Septrin 160 Mg/800 Mg Forte Tablets
Package Leaflet: Information for the User
Septrin® 160 mg/800 mg Forte Tablets
(co-trimoxazole)
This medicine is available as the above name but will be referred to as Septrin Forte throughout the following leaflet.
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.
In this leaflet:
1 What Septrin Forte is and what it is used for
2 Before you take Septrin Forte
3 How to take Septrin Forte
4 Possible side effects
5 How to store Septrin Forte
6 Further information
1 What Septrin Forte is and what it is used for
Septrin Forte is made up of two different medicines called sulfamethoxazole and trimethoprim. Both belong to a group of medicines called antibiotics. They are used to treat infections caused by bacteria. Like all antibiotics, Septrin Forte only works against some types of bacteria. This means that it is only suitable for treating some types of infections.
Septrin Forte can be used to treat or prevent:
• lung infections (pneumonia or PCP) caused by a bacteria called Pneumocystis jiroveci (previously known as Pneumocystis carinii)
• infections caused by a bacteria called Toxoplasma (toxoplasmosis).
Septrin Forte can be used to treat:
• bladder or urinary tract infections (water infections)
• lung infections such as bronchitis
• ear infections such as otitis media
• an infection called nocardiosis, it can affect the lungs, skin and brain.
2 Before you take Septrin Forte
Do not take Septrin Forte if:
• you are allergic (hypersensitive) to sulfamethoxazole, trimethoprim or any of the other ingredients of Septrin Forte (see section 6:
Further information)
• you are allergic to sulfonamide medicines. Examples include sulfonylureas (such as gliclazide and glibenclamide) or thiazide diuretics (such as bendroflumethiazide - a water tablet)
• you have liver or kidney problems
• you have ever had a problem with your blood
• it is for your child and they are less than 6 weeks old or were premature. Unless it is for the treatment or prevention of PCP. In this case, babies should be at least 4 weeks old.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Septrin Forte.
Take special care with Septrin Forte
Before you take Septrin Forte, tell your doctor or pharmacist if:
• you have severe allergies or asthma
• potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Septrin Forte appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
• additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
• these potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.
• the highest risk for occurrence of serious skin reactions is within the first weeks of treatment.
• if you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Septrin Forte you must not be re-started on Septrin Forte at any time.
• if you develop a rash or these skin symptoms, stop taking Septrin Forte, seek urgent advice from a doctor and tell him that you are taking this medicine.
• you have been told that you have a rare blood problem called porphyria, which can affect your skin or nervous system
• you don't have enough folic acid (a vitamin) in your body - which can make your skin pale and make you feel tired, weak and breathless. This is known as anaemia
• you have ever had jaundice which can cause yellowing of your skin or the whites of your eyes
• you have a problem with your metabolism called phenylketonuria and are not on a special diet to help your condition
• you are elderly
• you are underweight or malnourished
• you have been told by your doctor that you have a lot of potassium in your blood.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Septrin Forte.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Septrin Forte can affect the way some medicines work. Also some other medicines can affect the way Septrin Forte works.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
• Diuretics (water tablets), which help increase the amount of urine you produce
• Pyrimethamine, used to treat and prevent malaria, and to treat diarrhoea
• Ciclosporin, used after transplant operations or for your immune system
• Medicines used to thin the blood such as warfarin
• Phenytoin, used to treat epilepsy (fits)
• Medicines for diabetes, such as glibenclamide, glipizide or tolbutamide (sulfonylureas)
• Medicines to treat problems with the way your heart beats such as digoxin or procainamide
• Amantadine, used to treat Parkinson's disease, multiple sclerosis,
‘flu or shingles
• Medicines to treat HIV (Human Immunodeficiency Virus), called zidovudine or lamivudine
• Medicines that can increase the amount of potassium in your blood, such as diuretics (water tablets, which help increase the amount of urine you produce), steroids (like prednisolone) and digoxin
• Methotrexate, a medicine used to treat cancer or for your immune system.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Septrin Forte.
Taking Septrin Forte with food and drink
You should take Septrin Forte with some food or drink. This will stop you feeling sick (nausea) or having diarrhoea. Although it is better to take it with food, you can still take it on an empty stomach.
Drink plenty of fluid such as water while you are taking Septrin Forte.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, planning to get pregnant, or breast-feeding.
3 How to take Septrin Forte
Always take Septrin Forte exactly as your doctor has told you.
The label on your pack will tell you how much to take and how often to
take it. You should check with your doctor or pharmacist if you are not
sure.
Usual Dose
Adults and children over 12 years
• The usual dose is one tablet in a morning and one tablet in an evening.
• Septrin Forte should be taken for at least five days.
• Make sure that you finish the course of Septrin Forte which your doctor has prescribed. Septrin Forte is not usually given to children under 12 years old. If they have been given to your child please speak to your doctor or pharmacist for more information.
POM
Special Dose
The dose of Septrin Forte and how long you need to take it depends on the infection you have and how bad it is. Your doctor may prescribe you a different dose or length of course of Septrin Forte to
• treat urinary tract (water) infections
• treat and prevent lung infections caused by the bacteria
Pneumocystis jiroveci
• treat infections caused by the bacteria Toxoplasma (toxoplasmosis) or Nocardia (nocardiosis).
If you have kidney problems your doctor may
• prescribe a lower dose of Septrin Forte
• take blood to test whether the medicine is working properly.
If you take Septrin Forte for a long time your doctor may
• take blood to test whether the medicine is working properly
• prescribe folic acid (a vitamin) for you to take at the same time as Septrin Forte.
If you take more Septrin Forte than you should
If you take more Septrin Forte than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you. If you have taken too much Septrin Forte you may
• feel or be sick
• feel dizzy or confused.
If you forget to take Septrin Forte
• If you forget to take a dose, take it as soon as you remember it.
• Do not take a double dose to make up for the forgotten dose.
4 Possible side effects
Like all medicines Septrin Forte can cause side effects, although not everybody gets them. You may experience the following side effects with this medicine. Stop taking Septrin Forte and tell your doctor immediately if you have an allergic reaction. Chances of an allergic reaction is very rare (fewer than 1 in 10,000 people are affected), signs of an allergic reaction include
Allergic reactions
• Difficulty in breathing
• Fainting
• Swelling of face
• Swelling of mouth, tongue or throat which may be red and painful and/or cause difficulty in swallowing
• Chest pain
• Red patches on the skin
Very Common (more than 1 in 10 people)
• High levels of potassium in your blood, which can cause abnormal heart beats (palpitations).
Common (less than 1 in 10 people)
• An infection called thrush or candidiasis which can affect your mouth or vagina. It is caused by a fungus
• Headache
• Feeling sick (nausea)
• Diarrhoea
• Skin rashes.
Uncommon (less than 1 in 100)
• Being sick (vomiting).
Very Rare (less than 1 in 10,000 people)
• Fever (high temperature) or frequent infections
• Sudden wheeziness or difficulty breathing
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see Take special care with Septrin Forte).
• Mouth ulcers, cold sores and ulcers or soreness of your tongue
• Skin lumps or hives (raised, red or white, itchy patches of skin)
• Blisters on your skin or inside your mouth, nose, vagina or bottom
• Inflammation of the eye which causes pain and redness
• The appearance of a rash or sunburn when you have been outside (even on a cloudy day)
• Low levels of sodium in your blood
• Changes in blood tests
• Feeling weak, tired or listless, pale skin (anaemia)
• Heart problems
• Jaundice (the skin and the whites of your eyes turn yellow).
This can occur at the same time as unexpected bleeding or bruising
• Pains in your stomach, which can occur with blood in your faeces (poo)
• Pains in your chest, muscles or joints and muscle weakness
• Arthritis
• Problems with your urine. Difficulty passing urine. Passing more or less urine than usual. Blood or cloudiness in your urine.
• Kidney problems
• Sudden headache or stiffness of your neck, accompanied by fever (high temperature)
• Problems controlling your movements
• Fits (convulsions or seizures)
• Feeling unsteady or giddy
• Ringing or other unusual sounds in your ears
• Tingling or numbness in your hands and feet
• Seeing strange or unusual sights (hallucinations)
• Depression
• Muscle pain and/or muscle weakness in HIV patients. 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.
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 Septrin Forte
• Keep out of the sight and reach of children.
• Do not store above 25°C. Store in the original package.
• Do not take the tablets after the expiry date shown on the carton. The expiry date refers to the last day of that month.
• 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 protect the environment.
• If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your doctor or pharmacist, who will tell you what to do.
6 Further information
What Septrin Forte contains
Septrin Forte is made up of two different medicines called sulfamethoxazole and trimethoprim.
Each tablet contains 160 mg of trimethoprim and 800 mg of sulfamethoxazole.
The other ingredients of Septrin Forte are: sodium starch glycollate (type A) (from potato starch), povidone K30, docusate sodium and magnesium stearate.
What Septrin Forte looks like and contents of the pack
Septrin Forte is a white, oval shaped, biconvex tablet scored in half on one side and plain on the other side.
Septrin Forte is supplied to you in a blister pack, containing 50 or 100 tablets.
PL: 15814/1215
Manufactured by Alcala Farma, S.L, Ctra. M-300, Km 29,920 Alcala de Henares, 28802 Madrid, Spain OR Alcala Farma, S.L, Avenida de Madrid 82, Alcala de Henares, 28802 Madrid, Spain.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 08.08.2016.
Septrin Forte is a registered trademark of Aspen Global Incorporated. To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
Package Leaflet: Information for the User
Co-trimoxazole 160 mg/800 mg Forte Tablets
This medicine is available as the above name but will be referred to as Co-trimoxazole throughout the following leaflet.
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.
In this leaflet:
1 What Co-trimoxazole is and what it is used for
2 Before you take Co-trimoxazole
3 How to take Co-trimoxazole
4 Possible side effects
5 How to store Co-trimoxazole
6 Further information
1 What Co-trimoxazole is and what it is used for
Co-trimoxazole is made up of two different medicines called sulfamethoxazole and trimethoprim. Both belong to a group of medicines called antibiotics. They are used to treat infections caused by bacteria. Like all antibiotics, Co-trimoxazole only works against some types of bacteria. This means that it is only suitable for treating some types of infections.
Co-trimoxazole can be used to treat or prevent:
• lung infections (pneumonia or PCP) caused by a bacteria called Pneumocystis jiroveci (previously known as Pneumocystis carinii)
• infections caused by a bacteria called Toxoplasma (toxoplasmosis).
Co-trimoxazole can be used to treat:
• bladder or urinary tract infections (water infections)
• lung infections such as bronchitis
• ear infections such as otitis media
• an infection called nocardiosis, it can affect the lungs, skin and brain.
2 Before you take Co-trimoxazole
Do not take Co-trimoxazole if:
• you are allergic (hypersensitive) to sulfamethoxazole, trimethoprim or any of the other ingredients of Co-trimoxazole (see section 6: Further information)
• you are allergic to sulfonamide medicines. Examples include sulfonylureas (such as gliclazide and glibenclamide) or thiazide diuretics (such as bendroflumethiazide - a water tablet)
• you have liver or kidney problems
• you have ever had a problem with your blood
• it is for your child and they are less than 6 weeks old or were premature. Unless it is for the treatment or prevention of PCP. In this case, babies should be at least 4 weeks old.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Co-trimoxazole.
Take special care with Co-trimoxazole
Before you take Co-trimoxazole, tell your doctor or pharmacist if:
• you have severe allergies or asthma
• potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Co-trimoxazole appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk.
• additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).
• these potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.
• the highest risk for occurrence of serious skin reactions is within the first weeks of treatment.
• if you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Co-trimoxazole you must not be re-started on Co-trimoxazole at any time.
• if you develop a rash or these skin symptoms, stop taking Co-trimoxazole, seek urgent advice from a doctor and tell him that you are taking this medicine.
• you have been told that you have a rare blood problem called porphyria, which can affect your skin or nervous system
• you don't have enough folic acid (a vitamin) in your body - which can make your skin pale and make you feel tired, weak and breathless. This is known as anaemia
• you have ever had jaundice which can cause yellowing of your skin or the whites of your eyes
• you have a problem with your metabolism called phenylketonuria and are not on a special diet to help your condition
• you are elderly
• you are underweight or malnourished
• you have been told by your doctor that you have a lot of potassium in your blood.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Co-trimoxazole.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Co-trimoxazole can affect the way some medicines work. Also some other medicines can affect the way Co-trimoxazole works.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
• Diuretics (water tablets), which help increase the amount of urine you produce
• Pyrimethamine, used to treat and prevent malaria, and to treat diarrhoea
• Ciclosporin, used after transplant operations or for your immune system
• Medicines used to thin the blood such as warfarin
• Phenytoin, used to treat epilepsy (fits)
• Medicines for diabetes, such as glibenclamide, glipizide or tolbutamide (sulfonylureas)
• Medicines to treat problems with the way your heart beats such as digoxin or procainamide
• Amantadine, used to treat Parkinson's disease, multiple sclerosis,
‘flu or shingles
• Medicines to treat HIV (Human Immunodeficiency Virus), called zidovudine or lamivudine
• Medicines that can increase the amount of potassium in your blood, such as diuretics (water tablets, which help increase the amount of urine you produce), steroids (like prednisolone) and digoxin
• Methotrexate, a medicine used to treat cancer or for your immune system.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Co-trimoxazole.
Taking Co-trimoxazole with food and drink
You should take Co-trimoxazole with some food or drink. This will stop you feeling sick (nausea) or having diarrhoea. Although it is better to take it with food, you can still take it on an empty stomach.
Drink plenty of fluid such as water while you are taking Co-trimoxazole.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, planning to get pregnant, or breast-feeding.
3 How to take Co-trimoxazole
Always take Co-trimoxazole exactly as your doctor has told you.
The label on your pack will tell you how much to take and how often to
take it. You should check with your doctor or pharmacist if you are not
sure.
Usual Dose
Adults and children over 12 years
• The usual dose is one tablet in a morning and one tablet in an evening.
• Co-trimoxazole should be taken for at least five days.
• Make sure that you finish the course of Co-trimoxazole which your doctor has prescribed. Co-trimoxazole is not usually given to children under 12 years old. If they have been given to your child please speak to your doctor or pharmacist for more information.
POM
Special Dose
The dose of Co-trimoxazole and how long you need to take it depends on the infection you have and how bad it is. Your doctor may prescribe you a different dose or length of course of Co-trimoxazole to
• treat urinary tract (water) infections
• treat and prevent lung infections caused by the bacteria
Pneumocystis jiroveci
• treat infections caused by the bacteria Toxoplasma (toxoplasmosis) or Nocardia (nocardiosis).
If you have kidney problems your doctor may
• prescribe a lower dose of Co-trimoxazole
• take blood to test whether the medicine is working properly.
If you take Co-trimoxazole for a long time your doctor may
• take blood to test whether the medicine is working properly
• prescribe folic acid (a vitamin) for you to take at the same time as Co-trimoxazole.
If you take more Co-trimoxazole than you should
If you take more Co-trimoxazole than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you. If you have taken too much Co-trimoxazole you may
• feel or be sick
• feel dizzy or confused.
If you forget to take Co-trimoxazole
• If you forget to take a dose, take it as soon as you remember it.
• Do not take a double dose to make up for the forgotten dose.
4 Possible side effects
Like all medicines Co-trimoxazole can cause side effects, although not everybody gets them. You may experience the following side effects with this medicine. Stop taking Co-trimoxazole and tell your doctor immediately if you have an allergic reaction. Chances of an allergic reaction is very rare (fewer than 1 in 10,000 people are affected), signs of an allergic reaction include
Allergic reactions
• Difficulty in breathing
• Fainting
• Swelling of face
• Swelling of mouth, tongue or throat which may be red and painful and/or cause difficulty in swallowing
• Chest pain
• Red patches on the skin
Very Common (more than 1 in 10 people)
• High levels of potassium in your blood, which can cause abnormal heart beats (palpitations).
Common (less than 1 in 10 people)
• An infection called thrush or candidiasis which can affect your mouth or vagina. It is caused by a fungus
• Headache
• Feeling sick (nausea)
• Diarrhoea
• Skin rashes.
Uncommon (less than 1 in 100)
• Being sick (vomiting).
Very Rare (less than 1 in 10,000 people)
• Fever (high temperature) or frequent infections
• Sudden wheeziness or difficulty breathing
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see Take special care with Co-trimoxazole).
• Mouth ulcers, cold sores and ulcers or soreness of your tongue
• Skin lumps or hives (raised, red or white, itchy patches of skin)
• Blisters on your skin or inside your mouth, nose, vagina or bottom
• Inflammation of the eye which causes pain and redness
• The appearance of a rash or sunburn when you have been outside (even on a cloudy day)
• Low levels of sodium in your blood
• Changes in blood tests
• Feeling weak, tired or listless, pale skin (anaemia)
• Heart problems
• Jaundice (the skin and the whites of your eyes turn yellow).
This can occur at the same time as unexpected bleeding or bruising
• Pains in your stomach, which can occur with blood in your faeces (poo)
• Pains in your chest, muscles or joints and muscle weakness
• Arthritis
• Problems with your urine. Difficulty passing urine. Passing more or less urine than usual. Blood or cloudiness in your urine.
• Kidney problems
• Sudden headache or stiffness of your neck, accompanied by fever (high temperature)
• Problems controlling your movements
• Fits (convulsions or seizures)
• Feeling unsteady or giddy
• Ringing or other unusual sounds in your ears
• Tingling or numbness in your hands and feet
• Seeing strange or unusual sights (hallucinations)
• Depression
• Muscle pain and/or muscle weakness in HIV patients. 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.
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 Co-trimoxazole
• Keep out of the sight and reach of children.
• Do not store above 25°C. Store in the original package.
• Do not take the tablets after the expiry date shown on the carton. The expiry date refers to the last day of that month.
• 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 protect the environment.
• If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your doctor or pharmacist, who will tell you what to do.
6 Further information
What Co-trimoxazole contains
Co-trimoxazole is made up of two different medicines called sulfamethoxazole and trimethoprim.
Each tablet contains 160 mg of trimethoprim and 800 mg of sulfamethoxazole.
The other ingredients of Co-trimoxazole are: sodium starch glycollate (type A) (from potato starch), povidone K30, docusate sodium and magnesium stearate.
What Co-trimoxazole looks like and contents of the pack
Co-trimoxazole is a white, oval shaped, biconvex tablet scored in half on one side and plain on the other side.
Co-trimoxazole is supplied to you in a blister pack, containing 50 or 100 tablets.
PL: 15814/1215
Manufactured by Alcala Farma, S.L, Ctra. M-300, Km 29,920 Alcala de Henares, 28802 Madrid, Spain OR Alcala Farma, S.L, Avenida de Madrid 82, Alcala de Henares, 28802 Madrid, Spain.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 08.08.2016.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.