CAPTOPRIL / HYDROCHLOROTHIAZIDE NORMON 50 mg/25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Captopril/Hydrochlorothiazide Normon 50 mg/25 mg Tablets EFG

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

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

Captopril/Hydrochlorothiazide Normon is a medicine that contains an association of two substances, captopril and hydrochlorothiazide.

Captopril is a substance that belongs to the group of so-called angiotensin-converting enzyme inhibitors (ACE inhibitors) that produce relaxation of blood vessels and reduce blood pressure.

Hydrochlorothiazide is a substance that belongs to the group of so-called thiazide diuretics, which act by increasing urine elimination and thereby reducing blood pressure.

The two active substances in this medicine work together to achieve a reduction in blood pressure, greater than that obtained with each of them separately.

This medicine is indicated for the treatment of high blood pressure (essential hypertension) when blood pressure has not been adequately controlled with each of the components, captopril and hydrochlorothiazide, separately.

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

Please read the following section carefully. It contains important information that you and your doctor should consider before taking Captopril/Hydrochlorothiazide Normon.

Do not take Captopril/Hydrochlorothiazide Normon

• if you are allergic (hypersensitive) to captopril, other ACE inhibitors, or any of the other components of this medicine (listed in section 6).
• if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicine.
• if you have already been treated with medicines from the same group of drugs as this medicine (ACE inhibitors) and have suffered allergic reactions that cause swelling of the arms, legs, ankles, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema) or if a family member has suffered a similar reaction.
• if you have severe liver or kidney problems (consult your doctor if you have any doubts).
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• if you are pregnant more than 3 months. It is also best to avoid this medicine during the first months of pregnancy (see pregnancy section).

This medicine must not be administered to children and adolescents (<18 years).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Captopril/Hydrochlorothiazide Normon.

Be especially careful with this medicine:

• if you have severe or persistent vomiting or diarrhea.
• if you follow a low-salt diet, use salt substitutes, or take potassium supplements.
• if you have liver or kidney disorders (consult your doctor if you have any doubts).
• if you suffer from aortic stenosis or renal artery stenosis.
• if you have diabetes. This medicine may alter the effects of insulin or any other oral antidiabetic medicine. Please consult your doctor.
• if you undergo dialysis. Allergic reactions have been reported in patients treated with this medicine with certain dialysis membranes (called high-flux hemodialysis membranes or low-density lipoprotein apheresis with dextran sulfate absorption). Consult your doctor before the next dialysis treatment.
• if you are undergoing desensitization procedures for bee or wasp stings. Allergic reactions have been reported in patients treated with this medicine along with desensitization treatments. Consult your doctor before starting your treatment.
• if you have lupus (an inflammatory disease that can affect various organs, including the skin) or lupus-like disorders.
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARA) (also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
• Aliskiren
• if you are using any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) increases:
• sirolimus, everolimus, and other mTOR inhibitor class medicines (used to prevent organ rejection after transplantation).
• if you have had skin cancer or if an unexpected skin lesion appears during treatment. Treatment with hydrochlorothiazide, particularly 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 exposure while taking Captopril/Hydrochlorothiazide Normon.
• 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 pressure in the eye, and can occur within a few hours to a week after taking Captopril/Hydrochlorothiazide Normon. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing it.
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Captopril/Hydrochlorothiazide Normon, seek medical attention immediately.

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 Captopril/Hydrochlorothiazide Normon”.

Tell your doctor if you are pregnant (or think you may be). It is not recommended to use this medicine at the start of pregnancy, and in no case should it be administered if you are pregnant more than 3 months, as it can cause serious harm to your baby when administered from that time on (see pregnancy section).

Lithium-containing medicines should not be administered with this medicine without close monitoring by your doctor.

If you develop any of the following reactions, consult your doctor immediately

• swelling of the arms, legs, ankles, face, lips, tongue, and/or throat with difficulty swallowing or breathing,
• any sign of infection (such as sore throat or fever) that does not respond quickly to usual treatment,
• dizziness or fainting,
• severe abdominal pain,
• unusually fast or irregular heartbeat,
• jaundice (yellow eyes/skin),
• any sudden or unexplained rash, peeling, or redness of the skin.

Please inform the following people if you are taking Captopril/Hydrochlorothiazide Normon

• hospital staff, especially the anesthesiologist (if you are going to undergo surgery) or if you are hospitalized.
• your dentist before undergoing a dental procedure that requires anesthesia.

If this is the first time you are taking this medicine, you may feel dizzy or lightheaded for a short period. In this case, it may help to stay seated or lie down. However, it is unlikely to occur when you take the tablets regularly. If this situation concerns you, consult your doctor.

Use in athletes:

This medicine contains hydrochlorothiazide, which may produce a positive result in doping tests.

Taking Captopril/Hydrochlorothiazide Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. This includes medicines for colds, coughs, allergies, or sinusitis, as they may increase your blood pressure.

It is very important that you inform your doctor if you are taking any of the following medicines:

• certain pain relievers also known as anti-inflammatory drugs (e.g., indomethacin and ibuprofen),
• lithium (for the treatment of mental disorders),
• carbenoxolone (for the treatment of gastrointestinal ulcers),
• corticosteroids, corticotropin (ACTH),
• certain laxatives,
• antifungal injections (amphotericin),
• muscle relaxants (administered during surgical procedures),
• cholestyramine, colestipol (to lower blood cholesterol),
• allopurinol (for the treatment of gout),
• procainamide, digoxin, and other cardiac glycosides (for the treatment of heart rhythm disorders),
• cytostatics or immunosuppressive agents (e.g., azathioprine and cyclophosphamide),
• calcium salts,
• medicines used more frequently to prevent organ rejection after transplantation (sirolimus, everolimus, and other mTOR inhibitor class medicines). See the section “Warnings and precautions”.
• potassium supplements or salt substitutes that contain potassium, diuretics (especially potassium-sparing diuretics), and other medicines that can increase potassium levels in your body (e.g., heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole),
• medicines that lower blood pressure by dilating blood vessels (e.g., minoxidil),
• carbamazepine (for the treatment of epilepsy),
• medicines used in diabetes (insulin and other oral antidiabetics like sulfonylureas),
• medicines used to treat psychotic disorders and some of the older antidepressants,
• any medicine used to treat high blood pressure.

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

If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Captopril/Hydrochlorothiazide Normon” and “Warnings and precautions”)

Taking Captopril/Hydrochlorothiazide Normon with food and drinks

Captopril/Hydrochlorothiazide Normon can be administered with or without food.

Tell your doctor if you take potassium supplements or follow a potassium-rich diet.

Pregnancy, breastfeeding, and fertility

Pregnancy

You should inform your doctor if you are pregnant (or think you may be). Your doctor will generally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of this one. It is not recommended to use this medicine at the start of pregnancy, and in no case should it be administered if you are pregnant more than 3 months, as it can cause serious harm to your baby when administered from that time on.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to start breastfeeding. It is not recommended to use this medicine during breastfeeding.

Driving and using machines

Caution is required when driving or using machines if you experience side effects such as dizziness, lightheadedness, or fatigue. These occur especially at the start of treatment, when the dose is changed, or when you have consumed alcohol.

Warnings about excipients:

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

This medicine may cause allergic reactions because it contains the yellow-orange S (E-110) colorant.

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

3. How to take Captopril/Hydrochlorothiazide Normon

Follow exactly the administration instructions of this medicine indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Your doctor has prescribed this medicine because previous treatments for high blood pressure did not provide adequate blood pressure reduction. Your doctor will indicate how to switch from previous treatments to this medicine.

Dosage

The usual dose is one tablet per day (corresponding to 50 mg of captopril and 25 mg of hydrochlorothiazide). Do not exceed the maximum daily dose of one tablet.

Method of administration

The tablets are for oral use only.

The tablets should be swallowed with sufficient liquid (e.g., a glass of water). This medicine can be administered with or without food. Try to take your daily dose at approximately the same time each day, preferably in the morning. It is important that you continue taking this medicine until your doctor advises you otherwise.

Use in special populations

If you have moderate kidney impairment, diabetes, or decreased salt or water levels in your body, your doctor may prescribe a lower dose of this medicine, e.g., half a tablet per day (corresponding to 25 mg of captopril and 12.5 mg of hydrochlorothiazide).

Elderly

Your doctor may prescribe a lower dose of this medicine, e.g., half a tablet per day (corresponding to 25 mg of captopril and 12.5 mg of hydrochlorothiazide).

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Captopril/Hydrochlorothiazide Normon than you should

If you take more tablets than you should, you may experience the following: frequent urination, changes in blood component levels, a significant drop in blood pressure, loss of consciousness or awareness of your surroundings (including coma), stroke, muscle weakness, irregular or slower heartbeat, or reduced kidney function.

If someone else has taken too many tablets and has fainted, lay them down and elevate their feet above their head.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Captopril/Hydrochlorothiazide Normon

If you forget to take the medicine, take the dose as soon as you remember on the same day. If you do not take your tablet one day, take your normal dose the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Captopril/Hydrochlorothiazide Normon

If you accidentally forget to take a dose, simply take your normal dose when it is due next. Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

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

Suspend treatment with this medicine and seek medical attention if you notice any of the following reactions:

• swelling of the arms, legs, ankles, face, lips, tongue, and/or throat with difficulty swallowing or breathing, sore throat, or fever,
• dizziness or fainting,
• severe abdominal pain,
• unusually fast or irregular heartbeat,
• jaundice (yellow eyes/skin),
• any sudden or unexplained rash or burning, peeling or reddened skin.

Next, you will find adverse effects classified by decreasing order of severity that were observed with captopril and/or other ACE inhibitors, in addition to the adverse effects observed with hydrochlorothiazide.

The following adverse effects were frequently observed (at least 1 in 100 patients and less than 1 in 10 patients) with captopril as well as with other ACE inhibitors:

• sleep disorders,
• taste alteration, dizziness,
• dry, irritating cough, breathing difficulties,
• nausea, vomiting, gastric irritation, abdominal pain, diarrhea, constipation, dry mouth,
• skin problems such as itching, rash, and hair loss.

The following adverse effects were infrequently observed (at least 1 in 1000 patients and less than 1 in 100 patients) with captopril as well as with other ACE inhibitors:

• heart problems such as unusually fast or irregular heartbeat, chest pain (angina), feeling heartbeats,
• low blood pressure, poor circulation in the fingers (Raynaud's syndrome), reddening or paleness of the skin,
• swelling of the hands, face, lips, and tongue,
• chest pain, fatigue, malaise.

The following adverse effects were rarely observed (at least 1 in 10,000 and less than 1 in 1000 patients) with captopril as well as with other ACE inhibitors:

• loss of appetite (anorexia),
• drowsiness, headache, and abnormal sensation in the skin such as burning or itching,
• mouth lesions, such as ulcers and blisters,
• gastrointestinal angioedema (allergic reaction that affects the intestine and causes severe pain),
• kidney function disorders, urinary elimination disorders.

The following adverse effects were very rarely observed (at least 1 in 10,000 patients, including isolated cases) with captopril as well as with other ACE inhibitors:

• side effects that affect the blood and its components, such as:
• anemia,
• infection, sore throat, or fever due to a lack of white blood cells, or bleeding,
• reduced ability of the blood to clot (thrombocytopenia) which can cause bleeding or bruising,
• confusion, depression,
• fainting, fainting spells,
• blurred vision,
• heart attack,
• respiratory disorders (including):
• difficulty breathing or wheezing
• stuffy or runny nose, a type of pneumonia caused by changes in the blood or some other condition that causes cough, fever, shortness of breath, or wheezing.

• tongue inflammation, stomach ulcer, pancreatitis (inflammation of the pancreas that causes stomach pain),
• liver alteration, including jaundice which causes yellowing of the skin and eyes, hepatitis,
• severe skin reactions such as:
• allergic reactions that cause itching and reddening of the skin (urticaria),
• whole-body rash (Stevens-Johnson syndrome),
• allergic rash that produces pink spots on the skin with a lighter center (erythema multiforme),
• sensitivity to light,
• skin reddening (erythroderma)
• a series of reactions that can cause fluid-filled blisters (pemphigoid reactions)
• skin peeling (exfoliative dermatitis),
• muscle and joint pain,
• kidney problems,
• impotence, excessive breast volume in men,
• fever,
• changes in laboratory test results.

The following adverse effects were observed with hydrochlorothiazide, the second active principle of this medicine:

• salivary gland inflammation,
• side effects that affect the blood and its components, which can cause:
• decreased functionality,
• fatigue,
• infection,
• sore throat or fever due to a lack of white blood cells,
• reduced ability of the blood to clot, which can cause bleeding or bruising,
• loss of appetite (anorexia), sugar in the urine, abnormal changes in blood components such as sugar, uric acid (gout), sodium, potassium, high levels of cholesterol and other lipids in the blood,
• agitation, depression, and sleep disturbances,
• tingling and dizziness,
• eye and vision problems such as "yellow vision" and blurred vision, 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],
• dizziness,
• low blood pressure, heart problems such as irregular pulse, circulation problems,
• circulatory problems such as vein inflammation, including those in the skin and other organs (angiitis)
• lung and respiratory problems such as breathing difficulties,
• gastric irritation, diarrhea, constipation, pancreatitis,
• jaundice (yellowing of the skin and eyes),
• severe skin reactions such as:
• sensitivity to light,
• rash,
• a rash around the nose and cheeks with pink spots in a butterfly shape (lupus and lupus-like disorders),
• allergic reactions that cause itching and reddening of the skin (urticaria),
• an overreaction of the body's natural defenses (hypersensitivity reactions),
• muscle spasms,
• kidney problems,
• fever, weakness.
• skin and lip cancer (non-melanoma skin cancer).
• acute breathing difficulties (symptoms include severe breathing difficulties, fever, weakness, and confusion) with very rare frequency.

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 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 Captopril/Hydrochlorothiazide Normon

Keep 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.

Do not store at a temperature above 30°C and keep in the original packaging to protect it from light.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Captopril/Hydrochlorothiazide Normon 50/25 mg tablets

The active ingredients of this medicine are captopril and hydrochlorothiazide. Each tablet contains 50 mg of captopril and 25 mg of hydrochlorothiazide.

The other components (excipients) are: microcrystalline cellulose, lactose monohydrate, sodium carboxymethyl starch (type A) (potato starch), orange yellow (E-110), and stearic acid

Appearance of the Product and Package Contents

Captopril/Hydrochlorothiazide NORMON is presented as orange, round, biconvex tablets with a break line and marked with "C" and "H" on one face.

The tablet can be divided into two equal halves.

Each package contains 30 tablets, in a PVC-Aluminum blister pack.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Prospectus:August 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