40 mg / ml + 8 mg / ml oral solution 
trimethoprim and sulfamethoxazole

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this leaflet, 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 Bactrim is and what it is used for 
2. What you need to know before you take Bactrim 
3. How to take Bactrim 
4. Possible side effects 
5. How to store Bactrim 
6. Contents of the packaging and other information 

1. What Bactrim is and what it is used for

What Bactrim is

Bactrim is a combination of two substances – sulfamethoxazole and trimethoprim. Together, they kill bacteria and stop them from growing and reproducing.

What Bactrim is used for

Bactrim is mainly used for

  • the infection you in the urinary tract
  • infection is in the prostate
  • lung infections that get worse over time
  • infection such as dysentery, typhoid, and paratyphoid fever

Bactrim can also be used to prevent and treat a type of pneumonia caused by a yeast-like fungus called ” Pneumocystis jirovecii “. Then the drug is used mainly in patients with weakened immune systems.

Bactrim is used in adults and children from 6 weeks of age.

2. What you need to know before taking Bactrim

Do not use Bactrim if:

  • you are allergic to trimethoprim, sulfamethoxazole, or any of the other ingredients of Bactrim (listed in section 6).
  • you have severe liver damage
  • you have a severe blood disease
  • a child is younger than 6 weeks
  • you have severe renal impairment
  • you are being treated with the drug dofetilide (used for arrhythmias in the heart).

Do not use Bactrim if any of the above apply to you. If you are not sure, talk to your doctor before taking Bactrim.

Warnings and cautions

Talk to your doctor or pharmacist before using Bactrim if:

  • you have impaired kidney function
  • you have low levels of folic acid
  • you are over 65 years old, malnourished, or severely dehydrated
  • you have cystic fibrosis

Be aware of the side effect s

Stop taking Bactrim and contact your doctor immediately if you experience any of the following side effects:

  • Infection:  Bactrim can impair your defenses against infection (by affecting white blood cells ). If you show signs of infection, you must see your doctor as soon as possible – see section 4 under “Serious side effects” for signs of infection.
  • Potentially life-threatening skin reactions: such as Stevens-Johnson syndrome, a drug-induced rash with increasing white blood cell count ( eosinophilia ) and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN) – see section 4 under “Serious side effects” for signs of these skin reactions.
  • Muscle pain, cramps, or weakness

Stop taking Bactrim and contact your doctor immediately if you experience any of these symptoms. It is important that you tell us that you have taken Bactrim.

Other medicines and Bactrim

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The effect of Bactrim may affect or be affected if Bactrim and certain other medicines are taken at the same time.

In particular, do not take Bactrim if you are taking dofetilide, a medicine used to treat heart problems.

Talk to your doctor or pharmacist if you are taking any of the following medicines:

  • drugs for type 2 diabetes such as chloropropamide, glibenclamide, repaglinide, pioglitazone, glipizide, tolbutamide, gliclazide, rosiglitazone, 
  • memantine, amantadine (for dementia),
  • warfarin, acenocoumarol, fenprocumon (blood thinner),
  • ciclosporin, tacrolimus, and azathioprine (immune suppressants),
  • prednisolone (for inflammation )
  • phenytoin (for epilepsy ),
  • digoxin, amiodarone (heart medicine),
  • ACE inhibitors (for high blood pressure or heart failure )
  • tricyclic antidepressants, clozapine (for mental health problems)
  • birth control pills,
  • zidovudine and lamivudine (for HIV ),
  • diuretics such as thiazides, potassium-sparing diuretics (for high blood pressure or heart failure ),
  • methotrexate, paclitaxel, and mercaptopurine (for cancer)
  • pyrimethamine (against malaria ).

If you are taking any of the above or if you are not sure, talk to your doctor or pharmacist before using Bactrim.

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. There is a risk that the fetus will be affected.

You should consult your doctor or pharmacist if you are breast-feeding or planning to breast-feed. This is because small amounts of Bactrim can pass over to the baby.

Driving and using machines

Bactrim is not expected to have any effect on the ability to drive and use machines.

Bactrim contains sorbitol, methyl parahydroxybenzoate, and Propyl parahydroxybenzoate

Bactrim contains 630 mg sorbitol per ml corresponding to 3 to 25 grams sorbitol per day.

Sorbitol is a source of fructose. If you (or your child) do not tolerate certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that prevents you from breaking down fructose, consult your doctor before using this medicine.

Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Bactrim contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause an allergic reaction (possibly delayed).

3. How to take Bactrim

Always use Bactrim exactly as your doctor has told you. Do not change the prescribed dose yourself. Ask your doctor or pharmacist if you are unsure.

When to take Bactrim

Take Bactrim twice daily, once in the morning and once in the evening.

Shake the bottle before use.

How much to take

The usual dose for adults and children over 12 years: 

  • 20 ml Bactrim oral solution morning and evening.

The usual dose for children under 12 years:

  • 6 weeks up to 5 months: 2.5 ml oral solution morning and evening.
  • 6 months up to and including 5 years: 5 ml oral solution morning and evening.
  • 6 years up to and including 12 years: 10 ml oral solution morning and evening.

If you forget to take Bactrim

  • If you forget to take a dose, take it as soon as you remember. But if it is soon time for the next dose, skip the missed dose and take the next dose as usual.
  • Do not take a double dose to compensate for a missed dose.

4. Possible side effects

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

Serious side effects are

Stop taking Bactrim and contact your doctor immediately if you get any of the following:

  • Potentially life-threatening skin reactions:
    • These skin reactions can often start with flu-like symptoms .
    • The risk is greatest during the first weeks of treatment.
    • Signs of skin reactions include:
      • red to violet, round areas with blisters in the middle that are often spread symmetrically over the body. The skin may begin to flake.
      • sores in the mouth, throat, nose, or genitals
      • eye inflammation (red and swollen eyes)
    • If you get any of the above after using Bactrim, do not use medicines containing trimethoprim or sulfamethoxazole again.
  • Muscle pain, cramps, or weakness :
    • Pain, cramps, or weakness that you can not explain.
  • Severe infection: your doctor must take a blood sample as soon as possible to rule out a lack of white blood cells ( agranulocytosis ). Look for signs of :
    • infection with fever or feeling unwell in general
    • sore throat or mouth
    • urinary tract infection
  • Severe allergic reaction
    • swelling of the face, tongue, or throat, difficulty swallowing
    • hives and facial diseases

Stop taking Bactrim and contact your doctor immediately if you experience any of the above.

Other side effects are

Talk to your doctor, pharmacist, or nurse if you experience any of the following side effects:

Common  (may affect up to 1 in 10 people): 

  • nausea or vomiting
  • blood tests that show liver or kidney problems
  • skin rash or inflammation, redness or itching

Uncommon  (may affect up to 1 in 100 people): 

  • fungal infections
  • cramps
  • diarrhea
  • colitis
  • liver inflammation ( hepatitis )
  • kidney failure
  • hives

Rare (may affect up to 1 in 1,000 people):

  • blood disorders such as low levels of white blood cells
  • lowered blood sugar
  • weakness, difficulty moving, “blackouts” (disorders of nerve function)
  • inflammation of the tongue and mouth 
  • bile problems (bile stasis)
  • crystals in the urine
  • inflammation of blood vessels ( vasculitis ) or disturbance of blood flow (pain in blood vessels)

Very rare (may affect up to 1 in 10,000 people):

  • lung problems such as cough, shortness of breath
  • blood tests showing increased levels of potassium in the blood,
  • hallucinations
  • difficulty coordinating muscle movements
  • eye inflammation
  • dizziness
  • allergic reaction with inflammation of the heart muscle (allergic myocarditis )
  • tinnitus
  • cell death in the liver (liver necrosis)
  • increased urine output or partially inflamed kidneys
  • meningitis
  • photosensitivity ( photosensitivity )
  • vasculitis ( vasculitis ) that affects the whole body
  • muscle dissolution ( rhabdomyolysis )

Has been reported (occurs in an unknown number of users):

  • blood tests that show a decrease in the amount of sodium in the blood
  • sudden inflammation of the pancreas ( acute pancreatitis)
  • damage to the bile ducts (disappearing bile duct syndrome)
  • joint and muscle pain
  • plum-colored, raised, and painful sores on limbs and sometimes on the face and neck along with fever (Sweets syndrome)

Talk to your doctor, pharmacist, or nurse if you experience any of the above side effects.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Bactrim

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last date of the specified month.

Bactrim oral solution should not be stored above 30 ° C.

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

What Bactrim contains:

  • The active substances are sulfamethoxazole and trimethoprim. One ml of Bactrim oral solution contains sulfamethoxazole 40 mg and trimethoprim 8 mg
  • The other ingredients are as follows: sorbitol (sweetener) 630 mg/ml, microcrystalline cellulose, carmellose sodium, methyl parahydroxybenzoate ( preservative E218), propyl parahydroxybenzoate ( preservative E 216), polysorbate 80, banana and vanilla and vanilla.

What the medicine looks like and the contents of the pack

Bactrim: glass bottle with 100 ml oral solution

Marketing Authorization Holder and Manufacturer

Roche AB, Box 1228, 171 23 Solna

Muhammad Nadeem

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