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 only.
Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
* If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
1-DESCRIPTION:
A white to off-white color biconvex round shaped uncoated tablets with
breakline on one side and plain on the other side.
2-COMPOSITION:
Each METRODAZ-UBSA tablet contains 500mg of metronidazole.
Excipients: microcrystalline cellulose, maize starch, PVP-K30, methylpara-
ben, propyl paraben ,Sodium starch glycolate, magnesium stearate,
purified talc, colloidal silicone dioxide,lactose monohydrate, croscarmel-
lose sodium.
3-THERAPEUTIC INDICATIONS:
Pré and post-operative prophylaxis in gynecological and gastro-intestinal
surgery. Trichomoniasis. Intestinal and hepatic amoebiasis. Giardiasis
(lambliasis). Acute ulcerative gingivitis (Vincent’s gingivitis).Prevention
and treatment of infections due to anaerobic bacteria.
4-PHARMACOLOGICAL PROPERTIES:
METRODAZ-UBSA is an antibacterial and antiparasitic antibiotic belonging
to the 5-nitroimidazole group of medicines. METRODAZ-UBSA is the drug of
choice for the treatment of infections due to various protozoa such as:
amoeba, Giardia Lamblia and T. vaginalis. It’s indicated for the treatment
of hepatic and intestinal amoebiasis and forms of urethritis and vaginitis
cause by Trichomonas vaginalis: in the latter the simultaneous treatment
of patient and partner is strongly recommended. Metronidazole is also
very active against a wide range of obligate anaerobic bacteria such as
Fusobacterium. Clostridium and various strains of Bacteroides. It has
however no effect on facultative aerobic bacteria and its use therefore
doesn’t affect the normal population of these organisms in man. Cases of
resistance to metronidazole are rather rare.
5-PHARMACOKINETICS:
Metronidazole is absorbed rapidly and nearly completely from the
gatsro-intestinal tract. The maximum concentrations in the blood is
achieved about 4 hours after administration,About half the dose
administered is metabolized and 50% is rapidly eliminated via the kidneys
.The drug passes the placenta and is found in the breast milk in
concentration corresponding to those in the mother’s serum.
6-CONTRAINDICATIONS:
Anomalies of the blood formula. CNS disorders. First 3 months of
pregnancy, during the following months. Oral administration may be
limited to these cases in which local application has proved inadequate.
7- DOSE AND ADMINISTRATION:
-Trichominasis: 2g in a single dose or 250-500mg twice a day for 6 days.
The patient and partner should be treated simultaneously.
-Acute intestinal amoebiasis: 2g-2.5 g in a single dose for 2 -3 days or
500mg3 times daily for 5 days.
-Giardiasis:
Adults: 2g in a single dose for 3 days or 500mg twice daily for 5-10 days.
Children: 250mg once daily for 10 days.
Infants: 25mg/kg BW for 10 days.
Anaerobic Infection: Treatment: adults and children over 12 years old: an
initial dose of 30mg/kg BW followed by a dose of 7mg/kg every 8 hours. In
general, treatment should not be given for more than 7 days.
Prevention: In general, preventive treatment should not be given for more
than 3 to 7 days.
Adult and children over 12 years old: one day prior to surgery 1 g is
administered orally followed by 250mg orally every 8 hours up to
preoperative fast.
Operative and post operative periods: as quickly as possible return to
250mg x 3 times daily.
8-Drug Interactions:
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicines. Tell your doctor if you are taking:
- medicines containing alcohol because of the risk of side effects such as
redness of the face, feeling hot, vomiting and increased heart rate,
- busulfan (recommended for the treatment of certain types of blood
disorders and for the preparation of a bone marrow transplant),
- disulfiram (used to prevent relapse in alcohol-dependent patients)
Flagyl with alcohol Drinking alcoholic beverages should be avoided during
treatment because of the risk of side effects such as redness of the face,
feeling hot, vomiting and increased heart rate.
9-WARNINGS and PRECAUTIONS:
Do not take METRODAZ-UBSA:
- if you are allergic to metronidazole, to any medicine in the imidazole
group (the group of antibiotics that includes metronidazole) or to any other
ingredient of this medicine listed in Section 2.
- if you are allergic (hypersensitive) to wheat, as this medicine contains
wheat starch (gluten),
- if the patient is a child under 6 years of age (see “Warnings and
precautions”).
Warnings and precautions for use
Before taking Flagyl, tell your doctor if you have:
- neurological disorders,
- psychiatric disorders,
- blood disorders,
- ever had meningitis under metronidazole treatment.
Tell your doctor immediately if any of the following problems occur during
treatment with METRODAZ-UBSA:
From the first dose, there is a risk of severe and sudden allergic reaction
(anaphylactic shock, angioedema) possibly causing the following
symptoms: tight chest, dizziness, nausea or fainting, or dizziness when
standing up (see “Possible side effects”). If these symptoms occur, stop
taking this medicine because your life might be in danger and immediately
contact a doctor.
If, at the start of treatment, you experience redness all over the body and
pustules, accompanied by fever, a serious reaction known as acute
generalized exanthematous pustulosis should be suspected (see “Possible
side effects”); inform your doctor immediately as treatment must be
stopped. Any further administration of metronidazole alone or in
combination with another active substance in the same medicine is
contraindicated if such a reaction occurs.
You should watch out for any signs or potential aggravation of nervous
disorders such as difficulty coordinating movements, confusion, seizures,
difficulty speaking or walking, shakiness, involuntary eye movements, as well
as other effects on the hands and feet such as tingling, pricking, feeling
cold, numbness and reduced sense of touch. These disorders are generally
reversible on treatment discontinuation. It is therefore important to stop
taking this medicine and see a doctor immediately (see «Possible side
effects»). From the very first doses of treatment, your behavior may alter
and put you at risk, especially if you have had psychiatric problems in the
past. If this happens, you should stop taking the medicine and see a doctor
(see “Possible side effects”).
If you have had blood disorders in the past, or received high-dose and/or
long-term treatment, your doctor may prescribe regular blood tests to
check your complete blood count.
Inform the doctor or analysis laboratory that you are taking this medicine
if you have to have a medical laboratory test: taking metronidazole may
interfere with on some laboratory test results (test for treponema), by
triggering a false positive result for a test (Nelson test).
Children
The administration of tablets is contraindicated in children under 6 years
of age due to the risk of choking. Other dosage forms of this antibiotic that
are more suitable for young children are available. Talk to your doctor or
pharmacist before taking METRODAZ-UBSA.
Pregnancy and breast-feeding
If necessary, this medicine may be taken during pregnancy. However, you
must always ask your doctor or pharmacist for advice before taking it.
You should avoid breast-feeding while taking this medicine. If you are
pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this
medicine.
Driving and using machines You should be aware, particularly if you drive
or use machines, that there is a risk of dizziness, confusion, hallucinations,
convulsions or vision disorders associated with this medicine.
Important information about some of the ingredients of Flagyl This
medicine can be used in patients with celiac disease. Wheat starch can
contain gluten, but only traces, and is therefore considered safe for
patients with celiac disease
10-ADVERSE REACTIONS:
Digestive disorders:
- Digestive disorders that are not serious, such as stomach pains, nausea,
vomiting, diarrhea,
-inflammation of the tongue and dry mouth, inflammation of the mouth,
taste disorders, loss of appetite,
- pancreatitis (inflammation of the pancreas), which is reversible after
stopping treatment,
- discoloration or change in the appearance of the tongue (may be
caused by fungal growth).
Effects on the skin and mucous membranes:
- Hot flushes with redness of the face, itching, skin rashes sometimes
accompanied by fever,
- hives (skin rash similar to nettle rash), sudden allergic swelling of the
face and neck (angio-edema), allergic shock which could be
life-threatening (see “What you need to know before you take
METRODAZ-UBSA“), very rare cases of redness spreading to the whole
body with pustules, accompanied by fever (acute generalized exanthem-
atous pustulosis),
- a blistering rash with peeling of the skin which can rapidly spread to the
whole body and be life-threatening (toxic epidermal necrolysis,
Stevens-Johnson syndrome).
Nervous system disorders
- Nerve damage in the limbs (peripheral sensory neuropathy) with effects
on the hands and feet such as tingling, pricking, feeling cold, numbness
and reduced sense of touch,
- headache,
-dizziness,
- seizures,
- confusion,
- neurological disorders, known as encephalopathy or cerebellar
syndrome, with symptoms including confusion, consciousness disorders,
behavioral disorders, difficulty coordinating movements, pronunciation
disorders, gait disorders, involuntary eye movements, shakiness.
These disorders are generally reversible on treatment discontinuation
and may be associated with changes in MRI scans. Very rare cases of
fatal outcome have been reported (see «What you need to know before
you take METRODAZ-UBSA-non-bacterial meningitis.
Mental disorders
- hallucinations,
- personality disorders (paranoia, delusion) possibly with suicidal ideas or
attempts (see “What you need to know before you take “METRODAZ-UB-
SA”),
- depressive tendencies.
Vision disorders
- temporary vision disorders such as blurred vision, double vision,
short-sightedness, decreased vision, changes in color vision,
- optic nerve damage/inflammation.
Blood disorders
- abnormally low platelet counts, abnormally
low or major drop in the number of certain
white blood cells (neutrophils).
Effects on the liver
- elevated liver enzymes (transaminases,
alkaline phosphatase),
- very rare cases of serious liver disease
(sometimes accompanied by jaundice), in
particular cases of liver failure requiring a
transplant.
Other effects
- reddish-brown colored urine caused by the
medicine.
Reporting of side effects If you get any side
effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in
this leaflet. By reporting side effects, you can
help provide more information on the safety of
this medicine.
11-STORAGE CONDITIONS:
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH
OF CHILDREN.
Do not take METRODAZ-UBSA after the expiry
date which is stated on the outer packaging.
Store below 30°C. Protect from light.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help protect
the environment.
MANUFACTURER, MARKETING
AUTHORIZATION HOLDER:
This is a medicament:
- A medicament is a product which
affects your health and its consumption
contrary to instructions is dangerous for
you.
- Follow strictly the doctor's prescription,
the method of use and the instructions of
the pharmacist who sold the
medicament.
- The doctor and the pharmacist are the
experts in medicine, their benefits and
risks.
- Do not by yourself interrupt the period
of treatment prescribed.
- Do not repeat the same prescription
without consulting your doctor.
- Keep all medicaments out of reach of
children.
Council of Arab Health Ministers
Union of Arab pharmacists
Date of Revision: March 20, 2025
Metronidazole 500mg tablets
METRODAZ-UBSA 500 mg, 20 tablets Reg. N : 38825/1
PI020/01
