Trazodone Hydrochloride 100mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
Molipaxin® 100mg Capsules
(trazodone hydrochloride)
Read all of this leaflet carefully before you start taking this medicine
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Molipaxin 100mg Capsules but it will be referred to as Molipaxin throughout this leaflet. Please note that this leaflet also contains information about the other strength Molipaxin 50mg Capsules.
In this leaflet:
1. What Molipaxin is and what it is used for
2. Before you take Molipaxin
3. How to take Molipaxin
4. Possible side effects
5. How to store Molipaxin
6. Further information
1. What Molipaxin is and what it is used for
Molipaxin contains a medicine called trazodone hydrochloride. This belongs to a group of medicines called antidepressants.
Molipaxin can be used to treat anxiety and depression.
2. Before you take Molipaxin
Do not take this medicine and tell your doctor if:
• You are allergic (hypersensitive) to trazodone hydrochloride or any of the other ingredients of Molipaxin (listed in Section 6 ‘Further Information’). Signs of an allergic reaction can include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You have recently had a heart attack.
• You are a heavy drinker or are taking sleeping tablets.
• You are under 18 years of age.
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Molipaxin.
Take special care with Molipaxin 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.
Molipaxin should not be used in children and adolescents under 18 years of age.
If you are elderly, you may be more prone to side effects, increased caution is necessary especially when taking other medicines at the same time as Molipaxin or you have some other diseases.
Check with your doctor or pharmacist before taking this medicine if you:
• Have or have ever had fits or seizures (epilepsy)
• Have severe liver, kidney or heart problems
• Are pregnant, trying to become pregnant or are breast-feeding
• Have an overactive thyroid gland (hyperthyroidism)
• Have problems passing water or need to pass water (urine) frequently
• Have narrow angle glaucoma (an eye disorder)
• Have schizophrenia or other type of mental disorder
• Are elderly, as you may be more prone to side effects
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Molipaxin.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Molipaxin can affect the way some other medicines work. Also some medicines can affect the way Molipaxin works.
Tell your doctor if you are taking any of the following medicines:
• MAOI (MonoAmine Oxidase Inhibitors) medicines such as tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson’s disease), or have taken them in the last 2 weeks
• Other antidepressants (such as amitriptyline or fluoxetine)
• Sedatives (such as tranquilizers or sleeping pills)
• Medicines used to treat epilepsy such as carbamazepine and phenytoin
• Medicines used to treat high blood pressure, for example, clonidine
• Digoxin (used to treat heart problems)
• Medicines used to treat fungal infections such as ketoconazole and itraconazole
• Some medicines used to treat HIV such as ritonavir and indinavir
• Erythromycin, an antibiotic used to treat infections
• Levodopa (used to treat Parkinson’s disease)
• St. John’s Wort (a herbal remedy)
• Warfarin (used to stop your blood from clotting)
Anaesthetics
If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking Molipaxin.
Taking Molipaxin with food and drink
You should avoid drinking alcohol while taking Molipaxin
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.
Taking Molipaxin in the late stages of pregnancy may lead to your baby experiencing withdrawal symptoms when they are born.
If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
Molipaxin may make you feel sleepy or dizzy. If this happens do not drive or use any tools or machines.
Important information about some of the ingredients of Molipaxin
Molipaxin contain lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking Molipaxin.
3. How to take Molipaxin
Always take Molipaxin exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the capsules whole with a drink of water
• Take with or after food. This can help lower the chances of side effects
• If you have been told to take Molipaxin only once each day then you should take it before going to bed
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
How much to take
Adults:
Depression
• Adults usually start by taking 150mg each day
• Your doctor may increase the dose to 300mg each day depending on your condition
• For adults in hospital the dose may be as high as 600mg each day
Anxiety
• Adults usually start by taking 75mg each day
• Your doctor may increase the dose to 300mg each day
Elderly:
• Older people or those who are frail will usually be given a starting dose of 100mg each day.
Children:
Children and adolescents under 18 years should not take Molipaxin.
If you take more Molipaxin than you should
If you take more Molipaxin than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.
The following effects may happen: feeling sick or being sick, feeling sleepy, dizzy or faint, fits (seizures), confusion, breathing or heart problems.
If you forget to take Molipaxin
If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Molipaxin
Keep taking Molipaxin until your doctor tells you to stop. Do not stop taking Molipaxin just because you feel better. When your doctor tells you to stop taking these capsules he/she will help you stop taking them gradually.
4. Possible side effects
Like all medicines, Molipaxin can cause side effects, although not everybody gets them.
Stop taking Molipaxin and see a doctor or go to a hospital straight away if:
• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty swallowing or breathing, itching of the skin and nettle rash. This may mean you are having an allergic reaction to Molipaxin
• Painful erection of the penis, unrelated to sexual activity, that will not go away (priapism)
• Yellowing of the eyes or skin. This could be a liver problem (such as jaundice)
• Getting infections more easily than usual. This could be because of a blood disorder (agranulocytosis)
• Bruising more easily than usual. This could be because of a blood disorder (thrombocytopenia)
• You have severe abdominal pain and bloating, are being sick (vomiting) and have constipation. These may be signs that your intestine is not working properly (paralytic ilius)
Talk to your doctor straight away if you notice the following side-effects:
• You have thoughts of harming or killing yourself
• Feeling tired, faint, dizzy, having pale skin. These could be signs of anaemia
• Convulsions/fits
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (parasthesia)
• Feeling confused, restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heart beat, you may have something called Serotonin syndrome
• Feeling very unwell possibly with shortness of breath (dyspnoea), difficulty in walking or walking with a shuffling gait, shaking, uncontrolled muscle twitching, and a high temperature (above 38°C). This could be a rare condition known as Neuroleptic Malignant Syndrome
• Rapid, slow or irregular heart beat
Below is a list of other side effects that have been reported:
• Feeling drowsy or sleepy, tiredness
• Feeling less alert than usual
• Feeling sick (nausea) or being sick (vomiting), indigestion
• Constipation, diarrhoea
• Dry mouth, altered taste, increased amounts of saliva, blocked nose
• Sweating more than usual
• Dizziness, headache, confusion, weakness, tremor (shaking)
• Blurred vision
• Loss of appetite and weight loss
• Feeling dizzy or light-headed on standing or sitting up quickly (postural hypotension), fainting (syncope)
• Feeling restless and having difficulty sleeping
• Water retention which may cause swollen arms or legs
• Skin rash, itching
• Chest pain
• Pain in limbs, back pain, pain in your muscles, pain in your joints
• Jerking movements that you can not control, mainly in of the arms and legs, uncontrolled muscle movements or twitches
• Frequent infections with high temperature, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia.
• Feeling anxious or more nervous than usual, feeling agitated
• Overactive behaviour or thoughts (mania), believing things that are not true (delusions), memory disturbance
• Nightmares
• Decreased sex drive
• Feeling dizzy, possibly with a ‘spinning’ feeling (vertigo)
• High blood pressure
• High temperature
• Flu type symptoms
• Difficulty with speaking
• Higher than normal number of white blood cells (seen by a blood test)
• High levels of liver enzymes in your blood (shown by a blood test)
• Feeling tired, weak and confused, having muscle that ache, are stiff or do not work well. There may also be headache, loss of appetite, nausea or vomiting, convulsion. This may be due to low sodium levels in your blood.
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
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Molipaxin
Keep out of the sight and reach of children.
Do not take the capsules after the expiry date which is stated on the carton/blister label after ‘Exp’. The date refers to the last day of that month.
Do not store above 25°C. Store in a dry place.
Store in the original package.
If the medicine become discoloured or show any signs of deterioration, seek the advice of your pharmacist. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Molipaxin contains
Each hard capsule contains 100mg of the active substance, trazodone hydrochloride Other ingredients include lactose monohydrate, magnesium stearate, gelatin, titanium dioxide E171, erythrosine E127, indigo carmine E132, yellow iron oxide E172, red iron oxide (E172) and ink black containing shellac, iron oxide black (E172), propylene glycol and ammonium hydroxide or shellac, iron oxide black (E172), propylene glycol, strong ammonia solution and potassium hydroxide.
What Molipaxin looks like and contents of the pack
The capsules have an opaque violet cap and opaque fawn body. They are printed in black ink with the Roussel logo on the cap and R365C on the body.
The Molipaxin is available in blister packs containing 56 capsules.
Manufactured by: Sanofi Synthelabo Ltd., T/A Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon, Newcastle Upon Tyne NE3 3TT, UK.
OR
Zentiva, k.s. U Kabelovny 130, 102 37 Prague 10, Dolni Mecholupy, Czech Republic.
Procured from within the EU & repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Molipaxin 100mg Capsules;
PL 18799/2274 POM
Leaflet date: 06.06.2016
Molipaxin is a registered trade mark of Sanofi group of companies.
Trazodone Hydrochloride 100mg Capsules
Read all of this leaflet carefully before you start taking this medicine
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Trazodone Hydrochloride 100mg Capsules but it will be referred to as Trazodone throughout this leaflet. Please note that this leaflet also contains information about the other strength Trazodone Hydrochloride 50mg Capsules.
In this leaflet:
1. What Trazodone is and what it is used for
2. Before you take Trazodone
3. How to take Trazodone
4. Possible side effects
5. How to store Trazodone
6. Further information
1. What Trazodone is and what it is used for
Trazodone contains a medicine called trazodone hydrochloride. This belongs to a group of medicines called antidepressants.
Trazodone can be used to treat anxiety and depression.
2. Before you take Trazodone
Do not take this medicine and tell your doctor if:
• You are allergic (hypersensitive) to trazodone hydrochloride or any of the other ingredients of Trazodone (listed in Section 6 ‘Further Information’). Signs of an allergic reaction can include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You have recently had a heart attack.
• You are a heavy drinker or are taking sleeping tablets.
• You are under 18 years of age.
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Trazodone.
Take special care with Trazodone 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.
Trazodone should not be used in children and adolescents under 18 years of age.
If you are elderly, you may be more prone to side effects, increased caution is necessary especially when taking other medicines at the same time as Trazodone or you have some other diseases.
Check with your doctor or pharmacist before taking this medicine if you:
• Have or have ever had fits or seizures (epilepsy)
• Have severe liver, kidney or heart problems
• Are pregnant, trying to become pregnant or are breast-feeding
• Have an overactive thyroid gland (hyperthyroidism)
• Have problems passing water or need to pass water (urine) frequently
• Have narrow angle glaucoma (an eye disorder)
• Have schizophrenia or other type of mental disorder
• Are elderly, as you may be more prone to side effects
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Trazodone.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Trazodone can affect the way some other medicines work. Also some medicines can affect the way Trazodone works.
Tell your doctor if you are taking any of the following medicines:
• MAOI (MonoAmine Oxidase Inhibitors) medicines such as tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson’s disease), or have taken them in the last 2 weeks
• Other antidepressants (such as amitriptyline or fluoxetine)
• Sedatives (such as tranquilizers or sleeping pills)
• Medicines used to treat epilepsy such as carbamazepine and phenytoin
• Medicines used to treat high blood pressure, for example, clonidine
• Digoxin (used to treat heart problems)
• Medicines used to treat fungal infections such as ketoconazole and itraconazole
• Some medicines used to treat HIV such as ritonavir and indinavir
• Erythromycin, an antibiotic used to treat infections
• Levodopa (used to treat Parkinson’s disease)
• St. John’s Wort (a herbal remedy)
• Warfarin (used to stop your blood from clotting)
Anaesthetics
If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking Trazodone.
Taking Trazodone with food and drink
You should avoid drinking alcohol while taking Trazodone
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.
Taking Trazodone in the late stages of pregnancy may lead to your baby experiencing withdrawal symptoms when they are born.
If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.
Driving and using machines
Trazodone may make you feel sleepy or dizzy. If this happens do not drive or use any tools or machines.
Important information about some of the ingredients of Trazodone
Trazodone contain lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking Trazodone.
3. How to take Trazodone
Always take Trazodone exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the capsules whole with a drink of water
• Take with or after food. This can help lower the chances of side effects
• If you have been told to take Trazodone only once each day then you should take it before going to bed
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
How much to take
Adults:
Depression
• Adults usually start by taking 150mg each day
• Your doctor may increase the dose to 300mg each day depending on your condition
• For adults in hospital the dose may be as high as 600mg each day
Trazodone Hydrochloride100mg Capsules;
Anxiety
• Adults usually start by taking 75mg each day
• Your doctor may increase the dose to 300mg each day
Elderly:
• Older people or those who are frail will usually be given a starting dose of 100mg each day.
Children:
Children and adolescents under 18 years should not take Trazodone.
If you take more Trazodone than you should
If you take more Trazodone than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.
The following effects may happen: feeling sick or being sick, feeling sleepy, dizzy or faint, fits (seizures), confusion, breathing or heart problems.
If you forget to take Trazodone
If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Trazodone
Keep taking Trazodone until your doctor tells you to stop. Do not stop taking Trazodone just because you feel better. When your doctor tells you to stop taking these capsules he/she will help you stop taking them gradually.
4. Possible side effects
Like all medicines, Trazodone can cause side effects, although not everybody gets them.
Stop taking Trazodone and see a doctor or go to a hospital straight away if:
• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty swallowing or breathing, itching of the skin and nettle rash. This may mean you are having an allergic reaction to Trazodone
• Painful erection of the penis, unrelated to sexual activity, that will not go away (priapism)
• Yellowing of the eyes or skin. This could be a liver problem (such as jaundice)
• Getting infections more easily than usual. This could be because of a blood disorder (agranulocytosis)
• Bruising more easily than usual. This could be because of a blood disorder (thrombocytopenia)
• You have severe abdominal pain and bloating, are being sick (vomiting) and have constipation. These may be signs that your intestine is not working properly (paralytic ilius)
Talk to your doctor straight away if you notice the following side-effects:
• You have thoughts of harming or killing yourself
• Feeling tired, faint, dizzy, having pale skin. These could be signs of anaemia
• Convulsions/fits
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (parasthesia)
• Feeling confused, restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heart beat, you may have something called Serotonin syndrome
• Feeling very unwell possibly with shortness of breath (dyspnoea), difficulty in walking or walking with a shuffling gait, shaking, uncontrolled muscle twitching, and a high temperature (above 38°C). This could be a rare condition known as Neuroleptic Malignant Syndrome
• Rapid, slow or irregular heart beat
Below is a list of other side effects that have been reported:
• Feeling drowsy or sleepy, tiredness
• Feeling less alert than usual
• Feeling sick (nausea) or being sick (vomiting), indigestion
• Constipation, diarrhoea
• Dry mouth, altered taste, increased amounts of saliva, blocked nose
• Sweating more than usual
• Dizziness, headache, confusion, weakness, tremor (shaking)
• Blurred vision
• Loss of appetite and weight loss
• Feeling dizzy or light-headed on standing or sitting up quickly (postural hypotension), fainting (syncope)
• Feeling restless and having difficulty sleeping
• Water retention which may cause swollen arms or legs
• Skin rash, itching
• Chest pain
• Pain in limbs, back pain, pain in your muscles, pain in your joints
• Jerking movements that you can not control, mainly in of the arms and legs, uncontrolled muscle movements or twitches
• Frequent infections with high temperature, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia.
• Feeling anxious or more nervous than usual, feeling agitated
• Overactive behaviour or thoughts (mania), believing things that are not true (delusions), memory disturbance
• Nightmares
• Decreased sex drive
• Feeling dizzy, possibly with a ‘spinning’ feeling (vertigo)
• High blood pressure
• High temperature
• Flu type symptoms
• Difficulty with speaking
• Higher than normal number of white blood cells (seen by a blood test)
• High levels of liver enzymes in your blood (shown by a blood test)
• Feeling tired, weak and confused, having muscle that ache, are stiff or do not work well. There may also be headache, loss of appetite, nausea or vomiting, convulsion. This may be due to low sodium levels in your blood.
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
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Trazodone
Keep out of the sight and reach of children.
Do not take the capsules after the expiry date which is stated on the carton/blister label after ‘Exp’. The date refers to the last day of that month.
Do not store above 25°C. Store in a dry place.
Store in the original package.
If the medicine become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Trazodone contains
Each hard capsule contains 100mg of the active substance, trazodone hydrochloride Other ingredients include lactose monohydrate, magnesium stearate, gelatin, titanium dioxide E171, erythrosine E127, indigo carmine E132, yellow iron oxide E172, red iron oxide (E172) and ink black containing shellac, iron oxide black (E172), propylene glycol and ammonium hydroxide or shellac, iron oxide black (E172), propylene glycol, strong ammonia solution and potassium hydroxide.
What Trazodone looks like and contents of the pack
The capsules have an opaque violet cap and opaque fawn body. They are printed in black ink with the Roussel logo on the cap and R365C on the body.
The Trazodone is available in blister packs containing 56 capsules.
Manufactured by: Sanofi Synthelabo Ltd., T/A Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon, Newcastle Upon Tyne NE3 3TT, UK.
OR
Zentiva, k.s. U Kabelovny 130, 102 37 Prague 10, Dolni Mecholupy, Czech Republic.
Procured from within the EU & repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
PL 18799/2274
Leaflet date: 06.06.2016
POM