened patients and patients with damage to the heart, impaired brain function, circulatory and respiratory problems or impaired kidney or liver function.

type of application
It can be taken with or without food. Take Amitriptyline-Neuraxpharm with enough liquid. If taken undiluted, the tongue and oral mucosa may temporarily become numb.

Duration of application
The dosage and duration of treatment will be determined by your doctor, taking into account the nature and severity of your illness and your personal response to the drug.
The mean duration of a treatment period until the symptoms subside is generally at least 4 - 6 weeks.
After the depressive symptoms have regressed, the treatment should be continued for at least 6 months.

Please talk to your doctor or pharmacist if you have the impression that the effect of Amitriptyline-neuraxpharm is too strong or too weak.


If you take more Amitriptyline-Neuraxpharm than you should
Amitriptyline is relatively dangerous if overdosed - especially for children and toddlers. For this reason, if an overdose is suspected, a doctor should be informed immediately (e.g. poisoning emergency call)!
Overdoses with amitriptyline are expressed, depending on the dose taken, by disorders of the central nervous system (confusion, states of excitement up to seizures, clouding of consciousness up to coma, breathing disorders up to respiratory failure) and the cardiovascular system.

In addition, dry mucous membranes, visual disturbances, constipation and disturbances in urine output can occur.

If you forget to take Amitriptyline-Neuraxpharm
Do not take a double dose to make up for a forgotten dose, but continue to take Amitriptyline-neuraxpharm as directed by your doctor.

If you stop taking Amitriptyline-Neuraxpharm
In any case, talk to your doctor before you - e. B. because of intolerance - interrupt the treatment with Amitriptyline-neuraxpharm or end it prematurely! Sudden discontinuation of long-term or high-dose treatment with Amitriptyline-neuraxpharm should be avoided, as discontinuation symptoms such as restlessness, sweating, nausea, vomiting and sleep disorders are to be expected.


If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are the possible side effects?

Like all medicines, this medicine can have side effects, although not everybody gets them.
In the following we list possible side effects according to their frequency.

Very common (may affect more than 1 in 10 people)

  • Weight gain (especially at the beginning)
  • Irritability (especially at the beginning)
  • especially at the beginning: drowsiness, dizziness, speech disorders, tremors
  • Disorders of the eye's ability to focus (accommodation disorders) (especially at the beginning)
  • especially at the beginning: acceleration of the heartbeat, cardiac arrhythmias
  • especially at the beginning: low blood pressure, poor circulation with dizziness and blackness in front of the eyes when standing up suddenly (orthostatic dysregulation)
  • nasal congestion (especially at the beginning)
  • especially at the beginning: dry mouth, constipation
  • usually temporary increase in liver values ​​(especially at the beginning)
  • Sweating (especially at the beginning)
  • Tiredness (especially at the beginning)

Common (may affect up to 1 in 10 people)

  • a heart problem called "QT prolongation" (seen on your electrocardiogram, EKG)
  • inner restlessness, disorders of sexual excitability (loss of libido or impotence). Elderly patients are at an increased risk of confusion (delirious syndromes).
  • Rashes
  • Discomfort when urinating
  • Feeling thirsty
  • Sodium deficiency

Uncommon (may affect up to 1 in 100 people)

  • Changes in the blood count (especially a decrease in white blood cells)
  • allergic reactions of the skin
  • Circulatory collapse, conduction disorders of the heart. An existing heart muscle weakness can be aggravated.
  • inflammatory changes in the blood vessels (allergic vasculitis)
  • Bowel paralysis or obstruction (paralytic ileus)
  • Liver dysfunction (e.g. cholestatic hepatosis)
  • Urinary obstruction
  • Secretion of fluid from the mammary gland (galactorrhea)

Rare (may affect up to 1 in 1,000 people)

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

  • life-threatening destruction of the white blood cells (agranulocytosis). It manifests itself in a high fever, chills, sore throat, difficulty swallowing, inflammation in the mouth, nose, throat, genital and anal areas. If these symptoms occur, a doctor should be consulted immediately and a blood count should be carried out.
  • allergic inflammation of the alveoli or lung tissue (alveolitis, Löffler syndrome)
  • epileptic seizures, movement disorders (akathisia, dyskinesia), paresthesia and pain in the arms or legs (polyneuropathies)
  • attacks of increase in intraocular pressure (glaucoma attacks)
  • certain diseases of the heart muscle (cardiomyopathies). Inflammation of the heart muscle (hypersensitivity myocarditis) was observed in one case.

Not known (frequency cannot be estimated from the available data)

  • Water retention (e.g. face, tongue)
  • anorexia
  • Confusion, pathological elation, fear, delusions, suicidal thoughts, suicidal behavior. Cases of suicidal ideation and behavior have been reported during therapy with amitriptyline or shortly after stopping treatment (see section 2. under “Warnings and precautions”).
  • Headache, lack of concentration, coordination disorders, taste disorders
  • Dilatation of the pupils
  • Ringing in the ears
  • Increase in body temperature, high blood pressure
  • diarrhea
  • Sensitivity to light, hair loss
  • Enlargement of the male mammary gland
  • Dry eye

Certain cardiac arrhythmias may occur during treatment with Amitriptyline neuraxpharm (very rarely also the “Torsades de Pointes”, which can be life-threatening).

An increased risk of fractures has been observed in patients treated with this group of medicines.


Methyl 4-hydroxybenzoate (Paraben E 218) and propyl 4-hydroxybenzoate (Paraben E 216) can cause hypersensitivity reactions, including late reactions.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet.
You can also report side effects directly
Federal Institute for Pharmaceuticals and Medical Products
Pharmacovigilance Dept.
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Website: www.bfarm.de
Show.
By reporting side effects you can help provide more information on the safety of this medicine.

How should it be stored?

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

Do not use this medicine after the expiry date which is stated on the carton and bottle label after "use by:". The expiry date refers to the last day of the month indicated.

Storage conditions
Store in the original packaging in order to protect the contents from light!
Note on shelf life after opening
The shelf life after opening the bottle is 6 months.

additional Information

What Amitriptyline-Neuraxpharm contains
The active substance is amitriptyline hydrochloride.
1 ml oral solution (approx. 20 drops) contains 45.28 mg amitriptyline hydrochloride, equivalent to 40 mg amitriptyline.
The other ingredients are: methyl 4-hydroxybenzoate (Paraben E 218), propyl 4-hydroxybenzoate (Paraben E 216), caramelized sugar (E 150), purified water.

What Amitriptyline-Neuraxpharm looks like and contents of the pack
Clear, yellowish oral solution.
Amitriptyline-neuraxpharm is available in packs of 30 ml and 50 ml oral solution.

Marketing Authorization Holder and Manufacturer
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Strasse 23 • 40764 Langenfeld
Tel. 02173/1060 - 0 • Fax 02173/1060 - 333
This leaflet was last revised in December 2018.

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