Paroxetine Mylan Pharma

Package leaflet: Information for the user

Paroxetina Mylan Pharma 10 mg/ml, oral drops, solution

Equivalent medicine
Please read all of this 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 only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Paroxetina Mylan Pharma is and what it is used for
2. What you need to know before taking Paroxetina Mylan Pharma
3. How to take Paroxetina Mylan Pharma
4. Possible side effects
5. How to store Paroxetina Mylan Pharma
6. Contents of the pack and other information

1. What Paroxetina Mylan Pharma is and what it is used for

Paroxetina Mylan Pharma contains the active substance paroxetine, an antidepressant that belongs to a group of medicines called "selective serotonin reuptake inhibitors" (SSRIs). Everyone has a chemical in the brain called serotonin. People who are depressed or anxious tend to have lower levels of serotonin than others. It is not fully understood how Paroxetina Mylan Pharma and other SSRIs work, but they may help by increasing the level of serotonin in the brain.

Other medicines and psychotherapy can also treat depression and anxiety. Appropriate treatment of depression and anxiety disorders is important to help you feel better. If left untreated, your condition may not improve and could become more severe and harder to treat. You may find it helpful to talk to a friend or family member about your depression or anxiety disorder, and you may ask them to read this leaflet. You could ask them to let you know if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.

Paroxetina Mylan Pharma is used in adults for the treatment of:

• Depression (major depressive episode).
• Obsessive-compulsive disorder.
• Panic disorder with or without agoraphobia.
• Social anxiety disorder/social phobia (intense fear of any everyday social situation).
• Generalised anxiety disorder.
• Post-traumatic stress disorder.

Speak to your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Paroxetine Mylan Pharma

Do not take Paroxetine Mylan Pharma

• If you are currently taking or have taken within the last two weeks other medicines known as monoamine oxidase inhibitors (MAOIs, including moclobemide). Your doctor will advise you on how to start taking Paroxetine Mylan Pharma after stopping the MAOI.
• If you are taking an antipsychotic called thioridazine or an antipsychotic called pimozide.
• If you are allergic to paroxetine or to any of the other ingredients of this medicine (listed in section 6).

If any of these apply to you, talk to your doctor before taking Paroxetine Mylan Pharma.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paroxetine Mylan Pharma.
If you are taking other medicines (read "Other medicines and Paroxetine Mylan Pharma").
If you have eye, kidney, liver, or heart problems.
If you are taking tamoxifen for the treatment of breast cancer or fertility issues, Paroxetine Mylan Pharma may reduce the effectiveness of tamoxifen, so your doctor may recommend taking another antidepressant.
If you have epilepsy or have had seizures or convulsions.
If you have episodes of mania (manic thoughts or behaviors).
If you are undergoing electroconvulsive therapy (ECT).
If you have previously experienced bleeding or are taking other medicines that may increase the risk of bleeding (these include medicines used to thin the blood, such as warfarin, antipsychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs or 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 (increased eye pressure).
If you are pregnant or planning a pregnancy (see within this leaflet Pregnancy, breastfeeding and fertility).
If you are under 18 years of age.
Medicines such as Paroxetine Mylan Pharma (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
If you answer YES to any of these questions, and have not already discussed this with your doctor,
return to your doctor and ask what you should do regarding taking Paroxetine Mylan Pharma.
Suicidal thoughts and worsening of depression or anxiety disorder
If you suffer from depression and/or anxiety disorders, you may occasionally have self-harming or suicidal thoughts.
These may increase when you first start taking antidepressants, as these medicines take time to work—usually about two weeks, but sometimes longer.
You may be more prone to such thoughts:
if you have previously had suicidal or self-harming thoughts.
If you are a young adult. Adults under 25 years of age with psychiatric disorders treated with an antidepressant have shown an increased risk of suicidal behavior. If at any time you experience suicidal or self-harming thoughts, contact your doctor or go immediately to hospital.
You may find it helpful to talk to a friend or relative about your depression or anxiety disorder and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening or if they are concerned about changes in your behavior.
If you develop restlessness, agitation, or inability to sit still or stand still, usually associated with subjective distress. This is more likely to occur during the first weeks of treatment. If you develop these symptoms, increasing the dose may be harmful.
If you develop a specific syndrome called serotonin syndrome/neuroleptic malignant syndrome, which presents as a combination of symptoms such as increased body temperature, muscle rigidity, sudden muscle contractions (myoclonus), fluctuation in vital signs, changes in mental status including confusion, irritability, extreme restlessness progressing to delirium and coma. These syndromes may lead to potentially life-threatening conditions. If these events occur, paroxetine must be discontinued and symptomatic supportive treatment initiated.
If you develop manic behavior. In this case, you must stop treatment.
If you have liver or kidney problems, your doctor may need to adjust the dosage.
If you have diabetes.
If you suffer or have ever suffered from high eye pressure (glaucoma).
If you are elderly, taking other medicines, or have liver problems, as this may reduce sodium levels in the blood (hyponatremia).
If you have an increased tendency to bleed. Caution is advised if you are concurrently taking oral anticoagulants, e.g., drugs known to affect platelet function, or other medicines that may increase the risk of bleeding (such as atypical antipsychotics like clozapine, phenothiazines, most tricyclic antidepressants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors). This also applies if you have a clinical history of bleeding disorders or conditions that may cause bleeding.
If you wish to discontinue treatment with paroxetine. You may experience withdrawal symptoms, especially if treatment is stopped abruptly (see section “If you stop taking Paroxetine Mylan Pharma”).
If any of these apply to you, talk to your doctor.
Children and adolescents
Paroxetine Mylan Pharma is not recommended for children and adolescents.
Paroxetine must not be used in children and adolescents under 18 years of age, as they are more likely to develop suicidal behaviors (suicide attempts and suicidal ideation) and hostility (mainly aggression, oppositional behavior, and anger). If, based on medical necessity, a decision is made to prescribe treatment, the patient must be closely monitored for the emergence of suicidal symptoms.
Other medicines and Paroxetine Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Other medicines may affect the action of Paroxetine Mylan Pharma or make side effects more likely. Paroxetine Mylan Pharma may also interfere with the action of other medicines.
These include:
medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide). See section “Do not take Paroxetine Mylan Pharma”.
Thioridazine or pimozide, which are antipsychotic medicines. See section “Do not take Paroxetine Mylan Pharma” in this leaflet.
Acetylsalicylic acid, ibuprofen, and other medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) such as celecoxib, etodolac, diclofenac, meloxicam, and rofecoxib, used for pain and inflammation.
The painkillers tramadol, buprenorphine, and meperidine.
Buprenorphine in combination with naloxone, used in opioid dependence replacement therapy.
Medicines called triptans such as sumatriptan, used to treat migraine.
Other antidepressants including other SSRIs, tryptophan, and tricyclic antidepressants such as clomipramine, nortriptyline, and desipramine.
A dietary supplement called tryptophan.
Mivacurium and succinylcholine (used in anesthesia).
Medicines such as lithium, risperidone, perphenazine, pimozide (called antipsychotics or neuroleptics) 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 for depression.
Phenobarbital, phenytoin, carbamazepine used to treat seizures or epilepsy.
Atomoxetine used to treat attention deficit hyperactivity disorder (ADHD).
Procyclidine, used to relieve tremors, especially in Parkinson’s disease.
Warfarin or other medicines (called anticoagulants) used to thin the blood.
Propafenone, flecainide, and medicines used for irregular heartbeat.
Metoprolol, a beta-blocker used to treat high blood pressure and other heart problems.
Pravastatin, used to treat high cholesterol levels.
Rifampicin, used to treat tuberculosis (TB) and leprosy.
Linezolid, an antibiotic.
Tamoxifen, used for the treatment of breast cancer or fertility problems.
If you are taking or have recently taken any medicine from this list, and have not yet discussed it with your doctor, return to your doctor and ask what you should do. It may be necessary to adjust the dose or change the medicine.
Paroxetine Mylan Pharma with food and drink
Do not drink alcohol while taking Paroxetine Mylan Pharma. Alcohol may worsen your symptoms or side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
In newborns whose mothers took Paroxetine Mylan Pharma during the first months of pregnancy, there has been evidence of an increased risk of birth defects, particularly heart defects. You and your doctor will decide whether it is better for you to gradually discontinue Paroxetine Mylan Pharma during pregnancy. However, based on your clinical condition, your doctor may advise that it is better to continue taking Paroxetine Mylan Pharma.
Ensure that your midwife or doctor knows that you are taking Paroxetine Mylan Pharma.
When medicines such as Paroxetine Mylan Pharma are taken during pregnancy, particularly during the last three months, they may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the newborn’s heart and lungs is too high. If you take Paroxetine Mylan Pharma during the last three months of pregnancy, your baby may also experience other symptoms, which usually appear within the first 24 hours after birth.
These symptoms include:
breathing difficulties
bluish or unusually hot or cold skin
blue lips
vomiting or feeding difficulties
lethargy, inability to sleep, or excessive crying
stiff or floppy muscles
tremors, nervousness, or seizures.
If your baby shows any of these symptoms at birth or if you are concerned about your baby’s health, contact your doctor or midwife who will advise you.
Pregnancy
If you take Paroxetine Mylan Pharma near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders. Inform your doctor or midwife that you are taking Paroxetine Mylan Pharma so they can advise you on what to do.
Breastfeeding
Paroxetine Mylan Pharma may pass into breast milk in very small amounts. If you are taking Paroxetine Mylan Pharma, return to your doctor and discuss it before starting breastfeeding. You and your doctor can decide whether you can breastfeed while taking Paroxetine Mylan Pharma.
Fertility
Paroxetine has been shown to reduce sperm quality. Although the impact on fertility is not known, in some men taking Paroxetine Mylan Pharma, fertility may be impaired.
Driving and using machines
Possible side effects of Paroxetine Mylan Pharma include dizziness, confusion, or blurred vision. If you experience these side effects, do not drive and do not operate machinery.
Paroxetine Mylan Pharma contains benzoic acid
Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Paroxetine Mylan Pharma

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Take Paroxetine Mylan Pharma drops, diluted in water, in the morning with breakfast.
Mix the drops with 100 ml of plain water and then rinse the glass with another 100 ml of plain water and drink it within one minute.
Your doctor will tell you what dose to take when you first start taking Paroxetine Mylan Pharma.
Most people start to feel better after a couple of weeks. If you do not start to feel better after this time, inform your doctor, who may decide to gradually increase your dose up to the maximum allowed daily dose.
The recommended doses for the different indications are listed below:

Your doctor will inform you about the daily dose and how long you should take the medicine. This may be for several months or longer.

Use in children and adolescents
Paroxetina Mylan Pharma must not be used in children and adolescents under 18 years of age, as it has not been shown to be effective in these age groups. In addition, patients under 18 years of age have an increased risk of experiencing adverse effects such as suicidal thoughts and self-harming behaviour when taking Paroxetina Mylan Pharma. If your doctor has prescribed Paroxetina Mylan Pharma for you (or for your child) and you wish to discuss this, please consult your doctor again.

Elderly
The maximum recommended dose for people aged over 65 years is 4 ml per day.

Patients with liver or kidney problems
If you have liver or kidney problems, your doctor may decide to adjust the dose of Paroxetina Mylan Pharma from the usual dose.

If you take more Paroxetina Mylan Pharma than you should
Do not take more Paroxetina Mylan Pharma than recommended by your doctor.
If you take more Paroxetina Mylan Pharma than prescribed, you may experience the symptoms listed in Section 4, Possible side effects, or develop any of the following symptoms: vomiting, dilated pupils, fever, changes in blood pressure, headache, involuntary muscle contractions, agitation, anxiety, and faster than normal heartbeat.
If you take more Paroxetina Mylan Pharma than you should (or someone else does), inform your doctor or go immediately to a hospital, taking the medicine bottle with you.

If you stop taking Paroxetina Mylan Pharma
Do not stop treatment with Paroxetina Mylan Pharma unless your doctor tells you to do so.
When stopping treatment with Paroxetina Mylan Pharma, your doctor will help you gradually reduce the dose over several weeks or months – this will help reduce the possibility of withdrawal effects. One way to do this is to gradually reduce your dose of Paroxetina Mylan Pharma by 10 mg per week.
Most people find that withdrawal symptoms from Paroxetina Mylan Pharma are mild and disappear spontaneously within two weeks. For some people, these symptoms may be more severe or last longer.
If you experience withdrawal effects when stopping the drops, your doctor may decide to stop the medicine more slowly. If you experience severe withdrawal effects when stopping Paroxetina Mylan Pharma, contact your doctor. Your doctor may advise you to restart the medicine and then stop treatment more gradually.
Despite withdrawal effects, you will still be able to stop taking Paroxetina Mylan Pharma. For the complete list of possible side effects during discontinuation of treatment with this medicine, see Section 4: “Possible side effects”.

Possible withdrawal effects when stopping treatment
Common (may affect up to 1 in 10 people)
Dizziness, feeling unsteady or loss of balance.
Tingling, burning sensation and (less commonly) electric shock-like sensations, also in the head, and ringing, buzzing, hissing, or other persistent noises in the ears (tinnitus).
Sleep disturbances (vivid dreams, nightmares, difficulty falling asleep).
Anxiety.
Headache.

Uncommon (may affect 1 in 100 people)
Feeling unwell (nausea).
Sweating (including night sweats).
Restlessness or agitation.
Tremor.
Confusion or disorientation.
Diarrhoea (loose stools).
Emotional lability or irritability.
Vision disturbances.
Increased heart rate (palpitations).

Inform your doctor if you are concerned about these withdrawal effects when stopping treatment with Paroxetina Mylan Pharma.

What to do if you do not feel better
Paroxetina Mylan Pharma will not improve your symptoms immediately – all antidepressants require time to take effect.
Some people start to feel better within a couple of weeks, while others may need more time. Some people taking antidepressants may feel worse before they begin to improve. If you do not feel better after a couple of weeks, consult your doctor, who will advise you accordingly.
Your doctor should review your condition a few weeks after you have started treatment. Inform your doctor if you do not feel better.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are more likely to occur during the first weeks of treatment with Paroxetina Mylan Pharma.
Contact your doctor if you experience any of the following side effects during treatment:
you may need to contact your doctor or go to hospital immediately.

Allergic reactions to Paroxetina Mylan Pharma, which can be serious.
Very rare (may affect up to 1 in 10,000 people)
If you develop skin rashes with redness and lumps, swelling of the eyelids, face, lips, mouth or tongue, start itching or have difficulty breathing (shortness of breath) or swallowing, and if you feel weak or dizzy, leading to collapse or loss of consciousness, contact your doctor or go to hospital immediately.
Syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Uncommon (may affect up to 1 in 100 people)
If you experience unusual bruising or bleeding, including blood in vomit or faeces, contact your doctor or go to hospital immediately.
If you have difficulty urinating, contact your doctor or go to hospital immediately.

Rare (may affect up to 1 in 1,000 people)
If you have seizures (epileptic fits), contact your doctor or go to hospital immediately.
If you feel restless or unable to sit still, you may be experiencing a condition called akathisia. Increasing your dose of Paroxetina Mylan Pharma could worsen these symptoms. If you feel this way, contact your doctor.
If you feel tired, weak or confused and have muscle pain, stiffness or incoordination, this may be due to a rare effect of Paroxetina Mylan Pharma that can lead to low sodium levels in your blood. If you have these symptoms, contact your doctor.

Very rare (may affect up to 1 in 10,000 people)
Allergic reactions to Paroxetina Mylan Pharma, which can be serious. If you develop skin rashes with redness and lumps, swelling of the eyelids, face, lips, mouth or tongue, start itching or have difficulty breathing (shortness of breath) or swallowing, and if you feel weak or dizzy, leading to collapse or loss of consciousness, contact your doctor or go to hospital immediately.
If you have some or all of the following symptoms, you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Symptoms include: confusion, restlessness, sweating, tremors, chills, hallucinations (strange visions or sounds), muscle rigidity, sudden muscle contractions or rapid heartbeat.
Acute glaucoma. If your eyes become painful and you experience blurred vision, contact your doctor.
Intestinal bleeding.

Other possible side effects of lesser severity that may occur during treatment

Very common (may affect more than 1 in 10 people)
Feeling unwell (nausea). Taking the medicine in the morning with breakfast will reduce the likelihood of these symptoms occurring.
Changes in sexual habits or sexual function. For example, lack of orgasm and, in men, abnormal erection and ejaculation.

Common (may affect up to 1 in 10 people)
Increased blood cholesterol levels.
Loss of appetite.
Sleep disturbances (insomnia) or drowsiness.
Abnormal dreams (including nightmares).
Dizziness or shaking (tremors).
Headache.
Difficulty concentrating.
Feeling agitated.
Feeling weak.
Blurred vision.
Yawning, dry mouth.
Diarrhoea or constipation.
Vomiting.
Weight gain.
Sweating.

Uncommon (may affect up to 1 in 100 people)
Transient increase or decrease in blood pressure, with dizziness or fainting when standing up suddenly.
Altered control of blood sugar levels in diabetic patients.
Extrapyramidal disorders (movement disorders).
Faster than normal heartbeat.
Inability to move, stiffness, shaking or abnormal movements of the mouth and tongue.
Dilated pupils.
Skin rashes, itching.
Feeling confused.
Hallucinations (strange visions and sounds).
Inability to urinate (urinary retention) or uncontrolled and involuntary loss of urine (urinary incontinence).
Reduction in the number of white blood cells.

Rare (may affect up to 1 in 1,000 people)
Abnormal production of milk in the mammary glands of men and women.
Menstrual cycle disorders (including menorrhagia, metrorrhagia, amenorrhoea, delayed menstruation and irregular periods).
Slowed heartbeat.
Panic attacks.
Hyperactive behaviour or thoughts (mania).
Liver effects indicated by specific blood tests for liver function.
Feeling detached from oneself (depersonalization).
Feeling anxious.
Increased blood levels of a hormone called prolactin.
Irresistible urge to move the legs (Restless Legs Syndrome).
Joint or muscle pain.

Very rare (may affect up to 1 in 10,000 people)
Skin rash, which may present with blisters and resemble small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge), known as erythema multiforme.
A widespread skin rash with blisters and skin peeling, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
A widespread skin rash with blisters and skin peeling over a large part of the body surface (toxic epidermal necrolysis).
Severe skin reactions.
Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and sodium concentration (salt) decreases, due to improper chemical signals. Patients with SIADH may become seriously ill or may have no symptoms at all.
Low platelet count in the blood.
Liver problems causing yellowing of the skin or whites of the eyes.
Fluid or water retention, which may cause swelling of the arms or legs.
Liver effects indicated by specific blood tests for liver function.
Sensitivity to sunlight.
Prolonged and painful erection of the penis.
Unexpected bleeding, for example bleeding gums, blood in urine or vomit, or unexpected bruising or blood vessel rupture (vein rupture).

Frequency not known (frequency cannot be estimated from the available data)
Suicidal ideation, suicidal behaviour and aggression.
Inflammation of the colon (causing diarrhoea).
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for further information.
Teeth grinding.
Some patients have developed ringing, buzzing, whistling, tinkling or other persistent noises in the ear (tinnitus) when taking Paroxetina Mylan Pharma.
An increased risk of bone fractures has been observed in patients taking this type of medicine.

If you have any concerns while taking Paroxetina Mylan Pharma, speak to your doctor and/or pharmacist, who will be able to advise you.

Additional side effects in children and adolescents:
Common (may affect up to 1 in 10 people)
Increased suicidal thoughts and suicide attempts.
Deliberate self-harm.
Hostile, aggressive or detached behaviour.
Loss of appetite.
Tremor.
Abnormal sweating.
Hyperactivity (having too much energy).
Agitation.
Emotional changes (including crying and mood changes).
Unusual bruising or bleeding (such as nosebleeds).
Withdrawal effects similar to those observed in adults after discontinuation of treatment with Paroxetina Mylan Pharma.
Stomach ache.
Feeling nervous and emotional changes (including crying and mood changes, self-harm attempts, suicidal thoughts and suicide attempts).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paroxetina Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original packaging.
Shelf life after first opening of the bottle: 2 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Paroxetina Mylan Pharma contains

• The active substance is paroxetine (10 mg/ml) as hemihydrate hydrochloride. Each ml of liquid (1 ml corresponds to 14 drops) contains 10 mg of paroxetine.
• The other ingredients are: povidone K30, benzoic acid E210, sucralose, curcumin 8% (E100), natural orange/lemon flavour, purified water.

Description of the appearance of Paroxetina Mylan Pharma and contents of the pack
Paroxetina Mylan Pharma 10 mg/ml is a clear yellow liquid.
It is available in a 60 ml amber glass bottle with a tamper-evident screw cap, child-resistant closure and dropper.
Marketing Authorization Holder
Mylan S.p.A
Via Vittor Pisani 20, 20124 Milano
Italy
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de’ Stampi – Rozzano
(Milano) – Italy
Doppel Farmaceutici S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy
Vamfarma S.r.l.
Via Kennedy 5,
26833 Comazzo (LO)
Italy