Package Leaflet: Information for the User

Ramipril/Hydrochlorothiazide STADA 2.5mg/12.5 mg Film-coated Tablets

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 their symptoms are the same. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before taking Ramipril/Hydrochlorothiazide Stada

3. How to take Ramipril/Hydrochlorothiazide Stada

4. Possible side effects

5. Storage of Ramipril/Hydrochlorothiazide Stada

6. Contents of the pack and additional information

Ramipril/Hidroclorotiazida Stada 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 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 Stada

• If you are allergic to the active principles ramipril and/or hidroclorotiazida or to any of the other components of this medication (including those listed in section 6)
• If you are allergic (hypersensitive) to similar medications to ramipril/hidroclorotiazida (other ACE inhibitors or other sulfonamide derivatives)
• The symptoms of an allergic reaction may include skin rash, difficulty 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 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 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 breastfeeding”)
• If you are breastfeeding (see below, the section on “Pregnancy and breastfeeding”)
• 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 Stada if any of the above conditions apply to you.If you are unsure, speak with your doctor before taking ramipril/hidroclorotiazida.

Warnings and precautions

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

• 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 cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking ramipril/hidroclorotiazida.
• 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, low-sodium diet, long-term use of diuretics, or dialysis)
• If you are undergoing treatment to reduce your allergy to bee or wasp stings (hyposensitization)
• If you are to receive an anesthetic, for example, for surgery or dental intervention.You may need to stop taking ramipril/hidroclorotiazida for a day; 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:
• • Medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus) and other medications belonging to the mTOR inhibitors group
  • Vildagliptina, a medication used to treat type 2 diabetes
  • Inhibitors of neprilisina (INEP) such as racecadotrilo, a medication used to treat diarrhea)
  • Sacubitrilo/valsartán. For sacubitrilo/valsartán, see also “Do not take Ramipril/Hidroclorotiazida Stada”.
• If you have a vascular disease of the collagen, such as scleroderma or systemic lupus erythematosus
• Inform your doctor if you are pregnant (or if you suspect that you may be). Ramipril/hidroclorotiazida 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 below, the section on “Pregnancy and breastfeeding”)
• If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and may occur within a few hours to a few weeks after taking ramipril/hidroclorotiazida. This may lead to permanent vision loss if not treated. You may be at higher risk of developing this if you are at risk of developing a condition called glaucoma or if you have previously had an allergy to penicillin or sulfonamides.
• Ifyou are taking any of the following medications used to treat high blood pressure:

• An antagonist of the angiotensin II receptor (ARA-II) (also known as sartanes, for example, valsartán, telmisartán, irbesartán), especially if you have kidney problems related to diabetes
• Aliskirén

• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience shortness of breath or severe difficulty breathing after taking ramipril/hidroclorotiazida, seek medical attention immediately.

Your doctor may need to monitor your renal function, blood pressure, and electrolyte levels in the blood (e.g., potassium) at regular intervals.

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

Children and adolescents

Ramipril/hidroclorotiazida is not recommended for use in children and adolescents under 18 years of age, as 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.

Other medications and Ramipril/Hidroclorotiazida Stada

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 may affect the way some other medications work. Also, some medications may affect the way ramipril/hidroclorotiazida works.

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

• Medications for pain relief and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina and Aspirina)
• Medications for treating 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 side effects if taken with ramipril/hidroclorotiazida:

• Sacubitrilo/valsartán – used to treat a type of chronic heart failure in adults (see also “Do not take Ramipril/Hidroclorotiazida Stada”).
• Medications for pain relief and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina and Aspirina)
• Medications that may reduce potassium levels 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 cancer treatment (chemotherapy)
• Medications for heart problems, including arrhythmias
• 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 blood clots)
• Medications for inflammation, such as prednisolona
• Calcium supplements
• Alopurinol (to reduce uric acid in the blood)
• Procainamida (to treat arrhythmias)
• Colestiramina (to reduce cholesterol levels in the blood)
• Carbamazepina (for epilepsy)
• Medications used more frequently to prevent organ transplant rejection and for cancer (sirolimús, everolimús, temsirolimus, and other mTOR inhibitors). See section “Warnings and precautions”.
• Vildagliptina (used to treat type 2 diabetes)
• Racecadotrilo (a medication used to treat diarrhea)

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

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

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

• Medications for diabetes, such as oral medications to lower blood sugar and insulin. Ramipril/hidroclorotiazida may reduce blood sugar levels.Monitor your blood sugar levels carefully while taking ramipril/hidroclorotiazida
• Lithium (for mental health problems). Ramipril/hidroclorotiazida may increase lithium levels in the blood. Your doctor will closely monitor your lithium levels in the blood
• Medications for muscle relaxation
• Quinine (for malaria)
• Medications that contain iodine (such as those used occasionally in hospitals for scans or certain radiographs)
• Penicillin (for infections)
• Medications for making the blood more fluid that are taken orally (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.

Tests

Check with your doctor or pharmacist before taking your medication:

• If you are to undergo a parathyroid function test, ramipril/hidroclorotiazida may affect the results
• If you are participating in athletic competitions subject to doping control, be aware that ramipril/hidroclorotiazida may give a positive result

Taking Ramipril/Hidroclorotiazida Stada with food and alcohol

• Drinking alcohol with ramipril/hidroclorotiazida may make you feel dizzy or disoriented. If you are concerned about how much you can drink while taking ramipril/hidroclorotiazida, speak with your doctor, as medications used to lower blood pressure and alcohol may have additive effects.
• Ramipril/hidroclorotiazida can be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

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

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

If you become pregnant while taking ramipril/hidroclorotiazida, inform your doctor immediately. Alternative treatment should be carried out if you plan to become pregnant.

Lactation

You should not take ramipril/hidroclorotiazida if you are breastfeeding. Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Some side effects (e.g., symptoms of decreased blood pressure such as dizziness) may affect your ability to concentrate and react. This poses a risk in situations where these abilities are particularly important (e.g., driving a vehicle or operating machinery).

You may feel dizzy while taking ramipril/hidroclorotiazida, which is more likely to occur when starting ramipril/hidroclorotiazida or when starting a higher dose. If you felt dizzy, do not drive or operate tools or machinery.

Ramipril/Hidroclorotiazida Stada contains sodium

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.

How much medication to take

Hypertension treatment

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

Senior patients

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

How to take this medication

• Take this medication orally at the same time every 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 fracture the tablet.

If you take more Ramipril/Hidroclorotiazida 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 forgot to take Ramipril/Hidroclorotiazida

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

If you have any other questions about the use of 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 Stada 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 severe allergic reaction to ramipril/hidroclorotiazide.
• Important skin reactions, such as rashes, mouth sores, worsening of an existing skin condition, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Inform your doctor immediately if you experience:

• Fast 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 2-3 day fever and loss of appetite. These could be symptoms of lung problemsincludinginflammation.
• Appearance of bruises easily, bleeding for longer than normal, any sign of bleeding (e.g., from the gums), purple spots on the skin,spotsontheskinor catching infections more easily than normal, sore throat, and fever, feeling tired, dizziness, 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 (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 can be a disease called glaucoma;
• 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 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/hidroclorotiazide or when starting a higher dose.
• Dry, irritating cough or bronchitis.
• Blood test showing higher-than-normal sugar levels. If you have diabetes, this could worsen.
• Blood test showing higher-than-normal levels of uric acid or fats.
• Joint pain, redness, or inflammation.

Rare(may affect up to 1 in100 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 changes in taste.
• Difficulty sleeping.
• Depression, anxiety, more nervousness or restlessness than normal.
• Stuffy nose, sinusitis, difficulty breathing.
• Gum inflammation (gingivitis), mouth inflammation.
• 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 heartbeats.
• Swelling of arms and legs, which can be a sign that your body is retaining more fluids than normal.
• Fever.
• Impotence in men.
• Blood test showing a decrease in the number of red blood cells, white blood cells, or platelets, or hemoglobin levels.
• Blood test showing changes in how your liver, pancreas, or kidneys are functioning.
• Blood test showing lower-than-normal potassium levels.

Very rare(may affect up to 1 in10,000 people)

• Nausea, diarrhea, or stomach burning.
• Inflamed tongue and red or dry mouth.
• Blood test 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 and lip cancer (non-melanoma skin cancer).

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 anxious or confused.
• Fingers and toes that change color with cold and, afterwards, with tingling or pain when warming up, which could be a phenomenon of Raynaud.
• 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 hives on the skin.
• Spots on the skin and cold extremities.
• Problems with nails (e.g., 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.
• Concentrated urine (dark color), 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.
• Slowness or difficulty reacting.
• Change in the smell of things.
• Difficulty breathing or worsening of asthma.

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 of 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 usethismedicationafter the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not store above 25ºC.

Store in the original packaging to protect the product from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Compositionof Ramipril/Hidroclorotiazida Stada

• 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: hypromellose, microcrystalline cellulose, pregelatinized cornstarch and sodium stearate fumarate.

Appearance of the product and contents of the packaging

Ramipril/Hidroclorotiazida Stada 2.5 mg/12.5 mg: White or off-white, oblong-shaped 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 Stada is available in packaging 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 packaging sizes may be commercially available.

Marketing Authorization Holderand Responsible for Manufacturing

Marketing Authorization Holder

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for Manufacturing

Terapia SA

Str. Fabricii nr. 124, Cluj Napoca 400 632

Romania

or

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp,

Netherlands

Last review date of the leaflet: January 2022

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es