Prospect: information for the patient

Relafalk 200 mg modified-release tablets

rifamicina sódica

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Relafalk and what it is used for

2.What you need to know before starting to take Relafalk

3.How to take Relafalk

4.Possible adverse effects

5.Storage of Relafalk

6.Contents of the package and additional information

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Relafalk contains the active ingredient rifamicina sódica, an antibiotic that acts in the intestine. It is used to treat traveler's diarrhea accompanied by symptoms such as nausea, vomiting, flatulence, frequent urgent need to defecate, abdominal pain or intestinal cramps in adults. Relafalk should not be used if diarrhea is accompanied by fever or blood in the stool.

Do not take Relafalk:

-if you are allergic to rifamicin sodium, similar types of antibiotics, or any of the other components of this medication (listed in section 6),

-if you have vomiting, abdominal pain, or constipation caused by intestinal obstruction,

-if you have a perforation, wound, or injury in the digestive system,

-if you have diarrhea with fever or blood in the stool.

Relafalk contains soy lecithin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Relafalk:

• if your symptoms worsen during treatment,
• if you do not get better after three days of treatment,
• if your symptoms reappear shortly after stopping treatment.

It may cause a reddish discoloration of the urine during treatment with this medication.

Consult your doctor if you experience symptoms such as frequent liquid diarrhea, abdominal pain, or intense intestinal cramps, fever, or blood in the stool. This may be due to an infection (diarrhea associated with Clostridium difficile), which requires immediate medical attention.

If you are receiving treatment with a rifamicin antibiotic for a mycobacterial disease (such as tuberculosis), do not take Relafalk.

Children and adolescents

No experience is available with the use of Relafalk in children and adolescents.

Therefore, do not administer this medication to children and adolescents under 18 years of age.

Taking Relafalk with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

• Relafalk should not be taken with similar types of antibiotics.
• Inform your doctor if you are taking ciclosporin (an immunosuppressant), warfarin (an anticoagulant), or oral contraceptives.
• If you take activated charcoal (for example, to treat diarrhea), take Relafalk at least two hours after taking the charcoal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.Do not takeRelafalk if you are pregnant or breastfeeding, unless your doctor tells you to.

Driving and operating machines

It is unlikely that Relafalk will affect your reactions to driving and operating machines. Do not drive or operate machines if you experience dizziness or fatigue after taking Relafalk.

Relafalk contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended daily dose for adults over 18 years old is:

• Two tablets in the morning and two tablets at night for three days.
• Unless otherwise prescribed, the treatment durationshould notexceed three days. Consult your doctor if you do not feel better after three days.

Use in children and adolescents

Relafalk is not indicated for children or adolescents under 18 years old.

How to take the tablets:

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

If you take more Relafalk than you should

Consult a doctor if you have accidentally taken a dose higher than recommended.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Relafalk

Do not take a double dose to compensate for the missed doses. Take the next dose as prescribed.

If you interrupt the treatment with Relafalk

The recommended treatment duration is three days. Consult your doctor if symptoms worsen during treatment or if you do not feel better after three days.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Frequent: may affect up to 1 in 10 peoplepeople

• Headache
• Diarrhea

Less frequent: may affect up to 1 in 100 peoplepeople

• Loss of appetite
• Anxiety
• Dizziness
• Abdominal cramps and spasms, abdominal distension, upper abdominal pain, abdominal tenderness, aphthous ulcers (in the mouth), constipation, frequent and urgent need to defecate, dry mouth, indigestion, belching, flatulence, increased stomach acid, nausea
• Hair loss, increased sweating, nocturnal sweating, itching
• Muscle and joint pain, back pain, pain in the limbs and sides, muscle spasms and muscle weakness
• Abnormal urine color, pain or difficulty urinating, decreased urine output
• Weakness, chest pain, general feeling of illness, pain, fever
• Liver function changes (elevated ALT), changes in blood (elevated creatinine and urea)

The following side effects have been reported with similar antibiotics to Relafalk and may also occur with this medicine. The frequency of these side effects is currently unknown:

• Bacterial infections (clostridial infections), fungal infections
• Abnormal blood test results (decreased platelet count)
• Severe acute drug reactions (anaphylactic reactions), drug allergic reactions
• Severe allergic reaction causing facial or throat swelling, skin rash with itching, skin redness/roughness
• Swelling of the ankles and/or legs due to fluid accumulation

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and themedicines that you no longer need at the SIGRE collection pointof the pharmacy. If in doubtask your pharmacist how to dispose of the containers and the medicines that you no longer need. In this way, you will help protect the environment.

Composition of Relafalk

• The active ingredient is rifamicin sodium. Each modified-release tablet contains 200mg of rifamicin sodium.
• The other excipients are: ammonio methacrylate copolymer (type B), ascorbic acid (E300), diestearoyl glycerol, soy lecithin (E322), magnesium stearate, mannitol, copolymer of methacrylic acid and methyl methacrylate (1:2), macrogol 6000 (E1521), anhydrous colloidal silica (E551), talc, titanium dioxide (E171), triethyl citrate (E1505), yellow iron oxide (E172).

Appearance of the product and content of the container

Relafalk 200 mg modified-release tablets are yellow-brown elipsoid-shaped tablets with the inscription “SV2” on one side.

They are available in blister packs containing 12 tablets.

Marketing Authorization Holder

Dr. Falk Pharma GmbH

Leinenweberstr. 5

79108 Freiburg

Germany

Email:[email protected]

Responsible for manufacturing

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]

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Dr. Falk Pharma España

Camino de la Zarzuela,19

28023 Madrid

Spain

Tel +34 91 3729508

This medication is authorized in the member states of the European Economic Area with the following names:

Germany, Bulgaria, Denmark, Spain, Finland, Greece, Hungary, Norway, Poland, United Kingdom, Sweden: Relafalk

Portugal: Imfalda

Last review date of this leaflet:01/2025..