Patient Medication Information: uses, side effects, how to take - Rovamycine 500 Capsule 1500000 Unit
What is Rovamycine used for?
Rovamycine is used to treat certain types of infections that are caused by bacteria. It is most commonly used to treat infections of the:
- Lungs
- Skin
- Mouth
Rovamycine is sometimes used to treat gonorrhea for people who are allergic to penicillin. Antibacterial drugs like Rovamycine treat only bacterial infections. They do not treat viral infections.
How does Rovamycine work?
Rovamycin is an antibiotic. It reduces infections by stopping the growth of bacteria.
What are the ingredients in Rovamycine?
Rovamycine 250:
Active Ingredients: Spiramycin 250 mg (750, 000 IU)
Inactive Ingredients: Each capsule contains the following inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, sodium croscarmellose and titanium dioxide.
Rovamycine 500
Active Ingredients: Spiramycin 500 mg (1,500,000 IU)
Inactive Ingredients: Each capsule contains the following inactive ingredients: colloidal silicon dioxide, D&C Red No. 28, D&C Red No. 33, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium croscarmellose, talc and titanium dioxide.
Rovamycine (spiramycin) comes in the following dosage forms:
250 mg capsules and 500 mg capsules, available in bottles of 50 capsules.
Do not use Rovamycine (spiramycin):
- If you are allergic to spiramycin or to any of the ingredients of the medication.
- If you have meningitis.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Rovamycine. Talk about any health conditions or problems you may have, including if you: -Have allergies to other drugs. -Are pregnant or planning to become pregnant.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Rovamycine:
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How to take Rovamycine (spiramycin):
Your doctor will decide the total amount of Rovamycine to take, for the specific infection.
- Although you may feel better early in treatment, Rovamycine should be used exactly as directed.
- Misuse or overuse of Rovamycine could lead to the growth of bacteria that will not be killed by Rovamycine (resistance). This means that Rovamycine may not work for you in the future.
- Do not share your medicine.
Usual dose:
- Adults: 2 to 3 capsules at 500 mg (for a daily total dosage of 2,000 mg to 3,000 mg) every 24 hours in 2 divided doses.
- For severe infections, the dose may be increased to 4 to 5 capsules at 500 mg twice a day (for a daily total dosage of 4,000 mg to 5,000 mg) in 2 divided doses.
- For the treatment of gonorrhea, the dose is usually 8 or 9 capsules at 500 mg in a single dose.
Children's doses are based on their body weight (150,000 I.U. /kg body weight/24 hours) and are given 2 to 3 times a day.
Overdose: In oral doses over 4,000 mg (16,400,000 I.U.) per day, abdominal discomfort (stomach pain), nausea or diarrhea may occur.
| If you think you have taken too much Rovamycine, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you miss a dose of Rovamycine by a few hours, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
What are possible side effects from using Rovamycine?
These are not all the possible side effects you may feel when taking Rovamycine. If you experience any side effects not listed here, contact your healthcare professional.
Side effects of include:
- nausea
- vomiting
- diarrhea
- inflamed bowels
- pruritus (itchy skin)
- tingling or numbness in the skin
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| blood in the urine | ✓ | ||
| bloody stools | ✓ | ||
| chest pain | ✓ | ||
| fainting or dizziness | ✓ | ||
| irregular heartbeat | ✓ | ||
| signs of a severe allergic reaction (e.g., severe rash, hives, swollen face or throat, difficulty breathing) | ✓ |
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Suspected Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
The capsules should be stored in a dry place at room temperature 15 - 30°C.
Keep out of reach and sight of children.
If you want more information about Rovamycine (spiramycin):
- Talk to your healthcare professional.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website http://www.odanlab.com, or by calling 1-800-387-9342.
Date of Revision: Apr 27, 2018