STANGYL 25 mg - Information for the patient (2023)

2. What you need to know before using Stangyl 25mgobserve?

Stangel 25mgmust not take

• if you are allergic to trimipramine, other tricyclic antidepressants, wheat starch or any of the other ingredients of this medicine (listed in section 6)

• in case of acute intoxication with alcohol, sleeping pills, painkillers and psychotropic drugs,

• in acute states of confusion,

• with untreated increased pressure in the eye (narrow-angle glaucoma),

• urination problems such as urinary retention or an enlarged prostate (prostatic hyperplasia) with residual urine,

• if you have recently had a heart attack

• by narrowing of the stomach (pyloric stenosis),

• in case of intestinal paralysis and intestinal obstruction (paralytic ileus),

• while taking the so-called irreversibleMAO- Inhibiting.

Warnings and precautions

The following describes when you should take Stangyl 25mgmust be used only under certain conditions and with extreme caution. Please ask your doctor about this. This also applies if the information concerned you previously.

Stangel 25mgshould be used with particular caution in case of:

• Enlargement of the prostate gland (prostatic hyperplasia) without residual urine,

• increased readiness to have seizures (epilepsy),

• severe liver or kidney damage

• existing decrease in the efficiency of the hematopoietic systemLub.history of hematopoietic disorders,

• takes the so-called "reversible".MAO-Inhibitors" (see section "Use of Stangyl 25mgtogether with other substances")

• elderly patients, especially sensitive to sedatives and prone to hypotonia when moving from lying to standing position and chronic constipation,

• slow heart rate (bradycardia),

• some heart diseases (congenital QT syndrome or other clinically significant heart damage, especially circulation disorders in the coronary vessels, conduction disorders, arrhythmias),

• Concomitant treatment with medicines that also cause ECG changes (prolongation of the QT interval), slow heart rhythm or low potassium levels in the blood (see "Use of Stangyl 25 mg/ml").mgtogether with other substances")

• existing electrolyte disturbances (z. B.low levels of potassium or magnesium in the blood)

• Concomitant treatment with medicines that may increase the risk of serotonin syndrome (see the section "Use of Stangyl 25 mgmgtogether with other drugs"). Serotonergic syndrome is a potentially life-threatening condition. Symptoms of serotonin syndrome may include restlessness, confusion, rapid heart rate, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea and coma. If you experience any of these symptoms , you must contact your doctor immediately.

If manic mood occurs, Stangyl 25mgstop and initiate appropriate treatment.

Under treatment with Stangyl 25mgAs with other tricyclic antidepressants, laboratory tests including complete blood counts and liver enzymes should be performed regularly.

Treatment with tricyclic antidepressants increases the risk of developing diabetes. Therefore, your doctor will check your blood sugar accordingly if you are diabetic or if you are at increased risk of developing diabetes.

Because trimipramine can lower the seizure threshold, aEEG-monitoring (EEG= electroencephalography, measurement of brain activity currents) is recommended (see "Tag Stangyl 25mgtogether with other substances"). If convulsions occur, treatment should be discontinued.

Under the soothing, calming effects of Stangyl 25mgusually begins immediately within the first few hours, the mood-lifting antidepressant effect can usually only be expected after 1 to 3 weeks.

If you notice increased insomnia and nervousness at the start of treatment, your doctor may increase your dose of Stangyl 25mglimited or temporary additional treatment of symptoms becomes necessary.

Suicidal thoughts and deepening depression

Depressed people may sometimes have thoughts of harming or killing themselves. These may increase when you start antidepressants as all these medicines take time to work, usually around two weeks but sometimes longer.

Such thoughts are more likely

• if you have previously had thoughts of killing or harming yourself

• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders who were treated with antidepressants.

Contact your doctor or go to hospital immediatelyif you ever have thoughts of harming or killing yourself.

It may be helpful to tell a friend or relative about thisthat 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 concerned about changes in your behaviour.

Sudden discontinuation of long-term treatment with high doses of Stangyl 25mgshould be avoided as withdrawal symptoms such as headache, nausea, restlessness, restlessness, sweating, nausea, vomiting and difficulty sleeping may occur (see 'If you stop taking Stangyl 25 mgmginterrupt").

children and teenagers

Stangel 25mgshould not be used to treat depression in children and adolescents under the age of 18. Tricyclic antidepressants have shown no therapeutic benefit in depression trials in this age group. Studies with other antidepressants (SSRI,SNRI) have shown an increased risk of suicide, self-injurious and hostile behavior associated with the use of these drugs. These risks may also apply to Stangyl 25mgnot excluded. Furthermore, Stangyl is 25 years oldmgis associated with risk of cardiovascular side effects in all age groups. In addition, there is a lack of long-term safety data in children and adolescents with regard to growth, maturation and intellectual and behavioral development.

heart disease and the elderly

Heart disease and the elderly should have their heart function checked regularly, as this class of medication increases the risk of rapid heartbeat, low blood pressure and quinidine-like effects.

Elderly patients with reduced metabolism, kidney, liver or heart function before and during treatment with Stangyl 25mgadequate follow-up should be performed and the dose should be adjusted accordingly. In particular, a low starting dose followed by a slow dose escalation and a low maintenance dose should be chosen (see also section 3).

Taking Stangyl 25mgtogether with other substances

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

Effect of alcohol and concomitant use of other central nervous system depressants, such as:

• morphine derivatives (pain reliever, cough suppressant and substitution therapy),

• Sleeping pills and sedatives (e.gz. B.barbiturater, benzodiazepiner),

• sedative antihistamines (anti-allergy medicines that can make you feel tired)

• neuroleptics (medicines to treat schizophrenia and psychosis),

• centrally acting antihypertensives (some medicines used to treat high blood pressure,z. B.alfamethyldopa, clonidin)

• baclofen (a medicine used to relax skeletal muscles in spinal cord injury or multiple sclerosis),

• thalidomide (a medicine to treat multiple myeloma)

may lead to an increase in depression of the central nervous system.

Alcoholic beverages and other substances containing alcohol should be avoided during treatment with antidepressants.

Simultaneous use of baclofen can lead to a reduction in muscle tone.

With the simultaneous administration of other substances that also inhibit the effect of acetylcholine (have an anticholinergic effect), an increase in central symptoms (especially delirium) must be expected.

Stangel 25mgunwanted peripheral effects such asz. B.Urinary retention, occurrence of acute glaucoma, constipation and dry mouth after atropine-like drugs (z. B.bromek ipratropium, bromek tiotropium, chlorek trospium, butyloskopolamina).

The effectiveness of substances that directly or indirectly lead to stimulation of the sympathetic nervous system (sympathomimetic amines,z. B.adrenaline, norepinephrine, dopamine) can be reduced by simultaneous administration of Stangyl 25mgbe strengthened. This can lead to paroxysmal high blood pressure and cardiac arrhythmias.

Special attention should be paid to vasoconstrictor additives in local anesthesia. Adrenaline injected under the skin or into the gums to stop bleeding can lead to high blood pressure attacks and heart arrhythmias.

So-called irreversibleMAO- Inhibitors should be discontinued at least 14 days before starting treatment with trimipramine. Additional gift "reversibleMAO-inhibitory" (z. B.moclobemide) is possible in isolated cases if all necessary precautions are taken and the dose is slowly increased.

So-called "non-selective".MAO- inhibitor" (npz. B.Tranylcypromine) should not be taken with tricyclic antidepressants such as trimipramine due to possible effects on blood pressure.

With simultaneous or previous use of serotonin reuptake inhibitors, e.gz. B.Citalopram, fluoxetine, fluvoxamine, paroxetine and sertraline can increase blood levels of both antidepressants. Simultaneous use requires increased monitoring by the doctor and, if necessary, reduction of the dose of Stangyl 25mg Lub.serotonin reuptake inhibitor.

If you have taken fluoxetine before and are currently taking Stangyl 25mgto be treated, your doctor will start you on a lower dose than usual and increase it slowly.

Simultaneous use with other so-called administration of serotonergic active substances can lead to serotonin syndrome (see section 2 "Warnings and precautions").

Examples of such medicines are:

• triptans (used for migraines),

• other medicines used to treat depressionz. B.serotonin reuptake inhibitors,MAO- inhibitors or medicines containing lithium,

• medicines containing linezolid, an antibiotic (used to treat infections)

• medicines containing tramadol (used to treat severe pain)

• Preparations containing L-tryptophan (used e.gz. B.for insomnia and depression)

• Preparations containing St. John's wort (Hypericum perforatum, a natural remedy used to treat mild depression).

Buprenorphine - This medicine can be taken together with Stangyl 25mginteraction and symptoms such as involuntary, rhythmic muscle contractions, including those controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremors, hyperreflexia, increased muscle tension and body temperature above 38°Csee you. Contact your doctor if any of these symptoms occur.

Stangel 25mgmay reduce the effectiveness of guanethidine-type antihypertensivesLub.Reduction of clonidine with risk of excessive increase in blood pressure (rebound hypertension) in patients treated with clonidine.

Concomitant use of antihypertensive drugs (except clonidine and related drugs) may enhance their antihypertensive effect. There is an increased risk of a sudden drop in blood pressure when going from a lying to a standing position.

Concomitant use of medications that also cause ECG changes (QT prolongation) should be avoided (z. B.antiarrhythmic classIAor III, antibiotics, antimalarials, antihistamines, neuroleptics) leads to a decrease in the amount of potassium in the blood (hypokalemia) (z. B.certain diuretics, glucocorticoids) cause the heart to beat slowly (z. B.beta blockers, diltiazem, verapamil, clonidine, digitalis) or may inhibit the liver breakdown of trimipramine (z. B.so-called irreversibleMAO-Hemmer, Imidazol-Antimykotika).

Stangel 25mgthe effectiveness of drugs for heart rhythm disorders (antiarrhythmics), especially type Ia (z. B.Quinidine) and type III (z. B.amiodarone).

In combination therapy withAntipsychotics(Medicines for the treatment of split mental disorders) plasma concentrations of the tricyclic antidepressant may be increased.

Plasma concentrations of tricyclic antidepressants may also increase during concomitant treatment with cimetidine.

The dosage of antiepileptics (antiepileptics used for people with epilepsy) may need to be adjusted, as trimipramine may lower the seizure threshold and an increased tendency to seizures may be expected. These patients should be monitored clinically.

During the administration of valproic acid, patients should be monitored clinically and, if necessary, the dose of Stangyl should be adjusted.mgset.

Simultaneous administration of carbamazepine can lead to generalized seizures (lowering of the seizure threshold with antidepressants) and to a decrease in the plasma concentration of the tricyclic antidepressant (due to increased metabolism in the liver). Patients should be monitored clinically and doses adjusted as needed.

Taking Stangyl 25mgalong with food, drinks and alcohol

Taking Stangyl 25mgshould not be taken together with black tea, as tannic acids contained in tea weaken the effect of Stangyl 25mgcan reduce. However, you do not have to completely give up black tea if you drink it at a different time than taking Stangyl.

It cannot be excluded that the consumption of coffee or fruit juice also leads to a reduced effect due to the formation of poorly soluble complexes with trimipramine, which has been shown with other antidepressants.

When using Stangyl 25mgavoid drinking alcohol if possible.

pregnancy and breastfeeding period

If you are pregnant or breast-feeding, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.

Taking Stangyl 25mgnot recommended during pregnancy unless clearly necessary and only after a careful benefit/risk assessment.

If you have taken this medicine in the last stages of your pregnancy, your baby may experience adjustment problems and withdrawal symptoms such as irritability, low muscle tone, tremors, convulsions, irregular breathing, poor feeding and constipation.

Your doctor will advise you whether you should start, continue or stop breast-feeding or stop taking this medicine. She will consider the benefits of breastfeeding for your baby and the benefits of therapy for you.

Ability to drive and operate machinery

There is a potential hazard when driving or operating machinery due to impaired alertness. fixed 25mgmay cause blurred vision and drowsiness. Even when used as intended, responsiveness may change to such an extent thatz. B.the ability to drive and operate machinery is reduced. You can no longer react quickly and specifically enough to unexpected and sudden events.

Stangel 25mgcontains gluten.

This medicine contains very small amounts of gluten (from wheat starch) and if you have celiac disease it is very unlikely to cause problems.

One tablet contains no more than 261 micrograms of gluten.

If you are allergic to wheat (not the same as celiac disease), do not take this medicine.

3. How does Stangyl 25 perform?mgto take?

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are in doubt.

dosage

Unless your doctor tells you otherwise, the usual dose is:

The effective dose is reached gradually, starting with1-2Tabletten Stangyl 25mg(25-50 mgtrimipramine) daily, then slowly increase the dose if necessary. In moderate depressive states the daily dose is4-6Tabletten Stangyl 25mg(100-150 mgtrimipramine).

It can be taken during the day (morning, noon, evening) or as a single dose in the evening. Especially in cases of insomnia, it should be taken in the evening in a single dose.

Stangel 25mgshould not be used to treat depression in children and adolescents under the age of 18 (see also section 2 "Children and adolescents").

Elderly and debilitated patients with hypertension, low blood pressure and arteriosclerosis should take only moderate doses orally at longer intervals. The dose should be carefully adjusted in patients with liver or kidney insufficiency (failure).

application type

Stangel 25mg, tablets, swallowed whole with liquid, during or after a meal.

The tablets can be divided into equal doses.

period of use

From clinical experience, treatment with Stangyl 25mgfor a period of approx4-6weeks are necessary to achieve effective therapy with lasting mood normalization.

To prevent relapse to the depressive phase, maintenance treatment with trimipramine is recommended for several months - 4 to 9 months - after the first depressive phase with the dose used in the acute phase throughout the phaseLub.partial improvement. In patients with a history of several depressive phases, it may be necessary to continue treatment for several years at the dose that led to improvement in the current phase.

If you take a higher dose of Stangyl 25mgyou took than you should

While taking Stangyl 25mgin a higher dose than that indicated in the package insert, various degrees of dysfunction of the body may occur. The higher the dose, the greater the risk to the patient. Overdose can be fatal. Therefore increased intake of Stangyl 25mgrespond.

These dysfunctions in the body are manifested at the beginning of an increased need for sleep and even decreased consciousnessLub.Coma at high doses, in cardiovascular disorders up to cardiac arrest and convulsions. Cardiovascular disorders can be particularly dangerous for the patient, especially if the heart has already been damaged. Symptoms of poisoning can appear much earlier in childrenOkay.2mgTrimipramine prokgbody weight.

If you accidentally take more than the prescribed dose, contact your doctor. Depending on the dose takenLub.Based on the symptoms, the doctor decides on further treatment.

In the case of children, you must always consult a doctor - even if the intake is small.

It must be remembered that even with a slight overdose, the ability to react is always more reduced than with a normal dose.

When taking other medications, especially other psychotropic medications, the above-mentioned physical disorders may occur even at lower doses than indicated (see also the section "Using Stangyl 25 mg/ml").mgtogether with other substances").

Notes for the attending physician

Treatment should include symptomatic treatment and monitoring of vital signs, especially cardiac and respiratory function, for at least three to five days.

As an antidote, the use of physostigmine salicylate 2mgslowI. w.in adults, in children0,5–1 mg I. w.In case of pronounced hypotension or shock, the appropriate amount should be supplemented.No adrenaline!

If you stop taking Stangyl 25mgI forgot

The next dose of Stangyl is the 25thmgtaken in the prescribed dose. increase the dose,z. B.Do not take a double dose after forgetting a single dose.

If you stop taking Stangyl 25mginterrupt

In this case, the symptoms of depressive illness (z. B.sleep disorders, depression). That is why Stangyl 25 therapymgdon't finish early. As with initiation of treatment, weaning should be done gradually, as directed by your doctor, with a gradual reduction of the daily dose. With abrupt discontinuation, especially after prolonged use, withdrawal phenomena such as e.gz. B.There is discomfort, nausea, headache, sleep disturbances, anxiety, restlessness, increased irritability.

Ask the doctor or pharmacist if you have any further questions about the use of this medicine.

4. What side effects are possible?

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

The frequency of side effects is listed as "not known" because it cannot be estimated from the available data.

blood diseases

Some changes in blood counts (z. B.leukopenia, agranulocytosis, thrombocytopenia and eosinophilia). As with other tricyclic antidepressants, regular blood counts should therefore be monitored during treatment with trimipramine.

endocrine disorders

Increased water intake in the body (insufficientADHsecretion), a drop in blood sugar below normal (hypoglycaemia).

Similar to related drugs: increase in prolactin in the blood and/or discharge from the breast (galactorrhoea).

Metabolic and nutritional disorders

Increased blood sugar levels, increased risk of developing diabetes (see section 2 "Warnings and precautions").

Mental disorders

Anxiety, sleep disturbances, mood swings, confusion in elderly patients, disturbance of consciousness (delirium syndromes).

Turning depression into hypomania or mania.

Cases of suicidal thoughts and behavior during Stangyl therapy 25mgor shortly after treatment (see section 2 "Warnings and precautions").

disorders of the nervous system

Especially at the beginning of treatment: tremor, drowsiness, dizziness.

Speech disorders, abnormal sensations (usually on the skin,z. B.tingling), peripheral nerve diseases (polyneuropathy), drowsiness, convulsions and extrapyramidal disorders such as restlessness, gait disturbances, motor dysfunctions.

eye disorders

Especially at the beginning of treatment: blurred vision.

ear disorders

ringing in the ears (tinnitus).

Cardiovascular disorders

Especially at the beginning of treatment: orthostatic hypotension (impaired circulatory control with a drop in blood pressure), short-term loss of consciousness (syncope), increased heart rate.

lower blood pressure. Certain ECG changes (prolongation of the QT interval), potentially life-threatening "torsades de pointes". In such cases, treatment with Stangyl 25mgcancel.

Cardiac arrhythmias and conduction disorders (especially in case of overdose or existing diseases of the cardiovascular system).

vascular diseases

hot flashes.

Respiratory and chest disorders

Allergic lung reactions in the form of a certain type of pneumonia (interstitial pneumonitis,z. B.eosinophil lung infiltrate) or pleurisy.

Gastrointestinal disorders

Especially at the beginning of treatment: dry mouth, constipation, indigestion and nausea.

Liver and biliary disorders

As an expression of hypersensitivity: hepatobiliary reactions, usually manifested by transient increases in liver enzymes and serum bilirubin in the form of cytolytic or cholestatic hepatitis (hepatitis,you. AND.in case of biliary stagnation).

Regular laboratory tests with determination of liver enzymes should be carried out.

skin disorders

redness of the skin With the right disposition: Signs of an allergic event, especially of the skin. hair loss

bone disorders

An increased risk of bone fractures has been observed in patients treated with this class of drugs.

Kidney and urinary tract disorders

Difficulty urinating, urinary retention.

Diseases of the genitals and the mammary gland

Breast enlargement (macromastia).

Sexual dysfunctions.

General ailments

Especially at the beginning of the treatment: fatigue.

weight gain, sweating.

Wheat starch can cause hypersensitivity reactions.

What countermeasures should be taken in case of side effects?

To minimize possible side effects, a creeping dose should be used as described in the dosage instructions.

If you experience serious side effects (z. B.agranulocytosis, convulsions, thrombocytopenia) is Stangyl 25 treatmentmgshould be discontinued immediately and appropriate symptomatic treatment initiated.

In case of allergic reactions, you must consult your doctor before further use, who will decide on the further treatment.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes all side effects not mentioned in this leaflet. You can also directly discuss the side effects

Federal Institute for Pharmaceuticals and Medical Products

ca.Drug monitoring

Kurt-Georg-Kiesinger-Allee 3

D-53175Bonn

Internet side:www.bfarm.de

sue. By reporting side effects, you can help provide more information about the safety of this medication.