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SINEPIN CAPSULES 50MG

Active substance: DOXEPIN HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

• Other antidepressants, barbiturates (used to treat

Sinepin (doxepin)




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
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, 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
doctor.

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’ 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 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)






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
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 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
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 Sinepin 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 Sinepin 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 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
excessive sweating.

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
stay well.

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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 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.
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:
• 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 Sinepin. You should check with your doctor
immediately if any of the following occur:
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Breast enlargement in both men and women, breast
milk production when not pregnant or breast feeding;

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Worsening of asthma.

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Convulsions (fits) are unlikely unless you already
suffer from these.

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Nightmares, hallucinations (seeing or hearing things
that are not there), jaundice (yellow eyes or skin).

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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.

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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 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 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 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), patent 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
Manufacturer
Marketing Authorisation Holder

Marlborough Pharmaceuticals Ltd
35A High Street, Marlborough, SN8 1LW, U.K
Tel: 01672 514 187

Manufacturer

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 01672 514187.

Worsening of an existing mental disorder;

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Staggering walk which may occur on a mixture of
centrally acting drugs.

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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.

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Skin rash, itching, face swelling. Your skin may be
more sensitive to sunlight than it is normally.

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Leaflet prepared: July 2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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