10 mg, 15 mg, 20 mg hard capsules 
panobinostat

1. What Farydak is and what it is used for

What Farydak is

Farydak is a cancer medicine that contains the active substance panobinostat, which belongs to a group of medicines called pan-deacetylase inhibitors.

What Farydak is used for

Pharydac is used to treat adult patients with a rare type of blood cancer called multiple myeloma. In myeloma, the plasma cells (a type of blood cell ) grow in an uncontrolled manner in the bone marrow.

Farydak prevents this growth of plasma cells and reduces the number of cancer cells.

Pharydac is always used with two other medicines: bortezomib and dexamethasone.

Ask your doctor or pharmacist if you are wondering how Farydak works or why it has been prescribed for you.

2. What you need to know before taking Farydak

Do not take Farydak:

  • if you are allergic to panobinostat or any of the other ingredients of this medicine (listed in section 6).
  • if you are breast-feeding.

Warnings and cautions

Follow all your doctor’s instructions carefully.

Talk to your doctor or pharmacist before taking Farydak:

  • if you have liver problems or have ever had a liver disease
  • if you have problems with your heart or heartbeat, such as irregular heartbeat or a condition called long QT syndrome
  • if you have a bacterial, viral, or fungal infection
  • if you have problems with the gastrointestinal tract, such as diarrhea, nausea, or vomiting
  • if you have problems with blood coagulation (coagulation disorder).

Tell your doctor or pharmacist immediately while you are being treated with Farydak:

  • if you get signs of problems in the gastrointestinal tract
  • if you get signs of liver problems
  • if you get signs of infection
  • if you get signs of heart problems.

Section 4, “Possible side effects”, lists the symptoms that may occur.

The doctor may need to change the dose, suspend or completely discontinue Farydak if you experience side effects are.

Checks performed during treatment with Farydak

Blood samples will be taken regularly during treatment with Farydak. The blood samples are taken to:

  • check how your liver works (by measuring the amount of bilirubin and transaminases in the blood, substances produced in the liver)
  • check the number of certain cells in your blood ( white blood cells, red blood cells, and platelets )
  • Check the amount of electrolyte in your body (for example, potassium, magnesium, and phosphate ).
  • Check how well your thyroid and pituitary gland are working (by measuring your levels of thyroid hormones in your blood).

Your heart rate will also be checked with an ECG when measuring the heart’s electrical activity.

Children and young people

Farydak is not intended for children and adolescents under 18 years of age.

Other medicines and Farydak

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription such as vitamins and herbal medicines, as they may affect or be affected by Farydak.

You must tell your doctor or pharmacist if you are taking any of the following medicines:

  • medicines to treat infections, including fungal infections (eg ketoconazole, itraconazole, voriconazole, and posaconazole) and certain bacterial infections (eg antibiotics such as clarithromycin and telithromycin). Drugs used to treat tuberculosis, e.g. rifabutin and rifampicin.
  • medicines used to stop seizures ( antiepileptics such as carbamazepine, perphenazine, phenobarbital, or phenytoin ).
  • drugs for the treatment of HIV, e.g. ritonavir and saquinavir.
  • drugs for the treatment of depression, e.g. nefazodone.
  • St. John’s wort, herbal medicine for the treatment of mild depression and mild anxiety.
  • drugs that prevent the blood from clotting, so-called anticoagulants, e.g. warfarin and heparin.
  • drugs for the treatment of cough, e.g. dextromethorphan.
  • drugs for the treatment of irregular heartbeats, e.g. amiodarone, disopyramide, procainamide, quinidine, propafenone, and sotalol.
  • drugs that may hurt the heart (so-called QT prolongation), e.g. chloroquine, halofantrine, methadone, moxifloxacin, bepridil, or pimozide.
  • drugs for the treatment of high blood pressure, e.g. metoprolol or nebivolol.
  • drugs for the treatment of severe mental illness, e.g. risperidone.
  • drugs for the treatment of breast cancer, e.g. tamoxifen.
  • medicines for the treatment of nausea and vomiting, e.g. dolasetron, granisetron, ondansetron, and tropisetron. These can also have an unwanted effect on the heart ( QT prolongation).
  • atomoxetine, a drug for the treatment of hyperactivity disorder with attention deficit disorder.

These medicines should be taken with caution and may need to be avoided during treatment with Farydak. If you are taking any of these medicines, your doctor may prescribe another medicine for you while you are being treated with Farydak.

Ask your doctor or pharmacist if you are unsure if any of your medicines are included in the above groups.

During treatment with Farydak, you should also tell your doctor or pharmacist if you have been prescribed any other medicine that you have not taken before.

Farydak with food and drink

Do not eat star fruit (carambola), pomegranate, or grapefruit, and do not drink pomegranate or grapefruit juice during treatment with Farydak, as these may increase the number of medicines that enter the bloodstream.

Pregnancy and breastfeeding

Due to the possible risk of death or malformation of the fetus, Farydak should not be taken under:

Pregnancy

Farydak should not be taken during pregnancy unless the potential benefit of the treatment to the mother outweighs the potential risk to the baby. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice. Your doctor will talk to you about any possible risks of taking Farydak during pregnancy.

Breast-feeding

Do not take Farydak if you are breast-feeding.

Contraceptive methods for women and men

Due to the potential risk of death or malformation of the fetus, you should use the following contraceptive methods during treatment with Farydak:

For women taking Farydak

If you are a woman and sexually active, you should do a pregnancy test before starting treatment with Farydak and you must use a very safe method of contraception while you are being treated with Farydak. You must also use this method for three months after stopping taking Farydak. You and your doctor will discuss which method is most suitable for you. If you are using a hormonal contraceptive, you must also use a barrier contraceptive method (eg condoms or pessaries).

For men taking Farydak

If you are a man and sexually active, use a condom while you are being treated with Farydak. You should also use this method for six months after stopping taking Farydak. If your partner may become pregnant, she should also use a very safe method of contraception during your treatment and for six months thereafter. Tell your doctor immediately if your partner becomes pregnant while you are taking Farydak or within six months of stopping taking Farydak.

Driving and using machines

Farydak may have a minor effect on the ability to drive or use machines. If you feel dizzy while taking this medicine, do not drive or use any tools or machines.

3. How to take Farydak

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

How much to take

  • Pharydac is taken for 21 days (2 weeks with and 1 week without treatment) – this is called a treatment cycle.
  • You should not take this medicine every day.
  • Based on the recommendation of your doctor, the dose of one of Farydak is either 20 mg, 15 mg, or 10 mg, which should be taken once a day on days 1, 3, 5, 8, 10, and 12 of the 21-day cycle.
  • You should not take Farydak during week 3.
  • After week 3, start again on a new treatment cycle shown in Tables 1 and 2 below. See Table 1 for Cycles 1-8 and Table 2 for Cycles 9-16.

Table 1 Recommended schedule for taking Farydak in combination with bortezomib and dexamethasone (cycles 1-8)

Cycle 1-8(3-week cycles) Week 1Day Week 2Day Week 3
Farydak 1   3   5     8   10   12     Rest period
Bortezomib 1     4       8     11       Rest period
Dexamethasone 1 2   4 5     8 9   11 12     Rest period

Table 2 Recommended schedule for taking Farydak in combination with bortezomib and dexamethasone (cycles 9-16)

Cycle 9-16(3-week cycles) Week 1Day Week 2Day Week 3
Farydak 1   3   5     8   10   12     Rest period
Bortezomib 1             8             Rest period
Dexamethasone 1 2           8 9           Rest period

Your doctor will tell you exactly how many Farydak capsules you need to take. Do not change the dose without talking to your doctor.

Take Farydak once daily at the same time each time, only on the scheduled days.

How to take the medicine

  • Swallow the capsules whole with a glass of water.
  • The capsules can be taken with or without food.
  • The capsules must not be chewed or crushed.

If you vomit after swallowing the Farydak capsules, do not take more capsules until it is time for the next dose according to the schedule.

How to use Farydak blister cards how


A blister map = 3 weeks = 1 cycle

The bike days are numbered on the blister map.
Take Farydak on days 1, 3, and 5 and days 8, 10, and 12.

Push the Farydak capsule through the pocket on days 1, 3, and 5 of week 1 and days 8, 1,0, and 12 of week 2.

Scrape on the corresponding empty pocket with your nail on the days when you should not take Farydak, including the rest period during week 3, as an aid to keeping track of your medication schedule.

How long should you take Farydak?

Keep taking Farydak for as long as your doctor tells you to. This is a long-term treatment with 16 cycles (48 weeks). Your doctor will check your condition at regular intervals to see if the treatment is beneficial. Ask your doctor or pharmacist for advice on how long to take Farydak.

If you take more Farydak then you should

If you accidentally take more capsules than you should, or if someone else accidentally takes your medicine, contact a doctor or go to the hospital immediately. Bring the packaging and this leaflet. You may need medical treatment.

If you forget to take Farydak

  • If it has been less than 12 hours since you should have taken the medicine, take the missed dose as soon as you remember. Then continue to take the medicine as usual.
  • If it has been more than 12 hours since you should have taken the medicine, skip the missed dose. Then continue to take the medicine as usual.
  • Do not take a double dose to make up for a forgotten dose.

Never take a missed dose of Farydak on one of the days when you are not scheduled to take Farydak.

Tell your doctor about any dose you missed during a 21-day cycle.

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

4. Possible side effects

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

Some side effects can be serious

STOP taking Farydak and seek medical help immediately if you experience any of the following:

  • difficulty breathing or swallowing, swelling of face, lips, tongue, or throat, severely itchy skin with red rash or lumps (may be a sign of an allergic reaction )
  • severe headache, feeling weak or paralyzed in arms/legs or face, speech difficulties, sudden loss of consciousness (may be signs of problems in the nervous system such as bleeding or swelling in the skull or brain)
  • rapid breathing, dizziness
  • sudden chest pain with depressed feeling, tiredness, irregular heartbeat (may be a sign of a heart attack)
  • bloody cough, bloody fluid from the nose (signs of bleeding in the lungs)
  • bloody vomiting, black or blood-mixed stools, fresh blood flowing from the anal opening, usually in the stool or during bowel movements (signs of bleeding in the gastrointestinal tract)
  • difficulty breathing with bluish skin around the mouth, which can lead to unconsciousness (signs of severe lung problems)
  • fever, chest pain, rapid pulse, drop in blood pressure, shortness of breath, or rapid breathing (signs of blood poisoning, also called sepsis )
  • chest pain or discomfort, altered heart rate (faster or slower), palpitations, fainting, fainting, dizziness, blue lips, shortness of breath, swollen legs, or swollen skin (signs of heart problems)

If you get any of the following side effects, talk to your doctor or pharmacist immediately:

  • abdominal or abdominal pain, nausea, diarrhea, vomiting, black or blood-mixed stools, constipation, heartburn, swollen or distended abdomen (signs of gastrointestinal problems)
  • new or worsening symptoms in the form of cough with and without mucus formation, fever, difficulty breathing or pain when breathing, wheezing / wheezing, chest pain when breathing, shortness of breath or difficulty breathing, pain or burning sensation when urinating, heavy urination, blood in the urine ( signs of infection in the lungs or urinary tract)
  • fever, sore throat, or cold sores due to infection (signs of low white blood cell count ).
  • sudden bleeding or bruising under the skin (signs of low platelet count )
  • diarrhea, abdominal pain, and fever (signs of inflammation in the colon)
  • fainting, especially when getting up (signs of low blood pressure )
  • thirst, a small amount of urine, weight loss, dry and reddened skin, irritability (signs of dehydration)
  • swollen ankles (signs of low levels of albumin in the blood, so-called hypoalbuminemia)
  • fatigue, itching, yellowing of the skin and whites of the eyes, nausea or vomiting, loss of appetite, pain on the right side of the abdomen, dark or brown urine, bleeding or bruising occur more easily than normal (signs of liver problems)
  • sharply reduced urine output, swollen bones (signs of kidney problems)
  • muscle weakness, muscle spasms, unusual heartbeat (signs of altered potassium levels in the blood)

Other possible side effects are

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Very common (may affect more than 1 user in 10)

  • fatigue, pale skin. This may be a sign of low red blood cell count.
  • decreased appetite or weight loss
  • difficulty falling asleep or sleeping (insomnia)
  • headache
  • dizziness, tiredness, or weakness
  • vomiting, nausea, upset stomach, indigestion
  • swollen legs or arms
  • decreased level of phosphate or sodium in the blood

Common (may affect up to 1 in 10 people)

  • skin rash with small fluid-filled blisters on reddened skin, in the oral mucosa or gums (signs of a viral infection that can be serious)
  • ear inflammation, nosebleeds or bleeding in the whites of the eyes, bruising, inflamed skin due to infection (rash, redness, also called erythema )
  • abdominal pain, diarrhea, swollen or distended abdomen (signs of inflamed gastric mucosa)
  • cod (fungal infection of the oral cavity)
  • thirst, large amounts of urine, increased appetite with weight loss (signs of high blood sugar)
  • rapid weight gain, swollen hands, ankles, feet, or face (signs of fluid retention)
  • decreased amount of calcium in the blood can sometimes lead to seizures
  • uncontrolled tremors in the body
  • palpitation
  • clicking, rattling, or crackling sounds in the lungs when breathing
  • chapped and chapped lips
  • dry mouth or taste changes
  • intestinal gases
  • joint pain or inflammation of the joints
  • blood in the urine (signs of kidney problems)
  • lost or weak bladder control resulting in an inability to control urination
  • overindulge
  • weight gain, fatigue, hair loss, muscle weakness, chills (signs of the underactive thyroid gland, called hypothyroidism
  • general malaise
  • increased content uric acid in the blood
  • reduced content magnesium in the blood
  • increased content of the residual product creatinine in the blood
  • increased levels of the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) or alkaline phosphatase (ALP) in the blood.

Uncommon (may affect up to 1 in 100 people)

  • red or purple, flat pin-sized dots on the skin

5. How to store Farydak

  • 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 blister.
  • Do not store above 30 ° C.
  • Store in the original package. Moisture sensitive.
  • Do not take this medicine if you notice that the packaging is damaged or shows signs of being tampered with in any way.
  • Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is panobinostat.
  • Each Farydak 10 mg hard capsule contains anhydrous panobinostat lactate equivalent to 10 mg panobinostat. The other ingredients are magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, gelatin, titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac.
  • Each Farydak 15 mg hard capsule contains anhydrous panobinostat lactate equivalent to 15 mg panobinostat. The other ingredients are magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac.
  • Each Farydak 20 mg hard capsule contains anhydrous panobinostat lactate equivalent to 20 mg panobinostat. The other ingredients are magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, gelatin, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172), propylene glycol (E1520), shellac.

What the medicine looks like and the contents of the pack

Farydak 10 mg hard capsules are light green opaque capsules (15.6-16.2 mm) containing a white to off-white powder, marked with “LBH 10 mg” in black ink on the top and two strips in black ink on the bottom, packed in blister cards.

Farydak 15 mg hard capsules are orange opaque capsules (19.1-19.7 mm) containing a white to off-white powder, marked with “LBH 15 mg” in black ink on the top and two strips in black ink on the bottom, packaged in blister cards.

Farydak 20 mg hard capsules are red opaque capsules (19.1-19.7 mm) containing a white to off-white powder, marked with “LBH 20 mg” in black ink on the top and two strips in black ink on the bottom, packaged in blister cards.

Pack sizes: blister cards containing 6, 12, or 24 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Secura Bio Limited

32 Molesworth Street

Dublin 2

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Muhammad Nadeem

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