160 mg / 800 mg tablets
trimethoprim + sulfamethoxazole
Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.
- Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
- If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4
In this leaflet:
1. What Eusaprim forte is and what it is used for
2. What you need to know before taking Eusaprim forte
3. How to take Eusaprim forte
4. Possible side effects
5. How to store Eusaprim forte
6. Package contents and other information
1. What Eusaprim forte is and what it is used for
Eusaprim forte 160 mg / 800 mg tablets (called “Eusaprim forte” in this leaflet) are a combination of two different antibiotics called sulfamethoxazole and trimethoprim. It is used to treat infections caused by bacteria. This drug combination is also called cotrimoxazole. Like all antibiotics, Eusaprim forte only works against certain types of bacteria. This means that it is only suitable for treating certain types of infection.
Eusaprim forte can be used to treat:
- bladder or urinary tract infections
- lung infections such as bronchitis
- lung infections ( pneumonia or Pneumocystis jirovecii – pneumonia ) caused by a bacterium called Pneumocystis jirovecii
- infection is in the gastrointestinal tract.
Trimethoprim and sulfamethoxazole contained in Eusaprim forte may also be approved for the treatment of other conditions not mentioned in this leaflet.
Eusaprim forte tablets are intended for children (12 up to 18 years) and adults (> 18 years).
The account should be taken of official guidelines regarding the appropriate use of antibacterial agents.
What you need to know before taking Eusaprim forte
You should not be given Eusaprim forte
- if you are allergic (hypersensitive) to sulfamethoxazole, trimethoprim, cotrimoxazole, or any of the other ingredients of Eusaprim forte (see section 6: Contents of the pack and other information)
- if you are allergic to sulfonamide medicines. Such drugs may be sulphonylureas (eg glyclazide and glibenclamide) or thiazide diuretics (eg bendroflumethiazide – a diuretic tablet)
- if you have severe renal impairment
- if you have severe hepatic impairment
- if you have ever had problems with your blood that have caused bruising and bleeding ( thrombocytopenia )
- if you have been told that you have a rare blood problem called porphyria, which can affect your skin or nervous system.
- Eusaprim should not be given to infants during the first 6 weeks of life
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Eusaprim forte.
Warnings and cautions
Talk to your doctor or pharmacist before taking Eusaprim forte:
- if you develop a rash during treatment, you must seek medical attention immediately. Rash that may be life-threatening ( Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug-induced rash with eosinophilia and systemic symptoms) have been reported with the use of sulfamethoxazole and trimethoprim. See section 4 for more information on symptoms.
- At the beginning of treatment, the presence of generalized blushing with blisters together with fever should raise suspicion of a serious reaction called acute generalized exanthematous pustulosis (AGEP) (see section 4).
- if you have kidney disease
- if you have severe allergies or bronchial asthma
- if you do not have enough folic acid (a vitamin ) in your body which can make your skin pale and make you feel tired, weak, and short of breath. This is called anemia
- if you have been told that you are at risk for a rare blood disorder called porphyria if you have a severe blood disorder, such as low red blood cell count ( anemia ), low white blood cell count ( leukopenia ),, or low platelet count, which may cause bleeding and bruising ( thrombocytopenia )
- if you are older
- if you have a condition called glucose -6-phosphate dehydrogenase deficiency, which may cause jaundice or spontaneous red blood cell breakdown
- if you have a metabolic problem called phenylketonuria and are not on a special diet to improve your condition
- if you have been told by your doctor that you have a lot of potassium in your blood
- if you are underweight or malnourished.
Other medicines and Eusaprim forte
Tell your doctor or pharmacist if you are taking, have recently taken,, or might take any other medicines. The reason is that the Eusaprim forte may affect the way some other medicines work, and some other medicines may affect how the Eusaprim forte works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- cyclosporine, which inhibits the immune system
- phenytoin used to treat epilepsy (seizures)
- drugs to treat heart problems, e.g. digoxin or procainamide
- drugs for the treatment of diabetes, e.g. glibenclamide, glipizide, tolbutamide (sulphonylureas), and repaglinide
- blood-thinning drugs such as warfarin
- methotrexate, a medicine used to treat certain cancers or certain diseases that affect the immune system
- medicines to treat HIV (human immunodeficiency virus), called zidovudine or lamivudine
- diuretics ( diuretic tablets) that can increase the amount of urine you produce
- pyrimethamine used to treat and prevent malaria and to treat diarrhea
- rifampicin which is an antibiotic
- amantadine used to treat Parkinson’s disease, multiple sclerosis, influenza, or shingles
- drugs that can increase the amount of potassium in the blood, e.g. diuretics ( diuretic tablets such as spironolactone, which helps increase the amount of urine you produce) or ACE inhibitors (can be used to treat high blood pressure or certain heart problems)
- azathioprine, which can be used in patients after organ transplantation or for the treatment of disorders of the immune system or inflammatory bowel diseases
- folic acid.
Eusaprim forte with food and drink
Preferably take Eusaprim forte with some food or drink. This prevents you from feeling nauseous or having diarrhea. However, it is possible to take the Eusaprim forte on an empty stomach, although it is better to take it with food.
Drink plenty of fluids, e.g. water, when taking Eusaprim forte.
Pregnancy and breastfeeding
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.
Driving and using machines
Some patients have experienced dizziness or fainting when using Eusaprim. Do not drive or use machines if you experience these side effects.
3. How to take Eusaprim forte
Always take Eusaprim forte exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
What do you receive and how often you receive a dose depends on:
- what type of infection you have
- severity of infection
- your weight
- your age.
Norm Aldo Recommendations for acute infection s
Adults (> 18 years)
|> 18 years||1 tablet Eusaprim forte morning and evening|
Children 12-18 years
The dosing schedule for children follows the child’s age and body weight according to the table below:
The usual dose for children is approximately 6 mg trimethoprim and 30 mg sulfamethoxazole per kg body weight per day, divided into two equal doses.
|12-18 years||1 tablet Eusaprim forte morning and evening|
If you have kidney problems, your doctor may
- prescribe a lower dose of Eusaprim forte
- take blood samples to test if the medicine is working properly.
If you are taking Eusaprim forte for a long time, your doctor may
- take blood samples to test if the medicine is working properly
- prescribe folic acid (a vitamin ) that you should take at the same time as Eusaprim forte
If you take more Eusaprim forte then you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Take the medicine pack with you.
If you take more Eusaprim forte, you can
- feeling nauseous or vomiting
- feel dizzy or confused.
If you forget to take Eusaprim forte
- If you miss a dose, take it as soon as you remember.
- Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may experience the following side effects with this medicine.
Stop taking Eusaprim forte and contact a doctor immediately if you have an allergic reaction. The risk of an allergic reaction is very low (less than 1 in 10,000 people are affected). Signs of an allergic reaction include:
- breathing difficulties
- swelling of the face
- swelling of the mouth, tongue, or throat that can become red and painful and/or lead to difficulty swallowing
- chest pain
- red spots on the skin.
If you develop a rash during treatment, you must seek medical attention immediately. Rash that may be life-threatening ( Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug-induced rash with eosinophilia and systemic symptoms) has been reported with the use of sulfamethoxazole and trimethoprim. It can start as reddish-purple, target-like spots, or round spots with blisters in the middle, often symmetrically distributed on the body. These skin reactions, which can be life-threatening, often occur along with flu-like symptoms. The rash can develop into widespread blistering or flaking of the skin. Additional signs to be aware of are sores in the mouth, throat, nose, or genitals, or conjunctivitis(red and swollen eyes). If you get a rash or signs of these skin reactions, stop taking Eusaprim immediately, seek emergency medical advice and tell your doctor that you are taking this medicine.
If you get Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug-induced rash with eosinophilia and systemic symptoms after using sulfamethoxazole and trimethoprim, which are found in Eusaprim, you can never use drugs containing sulfamethoxazole or trimethoprim again.
The greatest risk of serious skin reactions is within the first few weeks of treatment.
Other side effects include:
Very common (more than 1 in 10 people)
- high levels of potassium in the blood, which can lead to abnormal heartbeats ( palpitations ).
Regular (less than 1 in 10 people)
- a fungal infection called cod or candida that can affect the mouth or vagina
Uncommon (less than 1 in 100 people)
Very rare (less than 1 in 10,000 people)
- high fever or recurrent infection er
- wheezing or difficulty breathing that occurs suddenly
- potentially life-threatening rash ( Stevens-Johnson syndrome, toxic epidermal necrolysis ) has been reported (see Warnings and Precautions)
- Very rare cases of generalized redness of the whole body ( acute generalized exanthematous pustulosis (AGEP)) (see section 2).
- sores in the mouth, cold sores and sores or soreness on the tongue
- skin lumps or hives (raised, red or white, itchy spots on the skin)
- blisters on the skin or in the mouth, nose, vagina, or tail
- inflammation of the eye leading to pain and redness
- rash or sun damage when you have been out (even on cloudy days)
- low levels of sodium in the blood
- altered blood levels
- feeling weak, tired or listless, pale skin ( anemia )
- heart problems
- jaundice (the skin or whites of the eyes turn yellow). This can occur at the same time as unexpected bleeding or a bruise
- abdominal pain, which may occur along with blood in the stool
- pain in the chest, muscles, or joints, and muscle weakness
- urinary problems Difficulty urinating. You urinate more or less than usual. Blood in the urine or cloudy urine
- kidney problems
- sudden headache or stiffness in the neck, accompanied by fever
- problems controlling movements
- seizures (convulsions or seizures)
- feeling unsteady or dizzy
- ringing or unusual sounds in the ears
- tingling or numbness in the hands or feet
- you get strange or unusual vision (hallucinations)
- muscle pain and/or muscle weakness in HIV patients
- loss of appetite.
Has been reported (occurs in an unknown number of users)
- psychotic states (mental states that can cause you to lose touch with reality)
- drug-induced rash with eosinophilia and systemic symptoms (a type of allergic reaction that can cause fever, rash, and abnormal results on blood tests and liver function tests [may be a sign of multiple organ failure]).
- plum-colored, raised, and painful sores on limbs and sometimes on the face and neck along with fever (Sweet’s syndrome)
5. How to store Eusaprim forte
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton.
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. Contents of the packaging and other information
- The active substances in Eusaprim forte are trimethoprim 160 mg and sulfamethoxazole 800 mg per tablet.
- The other ingredients are sodium starch glycolate, povidone, docusate sodium, and magnesium stearate.
What the medicine looks like and the contents of the pack
The tablets are white, oblong, cupped with a middle notch, and marked with S3.
20 or 50 tablets in a pressure pack.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36,
D-23843 Bad Oldesloe,