Futuran 600 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Futuran 600 mg film-coated tablets

eprosartan

Read all of this leaflet carefully before you start 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, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Futuran is and what it is used for

Futuran is used to:

• treat hypertension.

Futuran contains the active substance eprosartan:

• Eprosartan belongs to a group of medicines known as “angiotensin II receptor antagonists” and blocks the action of a substance called “angiotensin II”. This substance causes blood vessels to narrow, making it harder for blood to flow through them, which leads to increased blood pressure. By blocking this substance, blood vessels relax and blood pressure is reduced.

2. What you need to know before taking Futuran

Do not take Futuran:

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6),
• if you have severe liver disease,
• if you have serious problems with blood flow to the kidneys,
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren,
• if you are more than 3 months pregnant (it is also advisable not to take Futuran in early pregnancy; see the section “Pregnancy”).

If you are in any of these situations, you should inform your doctor before starting treatment.

Warnings and precautions:

Talk to your doctor, pharmacist, or nurse before taking Futuran:

• If you have any other liver problems.

• If you have any other kidney problems. Your doctor will check your kidney function before starting treatment and periodically during treatment. Your doctor will also monitor blood levels of potassium, creatinine, and uric acid.

• If you have a heart condition such as coronary heart disease, heart failure, narrowing of blood vessels or heart valves, or a problem with the heart muscle.

• If you produce too much of a hormone called “aldosterone.”

• If you are on a low-salt diet, take diuretics, or have vomiting or diarrhea. This is because these conditions may lead to reduced blood volume or low blood sodium levels. These conditions should be corrected before taking Futuran.

• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

• aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Futuran”.

• If you are taking any medicine that may increase your serum potassium levels (see section “Taking Futuran with other medicines”).
• If you think you are (or might become) pregnant. The use of Futuran is not recommended at the beginning of pregnancy, and you must not take this medicine if you are more than 3 months pregnant, as it may cause serious harm to your baby. See section “Pregnancy and breastfeeding”.
• If you are of Black African origin, as this medicine may be less effective in lowering blood pressure.

If you are in any of these situations (or are unsure), consult your doctor or pharmacist before taking Futuran.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Futuran. Your doctor will decide whether to continue treatment. Do not stop taking Futuran on your own.

Children and adolescents

Futuran must not be given to children and adolescents under 18 years of age.

Other medicines and Futuran:

Tell 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. This includes herbal medicines. This is because Futuran may affect how other medicines work, and other medicines may affect how Futuran works.

Specifically, inform your doctor or pharmacist if you are taking the following medicines:

• lithium, used for mood disorders. Your doctor must monitor lithium blood levels, as Futuran may increase them.

If this applies to you (or you are unsure), consult your doctor or pharmacist before taking Futuran.

The following medicines may increase the effect of Futuran:

• medicines that lower your blood pressure.

If this applies to you (or you are unsure), consult your doctor or pharmacist before taking Futuran.

The following medicines may reduce the effect of Futuran:

• indomethacin – used for pain, stiffness, swelling, and to reduce fever.

If this applies to you (or you are unsure), consult your doctor or pharmacist before taking Futuran.

If you are taking any of the following medicines, your doctor may need to perform blood tests:

• medicines containing potassium or potassium-sparing medicines.
• medicines that increase potassium levels, such as heparin, trimethoprim, and ACE inhibitors.

Consult your doctor or pharmacist before taking Futuran. Depending on the results of your blood tests, your doctor may decide to change your treatment with these medicines or with Futuran.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Futuran” and “Warnings and precautions”).

Taking Futuran with food

• You may take the tablets with or without food.
• Consult your doctor before taking Futuran if you are on a low-salt diet. Not consuming enough salt may lead to reduced blood volume or low blood sodium levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Usually, before you become pregnant, your doctor will replace Futuran with another antihypertensive medicine appropriate for use in pregnancy. Generally, your doctor will advise you to take a different medicine instead of Futuran, as the use of Futuran is not recommended during the first trimester (first 3 months) of pregnancy, and it must not be used during the last 6 months of pregnancy because it may cause serious harm to your baby.

Breastfeeding

• Inform your doctor if you are breastfeeding or plan to breastfeed.
• Futuran is not recommended for breastfeeding mothers. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines

It is unlikely that Futuran will affect your ability to drive or use machines. However, you may feel drowsy or dizzy while taking Futuran. If this occurs, do not drive or use tools or machines, and inform your doctor.

Futuran contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Futuran

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablet whole with plenty of liquid, for example with a glass of water.
• Do not crush or chew the tablets.
• Take the tablets in the morning, at approximately the same time each day.

Adults

The recommended dose is one tablet per day.

Use in children and adolescents

Futuran must not be given to children and adolescents under 18 years of age.

If you take more Futuran than you should

If you take more Futuran than you should, or if someone takes it accidentally, consult your doctor or go to a hospital immediately. Bring the medicine's packaging and leaflet with you. The following effects may occur:

• dizziness due to a drop in blood pressure (hypotension),
• feeling sick (nausea),
• drowsiness.

You may also contact the Toxicology Information Service at telephone number 91.562.04.20, stating the name of the medicine and the amount taken.

If you forget to take Futuran

• If you forget to take a dose, take it as soon as you remember.
• If you forget to take a dose and it is almost time for your next dose, do not take the missed dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking Futuran

Do not stop taking Futuran without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medicine:

Allergic reactions (may affect less than 1 in 100 people)

If you experience an allergic reaction, stop taking the medicine and see a doctor immediately. Signs may include the following:

• skin reactions such as rash or hives with swelling (urticaria),
• swelling of the lips, face, throat or tongue,
• difficulty breathing,
• swelling of the face or of the skin and mucous membrane (angioedema).

Other possible adverse effects

Very common (may affect more than 1 in 10 people)

• headache.

Common (may affect up to 1 in 10 people)

• dizziness,
• rash or itching (pruritus),
• nausea, vomiting, diarrhoea,
• weakness (asthenia),
• nasal congestion (rhinitis).

Uncommon (may affect up to 1 in 100 people)

• low blood pressure, including low blood pressure upon standing. You may feel dizzy.

Frequency not known (frequency cannot be estimated from available data)

• kidney problems, including renal failure.
• joint pain (arthralgia).
• intestinal angioedema: inflammation in the intestine has been reported with similar products, presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, 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. Storage of Futuran

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging, after CAD or EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Futuran

• The active substance is eprosartan. Each coated tablet contains 600 mg of eprosartan (as dihydrate mesylate).
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized gluten-free corn starch, crospovidone, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400 and polysorbate 80.

Appearance of the product and contents of the pack

White, oval-shaped tablets with the imprint 5046 on one side.

Futuran is packaged in opaque PVC/PCTFE blisters, in cartons containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Mylan Laboratories SAS

Route de Belleville, Lieu dit Maillard

F- 01400 Châtillon-sur-Chalaronne, France

Tel.: +33 4 74 45 54 42

Fax: +33 4 74 55 02 83

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the most recent review of this leaflet: January 2025

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