Package Insert: Information for the Patient

SPIRAXIN 200 mg Film-Coated Tablets

Rifaximina

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What Spiraxin is and what it is used for

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

3. How to take Spiraxin

4. Possible side effects

5. Storage of Spiraxin

6. Contents of the pack and additional information

Spiraxin belongs to the group of medications known as intestinal anti-infectives, antibiotics.

Spiraxin is indicated for:

• Resistant bacterial enterocolitis requiring symptomatic treatment in patients at risk due to associated pathology, immunosuppression, 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).

Do not take Spiraxin:

• If you are allergic to the active ingredient, rifamicin derivatives, or any of the other components of this medication (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 peeling of the skin, blisters, and/or mouth sores after taking rifaximina.
• During prolonged treatment at high doses, or in cases of intestinal injury, a slight absorption of the product may occur and upon elimination may cause a reddish discoloration of the urine, which is of no relevance.
• Rifaximina should be discontinued if diarrhea symptoms persist or worsen after 48 hours.
• Similarly, as with the use of many antibiotics, cases of diarrhea associated with Clostridioidesdifficile(DACD) have been reported during treatment with rifaximina, therefore the potential association of rifaximina treatment with DACD or pseudomembranous colitis cannot be ruled out.

Be especially careful with rifaximina:

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

Children

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

Taking Spiraxin with other medications

• Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

• In case of administration of activated charcoal, Spiraxin should be taken at least two hours after that administration.
• In case of liver insufficiency, be cautious when taking it with:
• • Warfarin (blood clotting prevention medication)
  • Antiepileptics (medications for treating epilepsy)
  • Antiarrhythmics (medications for treating abnormal heart rhythm)
  • Ciclosporina (immunosuppressant)
  • Oral contraceptives

Taking Spiraxin with food

Spiraxin can be taken with or without food.

Pregnancy, lactation, and fertility

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.

The safety of rifaximina for the fetus is unknown. Therefore, Spiraxin should not be used during pregnancy.

It is recommended to take additional contraceptive precautions if Spiraxin is taken with oral contraceptives (see section “Taking Spiraxin with other medications”),

The safety of rifaximina in breast milk is unknown. Therefore, Spiraxin should not be used during lactation.

Driving and operating machines

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

Spiraxin contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in 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 cases where, due to their complexity, a dose increase may be required and always under medical supervision. It is advised not to exceed 7 days of treatment.

No dose adjustment is necessary in patients with hepatic or renal insufficiency. Although no dose changes are anticipated, caution should be exercised in patients with renal function deterioration.

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 established.

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 Toxicological Information Service, phone 91-562 04 20, indicating the medication and the amount taken.

If you forgot to take Spiraxin

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Spiraxin

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.

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

- Flat, red spots, in the shape of a target or circles on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers.

These severe skin eruptions may be preceded by fever and flu-like symptoms.

Moreover, many of the side effects, mainly related to the gastrointestinal system, may be caused by the same illness that motivated the treatment.

Frequent side effects (in 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

Less frequent side effects (in 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, frontal or one-sided headache, tingling sensation, drowsiness
• Diplopia
• Ear pain, sensation of the room spinning (vertigo)
• Difficulty breathing, nasal congestion, dry throat, sore throat, cough, nasal discharge
• Ascites, heavy digestion, gastrointestinal motility disorders, upper abdominal pain, blood in the stool, mucous stools, hard stools, dry lips, taste disturbances
• Abnormal urine analysis results: presence of glucose in the urine, increased urine output, increased frequency of urination, presence of proteins in the urine, blood in the urine
• Acute skin eruptions and rashes that may appear suddenly, sunburn
• Back pain, muscle weakness, generalized muscle pain, muscle cramps, neck pain
• Loss of appetite, dehydration
• Candidiasis (infection caused by a type of fungus), inflammation or infection of the nose and/or throat, upper respiratory tract infection, herpes on the lips
• Hot flashes
• Exhaustion, chills, cold sweats, pain and discomfort, swollen arm (peripheral edema), excessive sweating, flu-like symptoms
• Abnormal liver function test results (increased aspartate aminotransferase)
• Prolonged and irregular menstrual periods
• Insomnia, abnormal dreams, depressed mood, nervousness

Side effects of unknown frequency (cannot be estimated from available data):

• Abnormal coagulation test results (International Normalized Ratio)
• Decreased platelet count in the blood
• Severe allergic reactions, hypersensitivity
• Sensation of fainting
• Skin and mucous membrane swelling, dermatitis, skin peeling dermatitis, eczema, erythema, itching, red skin patches (purpura), urticaria
• Infection caused by the bacteriaClostridium difficile
• Abnormal liver function test results

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of human medicines, https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require special storage conditions.

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

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

Medications should not be disposed of through drains or trash. Dispose of the packaging and medications you no longer need at the Sigre Point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Spiraxin Composition

• The active ingredient is rifaximin. Each tablet contains 200 mg of rifaximin.
• The other components (excipients) are sodium carboxymethylcellulose (type A) (from potato), glyceryl 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 iron oxide red (E-172).

Appearance of the product and contents of the packaging

Spiraxin are film-coated, biconvex, round, and pink tablets. They are presented in packs of 12 and 24 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder:

Alfasigma S.p.A

Via Ragazzi Del ’99, n.5

40133 Bologna. ITALIA

Responsible manufacturer:

Alfasigma, S.p.A.

Via Enrico Fermi, 1

65020 Alanno, Pescara. ITALIA

or

Alfasigma S.p.A

Via Pontina km 30.400

00071 – Pomezia, Roma. ITALIA

Local representative:

Alfasigma España, S.L.

Avda. Diagonal, 490

08006 Barcelona. ESPAÑA

Last review date of this leaflet:April 2024

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