Spiraxin 200 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

SPIRAXIN 200 mg film-coated tablets

Rifaximin

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Spiraxin is and what it is used for

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

Spiraxin is indicated for:

• Bacterial enterocolitis resistant to symptomatic treatment in high-risk patients 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.
• Adjunctive therapy in hyperammonemia (excessive increase in blood ammonia concentration).

2. What you need to know before taking Spiraxin

Do not take Spiraxin:

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

Warnings and precautions

• Consult your doctor or pharmacist before starting to take Spiraxin.
• If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking rifaximin.
• During prolonged treatment at high doses, or in cases of intestinal injury, slight absorption of the product may occur, and upon elimination may result in a reddish discoloration of the urine; this is not clinically significant.
• Rifaximin should be discontinued if diarrhea symptoms persist or worsen after 48 hours.
• As with the use of many antibiotics, cases of Clostridioides difficile-associated diarrhea (CDAD) have been reported during treatment with rifaximin; therefore, a potential association between rifaximin treatment and CDAD or pseudomembranous colitis cannot be ruled out.

Take special care 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). Discontinue rifaximin and seek immediate medical attention if you experience any 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

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

• If activated charcoal is administered, Spiraxin should be taken at least two hours after such administration.

• Caution is advised when taking Spiraxin concomitantly with the following in patients with hepatic impairment:

  • Warfarin (a medication to prevent blood clotting)
  • Antiepileptics (medications for treating epilepsy)
  • Antiarrhythmics (medications for treating abnormal heart rhythm)
  • Cyclosporine (an immunosuppressant)
  • Oral contraceptives

Taking Spiraxin with food

Spiraxin may be taken with or without food.

Pregnancy, breastfeeding, 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 medicine.

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

It is advisable to use additional contraceptive precautions if taking Spiraxin together with oral contraceptives (see section “Taking Spiraxin with other medicines”).

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

Driving and using machines

Spiraxin has negligible influence on the ability to drive and use machines, although dizziness or somnolence has been reported in some cases.

Spiraxin contains sodium

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

3. How to take Spiraxin

Follow exactly the instructions for use of this medicine as given 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 resolve. This dose may be increased to 400 mg in adults every 8 hours in cases where, due to their severity, a higher dose may be required, and always at the physician's discretion. It is recommended not to exceed 7 days of treatment.

It is not necessary to modify the dosage regimen in patients with hepatic or renal impairment. Although dosage adjustments are not anticipated, 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. A dosage recommendation cannot be made.

If you take more Spiraxin than you should

If you have taken more Spiraxin than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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 missed doses.

If you stop taking Spiraxin

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 may cause adverse effects, although not everyone will experience them.

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

• Red, flat spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers.

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

In addition, many of the adverse effects, mainly those related to the gastrointestinal system, may be caused by the underlying condition being treated.

Frequent adverse effects (in at least 1 out of 100 patients):

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

Uncommon adverse effects (in at least 1 out of 1,000 patients):

• Increased blood pressure
• Palpitations
• Abnormal white blood cell count (increase in lymphocytes and monocytes and decrease in neutrophils)
• Decreased sensitivity, migraine, frontal or unilateral headache, tingling sensation, somnolence
• Double vision
• Ear pain, sensation of spinning room (vertigo)
• Difficulty breathing, nasal congestion, dry throat, sore throat, cough, runny nose
• Fluid accumulation in the abdomen (ascites), indigestion, gastrointestinal motility disorders, upper abdominal pain, blood in stools, mucus in stools, hard stools, dry lips, taste disturbances
• Abnormal urine test results: presence of glucose in urine, increased volume of urine excreted, increased frequency of urination, presence of protein in urine, blood in urine
• Skin rashes and eruptions which may appear suddenly, sunburn
• Back pain, muscle weakness, generalized muscle pain, muscle cramps, neck pain
• Loss of appetite, dehydration
• Candidiasis (fungal infection), inflammation or infection of the nose and/or throat, upper respiratory tract infection, cold sores
• Hot flushes
• Fatigue, chills, cold sweat, pain and discomfort, swollen arm (peripheral edema), excessive sweating, flu-like symptoms
• Abnormal liver function tests (increase in aspartate aminotransferase)
• Prolonged and irregular menstrual periods
• Insomnia, abnormal dreams, depressed mood, nervousness

Adverse effects with unknown frequency (cannot be estimated from available data):

• Abnormal blood coagulation test results (International Normalized Ratio)
• Decreased number of platelets in the blood
• Severe allergic reactions, hypersensitivity
• Feeling of fainting
• Swelling of skin and mucous membranes, dermatitis, dermatitis with skin peeling, eczema, erythema, itching, red spots on the skin (purpura), urticaria
• Infection caused by the bacterium Clostridium difficile
• Abnormalities in liver function tests

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products, https://www.notificaRAM.es. By reporting adverse reactions, 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Collection Point at your pharmacy. If you have any doubts, 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 Spiraxin

• The active substance is rifaximin. Each tablet contains 200 mg of rifaximin.
• The other components (excipients) are sodium carboxymethyl starch (type A) (from potato), glycerol distearate, colloidal anhydrous 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 medicinal product and contents of the container

Spiraxin are film-coated, biconvex, round, pink tablets. They are available in packs of 12 and 28 tablets.

Marketing Authorization Holder and Manufacturer

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, Spain

Date of the most recent revision of this leaflet: April 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/