SPIRAXIN 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

SPIRAXIN 200 mg film-coated tablets

Rifaximin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Spiraxin is and what it is used for
2. What you need to know before you take Spiraxin
3. How to take Spiraxin
4. Possible side effects
5. Storage of Spiraxin
6. Contents of the pack and other information

1. What Spiraxin is and what it is used for

Spiraxin belongs to a group of medicines called intestinal anti-infectives, antibiotics.

Spiraxin is indicated in:

• Bacterial enterocolitis resistant to symptomatic treatment in patients at risk due to associated pathology, immunodepression, or advanced age.
• Pseudomembranous colitis in patients resistant to vancomycin.
• Acute diverticulitis.
• Pre- and post-operative prophylaxis in gastrointestinal tract surgery.
• Adjuvant therapy in hyperammonemia (excessive increase in blood ammonia concentration).

2. What you need to know before you take Spiraxin

Do not take Spiraxin:

• If you are allergic to the active substance, rifamycin derivatives, or any of the other components of this medicine (listed in section 6).
• If you have intestinal obstruction.
• If you have severe intestinal ulcerative lesions.
• If you have complicated diarrhea with fever or blood in the stool.

Warnings and precautions

• Consult your doctor or pharmacist before starting to take Spiraxin.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking rifaximin.
• During prolonged treatments at high doses, or in cases of intestinal injury, a slight absorption of the product may occur, and when eliminated, it may cause a reddish coloration of the urine, which is of no significant relevance.
• Rifaximin should be withdrawn if symptoms of diarrhea persist or worsen after 48 hours.
• As with the use of most antibiotics, during treatment with rifaximin, cases of diarrhea associated with Clostridioidesdifficile(CDAD) have been reported; therefore, the potential association of rifaximin treatment with CDAD or pseudomembranous colitis cannot be ruled out.

Be particularly careful with rifaximin:

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with rifaximin treatment. Most cases were reported in patients with liver disease (such as cirrhosis or hepatitis). Stop using rifaximin and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children

The safety and efficacy of rifaximin have not been established in children under 12 years of age.

Taking Spiraxin with other medicines

• Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

• In case of activated charcoal administration, Spiraxin should be taken at least 2 hours after that administration.
• In case of liver failure, caution should be exercised when taking:
• • Warfarin (a medicine to prevent blood clotting)
  • Antiepileptics (medicines to treat epilepsy)
  • Antiarrhythmics (medicines to treat abnormal heart rhythm)
  • Cyclosporin (an immunosuppressant)
  • Oral contraceptives

Taking Spiraxin with food

Spiraxin can be administered with or without food.

Pregnancy, breastfeeding, and fertility

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 medicine.

It is not known whether rifaximin can harm the fetus. Therefore, Spiraxin should not be used during pregnancy.

It is recommended to take additional contraceptive precautions if you are taking Spiraxin with oral contraceptives (see "Taking Spiraxin with other medicines"),

It is not known whether rifaximin is excreted in breast milk. Therefore, Spiraxin should not be used during breastfeeding.

Driving and using machines

Spiraxin has a negligible influence on the ability to drive and use machines, although some cases of dizziness or drowsiness have been reported.

Spiraxin contains sodium

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

3. How to take Spiraxin

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

Spiraxin is administered orally with a glass of water.

The recommended dose is 200 mg (1 tablet) every 6 hours, until symptoms subside. This dose may be increased to 400 mg in adults every 8 hours, in those cases that, due to their complexity, may require a dose increase and always under medical criteria. It is recommended not to exceed 7 days of treatment.

No dose adjustment is necessary in patients with liver or kidney failure. Although no dose changes are expected, caution should be exercised in patients with impaired renal function.

Use in children

The safety and efficacy of rifaximin have not been established in children under 12 years of age. No dosage recommendation can be made.

If you take more Spiraxin than you should

If you have taken more Spiraxin than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91-562 04 20, indicating the medicine and the amount taken.

If you forget to take Spiraxin

Do not take a double dose to make up for forgotten doses.

If you stop taking Spiraxin

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using rifaximin and seek immediate medical attention if you notice any of the following symptoms:

• Reddish patches, not raised, in a target or circular shape on the trunk, often with central blisters, skin peeling, mouth ulcers, and/or sores in the mouth, throat, nose, genitals, and eyes.

These severe skin rashes can be preceded by fever and flu-like symptoms.

Similarly, many of the side effects, mainly related to the gastrointestinal tract, may be caused by the same disease that motivated the treatment.

Common side effects (at least 1 in 100 patients):

• Dizziness, headache
• Constipation, abdominal pain, abdominal distension, diarrhea, flatulence, feeling of needing to defecate, involuntary and painful or ineffective straining, nausea, vomiting
• Fever

Uncommon side effects (at least 1 in 1,000 patients):

• Increased blood pressure
• Palpitations
• Abnormal white blood cell count in the blood (increased lymphocytes and monocytes and decreased neutrophils)
• Decreased sensitivity, migraine, forehead or one-sided headache, tingling sensation, drowsiness
• Double vision
• Ear pain, sensation of the room spinning (vertigo)
• Difficulty breathing, nasal congestion, dry throat, sore throat, cough, runny nose
• Fluid accumulation in the abdomen (ascites), heavy digestion, gastrointestinal motility disorders, upper abdominal pain, blood in the stool, mucous stools, hard stools, dry lips, taste disorders
• Abnormal urine test results: glucose in the urine, increased urine output, increased frequency of urination, protein in the urine, blood in the urine
• Skin rashes and eruptions that can be sudden, sunburn
• Back pain, muscle weakness, generalized muscle pain, muscle cramps, neck pain
• Loss of appetite, dehydration
• Candidiasis (a type of fungal infection), inflammation or infection of the nose and/or throat, upper respiratory tract infection, cold sores
• Hot flashes
• Exhaustion, chills, cold sweat, pain and discomfort, swollen arm (peripheral edema), excessive sweating, flu-like symptoms
• Abnormal liver test results (increased aspartate aminotransferase)
• Prolonged and irregular menstrual periods
• Insomnia, abnormal dreams, depressed mood, nervousness

Rare side effects (frequency not known):

• Abnormal blood coagulation test results (International Normalized Ratio)
• Decreased platelet count in the blood
• Severe allergic reactions, hypersensitivity
• Fainting sensation
• Swelling of skin and mucous membranes, dermatitis, skin peeling dermatitis, eczema, erythemas, itching, red spots on the skin (purpura), hives
• Clostridium difficileinfection
• Liver function test abnormalities

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for human use, https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Spiraxin

No special storage conditions are required.

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 after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the carton and any remaining medicine in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the carton and any remaining medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Spiraxin

• The active substance is rifaximin. Each tablet contains 200 mg of rifaximin.
• The other components (excipients) are sodium carboxymethyl starch (type A) (potato), glycerol distearate, anhydrous colloidal silica (E-551), talc (E-553b), microcrystalline cellulose (E-460), hypromellose (E-464), titanium dioxide (E-171), disodium edetate, propylene glycol (E-1520), and red iron oxide (E-172).

Appearance of the product and pack contents

Spiraxin is a film-coated tablet, biconvex, round, and pink in color. It is available in packs of 12 and 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Alfasigma S.p.A

Via Ragazzi Del ’99, n.5

40133 Bologna. ITALY

Manufacturer:

Alfasigma, S.p.A.

Via Enrico Fermi, 1

65020 Alanno, Pescara. ITALY

or

Alfasigma S.p.A

Via Pontina km 30.400

00071 – Pomezia, Roma. ITALY

Local representative:

Alfasigma España, S.L.

C/ Aribau 195, 4º

08021 Barcelona. España

Date of the last revision of this leaflet:April 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/