REGULATEN PLUS 600 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Regulaten Plus 600 mg/12.5 mg, Film-Coated Tablets

eprosartan and hydrochlorothiazide

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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Regulaten Plus and what is it 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 your blood vessels, which increases your blood pressure. By blocking this substance, your blood vessels relax and your blood pressure decreases.

• hydrochlorothiazide belongs to a group of medicines called "thiazide diuretics". It increases the frequency and amount of urine you produce. This decreases 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 you take 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 severe problems with blood flow to your kidneys
• you have diabetes or kidney problems and are being treated with a medicine to lower blood pressure that contains aliskiren
• you have high levels of calcium or low levels of potassium or sodium. 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)
• if you are pregnant for more than 3 months (also avoid taking Regulaten Plus at the start of pregnancy - see the section on pregnancy)

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take 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 your treatment and at regular intervals during your treatment. Your doctor will also check the levels of potassium, creatinine and uric acid in your blood
• you have a heart problem such as coronary heart disease, heart failure, narrowing of your 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 change the dose of your diabetes medicines
• 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 pills" (diuretics) or are vomiting or have diarrhea. This is because they can cause your blood volume or sodium levels in your blood to decrease. These situations should be corrected before starting treatment with Regulaten Plus
• 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) especially if you have kidney problems related to diabetes.

-aliskiren

Your doctor may check 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 are pregnant (or plan to be). This medicine is not recommended at the start of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see the section on pregnancy)
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking this medicine, seek medical attention immediately
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking this medicine.
• if you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (glaucoma) and can occur within hours to weeks after taking Regulaten Plus. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing it, you should discontinue treatment and consult your doctor
• if you are a black patient, as this medicine may be less effective in reducing blood pressure

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking this medicine.

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

Consult 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 should not be given to children and adolescents under 18 years of age.

Surgery and tests

Consult your doctor or pharmacist before taking this medicine if you are scheduled to have:

• surgery or an operation
• a doping test. The hydrochlorothiazide in this medicine may give a positive result
• any other blood test.

Taking Regulaten Plus with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because this medicine can affect the way other medicines work. Also, some medicines can affect the way Regulaten Plus works.

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

• lithium - for mood problems. Your doctor should check the lithium level in your blood because this medicine can increase it
• medicines for diabetes such as metformin or insulin. Your doctor may need to change the dose of your diabetes medicines
• medicines that can cause potassium loss. These include "water pills", laxatives, corticosteroids, amphotericin (an antifungal medicine), carbenoxolone (for the treatment of mouth ulcers) and a hormone produced by the pituitary gland called ACTH. This medicine can increase the risk of low potassium levels in the blood when taking these medicines
• medicines that reduce the amount of sodium in the blood. These include medicines for treating depression, psychosis and epilepsy. This medicine can increase the risk of low sodium levels in the blood when taken with these medicines
• digitalis glycosides such as digoxin, used for heart failure or a fast or slow heartbeat. This medicine can 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 increase
• medicines for treating cancer, such as "methotrexate" and "cyclophosphamide"
• medicines that narrow your blood vessels or stimulate your heart, such as noradrenaline
• anesthetics
• amantadine used for the treatment of Parkinson's disease or viral diseases. This medicine can increase the risk of side effects caused by amantadine.

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking this medicine.

Your doctor may need to change 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 Regulaten Plus" and "Warnings and precautions".

The following medicines may decrease the effect of Regulaten Plus:

• anti-inflammatory medicines such as "non-steroidal anti-inflammatory drugs" (NSAIDs) and "acetylsalicylic acid"
• medicines that lower the fat in your blood, such as "colestipol" and "cholestyramine".

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking Regulaten Plus.

The following medicines may increase the effect of Regulaten Plus:

• medicines that induce sleep, such as sedatives and narcotics.
• medicines for treating depression
• some medicines for Parkinson's disease, such as "biperiden"
• medicines that relax muscles, such as "baclofen" and "tubocurarine"
• medicines that lower blood pressure
• "amifostine" a medicine that protects cells from chemotherapy.

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking this medicine.

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" and "ACE inhibitors"
• medicines for gout such as "probenecid", "sulfinpyrazone" and "allopurinol"
• medicines for diabetes such as "metformin" and "insulin"
• medicines to control your heart rate, such as quinidine, disopyramide, amiodarone and sotalol
• some antibiotics, such as "tetracyclines"
• some antipsychotic medicines such as thioridazine, chlorpromazine and levopromazine
• calcium salts or vitamin D
• corticosteroids.

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

Taking Regulaten Plus with food, drinks and alcohol

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

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

Not having enough salt can cause your blood volume or sodium levels in your blood to be lower.

Pregnancy, breastfeeding and fertility

Pregnancy

• Tell your doctor if you think you are pregnant (or plan to be). Your doctor will normally advise you to stop treatment with this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Regulaten Plus.
• Regulaten Plus is not recommended at the start of pregnancy and should not be taken after the third month of pregnancy. It may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

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

• This medicine is not recommended for breastfeeding mothers. Your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

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

Driving and using machines

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

Regulaten Plus contains lactose (a type of sugar)

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

3. How to take Regulaten Plus

Follow exactly the instructions of administration of this medicine given to you by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Taking this medicine

• Take this medicine by mouth.
• You can take the tablets with or without food.
• Swallow the tablet whole with plenty of liquid like a glass of water
• Do not chew or crush the tablets.
• Take the tablets in the morning at the same time each day.

How to take it

Adults

The usual dose is one tablet a day.

Use in children and adolescents

This medicine should not be given to children and adolescents under 18 years of age. The safety and efficacy have not been established.

If you take more Regulaten Plus than you should

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

Bring the medicine pack with you. The following effects may occur:

• a feeling of slight dizziness and dizziness due to a drop in blood pressure (hypotension)
• a feeling of discomfort (nausea)
• drowsiness
• a 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 consulting your doctor first.

If you have any further questions on 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 all people suffer from them.

The following adverse effects may appear with this medicine:

Allergic Reactions

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

• skin reactions such as a rash or hives with swelling (urticaria), (may affect up to 1 in 10 people)
• swelling of the face, swelling of the 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
• feeling nauseous, vomiting or diarrhea
• feeling weak (asthenia)
• skin rash
• itching
• nasal congestion (rhinitis)

• low blood pressure, including low blood pressure when standing up. You may feel slightly dizzy.
• changes in blood tests, such as:

• increased blood glucose level (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 level (gout)
• increased fat (cholesterol)
• decreased potassium, sodium, and chloride levels
• decreased white blood cell count

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

• fluid in the lungs
• inflammation of the lungs
• inflammation of the pancreas

Very Rare(may affect less than 1 in 10,000 people)

• hemolytic anemia
• acute respiratory distress syndrome (signs include severe respiratory difficulty, fever, weakness, and confusion)

Frequency Not Known(frequency cannot be estimated from the available data) Loss of appetite, jaundice, decreased vision or eye pain due to high 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 count: decreased granulocytes and platelets, alterations in red blood cell formation; decreased magnesium level in the blood, increased calcium and triglyceride levels in the blood, kidney disorders, kidney inflammation, acute kidney failure, inflammation of the blood vessel wall, formation of bubbles in the skin including dead skin cells (toxic epidermal necrolysis), skin rash/lesions usually 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: inflammation in the intestine has been reported, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea after using similar products.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Regulaten Plus

• The active ingredients are 600 mg of eprosartan (in the form of dihydrate mesylate) and 12.5 mg of hydrochlorothiazide per tablet.
• The other components (excipients) are:

• Core of the tablet: 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 Package Contents

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

The tablets have the inscription “5147” on one of the faces.

Regulaten Plus is packaged in blisters in boxes 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the Last Revision of this Prospectus:January 2023

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