Eltrombopag Abdi 50 mg film-coated tablets – patient leaflet, side effects, dosage

1. What Eltrombopag Abdi is and what it is used for

Eltrombopag Abdi contains sodium

Eltrombopag Abdi contains eltrombopag, which belongs to a group of medicines called

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

thrombopoietin-receptor agonists. It is used to help increase the number of platelets in your blood. Platelets are blood cells that help to reduce or prevent bleeding.

1. 3. How to take Eltrombopag Abdi

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Do not change the dose or schedule for taking Eltrombopag Abdi unless your doctor or pharmacist advises you to. While you are taking Eltrombopag Abdi, you will be under the care of a doctor with specialist experience in treating your condition.

• Eltrombopag Abdi is used to treat a bleeding disorder called immune (primary) thrombocytopenia (ITP) in patients aged 1 year and above who have already taken other medicines (corticosteroids or immunoglobulins), which have not worked.

ITP is caused by a low blood platelet count (thrombocytopenia). People with ITP have an increased risk of bleeding. Symptoms patients with ITP may notice include petechiae (pinpoint- sized flat round red spots under the skin), bruising, nosebleeds, bleeding gums and not being able to control bleeding if they are cut or injured.

How much to take

For ITP

Adults and children (6 to 17 years) – the usual starting dose for ITP is one 50 mg tablet of Eltrombopag Abdi a day. If you are of East-/Southeast-Asian origin you may need to start at a lower dose of 25 mg.

• Eltrombopag Abdi can also be used to treat low platelet count (thrombocytopenia) in adults with hepatitis C virus (HCV) infections, if they have had problems with side effects while on interferon treatment. Many people with hepatitis C have low platelet counts, not only as a result of the disease, but also due to some of the antiviral medicines that are used to treat it. Taking Eltrombopag Abdi may make it easier for you to complete a full course of antiviral medicine (peginterferon and ribavirin).

  Children (1 to 5 years) — the usual starting dose for ITP is one 25 mg tablet of Eltrombopag Abdi a day.

  For hepatitis C

  Adults - the usual starting dose for hepatitis C is one 25 mg tablet of Eltrombopag Abdi a day. If you are of East-/Southeast-Asian origin you will start on the same 25 mg dose.

2. What you need to know before you take Eltrombopag Abdi

How to take the tablets

Swallow the tablet whole, with some water.

Do not take Eltrombopag Abdi

• if you are allergic to eltrombopag or any of the other ingredients of this medicine (listed in section 6 under ‘What Eltrombopag Abdi contains’).

  When to take it

  Make sure that –

→ Check with your doctor if you think this applies to you.

• in the 4 hours before you take Eltrombopag Abdi
• and the 2 hours after you take Eltrombopag Abdi

Warnings and precautions

Talk to your doctor before taking Eltrombopag Abdi:

you don’t consume any of the following:

• if you have liver problems. People who have low platelet counts as well as advanced chronic (long-term) liver disease are more at risk of side effects, including life-threatening liver damage and blood clots. If your doctor considers that the benefits of taking Eltrombopag Abdi outweigh the risks, you will be closely monitored during treatment.

  • dairy foods such as cheese, butter, yoghurt or ice cream
  • milk or milk shakes, drinks containing milk, yoghurt or cream
  • antacids, a type of medicine for indigestion and heartburn
  • some mineral and vitamin supplements including iron, calcium, magnesium, aluminium, selenium and zinc
• if you are at risk of blood clots in your veins or arteries, or you know that blood clots are common in your family.

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

You may be at higher risk of blood clots:

Take Eltrombopag

• as you get older

• if you have had to stay in bed for a long time

  ... and for 2 hours after For 4 hours

• if you have cancer

  before you take

• if you are taking the contraceptive birth control pill or hormone replacement therapy

  Eltrombopag...

• if you have recently had surgery or received a physical injury

• if you are very overweight (obese)

  NO dairy products, antacids or mineral supplements

• if you are a smoker
• if you have advanced chronic liver disease

→ If any of these apply to you, tell your doctor before starting treatment. You should not take Eltrombopag Abdi unless your doctor considers that the expected benefits outweigh the risk of blood clots.

For more advice about suitable foods and drinks, talk to your doctor.

If you take more Eltrombopag Abdi than you should Contact a doctor or pharmacist immediately. If possible show them the pack, or this leaflet. You will be monitored for any signs or symptoms of side effects and given appropriate treatment immediately.

• if you have cataracts (the lens of the eye getting cloudy)

• if you have another blood condition, such as myelodysplastic syndrome (MDS). Your doctor will carry out tests to check that you do not have this blood condition before you start Eltrombopag Abdi. If you have MDS and take Eltrombopag Abdi, your MDS may get worse.

  If you forget to take Eltrombopag Abdi

→ Tell your doctor if any of these apply to you.

Take the next dose at the usual time. Do not take more than one dose of Eltrombopag Abdi in one day.

Eye examinations

Your doctor will recommend that you are checked for cataracts. If you do not have routine eye-tests your doctor should arrange regular testing. You may also be checked for the occurrence of any bleeding in or around your retina (the light-sensitive layer of cells at the back of the eye).

If you stop taking Eltrombopag Abdi

Don’t stop taking Eltrombopag Abdi without talking to your doctor. If your doctor advises you to stop treatment, your platelet count will then be checked each week for four weeks. See also ‘Bleeding or bruising after you stop treatment’ in section 4.

You will need regular tests

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Before you start taking Eltrombopag Abdi, your doctor will carry out blood tests to check your blood cells, including platelets. These tests will be repeated at intervals while you are taking it.

4. Possible side effects

Blood tests for liver function

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Eltrombopag Abdi can cause blood test results that may be signs of liver damage - an increase of some liver enzymes, especially bilirubin and alanine / aspartate transaminases. If you are taking interferon-based treatments together with Eltrombopag Abdi to treat low platelet count due to hepatitis C, some liver problems can get worse.

Symptoms needing attention: see a doctor

People taking Eltrombopag Abdi for either ITP or low blood platelet counts due to hepatitis C could develop signs of potentially serious side effects. It is important to tell a doctor if you develop these symptoms.

You will have blood tests to check your liver function before you start taking Eltrombopag Abdi and at intervals while you are taking it. You may need to stop taking Eltrombopag Abdi if the amount of these substances increases too much, or if you get other signs of liver damage.

Higher risk of blood clots

Certain people may have a higher risk of blood clots, and medicines like Eltrombopag Abdi could make this problem worse. The sudden blocking of a blood vessel by a blood clot is an uncommon side effect and may affect up to 1 in 100 people.

→ Read the information ‘Liver problems’ in section 4 of this leaflet.

Get medical help immediately if you develop signs and symptoms of a blood clot, such as:

Blood tests for platelet count

If you stop taking Eltrombopag Abdi, your blood platelet count is likely to become low again within several days. The platelet count will be monitored, and your doctor will discuss appropriate precautions with you.

• swelling, pain, heat, redness, or tenderness in one leg
• sudden shortness of breath, especially together with sharp pain in the chest or rapid breathing
• abdominal (stomach) pain, enlarged abdomen, blood in your stools.

A very high blood platelet count may increase the risk of blood clotting. However blood clots can also form with normal or even low platelet counts. Your doctor will adjust your dose of Eltrombopag Abdi to ensure that your platelet count does not become too high.

Liver problems

Eltrombopag Abdi can cause changes that show up in blood tests, and may be signs of liver damage. Liver problems (increased enzymes showing up 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.

Get medical help immediately if you have any of these signs of a blood clot:

• swelling, pain or tenderness in one leg

• sudden shortness of breath especially together with sharp pain in the chest or rapid breathing

  If you have either of these signs of liver problems:

  • yellowing of the skin or the whites of the eyes (jaundice)

• abdominal (stomach) pain, enlarged abdomen, blood in your stools

  • unusually dark-coloured urine

→ tell your doctor immediately.

Tests to check your bone marrow

Bleeding or bruising after you stop treatment

In people who have problems with their bone marrow, medicines like Eltrombopag Abdi could make the problems worse. Signs of bone marrow changes may show up as abnormal results in your blood tests. Your doctor may also carry out tests to directly check your bone marrow during treatment with Eltrombopag Abdi.

Within two weeks of stopping Eltrombopag Abdi, your blood platelet count will usually drop back down to what it was before starting Eltrombopag Abdi. The lower platelet count may increase the risk of bleeding or bruising. Your doctor will check your platelet count for at least 4 weeks after you stop taking Eltrombopag Abdi. → Tell your doctor if you have any bleeding or bruising after stopping Eltrombopag Abdi.

Checks for digestive bleeding

If you are taking interferon-based treatments together with Eltrombopag Abdi you will be monitored for any signs of bleeding in your stomach or intestine after you stop taking Eltrombopag Abdi.

Some people have bleeding in the digestive system after they stop taking peginterferon, ribavirin, and Eltrombopag Abdi. Symptoms include:

Heart monitoring

• black tarry stools (discoloured bowel movements are a uncommon side effect that may affect up to 1 in 100 people)

Your doctor may consider it necessary to monitor your heart during treatment with Eltrombopag Abdi and carry out an

• blood in your stools

electrocardiogram (ECG) test.

• vomiting blood or something that looks like coffee grounds → Tell your doctor immediately if you have any of these symptoms.

Older people (65 years and above)

There are limited data on the use of Eltrombopag Abdi in patients aged 65 years and older. Care should be taken when using Eltrombopag Abdi if you are aged 65 years or above.

The following side effects have been reported to be associated with treatment with Eltrombopag Abdi in adult patients with ITP:

Children and adolescents

Very common side effects

Eltrombopag Abdi is not recommended for children aged under 1 year who have ITP. It is also not recommended for people under 18 years with low platelet counts due to hepatitis C or severe aplastic anaemia.

These may affect more than 1 in 10 people:

• common cold
• feeling sick (nausea)
• diarrhoea
• cough

Other medicines and Eltrombopag Abdi

• infection in the nose, sinuses, throat and upper airways (upper respiratory tract infection)

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without prescription and vitamins.

• back pain

Very common side effects that may show up in blood tests:

Some everyday medicines interact with Eltrombopag Abdi – including prescription and non-prescription medicines and minerals. These include:

• increased of liver enzymes (alanine aminotransferase (ALT))

Common side effects

• antacid medicines to treat indigestion, heartburn or stomach ulcers (see also ‘When to take it’ in section 3)

  These may affect up to 1 in 10 people:

  • muscle pain, muscle spasm, muscle weakness

• medicines called statins, to lower cholesterol

  • bone pain

• some medicines to treat HIV infection, such as lopinavir and/or ritonavir

  • heavy menstrual period
  • sore throat and discomfort when swallowing

• ciclosporin used in the context of transplantations or immune diseases

  • eye problems including abnormal eye test, dry eye, eye pain and blurred vision

• minerals such as iron, calcium, magnesium, aluminium, selenium and zinc which may be found in vitamin and mineral supplements (see also ‘When to take it’ in section 3)

  • vomiting
  • flu (influenza)
  • cold sore

• medicines such as methotrexate and topotecan, to treat cancer → Talk to your doctor if you take any of these. Some of them are not to be taken with Eltrombopag Abdi, or the dose may need adjusting, or you may need to alter the timing of when you take them.

  • pneumonia
  • irritation and inflammation (swelling) of the sinuses
  • inflammation (swelling) and infection of the tonsils,
  • infection of the lungs, sinuses, nose and throat
  • inflammation of the gum tissue

Your doctor will review the medicines you are taking, and suggest suitable replacements if necessary.

• loss of appetite
• feeling of tingling, prickling or numbness, commonly called “pins and needles”

If you are also taking medicines to prevent blood clots there is a greater risk of bleeding. 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 to stop taking them while you are taking Eltrombopag Abdi.

• decreased skin sensations
• feeling drowsy

• ear pain

  with warm skin in the affected area (signs of a blood clot in a deep vein)

  • localised swelling filled with blood from a break in a blood vessel (haematoma)
  • hot flushes
  • mouth problems including dry mouth, sore mouth, sensitive tongue, bleeding gums, mouth ulcers
  • runny nose
  • toothache
  • abdominal pain
  • abnormal liver function
  • skin changes including excessive sweating, itching bumpy rash, red spots, changes in appearance of the skin
  • hair loss
  • foamy, frothy or bubbly-looking urine (signs of protein in urine)
  • high temperature, feeling hot
  • chest pain
  • feeling weak
  • problems sleeping, depression
  • migraine
  • decreased vision
  • spinning sensation (vertigo)
  • digestive wind/gas
  • thrombotic microangiopathy with renal failure

Common side effects that may show up in blood test:

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

Uncommon side effects

These may affect up to 1 in 100 people:

• allergic reaction
• interruption of blood supply to part of the heart
• sudden shortness of breath, especially when accompanied with sharp pain in the chest and /or rapid breathing, which could be signs of a blood clot in the lungs (see ‘Higher risk of blood clots’ earlier in section 4)
• the loss of function of part of the lung caused by a blockage in the lung artery
• possible pain, swelling, and/or redness around a vein which could be signs of blood clot in a vein
• yellowing of the skin and/or abdominal pain which could be signs of a blockage in the bile tract, lesion on liver, liver damage due to inflammation (see ‘Liver problems’ earlier in section 4)
• liver injury due to medication
• heart beating faster, irregular heartbeat, bluish discolouration of the skin, disturbances of heart rhythm (QT prolongation) which could be signs of a disorder related to the heart and the blood vessels
• blood clot
• flushing
• painful swollen joints caused by uric acid (gout)
• lack of interest, mood changes, crying that is difficult to stop, or occurs at unexpected times
• problems with balance, speech and nerve function, shaking
• painful or abnormal skin sensations
• paralysis on one side of the body
• migraine with aura
• nerve damage
• dilation or swelling of blood vessels that cause headache
• eye problems including increased production of tears, cloudy lens in the eye (cataract), bleeding of the retina, dry eyes
• problems with the nose, throat and sinuses, breathing problems when sleeping
• mouth and throat blisters/sores
• loss of appetite
• digestive system problems including frequent bowel movements, food poisoning, blood in stool, vomiting of blood
• rectal bleeding, change in stool colour, abdominal bloating, constipation
• mouth problems, including dry or sore mouth, tongue pain, bleeding gums, discomfort in mouth
• sunburn
• feeling hot, feeling anxious
• redness or swelling around a wound
• bleeding around a catheter (if present) into the skin
• sensation of a foreign body
• kidney problems including inflammation of the kidney, excessive urination at night, kidney failure, white cells in urine
• cold sweat
• generally feeling unwell
• infection of the skin
• skin changes including skin discolouration, peeling, redness, itching and sweating
• muscular weakness
• cancer of rectum and colon

Uncommon side effects that may show up in laboratory tests:

• changes in the shape of red blood cells
• presence of developing white blood cells which may be indicative of certain diseases
• increased number of platelets
• decreased levels of calcium
• decreased number of red blood cells (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
• increased number of myelocytes
• increased band neutrophils
• increased blood urea
• increased levels of protein in urine
• increased levels of blood albumin
• increased levels of total protein
• decreased levels of blood albumin
• increased pH of urine
• increased level of haemoglobin

The following additional side effects have been reported to be associated with treatment with Eltrombopag Abdi in children (aged 1 to 17 years) with ITP:

If these side effects become severe, please tell your doctor, pharmacist or nurse.

Very common side effects

These may affect more than 1 in 10 children:

• infection in the nose, sinuses, throat and upper airways, common cold (upper respiratory tract infection)
• diarrhoea
• abdominal pain
• cough
• high temperature
• feeling sick (nausea)

Common side effects

These may affect up to 1 in 10 children:

• difficulty in sleeping (insomnia)
• toothache
• pain in the nose and throat
• itchy, 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 to be associated with treatment with Eltrombopag Abdi 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 sick (nausea), diarrhoea
• muscle pain, muscle weakness
• itching
• feeling tired
• fever
• unusual hair loss
• feeling weak
• flu-like illness
• swelling in the hands or feet
• chills

Very common side effects that may show up in blood tests:

• decreased number of red blood cells (anaemia)

Common side effects

These may affect up to 1 in 10 people:

• infection of the urinary system
• inflammation of the nasal passages, throat and mouth, flu-like symptoms, dry mouth, sore or inflamed mouth, toothache
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, problems with attention and memory, change in mood
• decreased brain function further to liver injury
• tingling or numbness of the hands or feet
• fever, headache
• eye problems, including cloudy lens in the eye (cataract), dry eye, small yellow deposits in the retina, yellowing of the whites of the eye
• bleeding of the retina
• spinning sensation (vertigo)
• fast or irregular heartbeat (palpitations), shortness of breath
• cough bringing up phlegm, runny nose, flu (influenza), cold sore, sore throat and discomfort when swallowing
• digestive system problems, including vomiting, stomach pain, indigestion, constipation, swollen stomach, taste disturbances, piles (haemorrhoids), stomach pain/discomfort, swollen blood vessels and bleeding in the gullet (oesophagus)
• toothache
• liver problems, including tumour in the liver, yellowing of the whites of the eyes or skin (jaundice), liver injury due to medication (see ‘Liver problems’ earlier in section 4)
• skin changes, including rash, dry skin, eczema, redness of the skin, itching, excessive sweating, unusual skin growths, hair loss
• joint pain, back pain, bone pain, pain in extremities (arms, legs, hands or feet), muscle spasms
• irritability, generally feeling unwell, skin reaction such as redness or swelling and pain at the site of injection, chest pain and discomfort, build-up of fluid in the body or extremities causing swelling
• infection in the nose, sinuses, throat and upper airways, common cold (upper respiratory tract infection), inflammation of mucous membrane lining the bronchi
• depression, anxiety, sleep problems, nervousness

Common side effects that may show up in blood tests:

• increased blood sugar (glucose)
• decreased number of white blood cells
• decreased number of neutrophils

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ELTROMBOPAG 25-50-75 mg

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• decreased level of blood albumin
• decreased level of haemoglobin
• increased levels of blood bilirubin (a substance produced by the liver)
• changes in the enzymes that control blood clotting

Uncommon side effects

These may affect up to 1 in 100 people:

• painful urination
• disturbances of heart rhythm (QT prolongation)
• stomach flu (gastroenteritis), sore throat
• mouth blisters/sores, inflammation of the stomach
• skin changes including change in colour, peeling, redness, itching, lesion and night sweats
• blood clots in a vein to the liver (possible liver and/or digestive system damage)
• abnormal blood clotting in small blood vessels with kidney failure
• rash, bruising at the injection site, chest discomfort
• decreased number of red blood cells (anaemia) caused by excessive destruction of red blood cells (haemolytic anaemia)
• confusion, agitation
• liver failure

The following side effects have been reported to be associated with treatment with Eltrombopag Abdi in patients with severe aplastic anaemia (SAA):

If these side effects become severe, please tell 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 sick (nausea)
• joint pain (arthralgia)
• pain in extremities (arms, legs, hands and feet)
• dizziness
• feeling very tired
• fever
• chills
• itchy eyes
• blisters in the mouth
• bleeding of the gums
• abdominal pain
• muscle spasms

Very common side effects that may show up in the blood tests

• abnormal changes to the cells in your bone marrow
• increased levels of liver enzymes (aspartate aminotransferase (AST))

Common side effects

These may affect up to 1 in 10 people.

• anxiety
• depression
• feeling cold
• generally feeling unwell
• eye problems including vision problems, blurred vision, cloudy lens in the eye (cataract), spots or deposits in eye (vitreous floaters), dry eye, itchy eye, yellowing of the whites of the eyes or skin
• nose bleed
• digestive system problems including difficulty swallowing, mouth pain, swollen tongue, vomiting, loss of appetite, stomach pain/discomfort, swollen stomach, digestive wind/gas, constipation, intestinal motility disorder which can cause contipation, bloating, diarrhea and/or above mentioned symptoms, change in stool colour
• fainting
• skin problems including small red or purple spots caused by bleeding into the skin (petechiae) rash, itching, hives, skin lesion
• back pain
• muscle pain
• bone pain
• weakness (asthenia)
• swelling of the lower limbs due to the accumulation of fluids
• abnormal colored urine
• interruption in blood supply to spleen (splenic infarction)
• runny nose

Common side effects that may show up in the blood tests

• increase in enzymes due to muscle breakdown (creatine phosphokinase)
• accumulation of iron in the body (iron overload)
• decrease in blood sugar levels (hypoglycaemia)
• increased levels of blood bilirubin (a substance produced by the liver)
• decreased levels of white blood cells

Side effects with frequency not known

Frequency cannot be estimated from the available data

• skin discolouration
• darkening of the skin
• liver injury due to medication

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Eltrombopag Abdi

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 carton and the blister after EXP.

This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Eltrombopag Abdi contains

The active substance in Eltrombopag Abdi is eltrombopag.

25 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.

50 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag.

75 mg film-coated tablets

Each film-coated tablet contains eltrombopag olamine equivalent to 75 mg eltrombopag.

The other ingredients are: Hypromellose (E464), macrogol / PEG (E1521), magnesium stearate, mannitol (E421), microcrystalline cellulose (Type 101), microcrystalline cellulose (Type 102), povidone (K30), sodium starch glycolate (Type A), titanium dioxide (E171).

Eltrombopag Abdi 25 mg and 50 mg film-coated tablets also contain Iron Oxide Yellow (E172) and Iron Oxide Red (E172).

Eltrombopag Abdi 75 mg film-coated tablets also contain iron oxide red (E172).

What Eltrombopag Abdi looks like and contents of the pack

Eltrombopag Abdi 25 mg film-coated tablets (7.5 mm) are round, biconvex, brown, debossed with “E1” on one side and plain on the other side.

Eltrombopag Abdi 50 mg film-coated tablets (10.7 mm) are round, biconvex, brown, debossed with “E2” on one side and plain on the other side.

Eltrombopag Abdi 75 mg film-coated tablets (12.1 mm) are round, biconvex, reddish brown, debossed with “E3” on one side and plain on the other side.

They are supplied in PVC/OPA/Al - aluminum blisters in a carton containing 14 or 28 film-coated tablets and multipacks containing 84 (3 packs of 28) film-coated tablets).

Not all pack sizes may be available in your country.

Marketing authorisation holder

Abdi Farma GmbH

Donnersbergstraße 4

64646 Heppenheim, Germany

Manufacturer

Flavine Pharma France

3 Voie d’Allermagne,

13127 Vitrolles

Frankreich

Interpharma Services Ltd.

43A Cherni Vrach Blvd.

1407 Sofia

Bulgaria

Pharmadox Healthcare Limited

KW20a Kordin Industrial Park

Paola PLA 3000, Malta

Abdi Farma GmbH

Donnersbergstraße 1

64646 Heppenheim, Germany

This leaflet was last revised in May 2025.

A20021338-00