Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
The name of this medicine is Doxepin 10 mg, 25 mg and 50 mg Capsules. The active ingredient is doxepin hydrochloride. Doxepin is an antidepressant. It is one of a group called tricyclic antidepressants. Your doctor has decided that this medicine is suitable for treating your depression. Depression is a clinical illness. If you have been feeling sad, tearful or unable to enjoy life as you used to, Doxepin Capsules may help you to feel better. It may also help if you have difficulty sleeping because of your depression. If you are not sure why you are on these capsules, ask your doctor.
Do not take Doxepin Capsules: • If you are allergic to tricyclic antidepressants, doxepin, or any of the other ingredients of this medicine (listed in section 6). • If you have serious liver problems. • If you have glaucoma (increased eye pressure). • If you suffer from difficulty in passing urine. • If you are breast-feeding. • If you are taking, or have taken in the last two weeks, any medicines called monoamine oxidase inhibitors (MAOIs for short). • If you suffer from a type of mood disorder called mania, where you experience an abnormally elevated mood state. • If the patient is under 18 years of age.
If you suffer from any of the above, speak to your doctor or pharmacist before taking Doxepin Capsules.
Warnings and precautions Talk to your doctor or pharmacist before taking Doxepin Capsules if: • You are pregnant or trying to become pregnant. • You have any heart problems. • You have had a heart attack recently. • You have kidney problems. • You suffer from epilepsy (fits). • You have suicidal thoughts or have attempted suicide in the past.
The use of Buprenorphine together with doxepin can lead to serotonin syndrome, a potentially life-threatening condition (see section 2 'Other medicines and Doxepin Capsules'). If you are not sure if any of above applies to you, talk to your doctor or pharmacist before taking this medicine.
Other medicines and Doxepin Capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are going to have a surgical operation or dental surgery tell the doctor or dentist in charge that you are taking this medicine.
Some medicines can interfere with the action of Doxepin Capsules, and Doxepin Capsules can sometimes affect the action of other medicines. Check with your doctor if you are taking any of the medicines listed below:
• Monoamine oxidase inhibitors. These must not be used with Doxepin Capsules (see section 2 'Do not take Doxepin Capsules' above) • Other antidepressants, barbiturates (used to treat insomnia) or other sleeping medicines or medicines for anxiety. Doxepin Capsules will add to their effects and may cause you to feel sleepy or drowsy. • Medicines to lower blood pressure. • Sympathomimetics, such as nasal decongestants (used for colds or hay fever) and bronchodilators (used to treat asthma). • Cimetidine (used to treat ulcers and other stomach complaints). • Thyroid hormones (used to treat thyroid disorders). • Chlorpromazine (used to treat mental illness). • Sublingual nitrates (used to treat angina and heart failure). • Buprenorphine/opioids (used to treat opioid overdose). This medicine may interact with Doxepin Capsules 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.
Doxepin Capsules with alcohol Be careful when drinking alcohol. Alcoholic drinks (wine, beer, spirits) may affect you much more than usual.
Pregnancy and breast-feeding 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.
Driving and using machines You may feel sleepy when you take these capsules, do not drive or work with machinery until this effect has worn off.
Always take Doxepin Capsules exactly as your doctor has told you. The label on the pack will tell you what dose YOU should take and how often
each day to take it. You should check with your doctor or pharmacist if you are not sure. • Your medicine should only be taken by mouth. • Swallow your capsules whole with a drink of water. • Take the capsules while standing or when sitting upright. • Do not crush or chew the capsules. • Keep taking the capsules every day. • For most patients, the recommended starting dose is 75 mg daily. This dose may be increased if necessary. • The maximum recommended dose is 100 mg three times daily. • If you are elderly these doses may be reduced. • If you are elderly and require an increased dose of the medicine your doctor may wish to see you regularly. • If you suffer from liver problems, you may also be started on a low dose. • The capsules may be prescribed once, twice or three times daily. • Up to 100 mg can be given as a single dose.
If you take more Doxepin Capsules than you should Too many capsules at once can be dangerous. Signs and symptoms of mild overdosage include drowsiness, stupor, blurred vision and excessive dryness of the mouth. Severe overdosage may cause loss of consciousness, reduced breathing rate, convulsions, low blood pressure, unusually fast heart-beat or palpitations. If you take too many capsules immediately contact your doctor or nearest hospital Accident and Emergency Department. Do not attempt to drive or work with machinery.
If you forget to take Doxepin Capsules Do not worry. Take your usual dose at the next correct time. Do not take a double dose to make up for a forgotten capsule.
If you stop taking Doxepin Capsules You should always check with your doctor before you stop treatment. Your doctor may want you to reduce gradually the amount you are taking before stopping the medicine completely. This may help to prevent a recurrence of the original trouble and reduce the chance of withdrawal effects such as insomnia, irritability and excessive sweating.
How quickly will the treatment start to work? • You may take Doxepin Capsules for 2-3 weeks before you start to feel better. • You must keep taking Doxepin Capsules to help you get better. • See your doctor before your capsules run out. • Even if you begin to feel better, keep taking your capsules. You may need to keep taking them to stay well.
What if you do not feel better? Tell your doctor if: • You have taken all your medicine and you still feel unwell. or • You feel worse.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Thoughts of suicide and worsening of your depression or anxiety disorder 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 a 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.
Bone fractures An increased risk of bone fractures has been observed in patients taking this type of medicine.
Doxepin Capsules are well tolerated. Most undesirable effects are usually mild and tend to wear off after continued treatment. However, if the side effects are troublesome, your doctor may decide to reduce your dose.
Other side effects that you may experience while taking this medicine are:
Common (may affect up to 1 in 10 people) • Drowsiness • Dry mouth • Constipation.
Uncommon (may affect up to 1 in 100 people) • A skin condition with itching, redness and a burning feeling called skin rash • Itching • Face swelling • Pinky, itchy swellings on the skin, also called hives or nettle rash • Increased sensitivity of the skin to sun.
Rare (may affect up to 1 in 1000 people) • Difficulty in passing urine • Breast enlargement in both men and women, breast milk production when not pregnant or breast-feeding • Changes to the heart rhythm • Jaundice (yellow eyes or skin) • Convulsions (fits) • Seeing, feeling or hearing things that are not there • Shakiness • Blood disorders: these may cause fever or chills and painful ulceration in the mouth or rectum • Ringing or buzzing in the ears • Excessive secretion of antidiuretic hormone (ADH).
Not Known (frequency cannot be estimated from the available data) • Insomnia • Nightmares • Mouth ulcers • Stiffness of arms or legs, slurred speech, odd tongue, eye movements • Nausea • Vomiting • Indigestion • Diarrhoea • Loss of appetite • Blurred vision
• Worsening of asthma • Fast heartbeat • Chills • Tiredness • Excessive sweating • Flushing • Excessive weakness • Suicidal thoughts and behaviour • High fever • Hair loss from the scalp • Dizziness on standing up, especially when getting up from a sitting or lying position. • Bone fracture • Changes in sex drive • Swelling of testicles • Dizziness • Headache • Unpleasant taste • Weight gain • Abnormal blood test results i.e.- change in blood sugar levels, lower sodium content of blood and low blood cell count • Agitation • Confusion • Disorientation • Trembling • Numbness in the hands or feet • Feeling of pins and needles.
Reporting of side effects 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 at: 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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister foil after "EXP". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Doxepin Capsules contain Each capsule contains either 10 mg, 25 mg or 50 mg of doxepin as the active ingredient.
The other excipients in each capsule are silica, colloidal anhydrous, magnesium stearate and co-processed starch.
The capsule shell contains:
Doxepin 10 mg Capsules: Gelatin, iron oxide red (E172) and titanium dioxide (E171).
Doxepin 25 mg Capsules: Gelatin, FD & C blue 2 (E132), iron oxide red (E172) and titanium dioxide (E171).
Doxepin 50 mg Capsules: Gelatin, FD & C blue 2 (E132) and titanium dioxide (E171).
Printing Ink - White on each capsule contains shellac (E904), titanium dioxide (E171) and propylene glycol (E1520).
What Doxepin Capsules look like and contents of the pack Doxepin 10mg Capsules are red opaque cap and body size '4' hard gelatin capsule, printed with white ink 'Doxepin' on cap and '10 mg' on body.
Doxepin 25mg Capsules are blue opaque cap and red opaque body size '3' hard gelatin capsule, printed with white ink 'Doxepin' on cap and '25 mg' on body.
Doxepin 50mg Capsules are blue opaque cap and body size '2' hard gelatin capsule, printed with white ink 'Doxepin' on cap and '50 mg' on body.
The capsules are packaged in PVC/PVDCaluminium blister in packs of 28.
Marketing Authorisation Holder Morningside Healthcare Ltd. Unit C, Harcourt Way Leicester, LE19 1WP UK
Manufacturer Morningside Pharmaceuticals Ltd. 5 Pavilion Way, Loughborough Leicestershire, LE11 5GW UK
For information in large print, tape, CD or Braille, please contact medical enquiries on 0116 478 0322.
This leaflet was last revised in May 2021.
Doxepin 25 mg Capsules comes as capsule containing 25mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Doxepin 25 mg Capsules is doxepin hydrochloride.
Medicines with the same active substance, strength and form include: Sinepin Capsules 25mg, Doxepin 25 mg Capsules, Doxepin 25 mg Capsules, hard. In total there are 7 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Doxepin 25 mg Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Symptoms of depressive illness in adults, especially where sedation is required.
Posology
The optimum oral dose depends on the severity of the condition and the individual patient's response. The dose required may vary from 25-300mg daily. Doses up to 100mg daily may be given on a divided or once daily schedule. Should doses over 100mg daily be required, they should be administered in three divided doses daily. 100mg is the maximum dose recommended at any one time. This dose may be given at bedtime.
For the majority of patients with moderate or severe symptoms, it is recommended that treatment commences with an initial dose of 75mg daily. Many of these patients will respond satisfactorily at this dose level. For patients who do not, the dosage may be adjusted according to individual response. In more severely ill patients, it may be necessary to administer a dose of up to 300mg in divided doses daily, to obtain a clinical response.
In patients where insomnia is a troublesome symptom, it is recommended that the total daily dose be divided so that a higher proportion is given for the evening dose; similarly, if drowsiness is experienced as a side effect of treatment, doxepin may be administered by this regimen or the dosage may be reduced. It is often possible, having once obtained a satisfactory therapeutic response, to reduce the dose for maintenance therapy.
The optimal anti-depressant effect may not be evident for two to three weeks.
Paediatric population
The safety and efficacy in children under 18 years have not been established.
Elderly
In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater susceptibility of elderly people to typical side effects of the drug.
Hepatic impairment
Dosage reduction may be required in patients with hepatic impairment (see section 4.4).
Renal impairment
Dosage reduction may be required in patients with renal impairment (see section 4.4).
Method of administration
For oral administration.
Hypersensitivity to tricyclic antidepressants (TCAs), doxepin or to any of the excipients listed in section 6.1.
Doxepin is also contra-indicated in patients with mania, severe liver disease, lactation, glaucoma, tendency to urinary retention.
Suicide/suicidal thoughts or clinical worsening
Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared with placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
The once-a-day dosage regimen of doxepin in patients with intercurrent illness or patients taking other medications should be carefully adjusted. This is especially important in patients receiving other medications with anti-cholinergic effects.
The use of doxepin on a once-a-day dosage regimen in geriatric patients should be adjusted carefully on the basis of the patient's condition. The elderly are particularly liable to experience toxic effects, especially agitation, confusion and postural hypotension. The initial dose should be increased with caution under close supervision. Half the normal maintenance dose may be sufficient to produce a satisfactory clinical response.
Patients should be warned that drowsiness may occur with the use of doxepin. Patients should also be cautioned that their response to alcohol may be potentiated.
Although Doxepin capsules carry less risk than other tricyclic antidepressants, caution should be observed in the treatment of patients with severe cardiovascular disease, including patients with heart block, cardiac arrhythmia and those who have experienced a recent myocardial infarction.
Serotonin syndrome
Concomitant administration of doxepin and buprenorphine/ opioids may result in serotonin syndrome, a potentially life-threatening condition (see section 4.5).
If concomitant treatment of buprenorphine/ opioids is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.
If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
Hepatic/renal impairment
Use with caution in patients with hepatic and/or renal impairment.
Patients with epilepsy
Use with caution in patients with a history of epilepsy.
Since suicide is an inherent risk in any depressed patient until significant improvement has occurred, patients should be closely supervised during early therapy.
Patients with benign prostatic hyperplasia may experience an increase in associated urinary retention (see section 4.8).
Doxepin, like other tricyclic antidepressants (TCAs), is metabolised by cytochrome P450 (CYP) 2D6. Inhibitors or substrates of CYP2D6 (e.g. quinidine, selective serotonin reuptake inhibitors [SSRIs]) may increase the plasma concentration of TCAs when administered concomitantly. The extent of interaction depends on the variability of effect on CYP2D6 and the therapeutic index of the TCA. The clinical significance of this interaction with doxepin has not been systematically evaluated.
Combined use with other anti-depressants, alcohol or anti-anxiety agents should be undertaken with due recognition of the possibility of potentiation. It is known, for example, that monoamine oxidase inhibitors may potentiate other drug effects, therefore doxepin should not be given concurrently, or within two weeks of cessation of therapy, with monoamine oxidase inhibitors.
Cimetidine has been reported to produce clinically significant fluctuations in steady-state serum concentrations of doxepin.
Doxepin should not be given with sympathomimetic agents such as ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine.
General anaesthetics and local anaesthetics (containing sympathomimetics) given during tricyclic or tetracyclic anti-depressant therapy may increase the risk of arrhythmias and hypotension, or hypertension. If surgery is necessary, the anaesthetist should be informed that a patient is being so treated.
Doxepin may decrease the anti-hypertensive effect of agents such as debrisoquine, bethanidine, guanethidine and possibly clonidine. It usually requires daily doses of doxepin in excess of 150mg before any effect on the action of guanethidine is seen. It would be advisable to review all antihypertensive therapy during treatment with tricyclic anti-depressants.
Barbiturates may increase the rate of metabolism of doxepin.
Doxepin capsules may reduce the effect of sublingual nitrates owing to dry mouth.
The dose of thyroid hormone medication may need reducing if Doxepin capsules are being given concurrently.
Doxepin capsules should be used cautiously when co-administered with:
• Buprenorphine/ opioids as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4).
Pregnancy
Doxepin crosses the placenta. Reproduction studies have been performed in rats, rabbits and monkeys and there was no evidence of harm to the animal foetus. The relevance to humans is not known. Since there is insufficient experience in pregnant women who have received this drug, its safety in pregnancy has not been established.
Breast-feeding
Doxepin and its active metabolite desmethyldoxepin are excreted in breast milk. There has been a report of apnoea and drowsiness occurring in a nursing infant whose mother was taking doxepin. The use of Doxepin capsules is contraindicated during lactation.
Fertility
No data available.
Since drowsiness may occur with the use of Doxepin capsules, patients should be warned of the possibility and cautioned against driving a car or operating machinery while taking this drug.
Frequency is defined as: very common (≥ 1/10), common (≥1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Note
Some of the side-effects noted below have not been specifically reported with doxepin. However, due to the close pharmacological similarities amongst the tricyclics, the reactions should be considered when prescribing doxepin.
System Organ Class
Adverse Reaction
Frequency
Blood and lymphatic system disorders
Eosinophilia, agranulocytosis, leucopoenia, thrombocytopenia, purpura, haemolytic anaemia
Rare
Endocrine disorders
Inappropriate anti-diuretic hormone secretion, gynaecomastia
Rare
Metabolism and nutrition disorders
Appetite decreased
Not known
Psychiatric disorders
Hallucinations
Rare
Insomnia, nightmares, mania, paranoid delusions, confusion, disorientation, agitation, suicidal ideation, suicidal behaviour
Not known
Renal and urinary disorders
Urinary retention
Rare
Reproductive system and breast disorders
Breast enlargement, galactorrhoea
Rare
Testicular swelling, libido increased or decreased
Not known
Nervous system disorders
Drowsiness
Common
Ataxia, convulsions
Rare
Tardive dyskinesia, dizziness, headache, dysgeusia, numbness, paraesthesia, tremor
Not known
Ear and labyrinth disorders
Tinnitus
Rare
Eye disorders
Blurred vision
Not known
Cardiac disorders
Tachycardia
Not known
Gastrointestinal disorders
Dry mouth, constipation
Common
Nausea, vomiting, indigestion, diarrhoea
Not known
Aphthous ulcer
Not known
Hepatobiliary disorders
Jaundice
Rare
Investigations
Electrocardiogram QRS complex prolonged,
Electrocardiogram PR prolongation
Rare
Blood sugar increased, blood sugar decreased, Weight increased
Not known
Respiratory, thoracic and mediastinal conditions
Asthma
Not known
Skin and subcutaneous tissue disorders
Skin rash, facial oedema, photosensitivity, pruritus, urticaria
Uncommon
Alopecia
Not known
Musculoskeletal and connective tissue disorders
Bone Fracture
Not known
Vascular disorders
Postural hypotension, flushing
Not known
General disorders and administration site conditions
Chills, fatigue, asthenia, hyperpyrexia, hyperhidrosis
Not known
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Signs and symptoms
Mild: drowsiness, stupor, blurred vision, excessive dryness of mouth.
Severe: respiratory depression, hypotension, coma, convulsions, cardiac arrhythmias and tachycardias.
Also, urinary retention (bladder atony), decreased gastrointestinal motility (paralytic ileus), hyperthermia (or hypothermia), hypertension, dilated pupils, hyperactive reflexes.
Deaths have been reported involving overdoses of doxepin. The reported cases involved doxepin alone and in combination with other drugs and/or alcohol.
Management and treatment
Mild: observation and supportive therapy is all that is usually necessary.
Severe: medical management of severe doxepin overdosage consists of aggressive supportive therapy. If the patient is conscious, gastric lavage with appropriate precautions to prevent pulmonary aspiration should be performed even though doxepin is rapidly absorbed. The use of activated charcoal has been recommended, as has been continuous gastric lavage with saline for 24 hours or more. An adequate airway should be established in comatose patients and assisted ventilation used if necessary. ECG monitoring may be required for several days since relapse after apparent recovery has been reported. Arrhythmias should be treated with the appropriate anti-arrhythmic agent. It has been reported that many of the cardiovascular and CNS symptoms of tricyclic anti-depressant poisoning in adults may be reversed by the slow intravenous administration of 1mg to 3mg of physostigmine salicylate.
Because physostigmine is rapidly metabolised, the dosage should be repeated as required. Convulsions may respond to standard anti-convulsant therapy. However, barbiturates may potentiate any respiratory depression. Dialysis and forced diuresis generally are not of value in the management of overdosage due to high tissue and protein binding of doxepin.
Ask anything about Doxepin 25 mg Capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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