10 mg/ml oral suspension
What Trimethoprim Meda is and what it is used for
Trimethoprim Meda reduces the bacteria’s ability to form an enzyme that is necessary for their production of folic acid. The bacteria can then not multiply and the remaining bacteria die.
Trimetroprim Meda is used against less serious urinary tract infections. Trimethoprim Meda is also used for preventive purposes in case of recurrent urinary tract infections.
The oral suspension is primarily intended for the treatment of children.
What you need to know before using Trimethoprim Meda
Do not use Trimethoprim Meda
– if you or your child are allergic to trimethoprim or any other ingredient in this medicine (listed in section 6).
Warnings and precautions
Talk to a doctor, pharmacist, or nurse before you/your child takes Trimethoprim Meda:
- If you/your child has severe kidney damage.
Simultaneous intake of Trimethoprim Meda with certain other medicines, potassium supplements, and potassium-rich food can lead to severe hyperkalemia (increased potassium levels in the blood). The symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat, diarrhea, nausea, dizziness, and headache.
Other medicines and Trimethoprim Meda
Tell the doctor or pharmacist if you/your child are taking, have recently taken, or maybe taking other medicines. Certain medicines can affect or be affected by treatment with Trimethoprim Meda, for example, medicines against
- blood clot ( warfarin )
- diabetes (glibenclamide)
- epilepsy ( phenytoin )
- rejection of transplanted organ (ciclosporin)
- tuberculosis (rifampicin)
- HIV infection (zidovudine )
- high blood pressure and heart failure ( spironolactone )
Pregnancy and breastfeeding
Experience with use during pregnancy is limited. If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Trimethoprim passes into breast milk but is unlikely to affect children who are breastfed. However, talk to your doctor if you use Trimethoprim Meda more than occasionally during breastfeeding.
Driving ability and use of machinery
Trimethoprim Meda has no or negligible effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Trimethoprim Meda contains sorbitol.
This medicine contains 200 mg of sorbitol per ml. Sorbitol is a source of fructose. If you (or your child) have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that makes it impossible to break down fructose, consult a doctor before using this medicine. Sorbitol can cause stomach/intestinal discomfort and can have a mild laxative effect.
Trimethoprim Meda also contains the preservatives propylparaben E 216 and methylparaben E 218, which can cause an allergic reaction (possibly delayed).
How to use Trimethoprim Meda
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The doctor determines a dose so that it is suitable for you/your child, adapted to body weight and age.
Shake the bottle well before use.
Even if you feel better already after a few days, the entire Trimethoprim Meda regimen must be completed as prescribed. Otherwise, some bacteria can survive for a while, grow and cause a new outbreak of infection.
If you have taken too much Trimethoprim Meda
If you/your child has ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Trimethoprim Meda and contact your doctor immediately if you experience any of the following reactions:
- Swelling of the face, tongue, or throat, difficulty swallowing, hives and difficulty breathing, and drop in blood pressure ( angioedema and anaphylactic reactions, may occur in up to 1 in 10,000 users ).
- An extremely strong allergic reaction with a skin rash usually in the form of blisters or sores in the mouth and eyes as well as other mucous membranes such as the genitals ( Stevens-Johnson syndrome, may occur in up to 1 in 10,000 users e).
Trimethoprim Meda can in rare cases affect the white blood cells so that the defense against infection deteriorates. If you/your child gets an infection with symptoms such as fever with a greatly worsened general condition or fever with local symptoms of infection such as, for example, sore throat/pharynx/mouth or vomiting, a doctor should be consulted as soon as possible so that a lack of white blood cells can be ruled out via a blood test ( agranulocytosis, may occur in up to 1 in 1000 users ). It is important that you then inform me about this medication.
In case of prolonged or severe diarrhea, you should also consult a doctor.
Other side effects that may occur:
Common (may affect up to 1 in 10 users): Nausea, vomiting, skin rash, itching, inflammation of the tongue.
Uncommon (may affect up to 1 in 100 users): Hives, blood disorders (increased or decreased number of white blood cells ).
Rare (may affect up to 1 in 1000 users): Fever, meningitis, diarrhea, inflammation of the colon, sensitivity to sunlight, conjunctivitis of the eye, blood count changes (reduced number of red blood cells or platelets ), skin changes (sometimes serious).
Very rare (may affect up to 1 in 10,000 users):
Inflammation of the eye ( uveitis ). Increased levels of potassium in the blood. It can cause symptoms such as heart rhythm disturbances, nausea, anxiety, confusion, and muscle weakness.
Not known frequency (may occur in an unknown number of users): Low levels of sodium in the blood. It can cause symptoms such as confusion, nausea, vomiting, and muscle cramps.
Itching in the abdomen can be caused by fungal overgrowth.
How to store Trimethoprim Meda
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and label after “EXP”. The expiration date is the last day of the specified month.
Store at a maximum of 25°C.
To be used within 6 weeks after first opening the bottle.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substance is trimethoprim. 1 ml of oral suspension contains 10 mg of trimethoprim.
- Other ingredients are sorbitol, xylitol, polysorbate 80, xanthan gum, preservatives (methyl parahydroxybenzoate E 218, propyl parahydroxybenzoate E 216), water, flavoring (apricot aroma).
Marketing Authorisation Holder
Meda AB, Box 906, 170 09 Solna. Phone 08-630 19 00.