Septrin Forte 160 mg / 800 mg
(German name "Bactrim forte")
50 tablets
Active ingredients: trimethoprim / sulfamethoxazole
The other ingredients are: povidone, Natriumamyloglycolat,
Magnesium stearate, sodium docusate.
Septrin Forte contains two different medicines: sulfamethoxazole (a "sulfonamide"), and trimethoprim. These are drugs used to treat bacterial infections.
Septrin Forte is administered for the treatment of infections caused by bacteria. Prior to administration of Septrin Forte is checked, the benefits and risks associated with a Septrin Forte treatment.
Septrin Forte is indicated for the treatment of infections:
· The lungs,
· Of the middle ear in children,
· The genitourinary tract,
· The intestine,
· the bone,
· Certain other infections to their treatment, your doctor Septrin Forte prescribed.
What you need to know before taking
Septrin Forte should not be used,
· If you are hypersensitive (allergic) to sulfonamides, trimethoprim or
any of the excipients of Septrin Forte (full list see section 6) react
· If you have severe liver disease,
· If you suffer from severe kidney disease,
· If you want of an enzyme (glucose 6-phosphate dehydrogenase) to anemia (anemia) tend unless you are otherwise instructed by the doctor,
· If you are suffering from a blood disorder,
· In premature infants or infants under 6 weeks
· If you dofetilide (a medicine used to treat cardiac arrhythmias)
taking.
If any of the above conditions apply to you, you may never use Septrin Forte. If in doubt, be sure to seek the advice of your doctor or pharmacist before you start taking Septrin Forte.
Take special care when taking Septrin Forte is required
· Tell your doctor with all diseases in which you are suffering or have suffered recently, so the doctor can decide whether you can take Septrin Forte.
· With the use of Septrin Forte accompanied may have been
life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal
Necrolysis) reported that initially the fuselage as reddish
Shooting discoid lesions or circular patches often with
Blistering in the center show. More to be observed signs are ulcers of the mouth, throat, nose and Genitalienbereich and conjunctivitis (red, swollen eyes). This potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash can spread to a large area bubble formation or lead to peeling of the skin.
The highest risk of occurrence of serious skin reactions occurs in the first weeks of treatment. If has developed a Stevens-Johnson syndrome or toxic epidermal necrolysis with you during the use of Septrin Forte, you should start taking Septrin Forte at any time again.
If at you developed a rash or these skin symptoms occur, contact Septrin Forte from, seek immediate medical attention and tell the doctor that you are taking this medication.
· In some cases, prescribe laboratory tests the doctor.
Taking Septrin Forte with other medicinal products
Please inform your doctor or pharmacist if you are taking or have recently taken, even if it is not prescribed or herbal medicines other medicines. The reason is as follows: Septrin Forte may interact with other medicines, and other medicines may influence the effect of Septrin Forte.
Do this medicine especially not use and have your doctor or pharmacist if you also take the following medicines:
· Dofetilide, a drug used to treat heart arrhythmias
Let us know if you use your doctor or pharmacist the following medicines:
· Medicines to treat blood sugar (diabetes mellitus)
· Medicines to treat or prevent seizures (antiepileptics)
· Medicines which inhibit blood clotting,
· Diuretic drugs,
· Potassium salts,
· ACE inhibitors (used to treat or prevent high blood pressure),
· Contraceptive drugs (see below: section "Pregnancy and lactation")
· Cyclosporine,
· Methotrexate,
· Tricyclic antidepressants,
· Digoxin,
· Indomethacin,
· Any other medicines or herbal remedies.
Inform (or if you are not sure) your doctor or pharmacist before you start taking Septrin Forte, if any of the above conditions apply to you.
laboratory tests
If laboratory tests are required for you, you must tell the doctor that you are taking Septrin Forte because Septrin Forte can affect the results of laboratory tests.
pregnancy and breast feeding period
· If you are pregnant or breastfeeding your child, you should consult your doctor before
You start taking Septrin Forte. Septrin Forte may only be administered if the doctor considers it essential.
· If you are taking the pill and Septrin Forte, the effectiveness of the pill may be decreased. to taking the first pill of the following 21-day cycle, you should use during Septrin Forte-taking and after the Septrin Forte treatment therefore another method of contraception as the pill.
Please ask your doctor or pharmacist before taking any medicine.
dosage
· If you suffer from severe kidney disease, the physician will determine the dosage
adjust accordingly.
· The doctor may increase the dose if it deems it necessary.
Adults and children over 12 years
· In adults and children over 12 years, the usual dose is 1
Tablet in the morning and 1 tablet in the evening.
· The minimum dose is ½ tablet in the morning and ½ tablet in the evening. These
Dosage applies with a treatment time of longer than 14 days.
· The maximum dose is administered in severe cases and is 1 ½ tablets in the morning and 1 ½ tablets in the evening.
type of application
· The tablets may be halved.
· Take Septrin Forte medicine with a full glass of water.
· During the Septrin Forte intake you need to drink plenty of water.
· Take Septrin Forte an after meals.
duration of treatment
· Usually Septrin Forte is taken in 5 days in the above dosages.
· In some infections, the doctor will prescribe a different dose and duration of treatment.
· In any case Septrin Forte must be taken for a further 2 days from the date on which one no longer feels sick.
If you take more Septrin Forte than you should:
· If you take too large a quantity Septrin Forte, you must contact your doctor, pharmacist, the emergency medical service (Tel. 112) or the
inform Poisons Information Centre.
Symptoms of overdose include nausea, vomiting, diarrhea, headache, dizziness, drowsiness, mental disorders, visual disturbances, severe sore throat, blood in urine or stoppage of urine production.
An emergency even hospitalization may be necessary to allow for appropriate treatment: amplification of urine output (forced diuresis), controlling the composition of the blood counts and liver function, possibly hemodialysis.
If you have forgotten to take Septrin Forte
If you miss a dose Septrin Forte, take this dose as soon as possible after. Then continue the treatment at the prescribed dosing.
If you issue Septrin Forte
You must not stop prematurely Septrin Forte treatment without first talking to your doctor. If not all bacteria are killed, the symptoms may reappear.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
What side effects are possible?
Like all medicines, Septrin Forte can cause side effects, although not everybody gets them.
Allergic reaction
If you experience an allergic reaction occurs, discontinue Septrin Forte and seek medical attention immediately. The following symptoms may occur:
· Common: Skin reactions such as redness or rash.
· Very rare: skin redness, temporarily disappears when the pressure (erythema); there are different forms of erythema, including some severe forms:
- There are reports of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).
- Appearance of red spots due to subcutaneous bleeding (purpura),
· Very rare: fever, facial swelling (angioedema). Various allergic reactions (anaphylactic reaction) or a few days can occur immediately after taking the drug after ingestion (serum sickness)
· Very rare: cough and shortness of breath due to pneumonia.
· Very rare: inflammation of the blood and lymph vessels in various organs
(Polyarteritis nodosa)
· Very rare: inflammation of the heart muscle (myocarditis).
Put Septrin Forte from, and inform your doctor immediately if you notice any of the above side effects.
Other adverse effects:
Common (affecting fewer than one in 10 people)
· Nausea with or without vomiting,
· Skin reactions are usually mild and after completion of the
disappear therapy quickly,
Rarely (less than one in 1,000 people)
· Decrease in the number of white blood cells (leukopenia and granulocytopenia)
and the platelet count (thrombocytopenia). This can be based on
demonstrate examinations of blood counts. Most changes in the
Blood counts are very pronounced, lead to any specific symptoms and
go after stopping treatment back.
· Inflammation in the mouth (stomatitis)
· Inflammation of the tongue (glossitis)
· Diarrhea.
Very rarely (less than one in 10,000 people)
· Infection by fungi, z. B. the type "Candida"
· Strong decrease of some white blood cells or complete disappearance of these white blood cells (agranulocytosis)
· Decrease in the number of red blood cells (anemia)
· Detection of oxidized hemoglobin (methemoglobin) in the blood,
· Gradual increase of potassium in the blood (hyperkalemia) in patients receiving Septrin Forte in high doses, for example in the treatment of
Pneumocystis jirovecii pneumonia, in patients with pre-existing disturbance of
Potassium metabolism in patients with renal insufficiency and in patients where other drugs are administered, which the also in an increase
Potassium levels lead. In these patients, careful monitoring of
Potassium levels in the blood appears. After completion of the treatment is the
Potassium levels back.
· Decrease in sodium level (hyponatremia) and the blood glucose level
(Hypoglycemia) in non-diabetic patients after a few days of treatment.
Particularly at risk are patients who has renal impairment,
suffering from liver disease or malnutrition, received high dose and patients who Septrin Forte.
· Delusions, hallucinations, personality disorders (psychosis)
· Inflammation of the peripheral nerves (peripheral neuropathy) with numbness or tingling (paraesthesia),
· Inflammation of the eye (uveitis),
· Meningitis or meningitis-like symptoms,
· Shaking (tremor)
· Disturbed coordination of movements (ataxia)
· Seizures, hearing loss, ringing in the ears (tinnitus), dizziness,
· Inflammation of the small intestine and the large intestine (enterocolitis),
· Acute inflammation of the pancreas (acute pancreatitis)
· Increased liver enzymes in the blood, liver inflammation (hepatitis),
Bile outflow obstruction, destruction of the liver, atrophy of the bile duct,
· Light sensitivity (photosensitivity)
· Joint pain (arthralgia) and muscle pain (myalgia)
· Muscle degeneration (rhabdomyolysis)
· Renal impairment (kidney failure), kidney inflammation (nephritis), with
Increase in the urea concentration in the blood, increase in creatinine concentration in the
Blood, occurrence of Harnkristallen (crystalluria). Septrin Forte, the urine
increase, especially in patients with edema caused by heart disease
caused.
Patients with HIV infection
In HIV-positive patients experience certain adverse effects special
frequently. The most common adverse reactions are:
Very common (more than one in 10 people)
· Decrease in the number of white blood cells (leukopenia and granulocytopenia)
and the platelet count (thrombocytopenia). This can be based on
demonstrate examinations of blood counts.
· Increase of potassium in the blood (hyperkalemia); after completion of the
Treatment go the potassium in the blood back. This can be demonstrated using blood tests.
· Loss of appetite,
· Nausea with or without vomiting and diarrhea,
· Skin rash with pus formation,
· Fever that comes usually with a rash.
Common (affecting fewer than one in 10 people)
· Increased liver enzymes in the blood; this can be based on
Blood tests to prove.
Rarely (less than one in 100 people)
· Decrease in sodium levels in the blood (hyponatraemia); this can be based on
Blood tests to prove.
· Low blood sugar (hypoglycemia); this can lead to the following symptoms: craving, difficulty concentrating, slowed reflexes.
Very rare (affects less than one in 10,000 people on)
· Shaking (tremor) similar to Parkinson's disease and gait
Please tell your doctor or pharmacist if any of the listed
Side effects gets serious, or you notice any side effects not listed in this leaflet.
Storage of Septrin Forte Tablets: No special storage conditions.
store drug out of reach of children
Do not store above 30 °.
You may Septrin Forte not after the expiry date stated on the pack
Apply more. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask yourself if you no longer need your pharmacist how to dispose of medicines there.
These measures will help to protect the environment.
