RAMIPRIL/HYDROCHLOROTHIAZIDE TECNIGEN 2.5/12.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ramipril/Hydrochlorothiazide TecniGen 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. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Ramipril/Hydrochlorothiazide TecniGen and what is it used for
2. What you need to know before you take Ramipril/Hydrochlorothiazide TecniGen
3. How to take Ramipril/Hydrochlorothiazide TecniGen
4. Possible side effects
   1. Storage of Ramipril/Hydrochlorothiazide TecniGen
   2. Pack contents and further information

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

Ramipril/Hydrochlorothiazide TecniGen 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 way:

• 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 (diuretics are also known as 'water tablets'). It works by increasing the amount of water (urine) that is removed, which reduces blood pressure.

Ramipril/Hydrochlorothiazide TecniGen is used to treat high blood pressure. The two active substances 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 TecniGen

Do not take Ramipril/Hydrochlorothiazide TecniGen

• If you are allergic to the active substances ramipril and/or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines similar to Ramipril/Hydrochlorothiazide TecniGen (other ACE inhibitors or other sulphonamide 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, skin rash (hives), red spots on hands, feet, and throat, swelling of the throat and tongue, swelling of the 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/Hydrochlorothiazide TecniGen 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 lower 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 your kidney function is impaired and you are being treated with medicines to lower blood pressure that contain aliskiren.

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ramipril/Hydrochlorothiazide TecniGen:

• 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 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, a low-salt diet, long-term use of diuretics, or 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 TecniGen 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 are in a situation that may lead to low sodium levels in your blood. Your doctor may need to perform regular blood tests to check your sodium levels, especially if you are an elderly person.
• If you have a disease of the collagen vascular system, such as scleroderma or systemic lupus erythematosus.

• Tell your doctor if you are pregnant (or think you might be). Ramipril/Hydrochlorothiazide TecniGen is not recommended during the first 3 months of pregnancy, as it may cause serious harm to your baby after the third month of pregnancy (see the section below on “Pregnancy and Breastfeeding”).
• If you are taking any of the following medicines used to treat high blood pressure:

• An angiotensin II receptor blocker (ARB II) (also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to your diabetes.
• Aliskiren

• If you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, and can occur between hours and weeks after taking ramipril/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be more likely to develop it if you have had an allergy to penicillin or sulphonamides.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Ramipril/Hydrochlorothiazide TecniGen, go to the doctor immediately.

Your doctor may check your kidney 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/Hydrochlorothiazide TecniGen with other medicines”

Pediatric population:

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

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

Taking Ramipril/Hydrochlorothiazide TecniGen with other medicines:

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

Tell your doctor if you have taken or are taking any of the following medicines, which may make Ramipril/Hydrochlorothiazide TecniGen 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, which may increase the risk of side effects if taken with Ramipril/Hydrochlorothiazide TecniGen:

• Pain and inflammation relievers (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin).
• Medicines that can lower potassium levels in the blood, such as laxatives, diuretics, amphotericin B (for fungal infections), and ACTH (to check if your adrenal glands are working properly)
• Cancer treatments (chemotherapy)
• Heart medicines, including heart rhythm problems
• Medicines to prevent organ rejection after a transplant, such as cyclosporine.
• Diuretics like furosemide.
• Medicines that can increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (to make the blood more fluid)
• Steroid medicines for inflammation, such as prednisolone.
• Allopurinol (to reduce uric acid in the blood)
• Procainamide (for heart rhythm problems)
• Colestyramine (to reduce blood fat levels)
• Carbamazepine (for epilepsy).
• Aliskiren (to lower blood pressure)

Tell your doctor if you are taking any of the following medicines, as they may be affected by Ramipril/Hydrochlorothiazide TecniGen:

• Diabetes medicines, such as oral medicines to lower blood sugar and insulin. Ramipril/Hydrochlorothiazide TecniGen may lower your blood sugar levels. Monitor your blood sugar levels carefully while taking Ramipril/Hydrochlorothiazide TecniGen.
• Lithium (for mental health problems). Ramipril/Hydrochlorothiazide TecniGen may increase lithium levels in your blood. Your doctor will closely monitor your lithium 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 coumarin derivatives.

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

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

If you are taking an angiotensin II receptor blocker (ARB II) or aliskiren (see information in the sections “Do not take Ramipril/Hydrochlorothiazide TecniGen” and “Warnings and precautions”)

Tests

Check with your doctor or pharmacist before taking your medicine:

• If you are going to have a parathyroid function test, Ramipril/Hydrochlorothiazide TecniGen may affect the results
• If you participate in doping-controlled athletic competitions, be aware that Ramipril/Hydrochlorothiazide TecniGen may give a positive result

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

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

You should not use Ramipril/Hydrochlorothiazide TecniGen if you are breastfeeding.

Driving and using machines:

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

Ramipril/Hydrochlorothiazide TecniGen contains lactose.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Ramipril/Hydrochlorothiazide TecniGen contains sodium

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

3. How to take Ramipril/Hydrochlorothiazide TecniGen

Take Ramipril/Hydrochlorothiazide TecniGen exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Taking this medicine

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

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 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 drive you or call an ambulance. Take the medicine pack 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 TecniGen

• 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 product, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking Ramipril/Hydrochlorothiazide TecniGen and consult your doctor immediately if you notice any of the following serious adverse effects. 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 on the skin, which can be a sign of a significant allergic reaction to Ramipril/Hydrochlorothiazide TecniGen.
• Serious skin reactions, such as rash, mouth sores, worsening of a pre-existing skin disease, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Tell 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 two to three days, and loss of appetite, which 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 getting 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.

Other adverse effects may be:

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

Frequent(affecting less than 1 in 10 patients)

• Headache or feeling of weakness or fatigue
• Feeling of dizziness, which is more likely to occur when starting to take Ramipril/Hydrochlorothiazide TecniGen or when starting to take 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 swelling of the joints

Uncommon(affecting less than 1 in 100 patients)

• Skin rash, with or without elevated areas
• Redness, feeling of dizziness, low blood pressure (especially when standing up or getting up quickly)
• Balance problems (vertigo)
• Itching and abnormal sensations on the skin, such as numbness, tingling, pinching, burning, or smarting of the skin (paresthesias)
• Loss or change in taste
• Sleep problems
• Depression, anxiety, more nervousness or restlessness than usual
• Stuffy nose, inflammation of the facial sinuses (sinusitis), difficulty breathing
• Gum inflammation (gingivitis), mouth inflammation
• Redness, itching, or swelling of the eyes or 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 (vomiting)
• Urinating more than usual during the day
• Sweating more than usual or feeling thirsty
• Loss or decrease in 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 fluids than normal
• Fever
• Sexual impotence in men
• Blood test showing a decrease in the number of red blood cells, white blood cells, or platelets, or the amount of hemoglobin
• Blood test showing changes in how your liver, pancreas, or kidney is functioning
• Blood test showing lower than normal potassium levels

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

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

Frequency not known(frequency cannot be estimated from the available data)

• Skin and lip cancer (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 effusion) or acute angle-closure glaucoma].

Other observed adverse effects:

Tell 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, which could be a Raynaud's phenomenon
• Breast growth in males
• Blood clot formation
• Hearing problems
• Less tear formation than normal
• Seeing objects in yellow color
• 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 flaking, skin rash with itching and lumps, or other skin reactions, such as 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)
• Weakness or muscle 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 test showing an increase in the number of a certain type of white blood cell (eosinophilia)
• 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
• Breathing problems or worsening of asthma

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed 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 TecniGen

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

Do not use this medicine after the expiration date stated on the packaging after "EXP.". The expiration date is the last day of the month indicated.

Do not store above 25°C. Keep in the original packaging to protect the product from moisture.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ramipril/Hydrochlorothiazide TecniGen

The active ingredients are ramipril and hydrochlorothiazide.

One tablet contains 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide

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

Appearance of the Product and Package Contents

Ramipril/Hydrochlorothiazide 2.5/12.5 mg tablets: White, modified capsule-shaped tablets. 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.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN

Manufacturer:

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 Ramipril/Hydrochlorothiazide Romazide 2.5/12.5 mg

Date of the last revision of this leaflet:March 2022

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