The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 23138/0002.
Sinepin (Doxepin) 25 mg and 50 mg Capsules
Sinepin (doxepin) 25mg and 50mg Capsules
1. What Sinepin is and what it is used for
2. What you need to know before you take Sinepin
3. How to take Sinepin
4. Possible side effects
5. How to store Sinepin
6. Contents of the pack and other information
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.
If you suffer from any of the above, speak to your doctor or pharmacist before taking Sinepin.
Talk to your doctor or pharmacist before taking Sinepin Capsules if you
The use of this medicine together with Sinepin can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Sinepin Capsules”).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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:
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.
You may feel sleepy when you take these capsules, do not drive or work with machinery until this effect has worn off.
Be careful when drinking alcohol. Alcoholic drinks (wine, beer, spirits) may affect you much more than usual.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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.
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.
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.
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.
Tell your doctor if:
You have taken all your medicine and you still feel unwell:
You feel worse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
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.
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1000 people)
Not Known (frequency cannot be estimated from the available data)
If you or your child 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 www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting the side effects you can help provide more information on the safety of this medicine.
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 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.
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).
Sinepin 25mg Capsules (blue and red) come in packs of 28.
Sinepin 50mg Capsules (blue) come in packs of 28.
Marketing Authorisation Holder
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.
This leaflet was last revised in May 2021