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DOSULEPIN 75 MG TABLETS - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - DOSULEPIN 75 MG TABLETS

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 25°C. 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 Tablets contain

  • The active substance is dosulepin hydrochloride. Each tablet contains 75 mg dosulepin hydrochloride.
  • The other ingredients are lactose monohydrate and magnesium stearate.
  • The coating of the tablets contains lactose monohydrate, polyethylene glycol, hypromellose and small amounts of Ponceau 4R (E124), sunset yellow (E110), yellow iron oxide (E172) and titanium dioxide (E171).

What Dosulepin Tablets look like and contents of the pack

Dosulepin tablets are red with the marking ‚MP76‘ on one side and plain on the other side.

Dosulepin tablets are available in blister packs of 14 or 28 tablets.

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

This leaflet was last revised in 09/2021. GE0045/O/PIL/GE5

PACKAGE LEAFLET: INFORMATION FOR THE USER Dosulepin 75 mg Tablets Dosulepin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • – 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

  • – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET

1. What Dosulepin is and what it is used for

2. What you need to know before you take Dosulepin

3. How to take Dosulepin

4. Possible side effects

5. How to store Dosulepin

6. Contents of the pack and other 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. what you need to know before you take dosulepin

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

  • if you are allergic to dosulepin hydrochloride or any of the other ingredients of this medicine (listed in section 6)
  • if you have an irregular heart beat or any other heart problems
  • if you have liver problems
  • you have an eye condition known as glaucoma
  • you are a man that has prostate problems (difficulty in passing water)
  • if 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:

  • if you are going to have general or dental surgery, tell your surgeon you are taking Dosulepin. It may affect the anaesthetic used
  • if you have fits (epilepsy)
  • if you have an eye condition known as glaucoma
  • if you are a man that has prostate problems (e.g. difficulty passing water)
  • if you are elderly and/or a patient with suspected cardiovascular disease
  • if you have a history of mania or psychoses (dosulepin may aggravate psychotic symptoms)
  • if you have conduction defects or cardiac arrhythmias
  • if you have severe renal disease
  • if you are elderly as you may be susceptible to experience adverse reactions to antidepressants (may suffer from e.g. agitation, confusion and postural hypotension)
  • if you have hyponatraemia (a low level of sodium in the blood).

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 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.

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.
  • 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. debrisoquine, guanethidine.
  • 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).
  • Buprenorphine/o­pioids- These medicines may interact with dosulepin and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.

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 this medicine.

Driving and using machines

These tablets 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 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 this can make the feeling of drowsiness worse.

Dosulepin Tablets contain lactose monohydrate, sunset yellow (E110) and ponceau 4R red (E124)

These tablets 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.

These tablets contain sunset yellow (E110) and ponceau 4R red (E124), which may cause allergic reactions.

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 tablets to take and when you should take them. Ask your doctor or pharmacist for help if you are not sure how to take your tablets or if you want more information. The following information is given as a guide only:

The tablets should be swallowed whole with a drink of water. Do not chew the tablets as you may get a bitter taste in your mouth and a temporary numbness of your tongue.

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.

The usual dose is:

Adults: The usual starting dose is 1 tablet a day. Your doctor may ask you to increase this. Your doctor will tell you if you should take the tablets 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 should be taken each day.

Elderly: The usual starting dose is 1 tablet a day.

If you take more Dosulepin than you should

You should only ever take the number of tablets that your doctor has told you to take. Do not change the dose yourself. If you think your tablets are not working well enough, speak to your doctor to see if the dose can be increased.

These tablets may seriously harm you and may be life threatening if you take too many. You should seek immediate help if a child takes any tablets or if you or anybody else accidentally takes too many tablets. Remember to take the pack with you, even if it is empty.

Symptoms of an overdosage include dryness of the 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), excitement, restlessness 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 tablets just because you feel better. If you stop taking this medicine too soon, your condition may get worse. If your doctor wants you to stop taking these tablets, 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 symptoms after taking these tablets, 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
  • nervousness
  • postural or orthostatic hypotension
  • insomnia
  • occasional hypertension
  • weakness and fatigue
  • ataxia
  • epileptiform seizures
  • occasional extrapyramidal symptoms including speech difficulties
  • gastric irritation with nausea and vomiting
  • photosensitization
  • idiosyncratic alveolitis (a condition where lungs become scarred and breathing becomes increasingly difficult) which may prove fatal.

The most common side effects (that affect less than 1 person in 10) are:

  • dry mouth disturbances of accommodation

Sources: Original (products.mhra.gov.uk)