Dosulepin 25mg Capsules
The most common side effects (that affect less than 1 person in 10) are:
• dry mouth
• blurred vision
• changes in the heart beat
• constipation and difficulty in passing water.
These side effects tend to improve with time.
Other side effects you may also experience are:
• drowsiness or disturbed sleep
• increased sweating
• feeling sick (nausea) or an unusal taste in the mouth
• skin rashes
• confusion
• tremor (shaking)
• changes in sexual function
• low blood pressure, which may cause dizziness or fainting.
• an increased risk of bone fractures has been observed in patients taking this type of medicines Rare side effects (that affect less than 1 person in 1000) are:
• changes in the blood and changes in hormone levels (these will be found if you have blood tests)
• severe mood changes such as extreme excitability
• fits.
If any of these side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE DOSULEPIN
Keep these capsules in the original container, and in a safe place (preferably a locked cupboard) where children cannot see or reach them. Your medicine could seriously harm them.
Do not take this product after the 'use by' date shown on the carton.
If your doctor decides to stop the treatment, you must return any left over capsules to your pharmacist. Only keep the capsules if your doctor tells you to.
6. FURTHER INFORMATION What Dosulepin capsules contain
The active substance is dosulepin hydrochloride
The other ingredients are lactose monohydrate and magnesium stearate.
The capsule shell contains gelatin with small amounts of erythrosine (E127), quinoline yellow (E104), titanium dioxide (E171), red, black and yellow iron oxides (E172). The printing ink contains shellac, isopropyl alcohol, black iron oxide (E172), n-butyl alcohol, propylene glycol (E1520) and ammonium hydroxide (E527).
What Dosuepin Capsules look like and contents of the pack
Dosulepin capsules are orange and caramel with the markings 'MP75' and '25 mg'.
Dosulepin capsules are provided in blister packs of 14 or 28 capsules.
Marketing Authorisation Holder
Genethics Europe Limited, 41 -43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus Manufacturer
DDSA Pharmaceuticals Limited, 310 Old Brompton Road, London SW5 9JQ, UK
This leaflet was last revised on April/2016. GE0044/0/PIL/GE1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Dosulepin 25 mg Capsules
Dosulepin hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, 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 becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Dosulepin is and what it is used for
2. Before you take Dosulepin capsules
3. How to take Dosulepin
4. Possible side effects
5. How to store Dosulepin
6. Further information
1. WHAT DOSULEPIN IS AND WHAT IT IS USED FOR
Dosulepin belongs to a group of medicines called antidepressants. Dosulepin is used to treat depression and can also help reduce feelings of anxiety. You will only be prescibed Dosulepin if other medicines have been found to be unsuitable for you.
Please ask your doctor or pharmacist if you need more information.
2. BEFORE YOU TAKE DOSULEPIN CAPSULES
Do not take Dosulepin capsules and speak to your doctor if:
- you know that you are allergic (hypersensitive) to dosulepin or any of the other ingredients (listed in section 6 of this leaflet) in Dosulepin capsules
- you have an irregular heart beat or any other heart problems
- you have liver or thyroid problems
- you have an eye condition known as glaucoma
- you are a man that has prostate problems (difficulty in passing water)
- you have been diagnosed as having mania (feeling over-excited with unusual behaviour)
- you have fits (epilepsy)
- you are undergoing electro-shock treatment
- you have an inherited disease called porphyria
- you have a disease called phaeochromocytoma.
Dosulepin capsules should not be given to children.
Take special care with Dosulepin capsules if:
- you are going to have surgery or dental treatment. Tell your surgeon or dentist that you are taking Dosulepin capsules as it may affect the anaesthetic used.
Taking other medicines
You should tell your doctor if you are taking or have taken any of the following medicines as they may affect how your Dosulepin capsules work:
• A medicine used to treat depression called a mono-amine oxidase inhibitor (MAOI). You should not take Dosulepin capsules at the same time as MAOIs or within 14 days of stopping them.
• Other medicines used to treat depression called SSRIs (selective serotonin re-uptake inhibitors).
• Any medicines used to treat other mental health problems (antipsychotics).
• Any medicines given to you for treating high blood pressure (hypertension).
• Any medicines to treat heart beat problems (e.g. Sotalol).
• Any hay fever/allergy medicines.
• Any medicines to treat epilepsy or fits.
• Halofantrine (for malaria) or Ritonavir (a medicine for viral infection).
• Any medicines called barbiturates (e.g. phenobarbitone for fits, amylobarbitone for sleeplessness) or methylphenidate (used to treat behavioural problems).
• Any medicine that contains an opioid (these include codeine, morphine, co-proxamol, co-dydramol and tramadol.)
• Medicines called sympathomimetic agents - these include ephedrine, pseudoephedrine, adrenaline and noradrenaline (these may be found in medicines used to treat heart problems and asthma as well as some decongestants and cough/cold remedies.)
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are or think you might be pregnant or you plan to become pregnant, or if you are breast-feeding you must tell your doctor before you take this medicine. Your doctor will decide if you can take these capsules.
Driving and using machines
These capsules can make you feel drowsy. Do not drive, operate machinery or do anything that requires you to be alert until you know how the capsules will affect you. Feeling drowsy in the day can improve with time, but if drowsiness becomes a problem, you should tell your doctor.
If you drink alcohol with these capsules this can make the feeling of drowsiness worse.
Important information about some of the ingredients of Dosulepin capsules
These capsules contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE DOSULEPIN
Your doctor will tell you how many capsules to take and when you should take them. This will also be on the carton label. Ask your pharmacist or doctor for help if you are not sure how to take your capsules or if you want more information. The following information is given as a guide only. The capsules should be swallowed whole with a drink of water. Do not chew the capsules as you may get a bitter taste in your mouth and a temporary numbness of your tongue.
Adults: The usual starting dose is 3 capsules a day. Your doctor may ask you to increase this. Your doctor will tell you if you should take the capsules as separate doses throughout the day, or a single dose each evening, usually a couple of hours before you go to bed. Normally, not more than 9 capsules should be taken each day.
Elderly: The usual starting dose is between 1 and 3 capsules a day.
It may take two to four weeks of treatment before you begin to see an improvement in your mood although you might feel there is an improvement in your anxiety symptoms before then. It is important that you keep taking these capsules until your doctor tells you to stop.
If you stop taking Dosulepin
Do not stop taking these capsules just because you feel better. If you stop taking the capsules too soon, your condition may get worse. If your doctor wants you to stop taking these capsules, your doctor will ask you to stop gradually.
If you forget to take Dosulepin
Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not take a double dose to make up for a forgotten capsule. If you are unsure, check again with your doctor or pharmacist.
If you take more Dosulepin than you should
You should only ever take the number of capsules that your doctor has told you to take. Do not change the dose yourself. If you think your capsules are not working well enough, speak to your doctor to see if the dose can be increased.
These capsules may seriously harm you and may be life threatening if you take too many capsules. You should SEEK IMMEDIATE HELP if a child takes any capsules or if you or anybody else accidentally takes too many capsules. Remember to take the pack with you, even if it is empty.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dosulepin capsules can cause side effects, although not everybody gets them. If you get any of the following symptoms after taking these capsules, you should contact your doctor immediately:
• yellowing of the skin or whites of the eyes (jaundice)
• a fever (high temperature, sweating, shivering)
• hepatitis (damage to the liver causing dark urine, jaundice, nausea and fever)
• discomfort around the right lower rib cage.
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 of 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 trial studies has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an anti-depressant.
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.
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