Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - fareston

Document Subject

Generated Narrative: MedicinalProductDefinition mpde5eecf9e44a37927bab25be6edb8bcb

identifier: http://ema.europa.eu/identifier/EU/1/96/004/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Fareston 60 mg tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-de5eecf9e44a37927bab25be6edb8bcb

identifier: http://ema.europa.eu/identifier/EU/1/96/004/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - fareston

Attesters

What is in this leaflet

1. What Fareston is and what it is used for
2. What you need to know before you take Fareston
3. How to take Fareston
4. Possible side effects
5. How to store Fareston
6. Contents of the pack and other information

Fareston contains the active substance toremifene, an anti-estrogen. Fareston is used for the treatment of a certain type of breast tumour in women who have had their menopause.

Do not take Fareston

if you are allergic to toremifene or any of the other ingredients of this medicine (listed in section 6).

if you have a thickening of the womb lining

if you have severe liver problems

if you were born with or have had any condition which causes certain abnormal changes in the electrical recording of the heart (electrocardiogram or ECG)

if you have a salt imbalance in the blood, especially low concentrations of potassium in the blood (hypokalaemia) which are currently not corrected by treatment

if you have a very slow heart rate (bradycardia)

if you have a heart failure

if you have a history of abnormal heart rhythms (arrhythmias)

if you are taking other medicines that may affect your heart (see section 2 Other medicines and Fareston). This is because Fareston can affect your heart by delaying the conduction of electrical signals within your heart (prolongation of QT-interval). Warnings and precautions Talk to your doctor or pharmacist before taking Fareston:

if you have unstable diabetes

if your general well-being is severely deteriorated

if you have previously had a condition in which blood clots formed in blood vessels, for example in your lungs (lung embolism) or in the veins of your legs (deep vein thrombosis). DNO 090017ff8067d83a In-Progress / 27.3 Confidential 18 / DNO 090017ff8067d83a Reviewed / 27.3 Confidential 18 / DNO 090017ff8067d83a Approved / 28.0 Confidential 18 / - if you experience an abnormal heart rhythm whilst taking Fareston. Your doctor may advise you to stop taking Fareston and perform a medical test to see how your heart is working (ECG). (see section 2 Do not take Fareston)

if you have any heart condition, including chest pain (angina)

if your cancer has spread to the bones (bone metastasis) as calcium blood levels may increase at the beginning of treatment with Fareston. Your doctor will conduct regular medical check-ups.

if you have been told by your doctor that you have an intolerance to certain sugars, like lactose (see section 2 Fareston contains lactose). You should have gynaecological examinations before you start treatment with Fareston and at least once a year following the start of treatment with Fareston. Your doctor will conduct regular medical check-ups if you have high blood pressure, diabetes, have taken hormone replacement therapy or if you are obese (BMI over 30). Other medicines and Fareston Tell your doctor if you are taking, have recently taken or might take any other medicines. The dose of some of these may have to be adjusted while you are on Fareston. In particular please tell your doctor if you are taking any of the following:

water tablets (diuretics of thiazide type)

medicines to prevent blood clotting such as warfarin

medicines used to treat epilepsy such as carbamazepine, phenytoin, phenobarbital

medicines used to treat fungal infections such as ketoconazole, itraconazole, voriconazole, posaconazole

medicines used to treat bacterial infections (antibiotics) such as erythromycin, clarithromycin and telithromycin

medicines used to treat viral infection such as ritonavir and nelfinavir. Do not take Fareston together with the following medicines as there is an increased risk that your heartbeat may be altered (see section 2 Do not take Fareston):

medicines used to treat abnormal heart rhythm (antiarrhythmics); such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide and ibutilide

medicines used to treat mental and behavioral disorders (neuroleptics); such as phenothiazines, pimozide, sertindole, haloperidol and sultopride

medicines used to treat infections (antimicrobials); such as moxifloxacin, erythromycin (infusion) pentamidine and antimalarials (particularly halofantrine)

certain medicines to treat allergies; such as terfenadine, astemizole and mizolastine

others; cisapride, intravenous vincamine, bepridil, diphemanil. If you are admitted to the hospital or if you are prescribed a new medicine, please tell your doctor that you are taking Fareston. Pregnancy and breast-feeding Do not use Fareston during pregnancy or breast feeding. Driving and using machines Fareston has no influence on the ability to drive and use machines. Fareston contains lactose Fareston contains 28.5 mg lactose (as 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 medicinal product. Other excipients This medicine contains less than 1 mmol (23 mg) sodium per tablet that is to say essentially sodium- free . DNO 090017ff8067d83a In-Progress / 27.3 Confidential 19 / DNO 090017ff8067d83a Reviewed / 27.3 Confidential 19 / DNO 090017ff8067d83a Approved / 28.0 Confidential 19 /

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one 60 mg tablet taken orally, once daily. Fareston can be taken with or without food. If you take more Fareston than you should Contact your doctor, pharmacist or the nearest hospital immediately. Symptoms of overdose may be dizziness and headache. If you forget to take Fareston If you miss one dose take the next tablet as usual and continue treatment as recommended. Do not take a double dose to make up for a forgotten tablet. If you have missed several doses, please inform your doctor and follow his instructions. If you stop taking Fareston The treatment with Fareston should only be stopped when advised by your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Very common side effects (may affect more than 1 in 10 people ):

hot flushes, sweating. Common side effects (may affect up to 1 in 10 people ):

fatigue, dizziness, depression

nausea (feeling sick), vomiting

rash, itching, oedema (swelling)

uterine bleeding, white discharge. Uncommon side effects (may affect up to 1 in 100 people):

headache, sleep disorders

weight increase, constipation, loss of appetite

thickening of the lining of the womb (endometrial hypertrophy)

blood clot for example in the lung (thromboembolic events)

shortness of breath. Rare side effects (may affect up to 1 in 1,000 people):

a feeling of spinning (vertigo)

growth on the lining of the womb (endometrial polyps)

increase in liver enzymes (increase of liver transaminases). Very rare side effects (may affect up to 1 in 10,000 people):

changes in the lining of the uterus (endometrium), cancer of the lining of the womb (endometrial cancer)

hair loss (alopecia)

cloudiness of the eye surface (transient corneal opacity)

yellowing of the skin or whites of the eyes (jaundice). Frequency not known (cannot be estimated from the available data):

low number of white blood cells, which are important in fighting infection (leukopenia)

low number of red blood cells (anaemia) DNO 090017ff8067d83a In-Progress / 27.3 Confidential 20 / DNO 090017ff8067d83a Reviewed / 27.3 Confidential 20 / DNO 090017ff8067d83a Approved / 28.0 Confidential 20 / - low number of platelets (thrombocytopenia)

inflammation of the liver (hepatitis). You should contact your doctor immediately if you notice any of the following:

swelling or tenderness in your calf

unexplained shortness of breath or sudden chest pain

vaginal bleeding or changes in vaginal discharge. Fareston causes certain abnormal changes in the electrical recording of the heart (electrocardiogram or ECG). See section 2 Warnings and precautions. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 label. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Fareston contains

The active substance is toremifene; each tablet contains 60 mg (as citrate).

The other ingredients are maize starch, lactose monohydrate, povidone, sodium starch glycolate, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate. What Fareston looks like and contents of the pack White, round, flat, bevelled edge tablet with TO 60 on one side. 30 and 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder Orion Corporation Orionintie 1 FI-02200 Espoo Finland Manufacturer Orion Corporation Orion Pharma Joensuunkatu 7 FI-24100 Salo Finland For any information about this human medicinal product, please contact the local representative of the marketing authorisation holder. DNO 090017ff8067d83a In-Progress / 27.3 Confidential 21 / DNO 090017ff8067d83a Reviewed / 27.3 Confidential 21 / DNO 090017ff8067d83a Approved / 28.0 Confidential 21 / Belgi /Belgique/Belgien Orion Corporation T l/Tel: +358 10 4Lietuva Orion Corporation Tel: +358 10 4 Orion Pharma Poland Sp. z o.o. Tel: + 48 22 8 333 Luxembourg/Luxemburg Orion Corporation T l/Tel: +358 10 4 esk republika Orion Corporation Tel: +358 10 4Magyarorsz g Orion Corporation Tel.: +358 10 4Danmark Orion Corporation Tlf: +358 10 4Malta Orion Corporation Tel: +358 10 4Deutschland Orion Corporation Tel: +358 10 4Nederland Orion Corporation Tel: +358 10 4Eesti Orion Corporation Tel: +358 10 4Norge Orion Corporation Tlf: +358 10 4 Orion Corporation : +358 10 4 sterreich Orion Corporation Tel: +358 10 4Espa a Orion Corporation Tel: +358 10 4Polska Orion Corporation Tlf: +358 10 4France Orion Pharma T l: +33 (0) 1 85 18 00 Portugal Orion Corporation Tel: +358 10 4Hrvatska Orion Corporation Tel.: +358 10 4Rom nia Orion Pharma Poland Sp. z o.o. Tel: + 48 22 8 333 Ireland Orion Corporation Tlf: +358 10 4Slovenija Orion Corporation Tel: +358 10 4 sland Orion Corporation S mi: +358 10 4Slovensk republika Orion Corporation Tel: +358 10 4Italia Orion Pharma S.r.l. Tel: + 39 02 67876Suomi/Finland Orion Corporation Puh./Tel: +358 10 4DNO 090017ff8067d83a In-Progress / 27.3 Confidential 22 / DNO 090017ff8067d83a Reviewed / 27.3 Confidential 22 / DNO 090017ff8067d83a Approved / 28.0 Confidential 22 /
Orion Corporation : +358 10 4Sverige Orion Pharma AB Tel: +46 8 623 6Latvija Orion Corporation Tel: +358 10 4United Kingdom (Northern Ireland) Orion Corporation Tel: +358 10 4This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: