Rulid

Package Leaflet: Information for the Patient

Rulid, 150 mg, Film-Coated Tablets

Roxithromycin

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep the Package Leaflet, so you can Read it Again if Necessary.
• If you have any Doubts, Consult your Doctor or Pharmacist.
• This Medication has been Prescribed Specifically for you. Do not Pass it on to Others. The Medication may Harm another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Adverse Reactions, including any Adverse Reactions not Listed in this Leaflet, they should Inform their Doctor or Pharmacist. See Section 4.

Table of Contents of the Package Leaflet

• 1. What Rulid is and what it is Used for
• 2. Important Information Before Taking Rulid
• 3. How to Take Rulid
• 4. Possible Adverse Reactions
• 5. How to Store Rulid
• 6. Package Contents and other Information

1. What Rulid is and what it is 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 Acute Bronchitis;
• Exacerbation of Chronic Bronchitis;
• Community-Acquired Pneumonia in Patients without Risk Factors, without Symptoms of Severe Clinical Condition, and without Clinical Symptoms Suggesting Pneumococcal Infection; if Atypical Pneumonia is Suspected, Macrolides are Indicated Regardless of the Severity of Symptoms;
• Mild Skin and Subcutaneous Tissue Infections Caused by Staphylococcus aureusor Streptococcus pyogenes;
• Non-Gonococcal Genital Infections Caused by Chlamydia trachomatis, Ureaplasma urealyticum.

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 Ingredients of this Medication (Listed in Section 6),
• If the Patient is Taking Ergot Alkaloids - Vasoconstrictor Medications, e.g., Used for Migraine (Such as: Ergotamine, Dihydroergotamine, Bromocriptine)
• If the Patient is Taking Medications such as Cisapride, Astemizole, Pimozide, or Terfenadine (See Sections Warnings and Precautions and Rulid and other Medications).

In Case of Doubts, Consult your Doctor.

Warnings and Precautions

Before Starting Rulid, Discuss it with your Doctor.
When Macrolide Antibiotics and Ergot Alkaloids with Vasoconstrictive Effects are Administered Concomitantly, Cases of Severe Vasoconstriction (Ergotism) have Occurred, with Possible Gangrene. If the Patient is Taking Ergot Alkaloids, they should Inform their Doctor before Starting Roxithromycin.
After Taking Roxithromycin, Cases of Severe Bullous 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 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, Generalized Poor Condition, Fever, Chills, and Muscle Pains) or AGEP (e.g., Red, Peeling Rash with Pustules under the Skin and Blisters), Rulid Treatment should be Discontinued and the Patient should Consult their Doctor Immediately, as these Skin Symptoms can be Life-Threatening.
No Dose Adjustment is Necessary in Elderly Patients.
Roxithromycin should not be Used in Patients with Severe Hepatic Impairment.
Particular Caution should be Exercised when Using Roxithromycin in Patients with Mild to Moderate Hepatic 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 Adverse Reactions).
Roxithromycin, like other Macrolides, may Exacerbate Myasthenia.
Clostridium difficile-Associated Disease
If the Patient Develops Diarrhea, Especially Severe, Persistent, and (or) Bloody, during or after Roxithromycin Treatment, they should Consult their Doctor, as it may be a Sign of Pseudomembranous Colitis Caused by Toxins Produced by Clostridium difficile. If Pseudomembranous Colitis is Suspected, Roxithromycin Treatment should be Discontinued Immediately. The Condition can be Mild or Severe. Mild Cases usually Resolve after Withdrawal of the Medication. In More Severe Cases, the Doctor may Prescribe Metronidazole or Vancomycin. Medications that Inhibit Peristalsis or have a Constipating Effect should not be Taken.
Medications that may Prolong the QT Interval
Caution should be Exercised when Using Roxithromycin in Patients Taking other Medications that may Prolong the QT Interval (See Section Other Medications and Rulid). These Include Antiarrhythmic Medications of Class IA (e.g., Quinidine, Procainamide, Disopyramide) and Class III (e.g., Dofetilide, Amiodarone), Citalopram, Tricyclic Antidepressants, Methadone, certain Antipsychotic Medications (e.g., Phenothiazines), Fluoroquinolones (e.g., Moxifloxacin), certain Antifungal Medications (e.g., Fluconazole, Pentamidine), and certain Antiviral Medications (e.g., Telaprevir).
Roxithromycin should be Used with Caution in Patients with Congenital Prolongation of the QT Interval, in Situations that Favor the Occurrence of Cardiac Rhythm Disorders (e.g., Uncompensated Hypokalemia or Hypomagnesemia, Clinically Significant Bradycardia), as well as in Patients Receiving Antiarrhythmic Medications of Class IA and III and Medications such as Astemizole, Cisapride, or Pimozide.

Rulid and other Medications

Inform your Doctor about all Medications you are Currently Taking or have Recently Taken, as well as any Medications you Plan to Take.
The Following Medications should not be Taken with Rulid:

• Medications Containing Ergot Alkaloids: Ergotamine, Dihydroergotamine (These Medications Constrict Blood Vessels, are Used, among other things, to Treat Migraine)
• Astemizole, Terfenadine (Used to Treat Allergies)
• Cisapride (Used to Stimulate Gastrointestinal Motility)
• Pimozide (Used to Treat Psychiatric Disorders)

The Following Medications should be Taken with Rulid with Caution:

• Quinidine, Procainamide, Disopyramide, Dofetilide, Amiodarone (Medications Used to Treat Heart Rhythm Disorders)
• Citalopram, Tricyclic Antidepressants (Used to Treat Depression)
• Methadone (Used to Treat Pain)
• Phenothiazines (Used to Treat Psychiatric Disorders)
• Fluoroquinolones, e.g., Moxifloxacin (Chemotherapeutic Agents Used to Treat Bacterial Infections)
• Fluconazole, Pentamidine (Antifungal Medications)
• Telaprevir (Antiviral Medication)
• Vitamin K Antagonists (Anticoagulant Medications)
• Digoxin and other Cardiac Glycosides (Used to Treat, among other things, Heart Failure)
• Midazolam, Triazolam (Psychotropic Medications)
• Theophylline (Used to Treat, among other things, Asthma)
• Bromocriptine (Used, among other things, to Treat Parkinson's Disease and Acromegaly)
• Cyclosporine (Used, among other things, in Transplants)
• Statins (Used to Treat Elevated Cholesterol and Triglycerides in the Blood)
• Rifabutin (Used to Treat Bacterial Infections)

There are no Interactions between Rulid and Carbamazepine (Used to Treat, among other things, Epilepsy and Bipolar Affective Disorder), Ranitidine (Used to Treat Gastric and Duodenal Ulcer Disease), Aluminum or Magnesium Hydroxide (Used to Treat 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, or Thinks they may be Pregnant or Plans to have a Child, they should Consult their Doctor before Taking this Medication.
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 Breast Milk. The Doctor will Decide whether to Discontinue Roxithromycin Treatment or Stop Breastfeeding in Case of Continuing Therapy.

Driving and Operating Machinery

The Medication may Cause Dizziness.
Visual Disturbances and Blurred Vision may Affect the Ability to Drive and Operate Machinery.

Rulid, 150 mg, Film-Coated Tablets, Contains Glucose

If the Patient has been Diagnosed with Intolerance to some Sugars, they should Consult their Doctor before Taking the Medication.

3. How to Take Rulid

Rulid, 150 mg, Film-Coated Tablets, is Intended for Use in Adults.
Rulid should be Taken as Directed by the Doctor. In Case of Doubts, Consult the Doctor.
Adults: 1 Tablet in the Morning and 1 Tablet in the Evening, every 12 Hours (300 mg per Day).
The Entire Tablet should be Swallowed with a Sufficient Amount of Water.
Rulid Tablets should be Taken before Meals.
The Duration of Treatment Depends on the Therapeutic Indications, the Causative Microorganism, and the Clinical Picture of the Disease.
Dosing in Patients with Hepatic Impairment
In Patients with Severe Hepatic Impairment [e.g., Liver Cirrhosis with Jaundice and (or) Ascites], Roxithromycin is not Recommended; however, if its Use is Necessary, the Doctor will Reduce the Dose by Half and Recommend Regular Monitoring of Liver Function.
Liver Function Parameters will also be Monitored in Patients with Impaired Liver Function and in those who have Experienced Hepatic Impairment during Previous Roxithromycin Treatment. If Liver Function Parameters Deteriorate during Roxithromycin Treatment, the Doctor should Consider Discontinuing the Medication.
Dosing in Patients with Renal Impairment
In Patients with Renal Impairment, there is no Need to Reduce the Medication Dose, as only about 10% of the Orally Administered Roxithromycin or its Metabolites are Excreted through the Kidneys.
Dosing in Elderly Patients
No Dose Adjustment is Necessary in Elderly Patients.
Use in Children and Adolescents
If Roxithromycin Needs to be Used in Children, Tablets with a Lower Active Substance Content are Available.
Overdose of Rulid
After Overdosing on the Medication, the Following Symptoms may Occur: Nausea, Vomiting, Diarrhea. Adverse Reactions such as Headache and Dizziness may also Occur or Intensify.
In Case of Overdose, the Patient should Immediately Consult their Doctor, who will Provide Appropriate Treatment. There is no Specific Antidote.

4. Possible Adverse Reactions

Like all Medications, Rulid can Cause Adverse Reactions, although not Everybody will Experience them.

If the Patient Experiences any of the Following Adverse Reactions (Frequency of Occurrence Unknown), they should Immediately Consult their Doctor:

• Anaphylactic Shock (Severe, Sudden Allergic Reaction Characterized by Difficulty Breathing, Rapid Heart Rate, often Excitement, Redness of the Skin),
• Bronchospasm (Shortness of Breath),
• Angioedema,
• Severe Skin Reaction: Erythema Multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Red, Peeling Rash with Pustules under the Skin and Blisters (Pustular Exanthem),
• Agranulocytosis, Neutropenia, Thrombocytopenia (Decreased Number of Granulocytes, Neutrophils, or Platelets in the Blood),
• Prolonged QT Interval,
• Pseudomembranous Colitis.

The Following Adverse Reactions may also Occur.
Frequent(in 1 to 10 out of 100 Patients)

• Dizziness, Headache,
• Nausea, Vomiting, Indigestion (Abdominal Pain), Diarrhea,
• Rash.

Uncommon(in 1 to 10 out of 1000 Patients)

• Eosinophilia (Increased Number of Eosinophils in the Blood),
• Polymorphic Erythema, Urticaria.

Frequency of Occurrence Unknown (Cannot be Determined from Available Data)

• Superinfections: as with other Antibiotics, Prolonged Use of Roxithromycin may Lead to an Increase in Resistant Microorganisms - Clostridium difficile. If the Patient does not Feel Better or Develops other Symptoms Suggesting a New Infection during Treatment, they should Immediately Consult their Doctor,
• Delirium, Confusion (Disorientation),
• Paresthesia (Tingling Sensation on the Skin), Taste Disturbances (including Loss of Taste) and (or) Smell Disorders (including Hallucinations, Loss of Smell),
• Transient Deafness, Hearing Loss, Vertigo of Vestibular Origin, Tinnitus,
• Bloody Diarrhea, Pancreatitis,
• Cholestatic or Acute Hepatocellular Injury (Sometimes with Jaundice),
• Increased Activity of Liver Enzymes: AST, ALT, and (or) Alkaline Phosphatase,
• Ventricular Tachycardia of the Torsades de PointesType,
• Visual Disturbances,
• Visual Problems (Blurred Vision).

Reporting Adverse Reactions

If any Adverse Reactions Occur, including any Adverse Reactions not Listed in the Leaflet, the Patient should Inform their Doctor or Pharmacist. Adverse Reactions can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal 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
Adverse Reactions can also be Reported to the Marketing Authorization Holder or its Representative in Poland.
Reporting Adverse Reactions will Help Gather more Information on the Safety of the Medication.

5. How to Store Rulid

The Medication should be Stored in a Place Invisible and Inaccessible to Children.
Do not Store above 25°C.
Before Taking the Medication, Check the Expiration Date on the Packaging. Do not Use this Medication after the Expiration Date on the Packaging.
Medications should not be Disposed of in Sewage or Household Waste. Ask your Pharmacist how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Package Contents and other Information

What Rulid Contains:

• -The Active Substance of the Medication is Roxithromycin. One Film-Coated Tablet Contains 150 mg of Roxithromycin.
• Other Ingredients are: Hydroxypropyl Cellulose, Polyethylene Glycol, Povidone K 30, Colloidal Silica, Magnesium Stearate, Talc, Corn Starch (Tablet Core) and Hydroxypropyl Methylcellulose, Anhydrous Glucose, Titanium Dioxide, Propylene Glycol (Coating).

What Rulid Looks Like and what the Package Contains

10 Film-Coated Tablets in a Blister Pack, in a Cardboard Box.
White, Film-Coated Tablet, Convex on both Sides, Cylindrical in Shape.

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 Compiégne
France
To Obtain more Detailed Information, 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