Package leaflet: Information for the user

Rifadin 150 mg hard capsules, 300 mg hard capsules, 450 mg coated tablets, 20 mg/ml syrup

rifampicin
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 they have the same symptoms as you, because 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:

What Rifadin is and what it is used for
What you need to know before taking Rifadin
How to take Rifadin
Possible side effects
How to store Rifadin
Contents of the pack and other information

1. What Rifadin is and what it is used for

Rifadin contains rifampicin, an antibiotic capable of suppressing various types of bacteria harmful to the body, particularly those causing tuberculosis, an infectious disease that usually affects the lungs.
Rifadin may be used in combination with other antibiotics or specific medicinal agents such as chemotherapeutics.

2. What you should know before taking Rifadin

Do not use Rifadin

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have a disease causing yellowing of the skin or eyes (jaundice);
if you are taking a medicine containing saquinavir and ritonavir used to treat HIV infection, the virus that causes AIDS (see section “Other medicines and Rifadin”);
if you are taking a medicine for schizophrenia and bipolar disorder called lurasidone (see section “Other medicines and Rifadin”).

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

you have liver problems;
you suffer from porphyria (a rare inherited disorder of blood metabolism);
you are malnourished, elderly, or if the person taking the medicine is a young child, particularly if also taking another antibiotic called isoniazid;
you have bleeding problems or a tendency to bruise easily (as this medicine may cause blood clotting disorders);
you are taking other antibiotics (as some of them may increase the risk of blood clotting disorders);
you have a history of lung inflammation (interstitial lung disease/pneumonitis).

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist before taking Rifadin.
It is important that before starting treatment with this medicine, the cause of your infection and the possible presence of tuberculosis are confirmed, to avoid ineffective therapy leading to worsening of the condition.
If you experience itching, fatigue, weakness, malaise, loss of appetite, nausea, vomiting, abdominal pain, yellowing of the eyes or skin, or dark urine, contact your doctor immediately. These symptoms may be related to liver inflammation or serious liver problems (hepatitis or cholestasis).
This medicine may cause a drug reaction (DRESS syndrome) characterized by rash, fever, internal organ inflammation, blood abnormalities, and systemic illness.
If you develop any of these symptoms, stop taking the medicine and contact your doctor as soon as possible; your doctor will assess whether treatment should be discontinued.
This medicine may cause severe skin reactions. If you notice any skin changes (e.g., mouth, throat, nose, or genital ulcers, widespread blisters and peeling), red and swollen eyes (Stevens-Johnson Syndrome – SJS), or severe and extensive skin damage with separation of the epidermis and superficial mucous membranes (toxic epidermal necrolysis – TEN), or a red, scaly rash with pustules and blisters (acute generalized exanthematous pustulosis – AGEP), stop taking the medicine and contact your doctor immediately.
If you develop new or sudden worsening of shortness of breath, possibly accompanied by dry cough or fever unresponsive to antibiotic treatment, inform your doctor immediately. These may be symptoms of lung inflammation (interstitial lung disease/pneumonitis) and may lead to serious breathing problems due to fluid accumulation in the lungs, interfering with normal respiration and potentially leading to life-threatening conditions.
If, while taking this medicine, your tuberculosis symptoms return or worsen, inform your doctor immediately (see section 4. Possible side effects).
This medicine, when taken together with other medicines, may reduce their effectiveness. If you are taking Rifadin, always inform your doctor before starting any other medicine (also see section “Other medicines and Rifadin”).
This medicine may cause a change in color (yellow, orange, red, brown) of teeth, urine, sweat, sputum, and tears, and may permanently stain soft contact lenses.

Laboratory tests
Before taking this medicine, your doctor will prescribe certain blood tests. During treatment, your doctor will examine you approximately once a month.

Other medicines and Rifadin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The use of Rifadin should be avoided at the same time as saquinavir/ritonavir (used to treat HIV infection), halothane (an anesthetic), and daclatasvir, simeprevir, sofosbuvir, telaprevir (used to treat hepatitis C, a liver infection caused by a virus).
The use of Rifadin should be avoided at the same time as lurasidone, a medicine for schizophrenia and bipolar disorder, as rifampicin may reduce blood levels of lurasidone.
The use of Rifadin with other antibiotics that affect blood clotting mechanisms (such as cefazolin) may lead to severe, even fatal, blood clotting disorders, and should therefore be avoided. If this combination cannot be avoided, your doctor will perform clinical monitoring, including monitoring of hemostasis.

In particular, inform your doctor if you are taking any of the following medicines, as dose adjustments may be necessary:

medicines for seizures or epilepsy (e.g., phenytoin);
medicines for heart rhythm disorders (e.g., disopyramide, mexiletine, quinidine, propafenone, tocainide);
medicines for treating certain cancers (e.g., tamoxifen, toremifene, irinotecan);
medicines for depression and other nervous system disorders (e.g., nortriptyline, haloperidol);
medicines used to thin the blood (e.g., warfarin, clopidogrel);
antifungal medicines (e.g., caspofungin, fluconazole, itraconazole, ketoconazole);
medicines for treating HIV infection (e.g., zidovudine, saquinavir, indinavir, efavirenz);
medicines used for anxiety and sleep disorders (e.g., zopiclone, zolpidem, benzodiazepines in general such as diazepam, barbiturates);
medicines for high blood pressure or other heart conditions (e.g., enalapril, losartan, diltiazem, nifedipine, verapamil, cardiac glycosides, and beta-blockers);
antibiotics (e.g., fluoroquinolones such as telithromycin, quinine, dapsone, doxycycline, chloramphenicol, clarithromycin);
anti-inflammatory medicines, such as cortisone;
cholesterol-lowering medicines (e.g., clofibrate, statins);
hormone-containing medicines (e.g., gestrinone, oral contraceptives such as the pill, estrogens and progestins);
medicines to reduce the body's immune response (e.g., tacrolimus, cyclosporine);
medicines for diabetes (e.g., sulfonylureas, thiazolidinediones such as rosiglitazone);
a thyroid medicine (levothyroxine);
narcotic pain relievers (e.g., oxycodone, morphine) or medicines used to treat drug addiction (e.g., methadone);
medicines for parasitic infections (e.g., praziquantel, atovaquone);
a medicine used in amyotrophic lateral sclerosis (riluzole);
medicines for nausea and vomiting, such as ondansetron;
a medicine for respiratory diseases (theophylline).

Pay special attention if you are taking:

antacids: Rifadin should be taken at least 1 hour before taking an antacid;
oral contraceptives: to avoid unintended pregnancy, you should switch to a different type of contraception, using a reliable barrier method such as condoms or an intrauterine device (IUD), as Rifadin reduces the effectiveness of oral contraceptives;
isoniazid: when used together with rifampicin, it may increase the risk of liver problems; therefore, your doctor may prescribe periodic blood tests;
para-aminosalicylic acid: Rifadin should be taken at least 8 hours apart from para-aminosalicylic acid (an antibiotic);
dapsone (an antibiotic): when used with rifampicin, it may cause hematological toxicity, including bone marrow suppression and reduced red blood cells, and methemoglobinemia (reduced oxygen in the blood due to red blood cell changes);
paracetamol: when used with rifampicin, it may increase the risk of liver damage.

Inform your doctor or pharmacist if you are pregnant and planning or need to undergo termination of pregnancy using mifepristone.

Diagnostic tests
Rifadin may alter certain diagnostic and laboratory tests. Inform your doctor if you are scheduled for medical or laboratory tests, particularly if you are undergoing:

a test to measure vitamin B12 or folate levels in the blood;
a gallbladder examination;
a urine test to detect opioids.
It is possible that, especially during the first days of treatment, there may be an increase in certain liver-related laboratory values, such as bilirubin and transaminases; your doctor will carry out appropriate monitoring.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, use this medicine only if your doctor considers it necessary and under medical supervision.

Driving and using machines
Rifadin may cause certain side effects (e.g., dizziness, low blood pressure, headache) that may reduce your ability to concentrate and perform tasks requiring attention. If this occurs, avoid driving or operating machinery.

Rifadin coated tablets contain:

sucrose and lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine;
sodium: this medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.

Rifadin syrup contains:

sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. This medicine contains 12 g of sucrose per dose (600 mg). This should be considered in patients with diabetes mellitus. It may also be harmful to teeth.
methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate: may cause allergic reactions (including delayed reactions).
sodium metabisulfite: rarely may cause severe hypersensitivity reactions and bronchospasm.
sodium: this medicine contains less than 1 mmol (23 mg) of sodium per ml of syrup, i.e., essentially ‘sodium-free’;
ethanol (contained in raspberry flavoring): this medicine contains 28.5 mg of alcohol (ethanol) in each 600 mg dose of rifampicin. The amount in each 600 mg dose is equivalent to less than 1 ml of beer or 0.5 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

Rifadin hard capsules contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially ‘sodium-free’.

3. How to take Rifadin

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Adults
Treatment of tuberculosis
The recommended dose, taken as a single administration, is:

patients weighing more than 50 kg: 600 mg daily;
patients weighing less than 50 kg: 450 mg daily.

Treatment of infections other than tuberculosis
The recommended dose may be increased up to 900–1200 mg, divided into two daily doses.
Use in children
The recommended dose is 10 mg–20 mg per kg of body weight daily, divided into two equal daily doses.
The daily dose must not exceed 600 mg.
Method of administration
Rifadin should be taken on an empty stomach, well apart from meals, at least 30 minutes before or 2 hours after eating.
Rifadin 20 mg/ml syrup: shake the bottle well and gently before use, avoiding the formation of foam. Pour the syrup into the dosing cup up to the mark corresponding to the prescribed dose (see figure). Rinse the dosing cup thoroughly with water after each use.

Technical drawing of a graduated dosing cup with markings for 2.5 ml, 5 ml, and 7.5 ml corresponding to 50 mg, 100 mg, and 150 mg

During the first three months of therapy, your doctor may prescribe Rifadin together with two other anti-tuberculosis drugs, one of which is isoniazid, followed by continued treatment with rifampicin for the entire duration of therapy. Treatment usually lasts 9 months.
If you take more Rifadin than you should
If you take more Rifadin than prescribed, inform your doctor immediately or go to the nearest hospital. Take the medicine package with you so that the doctor knows what you have taken.
Symptoms of overdose may include: nausea, vomiting, stomach pain, itching, headache, drowsiness, loss of consciousness (in cases of severe liver disease), increased bilirubin and liver blood tests (liver enzymes), usually transient. Other symptoms include: brownish-red or orange discoloration of the skin, urine, sweat, saliva, tears, and feces, with intensity proportional to the dose taken. In children, swelling of the face, eyes, or eyelids may occur. Less commonly, you may experience: decreased blood pressure, rapid and/or irregular heartbeat, seizures, and cardiac arrest.
If you forget to take Rifadin
Do not take a double dose to make up for the missed dose.
If you stop taking Rifadin
Do not stop treatment without consulting your doctor, as sudden discontinuation may trigger allergic (anaphylactic) reactions; see section 4.
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 will experience them.
If you experience any of the following symptoms, stop taking the medicine and contact your doctor
immediately:

skin disorders, difficulty swallowing or breathing, shortness of breath, swelling of the lips, face, throat or tongue. These may be symptoms of anaphylactic shock (a severe allergic reaction);
any skin changes (e.g. mouth, throat, nose, or genital ulcers, widespread blisters and peeling), conjunctivitis (red and swollen eyes). These may be symptoms of a serious skin reaction called “Stevens-Johnson Syndrome” – SJS;
severe and widespread skin damage (separation of the epidermis and superficial mucous membranes) (toxic epidermal necrolysis – TEN);
red, scaly rash with pustule and blister formation (acute generalized exanthematous pustulosis – AGEP);
a drug reaction causing erythema, fever, internal organ inflammation, hematological abnormalities, and systemic illness (DRESS syndrome);
inflammation of the small blood vessels in the skin causing a red-purple skin rash called “purpura”. The medicine may cause a reduction in the number of certain blood cells called platelets (thrombocytopenia, may affect up to 1 in 10 people), which may lead to this abnormal blood accumulation under the skin. This condition usually resolves upon discontinuation of treatment, but may worsen and lead to brain hemorrhage and death if treatment is not stopped or is resumed after the onset of this “purpura”.

The following side effects have also been reported with the use of this medicine:
Very common side effects (may affect more than 1 in 10 people)

fever, chills.

Common side effects (may affect up to 1 in 10 people)

headache, dizziness;
nausea, vomiting;
increased bilirubin in the blood (hyperbilirubinemia);
abnormal liver function tests (increased aspartate aminotransferase; increased alanine aminotransferase);
paradoxical reaction to the drug: during treatment, after initial improvement, symptoms of tuberculosis may reappear or new symptoms may develop. Paradoxical reactions have been reported as early as 2 weeks and up to 18 months after starting antituberculosis treatment. Paradoxical reactions are typically associated with fever, enlarged lymph nodes (lymphadenitis), shortness of breath, and cough. Patients experiencing a paradoxical drug reaction may also have headache, loss of appetite, and weight loss.

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

changes in blood cells (leukopenia);
diarrhea.

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

painful inflammatory condition of the colon (last part of the intestine), characterized by cramps, persistent diarrhea, weakness, and fever (pseudomembranous colitis);
changes in blood cells (agranulocytosis, eosinophilia, leukopenia, anemia);
blood clotting disorders (vitamin K-dependent);
bleeding;
inflammation of the liver (hepatitis);
alteration of bile flow (cholestasis);
decreased appetite (anorexia);
stomach and intestinal disturbances, abdominal discomfort;
redness and other skin disorders, with itching, urticaria;
muscle weakness, muscle diseases (myopathies);
bleeding after childbirth (in mother and fetus);
menstrual cycle disturbances;
fluid retention leading to swelling (edema);
changes in the color of tears, sputum, sweat, or urine;
tooth discoloration (which may be permanent);
porphyria attacks in patients who already suffer from this condition (a rare inherited blood metabolism disorder);
abnormal liver function tests (increased liver enzymes, increased alkaline phosphatase);
increased blood creatinine levels (creatinine indicates kidney function);
influenza-like symptoms with bone pain and general malaise;
breathing difficulties (dyspnea) and noisy breathing (wheezing);
low blood pressure;
low blood pressure leading to impaired consciousness and other mental functions (shock);
hot flushes;
acute kidney injury due to onset of kidney diseases (e.g. renal tubular necrosis or tubulo-interstitial nephritis);
a rare disease affecting the skin and mucous membranes characterized by blister formation on the skin (pemphigus);
a serious condition characterized by widespread blood clot formation (disseminated intravascular coagulation);
mental disorders;
altered adrenal function in patients who already have adrenal problems;
inflammation of blood vessels causing skin disorders, weakness, fever, joint and muscle pain (vasculitis);
lung inflammation (interstitial lung disease/pneumonitis): contact your doctor immediately if you develop new or sudden worsening of breathlessness, possibly with cough or fever.

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 website
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 Rifadin

Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 Rifadin Contains
Rifadin 150 mg hard capsules and Rifadin 300 mg hard capsules

The active substance is rifampicin. Each hard capsule contains 150 mg or 300 mg of rifampicin.
Other components: maize starch, magnesium stearate, gelatin, erythrosine (E 127), indigo carmine (E 132), titanium dioxide (E 171).

Rifadin 450 mg film-coated tablets

The active substance is rifampicin. Each film-coated tablet contains 450 mg of rifampicin.
Other components: sodium lauryl sulfate, microcrystalline cellulose, lactose, calcium stearate, sodium carmellose, maize starch, gum arabic, povidone, sucrose, talc, light magnesium carbonate, titanium dioxide, heavy kaolin, anhydrous colloidal silica, aluminium lake of erythrosine (E127), magnesium stearate, gelatin.

Rifadin 20 mg/ml syrup

The active substance is rifampicin. Each ml of syrup contains 20 mg of rifampicin.
Other components: agar-agar; sucrose; potassium sorbate; saccharin; methyl parahydroxybenzoate; propyl parahydroxybenzoate; sodium metabisulfite; polysorbate 80; raspberry flavour (containing ethanol); diethanolamine, purified water.

Description of the Appearance of Rifadin and Contents of the Pack
Rifadin hard capsules are supplied in a box containing 8 capsules.
Rifadin film-coated tablets are supplied in a box containing 8 tablets.
Rifadin syrup is supplied in a 60 ml bottle with a graduated dosing cup.

Marketing Authorization Holder and Manufacturer
Sanofi S.r.l. – Viale L. Bodio, 37/B – 20158 Milan
Manufacturer
Sanofi S.r.l. - Via Valcanello, 4 – 03012 Anagni (FR) - Italy

Package leaflet: information for the user

Rifadin 600 mg/10 ml powder and solvent for solution for infusion

rifampicin
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, pharmacist or nurse.
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 side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Rifadin is and what it is used for
What you need to know before using Rifadin
How to take Rifadin
Possible side effects
How to store Rifadin
Contents of the pack and other information

1. What Rifadin is and what it is used for

Rifadin contains rifampicin, an antibiotic capable of suppressing various types of harmful bacteria, particularly those causing tuberculosis, an infectious disease that usually affects the lungs.
Rifadin may be used in combination with other antibiotics or specific medications.
Rifadin 600 mg/10 ml powder and solvent for solution for infusion is particularly recommended in cases where the patient's condition does not allow oral administration of the medicine (for example, during surgical procedures, or in case of impaired gastrointestinal absorption or gastric tolerance problems).

2. What you should know before using Rifadin

Do not use Rifadin

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have a disease causing yellowing of the skin or eyes (jaundice);
if you are taking a medicine containing saquinavir and ritonavir used to treat HIV infection, the virus that causes AIDS (see section “Other medicines and Rifadin”);
if you are taking a medicine for schizophrenia and bipolar disorder called lurasidone (see section “Other medicines and Rifadin”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Rifadin if:

you have liver problems;
you suffer from porphyria (a rare inherited blood metabolism disorder);
you are malnourished, elderly, or if the person taking the medicine is a young child, especially if also taking another antibiotic called isoniazid;
you have bleeding problems or a tendency to bruise easily (as this medicine may cause blood clotting disorders);
you are taking other antibiotics (as some of them may increase the risk of blood clotting disorders);
you have a history of lung inflammation (interstitial lung disease/pneumonitis).

If you are unsure whether any of these conditions apply to you, consult your doctor, pharmacist, or nurse before taking Rifadin.
It is important that, before starting treatment with this medicine, the cause of your infection and the possible presence of tuberculosis are confirmed, to avoid ineffective therapy leading to worsening of the condition.
If you experience itching, fatigue, weakness, malaise, loss of appetite, nausea, vomiting, abdominal pain, yellowing of the eyes or skin, or dark urine, contact your doctor immediately. These symptoms may be related to liver inflammation or serious liver problems (hepatitis or cholestasis).
This medicine may cause a drug reaction (DRESS syndrome) characterized by rash, fever, internal organ inflammation, hematological abnormalities, and systemic illness.
If you develop any of these symptoms, stop taking the medicine and contact your doctor as soon as possible; your doctor will assess whether treatment should be discontinued.
This medicine may cause severe skin reactions. If you notice any skin changes (e.g., mouth, throat, nose, or genital ulcers, widespread blisters and peeling), red and swollen eyes (Stevens-Johnson Syndrome – SJS), or severe and extensive skin damage with separation of the epidermis and superficial mucous membranes (toxic epidermal necrolysis – TEN), or a red, scaly rash with pustules and blisters (acute generalized exanthematous pustulosis – AGEP), stop taking the medicine and contact your doctor immediately.
This medicine, when taken with other medicines, may reduce their effectiveness. If you are taking Rifadin, always inform your doctor before starting any other medicine (also see section “Other medicines and Rifadin”).
This medicine may cause discoloration (yellow, orange, red, brown) of teeth, urine, sweat, sputum, and tears, and may permanently stain soft contact lenses.
If you develop new or sudden worsening of shortness of breath, possibly accompanied by dry cough or fever unresponsive to antibiotic treatment, inform your doctor immediately. These may be symptoms of lung inflammation (interstitial lung disease/pneumonitis), which can lead to serious respiratory problems due to fluid accumulation in the lungs, interfering with normal breathing and potentially leading to life-threatening conditions.
If, while taking this medicine, symptoms of tuberculosis return or worsen, inform your doctor immediately (see section 4. Possible side effects).

Laboratory tests
Before taking this medicine, your doctor will prescribe certain blood tests. During treatment, your doctor will examine you monthly.

Other medicines and Rifadin
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.

The use of Rifadin must be avoided during concomitant administration of saquinavir/ritonavir (used to treat HIV infection), halothane (an anesthetic), and daclatasvir, simeprevir, sofosbuvir, telaprevir (used to treat hepatitis C, a viral liver infection).
The use of Rifadin must be avoided during concomitant administration of lurasidone, a medicine for schizophrenia and bipolar disorder, as rifampicin may reduce blood levels of lurasidone.
The use of Rifadin with other antibiotics that affect blood clotting mechanisms (such as cefazolin) may lead to severe, even fatal, blood clotting disorders and must therefore be avoided. If this combination cannot be avoided, your doctor will perform clinical monitoring, including hemostasis monitoring.

In particular, inform your doctor if you are taking any of the following medicines, as dose adjustments may be necessary:

anticonvulsants or medicines for epilepsy (e.g., phenytoin);
medicines for heart rhythm disorders (e.g., disopyramide, mexiletine, quinidine, propafenone, tocainide);
medicines for certain cancers (e.g., tamoxifen, toremifene, irinotecan);
medicines for depression and other nervous system disorders (e.g., nortriptyline, haloperidol);
medicines used to thin the blood (e.g., warfarin, clopidogrel);
antifungal medicines (e.g., caspofungin, fluconazole, itraconazole, ketoconazole);
medicines for HIV infection (e.g., zidovudine, saquinavir, indinavir, efavirenz);
medicines used to treat anxiety and sleep disorders (e.g., zopiclone, zolpidem, benzodiazepines in general, such as diazepam, or barbiturates);
medicines for high blood pressure or other heart conditions (e.g., enalapril, losartan, diltiazem, nifedipine, verapamil, cardiac glycosides, and beta-blockers);
antibiotics (e.g., fluoroquinolones such as telithromycin, quinine, dapsone, doxycycline, chloramphenicol, clarithromycin);
anti-inflammatory medicines, such as cortisone;
cholesterol-lowering medicines (e.g., clofibrate, statins);
hormone-containing medicines (e.g., gestrinone, oral contraceptives such as the pill, estrogens, progestins);
medicines to reduce the body's immune response (e.g., tacrolimus, cyclosporine);
diabetes medicines (e.g., sulfonylureas, thiazolidinediones such as rosiglitazone);
a thyroid medicine (levothyroxine);
opioids used to treat pain (e.g., oxycodone, morphine) or to treat drug addiction (e.g., methadone);
medicines for parasitic infections (e.g., praziquantel, atovaquone);
a medicine used in amyotrophic lateral sclerosis (riluzole);
medicines for nausea and vomiting, such as ondansetron;
a medicine for respiratory diseases (theophylline).

Pay special attention if you are taking:

antacids: Rifadin should be taken at least 1 hour before antacid administration;
oral contraceptives: to avoid unintended pregnancy, it is necessary to switch to a different type of contraception, using a reliable barrier method such as a condom or intrauterine device, as Rifadin reduces the effectiveness of oral contraceptives;
isoniazid: when used together with rifampicin, it may increase the risk of liver problems; therefore, your doctor may prescribe periodic blood tests;
para-aminosalicylic acid: Rifadin should be taken at least 8 hours apart from para-aminosalicylic acid (an antibiotic);
dapsone (an antibiotic): when used with rifampicin, it may cause hematological toxicity, including bone marrow suppression and reduced red blood cells, as well as methemoglobinemia (reduced oxygen in the blood due to red blood cell abnormalities);
paracetamol: when used with rifampicin, it may increase the risk of liver damage.

Inform your doctor or pharmacist if you are pregnant and planning or need to undergo termination of pregnancy using mifepristone.

Diagnostic tests
Rifadin may interfere with certain diagnostic and laboratory tests. Inform your doctor if you need to undergo medical or laboratory tests, particularly:

a test to measure vitamin B12 or folate levels in the blood;
a gallbladder examination;
a urine test to detect opiates.
Especially during the first days of treatment, increases in certain liver-related laboratory values (such as bilirubin and transaminases) may occur; your doctor will carry out appropriate monitoring.

Driving and use of machines
Rifadin may cause certain side effects (e.g., dizziness, low blood pressure, headache) that may impair your ability to concentrate and perform tasks requiring attention. If this occurs, avoid driving vehicles or operating machinery.

Rifadin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., essentially 'sodium-free'.

3. How to take Rifadin

Administration must be performed only by healthcare personnel.
Rifadin will be administered to you by slow intravenous infusion (intravenous drip) directly into a vein. The contents of the vial will first be dissolved with the solvent from the ampoule and then diluted in the infusion solution.
The recommended dose is 600 mg, corresponding to one vial, once daily (as judged by the physician).
If rifampicin is used for the treatment of tuberculosis, the therapy will include the concomitant use of other medicines used to treat this infection.

If you take more Rifadin than you should
If you take a dose of Rifadin higher than prescribed, inform your doctor immediately or go to the nearest hospital. Take the medicine pack with you so that the doctor can see what you have taken.
Some symptoms of overdose may include: nausea, vomiting, stomach pain, itching, headache, drowsiness, loss of consciousness (in case of severe liver disease), increased bilirubin and other liver blood tests (liver enzymes), usually transient. Other symptoms include: brownish-red or orange discoloration of the skin, urine, sweat, saliva, tears and faeces, the intensity of which is proportional to the dose taken. In children, swelling of the face, eyes or eyelids may occur. Less commonly, you may experience: decreased blood pressure, rapid and/or irregular heartbeat, seizures and cardiac arrest.

If you forget to take Rifadin
Do not administer a double dose to make up for the missed dose.

If you stop taking Rifadin
Do not stop treatment without consulting your doctor, as allergic (anaphylactic) reactions may occur if treatment is suddenly discontinued; see section 4.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, stop taking the medicine and contact your doctor
immediately:

skin diseases, difficulty swallowing or breathing, shortness of breath, swelling of the lips, face, throat or tongue. These may be symptoms of anaphylactic shock (a severe allergic reaction);
any skin changes (for example, mouth, throat, nose or genital ulcers, widespread blisters and peeling), conjunctivitis (red and swollen eyes). These may be symptoms of a serious skin reaction called “Stevens-Johnson Syndrome” - SJS;
severe and widespread skin damage (separation of the epidermis and superficial mucous membranes) (toxic epidermal necrolysis - TEN);
red, scaly rash with pustules and blisters (acute generalized exanthematous pustulosis - AGEP);
a drug reaction causing erythema, fever, internal organ inflammation, hematological abnormalities and systemic illness (DRESS syndrome);
inflammation of the small blood vessels in the skin causing a red-purple skin rash called “purpura”. The medicine may cause a reduction in the number of certain blood cells called platelets (thrombocytopenia, may affect up to 1 in 10 people), which can lead to this abnormal accumulation of blood under the skin. This condition usually improves when treatment is stopped, but may worsen, potentially leading to brain hemorrhage and death, if treatment is not discontinued or is resumed after the onset of this “purpura”.

The following side effects have also been reported with the use of this medicine:
Very common side effects (may affect more than 1 in 10 people)

fever, chills.

Common side effects (may affect up to 1 in 10 people)

headache, dizziness;
nausea, vomiting;
increased bilirubin in the blood (hyperbilirubinemia);
abnormal liver function test results (increased aspartate aminotransferase; increased alanine aminotransferase).
paradoxical drug reaction: during treatment, after an initial improvement, tuberculosis symptoms may reappear or new symptoms may arise. Paradoxical reactions have been reported as early as 2 weeks and up to 18 months after starting
antituberculosis treatment. Paradoxical reactions are typically associated with fever,
swollen lymph nodes (lymphadenitis), shortness of breath and cough. Patients experiencing a paradoxical drug reaction may also develop headache, loss of appetite and weight loss.
Uncommon side effects (may affect up to 1 in 100 people)
changes in blood cells (leukopenia);
diarrhea.

Side effects with unknown frequency (frequency cannot be determined from available data):

a painful inflammatory condition of the colon (the final part of the intestine), characterized by cramps, persistent diarrhea, weakness and fever (pseudomembranous colitis);
changes in blood cells (agranulocytosis, eosinophilia, leukopenia, anemia);
blood clotting disorders (vitamin K-dependent);
bleeding;
inflammation of the liver (hepatitis);
alteration in bile flow (cholestasis);
decreased appetite (anorexia);
stomach and intestinal disturbances, abdominal discomfort;
skin redness and other skin disorders, with itching, urticaria;
muscle weakness, muscle diseases (myopathies);
bleeding after childbirth (in mother and fetus);
menstrual cycle disturbances;
fluid retention leading to swelling (edema);
changes in the color of tears, sputum, sweat or urine;
tooth discoloration (which may be permanent);
porphyria attacks in patients who already suffer from this condition (a rare inherited blood metabolism disorder);
abnormal liver function test results (increased liver enzymes, increased alkaline phosphatase);
increased levels of creatinine in the blood (creatinine indicates the degree of kidney function);
influenza-like symptoms with bone pain and general malaise;
breathing difficulties (dyspnea) and noisy breathing (wheezing);
drop in blood pressure;
drop in blood pressure leading to impaired consciousness and other mental functions (shock);
hot flushes;
acute kidney injury due to onset of kidney diseases (e.g., renal tubular necrosis or tubulo-interstitial nephritis);
a rare disease affecting the skin and mucous membranes characterized by blister formation on the skin (pemphigus);
a serious condition characterized by widespread blood clot formation (disseminated intravascular coagulation);
mental disorders;
altered adrenal function in patients who already have adrenal problems;
inflammation of blood vessels causing skin disorders, weakness, fever, joint and muscle pain (vasculitis);
lung inflammation (interstitial lung disease/pneumonitis): contact your doctor immediately if you develop new or sudden worsening of breathlessness, possibly accompanied by cough or fever.

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 website
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 Rifadin

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Information on storage and duration of use of Rifadin after reconstitution/dilution and ready for use are described in the section "The following information is intended exclusively for physicians or healthcare professionals".
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Rifadin contains

The active substance is rifampicin. One vial of powder contains 600 mg of rifampicin.
The other ingredients in the powder vial are: sodium formaldehyde sulfoxylate and sodium hydroxide.
The other ingredients in the solvent vial are: water for injections.

Description of the appearance of Rifadin and contents of the pack
Rifadin 600 mg/10 ml powder and solvent for solution for infusion is supplied in a carton containing one vial with powder and one 10 ml ampoule containing the solvent.

Marketing Authorisation Holder and Manufacturer
Sanofi S.r.l. – Viale L. Bodio, 37/B – 20158 Milan
Manufacturer
Sanofi S.r.l. - Via Valcanello, 4 – 03012 Anagni (FR) - Italy

The following information is intended exclusively for physicians or healthcare professionals:
Preparation of the solution for intravenous administration
The solution is prepared by transferring the solvent from the ampoule provided in the pack into the vial containing rifampicin powder, then shaking vigorously and continuously for approximately 30 seconds.
Once the foam has completely disappeared, the solution should be immediately diluted in 500 ml of 5% glucose solution or 0.9% sodium chloride solution.

Administration and stability of the solution
The solution prepared as described above should be used within a few hours.
The in-use chemical and physical stability of the reconstituted solution (see section “Preparation of the solution for intravenous administration”) has been demonstrated for up to 30 hours at room temperature and under normal light conditions.
The in-use chemical and physical stability of the reconstituted solution diluted in 5% glucose infusion solution (see section “Preparation of the solution for intravenous administration”) has been demonstrated for up to 8 hours at room temperature and under normal light conditions.
The in-use chemical and physical stability of the reconstituted solution diluted in 0.9% sodium chloride infusion solution (see section “Preparation of the solution for intravenous administration”) has been demonstrated for up to 6 hours at room temperature and under normal light conditions.
It is recommended to adjust the infusion rate so that the intravenous infusion lasts approximately 3 hours.
If not used within a few hours, the storage times and conditions are the responsibility of the user.
Administration must be performed by healthcare personnel.
The Rifadin solution in vial is for intravenous infusion only and must not be administered intramuscularly or subcutaneously. Care should be taken to avoid leakage of the solution from the vascular site during infusion; cases of local irritation and inflammation due to extravasation of the infused solution have been observed. If such reactions occur, the infusion should be discontinued and restarted at another site.

Incompatible solutions
Physical incompatibility (precipitate formation) has been observed during simulated Y-site administration of undiluted diltiazem solution (5 mg/ml) and diluted diltiazem (1 mg/ml in normal saline) with rifampicin (6 mg/ml in normal saline).
Rifadin infusion solution must not be diluted in the following solutions, as precipitation may occur:

5% bicarbonate solution;
sodium lactate 1/6 mol.

Compatible solutions
For dilution of the reconstituted solution, the following are recommended:

5% glucose;
normal saline.

The use of other infusion solutions is not recommended.
Refer to the Summary of Product Characteristics for further information.