Rifamycin adalvo

Package leaflet: Information for the patient

Relafalk, 200 mg, modified release tablets
Rifamycinum natricum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you may read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Relafalk is and what it is 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 pack and other information

1. What Relafalk is and what it is used for

Relafalk contains an active substance called rifamycin sodium, an antibiotic that acts in the intestines. It is used to treat travellers' diarrhoea in adults accompanied by symptoms such as nausea, vomiting, bloating, frequent urge to defecate, or abdominal pain or cramps. Relafalk should not be used if diarrhoea is accompanied by fever or blood in the stool.

2. Important information before using Relafalk

When not to use Relafalk:

• if the patient is allergic to sodium rifamycin, similar types of antibiotics, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has vomiting, abdominal pain or constipation caused by intestinal obstruction;
• if the patient has a perforation, wound or injury of the gastrointestinal tract;
• if the patient has diarrhoea with fever or blood in the stool.

Relafalk contains soya lecithin. Do not use if hypersensitivity to peanuts or soya has been diagnosed.

Warnings and precautions

While taking Relafalk, consult a doctor or pharmacist if:

• symptoms worsen during treatment;
• there is no improvement after 3 days;
• symptoms reappear shortly after stopping treatment.

While taking this medicine, reddish discoloration of urine may occur.

Contact a doctor if symptoms such as frequent watery stools, severe cramps or abdominal pain, fever or blood in the stool occur. This may indicate an infection (diarrhoea caused by the bacterium Clostridium difficile) which requires immediate medical attention.

If the patient is being treated with a rifamycin-class antibiotic for a disease caused by mycobacteria (e.g. tuberculosis), Relafalk should not be taken.

Children and adolescents

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

Relafalk and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• Relafalk should not be taken at the same time as similar types of antibiotics.
• Inform the doctor if the patient is taking cyclosporine (an immunosuppressive medicine), warfarin (a blood-thinning medicine) or oral contraceptives.
• If the patient is taking activated charcoal (for example, to treat diarrhoea), Relafalk should be taken at least 2 hours after activated charcoal.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. If the patient is pregnant or breastfeeding, do not take Relafalk unless otherwise advised by a doctor.

Driving and operating machinery

The effect of Relafalk on the ability to drive and operate machinery is unlikely. However, do not drive or operate machinery if the patient experiences dizziness or fatigue after taking Relafalk.

Relafalk contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use the medicine Relafalk

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
The recommended daily dose for adults aged 18 years and above is:

• two tablets in the morning and two tablets in the evening for three days.
• unless otherwise advised, the duration of treatment should not exceed three days. If there is no improvement after three days, consult a 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:

• The tablets should be taken with a glass of water. Swallow them whole. Do not crush or chew.
• Tablets may be taken with or without food.

Accidental overdose of Relafalk
If a patient has accidentally taken more than the recommended dose, consult a doctor immediately.
Missed dose of Relafalk
Do not take a double dose to make up for a missed dose. Take the next dose as recommended.
Stopping treatment with Relafalk
The recommended duration of treatment is three days. If symptoms worsen during treatment, or if there is no improvement after 3 days, consult a doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Common: may occur in up to 1 in 10 people

• Headache
• Diarrhea

Uncommon: may occur in up to 1 in 100 people

• Loss of appetite
• Anxiety
• Dizziness
• Abdominal cramps and spasms, abdominal distension, epigastric pain, abdominal tenderness, aphthous ulceration (of the mouth), constipation, frequent urge to defecate, dry mouth, dyspepsia, belching, flatulence, increased gastric secretions, nausea
• Hair loss, increased sweating, night sweats, itching
• Muscle and joint pain, back pain, limb pain and flank pain, muscle cramps and muscle weakness
• Abnormal urine color, pain during urination or difficulty passing urine, reduced urine output
• Weakness, chest pain, general malaise, pain, fever
• Abnormal liver function test parameters (increased ALAT activity), blood parameter abnormalities (increased creatinine and urea levels)

The following adverse reactions have been reported with the use of antibiotics similar to
Relafalk and may therefore also occur during treatment with this medicine. The frequency of
occurrence of these adverse reactions is currently unknown.

• Bacterial infections (infections caused by bacteria of the genus Clostridium), fungal infections
• Abnormal blood test results (reduced platelet count)
• Severe acute drug reactions (anaphylactic reactions), allergic reactions to the medicine
• Severe allergic reaction causing facial or throat swelling, itchy rash, skin redness/roughness
• Ankle and/or lower limb swelling due to fluid accumulation

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 4921 301, Fax: +48 22 4921 309, e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Relafalk medicine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must 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 pack and other information

What Relafalk contains

• The active substance is rifamycin sodium. Each modified-release tablet contains 200 mg of rifamycin sodium.
• Other ingredients (excipients) are:
  Tablet core: Ascorbic acid (E 300), soy lecithin, glycerol distearate, ammonium methacrylate copolymer (type B), mannitol, colloidal anhydrous silica, magnesium stearate.
  Tablet coating: Methacrylic acid and 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 pack
Relafalk 200 mg modified-release tablets are yellowish-brown oval tablets marked "SV2" on one side.
They are available in blisters containing 12 tablets.

Marketing Authorisation 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: [email protected]

For further information, please contact the representative of the Marketing Authorisation Holder in Poland:
Ewopharma AG Sp. z o.o., ul. Leszno 14, 01-192 Warsaw, tel. 22 620 11 71.

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Bulgaria, Denmark, Finland, Germany, Greece, Hungary, Norway, Poland, Spain, Sweden, United Kingdom: Relafalk
Portugal: Imfalda