Patient Information Leaflet: Information for the user

RAMATES 2.5 mg film-coated tablets

Equivalent medicine
Letrozole
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

What RAMATES is and what it is used for
What you need to know before taking RAMATES
How to take RAMATES
Possible side effects
How to store RAMATES
Contents of the pack and other information

1. What RAMATES is and what it is used for

What RAMATES is and how it works
RAMATES 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 tumours is often stimulated by oestrogens, which are
female sex hormones. RAMATES reduces the amount of oestrogens by blocking an enzyme
(“aromatase”) involved in oestrogen production and therefore can block the growth of breast tumours that require oestrogens to grow. As a result, the growth of tumour cells and/or their spread to other parts of the body is slowed down or stopped.

What RAMATES is used for
RAMATES is used for the treatment of breast cancer in postmenopausal women, i.e.
women who no longer have menstrual periods.
It is used to prevent the recurrence of breast cancer. It may be used as initial treatment before breast surgery when immediate surgery is not possible, or as initial treatment after breast surgery or after five years of tamoxifen therapy. RAMATES is also used to prevent the spread of breast cancer to other parts of the body in patients with advanced-stage breast cancer.
If you have any questions about how RAMATES works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before taking RAMATES

Carefully follow all your doctor's instructions, which may differ from the general information
contained in this leaflet.
Do not take RAMATES

if you are allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6)
if you are still having menstrual periods, i.e. if you have not yet reached menopause
if you are pregnant
if you are breastfeeding. If any of these conditions apply to you, do not take this medicine and consult your doctor.

Letrozole may cause tendon inflammation or tendon injury (see section 4). At the first sign of tendon pain or swelling, rest the affected area and contact your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking RAMATES if you have severe kidney disease

if you have severe liver disease
if you have a history of osteoporosis or bone fractures (see also ‘Monitoring of RAMATES treatment’ in section 3).

If any of these conditions apply to you, inform your doctor. This will be taken into account by your doctor during your treatment with RAMATES.
Children and adolescents (under 18 years)
Children and adolescents must not use this medicine.
Elderly (65 years and older)
Women aged 65 years or older can take this medicine at the same dose as adult women.
Other medicines and RAMATES
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Pregnancy, breastfeeding and fertility

You should take RAMATES only after you have entered menopause. However, your doctor will discuss with you the need to use an effective contraceptive method, as pregnancy could potentially occur during treatment with RAMATES.
You must not take RAMATES if you are pregnant or breastfeeding, as it may be harmful to the baby.

Driving and using machines
If you experience dizziness, fatigue, drowsiness, or general malaise, do not drive or operate any tools or machinery until you feel normal again.
RAMATES contains lactose
RAMATES contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

How to take RAMATES
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

The usual dose is one RAMATES tablet taken once daily. Taking RAMATES at the same time each day will help you remember when to take the tablet.
The tablet should be taken with or without food and must be swallowed whole with a glass of water or another beverage.
How long you should take RAMATES
Continue taking RAMATES every day as directed by your doctor. You will likely need to take it for months or even years. Consult your doctor if you have any questions about the duration of treatment with RAMATES.
Monitoring during RAMATES treatment
You must take this medicine under close medical supervision. Your doctor will regularly monitor your health to ensure the treatment is having the desired effect.
RAMATES may cause bone fragility or loss of bone mass (osteoporosis) due to reduced estrogen levels in the body. Your doctor may decide to measure your bone density (a way to monitor osteoporosis) before, during, and after treatment.
If you take more RAMATES than you should
If you have taken too much RAMATES, or if someone else accidentally takes your tablets, contact your doctor or hospital immediately for advice. Show the tablet packaging. Medical treatment will likely be necessary.
If you forget to take RAMATES

If it is almost time for your next dose (e.g., within 2 or 3 hours), skip the missed dose and take the next dose at the usual time.
Otherwise, take the missed dose as soon as you remember, then take the next tablet at your usual time.
Never take a double dose to make up for a forgotten dose. If you stop taking RAMATES Do not stop taking RAMATES unless your doctor tells you to. See also the section above ‘How long you should take RAMATES’.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Most of the side effects are mild to moderate in severity and usually disappear after a few days or weeks of treatment.
Some of these side effects, such as hot flushes, hair loss or vaginal bleeding, may be due to low estrogen levels in the body.
Do not be alarmed by this list of possible side effects. You may not experience any of them.

Some side effects can be serious:
Uncommon or rare side effects (i.e. may affect from 1 to 100 out of 10,000 patients)

Weakness, paralysis or loss of sensation in any part of the body (especially arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (symptoms of a brain disorder, for example stroke).
Sudden chest pain with a feeling of tightness (symptom of a heart disease).
Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin discoloration, or sudden pain in the arm, leg or foot (symptoms of possible blood clot formation).
Swelling and redness along a vein that is extremely sensitive and painful to touch.
High fever, chills or mouth ulcers due to infections (caused by lack of white blood cells).
Severe and persistent blurred vision.
Some patients have experienced hepatitis, severe allergic reaction, malfunction and pain in the fingers during treatment with RAMATES.

If any of these effects occur, inform your doctor immediately.
You must contact your doctor immediately if any of the following symptoms occur during treatment with RAMATES:

Swelling mainly affecting the face and throat (signs of an allergic reaction).
Yellowing of the skin and eyes, nausea, loss of appetite, dark urine (signs of hepatitis).
Skin rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (signs of skin disorders).

Some side effects are very common. These side effects may affect more than 10 patients out of 100.

Hot flushes
Increased cholesterol levels (hypercholesterolemia)
Fatigue
Increased sweating
Bone and joint pain (arthralgia)
If any of these effects become severe, inform your doctor.

Some side effects are common. These side effects may affect between 1 and 10 patients out of 100.

Skin rash
Headache
Dizziness
Malaise (usually a general feeling of being unwell)
Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea
Increased or decreased appetite
Muscle pain
Fragility or loss of bone mass (osteoporosis), which in some cases leads to bone fractures (see also “Monitoring during treatment with RAMATES” in section 3)
Swelling of arms, hands, feet, ankles (edema)
Depression
Weight gain
Hair loss
Increased blood pressure (hypertension)
Abdominal pain
Dry skin
Vaginal bleeding
Palpitations, rapid heartbeat
Joint pain (arthritis)
Chest pain
If any of these effects become severe, inform your doctor.

Other side effects are uncommon. These side effects may affect between 1 and 10 patients out of 1,000.

Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia, numbness, tingling or burning sensation in the fingers
Impaired sensitivity, especially to touch
Eye disorders such as blurred vision, eye irritation
Skin disorders such as itching (urticaria)
Vaginal dryness or discharge
Breast pain
Fever
Thirst, taste disturbances, dry mouth
Dryness of mucous membranes
Weight loss
Urinary tract infections, increased frequency of urination
Cough
Increased levels of liver enzymes
Yellowing of the skin and eyes
High levels of bilirubin (a substance resulting from the breakdown of red blood cells)
Inflammation of a tendon or tendinitis (connective tissues linking muscles to bones)
Other side effects are rare. These side effects may affect between 1 and 10 patients out of 10,000
Rupture of a tendon (connective tissues linking muscles to bones)

If any of these effects become severe, inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RAMATES

Keep RAMATES out of the reach and sight of children.
Do not use RAMATES after the expiry date stated on the carton after 'Exp.'. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.
Store in the original packaging to protect the medicine from moisture.
Do not use any pack that is damaged or shows signs of tampering.

6. Package contents and other information

What RAMATES contains:
The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
The other components are:
Tablet core: monohydrate lactose, corn starch, hypromellose (E464), sodium starch glycolate, microcrystalline cellulose (E460), anhydrous colloidal silica (E551), magnesium stearate (E572).
Film coating: hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), macrogol 400 and talc (E553b).

Description of the appearance of RAMATES and pack sizes:
RAMATES 2.5 mg are yellow, round, biconvex, film-coated tablets, smooth on both sides. RAMATES is available in blister packs containing 10, 14, 28, 30, 50, 60, 84, 90, 98, 100 and 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Just Pharma S.r.l.
Via Pietro da Cortona, 13
00196 ROMA - Italy

Manufacturer:
Accord Healthcare Limited,
Sage House, 319, Pinner Road,
North Harrow HA1 4HF,
Middlesex, United Kingdom
Laboratori Fundació Dau,
Carrer de Lietra C, 12-14
PI Zona Franca – 08040
Barcelona - Spain.
Galenicum Health S.L.
Avda Diagonal, 123, 11th floor, 08005 (Barcelona), Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Member State name	Medicinal product name
Italy	RAMATES
Spain	Letrozol Pensa 2.5 mg film-coated tablets EFG

This patient information leaflet was last approved on: