Flutamide CINFA 250 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
flutamide cinfa 250 mg tablets EFG
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What flutamide cinfa is and what it is used for
- What you need to know before taking flutamide cinfa
- How to take flutamide cinfa
- Possible side effects
- How to store flutamide cinfa
- Contents of the pack and other information
1. What flutamide cinfa is and what it is used for
flutamide cinfa belongs to a group of medicines known as antiandrogens. flutamide cinfa blocks the effect of testosterone (a male hormone) in the body.
Please consult your doctor.
2. What you need to know before starting flutamide cinfa
Do not take flutamide cinfa
If you are allergic to flutamide or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take flutamide cinfa.
Flutamide is only used in men.
Inform your doctor if you have any heart or blood vessel condition or are being treated for such conditions, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when flutamide is used.
Other medicines and flutamide cinfa
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Flutamide may interfere with certain medicines used to treat heart rhythm disorders (e.g., quinidine, procainamide, amiodarone, and sotalol), or may increase the risk of heart rhythm problems when used together with other medicines (e.g., methadone (used for pain relief and detoxification from other drugs), moxifloxacin (an antibiotic), antipsychotics used to treat serious mental illnesses).
- If you are taking any medicine to prevent blood clotting, your doctor may need to adjust the dose of that medicine.
- If you are taking theophylline for a respiratory condition, you may need to adjust the dose.
Driving and use of machines
No effects on the ability to drive or operate machinery have been reported in the studied population.
flutamide cinfa contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.
flutamide cinfa contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.
3. How to take flutamide cinfa
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Take one tablet three times a day (morning, afternoon, and night), exactly as your doctor has instructed you. Continue taking flutamide regularly, even if you start to feel better. Your doctor may need to perform a blood test at some point during your treatment.
Flutamide has been prescribed only for your condition. Do not give this medicine to other people, and do not use it for other disorders.
Do not stop taking this medicine without first consulting your doctor.
Method of administration
This medicine is taken orally.
If you take more flutamide cinfa than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take flutamide cinfa
Do not take a double dose to make up for missed doses. If you forget a dose, take it as soon as possible and then continue with your regular dosing schedule.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Medicines can sometimes cause adverse effects. Although it is possible that not all of these effects will occur, if they do appear they may require medical attention.
Contact your doctor immediately if you experience skin itching, dark urine (amber to yellow-green coloured urine is not a cause for concern), nausea, vomiting, persistent loss of appetite, yellowing of the eyes or skin, pain in the upper right part of the abdomen, or flu-like symptoms. These symptoms may indicate a liver problem, which occurs very rarely (affecting up to 1 in 10,000 patients) with flutamide.
Very rarely (affecting up to 1 in 10,000 patients), blood sugar levels may increase. If you already have diabetes mellitus, your doctor may need to adjust the dose of your diabetes medication.
Contact your doctor immediately if you experience serious breathing problems. This has occurred very rarely (affecting up to 1 in 10,000 patients).
Other adverse effects you may experience might disappear as your body adjusts to the medicine. However, sometimes they require medical attention. Be sure to consult your doctor if any adverse effect does not go away or is bothersome.
When flutamide is taken alone, the most common adverse effect (affecting more than 1 in 10 patients) is an increase in breast size and/or breast pain, sometimes accompanied by fluid discharge through the nipple. These reactions disappear when your doctor stops treatment or reduces your dose (this type of reaction is less likely when flutamide is used in combination therapy).
Other possible common adverse effects (affecting up to 1 in 10 patients) include: diarrhoea, nausea, vomiting, increased appetite, fatigue, or insomnia.
Rarely (affecting up to 1 in 1,000 patients), you may experience decreased sexual desire or ability, stomach discomfort, loss of appetite, ulcer-like pain, heartburn, constipation, swollen feet or tired legs, bruising of the skin, shingles (herpes zoster), itching, headache, dizziness, a vague feeling of discomfort, blurred vision, thirst, chest pain, anxiety, depression, or difficulty breathing.
Very rarely (affecting up to 1 in 10,000 patients), photosensitivity (sensitivity to sunlight) may occur.
Uncommon adverse effects (affecting up to 1 in 100 patients)/Rare (affecting up to 1 in 1,000 patients)/Frequency not known* (cannot be estimated from available data):
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Changes in electrocardiogram (ECG) (prolongation of the QT interval).
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The frequency obtained from clinical trials/safety studies; if no data are available, the frequency should be listed as not known.
When flutamide is taken in combination with the injectable medicine prescribed by your doctor, the most common adverse effects (affecting more than 1 in 10 patients) are: hot flushes, decreased sexual desire or ability, diarrhoea, nausea, or vomiting.
Adverse effects that may occur rarely (affecting up to 1 in 1,000 patients) include: blood disorders, loss of appetite, irritation at the injection site, skin rash, swollen feet or tired legs, shortness of breath, muscle pains or cramps, increased blood pressure, depression, anxiety, drowsiness, confusion, nervousness, jaundice (yellowing of the skin), liver function abnormalities, and increases in certain laboratory values (blood urea nitrogen and serum creatinine).
Very rarely (affecting up to 1 in 10,000 patients), photosensitivity and skin disorders may occur.
If you are taking flutamide, alone or with other medicines, inform your doctor of any unusual changes in your breasts.
Some patients may experience other adverse effects not listed above.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Flutamide CINFA Storage
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25°C.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of flutamide cinfa
- The active substance is flutamide. Each tablet contains 250 mg of flutamide.
- The other components are: monohydrate lactose, sodium lauryl sulfate, microcrystalline cellulose, corn starch, silicon dioxide, and magnesium stearate.
Nature of the product and pack size
flutamide cinfa is presented as bright yellow tablets.
It is available in PVC-PVDC/Alu blisters. Each pack contains 50 or 84 tablets.
Marketing Authorization Holder and Manufacturer:
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Date of the most recent review of this leaflet: March 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62912/P_62912.html
QR code to: https://cima.aemps.es/cima/dochtml/p/62912/P_62912.html