Regulaten Plus 600 mg/12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Regulaten Plus 600 mg/12.5 mg, film-coated tablets

eprosartan and hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, as 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, 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 or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Regulaten Plus is and what it is used for

Regulaten Plus is used:

• to treat high blood pressure.

Regulaten Plus contains two active substances, eprosartan and hydrochlorothiazide.

• Eprosartan belongs to a group of medicines called “angiotensin II receptor antagonists”. It blocks the action of a substance in your body called “angiotensin II”. This substance causes your blood vessels to narrow. This makes it harder for blood to flow through the blood vessels, resulting in increased blood pressure. By blocking this substance, blood vessels relax and your blood pressure decreases.

• Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics”. It increases how often and how much urine you pass. This lowers your blood pressure.

You will only take Regulaten Plus if your blood pressure does not decrease sufficiently with eprosartan alone.

2. What you need to know before taking Regulaten Plus

Do not take Regulaten Plus if:

• you are allergic to eprosartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
• you are allergic to a group of medicines called “sulfonamides”
• you have severe liver disease
• you have severe kidney problems
• you have serious problems with blood flow to your kidneys
• you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren
• you have high calcium levels or low potassium or sodium levels. These levels can be measured in your blood
• you have a problem with your gallbladder or bile ducts (gallstones)
• you have gout or other signs of increased uric acid levels in your blood (hyperuricemia)
• you are more than 3 months pregnant (also avoid taking Regulaten Plus in early pregnancy – see pregnancy section)

Do not take Regulaten Plus if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Regulaten Plus if:

• you have any other liver problems
• you have had a kidney transplant
• you have other kidney problems. Your doctor will check how well your kidneys are working before starting treatment and at regular intervals during treatment. Your doctor will also monitor potassium, creatinine, and uric acid levels in your blood
• you have a heart condition such as coronary heart disease, heart failure, narrowing of blood vessels or heart valves, or a problem with your heart muscle
• you have a disease called “systemic lupus erythematosus” (SLE)
• you have diabetes. Your doctor may need to adjust the dose of your diabetes medication
• you produce too much of a hormone called “aldosterone”
• you have a history of allergies
• you are on a low-salt diet, are taking “water tablets” (diuretics), or are vomiting or have diarrhea. These conditions can reduce your blood volume or blood sodium levels. These situations should be corrected before starting treatment with Regulaten Plus
• 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 Plus”.

• you think you may be pregnant (or plan to become pregnant). This medicine is not recommended in early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to the unborn baby (see pregnancy section)
• you have had breathing or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking this medicine, seek medical help immediately
• you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun and UV exposure while taking this medicine.
• you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure (glaucoma), occurring within hours to weeks of taking Regulaten Plus. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk. You should stop treatment and contact your doctor immediately
• you are of Black African descent, as this medicine may be less effective in lowering blood pressure

If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking this medicine.

Treatment with hydrochlorothiazide may cause an electrolyte imbalance in your body. Your doctor should monitor your blood electrolytes regularly.

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

Children and adolescents

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

Surgery and tests

Talk to your doctor or pharmacist before taking this medicine if you are scheduled for:

• surgery
• a doping test. The hydrochlorothiazide in this medicine may cause a positive result
• any other blood tests.

Taking Regulaten Plus with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription, including herbal remedies. This is because this medicine may affect how other medicines work. Likewise, some medicines may affect how Regulaten Plus works.

In particular, consult your doctor or pharmacist if you are taking:

• lithium – used for mood disorders. Your doctor must monitor your blood lithium levels, as this medicine may increase them
• diabetes medicines such as metformin or insulin. Your doctor may need to adjust your diabetes medicine dose
• medicines that may cause potassium loss. These include “water tablets”, laxatives, corticosteroids, amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), and a hormone produced by the pituitary gland called ACTH. This medicine may increase the risk of low blood potassium levels when taken with these medicines
• medicines that reduce sodium levels in the blood. These include medicines used to treat depression, psychosis, and epilepsy. This medicine may increase the risk of low blood sodium levels when taken with these medicines
• digitalis glycosides such as digoxin, used for heart failure or irregular heartbeat. This medicine may increase its effect and also its side effects, such as irregular heartbeats
• beta-blockers and diazoxide. When taken with this medicine, blood sugar levels may rise
• cancer treatments such as “methotrexate” and “cyclophosphamide”
• medicines that constrict your blood vessels or stimulate your heart, such as noradrenaline
• anesthetics
• amantadine, used to treat Parkinson’s disease or viral infections. This medicine may increase the risk of side effects caused by amantadine.

If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking this medicine.

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 Plus” and “Warnings and precautions”).

The following medicines may reduce the effect of Regulaten Plus:

• anti-inflammatory medicines such as "non-steroidal anti-inflammatory drugs" (NSAIDs) and “acetylsalicylic acid”
• medicines that lower blood fats, such as “colestipol” and “cholestyramine”.

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

The following medicines may increase the effect of Regulaten Plus:

• medicines that cause drowsiness, such as sedatives and narcotics
• medicines used to treat depression
• some medicines for Parkinson’s disease, such as “biperiden”
• muscle relaxants, such as "baclofen" and "tubocurarine"
• medicines that lower blood pressure
• “amifostine”, a medicine that protects cells during chemotherapy.

If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before taking this medicine.

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

• medicines containing potassium or potassium-sparing medicines
• medicines that increase potassium levels, such as "heparin" and "ACE inhibitors"
• gout medicines such as “probenecid”, “sulfinpyrazone”, and “allopurinol”
• diabetes medicines such as "metformin" and "insulin"
• medicines to control your heart rhythm, such as quinidine, disopyramide, amiodarone, and sotalol
• some antibiotics, such as “tetracyclines”
• some antipsychotic medicines such as thioridazine, chlorpromazine, and levomepromazine
• calcium salts or vitamin D
• steroids.

Talk to your doctor or pharmacist before taking this medicine. Depending on your blood test results, your doctor may decide to change your treatment with these medicines or with Regulaten Plus.

Taking Regulaten Plus with food, drinks, and alcohol

Drinking alcohol while taking this medicine may lower your blood pressure and make you feel tired or dizzy.

Talk to your doctor before taking Regulaten Plus if you are on a low-salt diet.

Having too little salt may cause your blood volume or blood sodium levels to become too low.

Pregnancy, breastfeeding and fertility

Pregnancy

• Inform your doctor if you think you may be pregnant (or are planning to become pregnant). Your doctor will usually advise you to stop treatment with this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative treatment instead of Regulaten Plus.
• Regulaten Plus is not recommended during early pregnancy and must not be taken after three months of gestation. It may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

• Inform your doctor if you are breastfeeding or about to start breastfeeding.

• This medicine is not recommended for breastfeeding mothers. Your doctor may choose an alternative treatment for you if you wish to breastfeed, particularly if your baby is newborn or premature.

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

Driving and use of machines

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

Regulaten Plus contains lactose (a type of sugar)

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Regulaten Plus

Follow exactly the instructions for use of this medicine 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.
• You may take the tablets with or without food.
• Swallow the tablet whole with plenty of liquid, such as a glass of water.
• Do not chew or crush the tablets.
• Take the tablets in the morning at the same time each day.

Dosage

Adults

The usual dose is one tablet per day.

Use in children and adolescents

This medicine must not be given to children and adolescents under 18 years of age. Safety and efficacy have not been established.

If you take more Regulaten Plus than you should

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone: 91.562.04.20, consult your doctor, or go to a hospital immediately.

Take the medicine package with you. The following effects may occur:

• mild dizziness and dizziness due to a drop in blood pressure (hypotension)
• feeling of discomfort (nausea)
• drowsiness
• feeling of thirst (dehydration).

If you forget to take Regulaten Plus

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, skip the missed dose.

Do not take a double dose to make up for forgotten doses.

If you stop taking Regulaten Plus

Do not stop taking Regulaten Plus without first consulting your doctor.

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

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

If you have an allergic reaction, stop taking Regulaten plus and see a doctor immediately. Symptoms may include:

• skin reactions such as rash or hives with swelling (urticaria) (may affect up to 1 in 10 people)
• swelling of the face, skin, and mucous membranes (angioedema) (may affect up to 1 in 100 people)

Other possible adverse effects of Regulaten plus include:

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

• headache

Common (may affect up to 1 in 10 people)

• feeling dizzy

• tingling, nerve pain

• nausea, vomiting, or diarrhea

• feeling weak (asthenia), skin rash

• itching

• nasal congestion (rhinitis)

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

• changes in blood tests, such as:

• increased blood glucose levels (hyperglycemia)

Uncommon (may affect up to 1 in 100 people)

• sleep problems (insomnia)

• feeling depressed

• feeling anxious or nervous

• sexual dysfunction and/or change in sexual desire

• muscle cramps

• fever

• dizziness (vertigo)

• constipation

• changes in blood tests, such as:

• increased uric acid levels (gout)

• increased fat levels (cholesterol)

• decreased levels of potassium, sodium, and chloride

• decreased number of white blood cells

Rare (may affect up to 1 in 1,000 people)

• fluid in the lungs
• lung inflammation
• pancreas inflammation

Very rare (may affect fewer than 1 in 10,000 people)

• haemolytic anaemia
• acute respiratory distress syndrome (signs include severe breathing difficulty, fever, weakness, and confusion)

Frequency not known (frequency cannot be estimated from available data): Loss of appetite, jaundice, decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma], feeling restless, changes in blood cell counts: decreased granulocytes and platelets, disturbances in red blood cell formation; decreased magnesium levels in blood, increased calcium and triglyceride levels in blood, kidney disorders, kidney inflammation, acute renal failure, inflammation of blood vessel walls, skin blistering including necrotic skin cells (toxic epidermal necrolysis), skin rash/lesions typically in sun-exposed areas due to an autoimmune disease (cutaneous lupus erythematosus), systemic lupus erythematosus, joint pain (arthralgia), severe allergic reactions (anaphylactic reactions), increased sensitivity to sunlight (photosensitivity), skin and lip cancer (non-melanoma skin cancer). Intestinal angioedema: intestinal inflammation has been reported with similar products, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if these are possible adverse effects not listed in this leaflet. You can 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 Plus

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

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

Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be returned to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Regulaten Plus

• The active substances are 600 mg of eprosartan (as dihydrate mesylate) and 12.5 mg of hydrochlorothiazide per tablet.

• The other components (excipients) are:

• Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (from corn), crospovidone, magnesium stearate and purified water.

• Coating: polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350, yellow iron oxide (E 172) and black iron oxide (E 172).

Appearance of the product and contents of the pack

Film-coated tablets for oral use, white-yellowish in color and capsule-shaped.

The tablets are marked with the inscription "5147" on one side.

Regulaten Plus is packaged in blisters within cartons containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Mylan IRE Healthcare Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate, Dublin 13

Ireland

Manufacturer

Mylan Laboratories SAS

Route de Belleville, Lieu dit Maillard

F- 01400 Châtillon-sur-Chalaronne, France

For further information about this medicinal product, 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 2023

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