ACNISDIN 10 mg SOFT CAPSULES

Introduction

Patient Information: Summary of Product Characteristics

Acnisdin 10 mg soft capsules EFG

Acnisdin 20 mg soft capsules EFG

Acnisdin40 mg soft capsules

Isotretinoin

WARNING

IF YOU ARE PREGNANT, IT MAY SERIOUSLY HARM YOUR BABY.

Women must use effective contraceptives throughout treatment.

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

You can contribute by reporting any side effects you may have. The last part of section 4 includes information on how to report side effects.

Read the entire patient information leaflet carefully before starting to take this medication, as 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Patient Information Leaflet Contents

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

1. What is Acnisdin and what is it used for

This medication contains isotretinoin, a substance related to vitamin A that belongs to the group of medications called retinoids(for the treatment of acne).

Acnisdin is indicated for the treatment of severe forms of acne(such as nodular or conglobate acne, or acne that can cause permanent scarring) in adults and adolescents from 12 years of age, only after puberty. This medication is used when your acne has not improved after other treatments that may include antibiotics or dermatological treatments.

Treatment with isotretinoin should be carried out under the supervision of a dermatologist(a doctor specializing in the treatment of skin problems).

2. What you need to know before taking Acnisdin

Do not take this medicine:

• You are pregnant or breastfeeding.
• You plan to become pregnant.
• There is a possibility that you may become pregnant; you must follow the precautions of the "Pregnancy Prevention Plan", see the section "Warnings and precautions".
• You are allergic to isotretinoin, peanuts, or soy, or any of the components of Acnisdin. This medicine contains soybean oil, in addition to isotretinoin. See section 6 (Other information) at the end of the prospectus for the complete list of ingredients.
• You have been diagnosed with liver problems.
• You have been diagnosed with very high levels of fats in the blood (such as high cholesterol or triglycerides).
• You have been diagnosed with very high levels of vitamin A in your body (known as hypervitaminosis A).
• You are being treated at the same time with a type of antibiotic called tetracyclines (see "Other medicines and Acnisdin").

If you are affected by any of these situations, please consult your doctor again and do not take this medicine. Ask your doctor before taking it.

Warning for all patients

Consult your doctor before starting to take Acnisdin:

• If you have ever had any mental health problems. This includes depression, 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 Acnisdin.

Pregnancy Prevention Plan

Pregnant women should not take isotretinoin

This medicine can seriously harm the baby (the medicine is considered "teratogenic") - it can cause serious abnormalities of the brain, face, ear, eyes, heart, and certain glands of the baby (thymus and parathyroid). It also increases the likelihood of suffering a spontaneous abortion. This can happen even if Acnisdin is taken only for a short period during pregnancy.

• You must not take this medicine if you are pregnant or think you may be pregnant.
• You must not take this medicine if you are breastfeeding. It is likely that the medicine will pass into your milk and may harm your baby.
• You must not take this medicine if you can become pregnant during treatment.
• You must not become pregnant during the month following the interruption of this treatment because the medicine may still be in your body.

Pregnant women should not take Acnisdin

This medicine can cause serious harm to the fetus (the medicine is "teratogenic"); it can cause serious abnormalities in the brain, face, ears, eyes, heart, and certain glands (thymus and parathyroid) of the fetus. Additionally, it increases the risk of abortion, for example, if this medicine is taken only for a short period during pregnancy.

• You must not take Acnisdin if you are pregnant or think you may be.
• You must not take this medicine if you are breastfeeding. It is likely that the medicine will pass into your milk and may harm your baby.
• You must not take isotretinoin if there is a possibility that you may become pregnant during treatment.
• You must not become pregnant during the month following the interruption of this treatment, as the medicine may still be in your body.

Women who may become pregnant have Acnisdin prescribed under strict rules. This is due to the risk of serious harm to the baby.

These are the rules:

• Your doctor must explain to you the risk of harm to the baby - you must understand why you should not become pregnant and what you must do to avoid becoming pregnant.
• You must have spoken with your doctor about birth control (contraception). The doctor will give you information on how to avoid becoming pregnant. The doctor may refer you to a specialist for advice on contraception.
• Before starting treatment, your doctor will ask you to have a pregnancy test. The test must show that you are not pregnant when you start treatment with Acnisdin.

Women must use effective contraceptivesbefore, during, and after takingAcnisdin

• You must agree to use at least one very 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 would be suitable for you.
• You must use contraceptives during the month before taking Acnisdin, during treatment, and during the month after finishing treatment.
• You must use contraceptives even if you do not have your period or are not sexually active (unless your doctor decides it is not necessary).

Women must accept to have pregnancy tests before, during, and after taking Acnisdin

• You must agree to have regular follow-up visits, ideally every month.
• You must agree to have regular pregnancy tests, ideally every month during treatment and, because the medicine may still be in your body, 1 month after finishing treatment with this medicine (unless your doctor decides it is not necessary in your case).
• You must agree to have additional pregnancy tests if your doctor asks you to.
• You must not become pregnant during treatment or during the month after, because it is possible that the medicine may still be 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 about the risks and that you will follow the above rules.

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

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

Your doctor has printed information about pregnancy prevention for isotretinoin users that they should provide to you.

Advice for men

The levels of oral retinoids in the semen of men taking this medicine are too low to harm the baby of their partners. However, you should never share your medicine with anyone.

Additional precautions

Never give this medicine to another person. Please take any unused capsules to your pharmacist at the end of treatment.

You must not donate blood during treatment with this medicine, nor during 1 month after stopping Acnisdin, because a baby could be harmed if a pregnant patient receives your blood.

Mental health problems

You may not notice some changes in your mood and behavior, so it is very important that you tell your friends and family that you are taking this medicine. They may notice these changes and help you identify any problems that you need to discuss with your doctor.

Warning for all patients

• Tell your doctor if you have ever suffered from any mental illness(such as depression, suicidal behavior, or psychosis) or if you are taking medicines for these diseases.
• Severe skin reactions(e.g., erythema multiforme (EM), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (TEN)) have been reported with the use of this medicine. The skin rash may progress to widespread blistering or peeling of the skin. You should also be aware of the formation of ulcers in the mouth, throat, nose, or genitals, as well as the development of conjunctivitis (redness and swelling of the eyes).
• This medicine can rarely cause severe allergic reactions,some of which may affect the skin in the form of eczema, urticaria (skin rash with bumps), and bruising or red spots on arms and legs. If you experience an allergic reaction, stop taking the medicine, go to the doctor immediately, and tell them that you are taking this medicine.
• Reduce physical activity and intense exercise. Isotretinoin can cause muscle and joint pain, especially in young people.
• Talk to your doctor if you experience persistent pain in the lower back or buttocks during treatment with Acnisdin. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may interrupt treatment with Acnisdin and refer you to a specialist for treatment of inflammatory back pain. You may need further evaluation, including imaging modalities such as MRI.
• Isotretinoin has been associated with inflammatory bowel disease.If you suffer from severe diarrhea with blood and have no history of gastrointestinal disorders, your doctor will withdraw treatment with isotretinoin.
• Isotretinoin may cause dry eyes, intolerance to contact lenses, and visual difficulties such as decreased night vision.Cases of dry eyes that do not resolve after treatment have been reported. Tell your doctor if you experience any of these symptoms. Your doctor may recommend the use of an eye lubricant or artificial tears. If you are a contact lens user and develop intolerance, you may be advised to use glasses during treatment. If you experience visual disturbances, your doctor may refer you to a specialist for advice and may ask you to stop treatment with isotretinoin.
• It is likely that your skin will become dry:use a moisturizing cream and lip balm. To prevent skin irritation, it is best not to use "exfoliating" products or other acne products.
• Avoid exposure to the sun and do not use sunlamps or sunbeds.Your skin may become more sensitive to sunlight. Before exposing yourself to the sun, apply a sunscreen with a high protection factor (SPF 50 or higher).
• Do not have any cosmetic treatments on your skin.Isotretinoin can make your skin more fragile. Do not wax or have dermabrasion or laser treatments (to remove thickening of the skin's outer layer or scars) during treatment or in the 6 months after, as this could cause scarring, skin irritation, or, in rare cases, changes in skin color.

Children and adolescents

Isotretinoin is not recommended for use in children under 12 years of age. This is because it is not known if it is safe or effective in this age group.

Use in children over 12 years of age only after puberty.

Other medicines and Acnisdin

• Do not take supplements that contain vitamin A or tetracyclines(a type of antibiotic)
• Do notuse skin treatments for acne that dry or peel your skin while taking isotretinoin. You can use moisturizing and emollient products (creams or preparations that prevent water loss and have a softening effect on the skin).

Consult your doctor or pharmacist if you are taking any other medicine, including herbal products and over-the-counter products (such as multivitamin supplements) and skin products, or if you have taken them recently.

Pregnancy and breastfeeding

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

For more information about pregnancy and contraception, see the section "Pregnancy Prevention Plan" in section 2 "Warnings and precautions".

Special precautions

Do not take this medicine if you are pregnant.

Driving and using machines

You may have problems with your eyes and your vision may be affected during treatment. This can occur suddenly. In rare cases, night vision problems have continued after treatment was stopped.

In very rare cases, drowsiness and dizziness have been reported. If this happens to you, do not drive, ride a bike, or use machinery.

Important information about some of the components of Acnisdin:

Acnisdin contains:

• Soybean oil:It must not be used in case of peanut or soy allergy.
• Sorbitol:Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.
• If your doctor has told you that you (or your child) have an intolerance to some sugars or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before taking or receiving this medicine.

• Acnisdin 10 mg: this medicine contains 5 mg of sorbitol in each soft capsule.
• Acnisdin 20 mg: this medicine contains 7 mg of sorbitol in each soft capsule.
• Acnisdin 40 mg: this medicine contains 10 mg of sorbitol in each soft capsule.

Acnisdin 10mg and 40mg:these medicines may cause allergic reactions because they contain Ponceau 4R. They may cause asthma, especially in patients allergic to acetylsalicylic acid.

Acnisdin 20mg:this medicine may cause allergic reactions because it contains Orange Yellow S. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to Take Acnisdin

Follow the administration instructions for this medication exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The usual starting doseis 0.5 mg per kilogram of body weight and per day (0.5 mg/kg/day). Consequently, if you weigh 60 kg, you will normally start with a dose of 30 mg per day.

Take the capsules once or twice a day.Take them during meals or immediately after meals. Swallow them whole with the help of a liquid or a bite of food.

After a few weeks, your doctor may adjust your dose.This will depend on how you feel with the medication. For most people, the dose will range between 0.5 and 1 mg per kilogram of body weight and day. If you think this medication is too strong or too weak, consult your doctor or pharmacist.

If you have severe kidney problems, you will normally start with a lower dose (e.g., 10 mg per day) that will be increased until you reach the maximum dose your body can tolerate. If your body cannot tolerate the recommended dose, you may be prescribed a lower dose. This means that the treatment will be longer and it is more likely that your acne will reappear.

A treatment cycle usually lasts between 16 and 24 weeks.Most people only need one cycle. Your acne may continue to improve up to 8 weeks after treatment. You will not normally start another cycle before this time has passed.

You may experience worsening acne during the first week of treatment. It usually improves as treatment progresses.

If you take more Acnisdin than you should

If you take too many capsules, or if someone else takes your medication by accident, contact your doctor or pharmacist immediately, or go to the nearest hospital.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the nearest hospital immediately, or call the Toxicology Information Service, phone: 91 562 04 20.

If you forgot to take a dose

If you forgot to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue treatment as before. Do not take two doses at the same time.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them. Some of the side effects associated with the use of isotretinoin are related to the dose. They are side effects that usually reverse after changing the dose or interrupting treatment; however, some may continue after treatment is suspended. Some side effects can be serious and you should contact your doctor immediately. Your doctor can help you treat them.

Side effects that require immediate medical attention:

Skin problems

Unknown frequency(cannot be estimated from the available data)

• Severe skin rashes (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), potentially fatal and requiring immediate medical attention. They appear as circular spots, often with central blisters, on the arms and hands or legs and feet, the most severe rashes can occur with blisters on the chest and back. Other symptoms may appear, such as eye infection (conjunctivitis) or ulcers in the mouth, throat, or nose. The most severe forms of skin rash can cause the skin to peel off in a generalized manner, which can be fatal. These severe skin rashes are usually preceded by headache, fever, body aches (symptoms similar to those of the flu).

If you experience a severe rash or these skin symptoms, stop taking Acnisdin and contact your doctor immediately.

Mental health problems

You may not be aware of some changes in your mood and behavior, so it is very important that you discuss with your friends and family that you are taking this medication. They may notice these changes and help you identify any problems that you should consult with your doctor about.

Rare side effects(may affect 1 in 1,000 people)

• Depression or related disorders. Some symptoms are: feeling sad or empty, mood changes, anxiety, episodes of crying, irritability, loss of interest in social or sports activities, sleeping too much or too little, weight changes or altered appetite, decreased performance at work or school, or concentration problems.
• Worsening of existing depression.
• Violent or aggressive behavior.

Very rare side effects(may affect 1 in 10,000 people)

• Some people have had thoughts of harming themselves or ending their lives (suicidal thoughts), have tried to commit suicide, or have committed suicide. These people may not appear to be 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 symptoms of any of these mental problems.Your doctor may indicate that you should interrupt treatment with Acnisdin. It is possible that this may not be enough for the effects to disappear and that you may need more help (your doctor can organize it).

Allergic reactions

Rare side effects(may affect 1 in 1,000 people)

• Severe allergic reactions (anaphylactic): difficulty breathing or swallowing caused by a sudden swelling of the throat, face, lips, and mouth. Also, sudden swelling of the hands, feet, and ankles.

Very rare side effects(may affect 1 in 10,000 people)

• Chest tightness, sudden shortness of breath, and wheezing, especially if you have asthma.

If you experience a severe reaction, seek immediate emergency medical attention.

If you have an allergic reaction, stop taking this medication and contact your doctor.

Bones and muscles

Unknown frequency(cannot be estimated from the available data)

• Muscle weakness that can be potentially fatal; may be associated with problems moving the arms or legs, pain, swelling, bruising in the body, dark urine, low or no urine production, confusion, or dehydration. These are symptoms of rhabdomyolysis, a breakdown of muscle tissue that can cause kidney failure. This could occur if you engage in intense physical activity while taking Acnisdin.

Liver and kidney problems

Very rare side effects(may affect 1 in 10,000 people)

• Yellowing of the skin and eyes and feeling tired. They can be symptoms of hepatitis. Stop taking this medication immediately and contact your doctor.
• Difficulty urinating, swollen eyelids, excessive fatigue. They can be symptoms of kidney inflammation.

Stop taking Acnisdin immediately and contact your doctor.

Nervous system problems

Very rare side effects(may affect 1 in 10,000 people)

• Long-lasting headache, with nausea, vomiting, and changes in vision, such as blurred vision. They can be symptoms of benign intracranial hypertension, especially if Acnisdin is taken with antibiotics from the tetracycline group. Stop taking this medication immediately and contact your doctor.

Intestinal and stomach problems

Very rare side effects(may affect 1 in 10,000 people)

• Severe abdominal pain, accompanied or not by intense diarrhea with blood, nausea, and vomiting. They can be symptoms of serious intestinal disorders. Stop taking Acnisdin immediately and contact your doctor.

Eye disorders

Very rare side effects(may affect 1 in 10,000 people)

• Blurred vision.

If you experience blurred vision, stop taking this medication immediately and contact your doctor.If your vision is affected in any other way, consult your doctor as soon as possible.

Other side effects:

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

• Dry skin, especially on the lips and face; inflamed skin, cracked and inflamed lips, skin rash, mild itching, and slight peeling. Use a moisturizing cream from the start of treatment.
• The skin becomes more fragile and reddened than usual, especially on the face.
• Back pain; muscle pain; joint pain, especially in children and adolescents. To prevent bone and muscle problems from getting worse, reduce the intensity of physical activity while taking this medication.
• Eye inflammation (conjunctivitis) and eyelids; eyes feel dry and irritated. Consult your pharmacist for a suitable eye drop. If you have dry eyes and are a contact lens user, you may need to wear glasses instead.
• Increased levels of liver enzymes in blood tests.
• Changes in blood fat levels (such as HDL cholesterol and triglycerides).
• Increased tendency to bruise, bleed, or form clots: if the cells responsible for coagulation are affected.
• Anemia (weakness, dizziness, pale skin): if the red blood cells are affected.

Common side effects(may affect 1 in 10 people)

• Headache.
• High cholesterol levels in the blood.
• Protein or blood in the urine.
• Increased tendency to have infections, if the white blood cells are affected.
• Dryness and crust formation inside the nasal passages that can cause mild nosebleeds.
• Pain and inflammation of the throat and nose.
• Allergic reactions such as skin rash or itching. If you have an allergic reaction, stop taking this medication and contact your doctor.

Rare side effects(may affect 1 in 1,000 people)

• Hair loss (alopecia). This is usually a temporary effect. Your hair will return to normal after the end of treatment.

Very rare side effects(may affect 1 in 10,000 people)

• Worsening of night vision; color blindness and worsening of color vision.
• Increased sensitivity to light; you may need to wear dark glasses to protect your eyes from excessive sunlight.
• Other eye problems, such as blurred or distorted vision, and clouding of the cornea (corneal opacity, cataracts).
• Excessive thirst; frequent need to urinate; increased sugar levels in blood tests. They can all be symptoms of diabetes.
• Acne may worsen in the first few weeks, but symptoms improve over time.
• Inflamed, swollen, and darker skin than usual, especially on the face.
• Excessive sweating or itching.
• Arthritis; bone disorders (growth delay, increased growth, and changes in bone density); growing bones may stop growing.
• Calcium deposits in soft tissues, tendon pain, elevated levels of muscle breakdown products in the blood if you engage in vigorous exercise.
• Increased sensitivity to light.
• Bacterial infections at the base of the nails, changes in the nails.
• Swelling, suppuration, pus.
• Thickening of surgical scars.
• Increased body hair.
• Seizures, drowsiness, dizziness.
• The lymph nodes may become swollen.
• Dry throat, hoarseness.
• Hearing difficulties.
• Feeling of general discomfort.
• High levels of uric acid in the blood.
• Bacterial infections.
• Inflammation of blood vessels (sometimes with bruising or red spots).

Unknown frequency:(cannot be estimated from the available data)

• Dark urine (similar to Coca-Cola).
• Difficulty getting or maintaining an erection.
• Decreased libido.
• Breast inflammation with or without sensitivity in men.
• Vaginal dryness
• Urethra inflammation
• Sacroiliitis, a type of inflammatory lower back pain that causes pain in the buttocks or lower back.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Acnisdin

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice that the packaging is damaged or shows signs of tampering.

Store below 25 °C. Store in the original packaging and keep the blister pack in the outer packaging to protect it from light.

Medications should not be thrown down the drain or into the trash.

Deposit the packaging and medications you no longer need at the SIGRE Point in your usual pharmacy.

If you are in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Return the leftover capsules to the pharmacist.Store them only if your doctor tells you to.

6. Package Contents and Additional Information

Composition of Acnisdin

The active ingredient is isotretinoin.

• Each 10 mg Acnisdin soft capsule contains 10 mg of isotretinoin.
• Each 20 mg Acnisdin soft capsule contains 20 mg of isotretinoin.
• Each 40 mg Acnisdin soft capsule contains 40 mg of isotretinoin.

The other components are: all-rac-alfa-tocopherol acetate, hydrogenated vegetable oil (type II), hydrogenated soybean oil, yellow beeswax, refined soybean oil, gelatin, glycerol, partially dehydrated sorbitol liquid, patented blue V (E-131), and ponceau 4R red (E-124) for the 10 mg and 40 mg capsules, and orange yellow S (E-110) for the 20 mg capsules, and purified water.

Appearance of the Product and Package Contents

Acnisdin is marketed in 10 mg, 20 mg, or 40 mg soft capsules of isotretinoin.

• Acnisdin 10 mg: oval-shaped soft capsules, purple in color, size 3. The capsule is approximately 11.1 mm long and 6.8 mm wide.
• Acnisdin 20 mg: oval-shaped soft capsules, white to cream in color, size 6. The capsule is approximately 13.8 mm long and 8.1 mm wide.
• Acnisdin 40 mg: oval-shaped soft capsules, purple in color, size 12. The capsule is approximately 16.1 mm long and 10.1 mm wide.

PVC/TE/PVdC/aluminum foil blisters, orange in color.

• 10 mg soft capsules: packages of 30, 50, 60, and 100 capsules.
• 20 mg soft capsules: packages of 30, 50, 60, and 100 capsules.
• 40 mg soft capsules: packages of 30 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

ISDIN, S.A.

Provençals 33

08019 Barcelona

Spain

Manufacturer:

GAP SA

46, Agissilaou str.,

173 41 Agios Dimitrios, Attiki,

Greece

This medication is authorized in the Member States of the European Economic Area under the following names:

Austria:Isotretinoin GAP 5 mg, 10 mg, 20 mg, 40 mg soft capsules

Germany:Isotretinoin GAP 10 mg, 20 mg soft capsules

Ireland:Isotretinoin GAP 10 mg, 20 mg soft capsules

Portugal:Isotretinoin GAP 10 mg, 20 mg soft capsules

Denmark:Isotretinoin 2care4

Finland:Isotretinoin 2care4 10 mg, 20 mg soft capsules

Norway:Isotretinoin 2care4

Sweden:Isotretinoin 2care4 10 mg, 20 mg soft capsules

Spain:Acnisdin 10 mg soft capsules EFG, Acnisdin 20 mg soft capsules EFG, Acnisdin 40 mg soft capsules

Date of the last revision of this leaflet:January 2024

Detailed and updated information on this medication is available on the website of the

Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Detailed and updated information on this product is available by scanning the QR code

included in the leaflet using a smartphone. The same information is also available at the following link: