Patient leaflet - Dosulepin 25 mg capsules
1. WHAT DOSULEPIN IS AND WHAT IT IS USED FOR
Dosulepin hydrochloride 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOSULEPIN
Do not take Dosulepin capsules and speak to your doctor if:
- you are allergic (hypersensitive) to dosulepin hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- 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 or enlarged prostate)
- you have been diagnosed as having mania (feeling over-excited with unusual behaviour)
- you have fits (epilepsy).
Dosulepin should not be given to children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dosulepin capsules if:
- you are going to have general or dental surgery; tell your surgeon you are taking Dosulepin. It may affect the anaesthetic used
- You are diabetic, as your blood sugar levels may change whilst taking dosulepin
- You are receiving electro-shock therapy (ECT) (used in severe depression)
- You have a thyroid (a gland in your neck) problem, difficulty in passing urine, or a tumour of the adrenal gland (a gland above the kidney)
- You suffer from porphyria (a disease causing damage to nerves and skin sensitivity)
- you have a history of mania or psychoses (dosulepin may aggravate psychotic symptoms)
- you have cardiac disease ● you have severe renal disease
- you have fits (epilepsy) ● You suffer from hyperthyroidism.
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 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 trial studies has shown an increased risk of suicidal behaviour in adults (less than 25 years old) 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.
The use of Buprenorphine together with Dosulepin can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Dosulepin”).
Other medicines and Dosulepin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
- A medicine used to treat depression called a mono-amine oxidase inhibitor (MAOI). You should not take Dosulepin at the same time as MAOIs or within 14 days of stopping them, e.g. selegiline, rasagiline
- Other medicines used to treat depression called SSRIs (selective serotonin re-uptake inhibitors)
- Any medicines given to you for treating high blood pressure (hypertension) e.g. betanidine, debrisoquine, guanethidine, clonidine
- Medicines used in heart conduction disorders, e.g. quinidine, amiodarone, felcainide, procainamide, propafenone or disopyramide
- Any hay fever/allergy medicines which contains terfenadine or astemizole
- Sotalol uinidine, Cisapride, pentamidine isetionate, clonidine (a medicine for heart or blood pressure problems)
- Halofantrine (a medicine for malaria)
- Rifampicin (an antibacterial)
- Any medicines called barbiturates (e.g. amylobarbitone for sleeplessness) or methylphenidate (used to treat behavioural problems)
- Any medicine that contains an opioid/narcotic analgesic (these include codeine, morphine, co-proxamol and co-dydramol)
- Tramadol, a strong pain-killer
- 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)
- Medicines called antimuscarinics (medicines for Parkinson's Disease, stomach and bladder problems)
- Pimozide and sertindole (medicines for serious mental problems)
- Cimetidine (used to treat stomach ulcers)
- Diuretic medicines (“water tablets”)
- Calcium channel blockers (medicine for heart problems eg. amlodipine, diltiazem, nifedipine, verapamil)
- Medicines for epilepsy or fits e.g. phenytoin, primidone, carbamazepine
- Oestrogen-containing contraceptives (these may decrease the antidepressant effect of dosulepin)
- Local anaesthetics
- Quinolone antibiotics e.g. moxifloxacin
- Atomoxetine used to treat Attention-Deficit / Hyperactivity Disorder (ADHD)
- Wafarin, coumarin or other anticoagulants, as there could be changes in bleeding times
- Ritonavir used in the treatment of HIV
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Dosulepin Capsules with food, drink and alcohol
Dosulepin can make you feel drowsy. If you drink alcohol with these capsules this can make you feel more drowsy.
The capsules should be swallowed whole with a drink of water. Do not chew them.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you can take this medicine.
Driving and using machines
This medicine can make you feel drowsy. Do not drive, operate machinery or do anything that requires you to be alert until you know how the medicine 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 this medicine, it can make the feeling of drowsiness worse.
Dosulepin Capsules contain lactose monohydrate
These capsules contain a sugar called lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.
Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3. HOW TO TAKE DOSULEPIN
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how many capsules to take and when you should take them. Ask your doctor or pharmacist 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. The usual dose is:
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 this medicine until your doctor tells you to stop.
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. 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.
Symptoms of an overdose include dry mouth, ataxia (impaired balance), drowsiness, loss of consciousness, muscle twitching, widely dilated pupils, hyperreflexia (overactive reflexes), sinus tachycardia (increased heart rate), hypothermia (body temperature below 35 degrees), visual hallucinations (seeing things that are not there), delirium (serious disturbance in mental abilities), urinary retention, paralytic ileus (paralysis of the digestive tract), and respiratory or metabolic alkalosis. In severe overdosage, convulsions, hypotension, respiratory and cardiac depression may develop with life threatening cardiac arrhythmias (heart rhythm problems) which may even occur after apparent recovery.
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 dose. If you are unsure, check again with your doctor or pharmacist.
If you stop taking Dosulepin
Do not stop taking these capsules just because you feel better. If you stop taking this medicine too soon, your condition may get worse. Withdrawal symptoms may include insomnia, irritability, headache, nausea, giddiness, panic-anxiety, restlessness and increased sweating. If your doctor wants you to stop taking these capsules, your doctor will ask you to stop gradually.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following rare side effects (that affect less than 1 person in 1000) after taking these capsules, you should contact your doctor immediately:
- a fever (high temperature, sweating, shivering)
- hepatitis (damage to the liver causing dark urine, jaundice (yellowing of the skin or whites of the eyes), nausea and fever)
- discomfort around the right lower rib cage
- changes in the blood including bone marrow (these will be found if you have blood tests)
- severe mood changes such as extreme excitability ● epileptiform seizures
The most common side effects (that affect less than 1 person in 10) are:
- Dry mouth ● Blurred vision
- Changes in the heart beat or heart conduction ● Constipation and difficulty in passing water
- Increased appetite ● Weight gain or weight loss
These side effects usually lessen as treatment continues.
Other side effects you may also experience are:
- Drowsiness ● Increased sweating
- Skin rashes, including itchy rashes and hives ● Tremor (shaking)
- Changes in sexual function ● Low blood pressure, which may cause dizziness or fainting
- An allergic reaction (eg skin sensitivity to light, itching, redness) ● Confusion
- Changes in levels of sugar and sodium in the blood (seen in blood tests) ● Enlargement of the testicles
- Swelling of the breasts in men ● Milk production in the breasts not related to pregnancy or breast feeding
- Impairment of movement ● Abnormal body movements
- Delusions (abnormal thoughts) ● Nervousness
- Seizures ● Speech difficulties
- Dizziness ● Raised blood pressure
- Nausea and vomiting ● Weakness
- Tiredness
An increased risk of bone fractures has been observed in patients taking this type of medicines.
Reporting of side effects
If you get any side effects talk to your doctor 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 side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DOSULEPIN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not store above 25ºC. Store in the original package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Dosulepin Capsules contain
- The active substance is dosulepin hydrochloride. Each capsule contain 25 mg 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 Dosulepin Capsules look like and contents of the pack
Dosulepin capsules are orange and caramel with the markings 'MP75' and '25 mg'.
Dosulepin capsules are available in blister packs of 14 or 28 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited, 41 – 43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited, 84 Pembroke Road, London, W8 6NX, UK