2.5 mg film-coated tablet
letrozole
What Letrozole Accord is and what it is used for
What Letrozole Accord is and how it works
Letrozole Accord contains an active substance called letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or “endocrine”) treatment for breast cancer. The growth of breast tumors is often stimulated by the female sex hormone estrogen. Letrozole Accord reduces the amount of estrogen by blocking an enzyme (“aromatase”) that participates in the production of estrogen and can therefore stop the growth of breast tumors that need estrogen to grow. This slows or stops the growth of tumor cells and their spread to other parts of the body.
What Letrozole Accord is used for
Letrozole Accord is used to treat breast cancer in women who have undergone menopause, ie. no longer have menstruation.
It is used to prevent the recurrence of cancer. It can be used as first treatment before breast surgery when immediate surgery is not appropriate, or as first treatment after breast surgery or after five years of treatment with tamoxifen. Letrozole Accord is also used to prevent breast tumors from spreading to other parts of the body in patients with advanced breast cancer.
Ask your doctor if you are wondering how Letrozole Accord works or why you have been prescribed it.
Letrozole contained in Letrozole Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Letrozole Accord
Do not use Letrozole Accord
Follow your doctor’s instructions carefully. They may differ from the general information contained in this leaflet.
Do not use Letrozole Accord
- if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6),
- if you still have menstruation ie. if you have not yet undergone menopause one,
- if you are pregnant,
- if you are breast-feeding.
If any of these apply to you, do not take this medicine and talk to your doctor.
Warnings and cautions
Talk to your doctor or pharmacist before taking Letrozole Accord
- if you have a serious kidney disease,
- if you have severe liver disease,
- if you have problems with brittle bones ( osteoporosis ) and bone fractures (see also section 1 “Monitoring during treatment with Letrozole Accord”).
Letrozole may cause tendon inflammation or tendon damage (see section 4). In case of any sign of sensory pain or swelling – rest the painful area and consult a doctor.
If any of these apply to you, tell your doctor. Your doctor will take this into account during your treatment with Letrozole Accord.
Children and adolescents (under 18 years)
Children and adolescents should not use this medicine.
Elderly people (from 65 years)
People 65 years of age or older can use this medicine at the same dose as other adults.
Other medicines and Letrozole Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- You should only take Letrozole Accord after you have had a menopause (ie you are no longer menstruating). However, your doctor should talk to you about using an effective method of contraception as you may still become pregnant during treatment with Letrozole Accord.
- You must not take Letrozole Accord if you are pregnant or breast-feeding as it may harm your baby.
Driving and using machines
If you feel dizzy, tired, drowsy, or generally unwell, do not drive or use any tools or machines until you feel normal again.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Letrozole Accord contains lactose
Letrozole Accord contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Letrozole Accord
Use for children and adolescents
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose is one tablet of Letrozole Accord once a day. Taking Letrozole Accord at the same time each day will make it easier to remember when to take the tablet.
The tablet can be taken with or without food and should be swallowed whole with a glass of water or other beverage.
How long to use Letrozole Accord
Continue to take Letrozole Accord every day for as long as your doctor prescribes it. You may need to take it for months or even years. Talk to your doctor if you are wondering how long to continue taking Letrozole Accord.
Check during treatment with Letrozole Accord
You should only take this medicine under the supervision of a doctor. Your doctor will regularly check your condition to make sure the treatment is having the right effect.
Letrozole Accord may cause osteoporosis ( osteoporosis ) because of the reduced amount of estrogen in the body. Your doctor may decide to measure your bone density (a way to check if you have osteoporosis ) before, during, and after treatment.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most side effects are mild to moderate and usually, go away within a few days or a few weeks after starting treatment.
Some of these side effects, such as hemorrhages, hair loss, and vaginal bleeding, may be due to estrogen deficiency in the body.
Do not let this list of side effects worry you. You may not get any of them.
Some side effects can be serious:
Rare or uncommon side effects (ie may affect 1 to 100 users in 10,000):
- Weakness, paralysis or loss of sensation in any part of the body (especially an arm or a leg), impaired coordination, nausea, speech or breathing difficulties (signs of brain effects, eg stroke ).
- Sudden oppressive chest pain (signs of heart disease).
- Difficulty breathing, chest pain, fainting, increased heart rate , bluish discoloration of the skin or sudden pain in an arm, leg or foot (signs that a blood clot may have formed).
- Swelling and redness along a blood vessel that is very tender and possibly painful to the touch.
- High fever, chills, sores in the oral cavity caused by infection (lack of white blood cells ).
- Difficult, persistent blurred vision.
- Inflammation of a tendon (connective tissue that connects muscles to the skeleton).
- Rupture of a tendon (connective tissue that connects muscles to the skeleton).
If you experience any of these symptoms, tell your doctor immediately.
You should also inform your doctor immediately if you experience any of the following symptoms during treatment with Letrozole Accord:
- Swelling, mainly on the face and neck (signs of an allergic reaction ).
- Yellow skin and yellow whites of the eyes, nausea, decreased appetite, dark urine (signs of hepatitis ).
- Skin rash, red skin, blisters on the lips, eyes or mouth, skin rash, fever (signs of a skin disease).
Some side effects are very common (may affect more than 1 user in 10)
- Hemorrhoids
- Elevated cholesterol ( hypercholesterolemia )
- Fatigue
- Increased sweating
- Pain in the bones and joints ( arthralgia )
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Some side effects are common (may affect up to 1 in 10 people)
- Rash
- Headache
- Dizziness
- General malaise
- Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
- Increased or decreased appetite
- Muscle aches
- Brittle bones ( osteoporosis ), which in some cases leads to fracture s (see also “Controls during treatment with Letrozole Accord” in Section 3).
- Swelling of arms, hands, feet, ankles ( edema )
- Depression
- Weight gain
- Hair loss
- High blood pressure ( hypertension )
- Abdominal pain
- Dry skin
- Vaginal bleeding
- Palpitation is, fast heart rate
- Joint stiffness ( arthritis )
- Chest pain
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Other side effects are less common. These side effects may affect 1 to 10 users in 1,000:
- Nervous conditions such as anxiety, worry, irritability, drowsiness, memory problems, drowsiness, difficulty sleeping, numbness, tingling or burning sensation
- Pain or burning sensation in hands or wrists ( carpal tunnel syndrome )
- Impaired sensation, especially sensitivity to touch
- Eye problems such as blurred vision, eye irritation
- Skin problems such as itching ( hives )
- Vaginal discharge and dryness
- Chest pain
- Fever
- Thirst, taste changes, dry mouth
- Dry mucous membranes
- Weight loss
- Urinary tract infection, more frequent need to urinate
- Cough
- Elevated levels of enzyme s
- Yellowing of the skin or eyes
- High levels of bilirubin in the blood (a breakdown product of red blood cells )
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Side effects that occur in an unknown number of users:
Trigger finger, ie. a condition in which a finger or thumb gets stuck in a bent position.
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.
How to store Letrozole Accord
- 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 after EXP. The expiration date is the last day of the specified month.
- Store in the original package. Moisture sensitive.
- Do not use damaged or opened packaging.
- 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.
Contents of the pack and other information
Content declaration
The active substance is letrozole. Each film-coated tablet contains 2.5 mg letrozole.
Other ingredients are:
Tablet core: lactose monohydrate, maize starch, hypromellose (E464), sodium starch glycolate, microcrystalline cellulose (E460), anhydrous colloidal silica (E551), magnesium stearate (E572).
Coating film: hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), macrogol 400, and talc (E553b).
What the medicine looks like and contents of the pack
Letrozole Accord 2.5 mg tablets are yellow, round, biconvex, film-coated tablets, unlabeled on both sides. Pack sizes: 10 tablets, 14 tablets, 28 tablets, 30 tablets, 50 tablets, 60 tablets, 84 tablets, 90 tablets, 98 tablets, 98 tablets, 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex, HA1 4HF, UK
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht The
Netherlands
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland