Rolicin

Leaflet attached to the packaging: patient information

Rolicyn, 50 mg, coated tablets

Rolicyn, 100 mg, coated tablets

Rolicyn, 150 mg, coated tablets

Roxithromycin

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 their symptoms 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 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 packaging 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, rhinopharyngitis, sinusitis.
• Middle ear infection.
• Lower respiratory tract infections: pneumonia, bronchitis, lung abscess and bronchiectasis.
• Skin and soft tissue infections.
• Non-gonococcal genital tract infections.

2. Important information before taking Rolicyn

When not to take Rolicyn:

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

Warnings and precautions

Before starting Rolicyn, the patient should inform their doctor if:

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

The patient should inform their doctor if, during treatment, they experience:

• rash;
• symptoms of a new infection.

In case of doubts whether the above circumstances apply to the patient, they should consult their 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 nodules under the skin and blisters (acute generalized exanthematous pustulosis), the patient should immediately consult a doctor, as these skin symptoms can be life-threatening.
If the patient experiences diarrhea during or after taking Rolicyn, they should tell their doctor. This may be a symptom of pseudomembranous colitis - a complication associated with antibiotic use. It is then necessary to discontinue Rolicyn and sometimes use appropriate treatment. The patient should not take anti-diarrheal medications or other constipating agents.
In some cases, the doctor may examine what type of bacteria caused the patient's infection.
Depending on the results, the patient may receive Rolicyn in a different dose or a different medicine.

Rolicyn and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they 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 the patient should inform their 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);
• cyclosporine (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 the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor before taking this medicine.
If the patient is pregnant or thinks they may be pregnant
If the patient plans to become pregnant or suspects they are pregnant, they should tell their doctor. The medicine may be used in pregnant women only if the doctor considers it absolutely necessary.
If the patient is breastfeeding
Roxithromycin passes into breast milk in small amounts. If the patient is breastfeeding, they should stop breastfeeding for the duration of Rolicyn treatment.

Driving and using machines

It has not been found that Rolicyn affects the ability to drive vehicles or operate machines. However, if side effects occur that reduce concentration (e.g. pain, dizziness; see section 4. Possible side effects), it is not recommended to drive vehicles or operate machines. Vision disturbances and blurred vision may affect the ability to drive and operate 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

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult a 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 individually by the doctor, 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.

Treatment duration

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 and 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.
➢
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Taking a higher dose of Rolicyn than recommended

Overdosing on roxithromycin may cause gastrointestinal disorders (nausea, vomiting, diarrhea) and other intensified side effects, such as pain and dizziness.
In case of overdose, the patient should discontinue the medicine and induce vomiting if they are conscious.
If the patient takes too much Rolicyn (overdoses), they should consult a doctor or go directly to the hospital. They should show the packaging of the medicine.

Missing a dose of Rolicyn

In case of missing a dose at the scheduled time, the patient should 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.
The patient should not take a double dose to make up for the missed dose.

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 any of the following serious side effects occur, the patient should stop taking the medicine and immediately consult their 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 genital organs, loss of consciousness (fainting).
• Serious skin reactions In case of a severe skin reaction: red, peeling rash with nodules under the skin and blisters (acute generalized exanthematous pustulosis), the patient should immediately consult a doctor. The frequency of these adverse reactions is unknown (cannot be determined based on available data).
• Severe diarrhea, usually watery with blood and mucus, lasting for a longer period, accompanied by abdominal pain and/or fever. This may be a symptom of severe colitis (pseudomembranous colitis), which may occur after antibiotic use.

Other side effects

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

• superinfections: like other antibiotics, the use of roxithromycin, especially for a longer period, may cause the growth of resistant microorganisms. If symptoms of a new infection occur during roxithromycin treatment, the medicine should be discontinued and the doctor consulted.
• increased granulocyte count 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, and vertigo of labyrinthine origin.
• 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, more rarely, acute hepatitis (sometimes with jaundice)
• rash, urticaria
• increased activity of certain liver enzymes.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Rolicyn

The medicine should be stored out of 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. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Rolicyn contains

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

What Rolicyn looks like and what the packaging contains

The coated tablets are white to slightly creamy, round, and biconvex.
Packaging:10 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: 22 811-18-14

Date of last revision of the leaflet:

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