FLUTAMIDE CINFA 250 mg TABLETS

Introduction

Package Leaflet: Information for the User

flutamide cinfa 250 mg tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is flutamide cinfa and what is it used for
2. What you need to know before taking flutamide cinfa
3. How to take flutamide cinfa
4. Possible side effects
5. Storage of flutamide cinfa
6. Package Contents and Additional Information

1. What is flutamide cinfa and what is it used for

flutamide cinfa belongs to a group of medications 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 taking flutamide cinfa

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.

Tell 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 taking flutamide.

Other Medications and Flutamide Cinfa

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

Flutamide may interfere with some medications used to treat heart rhythm problems (such as quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of heart rhythm problems when used with other medications (such as methadone (used for pain relief and detoxification from other medications), moxifloxacin (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 the dose of this medication.
• If you are taking theophylline for any respiratory problem, you may need to adjust the dose.

Driving and Using Machines

No effects on the ability to drive and use machines 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".

3. How to Take Flutamide Cinfa

Follow the administration instructions for this medication exactly 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 evening), exactly as your doctor has indicated. 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.

Method of Administration

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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Flutamide Cinfa

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

Very rarely (may affect 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 the medication used to control it.

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

Other side effects 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 frequent side effect (may affect more than 1 in 10 patients) is an increase in breast size and/or pain, sometimes accompanied by a secretion of fluid through the nipple. These reactions disappear when your doctor stops the treatment or reduces the dose you are taking (it is less likely to occur when flutamide is taken in combination therapy).

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

Rarely (may affect up to 1 in 1,000 patients), you may experience a decrease in sexual desire or ability, stomach discomfort, loss of appetite, ulcer-like pain, heartburn, constipation, swelling of the feet or tired legs, bruising of the skin, shingles, itching, headache, dizziness, a feeling of vague discomfort, blurred vision, thirst, chest pain, anxiety, depression, or difficulty breathing.

Very rarely (may affect up to 1 in 10,000 patients), photosensitivity (sensitivity to sunlight) may occur.

Uncommon side effects (may affect up to 1 in 100 patients)/Rare (may affect 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 obtained from clinical trials/safety studies, if no data are available, should be unknown frequency.

When flutamide is taken in combination with the injectable medication indicated by your doctor, the most frequent side effects (may affect more than 1 in 10 patients) are: hot flashes, decreased sexual desire or ability, diarrhea, nausea, or vomiting.

Rare side effects that may occur (may affect 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 tired legs, shortness of breath, muscle pain or cramps, increased blood pressure, depression, anxiety, somnolence, confusion, nervousness, jaundice (yellowing of the skin), liver function changes, and increased laboratory values (blood urea nitrogen and serum creatinine).

Very rarely (may affect up to 1 in 10,000 patients), photosensitivity and skin changes may occur.

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

Some patients may experience other side effects not listed above.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, 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 not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Flutamide Cinfa

Keep this medication out of sight and reach of children.

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

Do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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 Package Contents

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

It is presented in PVC-PVDC/Alu blisters. Each package 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 Last Revision of this Package Leaflet:March 2021

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your mobile phone (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