• Active substance:  Amoxicillin trihydrate.
• Pharmaceutical form: film-coated tablets

Composition

What Dose Ospamox Contain?

• Ospamox 500 mg film-coated tablets:  1 tablet contains: 500 mg amoxicillin as trihydrate.
• Ospamox 750 mg film-coated tablets: 1 tablet contains: 750 mg amoxicillin as trihydrate.
• Ospamox 1000 mg film-coated tablets: 1 tablet contains: 1000 mg amoxicillin as trihydrate.

Mode Of Action

How Does Ospamox Act?

Ospamox contains amoxicillin which is an antibiotic in a class of drugs called aminopenicillins and can be used in various bacterial diseases. Ospamox is well absorbed by the body and readily distributes into various body fluids and tissues.

Indications

When Is Ospamox Used?

Since Ospamox is highly active and is absorbed virtually completely into the body, it can be used for oral treatment even of severe disorders. The following disorders can be treated with Ospamox provided they are caused by amoxicillin-sensitive organisms:

Airway Infections

• infections of the upper airways, inflammations of the paranasal sinuses and the middle ear (sinusitis, otitis media).
• infections of the lower airways, e.G. Acute and chronic bronchitis, inflammation of the lungs (pneumonia), accumulation of pus in the lungs (lung abscess), whooping cough.

Infections Of The Urinary Tract And Sex Organs

• acute and chronic inflammations of the kidneys, the renal pelvis, the prostate and the epididymis, which is a tube attached to each testicle (pyelonephritis, pyelitis, prostatitis, epididymitis).
• inflammations of the bladder (cystitis), inflammation of the urethra (urethritis), bacteria detectable in urine during pregnancy.
• gonorrhoea.

Gynaecological Infections Such As:

miscarriage associated with infection, inflammation of the ovaries, fallopian tubes or uterus (septic abortion, adnexitis, endometritis).

Gastro-Intestinal Infections

• typhoid fever, paratyphoid fever; Ospamox is also effective in the treatment of chronic carriers of salmonella.
• bacillary dysentery (shigelloses).
• mild infections of the bile ducts and the gall bladder (cholangitis, cholecystitis).

Infections Of The Skin And Soft Tissue

• leptospiroses.
• listerioses with or without signs and symptoms.

Where Treatment With Injections Is Not Necessary, Ospamox Can Be Used In The Following Disorders:

• short-term preventive treatment (24 — 48 hours) in connection with surgery (e.g. oral cavity).
• inflammation of the inside lining of the heart muscle (endocarditis).
• inflammation of the membranes of the brain caused by bacteria.
• blood poisoning (septicaemia) caused by amoxicillin-sensitive organisms.

Dosage And Mode Of Administration

What Dose Of Ospamox Should You Take And Hoe Often?

Follow the dosage instructions exactly, unless directed otherwise. Your doctor will determine the dose depending on the sensitivity of the disease-causing organism involved and the site of infection. It is generally recommended to divide the daily dose into 2 (3-4) doses.

• Average dosage for Children:  30 – 60 mg/kg of body weight a day.
• Average dosage for Adolescents and adults: 1500 — 2000 mg a day.

Special Dosage Instructions

Acute uncomplicated urinary tract infections, infections of the upper airways or the ears, nose and throat, infections of the skin and soft tissue:

• Children: about 25-30 mg/kg of body weight divided into 2 – 3 doses a day.
• Adolescents and adult: daily dose of 750 – 1500 mg divided into 2 – 3 doses a day.

Infections of the lower airways (e.g. bronchitis, pneumonia, lung abscess) and of the upper urinary tract:

• Children: 50 – 60 mg/kg of body weight divided into 2 – 3 doses a day.
• Adolescents and adults: 1500 – 3000 mg divided into adults 2 – 3 doses.

For the treatment of severe disorders, your doctor may increase the daily dose:

• Children: 100 mg/kg of body weight a day.
• Adolescents and adults: up to 6000 mg a day.

For severe infections, your doctor can prescribe daily doses of 200 mg/kg of body weight for children or 8000 mg for adults.

Preventive treatment of endocarditis after tooth extractions:

• Children: 1500 – 2000 mg 1 hour before surgery; repeat dose after 8 – 9 hours if appropriate.
• Adults: 3000 – 4000 mg before surgery; repeat dose after 8 – 9 hours if appropriate.

Dosage When Excretion Is Impaired

The doctor will decide whether to use this medicine in patients with impaired kidney function.

Mode Of Administration

How Do You Use Ospamox?

Ospamox can be taken before or after meals and is therefore also suitable for patients with sensitive stomachs. The medicine should be taken with plenty of liquid.

Duration Of Administration

After the signs of infection (fever, pain, etc) have disappeared, the treatment should be continues to- 2-5 days. According to the World Health Organization (WHO), a treatment duration of 10 days is recommended for infections with streptococci in order to prevent later complications.

Undesirable Effects

What Are The Possible Undesirable Effects (Side Effects) Of Ospamox, Which However Do Not Necessarily Occur In All Patients?

Ospamox is generally well tolerated. Occasionally, transient symptoms affecting the stomach and intestine (vomiting, diarrhoea, stomach discomfort, loss of appetite, inflammations of the inside of the mouth or the tongue) may occur.

Hypersensitivity reactions such as skin rashes, reddening and swelling of the skin are rare. They often take a mild course and usually disappear within a few days.

Changes in blood counts (indicated by tiredness, sore throat and inflammations in the mouth), inflammation of the kidneys (fever, swelling, especially in the face and/or blood in the urine), changes in taste perception, dry mouth or serious hypersensitivity reactions such as circulatory collapse and/or shortness of breath (anaphylactic shock) occur extremely rarely.

In a few cases, headaches, tiredness, fever and joint pain occur.

Viral diseases may more often than not be associated with rashes during administration of amoxicillin. Please therefore inform your doctor if such a disease occurs while you are taking Ospamox or you suspect that you have contracted e.g. some childhood disease such as measles, etc.

In the treatment of typhoid fever or syphilis, the decomposition of killed bacteria and the resultant release of bacterial poisons may cause fever and skin rashes.

Mild transient elevations in some liver test results have occasionally been reported.

If you note other side effects, please inform your doctor or pharmacist immediately.

Special Warnings And Precautions For Use

What Precautionary Measures Are To Be Considered When Taking Ospamox?

Please report first signs of side effects (e.g. sore throat, extreme tiredness and inflammations in the mouth) to your doctor immediately.

You should inform your doctor if you have a history of hypersensitivity (allergy, hayfever) or suffer from asthma. If you develop any allergic symptoms, in particular itching, chills, wheals, shortness of breath, chest tightness and diarrhoea or abdominal pain, contact your doctor immediately for advice.

For the duration of treatment with Ospamox, the patient should drink plenty of liquid to ensure adequate amounts of urine.

During long-term treatment, it is recommended to check blood counts, live function and kidney function.

A missed dose of Ospamox should be taken as soon as you realize the omission.

Please see your doctor if you have persistent diarrhoea.

Please inform your doctor if you are pregnant.

Even if symptoms improve or disappear, the treatment with Ospamox must not be changed or discontinued unless prescribed by the doctor in order to prevent any worsening or reappearance of the disease.

Keep this medicine out of the reach and sight of children at all times.

Pregnancy And Lactation

May Ospamox Be Used During Pregnancy Or Lactation?

• Ospamox may be taken during pregnancy. The dose used during pregnancy is determined by the doctor.
• As small amounts of the substance enter breast milk, nursing mothers should wean their babies.

Contraindications

When Should Ospamox Not Be Used?

Ospamox must not be used in patients with hypersensitivity (allergy) to amoxicillin or other penicillins. Patients who are allergic to cephalosporins may also be allergic to amoxicillin.

Use of aminopenicillins in patients with glandular fever (infectious mononucleosis) or lymphatic leukaemia (multiplication of certain white blood cells) very often caused skin rashes. Even though the frequency of these rashes was markedly lower with Ospamox, its use should be avoided in patients with these disorders. Please inform your doctor if you suffer from any of the disorders mentioned above.

Ospamox cannot be absorbed by the body in adequate amounts in patients with severe stomach and intestinal symptoms associated with persistent diarrhoea or vomiting. You therefore need to inform your doctor of any such condition immediately.

Mild infections do not require antibiotic therapy.

Ospamox- Information Leaflet