100 mg and 160 mg tablets
trimethoprim

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

1. What Idotrim is and what it is used for

Idotrim is used for urinary tract infections, as well as 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 the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any 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 a condition called megaloblastic anemia ( 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 diarrhea 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, diarrhea, nausea, dizziness, and 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 for 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 are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in this regard is the use of drugs due to their effects and/or 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 you have been told by your doctor 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 that 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.

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 individually according to the child’s weight (age) and disease state.
  • Children over 12 years: 150-200 mg twice a day 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 individually 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 on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Discontinue treatment and contact a doctor or 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 diarrhea (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 defense against infection deteriorates. If you 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 (may affect up to 1 in 10 people): Nausea, vomiting, inflammation of the tongue. 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 (eg fever, allergic shock ), diarrhea, 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 (eg 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 ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. 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.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Idotrim

No special temperature instructions. Store in the original package. Sensitive to light.

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

Do not use this medicine after the expiry date which is 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 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 respectively, microcrystalline cellulose, maize starch , pregelatinised starch , crospovidone, magnesium stearate, polysorbate 80, povidone, hypromellose, propylene glycol.

What the medicine looks like and contents of the pack

Appearance

100 mg tablets are white, film-coated, round, cupped with a notch, diameter 9 mm.

160 mg tablets are white, film-coated, round, cupped, 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 contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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