Prospecto: information for the user

Ramipril/Hidroclorotiazida TecniGen 2.5 mg/12.5 mg tablets EFG

Ramipril / Hidroclorotiazida

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only 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 adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1.What is Ramipril/Hidroclorotiazida TecniGen and for what it is used

2.What you need to know before starting to take Ramipril/Hidroclorotiazida TecniGen

3.How to take Ramipril/Hidroclorotiazida TecniGen

4.Adverse effects

1. Storage of Ramipril/Hidroclorotiazida TecniGen
2. Contents of the package and additional information

Ramipril/Hidroclorotiazida TecniGen is a combination of two medications called ramipril and hidroclorotiazida.

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

• Reducing the amount of 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 medications called "thiazide diuretics" (diuretics are also known as "urine tablets"). It works by increasing the amount of water (urine) that is eliminated, which reduces blood pressure.

Ramipril/Hidroclorotiazida TecniGen 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 TecniGen

• If you are allergic to the active ingredients ramipril and/or hidroclorotiazida or any of the other components of this medication (included in section 6).
• If you are allergic to similar medications to Ramipril/Hidroclorotiazida TecniGen (other ACE inhibitors or other sulfamides 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, skin eruptions (urticaria), red spots on hands, feet, and throat, swelling of throat and tongue, swelling of eyelids and lips, difficulty breathing and swallowing.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Ramipril/Hidroclorotiazida TecniGen 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 renal function is altered and are being treated with medications to lower blood pressure that contain aliskireno.

Do not take Ramipril/Hidroclorotiazida TecniGen if any of the above conditions apply to you.

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

Warnings and precautions

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

• 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 TecniGen.
• 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 diuretic use, or dialysis).
• If you are to undergo treatment to reduce your allergy to bee or wasp stings (hyposensitization).
• If you are to receive an anesthetic, for example, for surgery or dental procedure. You may need to stop taking Ramipril/Hidroclorotiazida TecniGen a day before; consult your doctor.
• If you have high levels of potassium in your blood (shown in blood test results).
• Si está tomando medicamentos o está en una situación que puede dar lugar a disminuir los niveles de sodio en la sangre. Su médico puede tener que realizarle análisis de sangre de forma regular para comprobar los niveles de sodio en sangre, especialmente si es una persona de edad avanzada.
• If you have a vascular collagen disease, such as scleroderma or systemic lupus erythematosus.

• Informe a su médico si está embarazada (o si sospecha que pudiera estarlo). No se recomienda el uso de Ramipril/Hidroclorotiazida TecniGen en los primeros 3 meses del embarazo ya que puede causar daños graves a su bebé después del tercer mes de embarazo (ver sección de abajo sobre “Embarazo y Lactancia”).
• Si está tomando alguno de los medicamentos siguientes utilizados para tratar la tensión arterial alta:

• Un bloqueante de los receptores de angiotensina II (ARA II) (también conocidos como “sartanes”- por ejemplo valsartán, telmisartan, irbesartan), en particular si tiene problemas de riñón relacionados con su diabetes.
• Aliskireno

• Si experimenta una disminución de la visión o dolor ocular, podrían ser síntomas de acumulación de líquido en la capa vascular del ojo (derrame coroideo) o un aumento de la presión en el ojo y se pueden producir entre horas y semanas después de tomar ramipril/hidroclorotiazida.Si no se trata, esto puede llevar a la pérdida permanente de la visión. Usted podría tener más riesgo de desarrollarlo si ha sufrido alergia a la penicilina o a las sulfonamidas.
• Si ha tenido problemas respiratorios o pulmonares (como inflamación o líquido en los pulmones) tras la toma de hidroclorotiazida en el pasado. Si presenta disnea o dificultad para respirar grave después de tomar Ramipril/Hidroclorotiazida TecniGen, acuda al médico inmediatamente.

Your doctor may check your renal function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also the information under the heading “Taking Ramipril/Hidroclorotiazida TecniGen with other medicines”

Pediatric population:

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

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

Taking Ramipril/Hidroclorotiazida TecniGen with other medicines:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Ramipril/Hidroclorotiazida TecniGen may affect how some other medicines work. Similarly, some medicines may affect how Ramipril/Hidroclorotiazida TecniGen works.

Inform your doctor if you have taken or are taking any of the following medicines, which may make Ramipril/Hidroclorotiazida TecniGen work less effectively:

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

• Medicines 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 medicines, which may increase the risk of side effects if taken with Ramipril/Hidroclorotiazida TecniGen:

• Medicines to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina and Aspirin).
• Medicines that can reduce the amount of potassium in the blood, such as laxatives, diuretics, anfotericina B (for fungal infections) and ACTH (to see if your adrenal glands are working properly)
• Medicines to treat cancer (chemotherapy)
• Medicines to treat heart problems, including heart rhythm problems
• Medicines to prevent organ rejection after a transplant, such as ciclosporina.
• Diuretics such as furosemida.
• Medicines that can increase the amount of potassium in the blood, such as espironolactona, triamtereno, amilorida, potassium salts, and heparina (to make the blood more fluid)
• Medicines to treat inflammation, such as prednisolona.
• Alopurinol (to reduce uric acid in the blood)
• Procainamida (to treat heart rhythm problems)
• Colestiramina (to reduce the amount of cholesterol in the blood)
• Carbamazepina (for epilepsy).
• Aliskireno (to lower blood pressure

Inform your doctor if you are taking any of the following medicines, which may be affected by Ramipril/Hidroclorotiazida TecniGen:

• Medicines to treat diabetes, such as oral medications to lower blood sugar and insulin. Ramipril/Hidroclorotiazida TecniGen may reduce the amount of sugar in the blood. Monitor your blood sugar levels carefully while taking Ramipril/Hidroclorotiazida TecniGen.
• Litio (to treat mental health problems). Ramipril/Hidroclorotiazida TecniGen may increase the amount of litio in the blood. Your doctor will closely monitor your litio blood levels.
• Medicines to relax muscles.
• Quinina (for malaria).
• Medicines that contain iodine (such as those used in hospitals for scans or certain radiographs)
• Penicilina (for infections)
• Medicines to make the blood more fluid that are taken orally (oral anticoagulants), such as derivatives of the cumarina.

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

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

If you are taking an angiotensin II receptor blocker (ARA II) or aliskireno (see information in the section “Do not take Ramipril/Hidroclorotiazida TecniGen” and “Warnings and precautions”)

Tests

Check with your doctor or pharmacist before taking your medicine:

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

Taking Ramipril/Hidroclorotiazida TecniGen with food, drinks, and alcohol:

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

Pregnancy and lactation

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

Do not take Ramipril/Hidroclorotiazida TecniGen in the first 12 weeks of pregnancy, and do not take it in any case after week 13, as its use during pregnancy may be potentially harmful to the baby.

If you become pregnant while taking Ramipril/Hidroclorotiazida TecniGen, inform your doctor immediately. A change to an alternative suitable treatment should be made if you plan to become pregnant.

Do not use Ramipril/Hidroclorotiazida TecniGen if you are breastfeeding.

Driving and operating machinery:

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

Ramipril/Hidroclorotiazida TecniGen contains lactose.

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

Ramipril/Hidroclorotiazida TecniGen contains sodium

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

Follow exactly the administration instructions for Ramipril/Hidroclorotiazida TecniGen as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Medication Taking

• 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.

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.

If You Take More Ramipril/Hidroclorotiazida TecniGen 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 TecniGen

• 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, pharmacist, or nurse.

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

Stop taking Ramipril/Hidroclorotiazida TecniGen 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 andhives on the skin, which can be a sign of a severe allergic reaction to Ramipril/Hidroclorotiazida TecniGen.
• Important skin reactions, such as rashes, mouth sores, worsening of a pre-existing skin condition, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or multiform erythema).

Inform your doctor immediately if you experience:

• Fast or irregular heartbeat, palpitations, chest pain, chest tightness, or more serious problems such as heart attack and stroke.
• Difficulty breathing, cough, and fever lasting two to three days, and loss of appetite, which could be symptomsof lung problems, including inflammation.
• Appearance of bruises easily, bleeding for longer than normal, any sign of bleeding (for example, from the gums), purple spots on the skin, or 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 (feeling like 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.

Other side effects may be:

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

Frequent(affect less than 1 in 10 patients)

• Headache or feeling weak or tired
• Sensation of dizziness, which is more likely to occur when starting to take Ramipril/Hidroclorotiazida TecniGen 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.
• Pain, redness, or inflammation of the joints

Rare(affect less than 1 in 100 patients)

• Skin rash, with or without raised areas
• Redness, sensation of dizziness, hypotension (too-low blood pressure), especially when getting 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 tearing
• Tinnitus (ringing in the ears)
• Blurred vision
• Hair loss
• Chest pain
• Muscle pain
• Constipation, stomach pain, or abdominal pain
• Discomfort in the stomach after meals or feeling like vomiting
• 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 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 less-than-normal potassium levels

Very rare (affect less than 1 in 10,000 patients)

• Vomiting, 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 unknown(the frequency cannot be estimated with the known data)

• Cancer of the skin and lips (non-melanoma skin cancer).
• 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 anxious or confused
• Fingers of hands and feet that change color with cold and, afterwards, with tingling or pain when warming up, which could be a phenomenon of Raynaud
• Male breast growth in men
• Formation of blood clots
• Auditory problems
• Less tear formation than normal
• Yellow vision of objects
• 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 peeling or flaking of the skin, skin rash with itching and swelling, or other skin reactions, such as red face or forehead rash
• Rash or cardinals on the skin
• Spots on the skin and cold extremities
• Nail problems (detachment or separation of a nail from its bed)
• Musculoskeletal stiffness or inability to move the jaw (tetany)
• Weakness or muscle 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
• Slowness or difficulty reacting
• Burning sensation
• Change in the smell of things
• Difficulty breathing or worsening of asthma

Communication 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medicationafter the expiration date that appears on the packaging after “CAD.”. The expiration date is the last day of the month indicated.

Do not store above25°C. Store in the original packaging to protect the product from moisture.

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

Compositionof Ramipril/Hidroclorotiazida TecniGen

The active principles are ramipril and hidroclorotiazida.

One tablet contains2.5 mg of ramipril and 12.5 mg of hidroclorotiazida

The other components (excipients) are lactose monohydrate, hypromellose(E464), crospovidone (E1202), microcrystalline cellulose and sodium fumarate stearate.

Appearance of the product and contents of the packaging

Ramipril/Hidroclorotiazida tablets of2.5/12.5 mg: White tablets with a modified capsule shape. With a square inscription on both sides, with “2.5”and "12.5”on each side of the square on one side.

The tablets are presented in a blister pack of 7, 10, 14, 20, 28, 50, 98, 100, 300 or 2x14 tablets. Not all presentations may be marketed.

Holder ofthe Marketing Authorization and responsible for Manufacturing

Holder of the Marketing Authorization:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3rd floor. Edificio América. Arroyo de la Vega Industrial Estate,

28108 Alcobendas (Madrid) SPAIN

Responsible for manufacturing:

Atlantic Pharma Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra,

Portugal

This medicine is authorized in Portugal under the name ofRamipril/Hidroclorotiazida Romazide 2.5/12.5 mg

Date of the last review of this leaflet:March 2022

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