[PRODYNA] contains bupropion, one of a group of medicines called antidepressants.
[PRODYNA] is a medicine to treat your depression.
1. What [PRODYNA] is and what it is used for
2. What you need to know before you take [PRODYNA]
Do not take [PRODYNA]:
• if you are hypersensitive (allergic) to bupropion or any of the other ingredients of [PRODYNA] (see section 6)
• if you are under 18 years old
• if you suffer from fits or seizures
• if you are taking any medicine which already contains bupropion hydrochloride
• if you have abruptly stopped drinking alcohol or using sedatives
• if you have or had been diagnosed with the eating disorders bulimia (binge eating followed by making yourself vomit) or anorexia (abnormal low body weight with an intense fear of gaining weight)
• if you are taking a medicine which is a monoamine oxidase inhibitor (MAOI) (antidepressants)
• if you have a liver disease.
Seizures:
You should not exceed the dose of [PRODYNA] as prescribed by your doctor as the risk of seizures increases. Your risk of seizures also increases in the following situations, therefore inform your doctor if any of the below pertains to you:
• if you've ever had any fits or seizures
• if you have ever had a serious head injury
• if you have a brain tumour
• if you are taking medicine for seizures
• if you have diabetes for which you use insulin or tablets
• if you regularly drink a lot of alcohol
• if you have had any mental illness other than depression, including eating disorders.
If you experience a seizure (fit) whilst during treatment, stop taking [PRODYNA] and contact your doctor immediately.
− if you have previously had thoughts about killing or harming yourself
− if you are under 25 years old.
If you have thoughts of harming or killing yourself at any time: Get medical advice as soon as possible (from a doctor or at a hospital).
You should talk to your doctor, especially if:
• you have uncontrolled coronary artery disease (a heart disease caused by poor blood flow in the blood vessels of the heart) with symptoms such as angina (characterised by chest pain) or a recent heart attack
• if you have liver or kidney problems
• you have a history of mania (feeling elated or over-excited, which causes unusual behaviour)
• if you are elderly.
• if you are hypersensitive (allergic) to bupropion or any of the other ingredients of [PRODYNA] (see section 6)
• if you are under 18 years old
• if you suffer from fits or seizures
• if you are taking any medicine which already contains bupropion hydrochloride
• if you have abruptly stopped drinking alcohol or using sedatives
• if you have or had been diagnosed with the eating disorders bulimia (binge eating followed by making yourself vomit) or anorexia (abnormal low body weight with an intense fear of gaining weight)
• if you are taking a medicine which is a monoamine oxidase inhibitor (MAOI) (antidepressants)
• if you have a liver disease.
Warnings and precautions
Take special care with [PRODYNA]:Seizures:
You should not exceed the dose of [PRODYNA] as prescribed by your doctor as the risk of seizures increases. Your risk of seizures also increases in the following situations, therefore inform your doctor if any of the below pertains to you:
• if you've ever had any fits or seizures
• if you have ever had a serious head injury
• if you have a brain tumour
• if you are taking medicine for seizures
• if you have diabetes for which you use insulin or tablets
• if you regularly drink a lot of alcohol
• if you have had any mental illness other than depression, including eating disorders.
If you experience a seizure (fit) whilst during treatment, stop taking [PRODYNA] and contact your doctor immediately.
Thoughts of suicide or worsening of your condition:
If you are depressed, you can sometimes have thoughts of harming or killing yourself. These thoughts may be increased when first starting antidepressants. 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 under 25 years old.
If you have thoughts of harming or killing yourself at any time: Get medical advice as soon as possible (from a doctor or at a hospital).
You should talk to your doctor, especially if:
• you have uncontrolled coronary artery disease (a heart disease caused by poor blood flow in the blood vessels of the heart) with symptoms such as angina (characterised by chest pain) or a recent heart attack
• if you have liver or kidney problems
• you have a history of mania (feeling elated or over-excited, which causes unusual behaviour)
• if you are elderly.
3. How to take [PRODYNA]
Do not share medicines prescribed for you with any other person. Always use [PRODYNA] exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Adults:
The usual starting dose for adults is one 150 mg tablet every day. Your doctor may increase your dose to 300 mg once a day if your depression does not improve after several weeks. Take your dose of [PRODYNA] early in the morning. Do not take [PRODYNA] more than once each day. Your doctor may alter your dose:
• if you have liver or kidney problems
• if you are over 65 years of age
Swallow the tablets whole. Do not chew them, crush them or split them – if you do, the medicine will be released into your body too quickly. If this happens you may be more likely to get side effects including seizures (fits). Your doctor will tell you how long your treatment with [PRODYNA] will last. Do not stop treatment early because your depression may return.
If you have the impression that the effect of [PRODYNA] is too strong or too weak, tell your doctor or pharmacist.
If you take more [PRODYNA] than you should
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.
Symptoms of overdose may include:
• drowsiness, loss of consciousness, irregular heartbeat.
If you forget to take/use [PRODYNA]
If you forget to take [PRODYNA], take a dose as soon as you remember, then continue to take [PRODYNA] at the usual times. Do not take a double dose to make up for forgotten individual doses.
If you stop taking [PRODYNA]
It is important that you continue the course of treatment even if you begin to feel better after a few days. If you suddenly stop taking this medicine, the depression symptoms may come back or unwanted effects such as fits may appear.
Adults:
The usual starting dose for adults is one 150 mg tablet every day. Your doctor may increase your dose to 300 mg once a day if your depression does not improve after several weeks. Take your dose of [PRODYNA] early in the morning. Do not take [PRODYNA] more than once each day. Your doctor may alter your dose:
• if you have liver or kidney problems
• if you are over 65 years of age
Swallow the tablets whole. Do not chew them, crush them or split them – if you do, the medicine will be released into your body too quickly. If this happens you may be more likely to get side effects including seizures (fits). Your doctor will tell you how long your treatment with [PRODYNA] will last. Do not stop treatment early because your depression may return.
If you have the impression that the effect of [PRODYNA] is too strong or too weak, tell your doctor or pharmacist.
If you take more [PRODYNA] than you should
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.
Symptoms of overdose may include:
• drowsiness, loss of consciousness, irregular heartbeat.
If you forget to take/use [PRODYNA]
If you forget to take [PRODYNA], take a dose as soon as you remember, then continue to take [PRODYNA] at the usual times. Do not take a double dose to make up for forgotten individual doses.
If you stop taking [PRODYNA]
It is important that you continue the course of treatment even if you begin to feel better after a few days. If you suddenly stop taking this medicine, the depression symptoms may come back or unwanted effects such as fits may appear.
4. Possible side effects
[PRODYNA] can have side effects. Not all side effects reported for [PRODYNA] are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using [PRODYNA], please consult your doctor, pharmacist or other healthcare professional for advice.
If any of the following happens, stop using [PRODYNA] and tell your doctor immediately or go to the casualty department at your nearest hospital:
• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• seizures, fainting.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to [PRODYNA]. You may need urgent medical attention or hospitalisation.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
• uneven heartbeat (palpitations), increased, irregular or fast heartbeat (tachycardia), heart attack, stroke
• mood changes or mood swings or changes in personality, confusion, depression, aggression, delusions, abnormal behaviour
• thinking about or feeling like killing yourself, suicide attempt
• hallucinations (hearing voices or seeing things which are not there), believing things that are not true or being suspicious
• sudden chest pain due to blood clots in your lungs
• Stevens Johnson Syndrome (a rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals)
• yellowing of the skin and eyes, also called jaundice and inflammation of the liver.
These are all serious side effects. You may need urgent medical attention.
If any of the following happens, stop using [PRODYNA] and tell your doctor immediately or go to the casualty department at your nearest hospital:
• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• seizures, fainting.
These are all very serious side effects. If you have them, you may have had a serious allergic reaction to [PRODYNA]. You may need urgent medical attention or hospitalisation.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
• uneven heartbeat (palpitations), increased, irregular or fast heartbeat (tachycardia), heart attack, stroke
• mood changes or mood swings or changes in personality, confusion, depression, aggression, delusions, abnormal behaviour
• thinking about or feeling like killing yourself, suicide attempt
• hallucinations (hearing voices or seeing things which are not there), believing things that are not true or being suspicious
• sudden chest pain due to blood clots in your lungs
• Stevens Johnson Syndrome (a rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals)
• yellowing of the skin and eyes, also called jaundice and inflammation of the liver.
These are all serious side effects. You may need urgent medical attention.
5. How to store [PRODYNA]
Store all medicines out of reach of children. Store at or below 25 °C in original container. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).