2.5 mg film-coated tablet
letrozole
What Letrozole Orion is and what it is used for
What Letrozole Orion is and how it works
Letrozole Orion 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 Orion 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 Orion is used for
Letrozole Orion is used to treating 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 Orion 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 Orion works or why you have been prescribed it.
Letrozole contained in Letrozole Orion 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 you use Letrozole Orion
Do not use Letrozole Orion
- if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6)
- if you are still menstruating, 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.
Carefully follow your doctor’s instructions. They may deviate from the general instructions in this leaflet.
Warnings and cautions
Talk to your doctor or pharmacist before taking Letrozole Orion
- if you have severe kidney disease
- if you have severe liver disease
- if you have or have had osteoporosis or fractures (see also “Checks during treatment with Letrozole Orion” in section 3).
If any of these apply to you, tell your doctor. Your doctor will take this into account during your treatment with Letrozole Orion.
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.
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 Orion
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
- You should only take Letrozole Orion 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 Orion.
- You must not take Letrozole Orion 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 Orion contains lactose and tartrazine (E102)
This medicine contains 42.8 mg of lactose (monohydrate) per tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains tartrazine which may cause allergic reactions.
Other ingredients
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Letrozole Orion
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 Letrozole Orion tablet once a day. Taking Letrozole Orion 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 take Letrozole Orion
Continue to take Letrozole Orion 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 Orion.
Controls during treatment with Letrozole Orion
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 Orion 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 of the side effects are mild to moderate and generally go away after a few days to a few weeks of treatment.
Some of these side effects, such as hemorrhages, hair loss, and vaginal bleeding can 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 less common side effects are (may affect up to 1 in 1000):
- weakness, paralysis or loss of sensation in any part of the body (especially an arm or a leg), impaired coordination, nausea, speech difficulties or difficulty breathing (signs of brain effects such as stroke )
- sudden oppressive chest pain (signs of heart disease)
- difficulty breathing, chest pain, fainting, rapid pulse , bluish discoloration of the skin or sudden pain in an arm, foot or leg (signs that a blood clot may have formed)
- swelling and redness along a vein that is very tender and possibly painful to the touch
- high fever, chills or cold sores due to infection (lack of white blood cells )
- severe, persistent blurred vision.
If you experience any of these symptoms, tell your doctor immediately.
You should also tell your doctor immediately if you get any of the following symptoms during treatment with Letrozole Orion:
- swelling, mainly on the face and neck (signs of an allergic reaction )
- yellow skin and 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).
Very common (may affect more than 1 user in 10):
- hot flashes
- elevated cholesterol ( hypercholesterolemia )
- fatigue
- increased sweating
- pain in the skeleton and joints ( arthralgia ).
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
- bone loss ( osteoporosis ) which in some cases may lead to fracture s (see also “Monitoring during treatment with Letrozole Orion” in section 3)
- swelling of arms, hands, feet, ankles ( edema )
- Depression
- weight gain
- hair loss
- high blood pressure ( hypertension )
- palpitations, fast heart rate
- chest pain
- abdominal pain
- dry skin
- joint stiffness ( arthritis )
- vaginal bleeding.
Uncommon (may affect up to 1 in 100 people):
- nervous conditions such as anxiety, worry, irritability, drowsiness, memory problems, drowsiness, difficulty sleeping
- pain or a burning sensation in the hands or wrists ( carpal tunnel syndrome )
- impaired sensation, especially sensitivity to touch
- eye problems, such as blurred vision, eye irritation
- skin disorders, such as itching ( urticaria )
- vaginal discharge or dryness
- chest pain
- fever
- thirst, taste disturbances, dry mouth
- dry mucous membranes
- weight loss
- urinary tract infection, increased bladder emptying frequency
- cough
- yellowing of the skin and eyes
- high levels of bilirubin in the blood (a breakdown product of red blood cells
- elevated levels of enzyme er
- inflammation of a tendon or tendinitis (connective tissue that connects muscles to the skeleton).
Rare (may affect up to 1 in 1,000 people):
- tendon rupture of a tendon (connective tissue that connects muscles to the skeleton).
Has been reported (occurs in an unknown number of users):
- trigger finger, a condition in which a finger or thumb locks in a bent position.
How to store Letrozole Orion
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 after “EXP”. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
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. One film-coated tablet contains 2.5 mg letrozole.
- Other ingredients are:
- Tablet core: lactose monohydrate , microcrystalline cellulose, sodium starch glycolate , hypromellose , anhydrous colloidal silica and magnesium stearate.
- Film coating (Opadry Yellow): hypromellose, titanium dioxide (E171), macrogol, iron oxide yellow (E172), iron oxide red (E172) and tartrazine aluminum lacquer (E102).
What the medicine looks like and contents of the pack
Letrozole Orion 2.5 mg tablets are yellow and round, cupped film-coated tablets that are smooth on both sides. The diameter of the tablet is 6.1 ± 0.20 mm.
Letrozole Orion 2.5 mg film-coated tablets are supplied in blister packs of 30 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Orion Pharma AB, Danderyd, medinfo@orionpharma.com