United Kingdom - English - eMC (Electronic Medicines Compendium)
INFORMATION FOR THE USER
25mg and 50mg Capsules
Read all of this leaflet carefully before you
start taking your medicine.
Keep this leaflet. You may need to read
it again. If you have any further questions,
please ask your doctor or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Sinepin is and what it is used for
2. Before you take Sinepin
3. How to take Sinepin
4. Possible side effects
5. How to store Sinepin
6. Further information
1. WHAT SINEPIN IS AND WHAT
IT IS USED FOR
The name of this medicine is Sinepin. The active
ingredient is doxepin hydrochloride.
Sinepin is an antidepressant. It is one of a group called
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, Sinepin
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
2. BEFORE YOU TAKE SINEPIN
Do not take Sinepin Capsules if:
You have ever had an allergic reaction to tricyclic
antidepressants,doxepin, or any of the inactive
ingredients of Sinepin Capsules
(see ‘Further information’
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
The patient is under 12 years of age
If you suffer from any of the above, speak to your doctor
or pharmacist before taking Sinepin.
Take special care with Sinepin 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 Sinepin 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 Sinepin,
and Sinepin 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 Sinepin (see ‘Before you take Sinepin’section above)
Other antidepressants, barbiturates (used to treat
insomnia) or other sleeping medicines or medicines
for anxiety. Sinepin 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
Thyroid hormones (used to treat thyroid disorders).
Chlorpromazine (used to treat mental illness).
Sublingual nitrates (used to treat angina and heart
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
Alcohol and Sinepin
Be careful when drinking alcohol. Alcoholic drinks (wine,
beer, spirits) may affect you much more than usual.
3. HOW TO TAKE SINEPIN
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
Do not crush or chew the capsules.
Keep taking the capsules every day
The usual starting dose is 75mg daily.
may be increased if necessary .
The maximum recommended dose is 100mg three
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
If you suffer from liver problems you may also be
started on a low dose.
The capsules may be prescribed once, twice or three
Up to 100mg can be given as a single dose.
If you take more Sinepin Capsules than
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
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 Sinepin Capsules
Do not worry. Take your usual dose at the next
Do not take a double dose to make up for a
If you stop taking Sinepin 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
How quickly will the treatment start to work?
You may take Sinepin for 2-3 weeks before you start
to feel better.
You must keep taking Sinepin 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
What if you do not feel better?
Tell your doctor if:
You have taken all your medicine and you
still feel unwell:
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
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
An increased risk of bone fractures has been observed
in patients taking this type of medicine.
Sinepin 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:
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
Dizziness, (if you experience dizziness you should be
particularly careful to stand up slowly).
Difficulty in passing urine.
Loss of appetite.
Vomiting or diarrhoea.
Fast heart beat (palpitations).
Changes in sex drive.
Swelling of testicles
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 Sinepin. 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.
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
5. HOW TO STORE SINEPIN
Do not take Sinepin after the date stamped on the pack.
The expiry date refers to the last day of the month.
Sinepin should be kept in a cool, dry place (below 25°C).
Keep this medicine out of the sight and reach
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 Sinepin Capsules contain
The capsules are free of gluten and sucrose.
Sinepin 25mg Capsule.
Each capsule contains
25mg doxepin. Other ingredients: lactose, maize starch,
magnesium stearate and sodium lauryl sulphate. The
gelatin capsules are coloured with amaranth (E123),
erythrosine, (E127), paten
t blue V (E131), sunset yellow
(E110) and titanium dioxide (E171).
Sinepin 50mg Capsule.
Each capsule contains
50mg 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 Sinepin Capsules look like and the
contents of the pack
Sinepin 25mg Capsules (blue and red) come in
packs of 28.
Sinepin 50mg Capsules (blue) come in packs of 28.
Marketing Authorisation Holder and
Marketing Authorisation Holder
Allphamed PHARBIL GmbH
Hildebrandstrasse 12, D-37081 Gottingen, Germany
This leaflet does not contain all the information about
this medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist.
For information in large print, tape, CD or
Braille, telephone 01279 406759.
Leaflet prepared: May 2018
Reporting of side effects
If you get any side effects, talk to your doctor, nurse 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
By reporting the side effects you can help provide more
information on the safety of this medicine.
Marlborough Pharmaceuticals Ltd.
Miles Gray Road, Basildon,
Essex SS14 3FR, United Kingdom
TRADE NAME OF MEDICINAL PRODUCT
SINEPIN Capsules 25mg
Doxepin 25mg Capsules
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: Doxepin Hydrochloride BP
The capsules contain Doxepin Hydrochloride BP equivalent to 25mg doxepin.
Capsules for oral administration.
Symptoms of depressive illness, especially where sedation is required.
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
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’).
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.
Special warnings and special precautions for use
Suicide/suicidal thoughts or clinical worsening
Depression is associated with an 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
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
Since suicide is an inherent risk in any depressed patient until significant
improvement has occurred, patients should be closely supervised during early
Patients with benign prostatic hyperplasia may experience an increase in
associated urinary retention (see ‘Undesirable effects’).
Interactions 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
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
The dose of thyroid hormone medication may need reducing if Doxepin 25mg
Capsules are being given concurrently.
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.
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.
Doxepin 25mg Capsules are well tolerated. Most side-effects are mild and
generally disappear with continued treatment, or if necessary a reduction in
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
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-
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,
Deaths have been reported involving overdoses of doxepin. The reported
cases involved doxepin alone and in combination with other drugs and/or
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.
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
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 l/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.
Pre-clinical Safety Data
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.
Special Precautions for Storage
Store below 25ºC.
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.
Instructions for Use and Handling
No special requirements.
MARKETING AUTHORISATION HOLDER
Marlborough Pharmaceuticals Ltd
Sovereign House, Miles Gray Road,
Basildon, Essex SS14 3FR, UK
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT