Rifaldin 600 mg powder and solvent for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rifaldin 600 mg powder and solvent for solution for infusion

Rifampicin

Read all of this leaflet carefully before you start using 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, and you should not give it to others, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Rifaldin 600 mg powder and solvent for solution for infusion is and what it is used for

2. What you need to know before using Rifaldin 600 mg powder and solvent for solution for infusion

3. How to use Rifaldin 600 mg powder and solvent for solution for infusion

4. Possible side effects

5. How to store Rifaldin 600 mg powder and solvent for solution for infusion

6. Contents of the pack and other information

1. What Rifaldin 600 mg powder and solvent for solution for infusion is and what it is used for

Rifaldin is an antibiotic belonging to a group of antibiotics called rifamycins. It works by inhibiting the growth of bacteria that cause infections.

Rifaldin is indicated in the treatment of infections caused by bacteria to which this medication is active, such as:

• Tuberculosis in all its forms and locations, when clinical conditions (loss of
  consciousness, surgical intervention, gastrointestinal absorption disorders, etc.) or the patient's gastric tolerance conditions do not permit or do not recommend oral administration of the drug.

In nontuberculous infections, Rifaldin may be used exceptionally, only in a hospital setting and after precise etiological confirmation and appropriate antibiogram, in infections caused by staphylococci (S. aureus, S. epidermidis, multidrug-resistant strains) and enterococci (E. faecalis, E. faecium), and when it would not be appropriate to administer other antibiotics or chemotherapeutic agents to the patient.

2. What you need to know before using Rifaldin 600 mg powder and solvent for solution for infusion

Do not take Rifaldin:

• if you are allergic to rifamycins, or to any of the other ingredients of this medicine
  (listed in section 6),
• if you have liver disease and your skin is yellow (jaundice),
• if you are taking medications containing:
  • Saquinavir/ritonavir or elvitegravir/cobicistat combinations (antiretroviral medicines).
  • Atazanavir, darunavir, fosamprenavir, tipranavir, rilpivirine, or dolutegravir/rilpivirine (antiviral medicines).
  • Nifedipine, nimodipine, nisoldipine, or nitrendipine (antihypertensive medicines).
  • Glecaprevir/pibrentasvir or elbasvir/grazoprevir (medicines for hepatitis C).
  • Voriconazole (antifungal medicine).
  • Artemether/lumeflantrine (antimalarial medicine).
  • BCG lyophilized live culture (interferon).
  • if you are currently taking any of the following medicines:
    • Sofosbuvir: an antiviral medicine used to treat hepatitis C virus infections.
    • Cabotegravir, fostemsavir, lenacapavir: HIV medicines.
    • Lurasidone: a medicine for schizophrenia and bipolar disorders (see section “Use of Rifaldin with other medicines” below).

Because rifampicin may reduce blood concentrations of several medicines, including those listed above.

Warnings and precautions

This formulation is for intravenous infusion only. It must not be administered intramuscularly or subcutaneously.

Consult your doctor or pharmacist before starting to use Rifaldin.

• If symptoms of tuberculosis reappear or worsen (see section “4. Possible side effects”).
• If you have any impairment of liver function. In this case, your doctor will reduce your dose and monitor your liver function periodically by performing blood tests before treatment and every 2–4 weeks during treatment. If liver cell damage occurs, your doctor will stop your treatment.
• If you experience itching, weakness, loss of appetite, nausea, vomiting, abdominal pain, yellowing of the eyes or skin, or dark urine, inform your doctor immediately. These symptoms may be related to severe liver damage.
• If you take rifampicin together with isoniazid (a medicine for tuberculosis), or if you are elderly or an adolescent, malnourished, or have a predisposition to nervous system disorders (e.g., if you are diabetic), your doctor may prescribe additional vitamin B6 supplementation.
• During treatment, a serious reaction such as drug reaction with eosinophilia and systemic symptoms (DRESS) may occur (see section 4. Possible side effects). If you develop early signs of hypersensitivity to Rifaldin such as fever, lymphadenopathy (swollen lymph nodes), or biological abnormalities (eosinophilia – increased levels of a specific type of white blood cells, liver disturbances), with or without skin rash, contact your doctor immediately.

Rifaldin should be discontinued if another cause for these symptoms cannot be established.

• If you develop a severe, widespread blistering rash, with blister formation or skin peeling, along with flu-like symptoms and fever (Stevens-Johnson syndrome), general malaise, fever, chills, and muscle pain (toxic epidermal necrolysis), or a red, scaly rash with bumps under the skin and blisters (acute generalized exanthematous pustulosis), consult your doctor as soon as possible, as treatment with rifampicin must be stopped immediately.

• If you are diabetic. Treatment with rifampicin may complicate the management of diabetic patients.

• Rifampicin may cause discoloration (yellow, orange, red, brown) of your teeth, urine, sweat, sputum, tears, and feces, which is clinically insignificant. Similarly, it may cause permanent staining of soft contact lenses.

• Rifampicin may interfere with various medicines at the level of absorption and biochemical metabolism, and therefore could decrease or increase the exposure, safety, and efficacy of these medicines (see “Use of Rifaldin with other medicines”).

• If you have a bleeding disorder or a tendency to bruise easily. Rifampicin may cause vitamin K-dependent coagulopathy (meaning it may reduce blood clotting ability) and severe bleeding (see section “Possible side effects”).

• If you are taking other antibiotics at the same time.

• If you have a history of lung inflammation (interstitial lung disease/pneumonitis).

• If you experience new or sudden worsening of breathing difficulty, possibly with dry cough or fever unresponsive to antibiotic treatment. These may be symptoms of lung inflammation (interstitial lung disease/pneumonitis) and may lead to serious respiratory problems and interfere with normal breathing due to fluid accumulation in the lungs, potentially leading to life-threatening conditions.

Contraception in men and women

Rifaldin may be harmful to the unborn child and may reduce the effectiveness of hormonal contraceptives (the "birth control pill"). If you are a man capable of fathering children, or a woman who could become pregnant, you must use effective non-hormonal contraceptive methods during treatment and for a period of time after treatment ends. A woman may be required to take a pregnancy test before starting treatment (see sections "Other medicines" and "Pregnancy, breastfeeding and fertility").

Use of Rifaldin with other medicines

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

Rifampicin increases the elimination of many medicines from the body, which may reduce their activity. These medicines include:

• medicines for epilepsy: phenytoin, phenobarbital
• medicines for irregular heartbeats (heart arrhythmias): disopyramide, mexiletine, quinidine, propafenone, tocainide
• medicines for other heart problems: beta-blockers and losartan (for high blood pressure), calcium channel blockers such as diltiazem, nifedipine, or verapamil, cardiac glycosides such as digoxin (for heart failure)
• medicines for blood clotting disorders: warfarin
• medicines for mental disorders: haloperidol
• antifungal medicines: caspofungin, fluconazole, itraconazole, ketoconazole
• HIV medicines: cabotegravir, fostemsavir, lenacapavir
• medicines for HIV infection: zidovudine, saquinavir, indinavir, efavirenz
• medicines used as anesthetics: thiopental
• some antibiotics: chloramphenicol, clarithromycin, doxycycline, fluoroquinolones, telithromycin
• corticosteroids (e.g., prednisolone)
• medicines to prevent transplant rejection: cyclosporine, tacrolimus, sirolimus
• systemic hormonal contraceptives (including estrogens and progestogens)
• other medicines for infections: dapsone (for leprosy and/or malaria), quinine (for malaria)
• medicines for diabetes: sulfonylureas (glipizide, glyburide), rosiglitazone
• medicines for depression: nortriptyline
• medicines for anxiety and/or insomnia: diazepam, zopiclone, zolpidem
• medicines for pain: opioid analgesics (oxycodone, morphine)
• medicines for high cholesterol: clofibrate, statins (e.g., simvastatin)
• medicines for nausea and vomiting: ondansetron
• medicines for cancer: irinotecan
• medicines for neurodegenerative diseases such as amyotrophic lateral sclerosis: riluzole
• medicines with estrogenic and antiestrogenic activity: tamoxifen, toremifene
• antiviral medicines for hepatitis C: daclatasvir, simeprevir, sofosbuvir, telaprevir, velpatasvir, voxilaprevir
• other medicines: hexobarbital (barbiturates), levothyroxine (for hypothyroidism), methadone, theophylline (for asthma), praziquantel (for helminthic parasites)
• some medicines used to thin the blood, such as clopidogrel
• dapsone: if you are taking dapsone (an antibiotic) with rifampicin, hematological toxicity may occur, including reduced blood cells and bone marrow suppression, and methemoglobinemia (reduced oxygen in the blood due to changes in red blood cells).
• lurasidone for schizophrenia and bipolar disorders, as rifampicin may reduce blood levels of lurasidone.

If you are taking any of these medicines, your doctor may need to adjust your dose.

If you are taking paracetamol and rifampicin, the risk of liver damage may increase.

If you are taking systemic hormonal contraceptives, you should use another non-hormonal contraceptive method during treatment with Rifaldin.

Concomitant use of ketoconazole and rifampicin reduces serum levels of both drugs.

Concomitant use of Rifaldin and enalapril reduces enalapril's activity. If your clinical condition allows, your doctor may need to adjust your dose.

When atovaquone and Rifaldin are used together, decreased atovaquone concentrations and increased rifampicin concentrations are observed.

Do not take Rifaldin with para-aminosalicylic acid (a medicine used to treat tuberculosis), as it reduces rifampicin blood levels; therefore, an 8-hour interval between the two medicines is recommended.

Antacids reduce the absorption of rifampicin, so you should take your daily dose of Rifaldin at least one hour before taking antacids.

Concomitant use of rifampicin with halothane or isoniazid increases the potential for hepatotoxicity. Do not use Rifaldin with halothane. If you are receiving treatment with both rifampicin and isoniazid, your doctor will monitor your liver function periodically (see section 2. Warnings and precautions).

Concomitant use is not recommended with a group of antiretroviral medicines, non-nucleoside reverse transcriptase inhibitors such as etravirine, nevirapine, or any protease inhibitor (alone or combined with an antiretroviral called ritonavir).

Concomitant use with maraviroc, another antiretroviral medicine, is also not recommended; if clinically justified, dose adjustment is required.

Concomitant use of rifampicin with other antibiotics that cause vitamin K-dependent coagulopathy (reduced blood clotting ability), such as cefazolin (or other cephalosporins of the same group), should be avoided, as it may cause severe coagulation disorders (when blood loses its liquidity and forms a gel to form a clot), potentially leading to fatal outcomes (especially with high doses).

Do not take Rifaldin with the saquinavir/ritonavir combination (antiretroviral medicines).

Rifaldin alters the results of certain laboratory tests, such as:

• blood tests for folate and vitamin B12,
• bromsulphthalein test,
• blood bilirubin levels,
• it may impair the elimination of contrast agents used in gallbladder imaging.

Therefore, if necessary, these tests should be performed in the morning and before taking your dose of Rifaldin.

In patients treated with rifampicin, false positive urine opiate test results have been reported when tested using the ICMS (Immunochemical Kinetic of Microparticles in Solution) assay. For this reason, alternative methods such as gas chromatography and mass spectrometry are recommended for these patients.

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Since rifampicin crosses the placental barrier and sufficient data are not available to establish its safety during pregnancy, your doctor will carefully assess the need for using Rifaldin during pregnancy. It must not be administered during the first three months of pregnancy.

Animal studies and laboratory tests have shown a potential risk of DNA damage.

If you are a man capable of fathering children, you must use effective contraceptive methods to avoid conceiving a child during treatment and for 3 months after treatment ends.

If you are a woman who could become pregnant, you must use effective contraceptive methods during treatment and for 6 months after treatment ends. Rifaldin may reduce the effectiveness of hormonal contraceptives (the "birth control pill"). Therefore, you should use other methods (barrier contraceptives) during treatment with Rifaldin. If you have any questions or are unsure which contraceptive methods to use, consult your doctor or pharmacist.

Breastfeeding

Although rifampicin is excreted in small amounts in breast milk, harmful effects in infants have not been established. If treatment of the mother is necessary, breastfeeding may be continued.

Fertility

There are no data on the long-term capacity of rifampicin to alter fertility.

It is unknown whether Rifaldin may affect fertility in humans; however, data from animal studies and laboratory tests suggest that fertility could be affected.

Rifaldin contains sodium

This medicine contains 13.84 mg of sodium per vial, equivalent to 0.692% of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.

Driving and use of machines

Rifampicin may cause certain adverse effects that could interfere with the ability to drive and operate machinery. If you experience these adverse effects (difficulty breathing, nausea, vomiting, muscle weakness), you should not drive or operate machinery.

3. How to use Rifaldin 600 mg powder and solvent for solution for infusion

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

Your doctor will determine your daily dose and the duration of your treatment. Do not stop your treatment prematurely. The dosage is individualized for you and may be adjusted by your doctor depending on your response to treatment.

Reconstitute the lyophilized powder by transferring 10 ml of water for injections into a 600 mg vial of rifampicin. Gently roll the vial between your hands until the antibiotic is completely dissolved. The resulting solution contains 60 mg of rifampicin per ml and remains stable at room temperature for 30 hours. Prior to administration, withdraw from the reconstituted solution a volume equivalent to the calculated amount of rifampicin to be administered and add it to 250 or 500 ml of infusion fluid. Mix well and infuse at a rate allowing complete infusion within three hours. Alternatively, the required amount of rifampicin may be added to 100 ml of infusion fluid and infused over 30 minutes.

After dilution with water for injections, the resulting rifampicin solution remains stable at temperatures not exceeding 25°C for 24 hours.

After dilution in 5% glucose solution, it remains stable for 8 hours at temperatures not exceeding 25°C; therefore, it must be prepared and used within this period. After this time, precipitation of rifampicin may occur in the infusion solution.

Dilutions in normal saline remain stable for 6 hours at temperatures not exceeding 25°C and must be prepared and used within this period.

Use of other infusion solutions is not recommended.

Dilution of the intravenous formulation in solutions other than 5% glucose or normal saline is not recommended. Intravenous solutions containing sodium bicarbonate and/or sodium lactate are physically incompatible with rifampicin.

Physical incompatibility (precipitation) has been observed with undiluted (5 mg/ml) and diluted (1 mg/ml in saline) diltiazem hydrochloride solutions and rifampicin (6 mg/ml in saline) during simulated Y-site administration.

Adults:

The recommended dose in adults depends on the disease for which this medicine has been prescribed to you, and is:

• Tuberculosis: The recommended daily dose is 600 mg given as a single administration. If you have impaired liver function, are elderly, or have poor general health, lower doses than the above will be administered. As a general rule, Rifaldin should always be administered in combination with other antituberculosis agents such as ethambutol or isoniazid for the treatment of tuberculosis.
• Other infections: The recommended daily dose is 900 to 1200 mg administered in two slow infusions (1–3 hours).

Children:

The dose for children is based on body weight. It usually ranges between 10 mg and 20 mg per kg of body weight per day.

The usual dose for children for the treatment of tuberculosis is 15 mg/kg/day. In children with altered body weight, a dose reduction may be necessary. In severe infections, such as meningitis, a higher dose may be used, such as 20 mg per kg of body weight per day.

Rifaldin 600 mg powder and solvent for solution for infusion is for intravenous infusion only. It must not be administered by intramuscular or subcutaneous routes.

If you use more Rifaldin than you should

Contact your doctor immediately or go to the nearest hospital emergency department, taking this leaflet with you.

After massive use of this medicine, nausea, vomiting, stomach pain, itching, headache, and progressive drowsiness may be expected. In patients with severe liver disease, loss of consciousness could occur. In pediatric patients, facial or peribuccal edema has also been reported. In some fatal cases, hypotension, sinus tachycardia, ventricular arrhythmias, seizures, and cardiac arrest have been reported.

A transient increase in liver enzymes and/or bilirubin may also occur.

Additionally, a reddish-brown or orange discoloration may appear in the skin, urine, sweat, saliva, tears, and feces. The intensity of this coloration will vary according to the amount of medicine used.

Your doctor will treat the symptoms as appropriate, such as gastric lavage and/or induction of vomiting, administration of symptomatic medications, and monitoring of liver and kidney function.

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Toxicology Information Service at telephone: 91 5620420, indicating the medicine and the amount ingested.

If you forget to use Rifaldin

Do not administer a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If any of the following serious adverse effects occur, stop taking Rifaldin and consult your doctor immediately:

• Renal failure (kidneys are unable to properly filter toxins).
• Thrombocytopenia (decrease in the number of platelets in the blood).
• Hemolytic anemia (destruction of red blood cells in the blood earlier than normal).

Your doctor will instruct you to immediately discontinue treatment with rifampicin and not to take this medicine again.

Very common adverse effects (may affect more than 1 in 10 people):

• Fever, chills.

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

• Thrombocytopenia (reduction in the number of platelets), with or without appearance of red skin spots caused by small subcutaneous hemorrhages (purpura).
• Headache, dizziness.
• Nausea, vomiting.
• Increased blood bilirubin, increased transaminases [aspartate aminotransferase (AST), alanine aminotransferase (ALT)].
• Paradoxical drug reaction: Symptoms of tuberculosis may reappear or new symptoms may arise after initial improvement during treatment. Paradoxical reactions have been reported as early as 2 weeks and as late as 18 months after starting tuberculosis treatment. Paradoxical reactions are usually associated with fever, lymph node inflammation (lymphadenitis), difficulty breathing, and cough. Patients experiencing paradoxical drug reactions may also have headache, loss of appetite, and weight loss.

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

• Leukopenia (decrease in the number of white blood cells).
• Diarrhea.

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

• Pseudomembranous colitis (severe inflammation of the intestine that may occur after antibiotic treatment).

• Influenza.

• Disseminated intravascular coagulation (widespread blood clotting problems within blood vessels).

• Eosinophilia (increase in a specific group of white blood cells).

• Agranulocytosis (decrease in a type of white blood cells, granulocytes).

• Hemolytic anemia (decrease in red blood cells due to their destruction).

• Vitamin K-dependent coagulation disorders.

• Anaphylactic reaction (severe allergic reaction with breathing difficulty and even loss of consciousness).

• Adrenal insufficiency (impaired function of the adrenal glands in patients with kidney disorders).

• Decreased appetite.

• Psychotic disorder (mental state involving loss of contact with reality).

• Cerebral hemorrhage and death, in cases where treatment with rifampicin was continued or restarted after the onset of purpura (purple skin spots).

• Change in the color of tears.

• Shock (cardiocirculatory failure syndrome), flushing (skin redness), vasculitis (inflammation of blood vessels), severe bleeding.

• Dyspnea (shortness of breath or difficulty breathing), wheezing (abnormal breathing sounds), change in sputum color.

• Gastrointestinal disorders, abdominal discomfort, discoloration of teeth (which may be permanent).

• Hepatitis (liver inflammation), hyperbilirubinemia (elevated bilirubin in blood), cholestasis (reduced bile flow) (see section 2. Warnings and precautions).

• Erythema multiforme.

• Severe skin reactions such as acute generalized exanthematous pustulosis (red, scaly rash with bumps under the skin and blisters), Stevens-Johnson syndrome (widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals), and toxic epidermal necrolysis [widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing widespread skin detachment (more than 30% of body surface area)], drug reaction with eosinophilia and systemic symptoms [(DRESS) flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results such as increased white blood cells (eosinophilia) and elevated liver enzymes] (see section 2. Warnings and precautions).

• Skin reactions, itching, pruritic skin rash, urticaria, allergic dermatitis, blistering skin lesions (pemphigus).

• Change in the color of sweat.

• Muscle weakness, myopathy (muscle disorder).

• Bone pain.

• Acute kidney injury, usually due to death of kidney cells (renal tubular necrosis) or inflammation of the kidneys (tubulointerstitial nephritis).

• Chromaturia (abnormal urine color).

• Postpartum hemorrhage.

• Feto-maternal hemorrhage (fetal blood entering maternal circulation).

• Menstrual disorder.

• Porphyria.

• Edema (skin swelling due to fluid accumulation).

• Decreased blood pressure.

• Increased creatinine in blood.

• Increased liver enzymes.

• Lung inflammation (interstitial lung disease/pneumonitis): inform your doctor immediately if you develop a new or sudden worsening of breathing difficulty, possibly with cough or fever.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rifaldin 600 mg powder and solvent for infusion solution

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

The solution obtained after reconstitution of the vial with 10 ml of water for injections has been shown to be chemically and physically stable for 30 hours at temperatures not exceeding 25°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to administration are the responsibility of the user and should normally not exceed 24 hours between 2 and 8°C (or the previously stated time for the chemical and physical stability of the reconstituted solution, whichever is shorter), unless reconstitution, dilution, etc., have been carried out under validated aseptic conditions.

The solution obtained by further diluting the reconstituted vial with 500 ml of 5% glucose solution has been shown to be chemically and physically stable for 8 hours at temperatures not exceeding 25°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to administration are the responsibility of the user and should normally not exceed 24 hours between 2 and 8°C (or the previously stated time for the chemical and physical stability of the diluted solution, whichever is shorter), unless reconstitution, dilution, etc., have been carried out under validated aseptic conditions.

The solution obtained by further diluting the reconstituted vial with 500 ml of 0.9% NaCl solution has been shown to be chemically and physically stable for 6 hours at temperatures not exceeding 25°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to administration are the responsibility of the user and should normally not exceed 24 hours between 2 and 8°C (or the previously stated time for the chemical and physical stability of the diluted solution, whichever is shorter), unless reconstitution, dilution, etc., have been carried out under validated aseptic conditions.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE point at your pharmacy. If in doubt, please consult your pharmacist on how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rifaldin

The active substance is rifampicin. Each vial of lyophilized powder contains 600 mg of sodium rifampicin.

The other components (excipients) are: sodium formaldehyde sulfoxylate and sodium hydroxide. The composition of the solvent ampoule is water for injections.

Appearance of the product and contents of the pack

Rifaldin 600 mg powder and solvent for solution for infusion is supplied in a pack containing 1 vial of lyophilized powder and 1 ampoule of solvent.

Marketing Authorization Holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer responsible:

Sanofi S.r.l.

Via Valcanello, 4

03012 Anagni (FR) Italy

Date of the most recent revision of this leaflet: March 2026

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