Rulid

Leaflet attached to the packaging: patient information

Rulid, 50 mg, tablets for oral suspension

Roxithromycin

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep the leaflet so that you can read it again if necessary.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rulid and what is it used for
• 2. Important information before taking Rulid
• 3. How to take Rulid
• 4. Possible side effects
• 5. How to store Rulid
• 6. Package contents and other information

1. What is Rulid and what is it used for

The active substance in Rulid is roxithromycin, which belongs to the group of macrolide antibiotics.
Rulid is used to treat the following bacterial infections caused by microorganisms sensitive to roxithromycin:

• tonsillitis (angina) caused by group A beta-hemolytic streptococci - as an alternative to beta-lactam antibiotics;
• acute sinusitis, when beta-lactam antibiotics cannot be used;
• superinfections in the course of acute bronchitis;
• exacerbation of chronic bronchitis;
• community-acquired pneumonia in patients without risk factors, without symptoms of severe clinical condition, and without clinical signs indicating pneumococcal infection; if atypical pneumonia is suspected, macrolides are indicated regardless of the severity of symptoms;
• skin and subcutaneous tissue infections of mild course, caused by Staphylococcus aureusor Streptococcus pyogenes.

2. Important information before taking Rulid

When not to take Rulid:

• if the patient is hypersensitive to roxithromycin or other macrolide antibiotics or to any of the other components of this medicine (listed in section 6),
• if the patient is taking ergot alkaloids - vasoconstrictor drugs, e.g. used during migraine (such as: ergotamine, dihydroergotamine, bromocriptine);
• if the patient is taking such drugs as cisapride, astemizole, pimozide, or terfenadine (see subsections Warnings and precautions and Rulid and other medicines).

In case of any doubts, you should consult a doctor.

Warnings and precautions

Before starting Rulid, you should discuss it with your doctor.
When macrolide antibiotics and ergot alkaloids with vasoconstrictive effects are administered simultaneously, cases of severe vasoconstriction (ergotism) with possible limb necrosis have occurred. If the patient is taking ergot alkaloids, they should inform their doctor before starting roxithromycin.
After taking roxithromycin, cases of severe blistering skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or acute generalized exanthematous pustulosis (AGEP) have occurred (see section 4). If the patient develops objective or subjective symptoms of SJS (e.g. widespread, severe skin rash with blistering or peeling, as well as flu-like symptoms and fever), TEN (e.g. progressive rash, often with blisters or mucosal lesions, general malaise, fever, chills, and muscle pains) or AGEP (e.g. red, peeling rash with nodules under the skin and blisters), Rulid treatment should be discontinued and the patient should immediately consult a doctor, as these skin symptoms can be life-threatening.
No dose modification is required in elderly patients.
Roxithromycin is not recommended in patients with severe liver impairment. Caution should be exercised when administering roxithromycin to patients with mild to moderate liver impairment.
Renal excretion of roxithromycin and its metabolites accounts for about 10% of the oral dose.
In renal impairment, the dosage remains unchanged.
It is recommended to monitor liver and kidney function, as well as blood morphology, especially during long-term treatment (i.e. longer than 2 weeks; see section Possible side effects).
Roxithromycin, like other macrolides, may exacerbate myasthenia.
Clostridium difficile-associated disease
If the patient experiences diarrhea, especially severe, persistent, and (or) bloody, during or after the end of roxithromycin treatment, they should inform their doctor, as it may be a symptom of pseudomembranous colitis caused by toxins of overgrown Clostridium difficilein the gut. If pseudomembranous colitis is suspected, roxithromycin treatment should be discontinued immediately. The disease can be mild or severe. Mild cases usually resolve after discontinuation of the drug. In more severe cases, the doctor may recommend taking metronidazole or vancomycin. Drugs that inhibit peristalsis or have a constipating effect should not be taken.
Medicines that may prolong the QT interval
Caution should be exercised when administering roxithromycin to patients taking other medicines that may prolong the QT interval (see section Other medicines and Rulid). These include antiarrhythmic drugs of class IA (e.g. quinidine, procainamide, disopyramide) and class III (e.g. dofetilide, amiodarone), citalopram, tricyclic antidepressants, methadone, some antipsychotic drugs (e.g. phenothiazines), fluoroquinolones (e.g. moxifloxacin), some antifungal drugs (e.g. fluconazole, pentamidine), and some antiviral drugs (e.g. telaprevir).
Roxithromycin should be used with caution in patients with congenital QT interval prolongation, in situations that favor the occurrence of arrhythmias (e.g. uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia), as well as in patients receiving antiarrhythmic drugs of class IA and III and drugs such as astemizole, cisapride, or pimozide.

Rulid and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The following medicines should not be taken with Rulid:

• medicines containing ergot alkaloids: ergotamine, dihydroergotamine (these drugs constrict blood vessels, are used, among others, in the treatment of migraine)
• astemizole, terfenadine (used in the treatment of allergies)
• cisapride (used to stimulate gastrointestinal motility)
• pimozide (used in the treatment of mental disorders)

The following medicines should be taken with Rulid with caution:

• quinidine, procainamide, disopyramide, dofetilide, amiodarone (drugs used in the treatment of arrhythmias)
• citalopram, tricyclic antidepressants (used in the treatment of depression)
• methadone (used in the treatment of pain)
• phenothiazines (used in the treatment of mental disorders)
• fluoroquinolones, e.g. moxifloxacin (chemotherapeutic agents used in bacterial infections)
• fluconazole, pentamidine (antifungal drugs)
• telaprevir (antiviral drug)
• vitamin K antagonists (anticoagulant drugs)
• digoxin and other cardiac glycosides (used in the treatment of, among others, heart failure)
• midazolam, triazolam (psychotropic drugs)
• theophylline (used in the treatment of, among others, asthma)
• bromocriptine (used, among others, in the treatment of Parkinson's disease and acromegaly)
• cyclosporin (used, among others, in the treatment of patients after transplants)
• statins (used in the treatment of elevated cholesterol or triglyceride levels in the blood)
• rifabutin (used in bacterial infections)

There are no interactions between Rulid and carbamazepine (used in the treatment of, among others, epilepsy and bipolar affective disorder), ranitidine (used in the treatment of gastric and duodenal ulcer disease), aluminum or magnesium hydroxide (used in the treatment of gastric hyperacidity), or oral contraceptives containing estrogens and progestogens.

Rulid with food and drink

Rulid should be taken before meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine.
There are no adequate studies on the use of roxithromycin in pregnant women, so it may only be used during this period if absolutely necessary.
There is no clinical experience with the use of roxithromycin in breastfeeding women.
Small amounts of roxithromycin pass into the breast milk of breastfeeding women. The doctor will therefore decide whether to discontinue roxithromycin treatment or stop breastfeeding the child in case of continued therapy.

Driving and operating machines

The medicine may cause dizziness.
Visual disturbances and blurred vision may affect the ability to drive vehicles and operate machines.

3. How to take Rulid

Rulid, 50 mg, tablets for oral suspension, is intended for use in children.
Rulid should be taken as directed by the doctor. In case of doubts, you should consult a doctor.
Use in children and adolescents
The recommended dose for children is 5-8 mg/kg body weight per day, given in two divided doses, every 12 hours.
Depending on body weight, the following dosing is used:

• children weighing 6-11 kg: ½ tablet in the morning and ½ tablet in the evening
• children weighing 12-23 kg: 1 tablet in the morning and 1 tablet in the evening
• children weighing 24-40 kg: 2 tablets in the morning and 2 tablets in the evening

The duration of treatment depends on the therapeutic indications, the microorganism causing the infection, and the clinical picture of the disease. The medicine should not be given for more than 10 days.

Method of administration

The tablet can be divided into equal doses.
Half a tablet or a whole tablet, depending on the prescribed dose, should be placed on a tablespoon with water. After 30-40 seconds, the tablet disintegrates, forming a suspension ready for consumption.
The prepared suspension should be given to the child immediately.
After administering the medicine, additional water should be given to drink.
Rulid tablets should be taken before meals.
Dosing in patients with liver impairment
In patients with severe liver impairment [e.g. liver cirrhosis with jaundice and (or) ascites], roxithromycin is not recommended; however, if the use of the medicine is necessary, the doctor will reduce the dose by half and recommend regular liver function tests.
Liver function parameters will also be monitored in patients with impaired liver function and in those who have had liver impairment during previous roxithromycin treatment. If liver function parameters worsen during roxithromycin treatment, the doctor should consider discontinuing the medicine.
Dosing in patients with renal impairment
In patients with renal impairment, there is no need to reduce the dose of the medicine, as only about 10% of the orally administered roxithromycin or its metabolites is excreted through the kidneys.
Adults
If roxithromycin needs to be used in adults, tablets with a higher active substance content are available.
Use of a higher than recommended dose of Rulid
After overdosing on the medicine, the following symptoms may occur: nausea, vomiting, diarrhea. The following side effects may also occur and worsen: headaches and dizziness.
In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor, who will administer appropriate treatment. There is no specific antidote.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects (frequency of occurrence unknown), they should immediately contact their doctor:

• anaphylactic shock (severe, acute systemic allergic reaction characterized by difficulty breathing, rapid heartbeat, often agitation, flushing of the skin),
• bronchospasm (shortness of breath),
• angioedema,
• severe skin reaction: rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, red, peeling rash with nodules under the skin and blisters (pustular exanthema),
• agranulocytosis, neutropenia, thrombocytopenia (decrease in the number of granulocytes, neutrophils, platelets in the blood),
• QT interval prolongation,
• pseudomembranous colitis.

The following side effects may also occur.
Frequent(in 1 to 10 out of 100 patients)

• dizziness, headaches,
• nausea, vomiting, indigestion (abdominal pain), diarrhea,
• rash.

Uncommon(in 1 to 10 out of 1000 patients)

• eosinophilia (increased number of granulocytes in the blood),
• erythema multiforme, urticaria.

Frequency not known (cannot be estimated from available data)

• superinfections: as with other antibiotics, the use of roxithromycin, especially for a longer period, may cause an increase in resistant microorganisms - Clostridium difficile; if the patient does not feel better or new symptoms occur during treatment, they should immediately consult their doctor,
• hallucinations, confusion (disorientation),
• paresthesia (tingling sensation on the skin), taste disorders (including loss of taste) and (or) smell disorders (including false smells, loss of smell),
• transient hearing loss, hearing impairment, vertigo of labyrinthine origin, tinnitus,
• bloody diarrhea, pancreatitis,
• cholestatic or acute hepatocellular hepatitis (sometimes with jaundice),
• increased activity of liver enzymes: AST, ALT, and (or) alkaline phosphatase,
• ventricular tachycardia of the torsade de pointestype,
• visual disturbances,
• vision problems (blurred vision).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: +48 22 49 21 301,
fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Rulid

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storing the medicine.
Before taking the medicine, you should check the expiration date on the packaging. Do not use this medicine after the expiration date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Rulid contains

• -The active substance of the medicine is roxithromycin. One tablet for oral suspension contains 50 mg of roxithromycin.
• The other ingredients are: polyethylene glycol 6000, methacrylic acid copolymer, sodium hydroxide, triethyl citrate, talc, microcrystalline cellulose, crospovidone, fumaric acid, sodium saccharin, sodium lauryl sulfate, colloidal silica, strawberry flavor, licorice flavor, magnesium stearate.

What Rulid looks like and what the package contains

10 tablets for oral suspension in a blister pack, in a cardboard box.
White, cylindrical tablets with a dividing line.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sanofi-Aventis France
82, Avenue Raspail
Gentilly, 94250
France
Manufacturer
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France
To obtain more detailed information, you should contact the representative of the marketing authorization holder in Poland:
Sanofi-Aventis Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Phone: +48 22 280 00 00
Date of last update of the leaflet:July 2021