LEAFLET: INFORMATION FOR USER
Moldamin® 1,200,000 IU, powder for suspension for injection
Benzathine benzylpenicillin
Read all of this leaflet carefully before you start taking this medicine.
-
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. Do not pass it on to others. It may do harm
them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor.
In this leaflet:
1. What Moldamin® is and what it is used for
2. Before you use Moldamin®
3. How to use Moldamin®
4. Possible side effects
5. How to store Moldamin®
6. Further information
1. What Moldamin® is and what it is used for
Moldamin® belongs to the group of the medicines called beta-lactam antibacterials,
penicillins sensitive to beta-lactamase.
Moldamin® works against of some penicillin-sensitive germs that cause the upper
respiratory tract infections. It is indicated in prophylaxis of streptococcal infection in the
patients with acute articular rheumatism and syphilis.
2. Before you use Moldamin®
You should not use Moldamin®:
- if you are allergic (hypersensitive) to benzathine benzylpenicillin and other betalactam antibacterials or other components of Moldamin®.
Take special care with Moldamin®
- if you have allergic reactions to any medicine;
- if you have kidney disease or the affections that cause the water retention;
- if you remark the acceleration of intestinal transit;
- if you remark the emergence of a new infection.
Moldamin® may cause false positive results of some tests of sugar determination or
protein level in urine.
Using of other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicine, including any that you buy without a prescription.
Concurrent use of Moldamin® with other medicines may change reciprocally their mode
of action. Ask your doctor or pharmacist if you take other medicines as: tetracycline,
probenecid, acetylsalicylic acid, oral anticoagulants and contraceptives.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, tell your doctor before taking any medicine.
Driving and using machines
Moldamin® has no influence on the capacity to drive or use machines.
Important information regarding some components of Moldamin®
Moldamin® contains sodium 0.30 mEq (7 mg)/vial; basically it contains no sodium.
3. How to use Moldamin®
Always use Moldamin® following carefully your doctor’s instructions. You should
contact your doctor or pharmacist if you have any doubts.
Moldamin® should be administered by your doctor or nurse.
- it is administered by injection;
- it should be administered by deep intramuscular injection in a muscle with large surface.
The dose administered by your doctor depends on the type and severity of your infection.
The dose is correlated with your body weight, too. Your doctor will explain to you this
thing. The usual dosages are the followings:
Prophylaxis of streptococcal infections
Children
In accordance with the age and body weight, the following dosages are recommended:
Children 2-11 years old, body weight < 30 kg: 300,000 IU-600,000 IU in a single dose,
deep intramuscular injection;
Teenagers: body weight > 30 kg: 900,000 IU in a single dose, deep intramuscular
injection.
Adults
1,2000,00 IU in a single dose, deep intramuscular injection.
Secondary prophylaxis
1,200,000 I.U. in a single dose, every 3-4 weeks or 600,000 IU every 2 weeks; it lasts at
least 5 years from AAR attack up to 20-25 years old.
Syphilis
Primary, secondary and latent (lasting less than 1 year) syphilis: a single dosage of
2,400,000 IU, deep intramuscular injection, half dose will be injected into each buttock.
Pregnant women with primary or secondary syphilis: a dosage of 2,400,000 IU, this dose
is repeated after one week.
Tertiary or latent syphilis (lasting over one year): a dosage of 2,400,000 IU, deep
intramuscular injection, every 7 days, for 3 weeks.
In case of seropositive primary syphilis, secondary florid syphilis, early latent syphilis,
late latent syphilis and tertiary syphilis, the preparation is done by administering
increasing doses of crystalline penicillin in order to prevent Jarisch-Herxhimer reaction.
Then, Moldamin® is administered by deep intramuscular injection.
Congenital syphilis: in children aged 6 months to 2 years, the recommended dosage is
50,000-100,000 IU/kg (maximum dose: 2,400,000 IU).
In children 2-12 years old, the recommended dose is 50,000-100,000 IU/kg (maximum
dosage: 2,400,000 IU).
If you use more Moldamin® than you should
Using more of any medicine may cause serious consequences. Unusual neurological
manifestations or convulsions may occur. In this case, contact the Emergency Department
of your nearest hospital or ask your doctor straight away.
If you forget to use Moldamin®
It is important to receive all doses according to schedule of drug administration.
If you fail to take a dose, ask your doctor immediately.
If you stop using Moldamin®
It is important to receive all doses for the full time of therapy. If you stop the schedule of
drug administration, your disease may worsen or return.
If you have additional questions regarding this medicine, please ask your doctor or
pharmacist.
4. Possible side-effects
Like all medicines, Moldamin® can cause undesirable effects, although not everybody
gets them.
Blood and lymphatic system disorders
- hemolytic anemia, leucopenia, thrombocytopenia.
Immune system disorders
- allergic reactions, particularly in patients which experienced allergy to penicillins
previously, or with history of allergy, asthma or urticaria. These reactions include:
skin eruptions (maculopapular dermatitis, exfoliative dermatitis), urticaria, laryngeal
edema, fever, eosinophilia, and anaphylaxis, including shock and death. JarishHerxheimer reaction may occur in syphilis treatment. Lymphadenopathy and fever
may be reported, too.
Psychiatric disorders
- irritability, confusion, anxiety, euphoria.
Nervous system disorders
- neuropathy, shiver, dizziness, somnolence, coma.
Respiratory, thoracic and mediastinal disorders
- hypoxia, respiratory arrest or dyspnea
Gastrointestinal disorders
- nausea, vomiting, blood in the stool, intestinal necrosis, pseudo-membranous colitis.
Cardiovascular disorders
- cardiac arrest, hypotension, tachycardia, palpitations, pulmonary hypertension,
pulmonary embolism, vasovagal reaction, stroke, syncope.
Metabolism and nutrition disorders
- increase of creatininemia and serum levels of ASAT .
Skin and subcutaneous tissue disorders
- excessive sweating.
Musculoskeletal and connective tissue disorders
- joint pains, periostitis, exacerbation of arthritis, rhabdomyolysis.
Renal and urinary disorders
- blood and proteins in urine, acute interstitial nephritis, renal insufficiency.
Reproductive system and breast disorders
- impotence, priapism.
Common disorders and disorders at the site of injection
- the following symptoms may occur at the site of injection: pain, inflammation, swelling,
nodules, abscess, necrosis, oedema, bleeding, cellulite, hypersensitivity, atrophy,
contusion and ulcer.
If any of these side-effects becomes severe or you notice other side-effects not specified in
this leaflet, please tell your doctor or pharmacist.
5. How to store Moldamin®
Keep out of the reach and sight of children.
This product should be stored in the original package, at temperatures below 25 0C.
Do not use Moldamin® after the expiry date printed on the package (EXP). The expiry
date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose medicines no longer required. These measures will help to
protect the environment.
6. Further information
What Moldamin® contains:
- The active substance is benzathine benzylpenicillin. One vial of powder for
suspension for injection contains 1,200,000 IU of benzathine benzylpenicillin.
- The other ingredients are: lecithin, sodium citrate.
What Moldamin® looks like and contents of the pack
Moldamin® is a white to almost white powder.
A colorless glass vial of 10 ml, closed with a rubber stopper and sealed with an aluminum
cap, containing powder for suspension for I.M. injection.
One box contains 50 (fifty) colorless glass vials of 10 ml, closed with a rubber stopper
sealed with an aluminum cap, containing powder for suspension for I.M. injection.
One box contains 100 (one hundred) colorless glass vials of 10 ml, closed with a rubber
stopper sealed with an aluminum cap, containing powder for suspension for I.M. injection.
Marketing Authorization holder and drug manufacturer
Antibiotice S.A.
1, Valea Lupului Street, 707410 Iasi, Romania, E.U.
This leaflet was last approved in March 2010
The following information is intended only for doctors and medical staff:
Moldamin® should be administered by deep injection, into a muscle (intramuscular
administration) by skilled health personnel.
The content of one vial of 1,200,000 I.U. should be dissolved in 4 ml of water for injections,
by shaking.
It should not be injected into a vein (intravenous administration) or near a nerve.
Subcutaneous injection or into superficial muscle layers is not recommended because it can
result in pain and nodules.
In children, Moldamin® is administered by deep intramuscular injections into upper outer
quadrant of buttock area, or mid-lateral aspect of the thigh (in infants and small children the
last part may be preferable).
Into mid-lateral aspect of the thigh, repeated intramuscular administration should avoid as the
risk of atrophy or fibrosis of the muscle can occur in new-born children and infants
particularly.
The administration should discontinue when severe acute pain occur at the injection site. Pain
and nodules that occur as result of improper and superficial administration may be improved
by applying an ice pack.
Only freshly prepared suspension should be injected. The reconstituted medicine is for a
single use only and any unused solution should be discarded.
Any complaint should be accompanied by this leaflet.