Package Leaflet: Information for the User

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

eprosartan and hydrochlorothiazide

Read 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Regulaten Plus

3. How to take Regulaten Plus

4. Possible side effects

5. Storage of Regulaten Plus

6. Contents of the pack and additional information

Regulaten Plus is used:

• to treat high blood pressure.

Regulaten Plus contains two active ingredients, 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 constrict. This makes it harder for blood to flow through your blood vessels, resulting in an increase in 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 eliminate. This decreases your blood pressure.

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

Do not take Regulatan Plus if:

- you are allergic to eprosartan, hydrochlorothiazide, or any of the other components of this medication (listed in section 6)

- you are allergic to a group of medications called "sulfonamides"

- you have severe liver disease

- you have severe kidney problems

- you have severe problems with blood flow in your kidneys

- you have diabetes or kidney insufficiency and are being treated with a medication 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 (biliary calculi)

- you have gout or other signs of an increase in uric acid levels in your blood (hyperuricemia)

- if you are more than 3 months pregnant (also avoid taking Regulaten Plus at the beginning of pregnancy – see the pregnancy section)

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

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 examine how your kidneys are functioning before starting your treatment and at intervals during your treatment. Your doctor will also monitor your blood levels of potassium, creatinine, and uric acid

- you have a heart problem such as coronary heart disease, heart failure, a 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 medications

- you produce too much of a hormone called "aldosterone"

- you have a history of allergies

- you have a low-sodium diet, are taking "diuretics" (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 must be corrected before starting treatment with Regulaten Plus

- if you are taking any of the following medications used to treat high blood pressure (hypertension):

- an angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril) particularly if you have kidney problems related to diabetes

- aliskiren

Your doctor may need to monitor your renal function, blood pressure, and electrolyte levels in your blood (such as 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 medication is not recommended at the beginning 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 found in this stage (see the pregnancy section)

- if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking this medication, seek medical attention immediately

- if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking this medication.

- if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (glaucoma) and may occur between hours and weeks after taking Regulaten Plus. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it, and you should discontinue treatment and seek medical attention

- if you are a black patient, as this medication may be less effective in reducing blood pressure

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

The treatment with hydrochlorothiazide may cause an electrolyte imbalance in your body. Your doctor should monitor your electrolyte levels in your blood regularly.

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 administered to children and adolescents under 18 years old.

Operations and tests

Consult your doctor or pharmacist before taking this medication if you have planned the following:

- surgery or operation

- a doping test. The hydrochlorothiazide in this medication may give a positive result

- any other blood test.

Taking Regulaten Plus with other medications

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

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

• lithium – for mood problems. Your doctor should monitor your lithium levels in your blood because this medication may increase them
• diabetes medications such as metformin or insulin. Your doctor may need to change the dose of your diabetes medications
• medications that may cause potassium loss. These include "diuretics", laxatives, corticosteroids, amphotericin (an antifungal medication), carbenoxolone (for mouth ulcer treatment), and a hormone produced by the pituitary gland called ACTH. This medication may increase the risk of low potassium levels in your blood when taken with these medications
• medications that reduce the amount of sodium in your blood. These include medications for depression, psychosis, and epilepsy. This medication may increase the risk of low sodium levels in your blood when taken with these medications
• digitalis glycosides such as digoxin, used for heart failure or irregular heartbeats. This medication may increase its effect and also its side effects, such as irregular heartbeats
• beta-blockers and diazoxide. When taken with this medication, your blood sugar levels may increase
• medications for cancer, such as "methotrexate" and "cyclophosphamide"
• medications that constrict your blood vessels or stimulate your heart, such as norepinephrine
• anesthetics
• amantadine used for Parkinson's disease or viral disease treatment. This medication may increase the risk of side effects caused by amantadine.

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

Your doctor may need to modify 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 Plus" and "Warnings and precautions").

The following medications may reduce the effect of Regulaten Plus:

• anti-inflammatory medications such as "non-steroidal anti-inflammatory drugs" (NSAIDs) and "aspirin"
• medications that reduce the amount of fat in your blood, such as "cholestyramine" and "colestipol".

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

The following medications may increase the effect of Regulaten Plus:

• sleep-inducing medications, such as sedatives and narcotics
• medications for depression
• some medications for Parkinson's disease, such as "biperiden"
• medications that relax your muscles, such as "baclofen" and "tubocurarine"
• medications that lower blood pressure
• "amifostine", a medication that protects cells from chemotherapy.

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

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

• medications that contain potassium or potassium-sparing medications
• medications that increase potassium levels, such as "heparin" and "ACE inhibitors"
• medications for gout, such as "probencid", "sulfinpyrazone", and "allopurinol"
• medications for diabetes, such as "metformin" and "insulin"
• medications to control your heart rhythm, such as quinidine, disopyramide, amiodarone, and sotalol
• some antibiotics, such as "tetracyclines"
• some antipsychotic medications, such as "thioridazine", "chlorpromazine", and "levopromazine"
• calcium salts or vitamin D
• steroids.

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

Taking Regulaten Plus with food, drinks, and alcohol

Consuming alcohol while taking this medication may reduce your blood pressure and make you feel drowsy or dizzy.

Consult your doctor before taking Regulaten Plus if you are following a low-sodium diet.

Not having enough salt may cause your blood volume or sodium levels in your blood to decrease.

Pregnancy, breastfeeding, and fertility

Pregnancy

• Inform your doctor if you think you are pregnant (or plan to be).Your doctor will usually advise you to stop treatment with this medication before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medication instead of Regulaten Plus.
• Regulaten Plus is not recommended at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant. 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 plan to start breastfeeding.

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

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

Driving and using machines

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

Regulaten Plus contains lactose (a type of sugar)

If your doctor has told you that you have a lactose intolerance, consult him before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Medication intake

• Take this medication orally.
• You can 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 every day.

How to take it

Adults

The usual dose is one tablet per day.

Use in children and adolescents

This medication should not be administered to children and adolescents under 18 years old. 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 Toxicological Information Service, phone: 91.562.04.20, consult with your doctor or go to the hospital immediately.

Bring the medication packaging with you. The following side effects may appear:

• 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 the next dose is near, omit the missed dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Regulaten Plus

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

This medicine may cause the following side effects:

Allergic reactions

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

• skin reactions such as hives or rashes 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 side 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 test results, 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 test results, such as:

- increased uric acid level (gout)

- increased cholesterol level

- decreased levels of potassium, sodium, and chloride

- decreased white blood cell count

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

• pulmonary edema
• inflammation of the lungs
• inflammation of the pancreas

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

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

Frequency not known(frequency that cannot be estimated from 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 levels of calcium and triglycerides in the blood, renal disorders, inflammation of the kidney, acute renal 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: intestinal inflammation has been reported, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea after use of similar products.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Regulanten Plus

• The active principles are 600 mg of eprosartan (in the form of dihydrochloride mesilate) and 12.5 mg of hydrochlorothiazide per tablet.
• The other components (excipients) are:

• Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, crospovidone, magnesium stearate, and purified water.
• Covering: 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 content of the packaging

Oral coated tablets, white-yellowish in color, and in the shape of a capsule.

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

Regulaten Plus is packaged in blisters in boxes containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Mylan IRE Healthcare Limited

Unit 35/36 Grange Parade,

Baldoyle Industrial Estate, Dublin 13

Ireland

Responsible for manufacturing

Mylan Laboratories SAS

Route de Belleville Lieu dit Maillard

F- 01400 Châtillon-sur-Chalaronne, France

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Last review date of this leaflet:January2023

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/