Dosulepin tablets 75 mg – patient leaflet, side effects, dosage

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

The name of your medicine is Dosulepin Tablets 75 mg (referred to as Dosulepin Tablets in this leaflet). Dosulepin hydrochloride belongs to a group of medicines called antidepressants.

Dosulepin Tablets are used to treat depression and can also help reduce feelings of anxiety. Your doctor has prescribed dosulepin as other medicines are unsuitable for you. Please ask your doctor or pharmacist if you need more information.

2. What you need to know before you take Dosulepin Tablets

Do not take Dosulepin Tablets

• if you are allergic to dosulepin or any of the other ingredients of this medicine (listed in section 6)
• if you have an irregular heartbeat or any other heart problems
• if you have liver problems
• if you have an eye condition known as glaucoma
• if you are a man that has prostate problems (difficulty in passing water or enlarged prostate)
• if you have been diagnosed as having mania (feeling over-excited with unusual behaviour)
• if you have fits (epilepsy).

Dosulepin Tablets are not for use in children.

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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dosulepin Tablets

• If you are going to the dentist or going to have surgery, tell your surgeon you are taking Dosulepin Tablets. It may affect the anaesthetic used.
• If you are diabetic, as your blood sugar levels may change whilst taking dosulepin.
• if you are receiving electro-shock therapy (ECT), used in severe depression.
• if 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)
• if you suffer from porphyria (a disease-causing damage to nerves and skin sensitivity)
• if you have a history of mania or psychoses
• if you have cardiac disease

• if you have severe renal disease

  • if you have a history of epilepsy
  • if you suffer from hyperthyroidism

Other medicines and Dosulepin Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including any medicines obtained without a prescription. In particular any of the following:

• A medicine used to treat depression is called a mono-amine oxidase inhibitor (MAOI). You should not take Dosulepin Tablets 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, flecainide, procainamide, propafenone or disopyramide
• Any hayfever/allergy medicines which contains terfenadine or astemizole
• Sotalol, quinidine, cisapride, pentamidine isetionate, clonidine (medicines for heart or blood pressure problems)
• Halofantrine (a medicine for malaria)
• Rifampicin (an antibacterial)
• Any medicine called barbiturates (e.g. amylobarbital for sleeplessness) or methylphenidate (used to treat behavioural problems)
• Any medicine containing 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 (medicines for heart problems e.g. 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)

• Warfarin, coumarin or other anticoagulants, as there could be changes in bleeding times.
• Ritonavir used in the treatment of HIV.

Dosulepin Tablets with food, drink and alcohol Dosulepin Tablets can make you feel drowsy. If you drink alcohol with Dosulepin Tablets this can make you feel drowsier.

The tablets should be swallowed whole with a drink of water. Do not chew them.

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 tablets.

Driving and using machines

Dosulepin 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.

Dosulepin Tablets contain Ponceau 4R (E124) Ponceau 4R (E124) can cause allergic reactions.

3. How to take Dosulepin Tablets

Your doctor will tell you how many tablets to take and when you should take them. This will also be on the pack label. Ask your pharmacist or doctor for help if you are not sure how to take your tablets or if you want more information.

The tablets should be swallowed whole with a drink of water. Do not chew the tablets.

UK-676-3544-04

Package leaflet: Information for the user Dosulepin Tablets 75 mg dosulepin hydrochloride

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Paper: 54 Gsm Maplitho / Date: 08.08.2025 / Glue: No / V1 / Shaji

The usual dose is:

Adults: The usual starting dose is 1 tablet a day. In some cases, your doctor may ask you to increase this if he/she considers it necessary. Normally, not more than 3 tablets should be taken each day.

Elderly: The usual starting dose is between 1 and 3 tablets 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 tablets until your doctor tells you to stop.

If you stop taking Dosulepin Tablets

Do not stop taking these tablets just because you feel better. If you stop taking the tablets 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 tablets, your doctor will ask you to stop gradually.

If you forget to take Dosulepin Tablets 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 take more Dosulepin Tablets 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, talk to your doctor to see if the dose can be increased.

Dosulepin may seriously harm you and may be life-threatening if you take too many tablets. 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. The main symptoms of overdose are unconsciousness, convulsions, reduction in heart and lung function and life-threatening heart rhythm disorders which may even occur after apparent recovery. Remember to take the pack with you, even if it is empty.

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 tablets, 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)
• changes in the blood including bone marrow (these will be found if you have blood tests)
• severe mood changes such as extreme excitability
• fits.

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

• dry mouth
• blurred vision
• changes in heartbeat 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 (e.g. 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 medicine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Tablets

Keep these tablets in the original packaging 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 that is stated on the carton and blister strip 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 Tablets contain

• The active substance is dosulepin hydrochloride. The other ingredients are tricalcium phosphate, maize starch, povidone and magnesium stearate.
• The coating of the tablets also contains talc, polyethylene glycol, lecithin, ponceau 4R(E124), quinoline yellow (E104), titanium dioxide (E171) and indigo carmine (E132).

What Dosulepin Tablets look like and contents of the pack

Dosulepin Tablets are red, round biconvex film-coated tablets.

Dosulepin Tablets are provided in calendar packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, UK

Manufacturer

Waymade Plc, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, UK

This leaflet was last revised in September 2025

PL 06464/0770 Dosulepin Tablets 75 mg

To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or

telephone: 01268 535200 (select option Medical Information) / email: medinfo@waymade.co.uk

UK-676-3544-04 PP000884