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COMPOSITION
Each tablet contains:
- Active ingredient:
Roxithromycin (INN)
.. 150 mg.
- Excipients (q.s.):
Core: Hydroxypropylcellulose, poloxamer, povidone, colloidal anhydrous silica, magnesium stearate, purified talc and maize starch.
Coating: hypromellose, anhydrous glucose (1,12 mg.), titanium dioxide, propylene glycol.
PHARMACEUTICAL FORM AND CONTENTS OF THE PACK
Tablets. Pack containing 12 tablets. Clinical pack containing 500 tablets.
INDICATIONS
It is indicated for use in the treatment of infections of the upper and lower respiratory tract, skin and soft tissue and genito-urinary tract caused by susceptible micro-organisms.
CONTRAINDICATIONS
- It should not be administered to patients that are allergic to macrolide antibiotics.
- Do not administer this medication concomitantly with vasoconstrictive ergot alkaloid derivatives.
PRECAUTIONS
This medicine has been prescribed for you personally. Only a doctor can prescribe it for you. Do not give this medication to anyone else; it may harm them, even if their symptoms appear to be the same as yours.
You should inform your doctor if you are allergic to or have had an allergic reaction in the past to any antibiotic.
If you experience any type of allergic reaction, discontinue treatment and consult your doctor.
INTERACTIONS
Tell your doctor or pharmacist if you are taking any other medicine to treat the following:
- Heart rhythm disorders or cardiac arrhythmia (disopyramide, digoxin and other cardiac glycosides).
- Sleep disturbances (midazolam).
- Allergies (terfenadine, astemizole), gastrointestinal problems (cisapride) and psychiatric disorders (pimozide). Concomitant administration of RULIDE with these medications may result in irregular heart rhythms.
- Anticoagulants (vitamin K antagonists).
INCOMPATIBILITIES
Concomitant administration of RULIDE with medicines used to treat migraines or uterine hemorrhage, called vasoconstrictive ergot alkaloid derivatives, is contraindicated.
WARNINGS
- Pregnancy and lactation:
Tell your doctor if you are pregnant or think you could be or if you are breastfeeding before you start to take this medication. Your doctor will probably not indicate this medication in these circumstances however there may be cases where he might decide to do so anyway.
Small amounts of roxithromycin are excreted in the breast milk. Therefore caution should be taken when administering this medication to breastfeeding mothers.
- Effects on the ability to drive:
This medication may cause dizzy sensations, which may affect the ability to drive and operate machinery.
Use in the elderly:
Indications and dosage recommended for elderly patients are the same as for other adults.
Use in children:
RULIDE should not be used in children under 4.
Warnings about excipients:
This medication contains 1,12 mg. glucose per tablet; this should be taken into account by diabetic patients.
POSOLOGY
- Adults:
One tablet of 150 mg. twice daily, in the morning and in the evening, before meals is recommended.
Impaired renal function:
Dosage reduction is not required in patients with renal insufficiency.
Impaired hepatic function:
Your doctor will decide whether it is necessay to reduce the dose of RULIDE to one tablet daily.
Continue to take this medication until the full-prescribed amount is finished. Do not interrupt the treatment even if you feel better. If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed and you might begin to feel unwell again.
INSTRUCTIONS FOR THE CORRECT ADMINISTRATION OF THIS MEDICATION
Tablets should be swallowed whole with some water. Do not chew the tablets.
Take this medication before meals.
OVERDOSAGE
Take the amount indicated by your doctor. If you take more RULIDE than you should go to your doctor immediately or contact the emergency department of the nearest hospital. Take this patient information leaflet with you.
In the case of an overdose or accidental ingestion immediately consult the local poison control centre.
ADVERSE REACTIONS
Most people who have taken this medication have not experienced any adverse reactions. However, as occurs with most medications some people may experience some side effects.
Tell your doctor immediately if you experience difficulty in breathing, palpitations, chest tightness, swelling of the eyelids, face or lips, urticaria bumps on the skin or intense abdominal pain. Discontinue the medication until your doctor decides what to do as he may decide to suspend the treatment.
Cases of diarrhoea, which may rarely contain blood, nausea, vomiting, epigastric pain and severe intestinal inflammation after treatment with this medication have been reported as well as skin rash (red patches), urticaria, dizzy sensation, headache, a sensation of tingling or numbness of a limb or other parts of the body (paresthesia). If any of these symptoms occur you should contact your doctor.
This medication may affect your liver function, which is manifested by an increase in serum transaminases (AST, ALT and/or alkaline phosphatase). Exceptionally, it can cause a hepatic disorder (cholestasis or rarely hepatocellular acute liver injury) which is manifested by yellow colour of the skin and the mucous membranes. If this occurs consult your doctor as soon as possible.
Fungal infection may occur.
Disturbances in taste and smell have been reported in some cases.
As occurs with other antibiotics, treatment with Rulide, particularly prolonged therapy may cause suprainfection.
If you experience any other adverse affect not mentioned above, consult your doctor or pharmacist.
STORAGE
Keep the medicine in a cool, dry place. Keep your tablets in the blister back until it is time to take them.
Keep the pack and the patient information leaflet until you complete the treatment because both contain important information about the medication.
EXPIRY
Do not use this product after the expiry date printed on the carton.
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