2.5 mg film-coated tablets
letrozole
1. What Femar is and what it is used for
What Femar is and how it works
Femar 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. Femar 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 Femar is used for
Femar 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 the first treatment before breast surgery when immediate surgery is not appropriate, or as the first treatment after breast surgery or after five years of treatment with tamoxifen. Femar 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 Femar works or why you have been prescribed it.
2. What you need to know before taking Femar
Carefully follow your doctor’s instructions. They may deviate from the general instructions in this leaflet.
Do not take Femar
- 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.
Warnings and cautions
Talk to your doctor or pharmacist before taking Femar
- 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 Femar” section 3).
If any of these apply to you, tell your doctor. Your doctor will take this into account during your treatment with Femar.
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 drugs and Femar
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 Femar when you have undergone menopause (ie no longer have menstruation). However, your doctor should talk to you about using an effective method of contraception as you may still become pregnant during treatment with Femar.
- You must not take Femar 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 increased vigilance. 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.
Five contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Five contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
3. How to use Femar
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 once a day. If you take Femar at the same time each day, it will be 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 Femar
Continue to take Femar 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 Femar.
Checks during treatment with Femar
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.
Femara 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.
If you take more Femar than you should
If you have taken too many Femart tablets, or if someone else accidentally takes your tablets, contact your doctor or hospital staff immediately and show them the pack of tablets. The Poison Information Center can also be contacted. Overdose may require treatment.
If you forget to take Femar
- If it is close to the next dose (eg 2 or 3 hours left until dose one), skip the missed dose and take the next dose when it is time to do so.
- Otherwise, take one dose as soon as you remember and then take the next tablet at the same time as usual.
- Do not take a double dose to make up for a forgotten tablet.
If you stop taking Femar
Do not stop taking Femar unless your doctor tells you to. See also the section “How long to take Femar” above.
4. 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 disappear 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:
Uncommon (may affect up to 1 in 100 people):
- 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 such as stroke )
- Sudden oppressive chest pain (signs of heart disease)
- 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 )
- Difficult, persistent blurred vision.
- Inflammation of a tendon (the connective tissue that connects muscles to the skeleton).
Rare ( may affect up to 1 in 1,000 people):
- Difficulty breathing, chest pain, fainting, rapid pulse, bluish discoloration of the skin, or sudden pain in one arm, foot, or leg (signs that a blood clot may have formed)
- Rupture of a tendon (the 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 Femar:
- 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 skin disease).
Some side effects are very common (may affect more than 1 in 10 people):
- Hemorrhoids
- Elevated cholesterol ( hypercholesterolemia )
- Fatigue
- Increased sweating
- Pain in the skeleton and joints ( arthralgia ).
Tell your doctor immediately if the side effects are perceived as serious.
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 can lead to fracture of you (see also “Follow-up during treatment with Femara” 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 er, fast heart rate
- Joint stiffness ( arthritis )
- Chest pain.
If any of these side effects gets serious, talk to your doctor about it.
Other side effects are uncommon (may affect up to 1 in 100 people):
- Nervous conditions such as anxiety, anxiety, 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
- 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 ).
Side effects without any known frequency (frequency can not be calculated from the available data)
Trigger finger, ie a condition where a finger or thumb locks in a bent position.
Tell your doctor immediately if the side effects are perceived as serious.
5. Storage of Femar
Keep out of 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.
Do not store above 30 ° C.
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.
6. Contents of the packaging and other information
Content declaration
- The active substance is letrozole. One film-coated tablet contains 2.5 mg letrozole.
- The other ingredients in the tablet are anhydrous colloidal silica, microcrystalline cellulose, lactose monohydrate, magnesium stearate, corn starch, and sodium starch glycolate.
- The film coating contains hypromellose (E464), macrogol 8000, talc, titanium dioxide (E 171), iron oxide yellow (E172).
What the medicine looks like and the contents of the pack
- Fives are provided as film-coated tablets. The film-coated tablets are dark yellow and round, marked with FV on one side and CG on the other.
- Pack sizes: 10, 14, 28, 30 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Novartis Sverige AB, Box 1218, SE-164 28 Kista
Manufacturer:
Novartis Farma SPA, Via Provinciale Schito 131, 80058 Torre Annunziata (NA), Italy
This medicinal product is authorized under the European Economic Area under the names
| Name of Member State | Name of the medicine |
| Belgium, Bulgaria, Cyprus, Estonia, France, Greece, Ireland, Italy, Croatia, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Romania, Slovakia, Slovenia, Spain, the Czech Republic, Germany, the United Kingdom, Hungary, and Austria | Femara |