RAMIPRIL/HYDROCHLOROTHIAZIDE NORMOGEN 5 mg/25 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

Contents of the pack

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

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

Ramipril/Hydrochlorothiazide Normogen 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 ways:

• 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 from the body, which reduces blood pressure.

Ramipril/Hydrochlorothiazide Normogen 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 your blood pressure.

2. What you need to know before you take Ramipril/Hydrochlorothiazide Normogen

1.

• If you are allergic to the active ingredients 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 Normogen (other ACE inhibitors or other sulfonamide derivatives).
• The symptoms of an allergic reaction can include skin 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, 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 sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under 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 Normogen may not be suitable for you.
• If you have significant liver problems.
• If you have abnormal amounts of salts (calcium, potassium, sodium) in your blood.
• If you have kidney problems where the blood that reaches your kidneys is less than normal (renal artery stenosis).
• During the last 6 months of pregnancy (see, later, the section on “Pregnancy and Breastfeeding”).
• If you are breastfeeding (see, later, the section on "Pregnancy and Breastfeeding").
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

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

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Ramipril/Hydrochlorothiazide Normogen:

• 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 and UV ray exposure while taking Ramipril/Hydrochlorothiazide Normogen.
• 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 after 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 your treatment with Ramipril/Hydrochlorothiazide Normogen one 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 have conditions that can lower the levels of sodium in your blood. Your doctor may perform periodic blood tests, especially to monitor sodium levels in your blood, especially if you are an elderly person.

• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase: sirolimus, everolimus, and other mTOR inhibitors (used to prevent organ transplant rejection); vildagliptin (a medicine used to treat diabetes); neprilysin inhibitors (e.g., racecadotril, a medicine used to treat diarrhea) or sacubitril/valsartan. For sacubitril/valsartan, see also “Do not take Ramipril/Hydrochlorothiazide Normogen”.
• If you have a vascular disease of the collagen, such as scleroderma or systemic lupus erythematosus
• Tell your doctor if you are pregnant (or think you might be). Ramipril/Hydrochlorothiazide Normogen 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 on “Pregnancy and Breastfeeding” below)
• If you experience a decrease in vision or have eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a few hours to a week after taking Ramipril/Hydrochlorothiazide Normogen. This can lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may have a higher risk of developing it.
• 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 Normogen, seek medical attention immediately
• 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 - e.g., 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 the information under the heading “Do not take Ramipril/Hydrochlorothiazide Normogen”

Children and Adolescents

Ramipril/Hydrochlorothiazide Normogen is not recommended for use in children and adolescents under 18 years of age. This is because the medicine has never been used in these age groups.

If you are not sure if any of the above conditions apply to you, talk to your doctor before taking Ramipril/Hydrochlorothiazide Normogen.

Taking Ramipril/Hydrochlorothiazide Normogen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ramipril/Hydrochlorothiazide Normogen can affect the way some other medicines work. Also, some medicines can affect the way Ramipril/Hydrochlorothiazide Normogen works.

Tell your doctor if you are taking any of the following medicines. These may make Ramipril/Hydrochlorothiazide Normogen 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 take your blood pressure.

Tell your doctor if you are taking any of the following medicines. These may increase the chance of side effects if taken with Ramipril/Hydrochlorothiazide Normogen:

• Sacubitril/valsartan - used to treat a type of long-term (chronic) heart failure in adults (see also “Do not take Ramipril/Hydrochlorothiazide Normogen”).
• Pain and inflammation relievers (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin).
• Medicines that can lower the amount of potassium in your blood, such as laxatives, diuretics, amphotericin B (for fungal infections), and ACTH (to check if your adrenal glands are working properly).
• Medicines for heart problems, including heart rhythm problems.
• Diuretics such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that can increase the amount of potassium in your blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, 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 the blood).
• Procainamide (to treat heart rhythm problems).
• Colestyramine (to reduce the amount of fat in the blood).
• Carbamazepine (for epilepsy).
• Temsirolimus (for cancer).
• Medicines used more frequently to prevent organ transplant rejection (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 (ARA II) or aliskiren (see also the information under the heading “Do not take Ramipril/Hydrochlorothiazide Normogen” and “Warnings and Precautions”).

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

• Medicines for diabetes, such as oral glucose-lowering medicines and insulin.
• Ramipril/Hydrochlorothiazide Normogen may lower your blood sugar levels. Monitor your blood sugar levels carefully while taking Ramipril/Hydrochlorothiazide Normogen.
• Lithium (for mental health problems). Ramipril/Hydrochlorothiazide Normogen may increase the amount of lithium in your blood. Your doctor will closely monitor your lithium blood levels.
• Muscle relaxants.
• Quinine (for malaria).
• Medicines that contain iodine (such as those used in hospitals for a scan or certain X-rays).
• Penicillin (for infections).
• Oral blood-thinning medicines (anticoagulants), such as warfarin derivatives.

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

Tests

Check with your doctor or pharmacist before taking your medicine:

• If you are going to have a test for parathyroid function, Ramipril/Hydrochlorothiazide Normogen may affect the results.
• If you participate in doping-controlled athletic competitions, be aware that Ramipril/Hydrochlorothiazide Normogen may give a positive result.
• Taking Ramipril/Hydrochlorothiazide Normogen with food and alcohol:

Drinking alcohol with Ramipril/Hydrochlorothiazide Normogen may make you feel dizzy or drowsy. If you are concerned about how much you can drink while taking Ramipril/Hydrochlorothiazide Normogen, talk to your doctor, as blood pressure-lowering medicines and alcohol can have additive effects.

• Ramipril/Hydrochlorothiazide Normogen 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 should not take Ramipril/Hydrochlorothiazide Normogen 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 possibly harm your baby.

If you become pregnant while taking Ramipril/Hydrochlorothiazide Normogen, inform your doctor immediately. Suitable alternative treatment should be carried out if you plan to become pregnant.

Breastfeeding

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

Ramipril/Hydrochlorothiazide Normogen contains sodium

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

3. How to take Ramipril/Hydrochlorothiazide Normogen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, 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 can be divided into equal doses.

How much medicine to take

Treatment of high blood pressure

Your doctor will adjust the amount you should 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 Normogen 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. Bring 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, indicating the medicine and the amount taken.

If you forget to take Ramipril/Hydrochlorothiazide Normogen

• If you forget to take a dose, take your normal dose when it is time for your next one.
• Do not take a double dose to make up for forgotten tablets.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Ramipril/Hydrochlorothiazide Normogen 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 swallowing or breathing difficult, as well as itching and rash, which can be a sign of a serious allergic reaction to Ramipril/Hydrochlorothiazide Normogen.
• Severe skin reactions, such as rash, sores in the mouth, worsening of a pre-existing skin condition, redness, blisters, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Report to 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 2 to 3 days and loss of appetite. These 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, skin spots or getting infections more easily than normal, sore throat and fever, feeling of tiredness, dizziness or paleness of the 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.
• Severe eye pain, blurred vision or seeing halos around lights, headache, excessive tearing or nausea and vomiting that can be a disease called glaucoma.

Other adverse effects may be:

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

Frequent(may affect up to 1 in 10 people)

• Headache or feeling of weakness or fatigue.
• Feeling of dizziness, which is more likely to occur when starting to take Ramipril/Hydrochlorothiazide Normogen 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 may worsen.
• Blood test showing higher than normal uric acid or fat levels.
• Pain, redness or swelling of the joints.

Uncommon(may affect up to 1 in 100 people)

• Skin rash, with or without raised areas.
• Redness, feeling of dizziness, low blood pressure (hypotension) 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 scorching 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.
• Gingivitis (gum inflammation), 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 pain or abdominal pain.
• Stomach upset after meals or nausea.
• 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.
• Impotence in men.
• Blood test showing decreased red blood cell count, white blood cell count or platelet count, or hemoglobin level.
• Blood test showing changes in how your liver, pancreas or kidney are functioning.
• Blood test showing lower than normal potassium levels.

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

• Vomiting, diarrhea or stomach burning.
• Inflamed and reddened tongue or dry mouth.
• Blood test showing higher than normal potassium levels.
• Acute difficulty breathing (signs 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).

• 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 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 of restlessness or confusion.
• Fingers and toes changing color with cold and then tingling or pain when warming up (Raynaud's phenomenon).
• Male breast growth.
• 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).
• Intestinal inflammation called "intestinal angioedema", with symptoms such as abdominal pain, vomiting and diarrhea.
• Increased sensitivity to sunlight.
• Important skin peeling or flaking, itchy rash with bumps or other skin reactions, such as reddened face or forehead rash.
• 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).
• 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 the 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, having muscle cramps, confusion and seizures that may be due to inadequate ADH (antidiuretic hormone) secretion. If you have these symptoms, consult your doctor as soon as possible.
• Slowness or difficulty reacting.
• 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 or pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. 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 Normogen

Keep this medicine out of sight and reach of children.

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

Store below 25°C.

Keep in the original packaging to protect it from moisture.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ramipril/Hydrochlorothiazide Normogen

• The active ingredients are ramipril and hydrochlorothiazide.
• • Each tablet contains 5 mg of ramipril and 25 mg of hydrochlorothiazide.
  • The other components are: microcrystalline cellulose, pregelatinized corn starch, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, sodium hydrogen carbonate and magnesium stearate.

Appearance of the product and package contents

Ramipril/Hydrochlorothiazide Normogen 5 mg/25 mg: White, elliptical, biconvex tablets, engraved with the letters "R H" with a break line on one side and anonymous on the other. The diameter of the tablet is 10.2 x 5.1 mm ± 10%.

The tablet can be divided into two equal doses.

Ramipril/Hydrochlorothiazide Normogen is available in packages of 28 tablets of Aluminum/ Polyamide-Aluminum-PVC.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of the prospectus: July 2025

March 2025

Other sources of information

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