PATIENT INFORMATION LEAFLET

Ramipril/Hidroclorotiazida SUN 2,5 mg/12,5 mg Tablets EFG

Ramipril / Hidroclorotiazida

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

Contents of the pack and additional information

Ramipril/Hidroclorotiazida SUN is a combination of two medicines called ramipril and hidroclorotiazida.

Ramipril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.It works as follows:

• Reducing the amount of certain substances produced by the body that can increase blood pressure.
• Relaxing and widening blood vessels.
• Making it easier for the heart to pump blood through the body.

Hidroclorotiazida belongs to a group of medicines called "thiazide diuretics" (diuretics are also known as "water tablets"). It works by increasing the amount of water (urine) that is eliminated, which reduces blood pressure.

Ramipril/Hidroclorotiazida SUN is used to treat high blood pressure. The two active ingredients it contains work together to reduce blood pressure. They are used together when treatment with only one of them does not provide adequate control of blood pressure.

Do not take Ramipril/Hidroclorotiazida SUN

• If you are allergic to the active ingredients ramipril and/or hidroclorotiazida or to any of the other components of this medication (listed in section 6).
• If you are allergic (hypersensitive) to similar medications to Ramipril/Hidroclorotiazida SUN (other ACE inhibitors or other sulfonamide derivatives).
• The symptoms of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue.
• If you have ever had a severe allergic reaction called “angioedema”, whose symptoms may be: itching, hives (urticaria), red patches on hands, feet, and throat, swelling of throat and tongue, swelling of eyelids and lips, difficulty breathing and swallowing.
• If you have taken or are currently taking sacubitrilo/valsartán, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Ramipril/Hidroclorotiazida SUN may not be suitable for you.
• If you have significant liver problems.
• If you have abnormal levels of salt substances (calcium, potassium, sodium) in your blood.
• If you have kidney problems due to which the blood that reaches your kidneys is less than normal (renal artery stenosis).
• During the last 6 months of pregnancy (see, below, the section on “Pregnancy and lactation”).
• If you are breastfeeding (see, below, the section on "Pregnancy and lactation").

• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

Do not take Ramipril/Hidroclorotiazida SUN if any of the above conditions apply.

If you are unsure, speak with your doctor before taking Ramipril/Hidroclorotiazida SUN

Warnings and precautions

Consult with your doctor or pharmacist before starting to take Ramipril/Hidroclorotiazida SUN:

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its 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 exposure and UV rays while taking Ramipril/Hidroclorotiazida SUN.
• If you have heart, liver, or kidney problems.

• If you have lost a lot of salt and water (by vomiting, diarrhea, excessive sweating, low-sodium diet, long-term diuretic use, or after dialysis).
• If you are going to undergo treatment to reduce your allergy to bee or wasp stings (hyposensitization).
• If you are going to receive an anesthetic, for example, for surgery or dental intervention. You may need to stop taking Ramipril/Hidroclorotiazida SUN a day in advance; consult your doctor.
• If you have high levels of potassium in your blood (shown in blood test results).
• If you are taking medications or have conditions that may decrease sodium levels in the blood. Your doctor may perform regular blood tests, especially to monitor sodium levels in the blood, especially if you are an elderly person.

• If you are taking any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase: sirolimus, everolimus, and other medications belonging to the mTOR inhibitor class (used to prevent organ transplant rejection); vildagliptina (a medication used to treat type 2 diabetes); neprilysin inhibitors (INEP) (such as racecadotrilo, a medication used to treat diarrhea) or sacubitrilo/valsartán. For sacubitrilo/valsartán, see also “Do not take Ramipril/Hidroclorotiazida SUN.”

• If you have a vascular collagen disease, such as scleroderma or systemic lupus erythematosus

• Inform your doctor if you are pregnant (or suspect you may be). Ramipril/Hidroclorotiazida SUN is not recommended for use in the first 3 months of pregnancy and may cause serious harm to your baby after the third month of pregnancy (see section below on “Pregnancy and Lactation”).

• If you experience a decrease in vision or have eye pain, they may be symptoms of fluid accumulation in the eye's vascular layer (choroidal effusion) or increased eye pressure and may occur within a few hours to a week after taking Ramipril/Hidroclorotiazida SUNThis may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may have a higher risk of developing it.

• If you are taking any of the following medications used to treat high blood pressure:

-Angiotensin II receptor antagonist (ARA-II), (also known as sartanes – for example valsartán, telmisartán, irbesartán), especially if you have kidney problems related to diabetes.

-Aliskirén.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (such as potassium), at regular intervals.

See also the information under the heading “Do not take Ramipril/Hidroclorotiazida SUN.”

Children and adolescents

Ramipril/Hidroclorotiazida SUN is not recommended for use in children and adolescents under 18 years of age. This is because the medication has never been used in these age groups.

If you are unsure whether any of the above conditions apply to you, speak with your doctor before taking Ramipril/Hidroclorotiazida SUN.

Taking Ramipril/Hidroclorotiazida SUN with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because Ramipril/Hidroclorotiazida SUN may affect the way some other medications work. Also, some medications may affect the way Ramipril/Hidroclorotiazida SUN works.

Inform your doctor if you are taking any of the following medications. These may make Ramipril/Hidroclorotiazida SUN work less effectively:

• Medications to relieve pain and inflammation (such as non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina and Aspirina).
• Medications to treat low blood pressure, shock, heart failure, asthma, or allergies, such as efedrina, noradrenalina, or adrenalina. Your doctor will need to take your blood pressure.

Inform your doctor if you are taking any of the following medications. These may increase the risk of adverse effects if taken with Ramipril/Hidroclorotiazida SUN:

• Sacubitrilo/valsartán – used to treat a type of chronic heart failure in adults (see also “Do not take Ramipril/Hidroclorotiazida SUN”).

• Medications to relieve pain and inflammation (such as non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina and Aspirina).
• Medications that may reduce the amount of potassium in the blood, such as medications for constipation, diuretics, anfotericina B (for fungal infections) and ACTH (to see if your adrenal glands are working properly).
• Medications for heart problems, including heart rhythm problems.
• Diuretics such as furosemida.
• Potassium supplements (including salt substitutes) and other medications that may increase potassium levels in the blood (e.g., trimetoprima and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressant used to prevent organ transplant rejection; and heparina, a medication used to thin the blood to prevent clots).
• Anti-inflammatory steroids, such as prednisolona.
• Calcium supplements.
• Alopurinol (to reduce uric acid in the blood).
• Procainamida (to treat heart rhythm problems).
• Colestiramina (to reduce the amount of fat in the blood).
• Carbamazepina (for epilepsy).
• Temsirolimus (for cancer).
• Medications used more frequently to prevent organ transplant rejection (sirolimús, everolimús, and other mTOR inhibitors). See section “Warnings and precautions.”
• Vildagliptina (used to treat type 2 diabetes)

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

- If you are taking an angiotensin II receptor antagonist (ARA II) or aliskirén (see also the information under the heading “Do not take Ramipril/Hidroclorotiazida SUN.” and “Warnings and precautions”).

Inform your doctor if you are taking any of the following medications. These may be affected by Ramipril/Hidroclorotiazida SUN:

- Medications for diabetes, such as oral medications to lower blood sugar and insulin.

- Ramipril/Hidroclorotiazida SUN may reduce blood sugar levels. Closely monitor your blood sugar levels while taking Ramipril/Hidroclorotiazida SUN.

- Lithium (to treat mental health problems). Ramipril/Hidroclorotiazida SUN may increase lithium levels in the blood. Your doctor will closely monitor your lithium levels in the blood.

- Muscle relaxants.

- Quinina (for malaria).

- Medications containing iodine (such as those used occasionally in hospitals for scans or certain radiographs).

- Penicilina (for infections).

- Oral anticoagulants, such as warfarin derivatives.

If any of the above conditions apply to you (or you are unsure), consult your doctor before taking Ramipril/Hidroclorotiazida SUN.

Tests

Check with your doctor or pharmacist before taking your medication:

• If you are to undergo a parathyroid function test, Ramipril/Hidroclorotiazida SUN may affect the results.
• If you participate in athletic tests subject to doping control, know that Ramipril/Hidroclorotiazida SUN may give a positive result.

Taking Ramipril/Hidroclorotiazida SUN with food and alcohol:

• Drinking alcohol with Ramipril/Hidroclorotiazida SUN may make you feel dizzy or disoriented.

If you are concerned about how much you can drink while taking Ramipril/Hidroclorotiazida SUN, speak with your doctor since medications used to lower blood pressure and alcohol may have additive effects.

• Ramipril/Hidroclorotiazida SUN can be taken with or without food.

Pregnancy and lactation

Pregnancy

If you are pregnant or suspect you may be, consult your doctor or pharmacist before using this medication.

You should not take Ramipril/Hidroclorotiazida SUN in the first 12 weeks of pregnancy, and you should not take it in any case after week 13 as its use during pregnancy may possibly be harmful to the baby.

If you become pregnant while taking Ramipril/Hidroclorotiazida SUN, inform your doctor immediately. An alternative treatment should be carried out if you plan to become pregnant.

Lactation

You should not take Ramipril/Hidroclorotiazida SUN if you are breastfeeding. Consult your doctor or pharmacist before using any medication.

Driving and operating machines:

You may feel dizzy while taking Ramipril/Hidroclorotiazida SUN, which is more likely to occur when starting to take Ramipril/Hidroclorotiazida SUN or when starting a higher dose. If you feel dizzy, do not drive or operate tools or machines.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

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

Medication Taking

• Take this medication orally at the same time each day, usually in the morning.
• Swallow the whole tablets with liquid.
• Do not crush or chew the tablets.

The groove should not be used to split the tablet

How Much Medication to Take

Hypertension Treatment

Your doctor will adjust the amount you should take until your blood pressure is under control.

Older Patients

Your doctor will reduce the initial dose and adjust the treatment more slowly.

If You Take More Ramipril/Hidroclorotiazida SUN Than You Should

Consult your doctor immediately or go to the nearest hospital emergency department. Do not drive to the hospital: ask someone to take you or call an ambulance. Bring the medication packaging with you, so your doctor knows what you have taken.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If You Forget to Take Ramipril/Hidroclorotiazida SUN

• If you forget to take a dose, take your regular dose when it is next due.
• Do not take a double dose to make up for the missed tablets.

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

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

Stop taking Ramipril/Hidroclorotiazida SUN and consult your doctor immediately if you notice any of the following serious side effects, you may need urgent medical treatment:

• Swelling of the face, lips, or throat, which can make it difficult to swallow or breathe, as well as itching and hives, which can be a sign of a serious allergic reaction to Ramipril/Hidroclorotiazida SUN.
• Important skin reactions, such as rashes, mouth sores, worsening of an existing skin disease, redness, blisters, or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Inform your doctor immediately if you experience:

• Fast or irregular heartbeat, strong heart palpitations, chest pain, chest tightness, or more serious problems such as heart attack and stroke.
• Difficulty breathing, cough, and fever lasting 2 to 3 days, and loss of appetite. These could be symptoms of lung problems, including inflammation.
• Easy bruising, prolonged bleeding, any sign of bleeding (e.g., from the gums), purple spots on the skin, skin spots, or cold hands and feet.

Infections more easily than normal, sore throat, and fever, feeling tired, dizziness, or paleness of the skin, which could be signs of blood or bone marrow problems.

• Severe stomach pain, which can radiate to the back, which could be a symptom of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (urge to vomit), yellowish skin or eyes (jaundice), which could be symptoms of liver problems, such as hepatitis (inflammation of the liver) or liver damage.
• Intense eye pain, blurred vision, or seeing halos around lights, headache, excessive tearing, or nausea and vomiting, which could be a disease called glaucoma.

Other side effects may be:

Inform your doctor if any of the following side effects worsen or last more than a few days.

Frequent(may affect up to 1 in 10 people)

• Headache or feeling weak or tired.
• Sensation of dizziness, which is more likely to occur when starting to take Ramipril/Hidroclorotiazida SUN or when starting a higher dose.
• Dry, irritating cough or bronchitis.
• Blood tests showing higher-than-normal sugar levels. If you have diabetes, this could worsen.
• Blood tests showing higher-than-normal levels of uric acid or fats.
• Joint pain, redness, or inflammation.

Rare(may affect up to 1 in 100 people)

• Skin rash, with or without raised areas.
• Redness, dizziness, low blood pressure, especially when standing up or getting up quickly.
• Balance problems (vertigo).
• Itching and abnormal sensations in the skin, such as numbness, tingling, pinching, burning, or aching (paresthesias).
• Loss or change in taste.
• Difficulty sleeping.
• Depression, anxiety, more nervousness or restlessness than normal.
• Stuffy nose, sinusitis, difficulty breathing.
• Gingivitis, inflammation of the mouth.
• Redness, itching, or swelling of the eyes or excessive tearing.
• Ear ringing.
• Blurred vision.
• Hair loss.
• Chest pain.
• Muscle pain.
• Constipation, stomach pain, or abdominal pain.
• Discomfort in the stomach after meals or urge to vomit.
• Urinating more than normal during the day.
• Sweating more than normal or feeling thirsty.
• Loss or decrease in appetite (anorexia), feeling less hungry.
• Fast or irregular heartbeat.
• Swelling of arms and legs, which can be a sign that your body is retaining more fluids than normal.
• Fever.
• Impotence in men.
• Blood tests showing a decrease in red blood cells, white blood cells, or platelets, or hemoglobin levels.
• Blood tests showing changes in how your liver, pancreas, or kidneys are functioning.
• Blood tests showing lower-than-normal potassium levels.

Very rare (may affect up to 1 in 10,000 people)

• Vomiting, diarrhea, or stomach burning.
• Inflamed tongue and red or dry mouth.
• Blood tests showing higher-than-normal potassium levels.
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Frequency not known (cannot be estimated from available data)

Skin cancer and lip cancer (non-melanoma skin cancer).

• Rapid onset of reduced distance vision (acute myopia), decreased vision, or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma).

Other side effects observed:

Inform your doctor if any of the following side effects worsen or last more than a few days.

• Difficulty concentrating, feeling uneasy or confused.
• Fingers of hands and feet that change color with cold and, afterwards, with tingling or pain when warming up (Raynaud's phenomenon).
• Male breast growth.
• Formation of blood clots.
• Auditory problems.
• Less tear formation than normal.
• Seeing objects as yellow.
• Dehydration.
• Swelling, pain, and redness in one cheek (inflammation of a salivary gland).
• Inflammation of the intestine called "intestinal angioedema," with symptoms such as abdominal pain, vomiting, and diarrhea.
• Increased sensitivity to sunlight.
• Significant skin peeling or shedding, skin rash with itching and swelling, or other skin reactions, such as red face or forehead rash.
• Rash or petechiae on the skin.
• Skin spots and cold extremities.
• Nail problems (separation or detachment of a nail from its bed).
• Musculoskeletal stiffness or inability to move the jaw (tetany).
• Muscle weakness or cramps.
• Decreased libido in men or women.
• Blood in the urine, which could be a sign of kidney problems (interstitial nephritis).
• Increased sugar in urine.
• Increased number of a certain type of white blood cell (eosinophilia) in a blood test.
• Blood test showing very few blood cells (pancytopenia).
• Blood test showing a change in the amount of salts, such as sodium, calcium, magnesium, and chloride, in the blood.

• Dark-colored urine, feeling or being sick, muscle cramps, confusion, and attacks that may be due to inadequate secretion of ADH (antidiuretic hormone). If you have these symptoms, consult your doctor as soon as possible.
• Lethargy or difficulty reacting.

• Change in the smell of things.
• Difficulty breathing or worsening of asthma.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it's possible side effects that don't appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https:HYPERLINK "http://www.notificaram.es/"//HYPERLINK "http://www.notificaram.es/"wwwHYPERLINK "http://www.notificaram.es/".nHYPERLINK "http://www.notificaram.es/"oHYPERLINK "http://www.notificaram.es/"tHYPERLINK "http://www.notificaram.es/"iHYPERLINK "http://www.notificaram.es/"fiHYPERLINK "http://www.notificaram.es/"cHYPERLINK "http://www.notificaram.es/"aHYPERLINK "http://www.notificaram.es/"rHYPERLINK "http://www.notificaram.es/"aHYPERLINK "http://www.notificaram.es/"mHYPERLINK "http://www.notificaram.es/".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. The expiration date is the last day of the month indicated.

Store below 25°C. Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGRE point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medications that you no longer need. By doing so, you will help protect the environment.

Composition of Ramipril/Hidroclorotiazida SUN

The active principles are ramipril and hidroclorotiazida.

• Each tablet contains 2.5 mg of ramipril and 12.5 mg of hidroclorotiazida.
• The other components are hypromelosa, microcrystalline cellulose, pregelatinized cornstarch and sodium fumarate stearate.

Appearance of the product and content of the container

Ramipril/Hidroclorotiazida tablets 2.5 mg/12.5 mg: White or off-white, oblong tablets, engraved with the letter “R” and the number “21” on each side of the groove on one face and also with a groove on the other. The groove should not be used to break the tablet.

Ramipril/Hidroclorotiazida SUN is available in containers of 14, 20, 28, 50 and 100 tablets in cold-forming blister packs with desiccant (OPA/Al//PE/HDPE) or triple blister pack (PVC/PE/PVdC/Al).

Only some container sizes may be marketed.

Holder of the Marketing Authorization and responsible for manufacturing

Holder of the Marketing Authorization

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH- Hoofddorp

Netherlands

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH- Hoofddorp

Netherlands

Terapia S.A.

Str. Fabricii nr. 124,

Cluj, Napoca,

Romania

Local Representative:

Sun Pharma Laboratorios S.L

Rambla de Catalunya 53 – 55

08007 – Barcelona

Spain

Tel.: +34 93 342 78 90

Last review date of the leaflet: November 2021

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)wwwHYPERLINK "http://www.aemps.gob.es/".aeHYPERLINK "http://www.aemps.gob.es/"mHYPERLINK "http://www.aemps.gob.es/"pHYPERLINK "http://www.aemps.gob.es/"s.HYPERLINK "http://www.aemps.gob.es/"gHYPERLINK "http://www.aemps.gob.es/"ob.es