RAMIPRIL/HYDROCHLOROTHIAZIDE SUN 2.5 mg/12.5 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ramipril/Hydrochlorothiazide SUN 2.5 mg/12.5 mg tablets EFG

Ramipril / Hydrochlorothiazide

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 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 pack and other information

1. What Ramipril/Hydrochlorothiazide SUN is and what it is used for
2. What you need to know before you take Ramipril/Hydrochlorothiazide SUN
3. How to take Ramipril/Hydrochlorothiazide SUN
4. Possible side effects
5. Storing Ramipril/Hydrochlorothiazide SUN

Contents of the pack and additional information

1. What Ramipril/Hydrochlorothiazide SUN is and what it is used for

Ramipril/Hydrochlorothiazide SUN is a combination of two medicines called ramipril and hydrochlorothiazide.

Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). It works in the following ways:

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

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

Ramipril/Hydrochlorothiazide 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 your blood pressure.

2. What you need to know before you take Ramipril/Hydrochlorothiazide SUN

Do not take Ramipril/Hydrochlorothiazide SUN

• If you are allergic to the active substances ramipril and/or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to medicines similar to Ramipril/Hydrochlorothiazide SUN (other ACE inhibitors or other sulfonamide derivatives).
• The symptoms of an allergic reaction can include rash, problems swallowing or breathing, swelling of the 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 the hands, feet, and throat, swelling of the throat and tongue, swelling of the eyelids and lips, difficulty breathing and swallowing.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (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/Hydrochlorothiazide SUN may not be suitable for you.
• If you have severe liver problems.
• If you have abnormal amounts of salts (calcium, potassium, sodium) in your blood.
• If you have kidney problems where the blood flow to your kidneys is reduced (renal artery stenosis).
• During the last 6 months of pregnancy(see also the section on "Pregnancy and breastfeeding").
• If you are breastfeeding (see also the section on "Pregnancy and breastfeeding").

• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Do not take Ramipril/Hydrochlorothiazide SUN if any of the above conditions apply to you.

If you are not sure, talk to your doctor before taking Ramipril/Hydrochlorothiazide SUN.

Warnings and precautions

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

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular 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/Hydrochlorothiazide SUN.
• If you have heart, liver, or kidney problems.

• If you have lost a lot of body salts or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, long-term use of diuretics, or after dialysis).
• If you are going to undergo treatment to reduce your allergy to bee or wasp stings (desensitization).
• If you are going to receive an anesthetic, for example, for an operation or dental procedure. You may need to stop taking Ramipril/Hydrochlorothiazide 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 medicines or have conditions that can lower the levels of sodium in your blood. Your doctor may perform regular blood tests, especially to monitor sodium levels in your blood, especially if you are an elderly person.

• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase: sirolimus, everolimus, and other mTOR inhibitors (used to prevent organ transplant rejection); vildagliptin (a medicine used to treat diabetes); neprilysin inhibitors (e.g., racecadotril, a medicine used to treat diarrhea) or sacubitril/valsartan. For sacubitril/valsartan, see also "Do not take Ramipril/Hydrochlorothiazide SUN".

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

• Tell your doctor if you are pregnant (or think you might be). Ramipril/Hydrochlorothiazide SUN is not recommended during the first 3 months of pregnancy and may cause serious harm to your baby after the third month of pregnancy (see section on "Pregnancy and breastfeeding").

• If you experience a decrease in vision or have eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and can occur within hours to a week after taking Ramipril/Hydrochlorothiazide SUN. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamides, you may be at higher risk of developing it.

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

• An angiotensin II receptor antagonist (ARA II) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially 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 Ramipril/Hydrochlorothiazide SUN".

Children and adolescents

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

If you are not sure if any of the above conditions apply to you, talk to your doctor before taking Ramipril/Hydrochlorothiazide SUN.

Taking Ramipril/Hydrochlorothiazide SUN with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ramipril/Hydrochlorothiazide SUN may affect the way some other medicines work. Also, some medicines may affect the way Ramipril/Hydrochlorothiazide SUN works.

Tell your doctor if you are taking any of the following medicines. They may make Ramipril/Hydrochlorothiazide SUN work less well:

• Pain and inflammation relievers (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin).
• Medicines for low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor will need to check your blood pressure.

Tell your doctor if you are taking any of the following medicines. They may increase the risk of side effects if taken with Ramipril/Hydrochlorothiazide SUN:

• Sacubitril/valsartan - used to treat a type of long-term (chronic) heart failure in adults (see also "Do not take Ramipril/Hydrochlorothiazide SUN").

• Pain and inflammation relievers (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin).
• Medicines that can lower the amount of potassium in the blood, such as laxatives, diuretics, amphotericin B (for fungal infections), and ACTH (to check if your adrenal glands are working properly).
• Heart medicines, including those for heart rhythm problems.
• Diuretics such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that can increase the amount of potassium in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Steroid medicines for inflammation, such as prednisolone.
• Calcium supplements.
• Allopurinol (to reduce uric acid in the blood).
• Procainamide (to treat heart rhythm problems).
• Colestyramine (to reduce the amount of fat in the blood).
• Carbamazepine (for epilepsy).
• Temsirolimus (for cancer).
• Medicines used more frequently to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitors). See section "Warnings and precautions".
• Vildagliptin (used to treat type 2 diabetes).

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

• If you are taking an angiotensin II receptor antagonist (ARA II) or aliskiren (see also the information under the heading "Do not take Ramipril/Hydrochlorothiazide SUN" and "Warnings and precautions").

Tell your doctor if you are taking any of the following medicines. They may be affected by Ramipril/Hydrochlorothiazide SUN:

• Diabetes medicines, such as oral glucose-lowering medicines and insulin.
• Ramipril/Hydrochlorothiazide SUN may lower your blood sugar levels. Monitor your blood sugar levels carefully while taking Ramipril/Hydrochlorothiazide SUN.
• Lithium (for mental health problems). Ramipril/Hydrochlorothiazide SUN may increase the amount of lithium in your blood. Your doctor will closely monitor your lithium blood levels.
• Muscle relaxants.
• Quinine (for malaria).
• Medicines containing iodine (such as those used in hospitals for scans or certain X-rays).
• Penicillin (for infections).
• Oral blood thinners (anticoagulants), such as warfarin derivatives.

If any of the above conditions apply to you (or you are not sure), consult your doctor before taking Ramipril/Hydrochlorothiazide SUN.

Tests

Check with your doctor or pharmacist before taking your medicine:

• If you are going to have a test for parathyroid function, Ramipril/Hydrochlorothiazide SUN may affect the results.
• If you participate in athletic competitions subject to doping control, be aware that Ramipril/Hydrochlorothiazide SUN may give a positive result.

Taking Ramipril/Hydrochlorothiazide SUN with food and alcohol:

• Drinking alcohol with Ramipril/Hydrochlorothiazide SUN may make you feel dizzy or faint.

If you are concerned about how much you can drink while taking Ramipril/Hydrochlorothiazide SUN, talk to your doctor, as blood pressure-lowering medicines and alcohol can have additive effects.

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

Pregnancy and breastfeeding

Pregnancy

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.

You should not take Ramipril/Hydrochlorothiazide SUN during the first 12 weeks of pregnancy, and you should not take it at all after week 13, as its use during pregnancy may be potentially harmful to your baby.

If you become pregnant while taking Ramipril/Hydrochlorothiazide SUN, inform your doctor immediately. Alternative appropriate treatment should be initiated if you plan to become pregnant.

Breastfeeding

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

Driving and using machines:

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Ramipril/Hydrochlorothiazide SUN

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Taking this medicine

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

The score line is not intended for breaking the tablet

How much to take

Treatment of high blood pressure

Your doctor will adjust the amount you need to take to control your blood pressure.

Elderly patients

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

If you take more Ramipril/Hydrochlorothiazide SUN than you should

Consult your doctor immediately or go to the emergency department of the nearest hospital. Do not drive to the hospital: ask someone to drive you or call an ambulance. Take the medicine package with you, so your doctor knows what you have taken.

You can also call the Toxicology Information Service, phone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Ramipril/Hydrochlorothiazide SUN

• If you forget to take a dose, take your normal dose when it is time for your next dose.
• Do not take a double dose to make up for forgotten tablets.

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.

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

• Swelling of the face, lips, or throat, which can make swallowing or breathing difficult, as well as itching and rash, which can be a sign of a significant allergic reaction to Ramipril/Hydrochlorothiazide SUN.
• Severe skin reactions, such as rash, mouth ulcers, worsening of a pre-existing skin disease, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Inform your doctor immediately if you experience:

• Faster heart rate, irregular or strong heartbeats (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, bleeding for longer than normal, any sign of bleeding (e.g., from the gums), purple spots on the skin, or skin spots or petechiae.

infections more easily than normal, sore throat, and fever, feeling tired, dizzy, or

pale 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 (vomiting), yellowing of the skin or eyes (jaundice), which could be symptoms of liver problems, such as hepatitis (inflammation of the liver) or liver damage.
• Severe eye pain, blurred vision, or seeing halos around lights, headache, excessive tearing, or nausea and vomiting, which can be a disease called glaucoma.

Other adverse effects may be:

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

Frequent(may affect up to 1 in 10 people)

• Headache or feeling of weakness or fatigue.
• Feeling dizzy, which is more likely to occur when starting to take Ramipril/Hydrochlorothiazide SUN or when starting to take a higher dose.
• Dry, irritating cough or bronchitis.
• Blood tests showing higher than normal sugar levels. If you have diabetes, this may worsen.
• Blood tests showing higher than normal uric acid or fat levels.
• Pain, redness, or swelling of the joints.

Uncommon(may affect up to 1 in 100 people)

• Skin rash, with or without raised areas.
• Redness, dizziness, hypotension (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 prickling of the skin (paresthesias).
• Loss or changes in taste.
• Sleep problems.
• Depression, anxiety, or more nervousness or restlessness than usual.
• Stuffy nose, inflammation of the facial sinuses (sinusitis), difficulty breathing.
• Gingivitis (gum inflammation), mouth inflammation.
• Redness, itching, or swelling of the eyes or excessive tearing.
• Ringing in the ears.
• Blurred vision.
• Hair loss.
• Chest pain.
• Muscle pain.
• Constipation, stomach pain, or abdominal pain.
• Stomach upset after meals or nausea.
• Urinating more often than usual during the day.
• Sweating more than usual or feeling thirsty.
• Loss or decreased appetite (anorexia), having less hunger.
• Faster or irregular heartbeats.
• Swelling of arms and legs, which can be a sign that your body is retaining more fluid than normal.
• Fever.
• Impotence in men.
• Blood tests showing a decrease in the number of red blood cells, white blood cells, or platelets, or the amount of hemoglobin.
• 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 heartburn.
• Inflamed, red tongue or dry mouth.
• Blood tests showing higher than normal potassium levels.
• Acute difficulty breathing (signs include severe difficulty breathing, fever, weakness, and confusion).

Frequency not known(cannot be estimated from available data)

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

• Rapid onset of decreased distant 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 effusion) or acute angle-closure glaucoma)

Other observed adverse effects:

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

• Difficulty concentrating, feeling restless or confused.
• Fingers and toes changing color with cold and then tingling or pain when warming up (Raynaud's phenomenon).
• Male breast growth.
• Blood clots.
• Hearing problems.
• Less tear formation than normal.
• Seeing objects with a yellow color.
• Dehydration.
• Swelling, pain, and redness in one cheek (inflammation of a salivary gland).
• Intestinal inflammation called "intestinal angioedema", with symptoms such as abdominal pain, vomiting, and diarrhea.
• Increased sensitivity to sunlight.
• Severe skin peeling or flaking, rash with itching and lumps, or other skin reactions, such as a red rash on the face or forehead.
• Rash or bruising on the skin.
• Spots on the skin and cold extremities.
• Nail problems (nail detachment or separation from the nail bed).
• Musculoskeletal stiffness or inability to move the jaw (tetany).
• Muscle weakness or cramps.
• Decreased sexual appetite in men or women.
• Blood in the urine, which could be a sign of kidney problems (interstitial nephritis).
• Higher than normal sugar levels in the urine.
• Blood tests showing an increase in the number of a certain type of white blood cell (eosinophilia).
• Blood tests showing very few blood cells (pancytopenia).
• Blood tests showing changes in the amount of salts, such as sodium, calcium, magnesium, and chloride, in the blood.

• Concentrated urine (dark color), feeling or being sick, having muscle cramps, confusion, and seizures, which can be due to inadequate ADH (antidiuretic hormone) secretion. If you have these symptoms, consult your doctor as soon as possible.
• Slowness or difficulty reacting.

• Change in the smell of things.
• Breathing problems or worsening asthma.

Reporting adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects that do not appear in this leaflet. 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 Ramipril/Hydrochlorothiazide SUN

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

Do not use this medicine after the expiration date shown 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.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ramipril/Hydrochlorothiazide SUN

The active ingredients are ramipril and hydrochlorothiazide.

• Each tablet contains 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide.
• The other ingredients are hypromellose, microcrystalline cellulose, pregelatinized cornstarch, and sodium stearyl fumarate.

Appearance of the product and package contents

Ramipril/Hydrochlorothiazide 2.5 mg/12.5 mg tablets: White or almost white, oblong tablets, engraved with the letter "R" and the number "21" on either side of the score line on one face and also with a score line on the other face. The score line should not be used to break the tablet.

Ramipril/Hydrochlorothiazide SUN is available in packages of 14, 20, 28, 50, and 100 tablets in cold-forming blisters with desiccant (OPA/Al/PE/HDPE) or triple-layer blister packaging (PVC/PE/PVdC/Al).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH- Hoofddorp

Netherlands

Manufacturer

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

Date of the last revision of the leaflet: November 2021

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