Ramipril/hydrochlorothiazide Tecnigen 2.5/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ramipril/Hydrochlorothiazide TecniGen 2.5 mg/12.5 mg tablets EFG

Ramipril / Hydrochlorothiazide

Read the entire 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, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

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

• By reducing the body's production of substances that may 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) removed from the body, thereby reducing blood pressure.

Ramipril/Hydrochlorothiazide TecniGen 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 either one alone does not provide adequate control of your blood pressure.

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

Do not take Ramipril/Hydrochlorothiazide TecniGen

• 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 to medicines similar to Ramipril/Hydrochlorothiazide TecniGen (other ACE inhibitors or other sulfonamide derivatives).

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 include: itching, skin rashes (urticaria), red patches on the hands, feet, and throat, swelling of the 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/Hydrochlorothiazide TecniGen may not be suitable for you.
• If you have severe liver problems.
• If you have abnormal levels of certain salts (calcium, potassium, sodium) in your blood.
• If you have kidney problems due to reduced blood flow to your kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see the section on "Pregnancy and breastfeeding" below).
• If you are breastfeeding (see the section on "Pregnancy and breastfeeding" below).
• If you have diabetes or impaired kidney function and are being treated with blood pressure-lowering medicines containing aliskiren.

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

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

Warnings and precautions

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

• If you have had skin cancer or 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 TecniGen.

• 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 diuretic use, or 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 TecniGen one day beforehand; 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 condition that may lead to low sodium levels in the blood. Your doctor may need to perform regular blood tests to monitor your blood sodium levels, especially if you are elderly.

• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus.

• Inform your doctor if you are pregnant (or suspect you might be). The use of 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 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) (also known as "sartans"—e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

• Aliskiren

• If you experience vision loss or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking ramipril/hydrochlorothiazide. If untreated, this may lead to permanent vision loss. Your risk may be higher if you have had an allergy to penicillin or sulfonamides.

• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Ramipril/Hydrochlorothiazide TecniGen, seek medical attention immediately.

Your doctor may check your kidney function, blood pressure, and levels 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.”

Paediatric 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 unsure), 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 need to take any other medicines. Ramipril/Hydrochlorothiazide TecniGen may affect how some other medicines work. Likewise, some medicines may affect how Ramipril/Hydrochlorothiazide TecniGen works.

Inform your doctor if you have taken or are taking any of the following medicines, which could make Ramipril/Hydrochlorothiazide TecniGen less effective:

• Medicines to relieve pain and inflammation (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 monitor your blood pressure.

Inform your doctor if you are taking any of the following medicines, which could increase the likelihood of side effects when taken with Ramipril/Hydrochlorothiazide TecniGen:

• Medicines to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin).
• Medicines that may reduce potassium levels in the blood, such as laxatives, diuretics, amphotericin B (for fungal infections), and ACTH (to test adrenal gland function).
• Medicines for cancer (chemotherapy).
• Medicines for heart problems, including heart rhythm disorders.
• Medicines to prevent organ rejection after transplant, such as cyclosporine.
• Diuretics such as furosemide.
• Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (to thin the blood).
• Steroid medicines for inflammation, such as prednisolone.
• Allopurinol (to reduce uric acid in the blood).
• Procainamide (to treat heart rhythm disorders).
• Cholestyramine (to reduce blood fats).
• Carbamazepine (for epilepsy).
• Aliskiren (to lower blood pressure).

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

• Medicines for diabetes, such as oral glucose-lowering agents and insulin. Ramipril/Hydrochlorothiazide TecniGen may reduce blood sugar levels. Monitor your blood sugar carefully while taking Ramipril/Hydrochlorothiazide TecniGen.
• Lithium (for mental health conditions). Ramipril/Hydrochlorothiazide TecniGen may increase lithium levels in the blood. 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 coumarin derivatives.

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

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

If you are taking an angiotensin II receptor blocker (ARB) 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 to undergo a parathyroid function test, Ramipril/Hydrochlorothiazide TecniGen may affect the results.
• If you participate in athletic events subject to doping controls, be aware that Ramipril/Hydrochlorothiazide TecniGen could result in a positive test.

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

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

Pregnancy and breastfeeding

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 not take Ramipril/Hydrochlorothiazide TecniGen during the first 12 weeks of pregnancy, and you must not take it at any time after week 13, as its use during pregnancy may harm your baby.

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

You must not use Ramipril/Hydrochlorothiazide TecniGen while breastfeeding.

Driving and using machines:

You may feel dizzy while taking Ramipril/Hydrochlorothiazide TecniGen, especially when you first start taking it or when you start a higher dose. If you feel dizzy, do not drive or operate tools or machinery.

Ramipril/Hydrochlorothiazide TecniGen contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Ramipril/Hydrochlorothiazide TecniGen contains sodium.

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

3. How to take Ramipril/Hydrochlorothiazide TecniGen

Follow exactly the instructions given by your doctor for taking Ramipril/Hydrochlorothiazide TecniGen. If in doubt, consult your doctor or pharmacist again.

How to take 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.

How much medicine to take

Treatment of high blood pressure

Your doctor will adjust your dose until your blood pressure is controlled.

Elderly patients

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

If you take more Ramipril/Hydrochlorothiazide TecniGen 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 knows 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 TecniGen

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

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

Stop taking Ramipril/Hydrochlorothiazide TecniGen and contact 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 skin rash, which could be signs of a serious allergic reaction to Ramipril/Hydrochlorothiazide TecniGen.
• 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 two to three days, and loss of appetite, which could be symptoms of lung problems, including inflammation.
• Easy bruising, bleeding that lasts longer than normal, any sign of bleeding (e.g., from gums), purple spots on the skin, or increased susceptibility to infections, sore throat and fever, feeling tired, dizzy, or pale skin, which could be signs of blood or bone marrow problems.
• 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 like vomiting), yellowing of the skin or eyes (jaundice), which could be symptoms of liver problems, such as hepatitis (liver inflammation) or liver damage.

Other adverse effects may include:

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

Common (affects less than 1 in 10 patients)

• Headache or feeling weak or tired
• Dizziness, which is more likely when starting Ramipril/Hydrochlorothiazide TecniGen or when starting a higher dose
• Dry, irritating cough or bronchitis
• Blood tests showing higher than normal blood sugar levels. If you have diabetes, it may worsen.
• Blood tests showing higher than normal levels of uric acid or fats.
• Joint pain, redness, or swelling

Uncommon (affects less than 1 in 100 patients)

• 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, prickling, burning sensation, or "pins and needles" (paresthesias)
• Loss or changes in taste
• Trouble sleeping
• Depression, anxiety, increased nervousness or restlessness
• Stuffy nose, facial sinus inflammation (sinusitis), difficulty breathing
• Gum inflammation (gingivitis), mouth inflammation
• Redness, itching, swelling, or watering of the eyes
• Ringing in the ears
• Blurred vision
• Hair loss
• Chest pain
• Muscle pain
• Constipation, stomach or abdominal pain
• Stomach discomfort 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), reduced hunger
• Faster or irregular heartbeats
• Swelling of arms and legs, which may indicate your body is retaining more fluid than normal
• Fever
• Sexual impotence in men
• Blood tests showing decreased numbers of red blood cells, white blood cells, or platelets, or decreased hemoglobin levels
• Blood tests showing changes in how your liver, pancreas, or kidneys are functioning
• Blood tests showing lower than normal potassium levels

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

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

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

• Skin and lip cancer (non-melanoma skin cancer)
• 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 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 of hands and feet changing color in cold conditions, followed by tingling or pain when warming up, which could be Raynaud's phenomenon
• Breast enlargement in men
• Blood clots formation
• Hearing problems
• Reduced tear production
• Objects appearing yellow in vision
• Dehydration
• Swelling, pain, and redness in one cheek (inflammation of a salivary gland)
• Intestinal inflammation called "intestinal angioedema," with symptoms such as abdominal pain, vomiting, and diarrhea
• Increased sensitivity to sunlight
• Severe skin peeling or flaking, itchy rash with bumps, 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 (detachment or separation of a nail from its 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 amount of sugar in urine
• Increased number of a certain type of white blood cells (eosinophilia) in a blood test
• Blood tests showing very low numbers of blood cells (pancytopenia)
• Blood tests showing changes in levels of electrolytes such as sodium, calcium, magnesium, and chloride
• Slowness or difficulty reacting
• Burning sensation
• Change in the smell of things
• Trouble breathing 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 TecniGen

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

Do not use this medicine after the expiry date stated on the packaging after "EXP.". The expiry date refers to 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Package contents and other information

Composition of Ramipril/Hydrochlorothiazide TecniGen

The active substances are ramipril and hydrochlorothiazide.

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

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

Appearance of the medicinal product and contents of the pack

Ramipril/Hydrochlorothiazide 2.5/12.5 mg tablets: White, modified capsule-shaped tablets. With a square imprint on both sides, with "2.5" and "12.5" on each side of the square on one of the tablet faces.

The tablets are presented in blister packs containing 7, 10, 14, 20, 28, 50, 98, 100, 300 or 2x14 tablets. Not all pack sizes 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 medicinal product is authorized in Portugal under the name Ramipril/Hydrochlorothiazide Romazide 2.5/12.5 mg

Date of the most recent review of this leaflet: March 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es