Ramipril/hydrochlorothiazide Sun 5 mg/25 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ramipril/Hydrochlorothiazide SUN 5 mg/25 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Ramipril/Hydrochlorothiazide SUN is and what it is used for.
2. What you need to know before taking Ramipril/Hydrochlorothiazide SUN.
3. How to take Ramipril/Hydrochlorothiazide SUN.
4. Possible side effects.
5. How to store Ramipril/Hydrochlorothiazide SUN.
6. Contents of the pack and other 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 as follows:

• By decreasing the body's production of substances that can increase blood pressure.
• By relaxing and widening blood vessels.
• By making it easier for the heart to pump blood around the body.

Hydrochlorothiazide 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 removed from the body, thereby reducing blood pressure.

Ramipril/Hydrochlorothiazide SUN is used to treat high blood pressure. The two active substances it contains work together to lower blood pressure. They are used in combination when treatment with only one of them does not provide adequate control of your blood pressure.

2. What you need to know before taking 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).
• 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”, the symptoms of which may include: itching, hives (urticaria), red spots 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 sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin in areas 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 levels of salts (calcium, potassium, sodium) in your blood.
• If you have kidney problems causing reduced blood flow to your kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see section on "Pregnancy and breastfeeding" below).
• If you are breastfeeding (see section on "Pregnancy and breastfeeding" below).

If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren, do not take Ramipril/Hydrochlorothiazide SUN if any of the above conditions apply to you. If you are unsure, speak with your doctor before taking Ramipril/Hydrochlorothiazide SUN.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril/Hydrochlorothiazide SUN:

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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Ramipril/Hydrochlorothiazide SUN.

• If you have heart, liver or kidney problems.
• If you have lost significant body salts or fluids (due to vomiting, diarrhea, excessive sweating, low-salt diet, long-term use of diuretics, or after dialysis).
• If you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitization).
• If you are to receive an anesthetic, for example during surgery or a dental procedure. You may need to stop taking Ramipril/Hydrochlorothiazide SUN one day before; 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 may reduce sodium levels in your blood. Your doctor may perform periodic blood tests, especially to monitor blood sodium levels, particularly if you are elderly.
• If you are taking any of the following medicines, the risk of developing angioedema (rapid swelling beneath the skin in areas such as the throat) may increase: sirolimus, everolimus, and other medicines belonging to the mTOR inhibitor group (used to prevent organ transplant rejection); vildagliptin (a medicine used to treat diabetes); neprilysin inhibitors (NEP inhibitors) (such as 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.
• Inform your doctor if you are pregnant (or suspect you might be). Use of 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 below on “Pregnancy and breastfeeding”).

If you experience a decrease in vision or have eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which may occur within hours to a week after taking Ramipril/Hydrochlorothiazide SUN. 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.

• 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 – for example, 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 information under the heading “Do not take Ramipril/Hydrochlorothiazide SUN”.

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 studied in these age groups.

If you are unsure whether any of the above conditions apply to you, speak with 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 need to take any other medicines. This is because Ramipril/Hydrochlorothiazide SUN may affect how some other medicines work. Also, some medicines may affect how Ramipril/Hydrochlorothiazide SUN works.

Inform your doctor if you are taking any of the following medicines. These may cause Ramipril/Hydrochlorothiazide SUN to work less effectively:

• Medicines to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and Aspirin).
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor will need to monitor your blood pressure.

Inform your doctor if you are taking any of the following medicines. These may increase the likelihood of side effects when 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”).

• Medicines to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and Aspirine).

• Medicines that may reduce potassium levels in blood, such as laxatives, diuretics, amphotericin B (for fungal infections), and ACTH (to check if your adrenal glands are functioning properly).

• Medicines for heart problems, including heart rhythm disorders.

• Diuretics such as furosemide.

• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, 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 blood).

• Procainamide (to treat heart rhythm disorders).

• Cholestyramine (to reduce blood fat levels).

• Carbamazepine (for epilepsy).

• Temsirolimus (for cancer).

• Medicines more commonly used to prevent rejection of transplanted organs (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 (ARB) or aliskiren (see also information under the headings “Do not take Ramipril/Hydrochlorothiazide SUN” and “Warnings and precautions”).

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

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

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

Tests

Check with your doctor or pharmacist before taking your medicine:

• If you are scheduled for a parathyroid function test, Ramipril/Hydrochlorothiazide SUN may affect the results.
• If you participate in doping-controlled athletic events, be aware that Ramipril/Hydrochlorothiazide SUN may produce a positive test result.

Taking Ramipril/Hydrochlorothiazide SUN with food and alcohol:

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

If you are concerned about how much alcohol you can drink while taking Ramipril/Hydrochlorothiazide SUN, talk to your doctor, as blood pressure-lowering medicines and alcohol may 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You must inform your doctor if you think you are pregnant (or suspect you might be).

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

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

Breastfeeding

You should not use 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, especially when you first start treatment or when your dose is increased. If you feel dizzy, do not drive or operate tools or machinery.

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

3. How to take Ramipril/Hydrochlorothiazide SUN

Follow exactly the instructions for using this medicine as 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 tablet may be divided into equal doses.

How much medicine to take

Treatment of high blood pressure

Your doctor will adjust the dose you need to take until your blood pressure is controlled.

Elderly patients

Your doctor will reduce your starting dose and adjust your treatment more slowly.

If you take more Ramipril/Hydrochlorothiazide SUN than you should

Contact 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. Take the medicine packaging with you so your doctor will know what you have taken.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ramipril/Hydrochlorothiazide SUN

• If you forget to take a dose, take your next dose at the usual time.
• Do not take a double dose to make up for forgotten tablets.

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.

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

• Swelling of the face, lips, or throat, which may make swallowing or breathing difficult, along with itching and rash, which could be signs of a serious allergic reaction to Ramipril/Hydrochlorothiazide SUN.
• Serious skin reactions, such as rash, mouth sores, worsening of a pre-existing skin condition, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Contact your doctor immediately if you experience:

• Faster heartbeat, irregular or strong heartbeats (palpitations), chest pain, chest tightness, or more serious problems such as heart attack or stroke.
• Difficulty breathing, cough, and fever lasting 2 to 3 days, and loss of appetite, which could be symptoms of lung problems including inflammation.
• Easy bruising, bleeding longer than normal, any sign of bleeding (e.g., from gums), purple spots on the skin, skin rashes, or increased susceptibility to infections, sore throat and fever, feeling tired, dizzy, or pale skin, which could be signs of blood or bone marrow disorders.
• Severe stomach pain that may radiate to the back, which could be a symptom of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (feeling sick), yellowing of the skin or eyes (jaundice), which could be symptoms of liver problems such as hepatitis (liver inflammation) or liver damage.
• Severe eye pain, blurred vision, or seeing halos around lights, headache, excessive tearing, or nausea and vomiting, which may indicate a condition called glaucoma.

Other adverse effects may include:

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

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Skin rash, with or without raised areas.
• Flushing, dizziness, hypotension (blood pressure too low), especially when standing up or getting up quickly.
• Balance problems (vertigo).
• Itching and abnormal skin sensations such as numbness, tingling, pricking, burning, or "pins and needles" sensations (paresthesias).
• Loss or changes in taste.
• Difficulty sleeping.
• Depression, anxiety, increased nervousness or restlessness.
• Stuffy nose, facial sinus inflammation (sinusitis), difficulty breathing.
• Gum inflammation (gingivitis), 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 or abdominal pain.
• Stomach discomfort after meals or nausea.
• Urinating more than normal during the day.
• Sweating more than normal or feeling thirsty.
• Loss or decrease in appetite (anorexia), reduced hunger.
• Faster or irregular heartbeats.
• Swelling of arms and legs, which may indicate fluid retention.
• Fever.
• Sexual impotence in men.
• Blood tests showing reduced numbers of red blood cells, white blood cells, or platelets, or reduced hemoglobin levels.
• Blood tests showing changes in liver, pancreas, or kidney function.
• Blood tests showing lower than normal potassium levels.

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

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

Frequency not known (cannot be estimated from available data)

• Skin and lip cancer (non-melanoma skin cancer).
• Sudden onset of reduced distance vision (acute myopia), decreased vision, or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Other adverse effects observed:

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

• Difficulty concentrating, restlessness, or confusion.
• Fingers and toes changing color in the cold, followed by tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Blood clot formation.
• Hearing problems.
• Reduced tear production.
• Seeing objects as yellow.
• 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 shedding, itchy skin rash with lumps, or other skin reactions such as red rash on the face or forehead.
• Rash or bruising on the skin.
• Skin spots and cold extremities.
• Nail problems (e.g., nail separation or detachment 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 urine.
• Increased numbers of a certain type of white blood cells (eosinophilia) in a blood test.
• Blood tests showing very low levels of blood cells (pancytopenia).
• Blood tests showing changes in levels of salts such as sodium, calcium, magnesium, and chloride.
• Concentrated urine (dark color), feeling or being unwell, muscle cramps, confusion, and seizures, which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you have these symptoms, consult your doctor as soon as possible.
• Slowed or impaired reaction.
• Change in the smell of things.
• Breathing difficulties or worsening of asthma.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/.

By reporting adverse effects, you can help provide 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 expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C. Keep in the original container to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ramipril/Hydrochlorothiazide SUN

The active substances are ramipril and hydrochlorothiazide.

One tablet contains 5 mg of ramipril and 25 mg of hydrochlorothiazide.

The other components are hypromellose, microcrystalline cellulose, pregelatinized corn starch and sodium stearyl fumarate.

Appearance of the medicinal product and contents of the pack

Ramipril/Hydrochlorothiazide 5 mg/25 mg tablets: White or almost white, oblong tablets, marked with the letter “R” and the number “22” on either side of the score on one side, and also with a score on the other side.

The tablet can be divided into equal doses.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH - Hoofddorp

The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH - Hoofddorp

The 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 latest revision of the leaflet: November 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) www.aemps.gob.es/