Idotrim 100 mg and idotrim 160 mg Trimethoprim Tablets
1. What Idotrim Is And What Is It Used For
Idotrim is used for urinary tract infections and as a preventative treatment for patients with recurrent urinary tract infections. Idotrim prevents bacterial growth in urinary tract infections.
Trimethoprim contained in Idotrim may also be approved for treating other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
2. What You Need To Know Before Using Idotrim
Do Not Take Idotrim
- If you are allergic to trimethoprim or any of the other ingredients of this medicine (listed in section 6).
- If you have severe renal or hepatic impairment.
- If you have a blood disorder called blood dyscrasia.
- If you have megaloblastic anaemia ( vitamin B 12 deficiency or folate ).
Warnings And Cautions
Talk to your doctor, pharmacist, or nurse before taking Idotrim:
- If you have kidney disease
- If you have a rare blood disorder called porphyria
- If you are older or your child is using this medicine for long-term treatment
- If you have suspected or confirmed folate deficiency.
Talk to your doctor if you suffer from diarrhoea during treatment.
Concomitant intake of trimethoprim with certain other drugs, e.g. spironolactone, may lead to severe hyperkalemia (elevated blood potassium levels). Symptoms of severe hyperkalemia may include
- Muscle cramps
- Irregular heartbeat
- Diarrhoea
- Nausea
- Dizziness
- Headache
Other Medicines And Idotrim
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Especially:
- Warfarin (to prevent blood clotting)
- Glibenclamide (for the treatment of diabetes )
- Phenytoin (for the treatment of epilepsy )
- Ciclosporin (to prevent transplant rejection)
- Antibiotics such as rifampicin, dapsone
- Zidovudine (for viral infection, HIV )
- Diuretics ( diuretics ), e.g. spironolactone
- ACE inhibitors (for the treatment of high blood pressure )
- Digoxin (for the treatment of heart problems)
- Pyrimethamine (for the treatment of malaria )
- Methotrexate (for the treatment of cancer or your immune system)
- Drugs that cause bone marrow suppression.
Trimethoprim can affect the test that determines the creatinine concentration in the body.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
The use of Idotrim is not recommended during pregnancy.
Breast-feeding
Idotrim passes into breast milk but is unlikely to affect breastfed infants. However, consult your doctor if you use Idotrim more than temporarily during breastfeeding.
Driving And Using Machines
Idotrim has no or negligible effect on the ability to drive and use machines.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring increased attention. One of the factors that can affect your ability in this regard is the use of drugs due to their effects and side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Idotrim Contains Lactose
Idotrim contains lactose . If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How To Use Idotrim
- Always take Idotrim exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- It is important to follow the prescribed course, so the infection does not flare up again.
- Dose one is determined by the doctor, who adjusts it individually for you.
- Adults
- The recommended dose for lower uncomplicated urinary tract infection:
- 150-200 mg twice a day or 300 mg at night.
- The recommended dose for long-term treatment:
- 100 mg at night.
- The recommended dose for lower uncomplicated urinary tract infection:
Use For Children And Adolescents.
The recommended dose for lower uncomplicated urinary tract infection:
- Children over 3 months: Dose one is determined by the doctor, who adjusts it according to the child’s weight (age) and disease state.
- Children over 12 years: 150-200 mg twice daily or 300 mg at night.
The recommended dose for long-term treatment:
- Children over 3 months: Dose one is determined by the doctor, who adjusts it according to the child’s weight (age) and disease state.
- Children over 12 years: 100 mg at night.
If You Take More Idotrim Than You Should
If you have ingested too much medicine or if, e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible Idotrim Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Discontinue treatment and contact a doctor or the nearest emergency department immediately if you get any of the following:
- Swelling of the face, tongue or throat
- Difficulty swallowing
- Hives and difficulty breathing ( angioedema may affect up to 1 in 1,000 people).
- Prolonged or severe diarrhoea (intestinal inflammation, may occur in up to 1 in 1000 users)
- An extremely severe allergic reaction with skin rash, usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes, such as genitals (may occur in up to 1 in 1000 users).
- Severe skin damage (skin detachment of the epidermis and superficial mucous membranes) (may affect up to 1 in 10,000 users).
Idotrim can, in rare cases, affect the white blood cells so that the defence against infection deteriorates. Get an infection with symptoms such as fever with severe deterioration of the general condition or fever with local infection symptoms such as sore throat/pharynx/mouth or difficulty urinating. You should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis may affect up to 1 in 1000 users). It is important that you then have information about your medication.
Other side effects may occur.
Common Idotrim side effects (may affect up to 1 in 10 people):
- Nausea
- Vomiting
- Tongue inflammation
- Itching
- Rash
Uncommon (may affect up to 1 in 100 people):
- Hives
- Blood clots (increased or decreased number of certain blood cells )
Rare (may affect up to 1 in 1,000 people):
- Meningitis
- Hypersensitivity reactions (e.g. fever, allergic shock )
- Diarrhoea
- Sensitivity to sunlight
- Skin changes (sometimes severe)
- Inflammation of the eye (conjunctivitis)
- Blood count changes
Very rare (may affect up to 1 in 10,000 people):
- Serum disease (e.g. skin rash and swelling
- Joint pain and glandular swelling)
- Inflammation of the eye ( uveitis )
- Elevated levels of potassium in the blood
Has been reported (cannot be calculated from the available data): Bile stasis, fungal overgrowth in the oral cavity and abdomen.
Reporting of side effects are
Talk to your doctor, pharmacist, or nurse if you get any side effects. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines.
5. How To Store Idotrim
- No special temperature instructions. Store in the original package. Sensitive to light.
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. Contents Of The Packaging And Other Information
Content Declaration
- The active substance is trimethoprim. One tablet contains 100 mg and 160 mg of trimethoprim, respectively.
- The other ingredients are lactose monohydrate 55 mg and 88 mg, microcrystalline cellulose, maize starch, pregelatinised starch, crospovidone, magnesium stearate, polysorbate 80, povidone, hypromellose, propylene glycol.
What The Medicine Looks Like And The Contents Of The Pack
- Appearance
- 100 mg tablets are white, film-coated, round, cup with a notch, and have a diameter of 9 mm.
- 160 mg tablets are white, film-coated, round, cupped, and 11 mm in diameter.
- Pack sizes
- 100 mg tablets: Plastic jars with 30 and 100 tablets.
- 160 mg tablets: Plastic jars with 14, 20, and 100 tablets.
Marketing Authorization Holder And Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information on this medicine, please get in touch with your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com
The Medical Products Agency
Box 26
751 03 Uppsala