Rifamycin Adalvo 200 mg modified-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rifamicina Adalvo 200 mg modified-release tablets

sodium rifamycin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

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

Leaflet contents

1. What Rifamicina Adalvo is and what it is used for
2. What you need to know before taking Rifamicina Adalvo
3. How to take Rifamicina Adalvo
4. Possible adverse effects
5. How to store Rifamicina Adalvo
6. Contents of the pack and other information

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

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

2. What you need to know before starting to take Rifamicina Adalvo

Do not take Rifamicina Adalvo:

• if you are allergic to sodium rifamycin, to similar types of antibiotics, or to any of the other ingredients of this medicine (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 tract,
• if you have diarrhea with fever or blood in the stool.

Rifamicina Adalvo contains soybean lecithin.

It should not be used in case of allergy to peanuts or soybeans.

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 reappear shortly after stopping treatment.

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

Consult your doctor if you experience symptoms such as frequent watery diarrhea, abdominal pain, severe intestinal cramps, 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 being treated with a rifamycin-group antibiotic for a mycobacterial disease (e.g., tuberculosis), you must 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 medicine to children and adolescents under 18 years of age.

Taking Rifamicina Adalvo with other medicines

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

• Rifamicina Adalvo should not be taken together with similar types of antibiotics.
• Inform 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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Do not take Rifamicina Adalvo if you are pregnant or breastfeeding, unless your doctor instructs you to do so.

Driving and using machines

It is unlikely that Rifamicina Adalvo will affect your ability to drive or operate machinery. However, do not drive or operate machinery if you experience dizziness or fatigue after taking Rifamicina Adalvo.

Rifamicina Adalvo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".

3. How to take Rifamicina Adalvo

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Recommended daily dose for adults over 18 years of age:

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

Use in children and adolescents

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

If you take more Rifamicina Adalvo than you should

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

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

If you forget to take Rifamicina Adalvo

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

If you stop taking Rifamicina Adalvo

The recommended duration of treatment 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Frequent: may affect up to 1 in 10 people

• Headache
• Diarrhoea

Uncommon: may affect up to 1 in 100 people

• Loss of appetite
• Anxiety
• Dizziness
• Intestinal colic and abdominal spasms, abdominal distension, upper abdominal pain, abdominal tenderness upon palpation, aphthous ulcers (in the mouth), constipation, frequent urgent need to defecate, dry mouth, dyspepsia, burping, flatulence, increased gastric acid in the stomach, nausea
• Hair loss, increased sweating, night sweats, itching
• Muscle and joint pain, back pain, pain in limbs and sides, muscle spasms and muscle weakness
• Abnormal urine colour, pain or difficulty urinating, decreased urine output
• Weakness, chest pain, general feeling of being unwell, pain, fever
• Changes in liver function parameters (elevation of ALT), blood changes (elevation of creatinine and urea)

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it involves possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rifamicina Adalvo

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Rifamicina Adalvo

• The active substance is sodium rifamycin. Each modified-release tablet contains 200 mg of sodium rifamycin.
• The other excipients are: ammonium methacrylate copolymer (type B), ascorbic acid (E300), glycerol distearate, soybean 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 contents of the container

Rifamicina Adalvo 200 mg modified-release tablets are yellowish-brown, ellipsoidal tablets with the imprint “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

E-Mail: [email protected]

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 about this medicinal product, please contact 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 medicinal product is authorized in the European Economic Area member states under the following names:

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

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

Germany: Gutivia

Date of latest review of this leaflet: 05/2025.