Package Leaflet: Information for the User

Flutamide Cinfa 250 mg Tablets EFG

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Flutamida cinfa belongs to a group of medicines known as antiandrogens. Flutamida cinfa blocks the effect of testosterone (a male hormone) in the body.

Please consult your doctor.

Do not take flutamide cinfa

If you are allergic to flutamide or any of the other components of this medication (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 it, including medications to control heart rhythm (arrhythmias). The risk of heart rhythm problems may increase when flutamide is used.

Other medications and flutamide cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those acquired without a prescription.

Flutamide may interact with some medications used to treat heart rhythm problems (e.g.: quinidina, procainamida, amiodarona, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (e.g.: metadona (used for pain relief and detoxification of other medications), moxifloxacino (an antibiotic), antipsychotics used to treat severe mental illnesses).

• If you are taking any medication to prevent blood clotting, your doctor may need to change your dose of this medication.
• If you are taking theophylline for a respiratory problem, you may need to adjust your dose.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been described in the studied population.

Flutamide cinfa contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Flutamide cinfa contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated 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. 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 only been prescribed for your condition. Do not give this medication to others and do not use it for other disorders.

Do not stop taking this medication without consulting your doctor first.

Administration form

This medication is taken orally.

If you take more flutamide cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take flutamide cinfa

Do not take a double dose to compensate for the missed doses. If you forget a dose, take it as soon as possible and continue with the regular administration.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Medicines can sometimes cause side effects. Although it is possible that not all of these side effects will occur, if they do, they may require medical attention.

Consult your doctor immediately if you have skin itching, dark urine (amber to yellow-green urine is not a cause for concern), nausea, vomiting, persistent loss of appetite, yellow color of the eyes or skin, certain pain in the upper right abdomen, or flu-like symptoms. These symptoms may indicate a rare liver problem (affecting up to 1 in 10,000 patients) with flutamide.

Rarely (affecting up to 1 in 10,000 patients), your blood sugar levels may increase. If you already have diabetes mellitus, your doctor may need to adjust the dose of the medication used to control it.

Inform your doctor immediately if you experience severe respiratory problems. This has occurred very rarely (affecting up to 1 in 10,000 patients).

Other side effects that you may experience may disappear as your body adapts to the medication. However, sometimes they require medical attention. Make sure to consult your doctor if any side effect does not disappear or is bothersome.

When flutamide is taken alone, the most common side effect (affecting more than 1 in 10 patients) is the enlargement and/or pain in the breasts, sometimes accompanied by a discharge of fluid through the nipple. These reactions disappear when your doctor suspends treatment or reduces the dose you are taking (it is less likely to occur this type of reaction when flutamide is taken in combination treatment).

Other possible frequent side effects (affecting up to 1 in 10 patients) include: diarrhea, nausea, vomiting, increased appetite, fatigue, or insomnia.

Rarely (affecting up to 1 in 1,000 patients), you may experience a decrease in sexual desire or ability, stomach discomfort, loss of appetite, stomach pain, heartburn, constipation, swelling of the feet or legs, tired legs, skin bruises, shingles, 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) occurs.

Frequent side effects (affecting up to 1 in 100 patients)/Rare (affecting up to 1 in 1,000 patients)/Unknown frequency* (cannot be estimated from available data):

• Changes in the electrocardiogram ECG (prolongation of the QT interval).

*The frequency that is obtained from clinical trials/safety studies, if there are no available data, it will be unknown frequency.

When flutamide is taken as combination treatment with the injectable medication indicated by your doctor, the most common side effects (affecting more than 1 in 10 patients) are: heat strokes, decreased sexual desire or ability, diarrhea, nausea, or vomiting.

The side 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, swelling of the feet or legs, shortness of breath, muscle pain or cramps, increased blood pressure, depression, anxiety, drowsiness, confusion, nervousness, jaundice (yellow color of the skin), liver function alterations, and increased values in laboratory tests (urea nitrogen in blood and serum creatinine).

Very rarely (affecting up to 1 in 10,000 patients), photosensitivity and skin alterations occur.

If you are taking flutamide, alone or with other medications, inform your doctor about any unusual changes in your breasts.

Some patients may experience other side effects not mentioned previously.

If you consider that any of the side effects you experience is severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of flutamide cinfa

• The active ingredient is flutamide. Each tablet contains 250 mg of flutamide.
• The other components are: lactose monohydrate, sodium lauryl sulfate, microcrystalline cellulose, cornstarch, silicon dioxide, and magnesium stearate.

Appearance of the product and contents of the packaging

Flutamide cinfa is presented in the form of yellow brilliant tablets.

It is presented in PVC-PVDC/Alu blisters. Each package contains 50 or 84 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Date of the last review of this leaflet:March 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can 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