Rovamycine

Uses

What is Rovamycine® (Spiramycin) used for?

Rovamycine® is commonly used for treating certain types of infections that are caused by bacteria. It is most commonly used to treat infections of the lung, skin, and mouth.

Spiramycin is sometimes used to treat gonorrhea for people who are allergic to penicillin.

How should I take Rovamycine® (Spiramycin)?

Spiramycin may be taken with or without food.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

How do I store Rovamycine® (Spiramycin)?

Rovamycine® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Rovamycine® in the bathroom or the freezer. There may be different brands of Rovamycine® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Rovamycine® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Rovamycine® (Spiramycin)?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breastfeeding, and any other significant facts about your health.

Spiramycin should not be taken if you are:

• Allergic to spiramycin or to any of the ingredients of the medication
• Using it to treat meningitis

Is it safe during pregnancy or breastfeeding?

Pregnancy:

There are no adequate studies in women for determining risk when using Rovamycine® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Rovamycine®. Rovamycine® is pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Breastfeeding:

This medication passes into breast milk. If you are a breastfeeding mother and are taking spiramycin, it may affect your baby. Talk to your doctor about whether you should continue breastfeeding.

Side effects

What side effects can occur from Rovamycine® (Spiramycin)?

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Diarrhea
• Nausea
• Numb or tingling sensation of the skin
• Vomiting

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Fever
• Signs of a mild allergic reaction (e.g., skin rash, itching)
• Stomach pain and tenderness
• Unusual bleeding and bruising
• Yellow eyes or skin

Stop taking the medication and seek immediate medical attention if anyof the following occur:

• 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)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Interactions

What drugs may interact with Rovamycine® (Spiramycin)?

There may be an interaction between spiramycin and any of the following:

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• Stop taking one of the medications
• Change one of the medications to another
• Change how you are taking one or both of the medications

Does food or alcohol interact with Rovamycine® (Spiramycin)?

Rovamycine® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

Grapefruit juice:

Grapefruit juice may interact with spiramycin if it is consumed while being treated with spiramycin and may cause an increase in serious side effects. Avoid grapefruit juice while taking spiramycin.

What health conditions may interact with Rovamycine® (Spiramycin)?

Rovamycine® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Rovamycine® (Spiramycin).

What is the dose of Rovamycine® (Spiramycin) for an adult?

The usual adult dose of spiramycin is 4 to 6 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 8 to 10 capsules at 500 mg (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.

What is the dose of Rovamycine® (Spiramycin) for a child?

Children’s doses are based on their body weight and are given 2 to 3 times a day.

How is Rovamycine® (Spiramycin) available?

Rovamycine® is available in the following dosage forms and strengths:

• Rovamycine® tablet 250mg
• Rovamycine® tablet 500mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Rovamycine®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.