Rolicin

Package Leaflet: Information for the Patient

Rolicyn, 50 mg, Film-Coated Tablets

Rolicyn, 100 mg, Film-Coated Tablets

Rolicyn, 150 mg, Film-Coated Tablets

Roxithromycin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Rolicyn and what is it used for
• 2. Important information before taking Rolicyn
• 3. How to take Rolicyn
• 4. Possible side effects
• 5. How to store Rolicyn
• 6. Contents of the pack and other information

1. What is Rolicyn and what is it used for

Rolicyn contains the active substance roxithromycin, which is a semi-synthetic macrolide antibiotic, a derivative of erythromycin.
Rolicyn is used to treat infections caused by bacteria sensitive to roxithromycin.

• Upper respiratory tract infections: tonsillitis, pharyngitis, rhinitis, sinusitis.
• Middle ear infection.
• Lower respiratory tract infections: pneumonia, bronchitis, lung abscess, bronchiectasis.
• Skin and soft tissue infections.
• Non-gonococcal genital infections.

2. Important information before taking Rolicyn

When not to take Rolicyn:

• if you are allergic to roxithromycin or any of the other ingredients of Rolicyn (listed in section 6);
• if you have been diagnosed with an allergy to other macrolide antibiotics;
• if you are taking vasoconstrictor medications (e.g. used during migraine, such as ergotamine, dihydroergotamine, bromocriptine);
• if you are taking astemizole, cisapride, pimozide, or terfenadine (see "Taking other medicines with Rolicyn"). ➢ If the above circumstances apply to you, you should not take Rolicyn.In case of doubts before starting Rolicyn, consult your doctor or pharmacist.

Warnings and precautions

Before starting Rolicyn, inform your doctor if:

• you have previously been allergic to roxithromycin or other macrolides;
• you have been diagnosed with myasthenia (a disease characterized by rapid muscle fatigue and weakness);
• you have liver disease;
• you have heart disease;
• you are taking anti-arrhythmic drugs of class IA and III (see section 2 "Rolicyn and other medicines").

Inform your doctor if, during treatment, you experience:

• rash;
• symptoms of a new infection.

In case of doubts whether the above circumstances apply to you, consult your doctor or pharmacist before starting Rolicyn.
In case of a widespread, severe skin rash, including blistering or peeling of the skin, as well as flu-like symptoms and fever (Stevens-Johnson syndrome), general malaise, fever, chills, and muscle pain (toxic epidermal necrolysis) or a red, peeling rash with bumps under the skin and blisters (acute generalized exanthematous pustulosis), seek medical attention immediately, as these skin symptoms can be life-threatening.
If you experience diarrhea during or after taking Rolicyn, inform your doctor. This may be a sign of pseudomembranous colitis - a complication associated with antibiotic use. It is necessary to discontinue the medicine and sometimes apply appropriate treatment. Do not take anti-diarrheal medications or other constipating agents.
In some cases, your doctor may test what type of bacteria caused your infection.
Depending on the results, you may receive Rolicyn in a different dose or a different medicine.

Rolicyn and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, especially those listed below.
Medicines that should not be taken during Rolicyn treatment:

• ergotamine derivatives (ergot alkaloids): ergotamine, dihydroergotamine, bromocriptine (used for migraines);
• terfenadine (used for allergic rhinitis);
• astemizole (used for allergic diseases);
• cisapride (used for delayed gastric emptying);
• pimozide (used to control involuntary movements [tics]).

Other medicines that you should inform your doctor about:

• anticoagulant medications (e.g. warfarin, vitamin K);
• disopyramide (a medication used for arrhythmias);
• midazolam, triazolam (used as sleeping pills and anxiolytics);
• theophylline (a medication that dilates the airways, used to treat asthma and chronic obstructive pulmonary disease);
• cyclosporin (used to treat patients after transplants);
• statin medications (e.g. simvastatin, atorvastatin, used to lower total cholesterol levels in the blood) - may increase the risk of adverse effects on muscles (myopathy, rhabdomyolysis) due to possible increased exposure to statins when taken with roxithromycin;
• other medications: carbamazepine, ranitidine, aluminum or magnesium hydroxide, oral contraceptives.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
If you are pregnant or think you may be pregnant
If you plan to become pregnant or suspect you are pregnant, inform your doctor. The medicine can be used in pregnant women only if the doctor considers it absolutely necessary.
If you are breastfeeding
Roxithromycin passes into breast milk in small amounts. If you are breastfeeding, you should stop breastfeeding your baby while taking Rolicyn.

Driving and using machines

Rolicyn has not been shown to affect the ability to drive or use machines. However, if you experience side effects that reduce concentration (e.g. pain, dizziness; see section 4. Possible side effects), it is not recommended to drive or operate machinery. Vision disturbances and blurred vision may affect your ability to drive or use machines.

Rolicyn 50 mg or 100 mg or 150 mg contains sodium

Rolicyn 50 mg or 100 mg or 150 mg contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Rolicyn

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.

Adults and children over 40 kg

Typically, a dose of 150 mg is taken twice a day (every 12 hours) or 300 mg once a day.

Children from 12 kg to 40 kg

Typically, a dose of 2.5 to 4 mg/kg body weight is taken twice a day.

• Children from 12 to 23 kg - 1 tablet of 50 mg twice a day (every 12 hours).
• Children from 24 to 40 kg - 1 tablet of 100 mg or 2 tablets of 50 mg twice a day (every 12 hours).

Elderly patients

There is no need to change the dosage of Rolicyn in elderly patients with normal liver and kidney function.

Using Rolicyn in patients with liver and/or kidney impairment

In patients with liver failure, the dosage is determined by the doctor individually for each patient, depending on the degree of liver function.
In patients with kidney failure, a change in dosage is usually not necessary.
In each case, the dosage of Rolicyn in patients with kidney and/or liver failure is determined by the doctor.

Duration of treatment

Treatment should be continued for at least two days after the symptoms of the disease have disappeared. It usually lasts from 5 to 10 days, depending on the sensitivity of the microorganism causing the infection, its location, and the patient's response to the antibiotic. Infections caused by streptococci, urethral infections, cervical infections are usually treated for 10 days.
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Method of administration

Rolicyn tablets should be taken 30 minutes before a meal. The tablet should be swallowed whole and washed down with a sufficient amount of water.
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If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Taking a higher dose of Rolicyn than recommended

Overdose of roxithromycin may cause gastrointestinal disorders (nausea, vomiting, diarrhea) and other intensified side effects, such as pain and dizziness.
In case of overdose, discontinue the medicine and induce vomiting if the patient is conscious.
If you have taken too much of the medicine (overdosed on Rolicyn), consult your doctor or go directly to the hospital. Show the packaging of this medicine.

Missing a dose of Rolicyn

If you miss a dose at the specified time, take the medicine as soon as possible, if the time to the next dose is long enough, or continue the regular administration of the medicine.
Do not take a double dose to make up for the missed dose of the medicine.

4. Possible side effects

Like all medicines, Rolicyn can cause side effects, although not everybody gets them.
The following side effects may occur when taking this medicine.

If you experience any of the following serious side effects, stop taking the medicine and immediately inform your doctor or go to the nearest emergency department in the hospital.

Serious side effects

• Allergic reactions, such as sudden shortness of breath and chest tightness, swelling of the eyelids, face, or lips, severe skin rashes, which may be accompanied by blistering, affecting the limbs, eyes, mouth, throat, and genitals, loss of consciousness (fainting).
• Serious skin reactions In case of a severe skin reaction: red, peeling rash with bumps under the skin and blisters (pustular exanthema), contact your doctor immediately. The frequency of these adverse reactions is unknown (cannot be determined from available data).
• Severe diarrhea, usually watery with blood and mucus, persistent, accompanied by abdominal pain and/or fever. This may be a sign of severe colitis (pseudomembranous colitis), which can occur after antibiotic use.

Other side effects

Side effects with unknown frequency (frequency cannot be determined from available data)

• superinfections: as with other antibiotics, the use of roxithromycin, especially for a long time, may cause the growth of resistant microorganisms. If you experience symptoms of a new infection during roxithromycin treatment, discontinue the medicine and consult your doctor.
• increased number of granulocytes in the blood (eosinophilia)
• hallucinations
• dizziness, headaches, tingling sensation on the skin (paresthesia), feeling of weakness.
• taste disorders (including loss of taste) and/or smell disorders (including loss of smell).
• vision problems (blurred vision)
• transient hearing loss, tinnitus, vertigo of labyrinthine origin, and ear noises.
• bronchospasm.
• nausea, vomiting, abdominal pain (dyspepsia), diarrhea. In individual cases, symptoms of pancreatitis have been observed - most of these patients were also taking other medications that could cause pancreatitis as a side effect.
• cholestatic hepatitis or, less frequently, acute hepatitis (sometimes with jaundice)
• rash, urticaria
• increased activity of some liver enzymes.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rolicyn

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Protect from moisture.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Rolicyn contains

• The active substance of Rolicyn is roxithromycin. Rolicyn, 50 mg- one film-coated tablet contains 50 mg of roxithromycin. Rolicyn, 100 mg- one film-coated tablet contains 100 mg of roxithromycin. Rolicyn, 150 mg- one film-coated tablet contains 150 mg of roxithromycin.
• Other ingredients of the medicine are: in the tablet core - cornstarch, povidone, sodium croscarmellose, silicon dioxide, poloxamer 188, talc, magnesium stearate in the tablet coating - hypromellose, macrogol 6000, titanium dioxide

What Rolicyn looks like and contents of the pack

The film-coated tablets are white to slightly creamy, round, and biconvex.
Packaging:10 film-coated tablets in a blister pack, in a cardboard box.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14

Date of last revision of the leaflet:

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