Paroxetine Qualigen Farma 20 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paroxetina Qualigen Farma 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet as 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Paroxetina Qualigen Farma is and what it is used for

Paroxetine is used for the treatment of depression and/or anxiety disorders in adults.

The anxiety disorders for which paroxetine is indicated are:

obsessive-compulsive disorder (obsessive, repetitive thoughts with uncontrollable behavior),
panic disorder (panic attacks, including those caused by agoraphobia, which is fear of open spaces),
social anxiety disorder (fear of or avoidance of social situations),
post-traumatic stress disorder (anxiety caused by a traumatic event), and

generalized anxiety disorder (regularly feeling excessive anxiety and nervousness).

Paroxetina Qualigen Farma belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). The precise mechanism of action of paroxetine and other SSRIs is not fully understood, but they work by increasing the level of serotonin in the brain. Properly treating depression or anxiety disorder is important to help you feel better.

2. What you need to know before taking Paroxetina Qualigen Farma

Do not take Paroxetina Qualigen Farma:

if you are being treated with medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride), or if you have been treated with any of these medicines within the last two weeks. Your doctor will advise you on how to start taking Paroxetina Qualigen Farma after stopping the MAOI.
if you are taking an antipsychotic medicine called thioridazine or the antipsychotic called pimozide.
if you are allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6).
this medicine contains soya lecithin, which may contain soya oil. It should not be used if you are allergic to peanuts or soya.
if you are in any of these situations, inform your doctor and do not take Paroxetina Qualigen Farma.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Paroxetina Qualigen Farma:

if you are taking other medicines (see section Other medicines and Paroxetina Qualigen Farma).
if you are taking tamoxifen for the treatment of breast cancer (or fertility problems). Paroxetina Qualigen Farma may make tamoxifen less effective, so your doctor should recommend an alternative antidepressant.
if you have any kidney, liver, or heart problems.
if you have an abnormality in your heart rhythm seen on an electrocardiogram (ECG) known as QT interval prolongation.
if you have a family history of QT interval prolongation, heart diseases such as heart failure, slow heart rate, or low levels of potassium or magnesium.
if you have epilepsy or experience seizures or epileptic fits.
if you have had manic episodes (excessively active thoughts or behaviors).
if you are receiving electroconvulsive therapy (ECT).
if you are prone to bleeding or bruising, or are taking any medicine that may increase the risk of bleeding (including medicines such as warfarin (acenocoumarol), antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines for pain and inflammation called non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
if you have diabetes.
if you are on a low-sodium diet.
if you have glaucoma.
if you are pregnant or think you may become pregnant (see section Pregnancy, breastfeeding and fertility).
if you are under 18 years of age (see section Children and adolescents under 18 years of age).

If you are in any of these situations and have not yet consulted your doctor, ask them about how to take Paroxetina Qualigen Farma.

Children and adolescents

Paroxetine should not normally be used to treat children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking Paroxetina Qualigen Farma. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is best for the patient. If your doctor has prescribed Paroxetina Qualigen Farma to you or your child under 18 years of age and you wish to discuss this decision, consult your doctor. You must inform your doctor if any of the symptoms listed above appear or worsen while you or your child under 18 years of age are taking Paroxetina Qualigen Farma. The long-term effects of Paroxetina Qualigen Farma on safety regarding growth, maturation, and cognitive and behavioral development in this age group have not yet been established.

In clinical studies with Paroxetina Qualigen Farma in patients under 18 years of age, the common adverse effects, affecting less than 1 in 10 children or adolescents, were: increased suicidal thoughts and attempts, self-harm attempts, hostile behaviors, aggressive or unfriendly behaviors, loss of appetite, tremors, abnormal sweating, hyperactivity (excessive energy), agitation, emotional instability (including crying and mood swings), and occurrence of bruises or bleeding (such as nosebleeds). These effects were also observed, though less frequently, in patients in these studies who did not take Paroxetina Qualigen Farma.

When discontinuing treatment with Paroxetina Qualigen Farma, some patients under 18 years of age in these studies reported withdrawal symptoms. These symptoms were very similar to those observed in adults discontinuing Paroxetina Qualigen Farma (see section 3). In addition, patients under 18 years of age frequently experienced (affecting less than 1 in 10) stomach pain, nervousness, and emotional instability (including crying, mood changes, self-harm attempts, suicidal thoughts and attempts).

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts of self-harm or suicide. These may increase when first starting antidepressants, as all these medicines require time to begin working—usually about two weeks, although in some cases it may take longer.

This is more likely to happen:

if you have previously had suicidal thoughts or thoughts of harming yourself.
if you are a young adult. Clinical trial data show an increased risk of suicidal behavior in psychiatric patients under 25 years of age being treated with an antidepressant.

If you have thoughts of harming yourself or of suicide at any time, consult your doctor or go to the hospital immediately.

It may be helpful for you to inform a family member or close friend that you are depressed or have anxiety disorders, and ask them to read this leaflet. You may also ask them to tell you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Important adverse effects observed with Paroxetina Qualigen Farma

Some patients taking Paroxetina Qualigen Farma develop a condition called akathisia and feel restless, unable to sit or stay still. Other patients develop a condition known as serotonin syndrome or neuroleptic malignant syndrome, and may experience one or more of the following symptoms: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle stiffness, sudden jerky movements, or increased heart rate. The condition may worsen and lead to loss of consciousness. Consult your doctor if you experience any of these symptoms. For more information on this or other adverse effects of Paroxetina Qualigen Farma, see section 4.

Some medicines in the same class as Paroxetina Qualigen Farma (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Other medicines and Paroxetina Qualigen Farma

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may alter the effect of Paroxetina Qualigen Farma or make it more likely that certain adverse effects occur. Paroxetina Qualigen Farma may also alter the effect of some medicines. For example:

Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylene blue chloride). See section Do not take Paroxetina Qualigen Farma.
Medicines known to increase the risk of changes in the heart's electrical activity (e.g., the antipsychotics thioridazine or pimozide). See section Do not take Paroxetina Qualigen Farma.
Acetylsalicylic acid, ibuprofen, and other medicines called non-steroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, etodolac, ibuprofen, and meloxicam, used to treat pain and inflammation.
Tramadol, buprenorphine, and meperidine, analgesics.
Buprenorphine combined with naloxone, used as opioid addiction replacement therapy.
Medicines called triptans, such as sumatriptan, used to treat migraine.
Other antidepressants, including other selective serotonin reuptake inhibitors and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
A dietary supplement called tryptophan.
Mivacurium and suxamethonium (used in anesthesia).
Medicines such as lithium, risperidone, perphenazine, clozapine (antipsychotics) used to treat certain psychiatric disorders.
Fentanyl, used in anesthesia or for treating chronic pain.
A combination of fosamprenavir and ritonavir, used to treat human immunodeficiency virus (HIV) infection.
St. John’s wort, a herbal remedy used to treat depression.
Phenobarbital, phenytoin, sodium valproate, or carbamazepine, used to treat seizures or epilepsy.
Atomoxetine, a medicine used to treat attention deficit hyperactivity disorder (ADHD).
Procyclidine, used to relieve tremors, especially in Parkinson’s disease.
Warfarin and other medicines (called anticoagulants) used to thin the blood.
Propafenone, flecainide, and medicines used to treat high blood pressure and heart disorders.
Metoprolol, a beta-blocker used to treat heart rhythm disorders. Pravastatin, used to treat high cholesterol.
Rifampicin, used to treat tuberculosis (TB) and leprosy.
Linezolid, an antibiotic.
Tamoxifen, used to treat breast cancer (or fertility problems).

If you are taking or have recently taken any of these medicines, inform your doctor and ask what you should do. Your doctor may decide to change your dose or prescribe a different medicine.

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

Taking Paroxetina Qualigen Farma with food, drinks, and alcohol:

Do not consume alcohol while taking paroxetine. Alcohol may worsen your symptoms or side effects.

Taking paroxetine in the morning with food may reduce the likelihood of nausea.

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.

Some studies have shown an increased risk of birth defects, particularly those affecting the heart, in newborns whose mothers took paroxetine during the first months of pregnancy. In the general population, approximately 1 in 100 newborns is born with a heart defect. This rate increased to 2 in 100 newborns in mothers who took paroxetine. Your doctor, in consultation with you, may switch you to another treatment or gradually discontinue paroxetine treatment during pregnancy. However, depending on your circumstances, your doctor may recommend continuing paroxetine.

Ensure your doctor or midwife knows that you are taking paroxetine. If you take this medicine in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking paroxetine so they can advise you appropriately. Medicines like Paroxetina Qualigen Farma may increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) when taken during pregnancy, particularly in the later stages. In newborns with PPHN, the pressure in the blood vessels between the heart and lungs is very high.

If you take Paroxetina Qualigen Farma during the third trimester of pregnancy, your newborn may also experience other symptoms, usually beginning within the first 24 hours after birth. These symptoms include:

difficulty breathing
bluish skin or appearance of being too hot or too cold
blue lips
vomiting or feeding difficulties
extreme tiredness, trouble sleeping, or frequent crying
muscle stiffness or floppiness
tremors, localized tremors, or seizures
exaggerated reflexes.

If your baby shows any of these symptoms at birth, or if you are concerned about your newborn’s health, contact your doctor or midwife, who will advise you.

Paroxetine passes into breast milk in very small amounts. Consult your doctor if you are taking paroxetine before starting breastfeeding. Your doctor, in consultation with you, may advise continuing breastfeeding while taking paroxetine.

Animal studies have shown that paroxetine reduces sperm quality. Theoretically, this could affect fertility in humans, but this effect has not yet been observed in people.

Driving and using machines

Some of the adverse effects that Paroxetina Qualigen Farma may cause include dizziness, confusion, drowsiness, or blurred vision. If you experience any of these effects, do not drive or operate machinery.

Paroxetina Qualigen Farma contains soya lecithin and sodium

This medicine contains soya lecithin, which may contain soya oil. It should not be used if you are allergic to peanuts or soya.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Paroxetine Qualigen Farma

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

Sometimes you may need to take more than one tablet or half a tablet.

The following table shows how many tablets you should take:

Dosage	Number of tablets to take
10 mg	Half a tablet
20 mg	One tablet
30 mg	One and a half tablets
40 mg	Two tablets
50 mg	Two and a half tablets
60 mg	Three tablets

The recommended dose for the different indications is detailed in the following table:

	Initial daily dose	Recommended daily dose	Maximum daily dose
Depression	20 mg	20 mg	50 mg
Obsessive-compulsive disorder	20 mg	40 mg	60 mg
Panic disorder	10 mg	40 mg	60 mg
Social phobia disorder	20 mg	20 mg	50 mg
Post-traumatic stress disorder	20 mg	20 mg	50 mg
Generalized anxiety disorder	20 mg	20 mg	50 mg

Your doctor will tell you what dose to take when starting treatment with paroxetine. Most people start to feel better after a couple of weeks. If you do not start to feel better after this time, consult your doctor, who will advise you on what to do. Your doctor may decide to gradually increase your dose in 10 mg increments up to the maximum daily dose.

Take the tablets in the morning, with food.

The tablets should be swallowed with water.

Do not chew the tablets.

Your doctor will determine how long your treatment should last. This period may extend for several months or even longer.

Elderly patients

The starting dose for people over 65 years of age is 40 mg per day.

Patients with kidney or liver problems

If you have severe liver or kidney impairment, your doctor may advise you to take lower doses of paroxetine than usual.

If you take more Paroxetina Qualigen Farma than you should

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

A person who has taken an overdose of paroxetine may experience some of the symptoms listed in section 4, Possible adverse effects, or any of the following symptoms: fever, involuntary muscle contractions.

If you forget to take Paroxetina Qualigen Farma

Take your medication at the same time each day.

If you forget to take a dose and remember before going to bed, take it immediately. Take the next dose at your usual time.

If you remember during the night or the following day, skip the missed dose. You may experience some withdrawal symptoms, but these should disappear after taking your next dose at the usual time.

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

What to do if you do not feel better

Paroxetine will not improve your symptoms immediately; all antidepressants take time to work. Some people start to feel better after a couple of weeks, but others may require more time. Some people taking antidepressants may feel worse before they begin to feel better. If you do not start to feel better after a couple of weeks, inform your doctor, who will advise you on what to do. Your doctor may have scheduled a follow-up appointment two weeks after you started treatment.

If you stop taking Paroxetina Qualigen Farma

Do not stop treatment until your doctor tells you to do so.

When stopping treatment with paroxetine, your doctor will advise you on how to gradually reduce the dose over a period of several weeks or months. This will help reduce the risk of experiencing withdrawal symptoms.

One way to do this is to gradually reduce your current dose of paroxetine by 10 mg each week.

Most people find that the possible symptoms occurring when stopping paroxetine are mild and disappear on their own within two weeks. For others, these symptoms may be more severe or last longer.

If you experience withdrawal effects while stopping your treatment, your doctor may decide to stop the treatment more slowly. If you experience severe withdrawal symptoms, please consult your doctor. They may advise you to restart treatment and then stop it again more gradually.

Even if you experience withdrawal effects, you may still be able to discontinue your treatment with paroxetine.

Possible withdrawal effects when stopping treatment

Studies have shown that 3 out of every 10 patients experience one or more symptoms when stopping treatment with paroxetine. Some of these effects occur more frequently than others.

Frequent adverse effects

May affect up to 1 in 10 people

Feeling dizzy, unsteady, or having balance disturbances.
Tingling, burning sensations, and less frequently, electric shock-like sensations, even in the head; ringing, buzzing, hissing, or other persistent noises in the ears (tinnitus).
Sleep disturbances (very vivid dreams, nightmares, inability to sleep).
Anxiety.
Headaches.

Uncommon adverse effects

May affect up to 1 in 100 people

Vomiting (nausea).
Sweating (including night sweats).
Restlessness or agitation.
Tremor.
Confusion or disorientation.
Diarrhea (loose stools).
Feeling overly sensitive or irritable.
Visual disturbances.
Rapid or very strong heartbeats (palpitations).

Consult your doctor if you are concerned about withdrawal effects from paroxetine.

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. Adverse effects are more likely to occur during the first weeks of treatment with Paroxetina Qualigen Farma.

Inform your doctor if you experience any of the adverse effects listed below during treatment with Paroxetina Qualigen Farma.

You may need to consult your doctor or go to hospital immediately.

Uncommon adverse effects

May affect up to 1 in 100 people

If you have bruising or unusual bleeding, such as blood in vomit or stools, contact your doctor or go to hospital immediately.
If you are unable to urinate, contact your doctor or go to hospital immediately.

Rare adverse effects

May affect up to 1 in 1,000 people

If you experience seizures (epileptic fits), contact your doctor or go to hospital immediately.
If you feel restless, unable to sit still or remain motionless, a condition known as akathisia. Increasing the dose of Paroxetina Qualigen Farma may worsen your symptoms. If you feel this way, consult your doctor.
Tiredness, weakness, confusion, and pain, stiffness, and lack of muscle coordination. This may be due to low sodium levels in the blood. If you have these symptoms, consult your doctor.

Very rare adverse effects

May affect up to 1 in 10,000 people

Allergic reactions to Paroxetina Qualigen Farma, which may be severe.

If you develop a rash with redness and lumps, swelling of the face, lips, mouth or tongue, itching, or difficulty breathing (shortness of breath) or swallowing, and a feeling of weakness or dizziness that may lead to collapse or loss of consciousness, contact your doctor or go to hospital immediately.

If you notice one or more of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome.

Symptoms include: feeling very agitated or irritable, confusion, restlessness, feeling hot, sweating, tremor, chills, hallucinations (strange sounds or visions), muscle rigidity, sudden jerky movements, or rapid heartbeat. Severity may increase and lead to loss of consciousness. If you feel this way, consult your doctor.

Acute angle-closure glaucoma.

If you develop eye pain and blurred vision, consult your doctor.

Frequency not known

Frequency cannot be estimated from the available data

Some people have experienced thoughts of harming themselves or of suicide while taking Paroxetina Qualigen Farma or shortly after stopping treatment (see Suicidal thoughts and worsening of depression or anxiety disorder in section 2).
Some people have experienced aggression while taking Paroxetina Qualigen Farma.
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage). See Pregnancy, breastfeeding and fertility in section 2 for more information.

If you experience any of these adverse effects, contact your doctor.

Other possible adverse effects during treatment:

Very common adverse effects

May affect more than 1 in 10 people

Feeling unwell (nausea). This effect may be reduced by taking your medicine in the morning after breakfast.
Changes in sexual desire or function, for example, lack of orgasm, and in men, abnormal erection and ejaculation.

Common adverse effects

May affect up to 1 in 10 people

Increased blood cholesterol levels.
Decreased appetite.
Difficulty sleeping (insomnia) or drowsiness.
Abnormal dreams (including nightmares).
Dizziness, tremors.
Headache.
Difficulty concentrating.
Agitation.
Unusual weakness.
Blurred vision.
Yawning.
Dry mouth.
Diarrhoea or constipation.
Vomiting.
Weight gain.
Sweating.

Uncommon adverse effects

May affect up to 1 in 100 people

Transient increases in blood pressure, or transient decreases in blood pressure which may cause dizziness or fainting when standing up quickly.
Faster than normal heartbeat.
Lack of movement, stiffness, tremor, or abnormal movements of the mouth and tongue.
Pupil dilation.
Skin rash.
Itching.
Confusion.
Hallucinations (strange sounds or visions).
Inability to urinate (urinary retention) or urinary incontinence (uncontrolled, involuntary urination).
If you are a diabetic patient, you may notice loss of control of blood sugar levels while taking Paroxetina Qualigen Farma. Consult your doctor about adjusting your insulin or diabetes medication dosage.
Decreased white blood cell count.

Rare adverse effects

May affect up to 1 in 1,000 people

Abnormal breast milk secretion in men and women.
Slowed heart rate.
Liver effects seen in laboratory tests indicating liver function abnormalities.
Panic attacks.
Excessively active behaviour or thoughts (mania).
Feeling detached from oneself (depersonalization).
Anxiety.
Irresistible urge to move the legs (Restless Legs Syndrome).
Joint or muscle pain.
Increased blood levels of a hormone called prolactin.
Menstrual cycle disturbances (including heavy or irregular periods, bleeding between periods, and absence or delay of periods).

Very rare adverse effects

May affect up to 1 in 10,000 people

Skin rash, in which blisters may appear with a target-like appearance (dark central spots surrounded by a pale area, with a dark ring around it), known as erythema multiforme.
Widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
Widespread rash affecting large areas of the body with blisters and skin peeling (toxic epidermal necrolysis).
Liver disturbances causing yellowing of the skin or whites of the eyes.
Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and sodium (salt) levels decrease, due to inappropriate chemical signals. Patients with SIADH may feel severely ill or may have no symptoms.
Water or fluid retention (causing swelling of arms or legs).
Sensitivity to sunlight.
Painful and prolonged penile erection.
Decreased platelet count in blood.

Frequency not known

Inflammation of the colon (causing diarrhoea).
Teeth grinding.

Some patients have experienced ringing, buzzing, hissing, tinkling or other persistent noises in the ears (tinnitus) while taking Paroxetina Qualigen Farma.

It has been observed that people taking medicines like Paroxetina Qualigen Farma have an increased risk of bone fractures.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 PAROXETINE QUALIGEN FARMA

Keep this medicine out of sight and reach of children. No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Paroxetina Qualigen Farma 20 mg tablets:

The active substance is paroxetine in the form of hydrochloride. Each tablet contains 20 mg of paroxetine.

The other components (excipients) are: magnesium stearate (E-572), sodium carboxymethyl potato starch (type A), mannitol (E-421), microcrystalline cellulose (E-460i), poly(methacrylic acid-co-vinyl alcohol) copolymer (polymethacrylate alcohol polyvinyl alcohol hydrolyzed), titanium dioxide (E-171), talc, soybean lecithin (E-322), xanthan gum (E-415).

Appearance of the product and contents of the pack

Paroxetina Qualigen Farma 20 mg is presented as white or off-white, oval-shaped, biconvex, film-coated tablets with a break line.

Each pack contains 14, 28, 56 or 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Av. Barcelona, 69

08970 – Sant Joan Despí, Barcelona

Spain

Manufacturer:

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas, Madrid

Spain

Date of the most recent review of this leaflet: July 2024

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/