BACTRIM 160 mg/800 mg Tablets

Зміст інструкції

1. Bactrim 160 mg/800 mg tablets
   1. What is Bactrim and what is it used for
   2. What you need to know before using Bactrim
   3. How to use Bactrim
   4. Possible side effects
   5. How to store Bactrim
   6. Contents of the pack and other information

Bactrim 160 mg/800 mg tablets

Trimethoprim + Sulfamethoxazole

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Bactrim is and what it is used for
• 2. What you need to know before you use Bactrim
• 3. How to use Bactrim
• 4. Possible side effects
• 5. How to store Bactrim
• 6. Contents of the pack and other information

1. What is Bactrim and what is it used for

Bactrim is a medicine that belongs to the group of antibiotics and contains the combination of two
active ingredients: sulfamethoxazole and trimethoprim.
Sulfamethoxazole causes the death of the bacteria responsible for the infection; trimethoprim increases
the activity of the medicine against bacteria.
Bactrim is indicated in adults and adolescents over 12 yearsto treat:

• Infections of the upper and lower respiratory tract and ear,
• Kidney and urinary tract infections,
• Genital organ infections,
• Infections of the digestive system.

2. What you need to know before using Bactrim

Do not use Bactrim

• If you are allergic to sulfamethoxazole, trimethoprim and/or sulfonamide antibiotics or to any of the other ingredients of this medicine (listed in section 6).
• If you have a severe kidney disease (severe renal insufficiency with creatinine clearance < 15 mL/min).
• If you have severe liver damage.
• If you suffer from abnormalities of the cells that make up the blood (blood dyscrasias).
• If you suffer from a deficiency of an enzyme called glucose-6-phosphate dehydrogenase.
• If you are taking a medicine called dofetilide (see section “Other medicines and Bactrim”).
• If you have an infection caused by group A beta-hemolytic streptococcus.

Warnings and precautions
Talk to your doctor or pharmacist before using Bactrim:

• If you are elderly.
• If you have a kidney disease. In this case, your doctor will determine the most appropriate dose for you (see section 3).
• If you have a liver disease.
• If you suffer from vitamin deficiencies (folates).
• If you suffer from or have suffered in the past from severe allergies and bronchial asthma.
• If your cough and shortness of breath worsen.
• If you suffer from blood disorders. The doctor will carefully assess whether to prescribe this medicine to you.
• If you suffer from a blood disease called porphyria or your thyroid (a gland in the neck) does not work properly.
• If you suffer from a metabolic disorder (where you are defined as a “slow acetylator”) which makes you more exposed to the risk of developing side effects due to the persistence of the medicine in the body.
• If you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).
• If you are taking methotrexate, a medicine to treat tumors (see section “Other medicines and Bactrim”).
• If you are taking clozapine, a medicine used to treat mental disorders. Your doctor may prescribe a different antibiotic because this medicine can cause effects on the blood (severe decrease of a type of white blood cells).
• If you suffer from fluid retention (edema) because your heart is working hard.
• If you are taking a medicine called paclitaxel (see section “Other medicines and Bactrim”).
• If you are taking a medicine called amiodarone (see section “Other medicines and Bactrim”).

During treatment with Bactrim, especially if prolonged, your doctor will subject you to periodic checks of the liver, kidneys and blood and urine tests.
If you experience cough or difficulty breathing during treatment, or if these symptoms worsen, tell your doctor, who will assess whether to stop therapy with Bactrim.
Your doctor will perform blood tests (potassium and kidney function) if you/the child have pneumonia, a potassium or kidney metabolism disease or are taking medicines that increase potassium concentrations in the blood (see section “Other medicines and Bactrim”).
Your doctor will monitor you carefully if you also have a kidney disease (e.g. creatinine clearance between 30 and 15 mL/min), in case of nausea, vomiting and high levels of potassium in the blood.
Stop treatment and consult your doctor immediately if you should develop rashes or skin eruptions, often with the presence of blisters or lesions on the mucous membranes (see also section “Possible side effects”). These could be signs of severe drug reactions, potentially fatal, such as Stevens Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and DRESS (drug rash with eosinophilia and systemic symptoms) and acute generalized exanthematous pustulosis (AGEP).
Hemophagocytic lymphohistiocytosis
Very rarely, excessive immune reactions due to uncontrolled activation of white blood cells causing inflammation (hemophagocytic lymphohistiocytosis) have been reported, which can be life-threatening if not diagnosed and treated early. If you experience more than one symptom such as fever, swollen lymph nodes, feeling weak, dizziness, shortness of breath, bruising or skin rash simultaneously or shortly after each other, contact your doctor immediately.

Children
The use of the medicine is contraindicated in children under 12 years of age.

Other medicines and Bactrim
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines, because it may be necessary for your doctor to monitor you or adjust the dose of Bactrim:

• dofetilide, medicine to treat irregular heartbeat. Do not use Bactrim if you are taking dofetilide (see section 2 “Do not use Bactrim”);
• amantadine, medicine to treat Parkinson's disease or memantine, medicine to treat Alzheimer's disease;
• lamivudine, medicine to treat hepatitis B virus (see section “Warnings and precautions”);
• tacrolimus, medicine to prevent organ rejection after transplantation (see section “Warnings and precautions”);
• paclitaxel, medicine to treat tumors;
• amiodarone, medicine to treat irregular heartbeat;
• dapsone, medicine to treat leprosy;
• medicines to treat diabetes including repaglinide, rosiglitazone or pioglitazone and sulfonylureas (such as glibenclamide, gliclazide, glipizide, chlorpropamide, and tolbutamide);
• coumarins (warfarin, acenocoumarol, phenprocoumone), medicines to make the blood more fluid;
• phenytoin, medicine to treat uncontrolled body movements (convulsions);
• digoxin, medicine to treat heart disorders;
• clozapine, medicine used to treat mental disorders;
• diuretics (especially thiazides) medicines to treat high blood pressure;
• methotrexate, medicine to treat tumors;
• pyrimethamine, medicine for the prevention of malaria;
• zidovudine, medicine to treat AIDS (which belongs to a class of medicines called “nucleoside analogs”);
• azathioprine, medicine to treat disorders of the body's defense system or mercaptopurine, medicine to treat blood cancers;
• medicines that increase the amount of potassium in the blood, such as angiotensin converting enzyme inhibitors and angiotensin receptor blockers, potassium-sparing diuretics and prednisolone, used to treat high blood pressure;
• cyclosporine, medicine to prevent rejection after a kidney transplant.

Laboratory tests
If you are about to have blood or urine tests, tell your doctor or nurse that you are taking Bactrim, as this may affect the results of some types of tests (such as the test to measure methotrexate or creatinine).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Your doctor will prescribe Bactrim during pregnancy only if the benefit is greater than the potential risk to the baby, especially in the first trimester of pregnancy.
If you are pregnant, or are planning a pregnancy, and are being treated with Bactrim, your doctor will tell you to also take a dose of 5 mg of folic acid per day. During the last stage of pregnancy, your doctor will not prescribe Bactrim due to possible complications for the newborn (deposition of bilirubin in the brain and possible neurological damage).

Breastfeeding
Both trimethoprim and sulfamethoxazole pass into breast milk. Your doctor will assess the possible risks to the infant (possible deposition of bilirubin in the brain, allergic reaction) in relation to the expected therapeutic benefit for you.

Driving and using machines
Studies have not been conducted on the effect of Bactrim on the ability to drive and use machines.
However, dizziness, convulsions, hallucinations may occur during treatment with Bactrim (see section 4). Keep this in mind before driving vehicles or using machines.

Bactrim tablets contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to use Bactrim

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Adults and adolescents over 12 years
The recommended dose is 1 tablet, 2 times a day.
The minimum dose and the dose for prolonged treatments (more than 15 days) is ½ tablet, 2 times a
day.
The maximum recommended dose for severe infections is 1 tablet and ½, 2 times a day.
The doctor may establish a different dose than the generally recommended one to treat some
types of infections (e.g. an infection affecting the genital organs called Chancroid, acute and uncomplicated urinary tract infections, a type of infection called nocardiosis or a type of
lung infection, called Pneumocystis jirovecii Pneumonia).

Patients with kidney disease
If you suffer from kidney diseases, including those in which the kidneys do not function and dialysis (hemodialysis and peritoneal dialysis) is required, the doctor will establish a dose
appropriate to your health condition.

Method of administration
Take the tablets in the morning and evening after meals, with an adequate amount of fluids.

Duration of treatment
The doctor will establish how long you should take the medicine. Generally, the treatment lasts
at least 5 days, or until 2 days after you no longer experience the symptoms of the infection. Contact
your doctor if you do not feel better or if you feel worse after 7 days of therapy.

If you use more Bactrim than you should
In case of accidental ingestion/taking of an excessive dose of Bactrim, immediately inform
your doctor or go to the nearest hospital.

Symptoms
The symptoms of an overdose may consist of: nausea, vomiting, diarrhea, headache,
dizziness, vertigo, mental and visual disturbances; effects affecting the kidneys and urinary tract such
as the presence of crystals in the urine (crystalluria), presence of blood in the urine (hematuria), difficulty or
inability to urinate (oliguria or anuria) in particularly severe cases.
The symptoms of a prolonged overdose may consist of a deficiency in the production
of blood cells (bone marrow depression), which manifests as a reduction in the number of
platelets or white blood cells (thrombocytopenia or leukopenia), and other abnormalities of the cells
that make up the blood (blood dyscrasias) due to vitamin deficiency (folates).

Treatment
The doctor will establish an adequate supportive treatment to treat the symptoms of an overdose
(e.g. gastric lavage, adequate fluid intake to accelerate renal elimination, hemodialysis,
control of the blood formula and, in case of alteration, administration of 6 - 12 mg of
calcium folinate).

If you forget to use Bactrim
Do not take a double dose to make up for the missed dose.

If you stop the treatment with Bactrim
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can also cause side effects, although not everyone will experience them.
If you experience the following side effects during treatment with Bactrim, STOP
TREATMENT andIMMEDIATELY INFORMyour doctor, who will assess whether to discontinue
treatment and prescribe an alternative medicine:

• allergic reactions,reported more frequently within the first few weeks of treatment, which can manifest as:
• life-threatening skin reactions that initially appear as red, round spots or circular patches often accompanied by blisters on the central part of the trunk and can progress with the development of widespread blisters, exfoliation, and death of skin cells (Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with increased white blood cells in the blood and generalized symptoms); changes in the color and appearance of the skin associated with irritation (rash) or rapid swelling of the skin (angioedema) or itching (urticaria); ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These skin reactions are often accompanied by symptoms similar to those of the flu (e.g., fever).
• alterations affecting the blood: abnormalities of the cells that make up the blood (blood dyscrasias), reduction in the number of blood cells (decreased blood count);
• respiratory symptoms: cough or difficulty breathing due to lung infiltrates.

Below are listed the possible side effects reported according to frequency:

Common (may affect up to 1 in 10 people)

• nausea
• vomiting
• high levels of enzymes produced by the liver (transaminases)
• high levels of waste products eliminated by the kidneys (urea, creatinine)
• skin reactions of various types, for example, after taking medicines (fixed drug eruption, exfoliative dermatitis) or the appearance of red patches on the skin (erythema, maculopapular rash, morbilliform rash), itching, rash

Uncommon (may affect up to 1 in 100 people)

• diarrhea
• inflammation of the intestine following antibiotic use (pseudomembranous enterocolitis)
• high levels of a substance produced by the liver (bilirubin)
• inflammation of the liver (hepatitis)
• infections caused by fungi (e.g., candidiasis)
• uncontrolled body movements (convulsions)
• reduced kidney function (impaired renal function)
• redness of the skin (urticaria)

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

• reduction in the number of white blood cells and platelets in the blood (leukopenia, granulocytopenia and thrombocytopenia)
• low levels of hemoglobin, the protein that carries oxygen, in the blood (megaloblastic, hemolytic/autoimmune, aplastic anemia)
• inflammation of the mucous membrane lining the oral cavity (stomatitis)
• inflammation of the tongue (glossitis)
• pain and inflammation of the veins (venous pain and phlebitis)
• disorder of the bile ducts (cholestasis)
• low blood sugar levels (hypoglycemia)
• nerve disease (neuropathy), including inflammation of the peripheral nerves (peripheral neuritis) and numbness (paresthesia)
• feeling of seeing or hearing things that do not exist (hallucinations)
• presence of crystals in the urine (crystalluria)

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

• reduction in the number of blood cells (agranulocytosis, pancytopenia)
• accumulation of an abnormal amount of hemoglobin in the blood (methemoglobinemia)
• increased number of a type of white blood cells (eosinophilia associated with DRESS)
• reduction of a blood clotting factor (hypoprothrombinemia)
• alteration of folate metabolism
• abdominal pain
• inflammation of the heart muscle (allergic myocarditis)
• inflammation of a membrane of the eye (uveitis)
• inflammation of the meninges, the membranes that cover the brain (aseptic meningitis) or similar symptoms
• insomnia
• headache
• progressive loss of muscle coordination that makes movements difficult (ataxia)
• ringing or buzzing in the ears (tinnitus)
• dizziness
• destruction of liver cells (hepatic necrosis)
• yellowing of the skin and whites of the eyes (jaundice)
• reactions following exposure of the skin to light (photosensitivity)
• erythema multiforme, purplish spots on the skin due to abnormal blood accumulation (purpura), also of an allergic nature (Henoch-Schönlein purpura)
• muscle tissue breakdown process (rhabdomyolysis)
• inflammation of the kidneys (interstitial nephritis), increased urine production
• adverse drug reaction, often severe, characterized by skin rash, enlarged lymph nodes, fever, and generalized symptoms affecting multiple organs (drug eruption with eosinophilia and systemic symptoms)
• lung alterations (pulmonary infiltrates)
• inflammation of the lungs (interstitial pneumonia)
• skin reactions red spots (erythema multiforme), widespread blisters with exfoliation and death of skin cells (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• increased sensitivity to light (photosensitivity)
• skin reactions caused by the drug (drug eruption with eosinophilia and systemic symptoms)
• rupture of skin capillaries (purpura)
• disease of blood vessels and skin (Henoch-Schönlein purpura)
• weakness (asthenia)
• allergic/hypersensitivity reactions, which can manifest with fever, rapid swelling of the skin (angioedema), skin rash with increased white blood cells in the blood and generalized symptoms (serum sickness), severe allergic reaction with generalized symptoms (anaphylactoid reaction), angioedema
• depression

Not known (frequency cannot be estimated based on available data)

• inflammation of the blood vessels of the eye (retinal vasculitis)
• acute inflammation of the pancreas (acute pancreatitis)
• reduction or damage to the bile ducts (vanishing bile duct syndrome)
• high levels of potassium in the blood (hyperkalemia)
• low levels of sodium in the blood (hyponatremia)
• joint pain (arthralgia)
• muscle pain (myalgia)
• inflammation of the blood vessels of the brain (cerebral vasculitis)
• inflammation of the blood vessels of the lung (pulmonary vasculitis)
• inflammation of the blood vessels (vasculitis), which can also lead to tissue death (necrotizing vasculitis, polyarteritis nodosa) or which may be characterized by manifestations affecting the ear, nose and throat (granulomatosis with polyangiitis)
• miscarriage
• appearance of painful, purplish, raised lesions on the limbs and sometimes on the face and neck, associated with fever (Sweet syndrome)
• kidney stones (urolithiasis).

HIV-positive patients (human immunodeficiency virus)
If you are HIV-positive, you may experience side effects similar tothe population that has not contracted the
virus. Some side effects may occur with a higher frequency and with a different clinical picture.
The following are the differences:

Very common (may affect more than 1 in 10 people)

• reduction in the number of white blood cells and platelets in the blood (leukopenia, granulocytopenia and thrombocytopenia)
• high levels of potassium in the blood (hyperkalemia)
• loss of appetite (anorexia)
• nausea
• vomiting
• diarrhea
• appearance of red patches on the skin (maculopapular rash)
• itching
• fever, usually accompanied by skin rashes
• high levels of enzymes produced by the liver (transaminases)

Uncommon (may affect up to 1 in 100 people)

• low levels of sodium in the blood (hyponatremia)
• low blood sugar levels (hypoglycemia)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of
this medicine.

5. How to store Bactrim

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after Scad. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bactrim contains
One tablet contains:

• The active ingredients are trimethoprim 160 mg and sulfamethoxazole 800 mg.
• The other ingredients are povidone K30, magnesium stearate, sodium docusate, sodium starch glycolate (see section 2 “Bactrim tablets contains sodium”).

Description of the appearance of Bactrim and contents of the pack
Bactrim is presented as tablets contained in blisters made of plastic and aluminum, packaged
in a cardboard box.
It is available in packs of 16 tablets.

Marketing Authorisation Holder
EUMEDICA Pharmaceuticals GmbH
Basler Straße 126
79540 Lörrach
Germany

Manufacturer
EUMEDICA Pharmaceuticals GmbH
Basler Straße 126
79540 Lörrach
Germany