Relafalk

Package Leaflet: Information for the Patient

Relafalk, 200 mg, Modified-Release Tablets

Rifamycin Sodium

Read the Package Leaflet Carefully Before Taking the Medicinal Product, as it Contains Important Information for You.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product has been prescribed for you. 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 any not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Relafalk and What is it Used For
• 2. Important Information Before Taking Relafalk
• 3. How to Take Relafalk
• 4. Possible Side Effects
• 5. How to Store Relafalk
• 6. Contents of the Package and Other Information

1. What is Relafalk and What is it Used For

Relafalk contains the active substance rifamycin sodium, an antibiotic that acts in the intestines. It is used to treat traveler's diarrhea in adults with accompanying symptoms such as nausea, vomiting, bloating, frequent urge to have a bowel movement, abdominal pain or cramps. Relafalk should not be taken if diarrhea is accompanied by fever or blood in the stool.

2. Important Information Before Taking Relafalk

When Not to Take Relafalk:

• if you are allergic to rifamycin sodium, similar types of antibiotics, or any of the other ingredients of this medicinal product (listed in section 6);
• if you have vomiting, abdominal pain, or constipation caused by intestinal obstruction;
• if you have a perforation, wound, or injury to the gastrointestinal tract;
• if you have diarrhea with fever or blood in the stool.

Relafalk contains soy lecithin. Do not take if you are hypersensitive to peanuts or soy.

Warnings and Precautions

While taking Relafalk, discuss with your doctor or pharmacist if:

• symptoms worsen during treatment;
• no improvement occurs after 3 days;
• symptoms recur shortly after stopping treatment.

While taking this medicinal product, urine may turn reddish. You should contact your doctor if you experience symptoms such as frequent watery stools, severe abdominal cramps, or blood in the stool. This could be due to an infection (diarrhea caused by the bacterium Clostridium difficile), which requires immediate medical attention.
If you are being treated with a rifamycin antibiotic for a disease caused by mycobacteria (e.g., tuberculosis), you should not take Relafalk.

Children and Adolescents

There is no experience with the use of Relafalk in children and adolescents.
Therefore, this medicinal product should not be given to children and adolescents under 18 years of age.

Relafalk and Other Medicinal Products

Tell your doctor or pharmacist about all medicinal products you are taking or have recently taken, as well as any you plan to take.

• Do not take Relafalk at the same time as similar types of antibiotics.
• Tell your doctor if you are taking cyclosporin (an immunosuppressant), warfarin (a blood thinner), or oral contraceptives.
• If you are taking activated charcoal (e.g., for the treatment of diarrhea), take Relafalk at least 2 hours after taking the charcoal.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicinal product. If you are pregnant or breastfeeding, do not takeRelafalk unless your doctor advises you to do so.

Driving and Using Machines

The effect of Relafalk on the ability to drive and use machines is unlikely to be significant. Do not drive or operate machinery if you experience dizziness or fatigue after taking Relafalk.

Relafalk Contains Sodium

This medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to Take Relafalk

Always take this medicinal product exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Recommended Daily Dose for Adults Over 18 Years:

• two tablets in the morning and two tablets in the evening for three days.
• unless otherwise advised, the duration of treatment should notexceed three days. If no improvement occurs after three days, contact your doctor.

Use in Children and Adolescents

Relafalk is not intended for use in children and adolescents under 18 years of age.

How to Take the Tablets:

• Take the tablets with a glass of water. Swallow them whole. Do not crush or chew.
• Tablets can be taken with or without food.

Overdose of Relafalk

If you accidentally take more than the recommended dose, contact your doctor.

Missed Dose of Relafalk

Do not take a double dose to make up for a missed dose. Take the next dose as recommended.

Stopping Relafalk Treatment

The recommended treatment duration is three days. If symptoms worsen during treatment or if no improvement occurs after 3 days, contact your doctor.
If you have any further questions about the use of this medicinal product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Relafalk can cause side effects, although not everybody gets them.

Very Common: May Affect Up to 1 in 10 People

• Headache
• Diarrhea

Uncommon: May Affect Up to 1 in 100 People

• Loss of appetite
• Restlessness
• Dizziness
• Abdominal cramps and spasms, bloating, abdominal pain, tenderness, mouth ulcers, constipation, frequent urge to have a bowel movement, dry mouth, nausea, vomiting, belching, flatulence, increased gastric juice, hair loss, increased sweating, night sweats, itching
• Muscle and joint pain, back pain, limb pain, muscle cramps and weakness
• Abnormal urine color, pain while urinating, difficulty urinating, decreased urine output
• Weakness, chest pain, general feeling of being unwell, pain, fever
• Abnormal liver function tests (elevated ALT), abnormal blood tests (elevated creatinine and urea)

The following side effects have been reported with the use of antibiotics similar to Relafalk, and may also occur with this medicinal product. The frequency of these side effects is currently unknown.

• Bacterial infections (infections caused by bacteria of the genus Clostridium), fungal infections
• Abnormal blood test results (decreased platelet count)
• Severe allergic reactions (anaphylactic reactions), allergic reactions to the medicinal product
• Severe allergic reaction causing facial or throat swelling, itchy rash, redness/roughness of the skin
• Swelling of the ankles and/or lower limbs due to fluid accumulation

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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, e-mail: ndl@urpl.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 medicinal product.

5. How to Store Relafalk

Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Package and Other Information

What Relafalk Contains

• The active substance is rifamycin sodium. Each modified-release tablet contains 200 mg of rifamycin sodium.
• The other excipients are: Tablet core: ascorbic acid (E 300), soy lecithin, glycerol distearate, ammonio methacrylate copolymer (type B), mannitol, silica colloidal anhydrous, magnesium stearate. Tablet coating: methacrylic acid - methyl methacrylate copolymer (1:2), titanium dioxide (E 171), talc, yellow iron oxide (E 172), triethyl citrate, macrogol 6000.

What Relafalk Looks Like and Contents of the Package

Relafalk 200 mg modified-release tablets are yellow-brown, oval, and marked with "SV2" on one side.
They are available in blisters containing 12 tablets.

Marketing Authorization Holder

Adalvo Competence Center SRL
47 Theodor Pallady Blvd
Building HBC, entrance B
032258 Bucharest
Romania

Manufacturer

Cosmo S.p.A
Via C. Colombo, 1
20045, Lainate
Milan, Italy
Phone: +39 02 93 3371
Fax: +39 02 93 33 7663
Email: glo-regulatory@cosmopharma.com
To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:
Ewopharma AG Sp. z o.o., ul. Leszno 14, 01-192 Warsaw, tel. 22 620 11 71.

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Bulgaria, Denmark, Finland, Germany, Greece, Hungary, Norway, Poland, Spain, Sweden, United Kingdom: Relafalk
Portugal: Imfalda
Date of Approval of the Package Leaflet: 01.2025.