Rifacol

Package leaflet: Information for the patient

Rifacol 200 mg film-coated tablets

rifaximin
Please read all of 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Rifacol is and what it is used for

Rifacol contains the active substance rifaximin. Rifaximin is a gastrointestinal antibiotic effective against a wide range of bacteria.
Rifacol is indicated in adults and adolescents (12-18 years of age) for:

• acute and chronic intestinal infections caused by bacteria known as gram-positive and gram-negative
• acute episodes of diarrhoea
• diarrhoea caused by an imbalance of intestinal bacteria, such as:
• 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 Rifacol

Do not take Rifacol

• 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 stools.

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

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

Take particular care when taking Rifacol:
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported during treatment with rifaximin.
Stop taking 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 Rifacol 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 (which cross the intestinal mucosa) that generally cause fever, blood in the stools, and severe diarrhoea with high frequency of bowel movements.

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

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

Before taking Rifacol, 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 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 Rifacol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Before taking Rifacol, 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 Rifacol at least 2 hours after activated charcoal.
Rifacol with food
You may take Rifacol with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
As a precautionary measure, Rifacol 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.
You must not drive or operate machinery if you experience dizziness or somnolence.

3. How to take Rifacol

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
You may take Rifacol with or without food.
Take the tablets with a glass of water.
Do not use Rifacol 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.

Treatment before and after surgical procedures
The recommended dose is 2 tablets every 12 hours, unless otherwise prescribed by your doctor.

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

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

If you forget to take Rifacol
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 Rifacol
Continue taking Rifacol as instructed by your doctor. You need to complete the course of Rifacol treatment to properly treat the intestinal infection. If you have any doubts 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 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, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Many of the side effects listed below, particularly those affecting the stomach and intestines, may be due to the intestinal infection itself rather than treatment with Rifacol.
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, drowsiness
• 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
• Changes in 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 urine volume
• Menstrual cycles occurring closer together
• Feeling of fatigue, chills, cold sweats, excessive sweating
• Various types of pain and discomfort
• 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 [reduced platelet count, abnormal liver function tests, abnormalities in blood coagulation tests (INR)]
• Hypersensitivity and allergic reactions, in some cases severe, up to shock
• Swelling of the face, lips, or 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 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 Rifacol

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 Rifacol 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 E 171, disodium edetate, propylene glycol, iron oxide red E172.
Description of the appearance of Rifacol and contents of the pack
Each pack contains a blister with 12 tablets.
Marketing Authorization Holder
GRÜNENTHAL ITALIA S.r.l.
Via Vittor Pisani 16 - 20124 Milano
Responsible manufacturer for batch release
FARMACEUTICI FORMENTI S.p.A. – Production site Origgio (VA) – Via di Vittorio 2.
ALFASIGMA S.p.A.– Via Enrico Fermi, n. 1 – Alanno (PE)

Patient Information Leaflet: Information for the patient

Rifacol 2 g/100 ml granules for oral suspension

rifaximin
Please read this leaflet carefully before taking this medicine, as 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 other people, even if their symptoms are the same as yours, as it could be dangerous.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Rifacol is and what it is used for

Rifacol contains the active substance rifaximin. Rifaximin is a gastrointestinal antibiotic effective against a wide range of bacteria.
Rifacol 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 due to intestinal bacterial imbalance, such as:
  • summer diarrhoea
  • traveller’s diarrhoea
  • enterocolitis (disorders affecting the small intestine and colon)
• prevention of infections before and after gastrointestinal surgery
• adjunctive treatment of hyperammonaemia (a condition characterized by abnormally high levels of ammonia in the blood).

2. What you need to know before taking Rifacol

Do not take Rifacol

• 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 Rifacol:
if you have developed a severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking rifaximin.
Pay special attention when taking Rifacol:
Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported during treatment with rifaximin.
Stop using rifaximin and contact your doctor immediately if you experience any of the symptoms related to these serious skin reactions described in section 4.
Stop treatment with Rifacol 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 if, during treatment or even after stopping Rifacol:

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

Before taking Rifacol, inform your doctor:

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

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 Rifacol
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Before taking Rifacol, 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 Rifacol at least 2 hours after activated charcoal.
Rifacol with food
You may take Rifacol with or without food.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
As a precautionary measure, Rifacol 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 or use machinery; however, dizziness and drowsiness have been reported.
Do not drive or operate machinery if you experience dizziness or drowsiness.
This medicine contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
The 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.
Patients with diabetes mellitus should consider that a single 10 ml dose of oral suspension contains 2.88 g of sucrose.
This medicine contains sodium benzoate
The medicine contains 6 mg of sodium benzoate per single 10 ml oral suspension dose.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How to take Rifacol

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You may take Rifacol with or without food.
Do not use Rifacol 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 10 ml of oral suspension (equivalent to 200 mg of active substance) every 6 hours, unless otherwise prescribed by your doctor.

Treatment before and after surgical procedures
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.

Supplementary 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 syringe is included in the package. 5 ml of suspension contains 100 mg of active substance.

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

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

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

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

If you stop taking Rifacol
Continue taking Rifacol as directed by your doctor. You need to complete the full course of Rifacol 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 everyone gets them.
Stop treatment with rifaximin and contact your doctor immediately if you experience any of the
following symptoms:

• Flat, reddish patches on the trunk, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Many of the side effects listed below, particularly those affecting the stomach and intestine, may be due to the intestinal infection itself rather than treatment with Rifacol.
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, drowsiness
• 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
• altered taste sensation
• 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 urine volume
• shortened menstrual cycles
• feeling of fatigue, chills, cold sweats, excessive sweating
• pains and discomforts of various kinds
• 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 [reduced platelet count, abnormal liver function tests, abnormalities in blood coagulation tests (INR)]
• hypersensitivity and allergic reactions, in some cases severe, up to shock
• swelling of the face, lips, pharynx
• itching, urticaria, erythema, eczema
• redness of the 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 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 Rifacol

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 Rifacol 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, cherry flavouring.
Description of the appearance of Rifacol and contents of the pack
Each pack contains one 60 ml bottle of granules for oral suspension and a dosing spoon.
Marketing Authorization Holder
GRÜNENTHAL ITALIA S.r.l. –
Via Vittor Pisani 16 - 20124 Milano
Responsible manufacturer for batch release
FARMACEUTICI FORMENTI S.p.A. – Production facility in Origgio (VA) – Via di Vittorio 2.
ALFASIGMA S.p.A. – Via Enrico Fermi, n. 1 – Alanno (PE)