Patient leaflet - Dosulepin capsules 25 mg

1. What Dosulepin capsules are and what they are used for

Dosulepin capsules contain dosulepin hydrochloride which belongs to a group of medicines called antidepressants. Dosulepin capsules are 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 capsules

Do not take Dosulepin capsules and speak to your doctor if:

you are allergic (hypersensitive) to dosulepin 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);
you have been diagnosed as having mania (feeling over-excited with unusual behaviour);
you have fits (epilepsy).

Warnings and precautions

Talk to your doctor or pharmacist before taking Dosulepin capsules

you are going to have general or dental surgery. Tell your surgeon or dentist you are taking Dosulepin capsules. It may affect the anaesthetic used.

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 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.

Taking other medicines

Tell your doctor if you are taking, have recently taken or might take 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 given to you for treating high blood pressure (hypertension).
Any hayfever/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 containing 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 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 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.

3. How to take Dosulepin capsules

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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 whether to take the capsules as separate doses throughout the day or as 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. UK-676-2512-07

100 mm

200 mm

Front 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.

Dosulepin capsules are not recommended for children.

If you take more Dosulepin capsules 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.

If you forget to take Dosulepin capsules

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 stop taking Dosulepin capsules

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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 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);
discomfort around the right lower rib cage;
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 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;
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 these types of medicines.

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to adjust the dose or give you a different medicine.

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 website: 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 capsules

Keep this medicine out of the sight and reach of children. 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 use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. 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.
The other ingredients are maize starch and magnesium stearate.
The capsule shell contains gelatin, with small amounts of iron oxide (E172), titanium dioxide (E171).

What Dosulepin capsules look like and contents of the pack

Dosulepin capsules are red.

Dosulepin capsules are available in blister pack of 14 and 28 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder:

Sovereign Medical

Sovereign House

Miles Gray Road

Basildon

Essex SS14 3FR

Manufacturer:

Waymade PLC