Naegoti: detailed information

Package leaflet: Information for the user

Naegoti 0.25 mg hard capsules, 0.5 mg hard capsules

fingolimod
equivalent medicine
Please read all of this leaflet carefully before 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 they have the same symptoms as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Naegoti is and what it is used for

What Naegoti is
The active substance of Naegoti is fingolimod.
What Naegoti is used for
Naegoti is used in adults and children and adolescents (aged 10 years and older) for the treatment of relapsing-remitting multiple sclerosis (MS), particularly in:

Patients who have not responded to therapy with a treatment for MS.

Patients with rapidly evolving severe MS.

Naegoti does not cure MS, but helps reduce the number of relapses and slow the progression of physical disability caused by MS.
What is multiple sclerosis
MS is a chronic disease that affects the central nervous system (CNS), which includes the brain and spinal cord. In MS, inflammation destroys the protective covering (called myelin) that surrounds nerves in the CNS, impairing normal nerve function. This process is known as demyelination.
Relapsing-remitting MS is characterized by recurrent attacks (relapses) of neurological symptoms reflecting inflammatory activity in the central nervous system. Symptoms vary from patient to patient, but usually involve difficulty walking, numbness, visual disturbances, or balance problems. Symptoms of a relapse may completely disappear once the relapse ends, although some deficits may persist.
How Naegoti works
Naegoti helps protect the nervous system from attacks by the immune system by reducing the ability of certain white blood cells (lymphocytes) to circulate freely throughout the body, thereby preventing them from reaching the brain and spinal cord. This limits nerve damage caused by MS. Naegoti also reduces some of the body's immune responses.

2. What you need to know before taking Naegoti

Do not take Naegoti

if you have a reduced immune response (due to an immunodeficiency syndrome, an illness, or medicines that suppress the immune system).
if you have a severe ongoing infection or chronic ongoing infection, such as hepatitis or tuberculosis.
if you have active cancer.
if you suffer from severe liver problems.
if, within the last 6 months, you have had a heart attack, angina, stroke, or a transient ischaemic attack (TIA), or certain types of heart failure.
if you have certain types of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with Naegoti.
if you are currently taking or have recently taken medicines for irregular heartbeat such as quinidine, disopyramide, amiodarone, or sotalol.
if you are pregnant or are a woman of childbearing potential who is not using effective contraception.
if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6).
If any of these apply to you or you are unsure, talk to your doctor before taking Naegoti.

Warnings and precautions
Talk to your doctor before taking Naegoti:

if you have severe breathing problems during sleep (severe sleep apnoea).
if you have been told you have an abnormal electrocardiogram (ECG).
if you experience symptoms of a slow heartbeat (e.g. dizziness, nausea, or palpitations).
if you are currently taking or have recently taken medicines that slow the heartbeat (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, anticholinesterase agents, or pilocarpine).
if you have previously experienced episodes of sudden loss of consciousness or fainting (syncope).
if you plan to get vaccinated.
if you have never had chickenpox.
if you have or have had vision problems or other signs of swelling in the central area of vision (macula) at the back of the eye (a condition known as macular oedema, see below), if you have or have had inflammation or infection of the eye (uveitis), or if you have diabetes (which can cause eye problems).
if you suffer from liver problems.
if you suffer from high blood pressure that cannot be controlled by medicines.
if you suffer from severe lung problems or if you have a smoker’s cough. If any of these apply to you or you are unsure, talk to your doctor before taking Naegoti.

Slow heartbeat (bradycardia) and irregular heartbeat
At the start of treatment, or when switching from the 0.25 mg daily dose to the first 0.5 mg dose, Naegoti causes a slowing of the heart rate. As a result, you may experience dizziness or fatigue, awareness of your heartbeat, or a drop in blood pressure. If these effects are severe, contact your doctor, as immediate treatment may be necessary.
Naegoti may also cause an irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal within less than a day. Slow heart rate usually returns to normal within one month. During this period, clinically significant effects on heart rate are generally not expected.

Your doctor will ask you to remain in the clinic or hospital for at least 6 hours after taking the first dose of Naegoti, or when switching from the 0.25 mg daily dose to the first 0.5 mg dose. During this time, your pulse and blood pressure will be measured hourly so that appropriate measures can be taken if any adverse effects occur at the beginning of treatment. You must have an electrocardiogram (ECG) performed before taking the first dose of Naegoti and again at the end of the 6-hour monitoring period. Your doctor may continuously monitor your ECG during this time. If, after 6 hours, your heart rate is very low or continues to decrease, or if your ECG shows abnormalities, you may need to remain under observation for a longer period (at least an additional 2 hours, and possibly until the next morning), until these issues resolve. The same may apply if you restart Naegoti after an interruption in treatment, depending on the length of the interruption and how long you had been taking Naegoti before the interruption.

If you have or are at risk of having an irregular or abnormal heartbeat, if your ECG is abnormal, or if you have heart conditions or heart failure, Naegoti may not be suitable for you.
If you have previously experienced episodes of sudden loss of consciousness or reduced heart rate, Naegoti may not be suitable for you. You will be evaluated by a cardiologist (a heart specialist) who will advise you on how to start treatment with Naegoti, including monitoring until the following morning.

If you are taking medicines that may reduce heart rate, Naegoti may not be suitable for you. You will be evaluated by a cardiologist who will assess whether you can switch to alternative medicines that do not reduce heart rate, allowing you to start treatment with Naegoti. If such a change in therapy is not possible, the cardiologist will advise you on how to start treatment with Naegoti, including monitoring until the following morning.

If you have never had chickenpox
If you have never had chickenpox, your doctor will check your immunity against the virus that causes it (varicella zoster virus). If you are not protected against the virus, vaccination may be necessary before starting treatment with Naegoti. If this is the case, your doctor will delay the start of Naegoti treatment until one month after completing the full vaccination course.

Infections
Fingolimod reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Naegoti (and up to 2 months after stopping treatment), you may be more likely to develop infections. Any existing infection may worsen. Infections can be severe and life-threatening. If you think you have an infection, if you have a fever, flu-like symptoms, shingles (herpes zoster), or a headache accompanied by neck stiffness, sensitivity to light, nausea, rash, and/or confusion or seizures (these may be symptoms of meningitis and/or encephalitis caused by a fungal or viral herpes infection), contact your doctor immediately, as this could be serious and life-threatening.

If you think your multiple sclerosis (MS) is worsening (e.g. if you experience weakness or vision problems) or if you notice any new symptoms, contact your doctor immediately, as these may be symptoms of a rare brain disorder caused by an infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that can lead to severe disability or death. Your doctor will consider performing an MRI scan to assess this condition and decide whether you should stop taking Naegoti.

Human papillomavirus (HPV) infection, including warts, dysplasia, condyloma, and HPV-related cancers, has been reported in patients treated with Naegoti. Your doctor will assess whether you need HPV vaccination before starting treatment. If you are a woman, your doctor will also recommend HPV screening.

Macular oedema
Before starting treatment with Naegoti, if you have or have had vision problems or other signs of swelling in the central area of vision (macula) at the back of the eye, if you have or have had inflammation or infection of the eye (uveitis), or if you have diabetes, your doctor may ask you to undergo an eye examination.

Your doctor may also ask you to have an eye examination 3–4 months after starting treatment with Naegoti.

The macula is a small area of the retina located at the back of the eye that allows you to see shapes, colours, and fine details clearly. Naegoti can cause swelling of the macula, a condition known as macular oedema. Swelling usually occurs within the first 4 months of treatment with Naegoti.

The risk of macular oedema is higher if you have diabetes or if you have had eye inflammation called uveitis. In these cases, your doctor may want to perform regular checks to detect early signs of macular oedema.

If you have previously had macular oedema, talk to your doctor before restarting treatment with Naegoti.

Macular oedema can cause some of the same visual symptoms (optic neuritis) that occur during MS relapses. In the early stages, there may be no symptoms. Be sure to inform your doctor of any changes in vision. Your doctor may ask you to have an eye examination, especially if:

the central area of vision is blurred or has shadows;
a blind spot develops in the central area of vision;
you have difficulty distinguishing colours or fine details.

Liver function tests
You must not take Naegoti if you have severe liver problems. Treatment with Naegoti may affect your liver function. You may not notice any symptoms, but if you notice yellowing of the skin or whites of the eyes, abnormally dark-coloured urine (brown), pain on the right side of the abdomen, fatigue, unusual loss of appetite, or unexplained nausea and vomiting, contact your doctor immediately. If you experience any of these symptoms after starting treatment with Naegoti, contact your doctor immediately.

Before, during, and after treatment, your doctor will ask you to have blood tests to monitor liver function. If test results indicate a liver problem, treatment with Naegoti may need to be stopped.

High blood pressure
Since Naegoti causes a slight increase in blood pressure, your doctor may monitor your blood pressure regularly.

Lung problems
Naegoti has a mild effect on lung function. Undesirable effects may occur more easily in patients with severe lung problems or a smoker’s cough.

Blood count
The intended effect of Naegoti treatment is to reduce the number of white blood cells in the blood. These usually return to normal levels within 2 months after stopping treatment. If you need blood tests, inform your doctor that you are taking Naegoti. Otherwise, your doctor may not be able to correctly interpret test results, and for certain types of tests, your doctor may need to draw more blood than usual.

Before starting treatment with Naegoti, your doctor will confirm that your white blood cell count is adequate and may ask you to have it checked regularly. If your white blood cell count is too low, treatment with Naegoti may need to be stopped.

Posterior reversible encephalopathy syndrome (PRES)
Posterior reversible encephalopathy syndrome (PRES) has been reported rarely in patients with multiple sclerosis treated with fingolimod. Symptoms may include sudden severe headache, confusion, seizures, and vision changes. Inform your doctor immediately if you experience any of these symptoms during treatment with Naegoti, as this could be serious.

Cancer
Skin tumours have been reported in patients with MS treated with fingolimod. Contact your doctor immediately if you notice any new skin lumps (e.g. shiny, pearly lumps), spots, or open sores that do not heal within a few weeks. Symptoms of skin cancer may include unusual growths or changes in the skin (e.g. unusual moles) that change in colour, thickness, or size over time. A skin examination is necessary before starting treatment with Naegoti to check for skin lumps. Your doctor will also perform periodic skin checks during treatment with Naegoti. If skin problems occur, your doctor may refer you to a dermatologist, who may recommend regular follow-up visits.

A type of cancer of the lymphatic system (lymphoma) has been reported in patients with MS treated with fingolimod.

Sun exposure and sun protection
Fingolimod weakens your immune system. This increases the risk of developing tumours, particularly skin tumours. You should limit exposure to sunlight and UV rays:

by wearing appropriate protective clothing.
by regularly applying sunscreen with high UV protection.

Unusual brain lesions associated with an MS relapse
Rare cases of unusually large brain lesions associated with an MS relapse have been reported in patients treated with fingolimod. In the event of a severe relapse, your doctor will assess whether an MRI scan is needed to evaluate this condition and decide whether you should stop taking Naegoti.

Switching from other treatments to Naegoti
Your doctor may switch you directly from treatment with interferon-beta, glatiramer acetate, or dimethyl fumarate to Naegoti if there are no signs of abnormalities caused by the previous treatment. Your doctor may perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait 2–3 months before starting treatment with Naegoti. For switching from teriflunomide, your doctor may advise you to wait for a certain period or proceed with an accelerated elimination procedure. If you have been treated with alemtuzumab, careful evaluation and discussion with your doctor are needed to determine whether Naegoti is suitable for you.

Women of childbearing potential
Naegoti may harm the unborn child if used during pregnancy. Before starting treatment with Naegoti, your doctor will explain the risks and ask you to take a pregnancy test to confirm you are not pregnant. Your doctor will give you a reminder card explaining why you must not become pregnant while taking Naegoti and what you should do to avoid pregnancy. You must use effective contraception during treatment and for 2 months after stopping treatment (see section “Pregnancy and breastfeeding”).

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

Pregnancy
Do not use Naegoti during pregnancy, if you are planning a pregnancy, or if you are a woman of childbearing potential and not using effective contraception. If Naegoti is used during pregnancy, there is a risk of harm to the unborn child. The rate of congenital malformations observed in newborns exposed to Naegoti during pregnancy is about twice the rate observed in the general population (in which the rate of congenital malformations is about 2–3%). The most frequently reported malformations include heart, kidney, and musculoskeletal abnormalities.

Therefore, if you are a woman of childbearing potential:

before starting treatment with Naegoti, your doctor will inform you of the risks to the unborn child and ask you to take a pregnancy test to confirm you are not pregnant, and
you must use effective contraception during treatment with Naegoti and for two months after stopping treatment to avoid pregnancy. Discuss reliable contraceptive methods with your doctor.

Your doctor will give you a reminder card explaining why you must not become pregnant while taking Naegoti.

If you become pregnant while taking Naegoti, inform your doctor immediately.
Your doctor will decide whether to stop treatment (see “If you stop taking Naegoti” in section 3 and also section 4, “Possible side effects”). You will also need specialised prenatal monitoring.

Breastfeeding
Do not breastfeed while taking Naegoti. Fingolimod may pass into breast milk and could cause serious adverse effects in the newborn.

Driving and using machines
Your doctor will advise you whether your condition allows you to drive (including bicycles) and use machines safely. Naegoti should not affect your ability to drive or use machines.
However, after taking the first dose of Naegoti, you must remain at your doctor’s office or in hospital for 6 hours. Your ability to drive and use machines may be impaired during this time and potentially afterwards.

Naegoti contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Naegoti

Treatment with Naegoti will be supervised by a physician experienced in the treatment of multiple sclerosis.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

Recommended dose:
Adults:
The dose is one 0.5 mg capsule once daily.

Children and adolescents (aged 10 years and older):
The dose depends on body weight:

Children and adolescents with body weight equal to or less than 40 kg: one 0.25 mg capsule daily.
Children and adolescents with body weight greater than 40 kg: one 0.5 mg capsule daily.

Children and adolescents who start treatment with a 0.25 mg capsule daily and subsequently reach a stable body weight above 40 kg will be instructed by the physician to switch to treatment with a 0.5 mg capsule daily. In this case, repeating the first-dose observation period is recommended.

Do not exceed the recommended dose.
Naegoti is for oral use.
Take Naegoti once daily with a glass of water. Naegoti capsules must always be swallowed whole, without opening them. Naegoti may be taken with or without food.
Taking Naegoti at the same time every day will help you remember to take your medicine.
If you have any doubts about the duration of treatment with Naegoti, consult your doctor or pharmacist.

If you take more Naegoti than you should
If you have taken too many Naegoti capsules, inform your doctor immediately.

If you forget to take Naegoti
If you have been taking Naegoti for less than 1 month and you miss a dose for a full day, contact your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose.

If you have been taking Naegoti for at least 1 month and you have missed taking the medicine for more than 2 weeks, contact your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose. However, if you have missed taking the medicine for 2 weeks or less, you may take the next dose as scheduled.
Never take a double dose to make up for a forgotten dose.

If you stop taking Naegoti
Do not stop taking Naegoti or change the dose without first consulting your doctor.
Fingolimod will remain in your body for up to 2 months after stopping treatment. The number of white blood cells (lymphocytes) may remain low during this period, and the side effects described in this leaflet may still occur. After stopping treatment with Naegoti, it may be necessary to wait 6–8 weeks before starting a new treatment for multiple sclerosis.

If it is necessary to restart Naegoti after an interruption of more than 2 weeks, the effect on heart rate that normally occurs at the beginning of treatment may occur again: therefore, restarting treatment will require observation in a clinic or hospital setting. Do not restart treatment with Naegoti after an interruption of more than two weeks without first consulting your doctor.

Your doctor will decide whether and how monitoring is needed after stopping treatment with Naegoti. Inform your doctor immediately if you think your multiple sclerosis is worsening after stopping treatment with Naegoti. This may be serious.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects may be or become serious.

Common (may affect up to 1 in 10 people):

Cough with phlegm, chest discomfort, fever (signs of lung disorders)
Herpes virus infection (shingles or herpes zoster), with symptoms such as blisters, burning, itching, or pain on the skin, usually on the upper body or face. Other symptoms may include fever and weakness in the early stages of infection, followed by numbness, itching, or red spots associated with severe pain
Slow heartbeat (bradycardia), irregular heart rhythm
A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may also have other appearances
Depression and anxiety are known to occur more frequently in the population affected by MS and have been reported in pediatric patients treated with fingolimod
Weight loss

Uncommon (may affect up to 1 in 100 people):

Pneumonia, with symptoms such as fever, cough, difficulty breathing
Macular edema (swelling in the central vision area of the retina at the back of the eye), with symptoms such as shadows or blind spots in the center of vision, blurred vision, problems distinguishing colors or details
Reduction in platelets in the blood, increasing the risk of bleeding or bruising
Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that change in size, shape, thickness, or color over time, or new moles. Moles may itch, bleed, or ulcerate
Seizures, epileptic fits (more frequent in children and adolescents than in adults)

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

A condition called reversible posterior encephalopathy syndrome (PRES). Symptoms may include sudden onset of severe headache, confusion, seizures, and/or visual disturbances
Lymphoma (a type of cancer affecting the lymphatic system)
Squamous cell carcinoma: a type of skin cancer that may appear as a hard, red nodule, an ulcerated lesion with a crust, or a new ulceration on a pre-existing scar

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

Abnormality on electrocardiogram (ECG) (T-wave inversion)
Tumor associated with human herpesvirus 8 infection (Kaposi's sarcoma)

Not known (frequency cannot be determined from available data):

Allergic reactions, including symptoms such as skin rash or hives, swelling of the lips, tongue, or face, which are more likely to occur on the first day of treatment with Naegoti
Signs of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the stomach (abdomen), dark urine (brown-colored), unusual feeling of loss of appetite, fatigue, and abnormal liver function tests. In a very limited number of cases, liver failure may lead to liver transplantation
Risk of developing a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble an MS relapse. Other symptoms may go unnoticed by the patient, such as changes in mood or behavior, memory lapses, or language and communication difficulties, which may require further medical evaluation to rule out the risk of PML. Therefore, if you feel that your MS is worsening, or if you or someone close to you notices any new or unusual symptoms, it is very important to contact your doctor as soon as possible
Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis, with symptoms such as headache accompanied by neck stiffness, sensitivity to light, nausea, and/or confusion
Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include painless flesh-colored or bluish-red nodules, often on the face, head, or neck. Merkel cell carcinoma may also present as a firm, painless nodule or mass. Long-term sun exposure and a weakened immune system may influence the risk of developing Merkel cell carcinoma
After stopping treatment with Naegoti, MS symptoms may reappear and possibly worsen compared to before or during treatment
Autoimmune form of anemia (reduction in red blood cells) where red blood cells are destroyed (autoimmune hemolytic anemia)

If you experience any of these side effects, inform your doctor immediately.

Other side effects

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

Influenza virus infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
Feeling of pressure or pain in the cheeks and forehead (sinusitis)
Headache
Diarrhea
Back pain
Blood tests showing higher levels of liver enzymes
Cough

Common (may affect up to 1 in 10 people):

Ringworm, a fungal skin infection (pityriasis versicolor)
Dizziness
Severe headache often accompanied by nausea, vomiting, and sensitivity to light (migraine)
Low levels of white blood cells in the blood (lymphocytes, leukocytes)
Weakness
Skin rash with itching, redness, and burning (eczema)
Itching
Increased blood levels of fats (triglycerides)
Hair loss
Shortness of breath
Depression
Blurred vision (see also the section on macular edema under “Some side effects may be or become serious”)
Hypertension (Naegoti may cause a slight increase in blood pressure)
Muscle pain
Joint pain

Uncommon (may affect up to 1 in 100 people):

Low levels of certain white blood cells in the blood (neutrophils)
Depressed mood
Nausea

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

Cancer of the lymphatic system (lymphoma)

Not known (frequency cannot be determined from available data):

Peripheral swelling

If any of these side effects become severe, inform your doctor.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, consult 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 Naegoti

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines 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 Naegoti contains

The active substance is fingolimod. Naegoti 0.25 mg hard capsules: Each capsule contains 0.25 mg of fingolimod (as hydrochloride). Naegoti 0.5 mg hard capsules: Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
The other ingredients are: Capsule contents: Pregelatinized starch (maize), Sodium lauryl sulfate. Naegoti 0.25 mg hard capsules: Capsule shell: Titanium dioxide (E171), gelatin. Naegoti 0.5 mg hard capsules: Capsule shell: Iron oxide yellow (E172), titanium dioxide (E171), gelatin. Printing ink: Lacquer, propylene glycol (E1520), ammonia solution concentrated, iron oxide black (E172), potassium hydroxide.

Description of the appearance of Naegoti and package contents
Naegoti 0.25 mg hard capsules: approximately 14 mm gelatin capsules, engraved in black with "TV 3654" on the opaque white cap and "TV 3654" on the opaque white body of the capsule.
Naegoti 0.5 mg hard capsules: approximately 14 mm gelatin capsules, engraved in black with "TV 7820" on the yellow cap and "TV 7820" on the opaque white body of the capsule.
Naegoti is available in boxes containing 7 and 84 hard capsules in blister packs, or 28x1 hard capsules in unit-dose divisible blister packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder
medac pharma s.r.l.
Via Viggiano 90,
00178 Rome, Italy

And manufacturers
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa, Bulgaria
Actavis Ltd
BLB015-016 Bulebel Industrial Estate
3000 Zejtun, Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: Naegoti 0.25mg Hartkapseln, Naegoti 0.5mg Hartkapseln
Italy: Naegoti