Xifaxan 550 mg 56 film-coated tablets

What is Xifaxan 550 mg and when is it used?

Xifaxan 550 mg is taken as prescribed by your doctor to reduce intestinal bacteria. In certain serious liver diseases, this protects the brain from bacterial toxins from the intestines.

Xifaxan 550 mg contains the active ingredient rifaximin (an antibiotic) and is used in adults with liver disease to reduce the recurrence of episodes of overt brain dysfunction in the setting of existing liver disease (symptoms of this disease include agitation, confusion, muscle problems, difficulty speaking, etc some cases coma).

In clinical trials, only Xifaxan 550 mg was shown to be effective in combination with medicines containing lactulose (a laxative) in the majority of patients. Differences in the effectiveness of Xifaxan in patients not taking lactulose could not be determined.

What precautions should be taken?

During treatment with Xifaxan 550 mg, your urine may take on a reddish color. This is completely normal.

When should Xifaxan 550 mg not be taken?

Xifaxan 550 mg must not be taken

• if you are allergic to

−rifaximin,

−similar types of antibiotics (such as rifampicin or rifabutin),

-one of the excipients of this medicine (see “What is contained in Xifaxan 550 mg?”). An allergy or hypersensitivity is manifested, for example, in symptoms such as red spots on the skin, fever, asthma, shortness of breath, circulatory problems, swelling of the skin (e.g. hives) and mucous membranes, skin rashes or a swollen tongue.

•if you have an obstruction (blockage) in your intestines.

When should you be careful when taking Xifaxan 550 mg?

If you have cirrhosis (a type of liver disease), you may experience serious skin reactions in the form of painful rashes or blisters on the skin, mouth, eyes and genitals, which can be life-threatening.

If severe skin reactions or other allergic reactions occur, stop taking this medicine and seek urgent medical advice.

Treatment with antibiotics, including rifaximin, can cause severe diarrhea. This can occur even several months after the end of treatment. If you experience severe diarrhea during or after using Xifaxan 550 mg, you must stop taking Xifaxan 550 mg and contact your doctor immediately. If diarrhea occurs, no medications that inhibit intestinal peristalsis (intestinal movement) should be taken.

If your liver disease is severe, your doctor will need to monitor you carefully.

Stop taking Xifaxan 550 mg and contact your doctor IMMEDIATELY if you notice any of the following side effects:

• If an allergic reaction, an anaphylactic reaction or angioedema occurs. Symptoms can be:

-Swelling of the face, tongue or throat area,

-Difficulties swallowing

-Skin rash, hives, itching and difficulty breathing.

•Bleeding from dilated blood vessels along the esophagus (esophageal varices).

•Severe diarrhea during or after treatment with this medicine. The reason for this may be a bacterial infection of the intestines.

•Unexpected or unusual bleeding or bruising. This may be due to a decrease in the number of platelets in the blood, which increases the risk of bleeding. (See section “What side effects can Xifaxan 550 mg have?)

Children and young people

The use of Xifaxan 550 mg in children and adolescents under 18 years of age is not recommended. This medicine has not been tested in children and adolescents.

Taking Xifaxan 550 mg with other medicines

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

Please tell your doctor if you are using one or more of the following medicines:

- Antibiotics (medicines used to treat infections)

- warfarin (medicine used to prevent blood clots)

- Antiepileptic drugs (medicines used to treat epilepsy)

- Antiarrhythmics (medicines used to treat an abnormal heart rhythm)

- Ciclosporin (medicine to inhibit the immune system)

- Oral contraceptives (contraceptive medicines/pills)

Ability to drive and use machines

Xifaxan 550 mg may cause dizziness in some patients, thereby affecting the ability to react, drive and use tools or machines. If you feel dizzy, you should not drive or use machines.

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, meaning it is almost “sodium-free”.

Tell your doctor or pharmacist if you

- suffer from other illnesses,

-Have allergies or

- take other medicines (including those you bought yourself!)

Can Xifaxan 550 mg be taken during pregnancy or while breastfeeding?

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicines.

It is not known whether Xifaxan 550 mg could harm an unborn baby. Xifaxan 550 mg must therefore not be used if you are pregnant.

It is not known whether rifaximin can be absorbed by your child through breast milk. Therefore, Xifaxan 550 mg must not be used if you are breast-feeding.

How do you use Xifaxan 550 mg?

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Usual dosage:

Adult

The recommended dose is 1 film-coated tablet twice daily.

Children and young people (under 18 years of age)

The use of Xifaxan 550 mg in children and adolescents under 18 years of age is not recommended. This medicine has not been tested in children and adolescents.

Method of intake

The film-coated tablet should be taken with a glass of water.

Xifaxan 550 mg can be taken with meals or outside meals.

After 6 months, your doctor will check whether you need to continue treatment.

If you take more Xifaxan 550 mg than you should

If you have taken more than the recommended number of film-coated tablets, please contact your doctor, even if you do not notice any problems.

If you forget to take Xifaxan 550 mg

Take your next dose at the usual time. Do not take a double dose if you forget to take the previous dose.

If you stop taking Xifaxan 550 mg

Do not stop taking Xifaxan without talking to your doctor first, as your symptoms may return.

If you have any further questions about taking this medicine, contact your doctor or pharmacist.

Do not change the prescribed dosage on your own. If you think the medicine is too weak or too strong, talk to your doctor or pharmacist.

What side effects can Xifaxan 550 mg have?

Stop taking Xifaxan 550 mg and contact your doctor IMMEDIATELY if you notice any of the following side effects:

• Allergic reaction, anaphylactic reaction or angioedema. Symptoms can be:

− Swelling of the face, tongue or throat area,

−Difficulty swallowing

−Skin rash, hives, itching and difficulty breathing.

• Life-threatening reactions with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)*

• Life-threatening reactions with flu-like symptoms and blistering of the skin, mouth, eyes and genitals (toxic epidermal necrolysis)*

• Bleeding from dilated blood vessels along the esophagus (esophageal varices).

• Severe diarrhea during or after treatment with this medicine. The reason for this may be an intestinal infection.

• Unexpected or unusual bleeding or bruising. This may be due to a decrease in the number of platelets in the blood, which increases the risk of bleeding.

*These side effects have been observed in patients with cirrhosis.

Common (affects 1 to 10 users in 100):

• Epigastric pain and/or bloating

• Dizziness

• Depressed mood

• Headache

• Nausea or vomiting

• Diarrhea

• Accumulation of fluid in the abdominal cavity

• Difficulty breathing

• Muscle cramps

• Joint pain

• Swelling of the ankles, feet or fingers

• Rash or itching

Uncommon (affects 1 to 10 users in 1,000):

• Imbalance disorders

• Memory loss or memory impairment

• Attention deficit disorder

• Confusion

• Feeling of fear

• Sleepiness

• Sleep disorders

• Dry mouth

• Hot flashes

• Severe diarrhea during or after treatment. The reason for this may be a bacterial infection of the intestine (clostridial infections)

• Bleeding from dilated blood vessels along the esophagus (esophageal varices)

• Yeast infections (such as thrush)

• Urinary tract infection (such as urinary tract infection)

• Anemia (reduced red blood cell count, which can cause pale skin and weakness or shortness of breath)

• Loss of appetite

• high potassium levels in the blood

• Urinating more frequently than usual

• Difficulty or pain when urinating

• Seizures

• Fever

• Decreased sensitivity to touch

• Falls

• Fluid accumulation in the pleural cavity

• Stomach pain

• Stomach discomfort

• Fluid retention

• Muscle aches

Rare (affects 1 to 10 users in 10,000):

• Bruises

• Protein in urine

• Chest infections including pneumonia

• Inflammation of the subcutaneous tissue

• Infections of the upper respiratory tract (nose, mouth, throat)

• Sniffles

• Loss of water from the body

• Changed blood pressure

• Persistent breathing problems (such as chronic bronchitis)

• Feeling weak

• Pain during/after procedures

• Constipation

• Back pain

Post-marketing adverse reactions (frequency not known)

• allergic reaction, anaphylactic reaction, angioedema

• Life-threatening reactions with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)*

• Life-threatening reactions with flu-like symptoms and blistering of the skin, mouth, eyes and genitals (toxic epidermal necrolysis)*

• Fainting or the feeling of impending fainting

• Skin inflammation, eczema (itchy, red, dry skin)

• Changes in liver function (shown in blood test)

• Changed blood clotting (INR value in the blood test, decrease in the number of blood platelets)

*These side effects have been observed in patients with cirrhosis.

If you notice any side effects, contact your doctor or pharmacist. This applies in particular to side effects that are not stated in this leaflet.

What should also be noted?

The medicine may only be used until the date marked “EXP” on the container.

Storage instructions

Do not store above 25°C. Keep medicines out of the reach of children.

Your doctor or pharmacist can provide you with further information. These people have the detailed information for specialists.

What is contained in Xifaxan 550 mg?

Film-coated tablets

Active ingredients

Rifaximin. 1 film-coated tablet contains 550 mg rifaximin.

Excipients
Carboxymethyl starch sodium (type A), glycerol distearate, colloidal silicon dioxide, talc, microcrystalline cellulose, hypromellose, titanium dioxide, sodium edetate, propylene glycol, red iron oxide.

Approval number

63216 (Swissmedic)

Where can you get Xifaxan 550 mg? Which packs are available?

In pharmacies, only with a prescription.

Packs of 28 and 56 film-coated tablets.

Authorization holder

Alfasigma Schweiz AG, 4800 Zofingen.