What to expect after taking sertraline

Patient Info Service - information for patients

1. What is Doxepin dura T and what is it used for?

Doxepin dura T is a drug used to treat depressive disorders (tricyclic antidepressant).

Doxepin dura T is used

  • in depressive illnesses

  • in pathological states of anxiety (anxiety syndromes)

  • for mild withdrawal symptoms in the case of alcohol, drug or drug addiction

  • for restlessness, anxiety or sleep disorders in connection with depressive illnesses or slight withdrawal symptoms

2. What you need to know before you take Doxepin dura T

Do not take Doxepin dura T

  • if you are allergic to doxepin, a related active ingredient (dibenzoxepine) or any of the other ingredients of this medicine (listed in section 6),

  • in the event of poisoning with drugs that depress the central nervous system (e.g. with sleeping pills, painkillers or psychotropic drugs),

  • in a state of delirium (clouding of consciousness combined with excitement, hallucinations and delusions),

  • with a certain form of untreated glaucoma (narrow-angle glaucoma),

  • with acute urinary retention,

  • with enlargement of the prostate gland (prostatic hyperplasia) with residual urine formation,

  • for intestinal paralysis (paralytic ileus),

  • during breastfeeding,

  • by children under 12 years of age.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Doxepin dura T if you have any of the following conditions:

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

  • severe liver damage,

  • Blood formation disorders,

  • Mental and mental disorders of various kinds that are caused by damage to the brain (organic brain psychosyndrome),

  • increased tendency to convulsions,

  • Potassium deficiency,

  • slow heartbeat,

  • certain heart diseases (congenital QT syndrome or other clinically significant heart damage, in particular circulatory disorders of the coronary arteries, conduction disorders, cardiac arrhythmias)

  • Depression or other illnesses with antidepressants or the so-called Opioid pain relievers, such as B. buprenorphine treated.
    Using these medicines together with Doxepin dura can lead to serotonin syndrome, a potentially life-threatening disease (see “Other medicines and Doxepin dura”).

Before starting and during treatment, blood pressure, ECG, blood count, liver function and, if necessary, the EEG should be checked at regular intervals. If the values ​​deviate from the norm, treatment with Doxepin dura T may only be carried out under close controls.

If you suffer from a disease in which lowering your blood pressure must be avoided at all costs, you should only take Doxepin dura T with careful blood pressure control.

While the calming, dampening effect of Doxepin dura T usually starts immediately in the first few hours, the mood-enhancing effect can usually only be expected after 1 to 3 weeks. Patients at risk of suicide in particular should therefore be closely monitored, especially at the start of treatment.

Sudden termination of a long-term, high-dose treatment with Doxepin dura T should be avoided, as withdrawal symptoms such as restlessness, sweating, nausea, vomiting and sleep disorders must be expected.

If you have previously received other drugs (e.g. benzodiazepines or barbiturates) to treat your illness, please inform your doctor about this because Doxepin dura T, in contrast to these drugs, can increase the tendency to cramp.

Please inform your doctor about taking Doxepin dura T if an operation is to be carried out under local anesthesia (e.g. at the dentist).

Children and adolescents

Doxepin dura T should not be used to treat depression in children over 12 years of age 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 Doxepin either.

Doxepin is also associated with a risk of cardiovascular side effects in all age groups.

In addition, no data are available on the safety of long-term use in children and adolescents with regard to growth, maturation or cognitive and behavioral development. (see also section 4. “Side effects”).

Thoughts of suicide and worsening of your depression / anxiety disorder

When you are depressed or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These thoughts may be aggravated the first time you use antidepressants 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 who have had a psychiatric illness and have been treated with an antidepressant.

Contact your doctor or go to a hospital straight away if at any time you have thoughts of harming or killing yourself.

It can be helpful if you tell a friend or relative that you are depressed or have an anxiety disorder. Ask them to read this leaflet. Ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Other medicines and Doxepin dura T

Tell your doctor or pharmacist if you are taking / using, have recently taken / used, or intend to take / use any other medicines, including medicines obtained without a prescription.

The effect of the following drugs with a central depressant effect can be increased if Doxepin dura T is used at the same time:

  • other agents used to treat depression, such as B. moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline or trimipramine. These medicines may interact with Doxepin and you may experience symptoms such as involuntary, rhythmic contractions of muscles including the muscles that control the movement of the eye, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension and body temperature above 38 ° C. Contact your doctor if you experience these symptoms.

  • Sleep pills, sedatives, painkillers

  • Means for the treatment of psychoses (neuroleptics)

  • certain remedies for allergies (sedating antihistamines)

  • Means for the treatment and prevention of epileptic seizures.

When used at the same time together with other agents with a similar effect, such as. B. related antidepressants (agents for the treatment of depression) or agents for the treatment of Parkinson's disease, an increase in the desired and undesirable effects of Doxepin can be expected.

So-called "MAO inhibitors" (agents used to treat depression) should be discontinued 14 days before starting treatment with Doxepin dura T. Otherwise, serious side effects such as agitation, delirium (clouding of consciousness associated with agitation, hallucinations and delusions), unconsciousness, high fever, seizures and sharp fluctuations in blood pressure can occur. In the case of depression that has not responded to previous treatment attempts, an additional administration of MAO inhibitors is possible in individual cases when treatment with Doxepin dura T is imminent. The doctor will then particularly monitor the treatment and slowly increase the dose.

Concomitant treatment with cimetidine (used to treat gastrointestinal disorders) can increase the blood level of doxepin, so that certain desired or undesired effects of doxepin can also be increased.

Simultaneous use of drugs that

  • also extend the QT interval in the ECG (e.g. agents against cardiac arrhythmias [antiarrhythmics class IA or III], some antibiotics such as erythromycin, antimalarials, agents against allergies [antihistamines]), agents for the treatment of certain mental illnesses (neuroleptics)

  • lead to a decrease in potassium levels (e.g. certain diuretics), or

  • can inhibit the breakdown of doxepin in the liver (e.g. MAO inhibitors)

is to be avoided.

The effects of sympathomimetic amines (agents that have a stimulating effect on the nervous system) can be significantly increased by taking Doxepin dura T at the same time. Particular attention should be paid to norepinephrine, which is contained as a vasoconstricting additive in agents for local anesthesia (see section “Warnings and precautionary measures”).

Doxepin dura T can reduce the effectiveness of certain agents used to treat high blood pressure (reserpine, clonidine). In patients being treated with clonidine, the blood pressure can suddenly rise sharply (so-called rebound hypertension).

The simultaneous use of nitrates (agents for widening the coronary arteries) or agents for the treatment of high blood pressure (e.g. beta-receptor blockers) may increase the antihypertensive effect.

Taking Doxepin dura T with alcohol

You should avoid alcohol during treatment with Doxepin dura T, as alcohol changes and increases the effect of Doxepin dura T in an unforeseeable way.

pregnancy and breast feeding period

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

There is so far insufficient experience with the use of Doxepin dura T during pregnancy. Therefore, Doxepin dura T may only be prescribed when absolutely necessary and after the attending physician has carefully weighed up the risks and benefits. After taking Doxepin dura T or other antidepressants before birth in higher doses or for a longer period of time, withdrawal or withdrawal symptoms may occur in the newborn.

You must not take Doxepin dura T during breastfeeding, as the active ingredient passes into breast milk and can lead to undesirable effects in the breastfed infant.

Driving and using machines

Even when used as directed, this medicinal product can change the ability to react to such an extent that the ability to actively drive or operate machines is impaired. This is particularly true after insufficient sleep time or in conjunction with alcohol. You should therefore refrain from driving vehicles, working with machines or working without a secure footing for at least the first few days of treatment. The decision about this will be made by your attending physician taking into account the prescribed dosage and your reaction to it.

Doxepin dura T contains lactose

Please take Doxepin dura Tere after consulting your doctor if you know that you suffer from a sugar intolerance.

3. How to take Doxepin dura T

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

The recommended dose is

For depressive illnesses and pathological anxiety states

It is recommended to start treatment with 1 film-coated tablet Doxepin dura T 50 mg (equivalent to 50 mg Doxepin) in the evening. If necessary, the dose can be increased to 1½ film-coated tablets Doxepin dura T 50 mg (equivalent to 75 mg Doxepin) after 3 to 4 days and to 2 to 3 film-coated tablets (equivalent to 100 to 150 mg Doxepin) per day after 7 to 8 days.
For outpatient treatment, a daily dose of 3 film-coated tablets Doxepin dura T 50 mg (equivalent to 150 mg Doxepin) should not be exceeded.

If a sleep-inducing effect is particularly desired, a larger part of the daily dose or the entire daily dose can be given at night.

In the hospital, the daily dose can be increased to 6 film-coated tablets Doxepin dura T 50 mg (equivalent to 300 mg Doxepin), taking the necessary precautionary measures.

With slight withdrawal symptoms

When treating withdrawal symptoms, it is often necessary to administer 1 film-coated tablet Doxepin dura T 50 mg 3 times per day (corresponding to 3 times 50 mg Doxepin) during the first 3 days. Thereafter, the dose may be slowly reduced to stop treatment.

Elderly patients

The risk of side effects is increased in elderly patients. Since these patients also often need significantly lower doses and often show a satisfactory treatment effect even at half the usual daily doses, the dosage must be carefully adjusted.

Children and adolescents

Children over 12 years of age and adolescents who should only be treated with Doxepin in exceptional cases also need significantly lower doses due to their lower body weight.

Children under 12 years of age must not be treated with Doxepin dura T.

Preparations with a higher or lower active ingredient content are also available for the upper and lower dose range.

Type and duration of application

The film-coated tablets should be swallowed whole with some liquid before or after meals or in the evening before going to bed.

The tablet can be divided into four equal doses.

The dosage and the duration of the treatment depend on the personal reaction situation, the area of ​​application and the severity of the disease. The principle here is that if the patient responds, the dose should be kept as small as possible, but otherwise the entire available dose range should be used.

The therapy should be initiated by gradually increasing the dose and terminating the therapy by slowly reducing the dose (reduction by half per week). The duration of the treatment will be determined by your doctor.
In the case of depression, the mean duration of a treatment period until the symptoms improve is generally at least 4 to 6 weeks. Thereafter, treatment should be continued for another 4 to 6 months to prevent relapse.


If you take more Doxepin dura T than you should

Doxepin is relatively dangerous if overdosed - especially for children and toddlers. For this reason, if an overdose is suspected, a doctor must be informed immediately (e.g. poisoning emergency number)! Overdoses with Doxepin 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, respiratory failure) and the cardiovascular system.

If you forget to take Doxepin dura T

Please do not make up for the missed dose, but continue taking it as prescribed at the next time.

If you stop taking Doxepin dura T.

Sudden termination of long-term or high-dose treatment with Doxepin dura T 50 mg should be avoided, as withdrawal symptoms such as restlessness, sweating, nausea, vomiting and sleep disorders must be expected.

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

4. What are the possible side effects?

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

If you observe the following side effects, please discuss this with your doctor, who will then determine how to proceed.

When evaluating side effects, the following frequencies are used as a basis:

Very often: affects more than 1 in 10 people

Often:may affect up to 1 in 10 people

Occasionally: may affect up to 1 in 100 people

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

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

Not known: Frequency cannot be estimated from the available data


The following side effects are to be expected especially at the beginning of treatment:

Dry mouth, stuffy or dry nose, tiredness, drowsiness, sweating, dizziness, drop in blood pressure, circulatory disorders when changing from lying down to standing, increased heartbeat, cardiac arrhythmia, tremors, visual disturbances, constipation, weight gain and mostly temporary increases in liver values ​​in the blood.

Often there are urination disorders, inner restlessness, feeling thirsty, allergic skin reactions and itching, sexual disorders (decrease in sexual interest, ejaculation disorders or erectile dysfunction). Elderly patients are at an increased risk of becoming confused.

Occasionally there are collapses, urinary behavior, secretion of secretions from the chest, disturbances in the conduction of excitation in the heart. An already existing cardiac insufficiency can be aggravated.

Occasionally there is also accumulation of fluid in the tissue, abnormal sensations such as tingling, heat and cold sensations, ringing in the ears and increased dreams.

Breast enlargement in men, breast enlargement in women and menstrual irregularities have been observed very rarely, as well as disorders of the production of a certain pituitary gland (ADH) hormone, hair loss and changes in blood sugar levels and drug-related inflammation of the liver (cholestatic hepatitis).

So-called "anticholinergic side effects" such as intestinal paralysis, increased intraocular pressure and urinary retention as well as nerve dysfunction (e.g. polyneuropathies and seizures) have been described as side effects of similar antidepressants and therefore cannot be ruled out for Doxepin dura T either.

Certain cardiac arrhythmias may occur during treatment with Doxepin dura T (prolongation of the QT interval in the ECG, very rarely also the possibly life-threatening torsades de pointes).

Changes in the blood count (decrease in white or red blood cells, decrease in blood platelets) can also occur very rarely.

In addition, it can also lead to sleep disorders.

In patients with a pre-existing brain disease (organic brain psychosyndrome), Doxepin dura T may cause a state of confusion (delirium).

Doxepin dura T can lower the brain's seizure threshold, which is why seizures may occur more frequently if people are more willing to have seizures (e.g. in epileptics or after suddenly stopping benzodiazepines or barbiturates).

Abuse has been observed in patients with a history of addiction.

Cases of suicidal ideation and behavior have been reported during treatment with Doxepin dura T or shortly after stopping treatment (see section “Warnings and precautions”).

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

If you experience serious side effects, such as

  • the above-mentioned cardiac arrhythmias (QT interval prolongation, torsades de pointes),

  • the very rare blood changes mentioned above,

  • a pathological high mood (manic mood),

  • the sudden occurrence of deceptions, hallucinations, delusions or similar phenomena in the treatment of depressive states in the course of schizophrenic illnesses,

you should inform your doctor immediately, who will then stop treatment with the preparation.

In the case of purulent angina or flu-like symptoms, which are accompanied by symptoms such as high fever, chills, sore throat, difficulty swallowing, inflammation in the mouth, nose, throat, genital or anal area, you must consult a doctor immediately. An examination of the blood count must be carried out, as a certain change in the blood count (agranulocytosis) must be ruled out. In this case, do not self-treat with antipyretic drugs, painkillers or antibiotics!

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 to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Doxepin dura T

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

You can use this medicine according to the “Usage” on the carton and the blister strip. Do not use until “stated expiry date. The expiry date refers to the last day of the month indicated.

Never throw away any medicines via wastewater (e.g. not using the toilet or sink). Ask your pharmacy how to throw away medicines you no longer use. You help to protect our environment. For more information, see www.bfarm.de/arzneimittelentsorgung.

6. Contents of the pack and other information

What Doxepin dura T contains

The active ingredient is doxepin.

Each film-coated tablet contains 56.43 mg doxepin hydrochloride, equivalent to 50 mg doxepin.

The other ingredients are:

Sodium starch glycolate (type A) (Ph.Eur.); Lactose monohydrate; Cellulose powder; microcrystalline cellulose; Copovidone; Magnesium stearate (Ph.Eur.); Hypromellose; Macrogol 400; Macrogol 6000; Titanium dioxide (E 171); Iron oxide hydrate x H2O (E 172).

What Doxepin dura T looks like and contents of the pack

Doxepin dura T 50 mg are smooth, light yellow film-coated tablets with a cross-break notch on one side.

Doxepin dura T 50 mg is available in packs of 20, 50 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Pharmaceutic entrepreneur

Mylan Germany GmbH

Lütticher Strasse 5

53842 Troisdorf, Germany

Co-distribution

Mylan Healthcare GmbH

Lütticher Strasse 5

53842 Troisdorf, Germany

Manufacturer

Mylan Germany GmbH

Lütticher Strasse 5

53842 Troisdorf, Germany

McDermott Laboratories Limited
T / A Gerard Laboratories
T / A Mylan Dublin
Unit 35/36 Baldoyle Industrial Estate
Baldoyle
Dublin 13
Ireland

This leaflet was last revised in August 2020.