Bactrim 400 mg / 80 mg tablets, Bactrim forte 800 mg / 160 mg tablets, 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 you will find information about: 
1. What Bactrim / Bactrim forte is and what it is used for 
2. What you need to know before you take Bactrim / Bactrim forte 
3. How to take Bactrim / Bactrim forte 
4. Possible side effects 
5. How Bactrim / Bactrim forte must be stored 
6. Contents of the packaging and other information 

1. What Bactrim / Bactrim forte is and what is it used for

Bactrim / Bactrim forte is a combination of two substances (sulfamethoxazole and trimethoprim) that work together. These inhibit the bacterium’s metabolism and thereby have a bactericidal effect.

Bactrim / Bactrim forte tablets are used in adults, adolescents, and children from 6 years of age.

Bactrim / Bactrim forte is mainly used for various types of infection in the urinary tract and in the prostate ( bladder neck gland ) as well as for worsening of chronic respiratory infection. Other infections (such as rubella, typhoid, and paratyphoid fever) can also be treated with Bactrim / Bactrim forte.

Furthermore, Bactrim / Bactrim forte is used prophylactically and in the treatment of infections caused by Pneumocystis jirovecii, especially in patients with weakened immune systems. Bactrim forte contains twice the number of active ingredients compared to Bactrim.

2. What you need to know before taking Bactrim / Bactrim forte

Do not use Bactrim / Bactrim forte

  • if you are hypersensitive (allergic) to trimethoprim, sulfamethoxazole, or any of the other ingredients of Bactrim / Bactrim forte.
  • if you have severe liver damage or blood disease.
  • Bactrim / Bactrim forte should not be used in children younger than 6 weeks.
  • if you have severe renal impairment
  • if you are being treated with dofetilide (used for arrhythmias in the heart).

Warnings and cautions

  • If you have impaired kidney function or folate deficiency, you should consult a doctor before starting treatment with Bactrim / Bactrim forte.
  • if you are over 65 years of age, malnourished, or severely dehydrated, you should also consult a doctor before starting treatment with Bactrim / Bactrim forte .
  • if you have cystic fibrosis, you should consult your doctor before starting treatment with Bactrim / Bactrim forte .

Bactrim 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 general deterioration or fever with local infection symptoms such as sore throat/throat/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then information about your medication.

Skin reactions, which may be life-threatening ( Stevens-Johnson syndrome, a drug-induced rash with increased white blood cell count ( eosinophilia ) and systemic symptoms (DRESS) and toxic epidermal necrolysis (TEN); an immunological reaction which may lead to skin detachment, have been reported when using trimethoprim and sulfamethoxazole, it can start as red-violet target-like or round spots with blistering in the middle, often symmetrically widespread, on the torso.

Additional signs to be aware of are sores in the mouth, throat, nose, genitals, or eye inflammation (red and swollen eyes).

The skin reactions, which can be life-threatening, are often followed by flu-like symptoms. The rash can develop into blisters over large areas or skin detachment.

The risk of serious skin reactions is greatest during the first weeks of treatment.

If you have had Stevens-Johnson syndrome, DRESS, or TEN after using trimethoprim, sulfamethoxazole in Bactrim, you should never use medicines containing trimethoprim and sulfamethoxazole again.

If you get a rash or signs of these skin reactions, stop taking Bactrim immediately, and contact your doctor immediately and tell them that you are taking this medicine.

Stop taking Bactrim and contact a doctor immediately if you get any of the following symptoms ( angioedema ):

• swelling of the face, tongue, or throat

• difficulty swallowing

• hives and difficulty breathing

Stop taking Bactrim and contact your doctor as soon as possible if you experience unexplained muscle pain, muscle cramps, or muscle weakness.

Other medicines and Bactrim / Bactrim forte

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effect of Bactrim / Bactrim forte may affect or be affected if Bactrim / Bactrim forte and certain other medicines are taken at the same time.

It concerns:

  • chloropropamide, glibenclamide, repaglinide, pioglitazone, and glipizide (for age-related diabetes),
  • memantine (for dementia),
  • warfarin (for blood clots),
  • ciclosporin, tacrolimus, and azathioprine (inhibits the immune system),
  • prednisolone (for inflammation )
  • phenytoin (for epilepsy ),
  • digoxin, amiodarone (heart medicine),
  • ACE inhibitors (for high blood pressure )
  • tricyclic antidepressants, clozapine (for psychosis )
  • birth control pills,
  • zidovudine and lamivudine (for HIV ),
  • thiazides , potassium-sparing diuretics ( diuretics ),
  • methotrexate, paclitaxel, and mercaptopurine (for cancer)
  • pyrimethamine (against malaria ).

Bactrim must not be given with dofetilide used in heart rhythm disorders.

Therefore, consult your doctor before using other medicines at the same time.

Pregnancy and breastfeeding

Bactrim / Bactrim forte should not be used during pregnancy unless clearly necessary.

There is a risk that the fetus is affected.

Bactrim / Bactrim forte should not be used during breast-feeding unless your doctor tells you to. Bactrim / Bactrim forte passes into breast milk.

Driving and using machines:

No studies have been performed but Bactrim / Bactrim forte is not expected to have any effect on the ability to drive and use machines.

3. How to take Bactrim / Bactrim forte

Always use Bactrim / Bactrim forte exactly as your doctor has told you. Never change the prescribed dose yourself and never end the treatment without consulting your doctor. Ask your doctor or pharmacist if you are unsure.

Bactrim: 
The usual dose for adults and children over 12 years: 2 tablets Bactrim morning and evening.

The usual dose for children under 12 years:

Children from 6 years up to 12 years: 1 tablet Bactrim morning and evening.

Bactrim forte: 
The usual dose for adults and children over 12 years: 1 tablet Bactrim forte morning and evening. 
For long-term treatment: 1 tablet daily.

If you forget to take Bactrim / Bactrim forte

Do not take a double dose to make up for forgotten dose.

4. Possible side effects

Like all medicines, Bactrim / Bactrim forte can cause side effect is, but not everybody gets them.

Common (affects more than 1 patient in 100):

  • nausea
  • vomiting
  • elevated liver values ​​(seen in blood tests)
  • elevated kidney values ​​(seen in blood tests)
  • rash
  • dermatitis and redness of the skin
  • itching

Uncommon (affects more than 1 patient in 1,000):

  • fungal infections
  • cramps
  • diarrhea
  • colitis
  • hepatitis
  • impaired renal function
  • hives

Rare (affects more than 1 in 10,000 but less than 1 patient in 1,000):

  • effects on blood count (eg agranulocytosis, see Take special care with Bactrim / Bactrim forte )
  • lowered blood sugar
  • disorders of nerve function
  • inflammation of the tongue and oral mucosa
  • allostasis
  • crystals in the urine
  • inflammation of blood vessels
  • pain in the blood vessels

Very rare (affects less than 1 patient in 10,000):

  • hypersensitivity reactions such as angioedema (see Take special care with Bactrim / Bactrim forte )
  • lung effects such as cough, shortness of breath
  • the increased amount of potassium in the blood
  • hallucinations
  • difficulty coordinating muscle movements
  • eye inflammation
  • dizziness
  • allergic reaction with inflammation of the heart muscle (allergic myocarditis )
  • tinnitus
  • liver necrosis (cell death in the liver)
  • inflammation in parts of the kidney
  • increased urine output
  • meningitis
  • photosensitivity
  • skin reactions, which may be life-threatening ( Stevens-Johnson syndrome and toxic epidermal necrolysis, see Before using Bactrim / Bactrim forte )
  • vasculitis that affects the whole body
  • muscle dissolution ( rhabdomyolysis, see Take special care with Bactrim / Bactrim forte )
  • drug-induced rash with an increase in the number of white blood cells in the blood ( eosinophilia ) and systemic symptoms (DRESS, see Before using Bactrim / Bactrim forte )

Without known frequency (can not be calculated from the available data):

  • decreased amount of sodium in the blood
  • acute pancreatitis
  • 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)

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 / Bactrim forte

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 / Bactrim forte must be stored in the original packaging. 
The medicine 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. One Bactrim tablet contains sulfamethoxazole 400 mg and trimethoprim 80 mg. One tablet of Bactrim forte contains sulfamethoxazole 800 mg and trimethoprim 160 mg.
  • Other ingredients are for Bactrim tablets: povidone K30, sodium starch glycolate, magnesium stearate, docusate sodium. Bactrim forte tablets: povidone K30, sodium starch glycolate, magnesium stearate, docusate sodium.

What the medicine looks like and the contents of the pack

Bactrim: blister pack of 20 tablets
Bactrim forte: blister pack of 50 tablets

Marketing Authorisation Holder:

Roche AB, Box 1228, 171 23 Solna

Muhammad Nadeem

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