Isoacne 40 mg soft capsules

Spain
Brand name Isoacne 40 mg soft capsules
Form capsules, soft gelatin
Active substance / Dosage
ISOTRETINOINA · 40,00 mg
Prescription type Hospital Diagnosis
ATC code
D10B D10BA D10BA01
Registration number 69927
Manufacturer Pierre Fabre Iberica S.A.
Isoacne 40 mg soft capsules capsules, soft gelatin

Table of Contents

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

ISOACNÉ 40mg soft capsules

Isotretinoin

WARNING

MAY SER SERIOUSLY HARMFUL TO THE UNBORN BABY IF PREGNANCY OCCURS

Women must use effective contraception throughout treatment.

Do not use if you are pregnant or think you may be pregnant.

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1 – What Isoacné 40 mg soft capsules (referred to hereinafter as Isoacné) is and what it is used for

2 – What you need to know before taking Isoacné

3 – How to take Isoacné

4 – Possible side effects

5 – How to store Isoacné

6 – Contents of the pack and other information

1. What Isoacné is and what it is used for

Isoacné contains isotretinoin as the active substance, which belongs to a group of medicines known as retinoids.

Isoacné is indicated for the treatment of severe acne (such as nodular acne, conglobata acne, or acne that may cause permanent scarring) that is resistant to conventional treatments, including oral antibiotics and topical therapy (cream, gel, ointment, or lotion).

Isoacné should only be prescribed under the supervision of a physician experienced in the use and monitoring of retinoids for the treatment of severe acne.

Isoacné is not indicated for the treatment of acne occurring before puberty, and administration is not recommended in children under 12 years of age.

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

Do not take Isoacné:

  • If you are pregnant or breastfeeding.
  • If there is any possibility that you could become pregnant, you must follow the precautions of the “Pregnancy Prevention Programme”; see the section “Warnings and precautions”.
  • If you are allergic to isotretinoin or to any of the other ingredients of this medicine (listed in section 6), especially to peanuts or soya.
  • If you have hepatic insufficiency (serious liver disease).
  • In case of hypervitaminosis A (very high levels of vitamin A in the body).
  • If you have high levels of lipids in the blood (cholesterol, triglycerides).
  • If you are taking any antibiotic from the tetracycline family.
  • If you are taking vitamin A or other retinoids (acitretin, alitretinoin).

Warnings and precautions

Consult your doctor before starting to take Isoacné:

  • If you have ever had any mental health problems. This includes depression, anxiety, aggressive tendencies, or mood changes. It also includes thoughts of self-harm or ending your life. This is because your mood may be affected while taking Isoacné.
  • If you have any kidney disorder. Your doctor may need to adjust your isotretinoin dose.
  • If you are overweight or have diabetes mellitus, high cholesterol or triglyceride levels, or consume large amounts of alcohol.

In these cases, an increase in blood lipid and triglyceride levels may occur.

If you are in any of these situations, your doctor may recommend more frequent blood tests. Elevated fasting blood glucose levels have been reported, and new cases of diabetes have been diagnosed during isotretinoin therapy.

If you have diabetes mellitus, monitor your blood glucose levels more closely throughout the treatment.

  • If you have any liver disorder.

Isoacné may cause increased levels of transaminases (liver enzymes). Your doctor will prescribe regular blood tests before and during treatment to monitor your liver function. Transient and reversible increases in liver transaminases have been reported.

Persistent elevation of these enzyme levels may lead your doctor to reduce the dose of Isoacné or discontinue treatment.

  • If you have a history of intestinal disorders.

Stop treatment immediately and contact your doctor promptly if:

  • You become pregnant during treatment or within one month after stopping treatment.

  • You notice:

  • A rash that may progress to blisters or widespread skin peeling, or ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, swollen eyes). These could be signs of a serious skin reaction (e.g., erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis), which can be potentially life-threatening. These severe skin rashes are often preceded by headache, fever, and body aches (flu-like symptoms).

  • Breathing difficulties, itching and/or skin rashes. These symptoms may be due to an allergic reaction, and some may manifest as bruises or red spots on the arms and legs.

  • Headache accompanied by nausea, vomiting, or vision problems.

  • Severe stomach pain, nausea or vomiting, or severe diarrhoea with blood in the stool.

  • Difficulty or even inability to urinate.

  • Decreased night vision and/or visual disturbances.

  • Mental health problems: particularly signs of depression (intense feelings of sadness or crying spells, self-harm attempts, or withdrawal from family and friends).

You may not notice some changes in your mood and behaviour, so it is very important to inform your friends and family that you are taking this medicine. They may observe these changes and help you quickly identify any problems that need to be discussed with your doctor.

? If you notice that your eyes or skin turn yellowish and feel dizzy.

Special warnings for women:

Important in Pregnancy and Breastfeeding

Pregnancy Prevention Programme

Pregnant women must not take Isoacné.

This medicine can seriously harm the unborn baby (the medicine is considered "teratogenic") – it may cause severe abnormalities in the baby's brain, face, ears, eyes, heart, and certain glands (thymus and parathyroid). It also increases the risk of miscarriage. This can happen even if Isoacné is taken for only a short time during pregnancy.

  • Do not take Isoacné if you are pregnant or think you may be pregnant.
  • Do not take Isoacné if you are breastfeeding. The medicine is likely to pass into your milk and may harm your baby.
  • Do not take Isoacné if you are capable of becoming pregnant during treatment.
  • Do not become pregnant during the month following discontinuation of this treatment, as medicine may still remain in your body.

Women who could become pregnant are prescribed Isoacné under strict rules due to the risk of harm to the unborn baby.

These rules are:

  • Your doctor must explain the risk of harm to the unborn baby to you – you must understand why you must not become pregnant and what you need to do to prevent pregnancy.
  • You must have discussed contraception (birth control) with your doctor. Your doctor will provide information on how to avoid pregnancy. Your doctor may refer you to a specialist for contraceptive advice.
  • Before starting treatment, your doctor will require you to take a pregnancy test. The test must confirm that you are not pregnant when starting treatment with Isoacné.

Women must use effective contraception before, during, and after taking Isoacné.

  • You must agree to use at least one highly reliable contraceptive method (e.g., an intrauterine device or contraceptive implant) or two effective methods that work in different ways (e.g., a hormonal contraceptive pill and a condom). Discuss with your doctor which methods are suitable for you.
  • You must use contraception for one month before starting Isoacné, throughout treatment, and for one month after stopping the medicine.
  • You must use contraception even if you are not having periods or are not sexually active (unless your doctor decides it is not necessary).

Women must agree to undergo pregnancy tests before, during, and after taking Isoacné.

  • You must agree to attend regular follow-up visits, ideally every month.
  • You must agree to undergo regular pregnancy tests before treatment, ideally every month during treatment, and one month after stopping Isoacné, because medicine may still remain in your body (unless your doctor decides it is not necessary in your case).
  • You must agree to undergo additional pregnancy tests if requested by your doctor.
  • You must not become pregnant during treatment or within one month after stopping treatment, as medicine may still be present in your body.
  • Your doctor will discuss all these points with you using a checklist and will ask you (or a parent/guardian) to sign it. This checklist confirms that you have been informed of the risks and will follow the above rules.

If you become pregnant while taking Isoacné, stop taking the medicine immediately and consult your doctor. Your doctor may refer you to a specialist for advice.

Additionally, if you become pregnant within one month after stopping Isoacné, you must consult your doctor. Your doctor may refer you to a specialist for advice.

Advice for men

The levels of oral retinoids in semen of men taking Isoacné are too low to harm their partner's baby. However, you should never share your medication with anyone.

Additional precautions

You must never give this medicine to anyone else. Please return any unused capsules to your pharmacist at the end of treatment.

You must not donate blood during treatment with this medicine, or for 1 month after stopping Isoacné, because a baby could be harmed if a pregnant woman receives your blood.

Advice for all patients

  • Talk to your doctor if you experience persistent pain in the lower back or buttocks during treatment with Isoacné. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may stop treatment with Isoacné and refer you to a specialist for management of inflammatory back pain. Further evaluation, including imaging modalities such as magnetic resonance imaging, may be required.

  • Isotretinoin may cause dry eyes, corneal opacities, keratitis, intolerance to contact lenses, and visual difficulties, including reduced night vision. Cases of dry eyes that do not resolve after discontinuation of treatment have been reported. Inform your doctor if you experience any of these symptoms. Your doctor may recommend using an eye lubricant or artificial tears. If you wear contact lenses and develop intolerance, you may be advised to wear glasses during treatment. Your doctor may refer you to a specialist for advice if you experience visual difficulties, and you may be asked to stop taking isotretinoin.

  • Acne may worsen during the first few weeks of treatment, with inflammatory skin lesions, but this usually resolves with continued treatment within 7 to 10 days and generally does not require dose adjustment.

  • Bone abnormalities (including delayed growth, additional growth, and reduced bone density) and calcium deposits in tendons and ligaments have occurred after several years of administration at very high doses for the treatment of keratinization disorders (keratin accumulation). The dose levels, duration of treatment, and total cumulative dose in these cases generally far exceeded those recommended for acne treatment.

  • Isotretinoin may cause hyperlipidemia (specifically increased triglycerides). Your doctor will evaluate these levels before, during, and after treatment with isotretinoin. If hyperlipidemia persists, your doctor may reduce your dose or discontinue isotretinoin. Hyperlipidemia may also be managed with dietary measures. Excessively high levels are sometimes associated with inflammation of the pancreas, which can be life-threatening.

Children

Do not give this medicine to children under 12 years of age, as it is not known whether it is safe or effective in this age group and it is not indicated for prepubertal acne.

Use of Isoacné with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Do not take medicines containing vitamin A or tetracyclines (a type of antibiotic), or use any topical acne treatments (other retinoids) during treatment with Isoacné.

Concomitant use of isotretinoin with topical keratolytics or anti-acne exfoliating agents should be avoided, as this may increase local irritation.

Pregnancy, breastfeeding and fertility

For more information about pregnancy and contraception, see the section “Pregnancy Prevention Programme” in the “Warnings and Precautions” section.

Driving and using machines

Exercise caution if driving or operating machinery at night, as your night vision may be impaired during treatment, sometimes suddenly.

These disturbances rarely persist after treatment is stopped.

Somnolence and dizziness have very rarely been reported.

If you experience these symptoms, you must not drive or operate machinery, or engage in any other activity where such symptoms could put you or others at risk.

Isoacné contains soybean oil.

Do not use this medicine if you are allergic to peanuts or soybeans.

Daily life recommendations:

  • Apply moisturizing creams or ointments to your skin and use a lip balm during treatment if you experience dry skin or lips.
  • In general, avoid using any skin-irritating products (e.g., exfoliating creams) during treatment.
  • Avoid excessive sun exposure: Isoacné may increase sun sensitivity during treatment.

If, nevertheless, you cannot avoid sun exposure, apply a sunscreen (sun protection factor of at least 15).

Do not use UV lamps, tanning beds, or tanning booths.

  • Avoid wax hair removal during treatment and for at least 6 months after stopping treatment. Also avoid surgical dermabrasion and laser treatments (cosmetic procedures designed to smooth the skin, reduce scars, and signs of aging). These procedures may result in scarring, hypo-/hyperpigmentation (decoloration or excessive skin coloring), or epidermal peeling.
  • If you experience severe dry eyes, try wearing glasses instead of contact lenses during treatment.
  • You may need to wear sunglasses to protect your eyes from glare.
  • Take all necessary precautions if driving or operating machinery at night, because visual changes (impaired night vision) may occur suddenly.
  • Avoid engaging in strenuous physical exercise during treatment with Isoacné, as the treatment may occasionally cause muscle and joint pain.

3. How to take Isoacné

Dosage

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

The usual starting dose is 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day).

For most patients, the dose will range between 0.5 and 1.0 mg/kg/day.

If you feel that the effect of Isoacné is too strong or too weak, inform your doctor.

The capsules should be taken once or twice daily with food (with a glass of water). Swallow the capsules whole without chewing or sucking them.

Patients with severe renal impairment

In patients with severe renal impairment, treatment should be initiated at the lowest dose (e.g., 10 mg/day).

Use in children

Isoacné is not indicated in children for the treatment of prepubertal acne and its use is not recommended in children under 12 years of age.

Patients with intolerance

In patients who experience severe intolerance to the recommended dose, the physician may continue treatment with the maximum tolerated dose.

A treatment cycle with Isoacné lasts between 16 and 24 weeks. Your skin condition may continue to improve for up to 8 weeks after the end of treatment.

Therefore, wait at least this 8-week period before starting a new treatment cycle, if necessary. Most patients require only one treatment cycle.

If you take more Isoacné than you should

If you have taken more Isoacné than you should, you may experience hypervitaminosis A, whose symptoms include severe headaches, nausea or vomiting, drowsiness, irritability, and itching.

If you have taken more Isoacné than you should, consult your doctor or pharmacist immediately, or go to the nearest hospital as soon as possible.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Isoacné

If you forget to take a dose of Isoacné, do not take a double dose to make up for the missed doses.

Continue with your scheduled doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

These effects often resolve during treatment or after stopping or adjusting the dose (discuss this with your doctor); however, some may persist even after treatment has been discontinued. Your doctor can help you manage the situation.

Some adverse effects may be serious

  • Mental health problems

Rare effects (may affect up to 1 in 1,000 people):

  • Depression or related disorders. These signs include sad or changed mood, anxiety, feelings of emotional distress.
  • Worsening of existing depression
  • Becoming violent or aggressive

Very rare effects (may affect up to 1 in 10,000 people):

  • Some people have had feelings or thoughts of harming themselves or ending their lives (suicidal thoughts), attempted suicide, or died by suicide. These individuals may not appear depressed.
  • Unusual behavior.
  • Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that are not there.

Contact your doctor immediately if you experience any of these mental health problems. Your doctor may advise you to stop taking Isoacné. This may not be sufficient to stop the effects: you may need further help, which your doctor can manage.

  • Rare effects (may affect up to 1 in 1,000 people): Sudden and rapid allergic reaction (anaphylactic reactions: difficulty breathing or swallowing due to sudden swelling of the throat, face, lips, and mouth. Additionally, sudden swelling of hands, feet, and ankles).

If you have any allergic reaction, stop taking Isoacné and contact your doctor immediately.

  • Frequency not known (cannot be estimated from available data): Severe skin rashes (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which are potentially life-threatening and require immediate medical attention. These rashes initially appear as circular spots, often with central blisters, typically on the arms and hands or legs and feet. More severe rashes may include blisters on the chest and back. Other symptoms may occur, such as eye infection (conjunctivitis) or mouth, throat, or nose ulcers. Severe forms of rash may progress to widespread skin peeling, which can be potentially fatal. These severe skin rashes are often preceded by headache, fever, and body aches (flu-like symptoms).

If you develop a severe rash or these skin symptoms, stop taking Isoacné and contact a doctor immediately.

All other adverse effects are listed below by frequency.

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

  • Decreased red blood cell count (anemia), decreased platelet count, and increased platelet count.

  • Increased erythrocyte sedimentation rate (marker of acute inflammation).

  • Increased blood fatty acids (elevated blood triglycerides), decreased fat/protein ratio (decreased high-density lipoproteins).

  • Elevated liver enzymes (increased transaminases).

Therefore, your doctor may request blood tests and take appropriate measures.

  • Red sores or deep cracks at the corners of the mouth or lips, skin inflammation, dry skin, localized peeling, itching, red skin rash, skin fragility (friction injury).

  • Eyelid inflammation, eye itching, and eyelid crusts (conjunctivitis), eye irritation, and dry eyes.

  • Back pain (particularly in adolescent patients), muscle pain, and joint pain. Therefore, it is advisable to reduce physical exercise during treatment. All these effects are reversible after stopping treatment.

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

  • Increased blood glucose and certain types of fat (cholesterol), presence of protein or blood in urine.
  • Decreased count of white blood cells, increasing susceptibility to infections.
  • Headache.
  • Dry nose, nosebleeds, and rhinopharyngitis.

Rare adverse effects: may affect up to 1 in 1,000 people

  • Skin allergic reactions, hypersensitivity.
  • Hair loss (alopecia).

Very rare adverse effects: may affect up to 1 in 10,000 people

  • Pancreatitis, gastrointestinal bleeding, or inflammatory bowel disease. If you experience deep abdominal pain, with or without bloody diarrhea, nausea, and vomiting, stop taking isotretinoin and contact your doctor as soon as possible.
  • Liver disorder (hepatitis), including nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes.
  • Kidney disease, including severe fatigue, difficulty urinating or inability to urinate, and swollen eyelids. If you experience these symptoms while taking isotretinoin, stop treatment and contact your doctor.
  • Very high blood sugar levels (diabetes), with symptoms including excessive thirst, frequent urination, increased appetite with weight loss, fatigue, drowsiness, weakness, depression, irritability, and general malaise. In such cases, consult your doctor.
  • Benign intracranial hypertension has occurred in some patients taking isotretinoin concomitantly with certain antibiotics (tetracyclines).

This hypertension presents as persistent headaches, with nausea, vomiting, or blurred vision (possibly caused by swelling of the optic nerve (papilledema)). Stop taking Isoacné and contact your doctor as soon as possible.

  • Seizures.

  • Narrowing or blockage of blood vessels.

  • Worsening of acne during the first weeks of treatment, with inflammatory skin lesions.

  • Severe form of acne (acne fulminans): sudden development of inflammatory nodules, ulcerated, necrotic, and hemorrhagic lesions on the face and/or trunk, with or without fever and joint pain. In this case, stop taking isotretinoin and contact your doctor as soon as possible.

  • Inflammation of the colon.

  • Localized bacterial infection may occur.

  • Facial erythema, cutaneous erythema.

  • Hair changes, abnormal hair growth, nail abnormalities, and nail infections.

  • Thickened scarring after surgery.

  • Benign vascular lesions of the skin and mucous membranes.

  • Increased sensitivity to sunlight (photosensitivity reaction, see daily life recommendations in section 2). Increased pigmentation, excessive sweating.

  • Enlargement of lymph nodes.

  • Elevated blood uric acid levels, which may cause gout.

  • This medicine may affect night vision and cause sudden visual disturbances. Rarely, these effects persist after treatment has ended.

  • Difficulty distinguishing colors, severe eye irritation, corneal opacity, eye irritation or sensation of a foreign body in the eye (keratitis), blurred vision, visual problems (cataracts), increased sensitivity to light, visual disturbances, and poor tolerance to contact lenses. You may need to wear sunglasses to protect your eyes from glare.

If this medicine causes you any visual difficulty, inform your doctor immediately.

  • Hearing impairment.

  • Sudden chest tightness with difficulty breathing and wheezing (bronchospasm), particularly in patients with asthma, abnormal voice changes (hoarseness).

  • Dry throat, nausea.

  • Malaise.

  • Excessive tissue production during wound healing (increased granulation tissue formation).

  • Disorders mainly affecting joints with pain and swelling, bone abnormalities (growth delay (caused by premature fusion of epiphyses), increased growth, and reduced bone density), calcium deposits in soft tissues, tendon inflammation.

  • Blood levels of an enzyme (creatine phosphokinase) released during muscle fiber breakdown may increase, particularly during intense physical exercise in patients taking isotretinoin, leading to muscle rupture that may cause kidney disorders.

  • Drowsiness and dizziness.

Frequency not known: cannot be estimated from available data

  • Difficulty achieving or maintaining an erection
  • Decreased libido
  • Breast swelling with or without tenderness in men
  • Vaginal dryness
  • Sacroiliitis, a type of inflammatory low back pain causing buttock or lower back pain
  • Urethritis

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 may 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 Isoacné

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

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

Do not store above 25°C. Keep in the original packaging. Keep the container tightly closed to protect from light.

When treatment is finished, any unused capsules must be returned to your pharmacist.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Isoacné 40 mg soft capsules

  • The active substance is isotretinoin. Each capsule contains 40 mg of isotretinoin.

  • The other components are: Soybean oil (see section 2), hydrogenated vegetable oil, and yellow beeswax.

Capsule shell composition: Gelatin, glycerol, purified water, red iron oxide (E172), yellow iron oxide (E172), 50% titanium dioxide (E171) in glycerol.

Black ink composition: Alcohol SDA 35, propylene glycol (E1520), black iron oxide, polyvinyl acetate phthalate, water, isopropyl alcohol, polyethylene glycol, ammonium hydroxide.

Appearance of the product and contents of the pack

Each 40 mg capsule has an opaque gelatin shell, brownish-orange in color, with a bright yellow/orange filling, and printed on one side with the logo “I40”.

Marketing Authorization Holder

PIERRE FABRE IBÉRICA, S.A.
C/ Ramón Trias Fargas, 7-11
08005 Barcelona - Spain
Telephone: 93 483 30 00
Fax: 93 483 30 59

Manufacturer

CATALENT FRANCE BEINHEIM SA
74, rue Principale
F-67930 Beinheim, France

Or

Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1 and 2
Schorndorf, Baden-Wuerttemberg
73614, Germany

Or

CATALENT GERMANY EBERBACH GmbH
Gammelsbacher Str. 2
Eberbach, Baden-Wuerttemberg
69412, Germany

This medicinal product is authorized in other EEA Member States under the following names:

  • Czech Republic, France, Poland: CURACNE
  • Spain: ISOACNÉ
  • Belgium: ISOCURAL
  • Italy: ISORIAC

Date of the most recent review of this package leaflet: March 2024

Prescription and dispensing conditions

Isoacné is a prescription-only medicine that requires special medical monitoring during treatment.

For women of childbearing potential

  • Prior to prescription, the patient must agree to take precautions and use contraceptive methods.

  • The duration of the prescription is limited to one month of treatment. Continuation of treatment requires a new prescription.

  • The treatment may only be dispensed if the following mandatory conditions for prescription are met:

    • For the first prescription:

      • Signed informed consent regarding contraceptive precautions.
      • Use of at least one effective contraceptive method for at least one month prior to starting treatment.
      • Assessment of the patient's level of understanding.
      • Date of the pregnancy test (plasma hCG).

    • For subsequent prescriptions:

      • Continued use of effective contraceptive methods.
      • Assessment of the patient's level of understanding.
      • Date of the most recent pregnancy test (plasma hCG).

Additional information about Isoacné can be obtained by consulting your doctor or pharmacist.

Detailed and up-to-date information on this product is available by scanning the QR code included in the package leaflet using a smartphone. The same information is also available at the following link: https://cima.aemps.es/cima/publico/home.html and on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/*

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