16 mg / ml + 80 mg / ml concentrate for solution for infusion 
trimethoprim + sulfamethoxazole

Read all of this leaflet carefully before you start using 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.

– 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 is and what it is used for 
2. What you need to know before you use Eusaprim 
3. How to use Eusaprim 
4. Possible side effects 
5. How to store Eusaprim 
6. Contents of the packaging and other information 

1. What Eusaprim is and what it is used for

Eusaprim 16 mg/ml + 80 mg/ml concentrate for solution for infusion (called “Eusaprim” in this leaflet) is 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 only works against certain types of bacteria. This means that it is only suitable for treating certain types of infection.

Eusaprim can be used to treat or prevent:

• lung infections ( pneumonia or Pneumocystis jirovecii – pneumonia ) caused by a bacterium called Pneumocystis jirovecii

• infection is caused by a bacterium called Toxoplasma (toxoplasmosis).

Eusaprim can be used to treat:

• bladder or urinary tract infections

• an infection called nocardiosis that can affect the lungs, skin, and brain.

Eusaprim infusion is usually only given to you if you are unable to take medicines by mouth.

Eusaprim concentrate for solution for infusion is intended for children from 6 weeks of age and adults (> 18 years).

The account should be taken of official guidelines regarding the appropriate use of antibacterial agents.

2. What you need to know before using Eusaprim

You should not be given Eusaprim:

  • if you are allergic (hypersensitive) to sulfamethoxazole, trimethoprim, cotrimoxazole, or any of the other ingredients of Eusaprim (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 ever 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.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before receiving Eusaprim:

  • 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 severe allergies or severe asthma
  • if you have kidney disease
  • if you have been told that you are at risk for a rare blood disorder called porphyria that can affect your skin or nervous system
  • 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 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 are older
  • if you have been told by your doctor that you have a lot of potassium in your blood
  • if you are underweight or malnourished
  • 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 ).

Other medicines and Eusaprim

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The reason is that Eusaprim may affect the way some other medicines work, and some other medicines may affect how Eusaprim works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • diuretics ( diuretic tablets) that can increase the amount of urine you produce
  • pyrimethamine used to treat and prevent malaria and to treat diarrhea
  • ciclosporin used after organ transplants
  • blood-thinning drugs such as warfarin
  • phenytoin used to treat epilepsy (seizures)
  • drugs for the treatment of diabetes, e.g. glibenclamide, glipizide, tolbutamide (sulphonylureas), and repaglinide
  • drugs to treat heart problems, e.g. digoxin or procainamide
  • amantadine used to treat Parkinson’s disease, multiple sclerosis, influenza, or shingles
  • medicines to treat HIV (human immunodeficiency virus), called zidovudine or lamivudine
  • 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
  • methotrexate, a medicine used to treat certain cancers or certain diseases that affect the immune system
  • rifampicin which is an antibiotic
  • folic acid.

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. Eusaprim should not be used during pregnancy, especially during the first 3 months, unless necessary. If you are breast-feeding, you should avoid Eusaprim as your baby would be at increased risk of jaundice.

See the next section for more information on the medicine’s ethanol content.

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.

Eusaprim contains

  • sodium metabisulfite. This can lead to allergic reactions, e.g. rash, swelling of the eyelids, face, or lips, or difficulty breathing. These reactions are rare, but the risk of being affected may be greater if you suffer from allergies or asthma.
  • 13.2% by volume of ethanol (alcohol). It can be up to 521 mg per dose, which is equivalent to 13.2 ml of beer or 5.5 ml of wine. This can be harmful if you are an alcoholic. You should also consider the ethanol content if you are pregnant or breastfeeding, have a baby, or if you have liver problems or epilepsy
  • 1.7 mmol (or 38.87 mg) sodium . This should be considered for patients prescribed a low-salt diet.

How to use Eusaprim

You are never expected to give yourself this medicine. It is always given by trained staff.

Eusaprim is given as a continuous infusion into a vein. This happens slowly over a period of time.

Before you receive the medicine, it will be diluted.

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.

Dosage

Norm Aldo Recommendations for acute infection s

Adults (> 18 years)

Age Dose
Adults (> 18 years) 2 ampoules (5 ml) morning and evening. The maximum dose is 3 ampoules (5 ml) of Eusaprim morning and evening.

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. The schedule for children corresponds to the child’s age and body weight according to the table below:

Children 12-18 years how

Age Dose
Children 12-18 years 2 ampoules (5 ml) morning and evening. The maximum dose is 3 ampoules (5 ml) of Eusaprim morning and evening.

Children from 6 weeks up to 12 years of age

Age Dose
Children from 6 weeks up to 6 months 1.25 ml morning and evening
Children from 6 months up to 6 years 2.5 ml morning and evening
Children 6-12 years 5 ml morning and evening

The infusion lasts about 1–1.5 hours, but this is balanced against your fluid needs.

If you have kidney problems, your doctor may

• prescribe a lower dose of Eusaprim

• take blood samples to check if the medicine is working properly.

If you are taking Eusaprim for a long time, your doctor may

  • take blood samples to test if the medicine works properly
  • prescribe folic acid (a vitamin ) that you should take at the same time as Eusaprim.

If you take more Eusaprim then you should

If you think you have been given too much Eusaprim, contact your doctor or nurse immediately.

If you think you have been given too much Eusaprim, you can:

• feel nauseous or vomit

• feel dizzy or confused.

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.

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:

Allergic reactions

• difficulty breathing

• fainting

• swelling of the face

• swelling of the mouth, tongue, or throat that may 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

• headache

• nausea

• diarrhea

• rash.

Uncommon (less than 1 in 100 people)

• vomiting

Very rare (less than 1 in 10,000 people)

• high fever or recurrent infection s

• wheezing or difficulty breathing

• 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

• lumps of skin 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

• changed blood levels

• feeling weak, tired or listless, pale skin ( anemia )

• heart problems

Jaundice (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 with blood in the stool

• pain in the chest, muscles or joints and muscle weakness

• arthritis

• 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)

• instability or dizziness

Ringing or unusual sounds in the ears

Tingling or numbness in the hands or feet

• you get strange or unusual vision (hallucinations)

• depression

• 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

Keep this medicine out of the sight and reach of children.

Protect from heat and direct sunlight.

Use before the expiry date which is stated on the carton and label.

Store in the original package together with the package leaflet.

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

Content declaration

– The active substances are sulfamethoxazole and trimethoprim. This combination of drugs is sometimes called cotrimoxazole. 5 ml Eusaprim contains 400 mg sulfamethoxazole and 80 mg trimethoprim.

– The other ingredients are:

propylene glycol (E1520), tromethamine, sodium hydroxide (E524), sodium metabisulfite (E223), ethanol, water for injection.

What the medicine looks like and the contents of the pack

Eusaprim 16 mg / ml + 80 mg / ml concentrate for solution for infusion in a 5 ml glass ampoule .

Each 5 ml ampoule contains 400 mg of sulfamethoxazole and 80 mg of trimethoprim.

The ampoules are delivered in packs of 10 pcs.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Aspen Pharma Trading Limited

3016 Lake Drive,

Citywest Business Campus,

Dublin 24, Ireland

Manufacturer:

Aspen Bad Oldesloe GmbH, Industriestrasse 32-36,

D-23843 Bad Oldesloe

Germany

Muhammad Nadeem

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