OSPEXIN 500mg x 24 tabl
Leaflet: patient information
Ospexin 500 mg film-coated tablets
Ospexin 500 mg film-coated tablets
Ospexin 1000 mg film-coated tablets
Ospexin 10 00 mg film-coated tablets
Cefalexin ( Cefalexin )
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep 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 personally. Don't leave it to other people. It can harm them even though the signs of their illness are the same as yours.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
What this leaflet contains :
- What Ospexin is and what it is used for
- What you need to know before taking Ospexin
- How to take Ospexin
- Possible side effects
- How to store Ospexin
- Package contents and additional information
1. What Ospexin is and what it is used for
Ospexin contains cephalexin (from the group of semi-synthetic cephalosporins). It is an antibiotic that destroys many different bacteria by suppressing cell wall biosynthesis. Therefore, it can be used for a wide range of diseases.
Ospexin is very well absorbed in the body. Since the presence of food does not significantly affect its absorption, patients with a sensitive stomach can also take Ospexin during meals. Ospexin is well distributed in various tissues of the body. Ospexin is excreted in active form with urine.
Diseases that can be treated with Ospexin are infections caused by microorganisms sensitive to cephalexin, such as:
- Infections of the genitourinary system, incl. prostatitis
- Skin and soft tissue infections
- Bone and joint infections
- Respiratory tract infections
- Ear, nose or throat infections
- Dental infections.
After significant improvement and confirmation that the causative agent of the infection is susceptible, treatment with cephalosporin injections can be continued with Ospexin.
2. What you need to know before you take Ospexin
Do not take Ospexin
- if you are allergic (hypersensitive) to cephalexin or other cephalosporins or to any of the other ingredients of Ospexin (listed in section 6). If you are allergic to penicillin, you may have cross-reactivity to Ospexin.
- Severe systemic infections should be treated from the outset with injectable antibiotics.
- Ospexin should not be used to treat infections of the brain and spinal cord.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you start taking Ospexin.
In case of previous hypersensitivity to penicillin, hypersensitivity to cephalexin is also possible. If you have ever been diagnosed with an allergy, especially to penicillin, you should definitely let your doctor know.
Tell your doctor before taking cephalexin if you have ever had a severe skin rash or skin peeling, blistering, and/or mouth sores after taking cephalexin or other antibacterial agents.
You should inform your doctor if you suffer from hypersensitivity (hives type allergies) or asthma. Treatment should be stopped and a doctor should be consulted immediately in case of signs of allergy, such as skin rashes, itching, tremors, urticaria, difficulty breathing, shortness of breath, diarrhea or stomach pains.
If severe and persistent diarrhea occurs, the possibility of inflammation of the large intestine (pseudomembranous colitis caused by the bacterium Clostridium difficile ) should be discussed. In this case, you should stop taking Ospexin and consult a doctor.
Blood tests and liver function tests are recommended for longer durations of treatment, as well as kidney function testing in the presence of kidney disease.
With prolonged treatment, the development of bacteria or fungi that are not sensitive to cephalexin is possible. In these cases, the necessary measures should be taken.
Acute generalized exanthematous pustulosis has been reported with the use of cephalexin. Acute generalized exanthematous pustulosis appears early in treatment as a red, scaly, widespread rash with subcutaneous bumps and blisters, accompanied by fever. The most common location: mainly localized in skin folds, on the torso and upper limbs. The highest risk of this serious skin reaction occurring is during the first week of treatment. If a serious rash or any of these skin symptoms develop, stop taking cephalexin and contact your doctor or get medical help right away.
If you suffer from diabetes, please do not take Ospexin before discussing it with your doctor.
Biochemical reactions
Cephalosporins can sometimes cause false positive results in urine glucose tests. In these cases, methods based on the glucose oxidase reaction can be used to measure glucose in the urine.
The direct Coombs test (a blood test for the presence of antibodies against red blood cells) can also show false positive results.
Cephalosporins can affect the determination of ketone bodies in the urine (metabolic products that result from the increased breakdown of fats) in the urine.
Other drugs and Ospexin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Ospexin should be taken at the same time as other antibiotics only on the express recommendation of your doctor, because some antibiotics can increase the effect of Ospexin, while others can weaken it.
Concomitant use with probenecid (a drug that reduces uric acid) may result in an increase and longer duration of cephalexin in the blood.
Combining cephalosporins with loop diuretics (medicines that increase urine output) such as ethacrynic acid or furosemide, or with other antibiotics that can be harmful to the kidneys (aminoglycosides, polymyxin, other cephalosporins) may increase the damaging effects on the kidneys. .
Concomitant administration of cephalosporins and oral anticoagulants may prolong clotting time.
The simultaneous use of cephalexin and metformin (a medicine for diabetes mellitus) can lead to undesirably high levels of metformin.
When cephalosporins are used together with some medicines for the treatment of leukemia, the levels of potassium in the blood may decrease.
Ospexin with food and drink
Film-coated tablets should be swallowed whole with a glass of water. They can be taken on an empty stomach or with food.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.
There are no studies in pregnant women, so caution is needed when cephalexin is prescribed during pregnancy.
As with other medicines, during pregnancy Ospexin should be taken only on the recommendation of your doctor. Small amounts of Ospexin are excreted in breast milk. Caution should be exercised when prescribing cephalexin to a nursing mother. The possibility of diarrhoea, fungal infection of mucous membranes and sensitization in the infant cannot be excluded. Your doctor will assess the need to use Ospexin during pregnancy and breastfeeding. No adverse effects are known in pregnant women, unborn or newborn children.
Driving and using machines
There are no data on the effect of cephalexin on the ability to drive and use machines.
Ospexin tablets contain lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. it can be said to be practically sodium-free.
3. How to take O spexin
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
The daily dose for infections with microorganisms highly sensitive to cephalexin (Gram-positive) is 1-4 g.
The daily dose for infections with less sensitive to cephalexin microorganisms (Gram-negative) is 4-6 g.
The daily dose can be divided into 2, 3 or 4 single doses. If necessary, the doctor may prescribe even higher doses.
Children and adolescents
For children under 6 years of age, the medicine is also available in liquid form.
The daily dose is 25-50 (up to 100) mg/kg of body weight, divided into 2, 3 or 4 single doses.
Children aged 6-10 years 3 times 1 film-coated tablet of 500 mg per day.
Children aged 10-14 years 3-4 times 1 film-coated tablet of 500 mg per day.
Adolescents and adults should not take a daily dose exceeding 4g (= 8 film-tablets Ospexin 500 mg; = 4 film-tablets Ospexin 1000 mg) without the express recommendation of the doctor. For adults, the daily dose should be at least 1g (= 2 film-tablets Ospexin 500 mg or 1 film-tablet Ospexin 1000 mg).
Infants (≥ 28 days) and children up to 12 years of age
The daily dose is 25-50 (up to 100) mg/kg of body weight, divided into 2, 3 or 4 single doses depending on the severity of the infection.
Infants and children under 6 years of age should not take more than 100 mg/kg body weight per day.
Newborn children (up to 28 days)
A daily dose of 50 mg/kg of body weight (including otitis media) should not be exceeded.
Duration of treatment
Your doctor will tell you how long to take Ospexin. . Do not stop treatment without discussing it with your doctor.
Treatment should be continued for 2-5 days after symptoms subside. Infections with beta-hemolytic streptococci (ie, angina, scarlet fever) should be treated for at least 10 days to avoid complications.
Dosage in impaired kidney function
If kidney function is severely reduced, your doctor will reduce the dose or increase the time between doses. You should therefore tell your doctor if you suffer from kidney disease.
If you have taken more than the required dose of Ospexin
Even if you accidentally swallow large doses of Ospexin, this usually does not lead to symptoms of poisoning. Overdose can cause stomach/intestinal complaints, as well as disturbances in the water and electrolyte balance, cramps, hallucinations, strengthening of some reflexes, blood in the urine.
If you take too many Ospexin tablets, please contact your doctor.
If you forget to take Ospexin
Do not take a double dose to make up for a missed dose.
If you stop taking Ospexin
Even when your condition improves or all symptoms have completely disappeared, you should never change or stop treatment with Ospexin without consulting your doctor to make sure that your condition does not get worse or that you get sick again.
If you have any further questions related to the use of this product, please ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet.
Common: may affect up to 1 in 10 patients
- Allergic reactions, with previous allergy to penicillins
Uncommon: may affect up to 1 in 100 patients
- Vaginitis (inflammation of the female genital organs), vaginal yeast infections, vaginal discharge, genital itching
- Diarrhea, nausea
- Eosinophilia, leukopenia, neutropenia, thrombocytopenia (increased number of certain types of blood cells)
- Skin rash, hives, itching, swelling
- Elevation of ALT and AST (liver enzymes) (reversible)
- Headache, dizziness
- Hallucinations, agitation, confusion
- Vomiting, loss of appetite (usually improve spontaneously during treatment), inflammation of the mucous membrane of the mouth, abdominal pain, dyspepsia (indigestion), pseudomembranous colitis (severe inflammation of the colon),
- Fatigue
Rare: may affect up to 1 in 1,000 patients
- Changes in the blood count (hemolytic anemia)
- Allergic reactions to cephalosporins (usually milder than penicillin allergies)
- Disorders of kidney function (appearance of blood in urine, thirst and increased amount of urine, easy fatigue). They are temporary and disappear after stopping the drug. In rare cases, inflammation of the kidneys (reversible interstitial nephritis) has been found.
Very rare: may affect up to 1 in 10,000 patients
- Joint pain, joint inflammation and joint diseases
- Transient elevation of liver enzymes SGOT and SGPT.
- Anal itching
- Anaphylactic reaction (hypersensitivity reaction)
- Inflammation of the liver, jaundice
- Rashes (erythema multiforme), sometimes serious with red, inflamed and oozing skin (Stevens-Johnson syndrome) and blistering of the skin (toxic epidermal necrolysis)
Not known: no estimate can be made from the available data
- Positive direct Coombs test. False positive reaction for glucose in urine
- A red, scaly, widespread rash with subcutaneous swelling and blistering accompanied by fever at initiation of treatment (acute generalized exanthematous pustulosis). Stop using cephalexin if you develop these symptoms and contact your doctor or get medical help right away. See also point 2.
Reporting adverse reactions
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the national reporting system to the Executive Medicines Agency, 8 Damyan Gruev Street, 1303 Sofia, phone: + 359 2 890 34 17, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Ospexin
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiration date corresponds to the last day of the specified month.
To be stored at a temperature below 25 ºС.
Store in the original package to protect from light and moisture.
Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of your unwanted medicines. These measures will help protect the environment.
6. Contents of the package and additional information
What Ospexin contains
Ospexin 500 mg film-coated tablets :
- The active substance is cephalexin. Each film-coated tablet contains 500 mg of cephalexin
- The other ingredients are: macrogol 6000, magnesium stearate, sodium starch glycolate (type A), povidone, lactose, saccharin sodium, peppermint oil, titanium dioxide (E-171), talc, hypromellose.
Ospexin 1000 mg film-coated tablets :
- The active substance is cephalexin. Each film-coated tablet contains 1000 mg of cephalexin
- The other ingredients are: macrogol 6000, magnesium stearate, sodium starch glycolate (type A), povidone, lactose, saccharin sodium, peppermint oil, titanium dioxide (E-171), talc, hypromellose
What Ospexin looks like and contents of the pack
Ospexin 500 mg film-coated tablets :
Oblong, biconvex film-coated tablet, scored on both sides, approximately 7 x 18 mm, white to pale yellowish in color. The film-coated tablet can be divided into equal halves.
Ospexin 1000 mg film-coated tablets :
White to pale yellowish elliptical, biconvex, film-coated tablet, approximately 10 x 21 mm.
Packs containing 12, 24, 100 and 1000 film-coated tablets.
Not all types of packaging can be marketed.
License holder
Sandoz GmbH
10 Biochemiestrasse, 6250 Kundl, Austria
Manufacturer
Sandoz GmbH, 10 Biochemiestrasse, 6250 Kundl, Austria
Date of last revision of leaflet
