Ramipril/hydrochlorothiazide Normon 5 mg/25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ramipril/Hydrochlorothiazide Normon 5 mg/25 mg tablets EFG

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 or pharmacist.
• This medicine has been prescribed for you 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 effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Ramipril/Hydrochlorothiazide Normon 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:

• By reducing the body's production of substances that can increase blood pressure.
• By relaxing and widening blood vessels.
• By making it easier for the heart to pump blood throughout 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, thereby reducing blood pressure.

Ramipril/Hydrochlorothiazide Normon is used to treat high blood pressure. The two active ingredients it contains work together to lower blood pressure. They are used in combination when treatment with only one of them does not provide adequate control of your blood pressure.

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

Do not take Ramipril/Hydrochlorothiazide Normon

• If you are allergic to the active substances ramipril and/or hydrochlorothiazide or to any of the other components of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to medicines similar to Ramipril/Hydrochlorothiazide Normon (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,” which may cause symptoms such as itching, hives (urticaria), red patches on the hands, feet, and throat, swelling of the throat and tongue, swelling of eyelids and lips, or 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, since the risk of angioedema (rapid swelling under the skin, for example in the throat) is high.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Ramipril/Hydrochlorothiazide Normon 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 causing 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 kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

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

Warnings and precautions

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

• If you have had skin cancer or if you 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 radiation while taking Ramipril/Hydrochlorothiazide Normon.

• If you have heart, liver, or kidney problems.

• If you have lost significant amounts of body salts or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, prolonged use of diuretics, or after dialysis).

• If you are undergoing treatment to reduce your allergy to bee or wasp stings (hyposensitization).

• If you are to receive anesthetic, for example, during surgery or a dental procedure. You may need to stop taking Ramipril/Hydrochlorothiazide Normon one day prior; 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 reduce sodium levels in your blood. Your doctor may perform periodic blood tests, particularly to monitor blood sodium levels, especially if you are elderly.

• If you are taking any of the following medicines, the risk of developing angioedema (rapid swelling beneath the skin, such as in the throat) may increase: sirolimus, everolimus, and other medicines belonging to the mTOR inhibitor group (used to prevent organ transplant rejection); vildagliptin (a medicine used to treat diabetes); neprilysin inhibitors (NEP inhibitors) (such as racecadotril, a medicine used to treat diarrhea) or sacubitril/valsartan. For sacubitril/valsartan, see also “Do not take Ramipril/Hydrochlorothiazide Normon”.

• If you have a collagen vascular 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 Normon 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 below on “Pregnancy and Breastfeeding”).

• If you experience a decrease in vision 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 one week after taking Ramipril/Hydrochlorothiazide Normon. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing this condition.

• If you have previously experienced respiratory 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 Normon, 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 – for example, 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 Normon."

Children and adolescents

Ramipril/Hydrochlorothiazide Normon is not recommended for use in children and adolescents under 18 years of age. This is because 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/Hydrochlorothiazide Normon.

Taking Ramipril/Hydrochlorothiazide Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This is because Ramipril/Hydrochlorothiazide Normon may affect how some other medicines work. Also, some medicines may affect how Ramipril/Hydrochlorothiazide Normon works.

Inform your doctor if you are taking any of the following medicines. These may cause Ramipril/Hydrochlorothiazide Normon to work less effectively:

• 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. These may increase the likelihood of side effects when taken together with Ramipril/Hydrochlorothiazide Normon:

• Sacubitril/valsartan – used to treat a type of long-term (chronic) heart failure in adults (see also “Do not take Ramipril/Hydrochlorothiazide Normon”).
• 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 medicines for constipation, diuretics, amphotericin B (for fungal infections), and ACTH (to assess whether your adrenal glands are functioning properly).
• Medicines for heart problems, including heart rhythm disorders.
• Diuretics such as furosemide.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole for bacterial infections; cyclosporine, 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 lower uric acid levels in the blood).
• Procainamide (to treat heart rhythm problems).
• Cholestyramine (to reduce blood fat levels).
• Carbamazepine (for epilepsy).
• Temsirolimus (for cancer).
• Medicines more commonly used 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 (ARB) or aliskiren (see also the information under the headings “Do not take Ramipril/Hydrochlorothiazide Normon” and “Warnings and precautions”).

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

• Medicines for diabetes, such as oral glucose-lowering medicines and insulin.
• Ramipril/Hydrochlorothiazide Normon may reduce blood sugar levels. Monitor your blood sugar carefully while taking Ramipril/Hydrochlorothiazide Normon.
• Lithium (for treating mental health conditions). Ramipril/Hydrochlorothiazide Normon may increase lithium levels in the blood. Your doctor will closely monitor your blood lithium levels.
• Medicines used to relax muscles.
• Quinine (for malaria).
• Medicines containing iodine (such as those sometimes used in hospitals for scans or certain X-rays).
• Penicillin (for infections).
• Oral medicines used to thin the blood (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/Hydrochlorothiazide Normon.

Tests

Check with your doctor or pharmacist before taking your medication:

• If you are going to have a parathyroid function test, Ramipril/Hydrochlorothiazide Normon may affect the results.
• If you participate in athletic events subject to doping controls, be aware that Ramipril/Hydrochlorothiazide Normon could lead to a positive test result.

Taking Ramipril/Hydrochlorothiazide Normon with food and alcohol:

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

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must not take Ramipril/Hydrochlorothiazide Normon during the first 12 weeks of pregnancy, and under no circumstances after week 13, as its use during pregnancy may possibly harm the baby.

If you become pregnant while taking Ramipril/Hydrochlorothiazide Normon, inform your doctor immediately. An appropriate alternative treatment should be initiated if you are planning to become pregnant.

Breastfeeding

You must not take Ramipril/Hydrochlorothiazide Normon if you are breastfeeding. Consult your doctor or pharmacist before using any medicine.

Driving and use of machines:

You may feel dizzy while taking Ramipril/Hydrochlorothiazide Normon, which is more likely to occur when starting treatment with Ramipril/Hydrochlorothiazide Normon or when starting a higher dose. If you feel dizzy, do not drive or operate tools or machinery.

Ramipril/Hydrochlorothiazide Normon contains sodium

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

3. How to take Ramipril/Hydrochlorothiazide Normon

Follow exactly the instructions for use 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 may be divided into equal doses.

How much medication 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 initial dose and adjust your treatment more slowly.

If you take more Ramipril/Hydrochlorothiazide Normon 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 package with you so your doctor will know 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 Normon

• 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 or pharmacist.

4. Possible adverse effects

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

Stop taking Ramipril/Hydrochlorothiazide Normon and consult your doctor immediately if you experience any of the following serious adverse effects, as you may require urgent medical treatment:

• Swelling of the face, lips, or throat, which may make swallowing or breathing difficult, as well as itching and rash, which could be signs of a severe allergic reaction to Ramipril/Hydrochlorothiazide Normon.
• Severe skin reactions, such as rash, mouth ulcers, worsening of a pre-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:

• 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 2 to 3 days, and loss of appetite. These could be symptoms of lung problems, including inflammation.
• Easy bruising, bleeding longer than normal, any sign of bleeding (e.g., from gums), purple spots on the skin, skin rashes, or becoming infected more easily than usual, sore throat and fever, feeling tired, dizziness, or pale skin, which could be signs of blood or bone marrow problems.
• Severe stomach pain, which may extend to the back, possibly indicating 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.
• Severe eye pain, blurred vision, or seeing halos around lights, headache, excessive tearing, or nausea and vomiting, which may indicate a condition called glaucoma.

Other possible adverse effects may include:

Inform your doctor if any of the following adverse effects worsens or lasts for more than a few days.

Frequent (may affect up to 1 in 10 people)

• Headache or feeling weak or tired.
• Dizziness, which is more likely to occur when starting Ramipril/Hydrochlorothiazide Normon or when starting a higher dose.
• Irritative dry 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.
• Pain, redness, or swelling in the joints.

Uncommon (may affect up to 1 in 100 people)

• Skin rash, with or without raised areas.
• Redness, 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, pricking, burning, or a "pins and needles" sensation (paresthesias).
• Loss of taste or changes in taste.
• Sleep disturbances.
• Depression, anxiety, increased nervousness or restlessness.
• Stuffy nose, facial sinus inflammation (sinusitis), difficulty breathing.
• Inflammation of the gums (gingivitis), inflammation of the mouth.
• Redness, itching, or swelling of the eyes or excessive tearing.
• 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), feeling less hungry.
• Faster or irregular heartbeat.
• Swelling of arms and legs, which may be a sign that your body is retaining more fluid than normal.
• Fever.
• Sexual impotence in men.
• Blood tests showing a reduced number of red blood cells, white blood cells, or platelets, or reduced 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 (may affect up to 1 in 10,000 people)

• Vomiting, diarrhea, or stomach burning.
• Swollen and red tongue or dry mouth.
• Blood tests showing higher than normal potassium levels.
• Acute breathing difficulty (symptoms include severe shortness of breath, 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 elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)

Other observed adverse effects:

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

• Difficulty concentrating, feeling restless or confused.
• Fingers of hands and feet changing color in response to cold, followed by tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement in males.
• Formation of blood clots.
• Hearing problems.
• Reduced tear production compared to normal.
• Vision of objects as yellowish in 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 compared to normal.
• Significant peeling or shedding of the skin, itchy skin rash with bumps, or other skin reactions such as reddish rash on the face or forehead.
• Skin rash or bruising.
• 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 the urine.
• Increased number of certain types of white blood cells (eosinophilia) in a blood test.
• Blood test showing very low levels of blood cells (pancytopenia).
• Blood test showing changes in levels of blood salts, such as sodium, calcium, magnesium, and chloride.
• Concentrated urine (dark color), feeling unwell or nauseous, muscle cramps, confusion, and seizures, which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, consult your doctor as soon as possible.
• Slowness or difficulty reacting.
• Change in the perception of smell.
• Breathing difficulties or worsening of asthma.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Ramipril/Hydrochlorothiazide Normon

Keep this medicine out of 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.

Store below 25°C.

Keep in the original packaging to protect 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. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ramipril/Hydrochlorothiazide Normon

• The active substances 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 hydroxypropyl cellulose, colloidal anhydrous silica, sodium hydrogen carbonate and magnesium stearate.

Appearance of the product and contents of the pack

Ramipril/Hydrochlorothiazide Normon 5 mg/25 mg: White, elliptical, biconvex tablets, engraved with the letters “R H” and a break line on one side and blank on the other.

The tablet diameter is 10.2 x 5.1 mm ± 10%.

The tablet can be divided into two equal doses.

Ramipril/Hydrochlorothiazide Normon is available in packs of 28 tablets made of Aluminium/Polyamide-Aluminium-PVC.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the most recent review of the leaflet: July 2025

March 2025

Other sources of information

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