Normix

Package leaflet: Information for the patient

Normix 200 mg film-coated tablets

rifaximin
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Normix is and what it is used for

Normix contains the active substance rifaximin. Rifaximin is an intestinal antibiotic effective
against a wide range of bacteria.
Normix is indicated in adults and adolescents (aged 12–18 years) for:

• intestinal infections in acute and chronic forms caused by gram-positive and gram-negative bacteria
• acute episodes of diarrhoea
• diarrhoea caused by an imbalance of intestinal bacteria, for example:
  • summer diarrhoea
  • traveller’s diarrhoea
  • enterocolitis (disorders affecting the small intestine and colon)
• prevention of infections before and after surgery of the gastrointestinal tract
• supplementary treatment of hyperammonaemia (a condition characterized by excessive levels of ammonia in the blood).

2. What you need to know before taking Normix

Do not take Normix

• if you are allergic to rifaximin, to other active substances belonging to the group of medicines known as rifamycins, or to any of the other ingredients of this medicine (listed in section 6)
• if you have intestinal obstruction, even partial
• if you have severe intestinal ulcers
• if you have diarrhoea accompanied by fever or blood in the stool.

Warnings and precautions
Talk to your doctor or pharmacist before taking Normix if you have developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking rifaximin.
Pay special attention when taking Normix:
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported during treatment with rifaximin. Most cases have been reported in patients with liver disease (such as cirrhosis or hepatitis).
Stop using rifaximin and contact your doctor immediately if you experience any of the symptoms related to these severe skin reactions described in section 4.
Stop treatment with Normix and contact your doctor:

• if your symptoms worsen or persist for more than 48 hours. This is because your condition could be due to invasive bacteria (which penetrate the intestinal mucosa) that generally cause fever, blood in the stool, and severe diarrhoea with high frequency of bowel movements.

Contact your doctor immediately during treatment or even after stopping
taking Normix:

• if you develop severe diarrhoea. This is because cases of diarrhoea due to overgrowth of the bacterium Clostridium difficile (pseudomembranous colitis) have been reported during antibiotic treatment, including with rifaximin.

Before taking Normix, inform your doctor:

• if you have severe liver function impairment
• if you have kidney function impairment.

Rifaximin may cause a reddish discoloration of the urine.
This medicine contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.
Children
The safety and efficacy of rifaximin in children under 12 years of age have not been established.
No dosage recommendation can be made for patients under 12 years of age.
Other medicines and Normix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Before taking Normix, inform your doctor if you are taking one or more of the following medicines:

• warfarin (anticoagulant)
• medicines for epilepsy (antiepileptics)
• medicines for heart rhythm disorders (antiarrhythmics)
• cyclosporine (a medicine used to prevent transplant rejection)
• oral contraceptives containing oestrogens.

If you need to take activated charcoal, take Normix at least 2 hours after activated charcoal.
Normix with food
You may take Normix with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
As a precautionary measure, Normix should not be used during pregnancy.
Breastfeeding
It is not known whether rifaximin passes into breast milk. If you are breastfeeding, consult your doctor.
Driving and using machines
Rifaximin has negligible influence on the ability to drive vehicles or operate machinery; however, dizziness and somnolence have been reported.
You should not drive vehicles or operate machinery if you experience dizziness or somnolence.

3. How to take Normix

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You may take Normix with or without food. Swallow the tablets with a glass of water.
Do not use Normix for more than 7 days unless otherwise prescribed by your doctor.

Use in adults and adolescents (12–18 years)
Treatment of intestinal infections and diarrhoea
The recommended dose is 1 tablet every 6 hours, unless otherwise prescribed by your doctor.

Pre- and post-operative treatment
The recommended dose is 2 tablets every 12 hours, unless otherwise prescribed by your doctor.

Supplementary treatment of hyperammonaemia
The recommended dose is 2 tablets every 8 hours, unless otherwise prescribed by your doctor.

If you take more Normix than you should
If you or someone else has taken an excessive dose of Normix, contact your doctor immediately.

If you forget to take Normix
If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Normix
Continue taking Normix as directed by your doctor. You need to complete the full course of Normix to properly treat the intestinal infection. If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop treatment with rifaximin and contact your doctor immediately if you notice any of the
following symptoms:

• Flat, reddish spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth ulcers, ulcers in the throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (frequency not known).

Many of the side effects listed below, particularly those affecting the stomach and intestine, may be due to the intestinal infection rather than to treatment with Normix.
Common side effects (may affect up to 1 in 10 people)

• Headache, dizziness
• Abdominal pain, abdominal distension, flatulence (gas), diarrhoea, constipation, urgency to defecate, false urge to defecate
• Nausea, vomiting
• Fever

Uncommon side effects (may affect up to 1 in 100 people)

• Candida infections
• Inflammation or infections of the nose and throat
• Upper respiratory tract infections
• Herpes simplex infections
• Changes in blood tests [increased lymphocytes, increased monocytes, decreased neutrophils, increased liver enzyme values (AST)]
• Decreased appetite
• Reduction in body fluids (dehydration)
• Abnormal dreams, insomnia, somnolence
• Depression, nervousness
• Frontal headache or headache on one side of the head
• Tingling sensation, decreased tactile sensitivity
• Double vision
• Ear pain, dizziness
• Palpitations, hot flushes, increased blood pressure
• Difficulty breathing, nasal congestion, dry throat, cough, nasal discharge, sore throat
• Stomach pain, indigestion, intestinal motility disorders
• Dry lips
• Hard stools, blood in stools, mucus in stools
• Taste disturbances
• Fluid accumulation in the abdomen (ascites)
• Skin irritations and rashes, sunburn
• Muscle cramps, muscle weakness, muscle pain
• Neck pain, back pain
• Changes in urine tests (blood in urine, sugar in urine, protein in urine)
• Increased frequency of urination, increased volume of urine
• Shortened menstrual cycles
• Feelings of fatigue, chills, cold sweats, excessive sweating
• Pains and discomforts of various nature
• Influenza-like symptoms
• Swelling of the legs or arms

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Clostridium difficile infections
• Feeling faint
• Changes in blood tests [reduced platelet count, abnormal liver function tests, abnormalities in blood coagulation test (INR)]
• Hypersensitivity and allergic reactions, in some cases severe, up to shock
• Swelling of the face, lips, larynx
• Itching, urticaria, erythema, eczema
• Reddened skin (dermatitis), skin peeling (exfoliative dermatitis)
• Presence of small purple spots on the skin (purpura)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Normix

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Normix contains

• The active substance is rifaximin. Each film-coated tablet contains 200 mg of rifaximin.
• The other components are sodium starch glycolate (type A), glycerol distearate, anhydrous colloidal silica, talc, microcrystalline cellulose, hypromellose, titanium dioxide E171, disodium edetate, propylene glycol, iron oxide red E172.

Description of the appearance of Normix and package contents
Each pack containing 12 tablets comprises one blister with 12 tablets.
Each pack containing 28 tablets comprises two blisters with 14 tablets each.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Alfasigma S.p.A. – Via Ragazzi del '99 n. 5 – 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. – Via E. Fermi, n. 1 - 65020 Alanno (PE)
Alfasigma S.p.A. – Via Pontina Km 30,400 - 00071 Pomezia (RM)

Patient information leaflet

Normix 2 g/100 ml granulate for oral suspension

rifaximin
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Normix is and what it is used for
2. What you need to know before taking Normix
3. How to take Normix
4. Possible side effects
5. How to store Normix
6. Package contents and other information

1. What Normix is and what it is used for

Normix contains the active substance rifaximin. Rifaximin is an intestinal antibiotic effective
against a wide range of bacteria.
Normix is indicated in adults and adolescents (aged 12–18 years) for:

• acute and chronic intestinal infections caused by gram-positive and gram-negative bacteria
• acute episodes of diarrhoea
• diarrhoea caused by an imbalance of intestinal bacteria, such as:
  o summer diarrhoea or traveller’s diarrhoea or enterocolitis (disorders affecting the small intestine and colon)
• prevention of infections before and after gastrointestinal surgery
• adjunctive treatment of hyperammonaemia (a condition characterised by excessive levels of ammonia in the blood).

2. What you need to know before taking Normix

Do not take Normix

• if you are allergic to rifaximin, to other active substances belonging to the class of medicines known as rifamycins, or to any of the other ingredients of this medicine (listed in section 6)
• if you have intestinal obstruction, even partial
• if you have severe intestinal ulcers
• if you have diarrhoea accompanied by fever or blood in the stool.

Warnings and precautions
Talk to your doctor or pharmacist before taking Normix if you have developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking rifaximin.
Pay special attention when taking Normix:
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported during treatment with rifaximin. Most cases have been reported in patients with liver disease (such as cirrhosis or hepatitis).
Stop using rifaximin and contact your doctor immediately if you experience any of the symptoms related to these severe skin reactions described in section 4.
Discontinue treatment with Normix and contact your doctor:

• if your symptoms worsen or persist for more than 48 hours. This is because your condition might be due to invasive bacteria (that cross the intestinal mucosa), which usually cause fever, blood in the stool, and severe diarrhoea with high frequency of bowel movements.

Contact your doctor immediately if, during treatment or even after stopping Normix:

• you develop severe diarrhoea. This is because cases of diarrhoea due to overgrowth of the bacterium Clostridium difficile (pseudomembranous colitis) have been reported during antibiotic treatment, including with rifaximin.

Before taking Normix, inform your doctor:

• if you have severe impairment of liver function
• if you have impaired kidney function.

Rifaximin may cause a reddish discoloration of urine.
Children
The safety and efficacy of rifaximin in children under 12 years of age have not been established.
No dosage recommendation can be made for patients under 12 years of age.
Other medicines and Normix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Before taking Normix, inform your doctor if you are taking one or more of the following medicines:

• warfarin (anticoagulant)
• medicines for epilepsy (antiepileptics)
• medicines for heart rhythm disorders (antiarrhythmics)
• ciclosporin (a medicine used to prevent transplant rejection)
• oral contraceptives containing oestrogens.
  If you need to take activated charcoal, take Normix at least 2 hours after activated charcoal.

Normix with food
You may take Normix with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
As a precautionary measure, Normix should not be used during pregnancy.
Breastfeeding
It is not known whether rifaximin passes into breast milk. If you are breastfeeding, consult your doctor.
Driving and using machines
Rifaximin has negligible influence on the ability to drive vehicles or use machines; however, dizziness and somnolence have been reported.
You should not drive vehicles or operate machinery if you experience dizziness or somnolence.
This medicine contains sucrose, sodium benzoate and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
This medicine contains 2.88 g of sucrose (sugar) per 10 ml of reconstituted suspension. This should be taken into account in patients with diabetes mellitus.
This medicine contains 6 mg of sodium benzoate per 10 ml dose of reconstituted suspension, equivalent to 60 mg/100 ml.
This medicine contains less than 1 mmol (23 mg) of sodium per 10 ml dose of reconstituted suspension, i.e. it is essentially "sodium-free".

3. How to take Normix

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
You may take Normix with or without food.
Do not use Normix for longer than 7 days unless otherwise prescribed by your doctor.

Use in adults and adolescents (12–18 years)
Treatment of intestinal infections and diarrhoea
The recommended dose is 10 ml of oral suspension (equivalent to 200 mg of active substance) every 6 hours,
unless otherwise prescribed by your doctor.

Preoperative and postoperative treatment
The recommended dose is 20 ml of oral suspension (equivalent to 400 mg of active substance) every 12 hours,
unless otherwise prescribed by your doctor.

Adjunctive therapy of hyperammonaemia
The recommended dose is 20 ml of oral suspension (equivalent to 400 mg of active substance) every 8 hours,
unless otherwise prescribed by your doctor.

How to prepare the suspension
A dosing spoon is included in the package. 5 ml of suspension contains 100 mg of active substance.

5 ml = 100 mg

• Add water to the granules up to the arrow mark on the label of the bottle
• Shake the bottle well
• Add more water to bring the suspension level up to the arrow mark

Shake the bottle vigorously before each administration.
The prepared suspension can be stored for 7 days at room temperature.

If you take more Normix than you should
If you have taken an excessive dose of Normix, inform your doctor immediately.

If you forget to take Normix
If you forget to take a dose, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

If you stop treatment with Normix
Continue taking Normix as directed by your doctor. You need to complete the full course of Normix treatment to properly treat the intestinal infection. If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment with rifaximin and contact your doctor immediately if you notice any of the
following symptoms:

• flat, reddish spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth ulcers, ulcers in the throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (frequency not known).

Many of the side effects listed below, particularly those affecting the stomach and intestine, may be due to the intestinal infection rather than to treatment with Normix.
Common side effects (may affect up to 1 in 10 people)

• Headache, dizziness
• Abdominal pain, abdominal distension, flatulence (gas), diarrhoea, constipation, urgency to defecate, false urge to defecate
• nausea, vomiting
• fever

Uncommon side effects (may affect up to 1 in 100 people)

• Candida infections
• Inflammation or infections of the nose and throat
• Upper respiratory tract infections
• Herpes simplex infections
• Blood test abnormalities [increased lymphocytes, increased monocytes, decreased neutrophils, increased liver enzyme values (AST)]
• Decreased appetite
• Reduction in body fluids (dehydration)
• Abnormal dreams, insomnia, somnolence
• Depression, nervousness
• Headache localized in the forehead or on one side of the head
• Tingling sensation, decreased tactile sensitivity
• Double vision
• Ear pain, dizziness
• Palpitations, hot flushes, increased blood pressure
• Difficulty breathing, nasal congestion, dry throat, cough, nasal discharge, sore throat
• Stomach pain, indigestion, intestinal motility disorders
• Dry lips
• Hard stools, blood in stools, mucus in stools
• Alterations in taste sensation
• Fluid accumulation in the abdomen (ascites)
• Skin irritations and rashes, sunburns
• Muscle cramps, muscle weakness, muscle pain
• Neck pain, back pain
• Urine test abnormalities (blood in urine, sugar in urine, protein in urine)
• Increased frequency of urination, increased urine volume
• Menstrual cycles occurring closer together
• Feelings of fatigue, chills, cold sweats, excessive sweating
• Pains and discomforts of various nature
• Influenza-like symptoms
• Swelling of the legs or arms

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Clostridium difficile infections
• Feeling of fainting
• Blood test abnormalities [decreased platelet count, abnormal liver function tests, abnormalities in blood coagulation test (INR)]
• Hypersensitivity and allergic reactions, in some cases severe, up to shock
• Swelling of the face, lips, larynx
• Itching, urticaria, erythema, eczema
• Reddened skin (dermatitis), skin peeling (exfoliative dermatitis)
• Presence of small purplish spots on the skin (purpura)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you
can help provide more information on the safety of this medicine.

5. How to store Normix

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
The suspension prepared by adding water to the oral suspension granulate may be stored for 7 days at room temperature.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Normix contains

• The active substance is rifaximin. 100 ml of suspension contain 2 g of rifaximin.
• The other components are microcrystalline cellulose, sodium croscarmellose, pectin, kaolin, sodium saccharin, sodium benzoate, sucrose, black cherry flavour.

Description of the appearance of Normix and contents of the pack
Each pack contains one 60 ml bottle of granules for oral suspension and a dosing spoon.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. - Via E. Fermi, n. 1 - 65020 Alanno (PE)

Patient information leaflet

Normix 400 mg film-coated tablets

rifaximin
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT NORMIX IS AND WHAT IT IS USED FOR

Normix contains the active substance rifaximin. Rifaximin is an intestinal antibiotic effective against a wide range of bacteria.
Normix 400 mg is indicated in adults and adolescents (aged 12–18 years) for:

• preventing infections before and after gastrointestinal tract surgery
• adjunctive therapy of hyperammonemia (a condition characterized by excessive levels of ammonia in the blood).

2. WHAT YOU NEED TO KNOW BEFORE TAKING NORMIX

Do not take Normix

• if you are allergic to rifaximin, to other active substances belonging to the class of medicines known as rifamycins, or to any of the other ingredients of this medicine (listed in section 6)
• if you have intestinal obstruction, even partial
• if you have severe intestinal ulcers

Warnings and precautions
Talk to your doctor or pharmacist before taking Normix:

• if you have developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking rifaximin.

Pay special attention when taking Normix:
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported during treatment with rifaximin. Most cases have been reported in patients with liver diseases (such as cirrhosis or hepatitis).
Discontinue use of rifaximin and contact your doctor immediately if you experience any of the symptoms related to these severe skin reactions described in section 4.
Contact your doctor immediately if, during treatment or even after stopping Normix:

• you develop severe diarrhea. This is because cases of diarrhea due to overgrowth of the bacterium Clostridium difficile (pseudomembranous colitis) have been reported during treatment with antibiotics including rifaximin.

Before taking Normix, inform your doctor:

• if you have severe impairment of liver function
• if you have impaired kidney function.

Rifaximin may cause a reddish discoloration of the urine.
This medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.
Children
The safety and efficacy of rifaximin in children under 12 years of age have not been established. No dosage recommendation can be made for patients under 12 years of age.
Other medicines and Normix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Before taking Normix, inform your doctor if you are taking one or more of the following medicines:

• warfarin (anticoagulant)
• medicines for epilepsy (antiepileptics)
• medicines for heart rhythm disorders (antiarrhythmics)
• cyclosporine (a medicine used to prevent transplant rejection)
• oral contraceptives containing estrogens.

If you need to take activated charcoal, take Normix at least 2 hours after activated charcoal.
Normix with food
You may take Normix with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
As a precautionary measure, Normix should not be used during pregnancy.
Breastfeeding
It is not known whether rifaximin passes into breast milk. If you are breastfeeding, consult your doctor.
Driving and using machines
Rifaximin has a negligible effect on the ability to drive vehicles or operate machinery; however, dizziness and somnolence have been reported.
Do not drive or operate machinery if you experience dizziness or somnolence.

3. HOW TO TAKE NORMIX

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
You may take Normix with or without food. Swallow the tablets with a glass of water.
Do not use Normix for more than 7 days unless otherwise prescribed by your doctor.

Use in adults and adolescents (12–18 years)
Pre- and post-surgical treatment
The recommended dose is 1 tablet every 12 hours, unless otherwise prescribed by your doctor.

Supplementary therapy for hyperammonaemia
The recommended dose is 1 tablet every 8 hours, unless otherwise prescribed by your doctor.

If you take more Normix than you should
If you or someone else has taken an excessive dose of Normix, contact a doctor immediately.

If you forget to take Normix
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Normix
Continue taking Normix as instructed by your doctor. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Stop treatment with rifaximin and contact your doctor immediately if you notice any of the following
symptoms:

• flat, reddish spots on the trunk, target-shaped or circular in appearance, often with central blisters, skin peeling, mouth ulcers, ulcers in the throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (frequency not known).

Many of the adverse reactions listed below, particularly those affecting the stomach and intestine, may be due to the intestinal infection rather than to treatment with Normix.
Common adverse reactions (may affect up to 1 in 10 people)

• headache, dizziness
• abdominal pain, bloating, flatulence (gas), diarrhoea, constipation, urgency to defecate, false urge to defecate
• nausea, vomiting
• fever

Uncommon adverse reactions (may affect up to 1 in 100 people)

• candida infections
• inflammation or infections of the nose and throat
• upper respiratory tract infections
• herpes simplex infections
• changes in blood tests [increased lymphocytes, increased monocytes, decreased neutrophils, increased liver enzyme values (AST)]
• decreased appetite
• reduction in body fluids (dehydration)
• abnormal dreams, insomnia, drowsiness
• depression, nervousness
• frontal headache or headache on one side of the head
• tingling sensation, reduced tactile sensitivity
• double vision
• ear pain, vertigo
• palpitations, hot flushes, increased blood pressure
• difficulty breathing, nasal congestion, dry throat, cough, nasal discharge, sore throat
• stomach pain, indigestion, intestinal motility disorders
• dry lips
• hard stools, blood in stools, mucus in stools
• altered taste sensation
• fluid accumulation in the abdomen (ascites)
• skin irritations and eruptions, sunburn
• muscle cramps, muscle weakness, muscle pain
• neck pain, back pain
• changes in urine tests (blood in urine, sugar in urine, protein in urine)
• increased frequency of urination, increased volume of urine
• shortened menstrual cycles
• sensations of fatigue, chills, cold sweats, excessive sweating
• various types of pain and discomfort
• influenza-like symptoms
• swelling of the legs or arms.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data)

• Clostridium difficile infections
• feeling of fainting
• changes in blood tests [reduced platelet count, altered liver function tests, altered blood coagulation test (INR)]
• hypersensitivity and allergic reactions, sometimes severe, up to shock
• swelling of the face, lips, or larynx
• itching, urticaria, erythema, eczema
• redness of the skin (dermatitis), skin peeling (exfoliative dermatitis)
• presence of small purple spots on the skin (purpura).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE NORMIX

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Normix contains

• The active substance is rifaximin. Each film-coated tablet contains 400 mg of rifaximin.
• The other ingredients are sodium starch glycolate (type A), glycerol distearate, anhydrous colloidal silica, talc, microcrystalline cellulose, hypromellose, titanium dioxide E171, disodium edetate, propylene glycol, iron oxide red E172.

Description of the appearance of Normix and pack contents
Each pack contains a blister of 12 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Alfasigma S.p.A. – Via Ragazzi del '99 n. 5 – 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. – Via E. Fermi, n. 1 – 65020 Alanno (PE)