Dosulepin Capsules 25mg
PACKAGE LEAFLET: INFORMATION FOR THE USER Dosulepin 75 mg tablets and 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 tablets or 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. This medicine will only be used when other medicines have been found to be unsuitable. Please ask your doctor or pharmacist if you need more information.
2. BEFORE YOU TAKE DOSULEPIN TABLETS OR CAPSULES
Do not take Dosulepin tablets or 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 tablets or capsules
- you have an irregular heart beat or any other heart problems
- you have liver 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)
Take special care with Dosulepin tablets or capsules if:
- you are going to have general or dental surgery, tell your surgeon or dentist you are taking Dosulepin tablets or capsules. 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 tablets or capsules work:
• A medicine used to treat depression called a mono-amine oxidase inhibitor (MAOI). You should not take Dosulepin tablets or 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 given to you for treating high blood pressure (hypertension).
• Any hay fever/allergy medicines which contains terfenadine or astemizole.
• Sotalol (a medicine for heart or blood pressure problems) or halofantrine (a medicine for malaria).
• 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 and co-dydramol.)
• 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 breastfeeding you must tell your doctor before you take this medicine. Your doctor will decide if you can take these tablets or capsules.
Driving and using machines
These tablets or 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 tablets or 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 tablets or capsules this can make the feeling of drowsiness worse.
Important information about some of the ingredients of Dosulepin tablets or capsules
These tablets or capsules contain an ingredient called lacctose. If you have been told by your doctor that you have an intolerance to lactose, contact your doctor before taking this medicine.
3. HOW TO TAKE DOSULEPIN
Your doctor will tell you how many tablets or 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 tablets or capsules or if you want more information. The following information is given as a guide only:
The tablets or capsules should be swallowed whole with a drink of water. Do not chew the tablets or capsules as you may get a bitter taste in your mouth and a temporary numbness of your tongue.
Adults: The usual starting dose is 1 tablet a day or 3 capsules per day. Your doctor may ask you to increase this to 2 or 3 tablets or not more than 9 capsules a day. Your doctor will tell you if you should take the tablets or 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 3 tablets or 9 capsules should be taken each day.
Elderly: The usual starting dose is 1 tablet a day or between 1 and 3capsules per 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 tablets or capsules until your doctor tells you to stop.
If you stop taking Dosulepin
Do not stop taking these tablets or capsules just because you feel better. If you stop taking the tablets or capsules too soon, your condition may get worse. If your doctor wants you to stop taking these tablets or 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 tablet or capsule. If you are unsure, check again with your doctor or pharmacist.
If you take more tablets or capsules than you should
You should only ever take the number of tablets or capsules that your doctor has told you to take. Do not change the dose yourself. If you think your tablets or capsules are not working well enough, speak to your doctor to see if the dose can be increased.
These tablets or capsules may seriously harm you and may be life threatening if you take too many tablets or capsules. You should seek immediate help if a child takes any tablets or capsules or if you or anybody else accidentally takes too many tablets or capsules. Remember to take the pack with you, even if it is empty.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Dosulepin tablets or capsules can cause side effects, although not everybody gets them.
If you get any of the following symptoms after taking these tablets or capsules, you should contact your doctor immediately:
• a fever (high temperature, sweating, shivering)
• discomfort around the right lower rib cage
• yellowing of the skin or whites of the eyes (jaundice)
• hepatitis (damage to the liver causing dark urine, jaundice, nausea and fever)
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 effect tend to improve with time. Other side effects you may also experience are:
• drowsiness
• increased sweating
• skin rashes
• tremor (shaking)
• changes in sexual function
• low blood pressure, which may cause dizziness or fainting.
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
An increased risk of bone fractures has been observed in patients taking this type of medicine.
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 tablets or 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 'EXP' date shown on the carton.
If your doctor decides to stop the treatment, you must return any left over tablets or capsules to your pharmacist. Only keep the tablets or capsules if your doctor tells you to.
6. FURTHER INFORMATION What Dosulepin contains
Tablets
- The active substance is dosulepin hydrochloride
- The other ingredient are lactose, maize starch, povidone, talc, sodium starch gylocollate and magnesium stearate.
- The coating of the tablets also contains polyvinyl alcohol, talc, lecithin soya, Xanthan gum, carnauba wax, titanium dioxide (E171) and ponceau (E124).
Capsules
- The active substance is dosulepin hydrochloride
- The other ingredient are lactose, sodium starch glycollate and magnesium stearate
- The capsule shell contains gelatine, with small amounts of iron oxide (E172), titanium dioxide (E171), ponceau (E142) and black printing ink
What Dosulepin looks like and contents of the pack
Tablets
Dosulepin tablets are red with the marking ‘DN/75’ on one side and “G” on the other. .
Dosulepin is provided in blister packs of 28 tablets.
Capsules
Dosulepin capsules are brown opaque body and red opaque cap size 3 capsules, marked “G DN 25” in black ink, containing a white to faintly yellow powder. Dosulepin is provided in blister packs of 28 capsules.
Marketing Authorisation Holder
Generics [UK] Limited Station Close Potters Bar Hertfordshire EN6 1TL
Manufacturer
This leaflet was last approved in 05/2010
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