Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Sinequan. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Sinequan against the benefits it is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Read this leaflet carefully before you start Sinequan and keep it with the medicine. You may need to read it again.
What Sinequan is used for
Sinequan is used to treat depression.
It belongs to a group of medicines called tricyclic antidepressants (TCAs).
Antidepressants are thought to work by their action on brain chemicals called amines which are involved in controlling mood.
Your doctor, however, may prescribe Sinequan for another purpose.
Ask your doctor if you have any questions about why Sinequan has been prescribed for you.
This medicine is only available with a doctor's prescription.
Before you take Sinequan
When you must not take it
Do not take Sinequan if you have an allergy to:
any medicine containing doxepin hydrochloride
any other tricyclic antidepressant
any of the ingredients listed at the end of this leaflet
Symptoms of an allergic reaction to Sinequan may include skin rash, itching, swelling of the face and increased sensitivity of the skin to the sun.
Do not take Sinequan if you are taking a medicine called a monoamine oxidase inhibitor (MAOI) or have been taking it within the last 14 days. Taking Sinequan with a MAOI may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and convulsions.
Ask your doctor or pharmacist if you are not sure if you are taking or have been taking a MAOI. MAOIs are medicines used to treat depression and symptoms of Parkinson's Disease. Examples of MAOIs are phenelzine (Nardil), tranylcypromine (Parnate), moclobemide (e.g. Aurorix) and selegiline (e.g. Eldepryl).
Do not take Sinequan if you are breastfeeding unless directed by your doctor. Like many other medicines, Sinequan can pass into breast milk and may affect your baby.
Do not take Sinequan if you have:
glaucoma (increased pressure in the eye)
urinary retention (difficulty in passing urine)
If you are not sure if you should be taking Sinequan, talk to your doctor.
Do not take Sinequan if the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
Do not give Sinequan to children of 18 years and under. The safety and effectiveness of Sinequan in this age group have not been established.
Before you start to take it
You must tell your doctor if you are allergic to:
any other medicines
any other substances such as foods, dyes or preservatives.
Tell your doctor if you are not well or have any other health problems or history of, including:
any mental illness
liver or kidney problems
Tell your doctor if you are pregnant or intend becoming pregnant. Your doctor will discuss the risks and benefits of using Sinequan during pregnancy.
If you have not told your doctor or pharmacist about these things, tell them before you start taking Sinequan.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines should not be taken with Sinequan. These include:
monoamine oxidase inhibitors (MAOIs), medicines used for the treatment of depression.
Taking Sinequan within 14 days of stopping a MAOI may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and convulsions.
Wait at least 14 days after stopping your MAOI before starting Sinequan.
In addition, you may respond differently to Sinequan, or to some other medicines, if you take them together. These include (not all brands given):
other medicines for depression (Tofranil, Pertofran, Prozac, Aropax, Zoloft)
cimetidine (e.g. Tagamet)
medicines for diabetes (e.g. Rastinon, Daonil, Diabinese, Minidiab)
anti-anxiety medicines (e.g. Diazepam, Valium, Ducene, Serepax, Tranxene)
medicines containing atropine (e.g. Atropt, Atropine eye drops, Atropine Sulphate injection) or medicines for irritable bowel syndrome (e.g. Probanthine, Buscopan)
tranquillisers such as Risperdal, Melleril, Modecate or Largactil
medicines for controlling abnormal heart beats (e.g Kinidin Durules, Tambocor)
medicines for epilepsy (e.g. Dilantin, Tegretol)
medicines containing adrenaline or noradrenaline (e.g. nasal drops, decongestants, some cough mixtures, some local anaesthetics)
stimulant medicines containing amphetamine (e.g. Dexamphetamine)
guanethidine (e.g. Ismelin)
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Sinequan. How to take Sinequan Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How much to take
The dose of Sinequan varies from patient to patient.
Your doctor will decide the right dose for you. This depends on your condition, age, whether or not you are taking any other medicines, and how you respond to Sinequan.
It is usual to start with a low dose and then, if necessary, increase it gradually until the right dose is reached.
How to take it
Swallow the capsules with a glass of water or other liquid.
When to take it
Sinequan can be taken with or without food.
Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
How long to take it
Keep taking Sinequan until your doctor tells you to stop. Most antidepressants take time to work so do not be discouraged if you do not feel better straight away. It may take 2 to 3 weeks to feel the full benefit of Sinequan.
Even when you feel well, you may need to take Sinequan for several months or longer to make sure that the benefits last.
If you forget to take it
If it is almost time for your next dose (e.g. within 2 or 3 hours), skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, then go back to taking it as you would normally.
Do not try to make up for missed doses by taking more than one dose at a time. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital if you think you or anyone else may have taken too much Sinequan. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Keep Sinequan out of reach of children. Children are much more sensitive than adults to tricyclic antidepressants. An accidental overdose is especially dangerous.
While you are using it
Things you must do
If you become pregnant while taking Sinequan, tell your doctor immediately.
If you are a woman of childbearing age, you should avoid becoming pregnant while taking Sinequan.
Tell your doctor immediately if you have any suicidal thoughts or other mental/mood changes.
If you or someone you know is demonstrating any of the following warning signs of suicide while taking Sinequan, contact your doctor or a mental health professional right away or go to the nearest hospital for treatment:
Thoughts or talk of death or suicide
Thoughts or talk of self-harm or harm to others
Any recent attempts of self-harm
Increase in aggressive behaviour, irritability or agitation
Worsening of depression
Occasionally, the symptoms of depression may include thoughts of suicide or self-harm. These symptoms may continue or get worse during the first one to two months of treatment until the full antidepressant effect of the medicine becomes apparent. This is more likely to occur in children, adolescents or young adults under 24 years of age.
All mentions of suicide or violence must be taken seriously.
If you are about to start any new medicine, tell your doctor and pharmacist that you are taking Sinequan.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Sinequan. Your doctor may ask you to stop taking Sinequan a few days before surgery.
Things you must not do
Do not stop taking Sinequan, or change the dose, without first checking with your doctor.
Do not let yourself run out of capsules over the weekend or on holidays. Suddenly stopping Sinequan may make you feel tired, sick in the stomach and give you a headache.
To prevent this, your doctor may want to gradually reduce the amount you take each day before stopping the medicine completely.
Do not give Sinequan to anyone else, even if they have the same condition as you.
Do not use Sinequan to treat any other complaints unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how Sinequan affects you. Sinequan may cause drowsiness and affect co-ordination in some people.
If this occurs, do not drive, operate machinery or do things that may be dangerous if you are not alert.
Be careful when drinking alcohol while taking Sinequan. Combining Sinequan and alcohol can make you more sleepy, dizzy or lightheaded.
Your doctor may suggest you avoid alcohol while you are being treated for depression.
All of the above precautions are important even after you have stopped taking Sinequan.
The effects of Sinequan may last for some days after you have stopped taking it.
Check with your doctor as soon as possible if you have any problems while taking Sinequan, even if you do not think the problems are connected with the medicine or are not listed in this leaflet. Like other medicines, Sinequan can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.
Ask your doctor or pharmacist any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
difficulty in sleeping, bad dreams
anxiety, nervousness, aggressive behaviour
difficulty in passing urine
feeling sick, vomiting, indigestion
changes in taste
loss of appetite or increase in appetite
These side effects are usually mild.
Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following:
fast heart beat
seizures or fits
bleeding or bruising more easily than normal, reddish or purple blotches under the skin
signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers
yellowing of the skin and eyes (also called jaundice)
symptoms of tiredness, abdominal pain, jaundice and history of gallstones
symptoms of high fever, drowsiness, sweating, fast heart beat and muscle stiffness
symptoms of allergy such as a skin rash or swelling of the face
symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal
unsteadiness, stiffness, shakiness or unwanted movements
These symptoms are usually rare but may be serious and need urgent medical attention.
Other side effects not listed above may occur in some people.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
After using Sinequan
Keep your capsules where children cannot reach them. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.
Keep Sinequan in a cool, dry place where the temperature stays below 30 °C. Do not store it, or any other medicine, in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.
Keep your capsules in their blister pack until it is time to take them. If you take the capsules out of their container they may not keep well.
If your doctor tells you to stop taking Sinequan, or the capsules have passed their expiry date, ask your pharmacist what to do with any left over.
What it looks like
Sinequan capsules come in two strengths:
Sinequan 10 mg - peach/pink capsules with "Pfizer" printed on top and bottom.
Sinequan 25 mg - pink/red capsules with "Pfizer" printed on top and bottom.
Each pack contains 50 capsules.
The active ingredient in Sinequan is doxepin hydrochloride.
Sinequan 10 mg - 10 mg doxepin per capsule
Sinequan 25 mg - 25 mg doxepin per capsule
The capsules also contain lactose, wheat starch (10 mg capsules only), maize starch (25 mg capsules only), magnesium stearate, sodium lauryl sulphate, gelatin, silica-colloidal anhydrous (25 mg capsules only) and the colouring agents brilliant blue FCF CI42090 (133), erythrosine CI45430, titanium dioxide (171) and sunset yellow FCF CI15985 (110) (10 mg capsules only).
Sinequan is supplied in Australia by:
Pfizer Australia Pty Limited
(ABN 50 008 422 348)
38-42 Wharf Road
West Ryde NSW 2114.
Australian Registration Number:
Sinequan 10 mg - AUST R 10767
Sinequan 25 mg - AUST R 10768
This leaflet was updated on 16 April 2008.