100 mg, 300 mg film-coated tablets 
vandetanib

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information and the patient card, you may need to read them again.
  • It is important that you carry the patient’s card with you throughout the treatment.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In addition to this leaflet, you will receive a patient information card containing important safety information that you need to know before using Caprelsa and during treatment with Caprelsa.

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

1. What Caprelsa is and what it is used for

Caprelsa is a treatment for adults and children from 5 years with:

Medullary thyroid cancer cannot be removed with surgery or has spread to other parts of the body.

Caprelsa works by slowing down the growth of new blood vessels in (cancer) tumors. In this way, the supply of nutrients and oxygen to the tumor is restricted. Caprelsa can also have a direct effect on cancer cells by killing the cells or slowing down the growth.

What you need to know before taking Caprelsa

Do not take Caprelsa:

  • if you are allergic to vandetanib or any of the other ingredients of this medicine (listed in section 6).
  • if you have a congenital heart disease called ‘long QTc’ syndrome. This can be seen on the electrocardiogram ( ECG ).
  • if you are breast-feeding.
  • if you are taking any of the following medicines: arsenic, cisapride (used to treat heartburn), intravenous erythromycin and moxifloxacin (used to treat infection ), toremifene (used to treat breast cancer), mizolastine (used to treat allergies ), class IA antiarrhythmics and III (for heart rhythm control).

Do not take Caprelsa if any of the above apply to you. Talk to your doctor if you are unsure.

Warnings and cautions

Talk to your doctor or pharmacist before taking Caprelsa:

  • If you are sensitive to sunlight. Some people who use Caprelsa become more sensitive to the sun. This can cause harmful sunburn. When using Caprelsa, you must protect yourself when you are outdoors by always using sunscreen and clothing to avoid sun exposure.
  • If you have high blood pressure.
  • If you have or have had an aneurysm (enlargement and weakening of a vessel wall) or a rupture in a vessel wall.

Checking your blood levels and your heart:

Your doctor or nurse should take samples to check the levels of potassium, calcium, magnesium, and thyroid-stimulating hormone ( TSH ) in your blood and check the electrical activity of the heart with a test called an electrocardiogram ( ECG ). The tests must be performed:

  • Before you start with Caprelsa
  • Regularly during treatment with Caprelsa
  • 1, 3, and 6 weeks after starting Caprelsa
  • 12 weeks after starting Caprelsa
  • Every 3 months thereafter
  • If your dose of Caprelsa is changed by a doctor or pharmacist
  • If you start taking medicines that affect the heart
  • According to the instructions of a doctor or pharmacist

Children

Caprelsa should not be given to children under 5 years of age.

Other medicines and Caprelsa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, herbal medicines, or other herbal medicines. Caprelsa can affect the way some medicines work and some medicines can have an effect on Caprelsa.

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • itraconazole, ketoconazole, ritonavir, clarithromycin, rifampicin, and moxifloxacin (medicines used to treat infections )
  • carbamazepine and phenobarbital (used to control seizures)
  • ondansetron (used to treat nausea and vomiting)
  • cisapride (used to treat heartburn), pimozide (used to treat uncontrolled repetitive motion and verbal outbursts), and halofantrine and lumefantrine (used to treat malaria )
  • methadone (used to treat drug addiction), haloperidol , chlorpromazine, sulpiride, amisulpride, and zuclopenthixol (used to treat mental illness)
  • pentamidine (used to treat infection )
  • Vitamin K antagonist er and dabigatran commonly referred to as blood thinners
  • cyclosporine and tacrolimus (used to prevent rejection of transplanted organs), digoxin (used to treat irregular heartbeat), and metformin (used to stabilize blood sugar levels)
  • proton pump inhibitor (used in the treatment of heartburn)

This information can also be found in the patient care that you received from your doctor. It is important that you bring the patient card with you and show it to your partner or caregiver.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Caprelsa can harm an unborn baby. Your doctor will discuss the benefits and risks of taking Caprelsa during this time.

  • If you are likely to become pregnant, you must use effective contraception when taking Caprelsa and at least four months after the last dose of Caprelsa.

To protect your baby, you must not breast-feed during treatment with Caprelsa.

Driving and using machines

Be careful when driving or using machines. Keep in mind that Caprelsa can make you feel tired and weak and can make you look blurry.

3. How to take Caprelsa

Use for adults

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

  • The recommended dose is 300 mg every day.
  • Take Caprelsa at about the same time each day.
  • Caprelsa can be taken with or without food.

Use for children

Your doctor will tell you how many Caprelsa tablets to give to your child. The amount of Caprelsa given depends on the baby’s body weight and height. The total daily dose for children should not exceed 300 mg. The treatment can either be given to your child as a single daily dose, a dose every other day, or according to a repeated 7-day schedule given in the dosing guide given to you by your doctor. It is important that you keep this dosing guide and show it to caregivers.

If you have difficulty swallowing the tablet

If you have difficulty swallowing the tablet, you can mix it with water as follows:

  • Take half a glass of plain (non-carbonated) water. Use only water, not other liquids.
  • Put the tablet in the water.
  • Stir until the tablet has dissolved in the water. It may take about 10 minutes.
  • Drink the liquid immediately.

To be sure that you have ingested all the medicine, fill the glass halfway with water again and drink it up.

If you get side effects ar

If you get any side effects, talk to your doctor at all times. Your doctor may then prescribe a lower or higher dose of Caprelsa (eg two 100 mg tablets or one 100 mg tablet). Your doctor may also prescribe other medicines to help you control the side effects. The side effects of Caprelsa are described in section 4.

If you take more Caprelsa than you should

If you take more Caprelsa than you should, contact a doctor or hospital immediately.

If you forget to take Caprelsa

What to do if you forget to take a tablet depends on how much time is left until the next dose.

  • If it is 12 hours or more until you take the next dose: Take the forgotten tablet as soon as you remember that you forgot to take the tablet. Then take the next dose at the usual time.
  • If it is less than 12 hours until you take the next dose: Skip the missed dose. Then take the next dose at the usual time.

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

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. If you get side effects, your doctor may ask you to take a lower dose of Caprelsa. Your doctor may also prescribe other medicines to help you control the side effects .

Contact your doctor immediately if you get any of the following side effects – you may need immediate medical attention:

  • Fainting attacks, dizziness, or altered heart rhythm. This may be a sign of a change in the electrical activity of the heart. This can be seen in 8% of people taking Caprelsa for medullary thyroid cancer. Your doctor may recommend that you take a lower dose of Caprelsa or stop taking Caprelsa. Caprelsa has in less common cases been associated with life-threatening changes in heart rhythm.
  • Severe skin reactions affecting large parts of the body. Signs of this can be redness, pain, sores, blisters, and flaking of the skin. Lips, nose, eyes, and genitals can also be affected. This can be common (affects less than 1 in 10 people) or less common (affects less than 1 in 100 people) depending on the type of skin reaction.
  • Severe diarrhea.
  • Severe shortness of breath, or sudden worsening of shortness of breath and possibly also cough and fever. This may mean that you have an inflammation of the lungs called interstitial lung disease. This is less common (affects less than 1 in 100 people) but can be life-threatening.
  • Seizures, headaches, confusion, or difficulty concentrating. This may be a sign of a condition called RPLS (reversible posterior leukoencephalopathy syndrome). The side effects usually disappear when treatment with Caprelsa is stopped. RPLS is less common (affects less than 1 in 100 people).

Contact your doctor immediately if you get any of the side effects listed above.

Other side effects are:

Very common (affects more than 1 in 10 people)

  • Diarrhea. Your doctor may prescribe medication to treat this. If it gets worse, contact your doctor immediately.
  • Stomach pain.
  • Skin rash or acne.
  • Depression.
  • Fatigue.
  • Nausea.
  • Stomach upset ( dyspepsia ).
  • Nail diseases.
  • Vomiting.
  • Loss of appetite ( anorexia ).
  • Weakness ( asthenia ).
  • High blood pressure. Your doctor may prescribe a medicine to treat this.
  • Headache.
  • Extreme fatigue.
  • Difficulty sleeping (insomnia).
  • Inflammation of the nasal passages.
  • Inflammation of the major airways to the lungs.
  • Infection is in the upper respiratory tract.
  • Urinary tract infections.
  • Numbness or tingling in the skin.
  • Abnormal sensation in the skin.
  • Dizziness.
  • Pain.
  • Swelling caused by an excess of fluid ( edema ).
  • Stones or calcium deposits in the urinary tract ( nephrolithiasis ).
  • Blurred vision, including minor changes in the eye that can lead to blurred vision (corneal opacity).
  • Sun-sensitive skin. When using Caprelsa, you must protect yourself when you are outdoors by always using sunscreen and clothing to avoid sun exposure.

Common (affects less than 1 in 10 people)

  • Dehydration.
  • Very high blood pressure.
  • Weight loss.
  • Stroke or other conditions with insufficient blood supply to the brain.
  • A type of rash that affects the hands and feet (hand-foot syndrome).
  • Soreness in the mouth ( stomatitis ).
  • Dry mouth.
  • Pneumonia.
  • The toxin is in the blood as a complication of infection is.
  • Influenza.
  • Inflammation of the bladder.
  • Inflammation of the sinuses.
  • Inflammation of the larynx ( larynx ).
  • Inflammation of the follicles, especially the hair follicles.
  • Boils.
  • Fungal infection.
  • Kidney infection.
  • Loss of body fluid ( dehydration ).
  • Concern.
  • Tremors.
  • Drowsiness.
  • Fainting attack.
  • Instability.
  • Increased intraocular pressure ( glaucoma ).
  • Blood in vomit.
  • Inflammation of the lung tissue.
  • Difficulty swallowing.
  • Constipation.
  • Inflammation of the gastric mucosa ( gastritis ).
  • Gastrointestinal bleeding.
  • Gallstones ( cholelithiasis ).
  • Pain when urinating.
  • Kidney failure.
  • Frequent urination.
  • Urgent need to pee.
  • Fever.
  • Nasal blood ( epistaxis ).
  • Eye dryness.
  • Eye irritation ( conjunctivitis ).
  • Visual impairment.
  • Halo effect on vision.
  • Flashes of light in the field of view ( photos ).
  • Corneal disease ( keratopathy ).
  • A certain type of diarrhea ( colitis ).
  • Hair loss from head or body ( alopecia ).
  • Taste disorders ( dysgeusia ).

Uncommon (affects less than 1 in 100 people)

  • Heart failure.
  • Appendicitis ( appendicitis ).
  • Bacterial infection.
  • Inflammation of the diverticula (small bulging sacs that can form in the digestive system).
  • Bacterial skin infection.
  • Abdominal wall abscess.
  • Malnutrition.
  • Involuntary muscle contractions (cramps).
  • Rapidly alternating between muscle contraction and muscle relaxation (clonus).
  • Swelling of the brain.
  • Cloudy eye lens.
  • Disorders of heart rate and heart rate.
  • Impaired heart function.
  • The inability of the lungs to function normally.
  • Pneumonia occurs when foreign matter inhales into the lungs.
  • Intestinal obstruction.
  • Holes in the intestine.
  • Inability to control bowel movements.
  • Discolored urine.
  • Lack of urine.
  • Inability to normal wound healing.
  • Inflammation of the pancreas ( pancreatitis ).
  • Skin blisters (bullous dermatitis ).

No known frequency (cannot be calculated from the available data)

  • An enlargement and weakening of a vessel wall or a rupture in a vessel wall ( aneurysms and arterial dissections).

The following side effects can be detected by tests performed by a doctor:

  • Protein or blood in the urine (detected by urine sample).
  • Altered heart rhythm (detected by ECG ). Your doctor may ask you to stop taking Caprelsa or to take a lower dose of Caprelsa.
  • Deviations in the liver or pancreas (detected by a blood test). The abnormalities usually do not cause any symptoms, but your doctor may want to monitor them.
  • Decreased levels of calcium in the blood. Your doctor may need to prescribe or change your thyroid hormone treatment.
  • Decreased levels of potassium in the blood.
  • Increased levels of calcium in the blood.
  • Increased levels of glucose in the blood.
  • Decreased levels of sodium in the blood.
  • Impaired thyroid function.
  • Elevated levels of red blood cells in the blood.

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 immediately.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Caprelsa

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 blister and carton after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. 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 vandetanib. Each tablet contains 100 or 300 mg of vandetanib.
  • The other ingredients are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, crospovidone (type A), povidone (K29-32), magnesium stearate, hypromellose, macrogol, and titanium dioxide (E171).

What the medicine looks like and the contents of the pack

Caprelsa 100 mg is a white, round film-coated tablet marked “Z100” on one side.

Caprelsa 300 mg is a white, oval film-coated tablet marked “Z300” on one side.

Caprelsa is supplied in blister packs of 30 tablets.

Marketing Authorisation Holder

Genzyme Europe BV, Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Manufacturer

AstraZeneca UK Limited, Macclesfield, Cheshire, SK10 2NA, UK

or

Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk, CB9 8PU, UK

or

Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgium / Belgium / 
Luxembourg / Luxembourg
Sanofi BelgiumTel: + 32 (0) 2 710 54 00
HungarySANOFI-AVENTIS Zrt.Tel: +36 1 505 0050
BulgariaSANOFI Bulgaria EOODPhone: +35 9 (0) 2 970 53 00 MaltaSanofi SrlTel: +39 02 39394275
Czech Republicsanofi-aventis, sroTel: +42 0 233 086 111 The NetherlandsGenzyme Europe BVTel: +31 20 245 4000
DenmarkSanofi A / STel: +45 45 16 70 00 Norwaysanofi-aventis Norge ASTel: + 47 67 10 71 00
GermanySanofi-Aventis Deutschland GmbHTel .: 0800 04 36 996Tel. from abroad: +49 69 305 70 13 Austriasanofi-aventis GmbHTel: + 43 1 80 185 – 0
Eestisanofi-aventis Estonia OÜTel. +372 6 273 488 Polandsanofi-aventis Sp. z ooTel .: +48 22 280 00 00
Greecesanofi-aventis AEBE:Ηλ: +30 210 900 16 00 PortugalSanofi – Pharmaceutical Products, Lda.Tel: +351 21 35 89 400
Spainsanofi-aventis, SATel: +34 93 485 94 00 RomaniaSanofi Romania SRLTel: +40 (0) 21 317 31 36
Francesanofi-aventis FranceTel: 0 800 222 555Call from abroad: +33 1 57 63 23 23 Sloveniasanofi-aventis dooTel: +386 1 560 4800
Croatiasanofi-aventis Croatia dooTel: +385 1 600 3 4 00 Slovak Republicsanofi-aventis Slovakia sroTel: +421 2 33 100 100
Irelandsanofi-aventis Ireland Ltd. T / A SANOFITel: +353 (0) 1 403 56 00 Finland / FinlandSanofi OyPuh / Tel: + 358 201 200 300
IcelandVistor hf.Phone: +354 535 7000
ItalySanofi SrlTel: +800 536 389 United KingdomSanofiTel: +44 (0) 845 372 7101
Κύπροςsanofi-aventis Cyprus Ltd.:Ηλ: +357 22 871600
Latviasanofi-aventis Latvia SIATel: +371 67 33 24 51
LithuaniaUAB “SANOFI-AVENTIS LIETUVA”Tel. +370 5 275 5224

Muhammad Nadeem

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