Regulaten 600 mg film-coated tablets

Package leaflet: Information for the user

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

Contents of this leaflet

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

1. What Regulaten is and what it is used for

Regulaten is used to:

• treat hypertension.

Regulaten 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, resulting in increased blood pressure. By blocking this substance, blood vessels relax and blood pressure decreases.

2. What you need to know before taking Regulaten

Do not take Regulaten:

• 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 are more than 3 months pregnant (it is also advisable not to take Regulaten during early pregnancy – see the section “Pregnancy”).
• If you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of these apply to you, it is important to inform your doctor before starting treatment.

Warnings and precautions:

Talk to your doctor, pharmacist, or nurse before taking 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 thereafter. They 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 your body produces too much of a hormone called "aldosterone".
• If you are on a low-salt diet, taking diuretics, or experiencing vomiting or diarrhoea. These conditions may lead to reduced blood volume or low blood sodium levels.

These conditions should be corrected before taking Regulaten.

• If you are taking any of the following medicines for 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 Regulaten”.

• If you are taking any medicine that may increase your serum potassium levels (see section “Taking Regulaten with other medicines”).
• If you think you are (or might become) pregnant. Use of Regulaten is not recommended in early pregnancy, and you must not take this medicine after the third month of pregnancy, as it may cause serious harm to your baby. See section “Pregnancy and breastfeeding”.
• If you are of Black race, as this medicine may be less effective in lowering blood pressure.

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

Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea 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 of age.

Other medicines and Regulaten

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. This includes herbal remedies. This is because Regulaten may affect how other medicines work, and other medicines may affect how Regulaten works.

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

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

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

The following medicines may reduce the effect of Regulaten:

• Indometacin – 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 Regulaten.

If you are taking any of the following medicines, your doctor may 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 Regulaten. Depending on your blood test results, 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 angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Regulaten” and “Warnings and precautions”).

Taking Regulaten with food

• You may 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 may lead to reduced blood volume or low blood sodium levels.

Pregnancy, breastfeeding and fertility

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

Pregnancy

Normally, before you become pregnant, your doctor will switch you from Regulaten to another appropriate antihypertensive medicine. Your doctor will generally advise you to take a different medicine instead of Regulaten, as the use of Regulaten is not recommended during pregnancy (first 3 months), and it must not be used under any circumstances during the last 6 months of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

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

Driving and use of machines

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

Regulaten contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Regulaten

Follow exactly the instructions for use of this medicine provided 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 fluid, for example 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 daily.

Use in children and adolescents

Regulaten must not be administered to children and adolescents under 18 years of age.

If you take more Regulaten than you should

If you take more Regulaten than you should, or if someone accidentally ingests it, consult your doctor or go to a hospital immediately. Take the medicine pack and leaflet with you. The following effects may occur:

• dizziness due to low blood pressure (hypotension)
• feeling sick (nausea)
• drowsiness

You may also contact the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount ingested.

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 the forgotten dose.

If you stop taking Regulaten

Do not stop taking Regulaten 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 fewer 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 membranes (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)
• stuffy nose (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 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 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 stated on the packaging, following CAD or EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point located in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Regulaten

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

Appearance of the product and contents of the container

White, oval-shaped tablets with the imprint 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

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 Madrid
Spain

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

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