Package leaflet: Information for the user

Lentulil, 4 mg, hard capsules
Lentulil, 10 mg, hard capsules
Lenvatinibum
Read the entire leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Lentulil is and what it is used for
Important information before taking Lentulil
How to take Lentulil
Possible side effects
How to store Lentulil
Contents of the pack and other information

1. What Lentulil is and what it is used for

Lentulil is a medicine containing an active substance called lenvatinib. It is used as a single agent in the treatment of adult patients with progressive or advanced thyroid cancer in whom radioactive iodine therapy has failed to halt disease progression.
Lentulil may also be used alone in the treatment of liver cancer (hepatocellular carcinoma) in adult patients who have not previously been treated with systemic anticancer therapy. Lentulil is administered to patients in whom liver cancer has spread or cannot be surgically removed.
Lentulil may also be used in combination with another anticancer medicine called pembrolizumab in the treatment of advanced endometrial cancer (cancer of the lining of the uterus) in adult patients whose cancer has spread after prior systemic anticancer therapy and cannot be removed surgically or with radiotherapy.
Lentulil is also used in combination with pembrolizumab as first-line treatment in adult patients with advanced renal cell cancer (advanced kidney cancer). It is also used in combination with everolimus in the treatment of adult patients with advanced renal cell cancer in whom prior therapy (known as "anti-VEGF targeted therapy") has failed to halt disease progression.

How Lentulil works
Lentulil blocks the activity of proteins known as tyrosine kinase receptors (RTKs), which are involved in the development of new blood vessels that supply oxygen and nutrients to cells and support their growth. These proteins may be present in high amounts in tumor cells. By inhibiting their activity, Lentulil may slow down the rate of tumor cell division and tumor growth, and help cut off the blood supply required by tumor tissues.

2. Important information before taking Lentulil

When not to take Lentulil:

If the patient is allergic to lenvatinib or any of the other ingredients of this medicine (listed in section 6).
If the patient is breastfeeding (see section below on pregnancy, breastfeeding and fertility).

Warnings and precautions
Before starting treatment with Lentulil, consult a doctor if the patient:

has high blood pressure;
is a woman of childbearing potential (see section below on pregnancy, breastfeeding and fertility);
has a history of heart disease or stroke;
has liver or kidney disease;
recently underwent surgery or radiotherapy;
needs to undergo surgery. The doctor may consider interrupting treatment with Lentulil if the patient is scheduled for major surgery, as Lentulil may affect wound healing. Treatment with Lentulil can be resumed once adequate wound healing has been established;
is over 75 years of age;
belongs to an ethnic group other than White or Asian;
has body weight less than 60 kg;
has previously had abnormal connections (fistulas) between different organs or between organs and the skin;
has or has had an aneurysm (a bulge and weakening of a blood vessel wall) or arterial dissection (tear in the blood vessel wall);
experiences or has experienced pain in the mouth, tooth or jaw pain, swelling or ulceration inside the mouth, numbness or heaviness in the jaw, or has or has had loose teeth. The doctor may recommend a dental examination before starting treatment with Lentulil, as cases of jaw bone damage (osteonecrosis) have been reported in patients treated with Lentulil. If the patient requires an invasive dental procedure or dental surgery, the dentist should be informed that the patient is taking Lentulil, especially if the patient is also receiving or has received intravenous bisphosphonates (medicines used to treat bone diseases or to prevent bone complications);
is currently or has previously received certain medicines used to treat osteoporosis (bone resorption inhibitors) or anticancer medicines that regulate blood vessel formation (so-called angiogenesis inhibitors), as this may increase the risk of jaw bone damage. Before taking Lentulil, the doctor may perform certain blood tests, for example to check blood pressure, liver or kidney function, or to determine whether the patient has low salt levels or high levels of thyroid-stimulating hormone in the blood. The doctor will discuss the test results with the patient and decide whether Lentulil can be administered. Additional treatment with other medicines, dose reduction of Lentulil, or special precautions due to increased risk of adverse reactions may be necessary.

If the patient has any doubts, they should consult a doctor before taking Lentulil.
Conditions requiring attention
During cancer treatment, tumor cell breakdown may cause substances to leak into the bloodstream, potentially leading to complications known as tumor lysis syndrome (TLS). Tumor lysis syndrome may cause kidney changes and can be life-threatening. The doctor will monitor the patient and may initiate treatment to reduce the risk. Immediately inform the doctor if the patient experiences signs of tumor lysis syndrome (see section 4: Possible side effects).
Children and adolescents
Lentulil is not currently recommended for use in children and adolescents under 18 years of age.
Lentulil with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes herbal preparations and over-the-counter medicines.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Patients must use an effective method of contraception during treatment and for at least 1 month after treatment ends. It is not known whether Lentulil may reduce the effectiveness of oral contraceptives. If oral contraception is the standard method, mechanical contraceptive methods such as a diaphragm or condom should be used during sexual intercourse while taking Lentulil.
Do not take Lentulil if the patient plans to become pregnant during treatment. This is important because the medicine may severely harm the unborn child.
If a patient becomes pregnant during treatment with Lentulil, she must inform the doctor immediately. The doctor will help decide whether to continue treatment.
A patient taking Lentulil must not breastfeed. This is important because the medicine passes into human milk and may severely harm the breastfed infant.

Driving and operating machinery
Lentulil may cause side effects that could affect the ability to drive or operate machinery. Patients should avoid driving and operating machinery if they experience dizziness or feel tired.
Lentulil contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, meaning the medicine is considered "sodium-free".

3. How to take Lentulil

This medicine should always be taken according to your doctor’s or pharmacist’s instructions. If you are unsure, you should consult your doctor or pharmacist.

What dose should be taken

Thyroid cancer

The recommended dose of Lentulil is usually 24 mg once daily (two 10 mg capsules and one 4 mg capsule).
If the patient has severe liver or kidney disease, the recommended dose is 14 mg once daily (one 10 mg capsule and one 4 mg capsule).
If the patient experiences symptoms related to adverse effects, the doctor may reduce the dose of the medicine.

Liver cancer

The recommended dose of Lentulil depends on the patient’s body weight at the start of treatment. The dose is usually 12 mg once daily (three 4 mg capsules) for patients weighing 60 kg or more, and 8 mg once daily (two 4 mg capsules) for patients weighing less than 60 kg.
If the patient experiences symptoms related to adverse effects, the doctor may reduce the dose of the medicine.

Uterine cancer

The recommended dose of Lentulil is 20 mg once daily (two 10 mg capsules) in combination with pembrolizumab. Pembrolizumab is administered by a doctor as an intravenous injection at a dose of 200 mg every 3 weeks or 400 mg every 6 weeks.
If the patient experiences symptoms related to adverse effects, the doctor may reduce the dose of the medicine.

Kidney cancer

The recommended daily dose of Lentulil is 20 mg once daily (two 10 mg capsules) in combination with pembrolizumab administered as a 30-minute intravenous infusion at a dose of 200 mg every 3 weeks or 400 mg every 6 weeks.
The recommended daily dose of Lentulil is usually 18 mg once daily (one 10 mg capsule and two 4 mg capsules) in combination with one 5 mg everolimus tablet taken once daily.
If the patient has severe liver or kidney disease, the recommended daily dose of Lentulil is 10 mg once daily (one 10 mg capsule) in combination with one 5 mg everolimus tablet once daily. If the patient is receiving lenvatinib in combination with pembrolizumab, the doctor or pharmacist will determine the appropriate dose of pembrolizumab.
If the patient experiences adverse effects, the doctor may reduce the dose of the medicine.

How to take the medicine

The capsule may be taken with or without food.
Do not open the capsules to avoid contact with the capsule contents.
Swallow the capsule whole with water.
Take the capsules at approximately the same time each day.

How long to take Lentulil

This medicine should usually be taken for as long as it continues to provide benefit.

Taking more Lentulil than recommended

If a patient takes more than the recommended dose of Lentulil, they should contact their doctor or pharmacist immediately. The medicine packaging should be taken along.

Missing a dose of Lentulil

Do not take a double dose (two doses at the same time) to make up for a missed dose.

If a patient forgets to take a dose, the action to take depends on how much time remains until the next scheduled dose.

If 12 hours or more remain until the next scheduled dose, take the missed dose as soon as possible. Take the next dose at the usual time.
If less than 12 hours remain until the next scheduled dose, skip the missed dose. Take the next dose at the usual time.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform your doctor if the patient notices any of the following
adverse symptoms – immediate treatment may be necessary:

Numbness or weakness on one side of the body, severe headache, seizures, confusion, difficulty speaking, changes in vision, or feeling dizzy – these may be symptoms of stroke, bleeding in the brain, or a reaction in the brain due to a severe increase in blood pressure.
Chest pain or pressure, pain in arms, back, neck, or jaw, shortness of breath, rapid or irregular heartbeat, cough, bluish discoloration of lips or fingers, or feeling extremely tired – these may be symptoms of heart disease, blood clots in the lungs, or air leaking from the lung into the pleural space, preventing the lung from filling properly.
Severe abdominal pain – this may result from perforation of the intestinal wall or a fistula (a hole in the intestine connecting via a tubular structure to another part of the body or to the skin).
Black, tarry, or bloody stools, blood in sputum – these may be symptoms of internal bleeding.
Yellowing of the skin or whites of the eyes (jaundice), or drowsiness, disorientation, difficulty concentrating – these may be symptoms of liver disease.
Diarrhea, nausea, vomiting – these are very common adverse reactions which may become severe if the patient becomes dehydrated; this may lead to kidney failure. The doctor may prescribe medications to relieve these adverse effects.
Mouth pain, tooth or jaw pain and/or swelling, ulceration inside the mouth, numbness or heaviness in the jaw, or loose teeth – these may be symptoms of jaw bone damage (osteonecrosis).
Nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, and feeling tired – these symptoms may indicate complications caused by the breakdown products of tumor cells, known as tumour lysis syndrome (TLS).

If the patient notices any of these symptoms, they should immediately inform their doctor.
The following adverse reactions may occur during treatment with this medicine:
Very common adverse reactions (may occur in more than 1 in 10 people):

High or low blood pressure
Loss of appetite or weight loss
Nausea and vomiting, constipation, diarrhea, abdominal pain, indigestion
Feeling extremely tired or weak
Hoarse voice
Swelling of legs
Rash
Dryness, pain, or inflammation in the mouth, altered taste sensations
Joint or muscle pain
Dizziness
Hair loss
Bleeding (most commonly from the nose, but also other types such as blood in urine, bruising, bleeding from gums, or intestinal wall)
Sleep disturbances
Changes in urine tests showing protein (high) and urinary tract infections (increased frequency of urination and painful urination)
Headache
Back pain
Redness, irritation, and swelling of the skin on hands and feet (hand-foot syndrome, palmar-plantar erythrodysesthesia)
Hypothyroidism (tiredness, weight gain, constipation, feeling cold, dry skin)
Changes in blood test results showing low potassium and low calcium levels
Decreased number of white blood cells
Changes in blood tests indicating liver function abnormalities
Low platelet count, which may lead to bruising and difficulty healing wounds
Changes in blood test results showing low magnesium, high cholesterol, and high thyroid-stimulating hormone (TSH) levels
Changes in blood tests indicating kidney function abnormalities and kidney failure
Increased lipase and amylase activity (enzymes involved in digestion)

Common adverse reactions (may occur in up to 1 in 10 people):

Fluid loss (dehydration)
Stroke symptoms, including numbness or weakness on one side of the body, severe headache, seizures, confusion, difficulty speaking, changes in vision, or feeling dizzy
Palpitations
Dry skin, skin thickening, and itching
Feeling bloated or excess gas
Heart disease or blood clots in the lungs (difficulty breathing, chest pain), or in other organs, which may include chest pain or pressure, pain in arms, back, neck, or jaw, shortness of breath, rapid or irregular heartbeat, cough, bluish discoloration of lips or fingers, and feeling extremely tired
Liver failure
Drowsiness, disorientation, difficulty concentrating, loss of consciousness – these may be symptoms of liver failure
General malaise
Gallbladder inflammation
Anal fistula (a small channel forming between the anus and nearby skin)
Perforation (hole) in the stomach or intestinal wall

Uncommon adverse reactions (may occur in up to 1 in 100 people):

Painful infections or irritation around the anus
"Mini" stroke (transient ischemic attack)
Severe breathing difficulties and chest pain caused by air leaking from the lung into the pleural space, preventing the lung from filling properly
Liver damage
Severe pain in the upper left abdomen, possibly accompanied by fever, chills, nausea, and vomiting (splenic infarction)
Pancreatitis
Wound healing problems
Jaw bone damage (osteonecrosis)
Colitis (inflammation of the large intestine)
Reduced secretion of hormones produced by the adrenal glands

Rare adverse reactions (may occur in up to 1 in 1000 people):

Tumour lysis syndrome (TLS)

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

Other types of fistulas (abnormal connections between organs or between the skin and deeper structures such as the throat or trachea). Symptoms depend on the location of the fistula. If the patient develops new or unusual symptoms such as coughing while swallowing, they should discuss this with their doctor.
Enlargement and weakening of blood vessel walls or blood vessel wall rupture (aneurysm and arterial dissection).

The following adverse reactions may occur during treatment with this medicine
in combination with pembrolizumab for the treatment of endometrial cancer:
Very common adverse reactions (may occur in more than 1 in 10 people):

Changes in blood tests showing high protein levels and urinary tract infections (increased frequency of urination and painful urination)
Low platelet count, which may lead to bruising and difficulty healing wounds
Decreased number of white blood cells
Decreased number of red blood cells
Hypothyroidism (tiredness, weight gain, constipation, feeling cold, dry skin) and increased thyroid-stimulating hormone (TSH) levels in blood tests
Hyperthyroidism (symptoms may include rapid heartbeat, sweating, and weight loss)
Low blood calcium levels
Low blood potassium levels
High blood cholesterol levels
Low blood magnesium levels
Loss of appetite or weight loss
Dizziness
Headache
Back pain
Dryness, pain, or inflammation in the mouth, altered taste sensations
Bleeding (most commonly from the nose, but also other types such as blood in urine, bruising, bleeding from gums, or intestinal wall)
High blood pressure
Hoarse voice
Nausea and vomiting, constipation, diarrhea, abdominal pain
Increased amylase activity (enzyme involved in digestion)
Increased lipase activity (enzyme involved in digestion)
Changes in blood tests indicating liver function abnormalities
Changes in blood tests indicating kidney function abnormalities
Redness, irritation, and swelling of the skin on hands and feet (hand-foot syndrome, palmar-plantar erythrodysesthesia)
Rash
Joint or muscle pain
Feeling extremely tired or weak
Swelling of legs

Common adverse reactions (may occur in up to 1 in 10 people):

Fluid loss (dehydration)
Sleep disturbances
Palpitations
Low blood pressure
Blood clots in the lungs (difficulty breathing, chest pain)
Pancreatitis
Feeling bloated or excess gas
Indigestion
Gallbladder inflammation
Hair loss
Kidney failure
General malaise
Colitis (inflammation of the large intestine)
Reduced secretion of hormones produced by the adrenal glands
Perforation (hole) in the stomach or intestinal wall

Uncommon adverse reactions (may occur in up to 1 in 100 people):

Headache, dizziness, seizures, and vision changes
Stroke symptoms, including numbness or weakness on one side of the body, severe headache, seizures, confusion, difficulty speaking, changes in vision, or feeling dizzy
"Mini" stroke (transient ischemic attack)
Symptoms of heart disease, including chest pain or pressure, pain in arms, back, neck, or jaw, shortness of breath, rapid or irregular heartbeat, cough, bluish discoloration of lips or fingers, and feeling extremely tired
Severe breathing difficulties and chest pain caused by air leaking from the lung into the pleural space, preventing the lung from filling properly
Painful infections or irritation around the anus
Anal fistula (a small channel forming between the anus and nearby skin)
Liver failure or symptoms of liver damage, including yellowing of skin or whites of the eyes (jaundice), drowsiness, disorientation, difficulty concentrating
Dry skin, skin thickening, and itching
Wound healing problems

Rare adverse reactions (may occur in up to 1 in 1000 people):

Tumour lysis syndrome (TLS)

The following adverse reactions may occur during treatment with this medicine
in combination with pembrolizumab for the treatment of renal cell carcinoma:
Very common adverse reactions (may occur in more than 1 in 10 people):

Low platelet count, which may lead to bruising and difficulty healing wounds
Decreased number of white blood cells
Hypothyroidism (tiredness, weight gain, constipation, feeling cold, dry skin) and increased thyroid-stimulating hormone (TSH) levels in blood tests
Low blood potassium and calcium levels
Low blood magnesium and high cholesterol levels
Loss of appetite or weight loss
Sleep disturbances
Dizziness
Headache
Bleeding (most commonly from the nose, but also other types such as blood in urine, bruising, bleeding from gums, or intestinal wall)
High blood pressure
Hoarse voice
Nausea and vomiting, constipation, diarrhea, abdominal pain, indigestion
Dryness, pain, or inflammation in the mouth, altered taste sensations
Increased lipase and amylase activity (enzymes involved in digestion)
Changes in blood tests indicating liver function abnormalities
Redness, irritation, and swelling of the skin on hands and feet (hand-foot syndrome, palmar-plantar erythrodysesthesia)
Rash
Back pain
Joint or muscle pain
High protein levels in urine tests
Changes in blood tests indicating kidney function abnormalities and kidney failure
Feeling extremely tired or weak
Swelling of legs

Common adverse reactions (may occur in up to 1 in 10 people):

Urinary tract infections (increased frequency of urination and painful urination)
Fluid loss (dehydration)
Palpitations
Heart disease or blood clots in the lungs (difficulty breathing, chest pain) or in other organs, which may include chest pain or pressure, pain in arms, back, neck, or jaw, shortness of breath, rapid or irregular heartbeat, cough, bluish discoloration of lips or fingers, and feeling extremely tired
Low blood pressure
Pancreatitis
Colitis (inflammation of the large intestine)
Feeling bloated or excess gas
Gallbladder inflammation
Dry skin, skin thickening, and itching
Hair loss
General malaise
Reduced secretion of hormones produced by the adrenal glands
Perforation (hole) in the stomach or intestinal wall

Uncommon adverse reactions (may occur in up to 1 in 100 people):

Painful infections or irritation around the anus
Stroke symptoms, including numbness or weakness on one side of the body, severe headache, seizures, confusion, difficulty speaking, changes in vision, or feeling dizzy
"Mini" stroke (transient ischemic attack)
Severe breathing difficulties and chest pain caused by air leaking from the lung into the pleural space, preventing the lung from filling properly
Anal fistula (a small channel forming between the anus and nearby skin)
Liver failure or symptoms of liver damage, including yellowing of skin or whites of the eyes (jaundice), drowsiness, disorientation, difficulty concentrating
Wound healing problems
Other types of fistulas (abnormal connections between organs or between the skin and deeper structures such as the throat or trachea). Symptoms depend on the location of the fistula. If the patient develops new or unusual symptoms such as coughing while swallowing, they should discuss this with their doctor.

Rare adverse reactions (may occur in up to 1 in 1000 people):

Tumour lysis syndrome (TLS)

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

Enlargement and weakening of blood vessel walls or blood vessel wall rupture (aneurysm and arterial dissection).

The following adverse reactions may occur during treatment with this medicine
in combination with everolimus for the treatment of renal cell carcinoma:
Very common adverse reactions (may occur in more than 1 in 10 people):

Low platelet count, which may lead to bruising and difficulty healing wounds
Decreased number of white blood cells
Hypothyroidism (tiredness, weight gain, constipation, feeling cold, dry skin) and increased thyroid-stimulating hormone (TSH) levels in blood tests
Low blood potassium and calcium levels
Low blood magnesium and high cholesterol levels
Loss of appetite or weight loss
Sleep disturbances
Headache
Bleeding (most commonly from the nose, but also other types such as blood in urine, bruising, bleeding from gums, or intestinal wall)
High blood pressure
Hoarse voice
Nausea and vomiting, constipation, diarrhea, abdominal pain, indigestion
Pain or inflammation in the mouth, altered taste sensations
Increased lipase and amylase activity (enzymes involved in digestion)
Changes in blood tests indicating liver function abnormalities
Redness, irritation, and swelling of the skin on hands and feet (hand-foot syndrome, palmar-plantar erythrodysesthesia)
Rash
Back pain
Joint or muscle pain
High protein levels in urine tests
Changes in blood tests indicating kidney function abnormalities and kidney failure
Feeling extremely tired or weak
Swelling of legs

Common adverse reactions (may occur in up to 1 in 10 people):

Urinary tract infections (increased frequency of urination and painful urination)
Fluid loss (dehydration)
Dizziness
Palpitations
Heart disease or blood clots in the lungs (difficulty breathing, chest pain) or in other organs, which may include chest pain or pressure, pain in arms, back, neck, or jaw, shortness of breath, rapid or irregular heartbeat, cough, bluish discoloration of lips or fingers, and feeling extremely tired
Low blood pressure
Severe breathing difficulties and chest pain caused by air leaking from the lung into the pleural space, preventing the lung from filling properly
Dry mouth
Feeling bloated or excess gas
Gallbladder inflammation
Hair loss
General malaise
Perforation (hole) in the stomach or intestinal wall

Uncommon adverse reactions (may occur in up to 1 in 100 people):

Painful infections or irritation around the anus
Stroke symptoms, including numbness or weakness on one side of the body, severe headache, seizures, confusion, difficulty speaking, changes in vision, or feeling dizzy
"Mini" stroke (transient ischemic attack)
Pancreatitis
Anal fistula (a small channel forming between the anus and nearby skin)
Colitis (inflammation of the large intestine)
Liver failure or symptoms of liver damage, including yellowing of skin or whites of the eyes (jaundice), drowsiness, disorientation, difficulty concentrating
Jaw bone damage (osteonecrosis)
Dry skin, skin thickening, and itching
Wound healing problems
Other types of fistulas (abnormal connections between organs or between the skin and deeper structures such as the throat or trachea). Symptoms depend on the location of the fistula. If the patient develops new or unusual symptoms such as coughing while swallowing, they should discuss this with their doctor.
Reduced secretion of hormones produced by the adrenal glands

Rare adverse reactions (may occur in up to 1 in 1000 people):

Tumour lysis syndrome (TLS)

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

Enlargement and weakening of blood vessel walls or blood vessel wall rupture (aneurysm and arterial dissection).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Lentulil

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 pack after:
"EXP". The expiry date refers to the last day of the specified month.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the pack and other information

What Lentulil contains

The active substance is lenvatinib.
Lentulil 4 mg, hard capsules: - Each hard capsule contains lenvatinib besylate equivalent to 4 mg of lenvatinib.
Lentulil 10 mg, hard capsules: - Each hard capsule contains lenvatinib besylate equivalent to 10 mg of lenvatinib.
The other ingredients are: sodium hydrogen carbonate, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, talc. The capsule shell contains hypromellose 2906 (5 mPas), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172). The printing ink contains shellac, black iron oxide (E 172), potassium hydroxide.

What Lentulil looks like and contents of the pack

The 4 mg capsule has a caramel-colored, opaque body and a caramel-colored, opaque cap, size 4 (approximately 14.3 mm in length), printed with "L7VB" above the symbol "4".
The 10 mg capsule has a yellow, opaque body and a caramel-colored, opaque cap, size 4 (approximately 14.3 mm in length), printed with "L7VB" above the symbol "10".
Each cardboard box contains 30, 60 or 90 hard capsules in OPA/Aluminum/PVC/Aluminum blisters or 30x1, 60x1 or 90x1 hard capsules in unit-dose OPA/Aluminum/PVC/Aluminum blisters.
Each cardboard box contains 30, 60 or 90 hard capsules in OPA/Aluminum/PVC/PE/Aluminum blisters with a desiccant or 30x1, 60x1 or 90x1 hard capsules in unit-dose OPA/Aluminum/PVC/PE/Aluminum blisters with a desiccant.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer/Importer
Synthon Hispania S.L.
Calle De Castello 1
08830 Sant Boi De Llobregat, Barcelona
Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic Lentulil
Netherlands Lentulil 4 mg, 10 mg hard capsules
Poland Lentulil
Romania Lentulil 4 mg, 10 mg capsules
Slovakia Lentulil 4 mg, 10 mg
Hungary Lentulil 4 mg, 10 mg kemény kapszula

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Tel.: +48 22 417 92 00