contains the active ingredient dosulepin (dothiepin) hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Dosulepin Mylan.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking Dosulepin Mylan against the benefits expected for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Please read this leaflet carefully and keep it with your medicine. You may need to read it again.
What Dosulepin Mylan is used for
Dosulepin Mylan is used to treat depression.
Dosulepin Mylan 25 mg capsules can be used at any stage in the treatment of depression. However, the higher strength Dosulepin Mylan 75 mg tablets are approved only for the maintenance treatment of depression (after your symptoms have improved).
Dosulepin Mylan belongs to a group of medicines called tricyclic antidepressants (TCAs). TCA medicines work by correcting the imbalance of certain chemicals in the brain. These chemicals, called amines, are involved in controlling mood. By correcting this imbalance, TCAs can help relieve the symptoms of depression.
Ask your doctor if you have any questions about why Dosulepin Mylan has been prescribed for you. Your doctor may have prescribed Dosulepin Mylan for another reason.
Dosulepin Mylan is not approved for use in children and adolescents below 18 years of age for the treatment of depression. The safe use and effectiveness of Dosulepin Mylan in treating depression, for this age group, has not been established.
Dosulepin Mylan is available only with a doctor's prescription.
Before you take Dosulepin Mylan
When you must not take it
Do not take Dosulepin Mylan if you are allergic to medicines containing dothiepin (e.g. Prothiaden) or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin
- discolouration of the skin upon exposure to sunlight
Do not take Dosulepin Mylan if you have:
Dosulepin Mylan may increase the chance of fitting or having convulsions.
- recently had a heart attack, for example within the past two months
Dosulepin Mylan may cause irregular and/or rapid heartbeat.
- liver failure.
Your body may not be able to remove Dosulepin Mylan from your body.
Do not take Dosulepin Mylan if you are taking a medicine called a monoamine oxidase inhibitor (MAOI), or have taken a MAOI within the last 14 days.
Stop taking MAOIs at least 14 days before starting Dosulepin Mylan. Taking Dosulepin Mylan with a MAOI may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions.
Ask your doctor or pharmacist if you are not sure if you have been taking a MAOI medicine. MAOIs are medicines used to treat depression and symptoms of Parkinson's disease, such as phenelzine (Nardil), tranylcypromine (Parnate), moclobemide (eg. Aurorix Arima) and selegiline (Eldepryl, Selgene).
Do not take Dosulepin Mylan if the expiry date (EXP.) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well.
Do not take Dosulepin Mylan if the packaging shows signs of tampering or the tablets or capsules do not look quite right.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
Tell your doctor if you are pregnant or plan to become pregnant. There have been reports of some babies experiencing complications immediately after delivery. Your doctor will discuss the possible risks and benefits of taking Dosulepin Mylan during pregnancy.
Tell your doctor if you are breastfeeding or wish to breastfeed. Like many other medicines, Dosulepin Mylan passes into breast milk.
Your doctor will discuss the risks and benefits of taking Dosulepin Mylan when breastfeeding.
Tell your doctor if you have, or have had, any medical conditions, especially the following:
- heart or blood vessel problems
- liver problems or hepatitis
- kidney problems or difficulty passing urine (water)
- glaucoma, a condition characterised by an increased pressure in the eye
- prostate problems
- difficulty in passing urine
- thyroid problems
- any other mental illness, such as schizophrenia or manic depression (alternating periods of elation/overactivity and depressed mood)
- family history of suicide or manic depression.
Tell your doctor if you plan to have surgery or if you are undergoing electroshock therapy.
If you have not told your doctor about any of the above, tell them before you start taking Dosulepin Mylan.
Taking other medicines
Do not take Dosulepin Mylan if you are taking a monoamine oxidase inhibitor (MAOI) such as:
- phenelzine (Nardil) and tranylcypromine (Parnate), moclobemide (eg. Aurorix, Arima), used to treat depression
- selegiline (Eldepryl, Selgene), used to treat symptoms of Parkinson's disease.
Wait at least 14 days after stopping your MAOI before starting Dosulepin Mylan.
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
Medicines that may be affected by Dosulepin Mylan or may affect how well it works include:
- sleeping tablets/sedatives, anti-anxiety medicines
- medicines used to treat epilepsy
- some medicines used to treat high blood pressure or other heart conditions
- some medicines used to relieve stomach cramps
- medicines used to treat Parkinson's disease
- medicines for travel sickness
- some cough and cold preparations
- some medicines for hayfever and allergies
- certain medicines for weight loss
- thyroid hormone medicines.
Your doctor can tell you what to do if you are taking any of these medicines.
If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Dosulepin Mylan.
How to take Dosulepin Mylan
Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist.
How much to take
The dose varies from person to person.
Your doctor will tell you how much Dosulepin Mylan you need to take each day and when to take it. This depends how well you respond to Dosulepin Mylan and whether or not you are taking any other medicines.
The usual starting dose is 25 mg three times daily for one to two weeks. Your doctor may then increase your dose, up to a maximum of 200 mg per day.
Once your symptoms improve, your doctor will then slowly reduce your dose to the lowest effective dose which maintains relief of symptoms.
Elderly people over 65 years of age and those with liver or kidney problems may need smaller doses.
How to take it
Swallow the tablets or capsules with a glass of water.
mg tablets can be divided in half along the breakline if advised by your doctor or pharmacist.
When to take it
Dosulepin Mylan can be taken as a single dose (e.g. at bedtime) or as divided doses (e.g. three times a day). Your doctor will advise you.
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 for
Keep taking Dosulepin Mylan for as long as your doctor recommends. The length of treatment will depend on how quickly your symptoms improve.
Most medicines for depression take time to work, so do not be discouraged if you do not feel better right away. Some of your symptoms may improve in 1 or 2 weeks but it can take up to 4 or 6 weeks to feel the full benefit of Dosulepin Mylan.
Even when you feel well, you will usually have to take Dosulepin Mylan for several months or longer, to make sure that the benefits last.
If you forget to take it
IF YOU TAKE ONE DOSE A DAY (AT BEDTIME)
If you forget to take Dosulepin Mylan before you go to bed and wake up late in the night or early in the morning, do not take the missed dose until you have checked with your doctor. You may have difficulty waking up, or experience drowsiness in the morning and during the day.
IF YOU TAKE MORE THAN ONE DOSE A DAY
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then go back to taking Dosulepin Mylan as you would normally.
Do not take a double dose to make up for the dose you missed.
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) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Dosulepin Mylan.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Too much Dosulepin Mylan may make you tremble, agitated and/or have difficulty walking. Other signs include fitting or convulsions, unusual muscle movements, difficulty breathing, a very high temperature or irregular heartbeat as well as other serious heart problems.
Keep Dosulepin Mylan out of the reach of children. Children are much more sensitive than adults to medicines such as Dosulepin Mylan. An accidental overdose is especially dangerous in children.
While you are taking Dosulepin Mylan
Things you must do
Tell your doctor immediately if you have any suicidal thoughts or other mental/mood changes. Occasionally, the symptoms of depression or other psychiatric conditions may include thoughts of harming yourself or committing suicide.
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 young adults under 25 years of age.
Contact your doctor or a mental health professional right away or go to the nearest hospital for treatment if you or someone you know is showing any of the following warning signs of suicide:
- worsening of your depression
- 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 any other unusual changes in behaviour or mood.
All mentions of suicide or violence must be taken seriously.
Families and caregivers of children and adolescents being treated with Dosulepin Mylan need to monitor these patients for the emergence of:
- panic attacks
- restlessness or difficulty sitting still
- unusual changes in behaviour
This will help your doctor determine the best way to control these feelings.
Tell your doctor if you feel Dosulepin Mylan is not helping your condition.
Keep all of your appointments with your doctor so that your progress can be checked. If you are taking Dosulepin Mylan for a long time, your doctor may ask you to have your eyes tested regularly.
Tell your doctor immediately if you become pregnant while taking Dosulepin Mylan. Do not stop taking your tablets or capsules until you have spoken to your doctor.
Before starting any new medicine, tell your doctor or pharmacist that you are taking Dosulepin Mylan.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking Dosulepin Mylan.
If you plan to have surgery, including dental surgery, tell your doctor that you are taking Dosulepin Mylan. Your doctor may ask you to temporarily stop taking Dosulepin Mylan a few days before elective surgery.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Things you must not do
Do not drive or operate machinery until you know how Dosulepin Mylan affects you. Dosulepin Mylan may cause drowsiness, dizziness or light-headedness in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.
Do not stop taking Dosulepin Mylan, or lower the dose, without checking with your doctor. If you stop taking Dosulepin Mylan suddenly you may feel sick (nausea), irritable, have a headache, difficulty sleeping or excessive sweating. Other more serious complications such as fits (convulsions) or blood clots may occur.
Your doctor will tell you how to gradually reduce the amount of Dosulepin mylan you are taking before stopping completely.
Do not use Dosulepin Mylan to treat any other conditions unless your doctor tells you to.
Do not give Dosulepin Mylan to anyone else, even if they have the same condition as you.
Things to be careful of
Be careful when drinking alcohol while taking Dosulepin Mylan. Combining Dosulepin Mylan and alcohol can make you more drowsy, dizzy or lightheaded. Your doctor may suggest you avoid alcohol while being treated for depression.
Be careful getting up from a sitting or lying position. Dizziness, light-headedness or fainting may occur, especially when you get up quickly. Getting up slowly may help.
Be careful if you are older than 65 years of age. Elderly people may become confused when taking Dosulepin Mylan. Families and carers should be aware of this. Special care may be needed.
Tell your doctor or dentist if your mouth continues to feel dry for more than 2 weeks. Dosulepin Mylan may cause dry mouth. This can be relieved by frequent sips of water, sucking sugarless lollies or chewing sugarless gum. However, continuing dryness of the mouth may increase the chance of dental disease, including tooth decay and gum disease.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Dosulepin Mylan.
Dosulepin Mylan helps most people with depression, but it may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Do not be alarmed by this list of p
ossible side effects. You may not experience any of them.
Tell your doctor if you notice any of the following and they worry you:
- dry mouth
- increased sweating
- feeling sick (nausea), vomiting
- blurred vision
- drowsiness, dizziness, light-headedness
- increased or decreased sex drive.
The above list includes the common and mild side effects of Dosulepin Mylan.
Tell your doctor as soon as possible if you notice any of the following:
- fast or irregular heart beat
- ongoing difficulty with passing urine
- signs of frequent infections such as fever, chills, sore throat or mouth ulcers
- unusual bruising or bleeding
- tingling or numbness of the hands or feet
- severe pain in the stomach with bloating, gut cramps and vomiting
- symptoms of liver disease such as yellowing of the eyes or skin (jaundice) and passing dark coloured urine
- feeling anxious, restless, or confused
- abnormal ideas, hallucinations
- sudden mood swings alternating from one of excitement, overactivity and uninhibited behaviour to a depressed mood
- uncontrollable movements, including trembling and shaking of the hands and fingers, twisting movements of the body, shuffling walk or stiffness of the arms and legs.
The above side effects are serious and may require medical attention.
Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:
- chest pain
- fainting or collapse
- allergic symptoms such as skin blisters, rash, itching or hives; swelling of the face, mouth, lips, throat or neck; difficulty swallowing or breathing;
- seizures or fits.
The above side effects are not common but very serious. You may require urgent medical attention or even hospitalisation if they occur.
Tell your doctor if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some patients.
After taking Dosulepin Mylan
Keep Dosulepin Mylan where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Keep Dosulepin Mylan in a cool, dry place where the temperature stays below 30 °C for tablets and below 25 °C for capsules.
Do not store Dosulepin Mylan or any other medicine in the bathroom or near a sink. Do not leave Dosulepin Mylan in the car or on window sills. Heat and dampness can destroy some medicines.
If your doctor tells you to stop taking Dosulepin Mylan, or your medicine has passed its expiry date, ask your pharmacist what to do with any that is left over.
What it looks like
Dosulepin Mylan is available in two strengths:
- Dosulepin Mylan 25 – hard capsule with green and red cap in PVC/PVdC/aluminium blister packs. Each pack contains 50 capsules.
- Dosulepin Mylan 75 – round, red, scored film-coated tablet marked "DT" over a breakline over "75" on one side and a Greek alpha symbol on the other. Each pack contains 30 tablets.
Dosulepin Mylan 25 capsules
- dothiepin hydrochloride 25 mg.
Ingredients of known effect:
- lactose (monohydrate and anhydrous)
- sulfites (present in trace amounts)
- sodium starch glycollate
- purified talc
- magnesium stearate
- sodium lauryl sulfate
- colloidal anhydrous silica
- erythrosine CI 45430 (127)
- iron oxide red CI 77491 (172)
- titanium dioxide (171)
- brilliant blue FCF CI 42090 (133)
- quinoline yellow CI 47005 (104).
Dosulepin Mylan 75 tablets
- dothiepin hydrochloride 75 mg.
Ingredients of known effect:
- sulfites (present in trace amounts)
- soya bean products (present in trace amounts)
- maize starch
- sodium starch glycollate
- purified talc
- magnesium stearate
- Opadry Red OY-B-25005 (includes colours brilliant scarlet 4R CI 16255 , titanium dioxide ).
Dosulepin Mylan tablets and capsules are gluten free.
Dosulepin Mylan is made in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
Australian registration numbers:
Dosulepin Mylan 25 – AUST R 289783
Dosulepin Mylan 75 – AUST R 289784
This leaflet was prepared on
05 July 2019.
Published by MIMS September 2019