RIFAMPICIN ADALVO 200 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Rifamicina Adalvo 200 mg Modified Release Tablets

sodium rifamycin

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Rifamicina Adalvo and what is it used for
2. What you need to know before taking Rifamicina Adalvo
3. How to take Rifamicina Adalvo
4. Possible side effects
5. Storage of Rifamicina Adalvo
6. Package Contents and Additional Information

1. What is Rifamicina Adalvo and what is it used for

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

2. What you need to know before taking Rifamicina Adalvo

Do not takeRifamicina Adalvoif:

• you are allergic to sodium rifamycin, similar types of antibiotics, or any of the other components of this medication (listed in section 6),
• you have vomiting, abdominal pain, or constipation caused by intestinal obstruction,
• you have a perforation, wound, or injury to the digestive system,
• you have diarrhea with fever or blood in the stool.

Rifamicina Adalvo contains soy lecithin.

It should not be used in case of peanut or soy allergy.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Rifamicina Adalvo:

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

A reddish discoloration of the urine may occur during treatment with this medication.

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

If you are receiving treatment with a rifamycin antibiotic for a mycobacterial disease (e.g., tuberculosis), you should not take Rifamicina Adalvo.

Children and Adolescents

There is no experience with the use of Rifamicina Adalvo in children and adolescents.

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

Taking Rifamicina Adalvo with other medications

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

• Rifamicina Adalvo should not be taken with similar types of antibiotics.
• Tell your doctor if you are taking cyclosporine (an immunosuppressant), warfarin (an anticoagulant), or oral contraceptives.
• If you take activated charcoal (e.g., to treat diarrhea), take Rifamicina Adalvo at least two hours after taking the activated charcoal.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Do not takeRifamicina Adalvo if you are pregnant or breastfeeding, unless your doctor advises you to do so.

Driving and Using Machines

It is unlikely that Rifamicina Adalvo will affect your ability to drive or use machines. Do not drive or use machines if you experience dizziness or fatigue after taking Rifamicina Adalvo.

Rifamicina Adalvo contains sodium

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

3. How to take Rifamicina Adalvo

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended daily dose for adults over 18 years is:

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

Use in Children and Adolescents

Rifamicina Adalvo is not indicated for 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 them.
• The tablets can be taken with or without food.

If you take moreRifamicina Adalvothan you should

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

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

If you forget to takeRifamicina Adalvo

Do not take a double dose to make up for forgotten doses. Take the next dose as prescribed.

If you stop takingRifamicina Adalvo

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Common: may affect up to 1 in 10 people

• Headache
• Diarrhea

Uncommon: may affect up to 1 in 100 people

• Loss of appetite
• Anxiety
• Dizziness
• Intestinal colic and abdominal spasms, abdominal distension, pain in the upper abdominal region, pain on palpation of the abdomen, aphthous ulcers (in the mouth), constipation, frequent urgent need to defecate, dry mouth, dyspepsia, belching, flatulence, increased gastric acid in the stomach, nausea
• Hair loss, increased sweating, night sweats, itching
• Pain in muscles and joints, 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 being unwell, pain, fever
• Changes in liver function parameters (elevated ALT), changes in blood (elevated creatinine and urea)

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

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's online platform: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Rifamicina Adalvo

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

Do not use this medication after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofRifamicina Adalvo

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

Appearance of the Product and Package Contents

Rifamicina Adalvo 200 mg modified-release tablets are yellow-brown elliptical 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: zentrale@drfalkpharma.de

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

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

Dr. Falk Pharma España

Camino de la Zarzuela, 19

28023 Madrid

Spain

Phone: +34 91 3729508

This medication is authorized in the Member States of the European Economic Area under the following names:

Bulgaria, Denmark, Finland, Hungary, Norway, United Kingdom: Travyc

Spain, Greece, Sweden, Poland, Portugal: Rifamicina Adalvo

Germany: Gutivia

Date of the last revision of this package leaflet:05/2025.