Prospecto: information for the user

Captopril/Hidroclorotiazida Normon 50 mg/25 mg tablets EFG

Captopril/Hidroclorotiazida

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in the prospect. See section 4.

1. What isCaptopril/Hidroclorotiazida Normonand for what it is used

2. What you need to know before starting to takeCaptopril/Hidroclorotiazida Normon

3. How to takeCaptopril/Hidroclorotiazida Normon

4. Possible adverse effects

5. Storage ofCaptopril/Hidroclorotiazida Normon

6. Contents of the package and additional information

Captopril/Hidroclorotiazida Normon is a medication that contains an association of two substances, captopril and hidroclorotiazida.

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

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

The two active substances of this medication act together to achieve a decrease in blood pressure, superior to that obtained with each of them separately.

This medication 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 hidroclorotiazida, separately.

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

Do not take Captopril/Hidroclorotiazida Normon

• if you are allergic (hypersensitive) to captopril, other ACE inhibitors, or any of the other components of this medication (including those listed in section 6).
• if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medication.
• if you have previously been treated with medications from the same group as this medication (ACE inhibitors) and have experienced allergic reactions that cause swelling of the arms, legs, ankles, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema) or if any member of your family has experienced 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 insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.
• if you are more than 3 months pregnant. It is also recommended to avoid this medication during the first months of pregnancy (see pregnancy section).

This medication should not be administered to children and adolescents (<18 years old).

Warnings and precautions

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

Be especially careful with this medication:

• if you experience intense or persistent vomiting or diarrhea.
• if you follow a low-sodium diet, use salt substitutes, or take potassium supplements.
• if you have liver or kidney problems (consult your doctor if you have any doubts).
• if you suffer from aortic stenosis or renal artery stenosis.
• if you have diabetes. This medication may alter the effects of insulin or any other antidiabetic medication.Please consult your doctor.
• if you are undergoing dialysis. Allergic reactions have been reported in patients treated with this medication using certain types of dialysis membranes (high-flow hemodialysis or low-density lipoprotein apheresis with dextran sulfate absorption). Consult your doctor before the next dialysis treatment.
• if you are undergoing allergy desensitization treatment for bee or wasp stings. Allergic reactions have been reported in patients treated with this medication in conjunction with desensitization treatments.Please 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 medications used to treat high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• Aliskiren
• if you are taking any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) increases:
• sirolimus, everolimus, and other mTOR inhibitors (used to prevent organ rejection after transplantation).
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The use of hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Captopril/Hidroclorotiazida.
• if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, and may occur within a few hours to a week after taking Captopril/Hidroclorotiazida Normon. This can lead to permanent vision loss if not treated. If you have previously experienced an allergy to penicillin or sulfonamide, you may be at higher risk.
• 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/Hidroclorotiazida, seek medical attention immediately.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Captopril/Hidroclorotiazida Normon”.

Inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking this medication before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of this one. This medication is not recommended for use during the first months of pregnancy, and in any case, it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point on.

Medications containing lithium should not be administered with this medication 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 rapid or irregular heart rate,
• jaundice (yellow eyes/skin),
• any sudden, inexplicable rash or burning, peeling, or red skin.

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

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

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

Use in athletes:

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

Taking Captopril/Hidroclorotiazida Normon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription. This includes medications for colds, coughs, allergies, or sinusitis, as they may increase your blood pressure.

It is essential to inform your doctor if you are taking any of the following medications:

• some analgesics also known as anti-inflammatory medications (for example, indomethacin and ibuprofen),
• lithium (for the treatment of mental disorders),
• carbenoxolone (for the treatment of gastrointestinal ulcers),
• corticosteroids, corticotropin (ACTH),
• some laxatives,
• intravenous antifungals (amphotericin),
• muscle relaxants (administered during surgery),
• colestiramine, colestipol (to lower blood cholesterol),
• allopurinol (for the treatment of gout),
• procainamide, digoxin, and other cardiac glycosides (for the treatment of arrhythmias),
• cytostatics or immunosuppressants (for example, azathioprine and cyclophosphamide),
• calcium salts,
• medications used more frequently to prevent organ rejection after transplantation (sirolimus, everolimus, and other mTOR inhibitors).See the section “Warnings and precautions”.
• potassium supplements or salt substitutes that contain potassium, diuretics (particularly those called potassium-sparing diuretics) and other medications that may increase potassium levels in your body (for example, heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole),
• medications that lower blood pressure by dilating blood vessels (for example, minoxidil),
• carbamazepine (for the treatment of epilepsy),
• medications used in diabetes (insulin and other oral antidiabetic medications such as sulfonylureas),
• medications used to treat psychotic disorders and some of the older antidepressants,
• any medication 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/Hidroclorotiazida Normon” and “Warnings and precautions”)

Taking Captopril/Hidroclorotiazida Normon with food and drinks

Captopril/Hidroclorotiazida Normoncan be taken with or without food.

Inform your doctor if you are taking potassium supplements or consuming a diet rich in potassium.

Pregnancy, lactation, and fertility

Pregnancy

You should inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking this medication before becoming pregnant or as soon as you know you are pregnant and recommend that you take another medication instead of this one. This medication is not recommended for use during the first months of pregnancy, and in any case, it should not be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that point on.

Lactation

Inform your doctor if you are breastfeeding or plan to start. This medication is not recommended for use during lactation.

Driving and operating machinery

You should exercise caution when driving or operating machinery if you experience side effects such as dizziness, lightheadedness, or fatigue. These occur especially at the beginning of treatment, when changing the dose, or when consuming alcohol.

Warnings about excipients:

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

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

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

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

Your doctor has prescribed this medication since the previous treatment for high blood pressure did not provide the adequate reduction in blood pressure. Your doctor will instruct you on how to switch from previous treatments to this medication.

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 exclusively for oral use.

The tablets should be swallowed with sufficient liquid (for example, a glass of water). This medication can be taken with or without food. You should try to take your daily dose approximately at the same time each day, preferably in the morning. It is essential that you continue taking this medication until your doctor advises you otherwise.

Use in special populations

If you have moderate renal impairment, diabetes, or if you have a decrease in the levels of salt or water in your body, your doctor may prescribe a lower dose of this medication, for example, half a tablet per day (corresponding to 25 mg of captopril and 12.5 mg of hydrochlorothiazide).

Seniors

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

If you estimate that the effect of this medication is too strong or too weak, inform 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: urinating more frequently, changes in the levels of some components of your blood, a significant drop in your blood pressure, loss of consciousness or awareness of your surroundings (including coma), attack, muscle weakness, irregular or slow heartbeat, or reduced renal function.

If another person 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 Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forgot to take Captopril/Hydrochlorothiazide Normon

If you forgot to take the medication, you should take the dose as soon as you remember on the same day. If you miss a dose, take your normal dose the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Captopril/Hydrochlorothiazide Normon

If you accidentally forget to take a dose, simply take your normal dose when it is due. Do not take a double dose to compensate for the missed doses.

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

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

Stop taking this medicine and seek medical help 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 (yellowing of the eyes/skin),
• any sudden or unexplained rash or burning sensation, peeling or redness of the skin.

You will find side effects classified by decreasing severity that were observed with captopril and/or other ACE inhibitors, as well as side effects observed with hydrochlorothiazide.

The following side 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 disturbances,
• alteration of taste, dizziness,
• dry, irritating cough, difficulty breathing,
• nausea, vomiting, stomach irritation, abdominal pain, diarrhea, constipation, dry mouth,
• dermatological problems such as itching, skin rash, and hair loss.

The following side 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:

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

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

• loss of appetite (anorexia),
• sensation of sleepiness, headache, and abnormal sensation in the skin such as burning or itching,
• mouth lesions, such as sores and blisters,
• gastrointestinal angioedema (allergic reaction that affects the intestine causing intense pain),
• renal function disorders, disorders in urine elimination.

The following side 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,
• reduction in the blood's ability to clot (thrombocytopenia) which can cause bleeding or bruises,
• confusion, depression,
• weakness, fainting,
• blurred vision,
• heart attack,
• respiratory disorders (including):
• difficulty breathing or wheezing
• stuffy nose or mucus, a type of pneumonia, caused by changes in the blood or some other condition that causes cough, fever, shortness of breath, or wheezing.

• inflammation of the tongue, stomach ulcer, pancreatitis (inflammation of the pancreas that causes abdominal 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 redness of the skin (urticaria),
• body-wide rash (Steven Johnson syndrome),
• allergic rash that causes the appearance of pink spots on the skin with a clearer center (erythema multiforme),
• sensitivity to light,
• redness of the skin (erythrodermia)
• series of reactions that can cause blisters filled with fluid, (penfigoid reactions)
• peeling of the skin (dermatitis exfoliativa),
• muscle and joint pain,
• renal problems,
• impotence, excessive breast volume in men,
• fever,
• changes in laboratory test results.

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

• inflammation of the salivary glands,
• 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,
• reduction in the blood's ability to clot which can cause bleeding or bruises,
• 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, disminución de la visión o dolor en los ojos debido a una presión elevada [signos posibles de acumulación de líquido en la capa vascular del ojo (derrame coroideo) o glaucoma agudo de ángulo cerrado],
• dizziness,
• low blood pressure, heart problems such as irregular heartbeat, circulation problems,
• circulatory problems such as inflammation of the veins including those in the skin and other organs (angiitis)
• respiratory and lung problems such as difficulty breathing,
• stomach irritation, diarrhea, constipation, pancreatitis,
• jaundice (yellowing of the skin and eyes),
• severe skin reactions such as:
• sensitivity to light,
• eruption,
• a rash around the nose and cheeks with red spots in the shape of a butterfly (lupus and lupus-like disorders),
• allergic reactions that cause itching and redness of the skin (urticaria),
• over-reaction of the body's natural defenses (hypersensitivity reactions),
• muscle spasms,
• renal problems,
• fever, weakness.
• skin cancer and lip cancer (non-melanoma skin cancer).
• acute respiratory distress (the signs include severe difficulty breathing, fever, weakness, and confusion) very rarely.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can alsoreport them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medication 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 store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Captopril/Hidroclorotiazida Normon 50/25 mg tablets composition

The active principles of this medication are captopril and hidroclorotiazida. Each tablet contains 50 mg of captopril and 25 mg of hidroclorotiazida.

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

Product appearance and packaging contents

Captopril/Hidroclorotiazida NORMON is presented as orange-colored, round, biconvex tablets with a breaking bar 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.

Marketing authorization holder and responsible manufacturer

Laboratorios Normon, S.A.

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

Last review date of this leaflet:August 2022

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es