REGULATEN 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Regulaten 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Regulaten and what is it used for

Regulatenis used to:

• treat high blood pressure.

Regulaten contains the active substance eprosartan.

• Eprosartanbelongs to a group of medicines known as “angiotensin II receptor inhibitors” and blocks the action of a substance called “angiotensin II”. This substance causes blood vessels to narrow, making it harder for blood to pass through them, which leads to an increase in blood pressure. By blocking this substance, blood vessels relax and blood pressure decreases.

2. What you need to know before you take Regulaten

Do not take Regulaten:

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver disease.
• If you have severe kidney problems.
• If you are more than 3 months pregnant (it is also better not to take Regulaten at the start of pregnancy - see the section “Pregnancy”).
• If you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren.

If you are in any of these situations, it is advisable to inform your doctor before starting treatment.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to take Regulaten:

• 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 once treatment has started. They will also determine the levels of potassium, creatinine, and uric acid in your blood.
• If you have a heart problem such as coronary heart disease, heart failure, narrowing of the 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, taking diuretics, or suffering from vomiting or diarrhea. This is because these situations can lead to a decrease in blood volume or blood sodium levels.

These situations must be corrected before taking Regulaten.

• If you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially 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 Regulaten”.

• If you are taking any medicine that may increase your potassium levels (see section “Taking Regulaten with other medicines”).
• If you think you are (or might become) pregnant. Regulaten is not recommended at the start 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 breast-feeding.
• If you are a black patient, as this medicine may be less effective at reducing blood pressure.

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

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

Children and adolescents

Regulaten must not be given to children and adolescents under 18 years.

Other medicines and Regulaten

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. These include herbal medicines. This is because Regulaten may affect the way other medicines work, and they may affect the way Regulaten works.

In particular, tell your doctor or pharmacist if you are taking the following medicines:

• lithium, for mood problems. Your doctor should monitor your lithium blood levels because Regulaten may increase them.

If this is the case (or you are unsure), consult your doctor or pharmacist before taking Regulaten.

The following medicines may increase the effect of Regulaten:

• medicines that lower your blood pressure.

If this is the case (or you are unsure), consult your doctor or pharmacist before taking Regulaten.

The following medicines may reduce the effect of Regulaten:

• indomethacin - for pain, stiffness, and swelling, and to lower fever.

If this is the case (or you are unsure), consult your doctor or pharmacist before taking Regulaten.

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

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

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

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

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

Taking Regulaten with food

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Normally, before you become pregnant, your doctor will switch you to another blood pressure medicine. Usually, your doctor will advise you to take another medicine instead of Regulaten, as it is not recommended to take Regulaten at the start of pregnancy (first 3 months) and should not be used in the last 6 months of pregnancy, as it may cause serious harm to your baby.

Breast-feeding

• Tell your doctor if you are breast-feeding or plan to breast-feed your child.
• Regulaten is not recommended for mothers who are breast-feeding. Your doctor may choose another treatment if you want to breast-feed, especially if your baby is newborn or premature.

Driving and using machines

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

Regulaten contains lactose.If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Regulaten

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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, approximately at the same time each day.

Adults

The recommended dose is one tablet per day.

Use in children and adolescents

Regulaten must not be given to children and adolescents under 18 years.

If you take more Regulaten than you should

If you take more Regulaten than you should or someone else takes your medicine by mistake, contact your doctor or go to a hospital immediately. Take the medicine pack and this leaflet with you. The following effects may happen:

• feeling dizzy due to low blood pressure (hypotension)
• feeling sick (nausea)
• feeling sleepy

You can also contact the Toxicology Information Service, phone 91.562.04.20, stating the medicine and the amount taken.

If you forget to take Regulaten

• 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 a forgotten dose.

If you stop taking Regulaten

Do not stop taking Regulaten without talking to your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Allergic reactions(may affect up to 1 in 100 people)

If you have an allergic reaction, stop taking the medicine and see a doctor immediately. The signs may include:

• 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 skin and mucous membranes (angioedema).

Other possible side 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, diarrhea
• weakness (asthenia)
• stuffy nose (rhinitis).

Uncommon(may affect up to 1 in 100 people)

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

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

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Regulaten

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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Regulaten contains

• The active substance is eprosartan. Each film-coated tablet contains 600 mg of eprosartan (as dihydrate mesilate).
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, crospovidone, magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 400, and polysorbate 80.

Appearance and packaging

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

Regulaten 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

You can ask for more information about this medicine from the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of last revision of this leaflet:January 2025

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