MylatAbi

Patient Information Leaflet: Information for the User

Mylatabi 25 mg film-coated tablets, 50 mg film-coated tablets

eltrombopag
Generic medicine
Please read 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 their symptoms are the same 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

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

1. What Mylatabi is and what it is used for

Mylatabi contains eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. It is used to help increase the number of platelets in the blood. Platelets are blood cells that help reduce or prevent bleeding.

• Mylatabi is used to treat a blood clotting disorder called immune (primary) thrombocytopenia (ITP) in patients aged 1 year and older who have already been treated with other medicines (corticosteroids or immunoglobulins) that were not effective.

ITP is caused by a low number of platelets in the blood (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms in patients with ITP may include petechiae (small, flat, red, round spots on the skin), bruising, nosebleeds, bleeding gums, and difficulty controlling bleeding in case of cuts or injuries.
Mylatabi may also be used to treat low platelet count (thrombocytopenia) in adult patients with hepatitis C virus (HCV) infection who have experienced problems with adverse reactions during interferon treatment. Many people with hepatitis C have a low platelet count not only as a result of the disease itself but also due to certain antiviral medicines used to treat it. Taking Mylatabi may make it easier for you to complete a full course of antiviral therapy (peginterferon and ribavirin).

2. What you need to know before taking Mylatabi

Do not take Mylatabi
If you are allergic to eltrombopag or to any of the other ingredients of this medicine
(listed in section 6, “What Mylatabi contains”).
Check with your doctor if you think this applies to you.
Warnings and precautions
Talk to your doctor before taking Mylatabi:

• If you have liver problems. People who have a low platelet count and advanced chronic (long-term) liver disease are at higher risk of experiencing side effects, including liver damage and life-threatening blood clots. If your doctor considers that the benefits of taking Mylatabi outweigh the risks, you will be closely monitored during treatment.
• if you are at risk of forming blood clots in veins or arteries, or if you know that blood clots are common in your family. You may be at increased risk of forming blood clots:
  • if you are elderly
  • if you have had to remain bedridden for a long time
  • if you have cancer
  • if you are taking oral contraceptives for birth control or hormone replacement therapy
  • if you have recently undergone surgery or suffered physical trauma
  • if you are very overweight (obese)
  • if you are a smoker
  • if you have advanced chronic liver disease → If any of these apply to you, inform your doctor before starting treatment. You must not take Mylatabi unless your doctor considers that the expected benefits outweigh the risks of blood clot formation.
• if you suffer from cataracts (clouding of the eye's lens)
• if you suffer from another blood disorder, such as myelodysplastic syndrome (MDS). Your doctor will perform tests to check that you do not have this blood disorder before you start taking Mylatabi. If you have MDS and take Mylatabi, the MDS may worsen. → Inform your doctor if any of these apply to you.

Eye examination
Your doctor will recommend regular checks for cataracts. If you do not routinely have eye examinations, your doctor will schedule regular eye exams. You may also be monitored for any bleeding in or around the retina (the layer of light-sensitive cells at the back of the eye).
You will need regular blood tests
Before starting Mylatabi, your doctor will perform blood tests to monitor blood cells, including platelets. These tests will be repeated at intervals while you are taking the medicine.
Blood tests for liver function
Mylatabi may affect blood test results, which could be signs of liver damage – an increase in certain liver enzymes, particularly bilirubin and alanine/aspartate transaminase. If you are receiving interferon-based treatment in combination with Mylatabi for low platelet count due to hepatitis C, some liver problems may worsen.
You will need blood tests to monitor liver function before starting Mylatabi and during treatment. You may need to stop taking Mylatabi if levels of these enzymes rise too much, or if other physical signs of liver damage appear.
→ Read the information “Liver problems” in section 4 of this leaflet.
Blood tests for platelet count
If you stop taking Mylatabi, your platelet count is likely to decrease again within a few days. Your platelet count will be monitored, and your doctor will discuss appropriate precautions with you.
A very high platelet count may increase the risk of blood clots. However, blood clots can also form when platelet count is normal or even low. Your doctor will adjust the dose of Mylatabi to ensure that your platelet count does not rise too high.

Seek immediate medical help if you experience any of the following signs indicating a blood clot:

• Swelling, pain, or tenderness in one leg
• Sudden shortness of breath, especially along with sharp chest pain or rapid breathing
• Abdominal (stomach) pain, abdominal swelling, blood in the stool

Tests to monitor bone marrow
In people with bone marrow problems, medicines such as Mylatabi may worsen these conditions. Signs of bone marrow changes may appear as abnormalities in blood test results. Your doctor may perform tests to directly monitor your bone marrow during treatment with Mylatabi.
Tests for gastrointestinal bleeding
If you are treated with interferon-based medicines in combination with Mylatabi, you will be monitored for any signs of bleeding in your stomach or intestines after stopping Mylatabi.
Heart monitoring
Your doctor may consider it necessary to monitor your heart during treatment with Mylatabi and may perform an electrocardiogram (ECG).
Elderly people (65 years and older)
There is limited data on the use of Mylatabi in patients aged 65 years and older. Exercise caution when taking Mylatabi if you are aged 65 or older.
Children and adolescents
Mylatabi is not recommended for children under 1 year of age with ITP. Also, it is not recommended for people under 18 years of age with low platelet count due to hepatitis C.
Other medicines and Mylatabi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines used without a prescription and vitamins.
Some common medicines interact with Mylatabi – including prescription and over-the-counter medicines and minerals. These include:
medicines for indigestion, heartburn, or stomach ulcers (see also “When to take it” in section 3)

• medicines called statins, used to lower cholesterol
• certain medicines for HIV infection, such as lopinavir and/or ritonavir
• cyclosporine, used in organ transplants and immune system disorders
• minerals such as iron, calcium, magnesium, aluminium, selenium, and zinc found in vitamin and mineral supplements (see also “When to take it” in section 3)
• medicines such as methotrexate and topotecan, used to treat cancer

→ Inform your doctor if you are taking any of these medicines. Some of them cannot be taken with Mylatabi, or you may need a dose adjustment, or the timing of administration may need to be changed. Your doctor will review all the medicines you are taking and, if necessary, suggest suitable alternatives.
There is an increased risk of bleeding if you are also taking medicines to prevent blood clots. Your doctor will discuss this with you.
If you are taking corticosteroids, danazol, and/or azathioprine, you may need to take a lower dose or stop taking them while on Mylatabi.
Mylatabi with food and drink
Do not take Mylatabi with food or drinks containing dairy products, as the calcium in dairy affects the absorption of the medicine. For further information, see ‘When to take it’ in section 3.
Pregnancy and breastfeeding
Do not use Mylatabi if you are pregnant unless specifically recommended by your doctor. The effect of Mylatabi during pregnancy is unknown.

• Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning to become pregnant
• Use a reliable method of contraception while taking Mylatabi to prevent pregnancy
• If you become pregnant during treatment with Mylatabi, inform your doctor

Do not breastfeed while taking Mylatabi. It is not known whether Mylatabi passes into breast milk.
→ If you are breastfeeding or planning to breastfeed, inform your doctor.
Driving and using machines
Mylatabi may cause dizziness and other side effects that may reduce alertness.
→ Do not drive or operate machinery unless you are sure you are not affected
Mylatabi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Mylatabi

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not change the dose or dosing schedule of Mylatabi unless your doctor or pharmacist advises you to do so. While taking Mylatabi, you will be under the care of a doctor experienced in managing your condition.

Dosage

For ITP

Adults and children (6 to 17 years of age) – the usual starting dose for ITP is one 50 mg tablet of Mylatabi daily. If you are of East or Southeast Asian origin, you may need to start with a lower dose of 25 mg.

Children (1 to 5 years of age) – the usual starting dose for ITP is one 25 mg tablet of Mylatabi daily.

For hepatitis C

Adults – the usual starting dose for hepatitis C is one 25 mg tablet of Mylatabi daily. If you are of East or Southeast Asian origin, you will start with the same 25 mg dose.

Mylatabi may take 1 to 2 weeks to take effect. Based on your response to Mylatabi, your doctor may recommend adjusting the daily dose.

How to take the tablets

Swallow the tablet whole with some water.

When to take it

Make sure that

• 4 hours before taking Mylatabi
• and 2 hours after taking Mylatabi

you do not consume any of the following:

• Dairy products such as cheese, butter, yoghurt, or ice cream
• Milk or milk-based shakes, beverages containing milk, yoghurt, or cream
• Antacids, a type of medicine used for indigestion and heartburn
• certain vitamin and mineral supplements including iron, calcium, magnesium, aluminium, selenium, and zinc.

If you do, the medicine will not be properly absorbed into your body.

Take eltrombopag

For 4 hours before …and for 2 hours

of taking after

eltrombopag…

NO dairy products, antacids, or mineral supplements

For further advice on suitable foods and drinks, consult your doctor.

If you take more Mylatabi than you should

Contact your doctor or pharmacist immediately. If possible, show them the pack or this leaflet. You will be monitored for any signs or symptoms of adverse effects and treated appropriately without delay.

If you forget to take Mylatabi

Take your next dose at the usual time. Do not take more than one dose of Mylatabi in a single day.

If you stop taking Mylatabi

Do not stop taking Mylatabi without first discussing it with your doctor. If your doctor advises stopping treatment, your platelet count will be monitored weekly for four weeks. See also 'Bleeding or bruising after stopping treatment' in section 4.

If you have any questions 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.

Symptoms requiring attention: consult a doctor
People taking Mylatabi for ITP or low platelet count due to hepatitis C may develop signs of potentially serious side effects. It is important to inform your doctor if you develop any of these symptoms.

Higher risk of blood clots
Some people may have an increased risk of blood clots, and medicines such as Mylatabi can worsen this problem. Sudden blockage of a blood vessel by a blood clot is an uncommon side effect and may affect up to 1 in 100 people.

Seek immediate medical help if you experience signs or symptoms of a blood clot, such as:

• swelling, pain, warmth, redness or tenderness in one leg
• sudden onset of shortness of breath, especially together with sharp chest pain or rapid breathing
• abdominal pain (stomach), abdominal swelling, blood in the stool

Liver problems
Mylatabi may cause changes detectable in blood tests, which may indicate liver damage. Liver problems (increased liver enzymes detected in blood tests) are common and may affect up to 1 in 10 people. Other liver problems are uncommon and may affect up to 1 in 100 people.
If you experience any of the following signs of liver problems:

• yellowing of the skin or whites of the eyes (jaundice)
• urine that is unusually dark-colored → inform your doctor immediately

Bleeding or bruising after stopping treatment
Within two weeks after stopping Mylatabi, platelet counts usually decrease to the level they were before starting Mylatabi. A lower platelet count may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least 4 weeks after you stop taking Mylatabi.
→ Inform your doctor if you experience bleeding or bruising after stopping Mylatabi.
Some people may experience gastrointestinal bleeding after discontinuation of peginterferon, ribavirin, and Mylatabi. Symptoms include:

• dark stools (change in stool color is an uncommon side effect that may affect up to 1 in 100 people)
• blood in the stool
• vomiting blood or material resembling coffee grounds → Inform your doctor immediately if you experience any of these symptoms

The following side effects have been reported in association with Mylatabi treatment in adult patients with ITP:

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

• cold
• feeling unwell (nausea)
• diarrhoea
• cough
• infection of the nose, sinuses, throat, and upper respiratory tract (upper respiratory tract infection)
• back pain

Very common side effects detectable in blood tests:

• increased liver enzymes (alanine aminotransferase (ALT))

Common side effects
These may affect up to 1 in 10 people:

• muscle pain, muscle spasms, muscle weakness
• bone pain
• heavy menstrual period
• sore throat and pain when swallowing
• eye problems including abnormal eye test results, dry eyes, eye pain, blurred vision
• vomiting
• influenza
• cold sores
• pneumonia
• irritation and inflammation (swelling) of the sinuses
• inflammation (swelling) and infection of the tonsils
• infections of the lungs, sinuses, nose, and throat
• inflammation of the gum tissue
• loss of appetite
• sensation of tingling, pricking, or numbness, commonly known as “pins and needles”
• decreased skin sensitivity
• feeling sleepy
• ear pain
• pain, swelling, and tenderness in one leg (usually calf) with warm skin in the affected area (signs of a blood clot in a deep vein)
• localized swelling filled with blood due to rupture of a blood vessel (haematoma)
• hot flushes
• mouth problems including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers
• runny nose
• toothache
• abdominal pain
• liver function abnormalities
• skin disorders including excessive sweating, irregular itchy rash, red spots, skin appearance changes
• hair loss
• foamy, frothy, or fizzy-looking urine (signs of protein in the urine)
• elevated temperature, feeling hot
• chest pain
• feeling weak
• sleep problems, depression
• headache
• decreased vision
• sensation of spinning (dizziness)
• gas/air due to digestion

Common side effects detectable in blood tests:

• decreased number of red blood cells (anaemia)
• decreased number of platelets (thrombocytopenia)
• decreased number of white blood cells
• decreased haemoglobin levels
• increased number of eosinophils
• increased number of white blood cells (leucocytosis)
• increased uric acid levels
• decreased potassium levels
• increased creatinine levels
• increased alkaline phosphatase levels
• increased liver enzymes (aspartate aminotransferase (AST))
• increased bilirubin in the blood (a substance produced by the liver)
• increased levels of certain proteins

Uncommon side effects
These may affect up to 1 in 100 people:

• allergic reaction
• interruption of blood flow to part of the heart
• sudden breathing difficulty, especially if accompanied by sharp chest pain and/or rapid breathing, which may indicate a blood clot in the lungs (see "Higher risk of blood clots" at the beginning of section 4)
• loss of function in part of the lung due to blockage of the pulmonary artery
• possible pain, swelling, and/or redness around a vein, which may indicate blood clot formation in a vein
• yellowing of the skin and/or abdominal pain, which may indicate obstruction of the bile duct, liver injury, or liver damage due to inflammation (see "Liver problems" at the beginning of section 4)
• liver damage due to medication
• rapid heartbeat, irregular heartbeat, bluish skin discoloration, heart rhythm disorders (QT prolongation), which may indicate heart and blood vessel disorders
• blood clot
• redness
• painful swelling of joints due to uric acid (gout)
• loss of interest, mood changes, uncontrollable or unexpected crying
• balance problems, speech and nerve function issues, tremor
• painful or abnormal skin sensations
• paralysis on one side of the body
• migraine with aura
• nerve damage
• dilation or swelling of blood vessels causing headache
• eye problems including increased tear production, clouding of the eye lens (cataract), retinal bleeding, dry eyes
• problems with nose, throat, and sinuses, breathing problems during sleep
• mouth and throat blisters/ulcers
• loss of appetite
• digestive system problems including frequent bowel movements, food poisoning, blood in stool, vomiting with blood
• rectal bleeding, change in stool color, abdominal swelling, constipation
• mouth problems including dry mouth, sore mouth, painful tongue, bleeding gums, mouth discomfort
• sunburn
• feeling hot, anxiety
• redness or swelling around a wound
• bleeding around a catheter (if present) in the skin
• foreign body sensation
• kidney problems including kidney inflammation, excessive urination at night, kidney failure, presence of white blood cells in urine
• cold sweat
• general feeling of malaise
• skin infection
• skin changes including skin discoloration, peeling, redness, itching, and sweating
• muscle weakness
• cancer of the rectum and colon

Uncommon side effects detectable in laboratory tests:

• changes in the shape of red blood cells
• presence of abnormal white blood cell development, which may indicate certain diseases
• increased number of platelets
• decreased calcium levels
• decreased number of red blood cells (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia)
• increased number of myelocytes
• increased band neutrophils
• increased blood urea levels
• increased protein levels in urine
• increased albumin levels in blood
• increased total protein levels
• decreased albumin levels in blood
• increased urine pH
• increased haemoglobin levels

The following side effects have been reported in association with Mylatabi treatment in paediatric patients (aged 1 to 17 years) with ITP:
If these side effects worsen, inform your doctor, pharmacist, or nurse.

Very common side effects
These may affect more than 1 in 10 children:

• infections of the nose, sinuses, throat, and upper respiratory tract, common cold (upper respiratory tract infection)
• diarrhoea
• abdominal pain
• cough
• high temperature
• feeling unwell (nausea)

Common side effects
These may affect up to 1 in 10 children:

• difficulty sleeping (insomnia)
• toothache
• nose and throat pain
• itchy nose, runny or blocked nose
• sore throat, runny nose, nasal congestion, and sneezing
• mouth problems including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers

The following side effects have been reported in association with Mylatabi treatment in combination with peginterferon and ribavirin in patients with HCV:

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

• headache
• loss of appetite
• cough
• feeling unwell (nausea), diarrhoea
• muscle pain, muscle weakness
• itching
• feeling tired
• fever
• unusual hair loss
• feeling weak
• flu-like illness
• swelling of hands or feet
• chills

Very common side effects detectable in blood tests:

• decreased number of red blood cells (anaemia)

Common side effects
These may affect up to 1 in 10 people:

• urinary tract infections
• inflammation of the nose, throat, and mouth, flu-like symptoms, dry mouth, sore or inflamed mouth, toothache
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, problems with concentration and memory, mood changes
• decreased brain function due to liver damage
• tingling or numbness in hands or feet
• fever, headache
• eye problems including clouding of the eye lens (cataract), dry eyes, small yellow deposits in the retina, yellowing of the whites of the eyes
• retinal bleeding
• sensation of spinning (dizziness)
• fast or irregular heartbeat (palpitations), shortness of breath
• productive cough, runny nose, influenza, cold sores, sore throat, and pain when swallowing
• digestive system problems including vomiting, stomach ache, indigestion, constipation, stomach bloating, taste disturbances, haemorrhoids, stomach pain/discomfort, dilated blood vessels and bleeding in the oesophagus
• toothache
• liver problems, including liver tumour, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver damage (see "Liver problems" at the beginning of section 4)
• skin changes including rash, dry skin, eczema, skin redness, itching, excessive sweating, unusual skin growths, hair loss
• joint pain, back pain, bone pain, limb pain (arms, legs, or feet), muscle spasms
• irritability, general feeling of malaise, skin reaction such as redness or swelling and pain at injection site, chest pain and discomfort, fluid accumulation in the body or limbs causing swelling
• infections of the nose, sinuses, throat, and upper respiratory tract, common cold (upper respiratory tract infection), inflammation of the mucosa lining the bronchi
• depression, anxiety, sleep disorders, nervousness

Common side effects detectable in blood tests:

• increased blood sugar (glucose)
• reduced number of white blood cells
• reduced number of neutrophils
• reduced albumin levels in blood
• reduced haemoglobin levels
• increased bilirubin (a substance produced by the liver)
• changes in enzymes controlling blood clotting

Uncommon side effects
These may affect up to 1 in 100 people:

• pain when urinating
• heart rhythm disorders (QT interval prolongation)
• stomach flu (gastroenteritis), sore throat
• blisters/ulcers in the mouth, stomach inflammation
• skin changes including color changes, peeling, redness, itching, lesions, and night sweats
• blood clots in a liver vein (possible liver and/or digestive system damage)
• abnormal blood clotting in small blood vessels with kidney failure
• rash, bruising at injection site, chest discomfort
• decreased number of red blood cells (anaemia) due to excessive destruction of red blood cells (haemolytic anaemia)
• confusion, agitation
• liver failure

The following side effects have been reported in association with Mylatabi treatment in patients with severe acquired aplastic anaemia (SAA):
If these side effects worsen, inform your doctor, pharmacist, or nurse.

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

• cough
• headache
• mouth and throat pain
• diarrhoea
• feeling unwell (nausea)
• joint pain (arthralgia)
• limb pain (arms, legs, hands, and feet)
• dizziness
• feeling tired
• fever
• chills
• itchy eyes
• mouth blisters
• bleeding gums
• abdominal pain
• muscle spasms

Very common side effects detectable in blood tests:

• abnormal changes in bone marrow cells
• increased liver enzyme levels (aspartate aminotransferase (AST))

Common side effects
These may affect up to 1 in 10 people:

• anxiety
• depression
• feeling cold
• general feeling of malaise
• eye problems including vision problems, blurred vision, clouding of the eye lens (cataract), spots or deposits in the eye (vitreous floaters), dry eyes, itchy eyes, yellowing of the white part of the eye or skin
• nosebleeds
• digestive system problems including difficulty swallowing, mouth pain, tongue swelling, vomiting, loss of appetite, stomach pain/discomfort, stomach bloating, intestinal gas/farting, constipation, intestinal motility disorder that may cause constipation, bloating, diarrhoea, and/or the above-mentioned symptoms, change in stool color
• fainting
• skin problems including small red or purple spots due to bleeding under the skin (petechiae), rash, itching, hives, skin lesions
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of lower limbs due to fluid accumulation
• abnormally colored urine
• interruption of blood supply to the spleen (splenic infarction)
• runny nose

Common side effects detectable in blood tests:

• increased enzymes due to muscle injury (creatine phosphokinase)
• iron accumulation in the body (iron overload)
• decreased blood sugar levels (hypoglycaemia)
• increased bilirubin levels in blood (a substance produced by the liver)
• reduced white blood cell levels

Side effects with unknown frequency
Frequency cannot be estimated from the available data:

• skin discoloration
• skin darkening
• drug-induced liver damage

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 Mylatabi

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 does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mylatabi contains
25 mg film-coated tablets
50 mg film-coated tablets
The other ingredients are: microcrystalline cellulose (E460), mannitol (E421), povidone (E1201),
sodium starch glycolate and magnesium stearate, polyvinyl alcohol (partially hydrolysed) (E1203), talc
(E553b), titanium dioxide (E171), glycerol monocaprylocaprate (E422) and sodium lauryl sulfate.
Mylatabi 50 mg film-coated tablets also contain red iron oxide (E172) and yellow iron oxide (E172).

Description of the appearance of Mylatabi and contents of the pack
Mylatabi 25 mg film-coated tablets are white, round, biconvex, film-coated tablets, marked “C21” on one side.
Mylatabi 50 mg film-coated tablets are beige, round, biconvex, film-coated tablets, marked “C22” on one side.
Mylatabi is available in Alu/PVC/Alu/OPA blisters containing 14 or 28 film-coated tablets, and in multiple packs of 84 film-coated tablets (3 packs of 28).
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Tillomed Italia S.r.l.
Viale Giulio Richard 1, Torre A
20143 Milano (MI), Italy

Manufacturer
Coripharma ehf.
Reykjavikurvegur 78-80
IS -220 Hafnarfjörður
Iceland

This medicinal product is authorised in the European Economic Area Member States under the
following names:

Germany	Mylatabi 25 mg Film tablets Mylatabi 50 mg Film tablets Mylatabi 75 mg Film tablets
Austria	Mylatabi 25 mg Film tablets Mylatabi 50 mg Film tablets Mylatabi 75 mg Film tablets
Ireland	Mylatabi 25 mg film-coated tablets Mylatabi 50 mg film-coated tablets Mylatabi 75 mg film-coated tablets
Spain	Mylatabi 25 mg film-coated tablets Mylatabi 50 mg film-coated tablets Mylatabi 75 mg film-coated tablets
Netherlands	Mylatabi 25 mg film-coated tablets Mylatabi 50 mg film-coated tablets Mylatabi 75 mg film-coated tablets
Denmark	Mylatabi
Sweden	Mylatabi
Norway	Mylatabi
Finland	Mylatabi
Poland	Mylatabi
Croatia	Mylatabi 25 mg film-coated tablets Mylatabi 50 mg film-coated tablets Mylatabi 75 mg film-coated tablets
Czech Republic	Mylatabi
Portugal	Mylatabi 25 mg film-coated tablets Mylatabi 50 mg film-coated tablets Mylatabi 75 mg film-coated tablets