Doxepin Capsules USP 50mg Taj Pharma

1. Name of the medicinal product
a) Doxepin Capsules USP 10mg Taj Pharma
b) Doxepin Capsules USP 25mg Taj Pharma
c) Doxepin Capsules USP 50mg Taj Pharma
d) Doxepin Capsules USP 75mg Taj Pharma
e) Doxepin Capsules USP 100mg Taj Pharma
f) Doxepin Capsules USP 150mg Taj Pharma

2. Qualitative and quantitative composition
a) Each capsule contains:
Doxepin Hydrochloride USP
equivalent to 10mg of Doxepin.
Excipients       q.s.

b) Each capsule contains:
Doxepin Hydrochloride USP
equivalent to 25mg of Doxepin.
Excipients         q.s.

c) Each capsule contains:
Doxepin Hydrochloride USP
equivalent to 50mg of Doxepin.
Excipients          q.s.

d) Each capsule contains:
Doxepin Hydrochloride USP
equivalent to 75mg of Doxepin.
Excipients           q.s.

e) Each capsule contains:
Doxepin Hydrochloride USP
equivalent to 100mg of Doxepin.
Excipients             q.s.

f) Each capsule contains:
Doxepin Hydrochloride USP
equivalent to 150mg of Doxepin.
Excipients             q.s.

3. Pharmaceutical form
Capsules for oral administration.

4. Clinical particulars

4.1 Therapeutic indications
Symptoms of depressive illness, especially where sedation is required.

4.2 Posology and method of administration
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 25mg 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.

Use in children The use of Doxepin 25mg Capsules in children under 12 years is not recommended because safe conditions for its use have not been established.

Use in the 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.

Use in hepatic impairment Dosage reduction may be required in patients with hepatic impairment (see ‘Special warnings and special precautions for use’).

Use in renal impairment Dosage reduction may be required in patients with renal impairment (see ‘Special warnings and special precautions for use’).

4.3 Contraindications
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.

4.4 Special warnings and precautions for use
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 many 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 25mg Capsules 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 25mg Capsules 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 25mg Capsules. Patients should also be cautioned that their response to alcohol may be potentiated.

Although Doxepin 25mg Capsules carry less risk than other tricyclic anti-depressants, 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.

Use in hepatic/renal impairment Use with caution in patients with hepatic and/or renal impairment.

Use in 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 ‘Undesirable effects’).

4.5 Interaction with other medicinal products and other forms of interaction
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 25mg 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 anti-hypertensive therapy during treatment with tricyclic anti-depressants.

Barbiturates may increase the rate of metabolism of doxepin.

Doxepin 25mg Capsules may reduce the effect of sublingual nitrates owing to dry mouth.

The dose of thyroid hormone medication may need reducing if Doxepin 25mg Capsules are being given concurrently.

4.6 Fertility, pregnancy and lactation
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.

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 25mg Capsules is contraindicated during lactation.

4.7 Effects on ability to drive and use machines
Since drowsiness may occur with the use of Doxepin 25mg Capsules, patients should be warned of the possibility and cautioned against driving a car or operating machinery while taking this drug.

4.8 Undesirable effects
Doxepin 25mg Capsules are well tolerated. Most side-effects are mild and generally disappear with continued treatment, or if necessary a reduction in dose.

Note Some of the side-effects noted below have not been specifically reported with Doxepin 25mg Capsules. However, due to the close pharmacological similarities amongst the tricyclics, the reactions should be considered when prescribing Doxepin 25mg Capsules.

The most common side-effects to Doxepin 25mg Capsules are drowsiness, dry mouth and constipation. For further details see below under central nervous system and anti-cholinergic effects.

Suicidal Ideation and Behaviours Cases of suicidal ideation and suicidal behaviours have been reported during doxepin therapy or early after treatment discontinuation (see section 4.4).

Bone fractures Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown.

Anti-cholinergic effects Anti-cholinergic effects are relatively common and may occur immediately following the first dose of a tricyclic anti-depressant. Dry mouth and constipation are the most common anti-cholinergic effects. Blurred vision and sweating occur occasionally. Urinary retention is rare except in predisposed males who have an enlarged prostate gland. Tolerance is often achieved if treatment is continued. If these undesirable effects do not subside with continued therapy, or if they become severe, it may be necessary to reduce the dosage.

Central nervous system effects Drowsiness is the most commonly noticed side effect. This tends to disappear as therapy is continued. Insomnia and nightmares have also been reported. Other infrequently reported CNS side effects are confusion, disorientation, agitation, numbness or paraesthesiae, tremor (which is usually mild). But at high doses, in susceptible individuals (particularly the elderly) other extrapyramidal symptoms may occur including tardive dyskinesia. Rarely reported are hallucinations, ataxia (generally where mixtures of CNS drugs have been given), and convulsions. Convulsions are unlikely except in people predisposed to seizure activity by brain damage or alcohol and drug abuse.

Psychotic manifestations, including mania and paranoid delusions may be exacerbated during treatment with tricyclic anti-depressants.

Cardiovascular Cardiovascular effects including postural hypotension, and tachycardia have been reported occasionally and changes in ECG parameters (widening of the QRS and PR interval) very rarely (see ‘Special warnings and special precautions for use’).

Allergic Allergic reactions to tricyclic anti-depressants are uncommon. They include skin rash, facial oedema, photosensitisation, pruritus and urticaria.

Haematological Rare cases of eosinophilia and bone marrow depression manifesting as agranulocytosis, leucopenia, thrombocytopenia and purpura. Haemolytic anaemia.

Gastro-intestinal Nausea, vomiting, indigestion, taste disturbances, diarrhoea, anorexia and aphthous stomatitis have been reported (see ‘Anti-cholinergic effects’).

Endocrine Occasional reports of raised or lowered libido, testicular swelling, raised or lowered blood sugar levels. Rarely the syndrome of inappropriate anti-diuretic hormone secretion, gynaecomastia, enlargement of breasts and galactorrhoea in the female.

Other Dizziness, weight gain, chills, fatigue, weakness, flushing, alopecia, headache, exacerbation of asthma and hyperpyrexia (in association with chlorpromazine) have been occasionally observed. Rare reports of jaundice and of tinnitus.

Withdrawal Withdrawal symptoms may occur on abrupt cessation of tricyclic anti-depressant therapy and include insomnia, irritability and excessive perspiration. Withdrawal symptoms in neonates whose mothers received tricyclic anti-depressants during the third trimester have also been reported and include respiratory depression, convulsions and “jitteriness” (hyper-reflexia).

4.9 Overdose
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.

5. Pharmacological properties

5.1 Pharmacodynamic properties
The mechanism of action of doxepin is not definitely known. It is not a central nervous system stimulant nor a monoamine oxidase inhibitor. The current hypothesis is that the clinical effects are due, at least in part, to influences on the adrenergic activity at the synapses so that deactivation of noradrenaline by reuptake into the nerve terminals is prevented. In animal studies anti-cholinergic, anti-serotonergic and anti-histaminergic effects on smooth muscle have been demonstrated. At higher than usual clinical doses, adrenaline response was potentiated in animals. This effect was not demonstrated in humans.

5.2 Pharmacokinetic properties
Doxepin is well absorbed from the gastro-intestinal tract. Approximately 55%-87% of orally administered doxepin undergoes first pass metabolism in the liver, forming the primary active metabolite desmethyldoxepin.

In healthy volunteers, a single oral dose of 75mg resulted in peak plasma concentrations for doxepin ranging from 8.8-45.8 ng/ml (mean 26.1 ng/ml). Peak levels were reached between 2 and 4 hours (mean 2.9 hours) after administration. Peak levels for the primary metabolite desmethyldoxepin ranged from 4.8-14.5 ng/ml (mean 9.7 ng/ml) and were achieved between 2 and 10 hours after administration. The mean apparent volume of distribution for doxepin is approximately 20 l/kg. The protein binding for doxepin is approximately 76%. In healthy volunteers the plasma elimination half-life of doxepin ranged from 8 to 24 hours (mean 17 hours). The half-life of desmethyldoxepin ranged from 33-80 hours (mean 51 hours). Mean plasma clearance for doxepin is approximately 0.84 1/kg/hr. Paths of metabolism of doxepin include demethylation, N-oxidation, hydroxylation and glucuronide formation. Doxepin is excreted primarily in the urine, mainly as its metabolites, either free or in conjugate form.

5.3 Preclinical safety data
Not applicable.

6. Pharmaceutical particulars

6.1 List of excipients
Doxepin 25mg Capsule:
 lactose, magnesium stearate, maize starch dried, sodium lauryl sulphate; capsule shell constituents: amaranth (E123), erythrosine (E127), gelatin, patent blue V (E131), sunset yellow (E110) and titanium dioxide (E171).
Doxepin 25mg Capsules are free of gluten and sucrose.

6.2 Incompatibilities
None known.

6.3 Shelf life
3 years.

6.4 Special precautions for storage
Store below 25°C.

6.5 Nature and contents of container
Doxepin 25mg Capsules are available as:
Packs of 28 capsules. Aluminium/PVC blister strips; 2 rows of 7 capsules per strip, 2 strips in a carton box.

6.6 Special precautions for disposal and other handling
No special requirements.

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Doxepin Capsules USP 50mg Taj Pharma

Package leaflet: Information for the patient

a) Doxepin Capsules USP 10mg Taj Pharma
b) Doxepin Capsules USP 25mg Taj Pharma
c) Doxepin Capsules USP 50mg Taj Pharma
d) Doxepin Capsules USP 75mg Taj Pharma
e) Doxepin Capsules USP 100mg Taj Pharma
f) Doxepin Capsules USP 150mg Taj Pharma

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
 – If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet
1. What  Doxepin Capsules is and what it is used for
2. Before you are given Doxepin Capsules
3. How you will be given  Doxepin Capsules
4. Possible side effects
5. How Doxepin Capsules is stored
6. Further Information

1. What Doxepin Capsules is and what it is used for
The name of this medicine is Doxepin 25mg and 50mg 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.

2. Before you are given Doxepin Capsules
Do not take Doxepin Capsules if:
• You have ever had an allergic reaction to tricyclic antidepressants, doxepin, or any of the inactive ingredients of Doxepin Capsules (see ‘Further information’ section)
• You have serious liver problems
• You have glaucoma (increased eye pressure)
• You suffer from difficulty in passing urine
• You are breast-feeding
• You are taking, or have taken in the last two weeks, any medicines called monoamine oxidase inhibitors (MAOIs for short)
• You suffer from a type of mood disorder called mania, where you experience an abnormally elevated mood state.
• The patient is under 12 years of age If you suffer from any of the above, speak to your doctor or pharmacist before taking Doxepin Capsules.

Take special care with 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

If you answer YES to any of the above questions talk to your doctor before taking this medicine.

If you are taking other medicines
It is very important that you inform your doctor if you are taking or have taken any other medicines, as some medicines may affect the way Doxepin Capsules works.

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 ‘Before you take Doxepin Capsules’ section 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).

Pregnancy and breast-feeding
Do not take this medicine if you are pregnant or trying to become pregnant without consulting your doctor.

Do not take this medicine if you are breast-feeding without consulting your doctor.

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.

Alcohol and Doxepin Capsules
Be careful when drinking alcohol. Alcoholic drinks (wine, beer, spirits) may affect you much more than usual.

3. How you will be given Doxepin Capsules
The label on the pack will tell you what dose YOU should take and how often each day to take it. If you are still not sure, ask your doctor or pharmacist.

  • 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 • The usual starting dose is 75mg daily. This dose may be increased if necessary .
    • The maximum recommended dose is 100mg 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 100mg 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.

4. Possible Side Effects
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 tellarelative 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 is 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.

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 listed below. If they don’t wear off after a few days or trouble you, 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 tests 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

It is important to tell your doctor or pharmacist if you suffer any of these or any other undesirable effects which are not listed above.

5. How Doxepin Capsules is stored
Do not take Doxepin Capsules after the date stamped on the pack.The expiry date refers to the last day of the month.
Doxepin Capsules should be kept in a cool, dry place (below 25ºC).
Keep this medicine out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information

What Doxepin Capsules contains
The active ingredient in the capsule is Doxepin Hydrochloride USP. The capsules are free of gluten and sucrose.

a) Each capsule contains:Doxepin Hydrochloride USP equivalent to 10mg of Doxepin.
b) Each capsule contains:Doxepin Hydrochloride USP equivalent to 25mg of Doxepin.
c) Each capsule contains:Doxepin Hydrochloride USP equivalent to 50mg of Doxepin.
d) Each capsule contains:Doxepin Hydrochloride USP equivalent to 75mg of Doxepin.
e) Each capsule contains:Doxepin Hydrochloride USP equivalent to 100mg of Doxepin.
f) Each capsule contains: Doxepin Hydrochloride USP equivalent to 150mg of Doxepin.
Other ingredients: lactose, maize starch, magnesium stearate and sodium lauryl sulphate. The gelatin capsules are coloured with erythrosine, (E127), patent blue V (E131) and titanium dioxide (E171).

What Doxepin Capsules looks like and contents of the pack
Doxepin 25mg Capsules (blue and red) come in packs of 28.
Doxepin 50mg Capsules (blue) come in packs of 28.

7. Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com