Rifinah 300 mg/150 mg film-coated tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rifinah 300 mg/150 mg film-coated tablets

Rifampicin/Isoniazid

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

Leaflet contents:

1. What Rifinah is and what it is used for
2. What you need to know before taking Rifinah
3. How to take Rifinah film-coated tablets
4. Possible adverse effects
5. How to store Rifinah film-coated tablets

Pack contents and additional information

1. What Rifinah is and what it is used for

Rifinah 300 mg/150 mg film-coated tablets is supplied in blisters of 60 film-coated tablets and is an antibiotic belonging to the group of antituberculosis combinations. Antibiotics stop the growth of bacteria that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

It is used for the treatment of tuberculosis in all its forms.

2. What you need to know before starting to take Rifinah

Do not take Rifinah

• If you are allergic to rifamycins, isoniazid, or any of the other ingredients of this medicine (see section 6).

• If you have liver disease or suffer from jaundice (yellowing of the skin and/or the eye's conjunctiva).

• If you are pregnant or breastfeeding.

• If you are under 12 years of age.

• If you are taking medicines containing:

• Combinations of saquinavir/ritonavir or elvitegravir/cobicistat (antiretroviral medicines).

• Atazanavir, darunavir, fosamprenavir, tipranavir, rilpivirine, or dolutegravir/rilpivirine (antiretroviral medicines).

• Nifedipine, nimodipine, nisoldipine, or nitrendipine (antihypertensive medicines).

• Glecaprevir/pibrentasvir or elbasvir/grazoprevir (medicines for hepatitis C).

• Voriconazole (antifungal medicine).

• Artemether/lumefantrine (antimalarial medicine).

• BCG live dried 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: medicines for HIV.
    • Lurasidone: a medicine for schizophrenia and bipolar disorders, (see section “Use of Rifinah with other medicines” below).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rifinah:

- If symptoms of tuberculosis recur or worsen (see section 4. Possible side effects).

• If you are diabetic. Treatment with rifampicin may make diabetes management more difficult.
• This medicine is a combination of two drugs (rifampicin and isoniazid), each of which has been associated with liver function impairment. Therefore, your doctor will periodically monitor your liver by performing blood tests before starting treatment and every 2–4 weeks during treatment. If any liver cell damage occurs, your doctor will discontinue the 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 indicate serious liver damage.
  • During treatment, severe skin reactions may occur, such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), some of which can be fatal (see section 4. Possible side effects). If you develop signs of hypersensitivity to Rifinah such as fever, lymphadenopathy (swollen lymph nodes), biological abnormalities (eosinophilia—increased levels of a specific type of white blood cells, liver disorders), with or without skin rash, blisters, or mucosal lesions, contact your doctor immediately.

Rifinah should be discontinued if no other cause for these symptoms can 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 subcutaneous nodules and blisters (acute generalized exanthematous pustulosis), consult your doctor as soon as possible, as treatment with rifampicin must be stopped immediately.

• If you are elderly, an adolescent, malnourished, or have a predisposition to neuropathy (e.g., if you are diabetic), you may need to take supplemental vitamin B6.

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

• Rifampicin may interact with various medications at the level of absorption, biochemical changes, and metabolism, and thus could decrease or increase the exposure, safety, and efficacy of these drugs (see “Use of Rifinah 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 simultaneously.

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

• If you experience new or sudden worsening of breathing difficulties, 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.

• If you notice any symptoms related to cerebellar syndrome described in section 4—Possible side effects. This syndrome has been mainly reported in patients with chronic kidney disease. Your healthcare provider may reduce your dose or instruct you to stop treatment.

Use of Rifinah with other medicines

Rifinah may alter the effects of many medicines, so it is very important that you inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Rifampicin increases the elimination of many drugs from the body, which may result in reduced activity of these drugs. These include:

• medicines for the treatment of epilepsy: phenytoin, phenobarbital

• medicines for treating irregular heartbeats (heart arrhythmias): disopyramide, mexiletine, quinidine, propafenone, tocainide

• medicines for other heart problems: beta-blockers and losartan (for treatment of high blood pressure), calcium channel blockers such as diltiazem, nifedipine, or verapamil, cardiac glycosides such as digoxin (for treatment of heart failure)

• medicines for treating blood clotting disorders: warfarin

• medicines for treating mental disorders: haloperidol

• medicines for treating fungal infections: caspofungin, fluconazole, itraconazole, ketoconazole

  • medicines for HIV: cabotegravir, fostemsavir, and 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 treating infections: dapsone (for treatment of leprosy and/or malaria) and quinine (for treatment of malaria)

• medicines for treating diabetes: sulfonylureas (glipizide, glyburide), rosiglitazone

• medicines for treating depression: nortriptyline

• medicines for treating anxiety and/or insomnia: diazepam, zopiclone, zolpidem

• medicines for treating pain: opioid analgesics (oxycodone, morphine)

• medicines for treating high cholesterol: clofibrate, statins (e.g., simvastatin)

• medicines for treating vomiting: ondansetron

• medicines for treating cancer: irinotecan

• medicines for treating neurodegenerative diseases such as amyotrophic lateral sclerosis: riluzole

• medicines with estrogenic and antiestrogenic activity (tamoxifen, toremifene)

• antiviral medicines for treating hepatitis C (daclatasvir, simeprevir, sofosbuvir, telaprevir, velpatasvir, voxilaprevir)

• Other medicines: hexobarbital (barbiturate), levothyroxine (for treatment of hypothyroidism), methadone, theophylline (for treatment of asthma), praziquantel (for treatment of 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 decreased 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 lurasidone blood levels.

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

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

The combination of rifampicin with isoniazid increases the potential for hepatotoxicity. There is a high frequency of association between this combination and hepatitis in individuals over 35 years of age, so your doctor will periodically monitor your liver function (see section 2. Warnings and precautions).

When atovaquone and Rifinah are used simultaneously, a decrease in atovaquone concentrations and an increase in rifampicin concentrations have been observed.

Concurrent use of ketoconazole and rifampicin decreases serum levels of both drugs.

If you are taking enalapril (a medicine for treating high blood pressure) at the same time as Rifinah, your doctor will adjust your enalapril dose, as rifampicin reduces its blood concentration and thus its effectiveness.

If you are taking systemic hormonal contraceptives, your doctor will advise you to switch to a non-hormonal contraceptive method during treatment with Rifinah, as its contraceptive effect may be reduced.

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

Concomitant use of rifampicin with other antibiotics that cause vitamin K-dependent coagulopathy (reduced blood clotting ability), such as cefazolin (or other cephalosporins in the same group), should be avoided, as this may lead to serious coagulation disorders (when blood loses its fluidity and becomes gel-like to form a clot), potentially resulting in fatal outcomes (especially with high doses).

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

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

When Rifinah is taken with the combination saquinavir/ritonavir, the risk of hepatotoxicity increases. Therefore, concomitant use of Rifinah with the saquinavir/ritonavir combination is contraindicated.

Isoniazid inhibits the metabolism of carbamazepine and phenytoin (medicines for treating epilepsy), so dose adjustments will be required for these medicines.

Para-aminosalicylic acid increases blood concentrations of isoniazid and decreases those of rifampicin.

Interference with laboratory tests

This medicine may alter the results of certain laboratory tests such as:

• blood folate and vitamin B12 measurements,
• bromsulphthalein test (transient elevations),
• blood bilirubin levels,
• may impair the excretion of contrast agents used in gallbladder imaging.

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

In patients treated with rifampicin, false-positive results for opioids in urine have been reported when tested using the ICMS (Immunochemical Microparticle Kinetic Interaction) 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.

Taking Rifinah with food, drinks, and alcohol

Isoniazid interacts with foods containing a substance called tyramine, found in foods such as cheese and red wine. Also, if you consume foods containing histamine (e.g., tuna or other tropical fish), an exaggerated response may occur, including headache, sweating, palpitations, flushing, and low blood pressure. For this reason, your doctor will advise you not to eat foods containing tyramine or histamine during treatment with Rifinah.

Pregnancy, lactation and fertility

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

This medicine should not be taken during pregnancy.

Rifampicin and isoniazid are excreted in breast milk; therefore, you must not breastfeed your child during treatment.

Consult your doctor or pharmacist before taking a medicine.

There are no human data available on the long-term ability of Rifinah to alter fertility.

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.

Important information about some of the components of Rifinah

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 180.90 mg of sucrose per coated tablet.

This medicine may cause allergic reactions as it contains Sunset Yellow FCF (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains less than 23 mg of sodium (1 mmol) per coated tablet, i.e., essentially "sodium-free".

3. How to take Rifinah

Follow exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. Remember to take your medicine.

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

Swallow the tablets with a sufficient amount of liquid (a glass of water).

The absorption of Rifinah is affected by food; therefore, to ensure adequate absorption, Rifinah must be taken on an empty stomach, that is:

• at least 30 minutes before a meal, or
• at least 2 hours after a meal.

If you think that the effect of Rifinah is too strong or too weak, tell your doctor or pharmacist.

The usual dose for adults weighing more than 50 kg and with normal liver function is 2 tablets (600 mg rifampicin and 300 mg isoniazid) taken once daily in the morning on an empty stomach.

This medicine is not recommended for use in children due to differing dosage requirements.

If you take more Rifinah than you should

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

After a large intake of this medicine, nausea, vomiting, stomach pain, itching, headache and increasing drowsiness may be expected. If you have a serious liver disease, loss of consciousness could occur. Dizziness, difficulty speaking, blurred vision and visual hallucinations (bright colors and strange shapes) may also appear, as well as severe breathing difficulties and serious convulsions.

Additionally, due to rifampicin, a reddish discoloration may appear in the skin, urine, sweat, saliva, tears and faeces; the intensity of this coloration will vary depending on the amount of medicine taken. It may also cause permanent staining of soft contact lenses.

Your doctor will provide appropriate symptomatic treatment, such as gastric lavage and/or induction of vomiting, and administration of medicines for your symptoms, as well as monitoring your liver and kidney function.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 5620420.

If you forget to take Rifinah

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

If you interrupt treatment with Rifinah

It is important that you follow your doctor's instructions, as taking the treatment intermittently (less than 2 or 3 times per week) may cause severe allergic reactions. If you interrupt the treatment and then restart it, you will begin again with small doses, which will be gradually increased.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

Due to Rifinah

Adverse effects common (may affect up to 1 in 10 patients):

• 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 anti-tuberculosis treatment. Paradoxical reactions are usually associated with fever, lymph node swelling (lymphadenitis), difficulty breathing, and cough. Patients experiencing paradoxical drug reactions may also have headache, loss of appetite, and weight loss.

Due to rifampicin:

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

If any of the following serious adverse effects occur, stop taking Rifinah and consult your doctor immediately (see section 2 - Warnings and precautions):

• Renal failure (kidneys unable to properly filter toxins).
• Thrombocytopenia (decrease in the number of platelets in the blood).
• Haemolytic anaemia (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.

Adverse effects very common (may affect more than 1 in 10 patients):

• Fever, chills.

Adverse effects common (may affect up to 1 in 10 patients):

• Thrombocytopenia (reduction in the number of platelets), with or without appearance of red skin spots caused by small subcutaneous bleeding (purpura).
• Headache, dizziness.
• Nausea, vomiting.
• Increased blood bilirubin, increased transaminases [aspartate aminotransferase (AST), alanine aminotransferase (ALT)].

Adverse effects uncommon (may affect up to 1 in 100 patients):

• Leucopenia (decrease in the number of white blood cells).
• Diarrhoea.

Other adverse effects with frequency not known (cannot be estimated from available data) that may occur with rifampicin are:

• Pseudomembranous colitis (severe inflammation of the intestine that may appear after antibiotic treatment).
• Flu.
• 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).
• Haemolytic anaemia (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 haemorrhage and death, in cases where treatment with rifampicin was continued or restarted after the onset of purpura (purple skin spots).
• Change in the colour of tears.
• Shock (cardiocirculatory failure syndrome), rubefaction (skin reddening), vasculitis (inflammation of blood vessels), severe bleeding.
• Dyspnoea (suffocation or difficulty breathing), wheezing (noises during breathing), change in sputum colour.
• Gastrointestinal disorder, abdominal discomfort, discolouration of teeth (which may be permanent).
• Hepatitis (liver inflammation), hyperbilirubinaemia (elevated bilirubin in blood), cholestasis (reduced bile flow) (see section 2. Warnings and precautions).
• Erythema multiforme.
• Severe skin reactions such as acute generalised exanthematous pustulosis (red, scaly rash with bumps under the skin and blisters), Stevens-Johnson syndrome (widespread blistering rash with skin peeling, particularly around the mouth, nose, eyes, and genitals), and toxic epidermal necrolysis [widespread blistering rash with skin peeling, particularly around the mouth, nose, eyes, and genitals, causing widespread skin peeling (more than 30% of body surface)], 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 colour 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 (abnormally coloured urine).
• Postpartum haemorrhage.
• Fetomaternal haemorrhage (fetal blood entering maternal circulation).
• Menstrual disorder.
• Porphyria.
• Oedema (skin swelling due to fluid accumulation).
• Drop in blood pressure.
• Increased blood creatinine.
• Increased liver enzymes.
• Inflammation of the lungs (interstitial lung disease/pneumonitis): Inform your doctor immediately if you develop new or sudden worsening of breathing difficulty, possibly with cough or fever.

Due to isoniazid:

Adverse effects uncommon (may affect up to 1 in 100 patients):

• Seizures, toxic encephalopathy (brain impairment due to a neurological disorder caused by toxic substances), optic neuritis (inflammation of the optic nerve that may cause sudden partial or complete vision loss, although visual function often recovers), optic atrophy, memory impairment, and toxic psychosis (psychotic disorder caused by substance abuse).

• Nausea, vomiting, stomach pain.

• Hepatitis: Symptoms such as yellowing of the skin and whites of the eyes (jaundice), dark urine and pale stools, fatigue, weakness, malaise, loss of appetite, nausea or vomiting, which may be severe and occasionally fatal.

Adverse effects rare (may affect up to 1 in 1,000 patients):

• Widespread blistering rash with skin peeling, particularly around the mouth, nose, eyes, and genitals, causing widespread skin peeling (more than 30% of body surface) (toxic epidermal necrolysis or TEN).
• 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 [drug reaction with eosinophilia and systemic symptoms (DRESS)].
• Anaemia (decrease in the number of red blood cells in the blood).

Adverse effects very rare (may affect up to 1 in 10,000 patients):

• Thrombocytopenia (reduction in the number of platelets), eosinophilia (increase in white blood cells), agranulocytosis (decrease in a type of white blood cells, granulocytes).
• Anaphylactic reactions (severe allergic reaction with breathing difficulty and even loss of consciousness).
• Pellagra (digestive disorders, limb pains, weakness, redness and skin desquamation, and nervous system disturbances).
• Polyneuritis (inflammation of several nerves) presenting as paraesthesia (tingling sensations), muscle weakness, and loss of tendon reflexes.
• Rash, acne, exfoliative dermatitis (skin inflammation with peeling), Stevens-Johnson syndrome (SSJ) (widespread blistering rash with skin peeling, particularly around the mouth, nose, eyes, and genitals), pemphigus (skin disorder with blisters).
• Systemic lupus erythematosus-like syndrome (serious skin and mucous membrane disease of unknown origin that sometimes causes fatigue and weight loss, fever, arthritis, kidney involvement, seizures, mental disorders, and gastrointestinal disturbances).
• Fever.

Adverse effects with frequency not known (cannot be estimated from available data):

• Inflammation of the pancreas, causing severe abdominal and back pain (pancreatitis).
• Gynaecomastia (pathological enlargement of one or both mammary glands).
• Vasculitis (inflammation of blood vessels).
• Cerebellar syndrome including: poor coordination of movements, imbalance, changes in speech, involuntary eye movements.
• Hair loss.

If you notice any other reaction not described in this leaflet, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any kind of adverse effect, talk to 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 Rifinah

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

Do not store above 25°C.

Do not use Rifinah after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rifinah 300 mg/150 mg film-coated tablets

The active substances are rifampicin and isoniazid. Each film-coated tablet contains 300 mg of rifampicin and 150 mg of isoniazid.

The other components are: sodium lauryl sulfate, magnesium stearate, calcium stearate, sodium carboxymethylcellulose, microcrystalline cellulose (avicel pH 101).

Coating: gum arabic, povidone K30, sucrose, talc, magnesium carbonate, titanium dioxide, kaolin, gelatin, aerosil 200, colouring agent FDC Yellow No. 6, 17% aluminium lake (Orange Yellow S (E-110)). Polishing wax: carnauba wax.

Appearance of the product and contents of the pack

Rifinah is presented as oblong, orange-pink film-coated tablets with a smooth and shiny surface.

Each pack contains 60 tablets in blisters.

Marketing Authorisation Holder:

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer:

Sanofi S.r.l.

Via Valcanello, 4

03012 Anagni (FR) Italy

Date of the most recent revision of this leaflet: February 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/.