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.
Doxepin 25mg hard capsules and Doxepin 50mg hard capsules (called Doxepin capsules in this leaflet) contain the active substance Doxepin as doxepin hydrochloride. This belongs to a group of medicines called tricyclic antidepressants. Doxepin is used to treat depression in adults and it may help if you have trouble sleeping because of your depression.
Do not take Doxepin hard capsules if you: • are allergic to doxepin hydrochloride or other tricyclic antidepressant or any of the other ingredients of this medicine (listed in Section 6)
• have a serious liver problem
• have glaucoma (increased eye pressure)
• are breastfeeding
• have difficulty passing urine
• have a disorder called mania where your mood can be artificially high.
Talk to your doctor before taking this medicine if you: • have a history of suicidal thoughts or have attempted suicide
• are elderly
• have a heart condition
• have problems with your liver or kidneys
• have epilepsy (fits)
Children Not to be given to children under 18 years.
Other medicines and Doxepin hard capsules Tell your doctor or pharmacist if you are taking any of the following medicines:
• Other antidepressants, barbiturates (for lack of sleep), or other sleeping medicines or medicines for anxiety. Doxepin will increase their effect.
• Monoamine Oxidase Inhibitors (MAOIs). Use of these medicines must stop two weeks before taking Doxepin hard capsules.
• Cimetidine used to treat ulcers.
• Thyroid hormones
• Nitrates to treat angina and heart failure
• Ephidrine, isoprenaline, noradrenaline normally given in a hospital setting.
• Phenylephrine or phenylpropanolamine for colds or hayfever
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines without prescription.
If you need surgery tell your doctor you are taking Doxepin hard capsules.
Pregnancy and breastfeeding Tell your doctor before taking this medicine if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Breastfeeding
Doxepin can pass into breast milk. Do not breastfeed while taking Doxepin hard capsules.
Fertility It is not known if doxepin affects fertility.
Doxepin hard capsules and alcohol Avoid drinking alcohol while taking Doxepin hard capsules. Alcohol may affect you more than usual.
Driving and using machines Doxepin hard capsules may make you feel drowsy. Do not drive or use machinery if you feel sleepy, wait until the effect has worn off.
Important information about some of the ingredients of Doxepin hard capsules This medicine contains:
• Sodium : contains less than 23mg of sodium (main component of cooking/table salt) in each tablet, essentially sodium free.
• Lactose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Important: Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not or you are not sure, ask your doctor or pharmacist.
Swallow your capsules whole.
Adults The dose will be decided by your doctor. It can vary between 25mg to 300mg per day. A usual starting dose is 75mg per day.
Elderly or if you have liver or kidney problems The dose will be decided by your doctor. The starting dose is normally at the low end of the dose range given for adults.
While you are taking this medicine, your doctor may ask you to have check-ups.
These are to make sure that your medicine is working properly and that the dose you are taking is right for you. You may not feel the effect of Doxepin hard capsules for two to three weeks.
Use in children and adolescents No data are available. Doxepin hard capsules should not be used in children and adolescents aged less than 18 years.
If you take more Doxepin hard capsules than you should • If you take more than the label states, or if you think a child has accidentally swallowed any capsules, contact the nearest hospital casualty department or doctor immediately.
• Take this leaflet with you
If you forget to take Doxepin hard capsules If you forget a dose, take the next dose as soon as you remember.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Doxepin hard capsules It is very important that you do not stop taking Doxepin hard capsules, even if you feel better or are suffering from a side effect, unless your doctor tells you to. Your doctor will tell you how to stop taking Doxepin hard capsules.
If you stop taking your medicine suddenly, you may suffer from some of the following side effects: unable to sleep, irritability, and sweating.
If you have any further questions on the use of this product, 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 has been seen in patients taking this type of medicine.
Most undesirable effects are usually mild and tend to wear off after continued treatment. However, if the side effects concern you, your doctor may decide to reduce your dose.
The most common side effects are:
• Drowsiness
• Dry mouth
• Constipation
These are usually mild. If they last for more than several days, check with your doctor.
Less common or rare side effects are listed below. If they don't wear off after a few days or you are worried, check with your doctor.
• Dizziness, (if you experience dizziness you should be particularly careful to stand up slowly).
• Sweating
• Blurred vision
• Headache
• Insomnia
• Difficulty in passing urine
• Tiredness
• Weakness
• Weight gain
• Upset stomach
• Loss of appetite
• Vomiting or diarrhoea.
• Mouth ulcers.
• Unpleasant taste.
• Fast heart beat (palpitations).
• Changes in sex drive
• Swelling of testicles
• Chills
• Flushing
• Hair loss from the scalp
• Shakiness or trembling
• Numbness in the hands or feet
• Feeling of pins and needles
• Agitation or confusion
• Ringing or buzzing in the ears
Rare side effects:
The undesirable effects below are rare but they have occurred in patients taking one of the tricyclic antidepressants, however, not all have occurred with Doxepin.
You should check with your doctor immediately if any of the following occur:
• Skin rash, itching, face swelling. Your skin may be more sensitive to sunlight than it is normally.
• At high doses particularly in the elderly, unwanted effects on muscles which may cause slowed movements or stiffness of arms and legs, slurred speech or odd tongue or eye movements.
• Staggering walk which may occur on a mixture of centrally acting drugs.
• Worsening of an existing mental disorder;
• Breast enlargement in both men and women, breast milk production when not pregnant or breast feeding;
• Worsening of asthma.
• Convulsions (fits) are unlikely unless you already suffer from these.
• Nightmares, hallucinations (seeing or hearing things that are not there), jaundice (yellow eyes or skin).
• Changes to the heart rhythm may occur very rarely.
• Blood disorders; these may cause fever or chills and painful ulceration in the mouth or rectum; unusual bruising or bleeding.
• Abnormal blood test results i.e. change in blood sugar levels, lower sodium content of blood and low blood cell count.
Elderly patients: If you are elderly, you may be more likely to be troubled by agitation or confusion
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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 affects you can help provide more information on the safety of this medicine.
Store below 30°C.
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 after "EXP". The expiry date refers to the last day of that month.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
What Doxepin hard capsules contain • Doxepin 25mg hard capsule contains 25mg of the active substance, doxepin, as doxepin hydrochloride. The other ingredients are: maize starch, lactose monohydrate, sodium lauryl sulphate (E487) and magnesium stearate. The capsule shell contains indigotine - FD&C blue 2 (E132), titanium dioxide (E171) and gelatin.
• Doxepin 50mg hard capsule contains 50mg of the active substance, doxepin, as doxepin hydrochloride. The other ingredients are: maize starch, lactose monohydrate, sodium lauryl sulphate (E487) and magnesium stearate. The capsule shell contains indigotine - FD&C blue 2 (E132), titanium dioxide (E171) and gelatin.
What Doxepin hard capsules look like and contents of the pack The Doxepin 25mg hard capsules are white and light blue.
The Doxepin 50mg hard capsules are light blue.
They are supplied in packs of 28 capsules.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
ROMA Pharmaceuticals Limited
Gibraltar House
Crown Square
Centrum 100
Burton-upon-Trent
DE14 2WE
Manufacturer
CANA AE FARMAKEFTIKA ERGASTIRIA
Irakliou Ave. 446
Iraklio
Attiki
14122
Greece
This leaflet was last revised in November 2020
For information in other formats contact [email protected]
Roma Pharmaceuticals Limited
Address
Gibraltar House, Crown Square, First Avenue, Centrum 100, Burton upon Trent, Staffordshire, DE14 2WE
Telephone
01283 890091
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Doxepin 50 mg Hard Capsules comes as capsule containing 50 mg. 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 50 mg Hard Capsules is doxepin hydrochloride.
Medicines with the same active substance include: Doxepin 10mg Capsules, Doxepin 25 mg Capsules, Doxepin 25 mg Capsules, hard, Doxepin 25mg Capsules, Doxepin 50 mg Capsules, Doxepin 50 mg Capsules, Hard. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Doxepin 50 mg Hard 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 Capsules 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 of doxepin 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 'Special warnings and special precautions for use').
Renal impairment
Dosage reduction may be required in patients with renal impairment (see 'Special warnings and special precautions for use').
Method of administration
For oral use. Capsules should be swallowed whole with fluid.
Doxepin is contra-indicated in individuals who have shown hypersensitivity to tricyclic antidepressants (TCAs), doxepin, or any of the inactive ingredients.
Doxepin is also contra-indicated in patients with mania, severe liver disease, lactation, glaucoma, tendency to urinary retention.
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 Capsules 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.
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
There are no fertility 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.
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 50 mg Hard 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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