Acediur 20 mg/12.5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ACEDIUR 20 mg/12.5 mg tablets

enalapril maleate/hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

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

Leaflet contents

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

1. What Acediur is and what it is used for

ACEDIUR is a medicine that contains two active substances: enalapril maleate and hydrochlorothiazide.

The enalapril component of ACEDIUR is an active substance belonging to a group of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors). The hydrochlorothiazide component of ACEDIUR is an active substance belonging to a group of medicines called diuretics (which increase urine production). Together, enalapril and hydrochlorothiazide help reduce high blood pressure.

Your doctor has prescribed ACEDIUR to treat hypertension (high blood pressure).

2. What you need to know before taking Acediur

Do not take ACEDIUR

• If you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously been treated with a medicine from the same drug class as ACEDIUR (ACE inhibitors) and experienced allergic reactions such as swelling of the face, lips, tongue, and/or throat, with difficulty swallowing or breathing.
• If you are allergic to any sulfonamide-derived medicine (ask your doctor if you are unsure what sulfonamide-derived medicines are).
• If you are not urinating.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have severe kidney failure.
• If you have been diagnosed with hereditary or idiopathic angioedema (an immune system disorder causing swelling in the face and airways, and abdominal cramps).
• If you have severe liver failure.
• If you are more than 3 months pregnant. It is also advisable to avoid ACEDIUR during the first months of pregnancy (see section on pregnancy).

If you are unsure whether you should start taking this medicine, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ACEDIUR.

• If you have had liver or kidney problems, diabetes, if you are undergoing dialysis, or if you are receiving treatment with diuretics (water tablets). Inform your doctor if you are on a salt-free diet, take potassium supplements, potassium-sparing medicines, or salt substitutes containing potassium, or if you have recently experienced vomiting or diarrhea. In these cases, your doctor may need to adjust the dose of ACEDIUR.

• If you have a heart condition involving narrowing of heart valves, if you have blood disorders, or notice any signs of infection.

• If you are about to undergo LDL apheresis (a procedure to remove LDL particles—known as "bad cholesterol"—from the blood when levels are excessively high).

• If you notice signs of fluid or electrolyte imbalance, such as thirst, dry mouth, weakness, numbness, drowsiness, restlessness, muscle pain or cramps, muscle fatigue, low blood pressure, reduced urine output, rapid heartbeat, nausea and/or vomiting.

• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

  • an angiotensin II receptor antagonist (ARA-II) (also known as "sartans"—e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskiren

• If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially 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 sun exposure and UV radiation while taking ACEDIUR.

• If you are using any of the following medicines, the risk of angioedema (rapid swelling under the skin, such as in the throat) may increase:

  • Sirolimus, everolimus, and other medicines in the mTOR inhibitor class (used to prevent rejection of transplanted organs).

• If you experience vision changes or eye pain, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure. These may occur within hours to a week after taking ACEDIUR.

• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking ACEDIUR, 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 ACEDIUR”.

Before undergoing surgery or anesthesia (including at the dentist), inform the doctor or dentist that you are taking ACEDIUR, as a sudden drop in blood pressure may occur in association with anesthesia.

If you have any doubts about these matters, consult your doctor or pharmacist before taking this medicine.

Your skin becomes more sensitive to sunlight or ultraviolet (UV) radiation when taking ACEDIUR. Avoid exposure to intense sunlight or artificial UV radiation, such as tanning beds.

Inform your doctor if you are pregnant (or suspect you might be). ACEDIUR is not recommended during early pregnancy, and must not be used after 3 months of pregnancy, as it may harm your baby when taken from that point onward (see section: Pregnancy).

Use in children

The safety and efficacy of this medicine have not been established in children.

Use in elderly patients

In studies combining enalapril and hydrochlorothiazide (the active ingredients of ACEDIUR), the effects and tolerability of the drugs were similar in younger and older adult patients with high blood pressure.

Other medicines and ACEDIUR

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In general, ACEDIUR can be taken with other medicines. However, it is important to inform your doctor about any other medicines you are taking, as some may affect the action of others.

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 information under the headings “Do not take ACEDIUR” and “Warnings and precautions”).

To prescribe the correct dose of ACEDIUR, it is especially important that your doctor knows if you are taking other medicines that lower blood pressure, diuretics (water tablets), potassium-containing medicines (including dietary salt substitutes), or lithium (a medicine used to treat certain types of depression).

Inform your doctor if you are taking any of the following medicines:

• Medicines used for pain or inflammation such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors.

• Tricyclic antidepressants, antipsychotics.

• Sympathomimetic medicines (used in the treatment of certain heart and blood vessel disorders).

• Gold salts (used in the treatment of rheumatoid arthritis).

• Antidiabetic medicines (both insulin and oral antidiabetics).

• Ion-exchange resins (medicines used to reduce blood cholesterol) such as cholestyramine and colestipol.

• Antiarrhythmics (medicines used to control heart rhythm disorders) such as quinidine, procainamide, amiodarone, sotalol, and digitalis glycosides.

• Corticosteroids.

• Cytostatic medicines (used in cancer treatment).

This is especially important if you are also taking:

• Medicines more commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section: “Warnings and precautions”.

• Potassium supplements or potassium-containing salt substitutes, diuretics (water tablets, especially potassium-sparing types), or other medicines that may increase potassium levels in the body (such as heparin and cotrimoxazole, also known as trimethoprim/sulfamethoxazole).

If you have any doubts about the above, consult your doctor or pharmacist before taking this medicine.

Taking ACEDIUR with food, drinks, and alcohol

Alcohol may enhance the blood pressure-lowering effect (hypotensive effect) of this medicine. See section: ‘How to take Acediur’.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

Inform your doctor if you are pregnant (or suspect you might be). Your doctor will usually advise you to stop taking ACEDIUR before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. ACEDIUR is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when used from that point.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Use of ACEDIUR is not recommended during breastfeeding.

Driving and using machines

Most patients can drive safely, but remember that you should not perform tasks requiring special attention until you know how you react to the medicine (e.g., operating dangerous machinery).

Use in athletes:

Athletes are advised that this medicine contains a component that may lead to a positive analytical finding in doping control tests.

ACEDIUR contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Acediur

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

ACEDIUR tablets are taken orally. The tablets may be taken before or after meals, with a glass of water.

Your doctor will decide the appropriate dose depending on your condition and whether you are taking other medicines.

The usual dose is one tablet once daily.

Take ACEDIUR every day, exactly as directed by your doctor. It is very important to continue taking this medicine for the length of time recommended by your doctor. Do not take more tablets than the prescribed dose.

If you take more ACEDIUR than you should

The most likely symptoms would be dizziness or vertigo due to a sudden or excessive drop in blood pressure and/or excessive thirst, disorientation, decreased urine output, and/or tachycardia.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take ACEDIUR

You should take this medicine exactly as prescribed. Do not take a double dose to make up for missed doses. Take the next dose as usual.

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 may cause adverse effects, although not everyone experiences them.

ACEDIUR is generally well tolerated. The most common adverse reactions are dizziness and fatigue. Other less common reactions include: feeling dizzy or lightheaded when standing up quickly (due to a drop in blood pressure), muscle cramps, nausea, weakness, headache, cough, and impotence.

Stop taking ACEDIUR and contact your doctor immediately if any of the following occur:

• swelling of the face, lips, tongue, and/or throat, making it difficult to breathe or swallow.
• swelling of the hands, feet, or ankles.
• appearance of hives.

The adverse effects reported for enalapril-hydrochlorothiazide administered in combination are listed below, classified according to the following frequency categories:

Very common adverse effects (occur in at least 1 in 10 treated patients):

• blurred vision
• dizziness
• cough
• nausea
• erectile dysfunction
• fatigue

Common adverse effects (occur in at least 1 in 100 and less than 1 in 10 treated patients):

• angioedema (allergic reaction that may include swelling of the limbs, lips, tongue, and/or throat), hypersensitivity (allergic reaction)
• decreased potassium levels in blood, increased blood cholesterol, increased blood triglycerides, increased blood uric acid levels
• depression
• headache, fainting, altered taste
• arrhythmias, angina pectoris, chest pain, tachycardia
• decreased blood pressure, orthostatic hypotension (fainting due to drop in blood pressure)
• dyspnea (difficulty breathing)
• diarrhea, abdominal pain
• skin rash (exanthema)
• muscle cramps¥
• chest pain, fatigue
• increased creatinine in blood, increased blood triglycerides, increased serum cholesterol

Uncommon adverse effects (occur in at least 1 in 1,000 and less than 1 in 100 treated patients):

• anemia (including aplastic and hemolytic anemia)
• decreased blood glucose, decreased serum magnesium, gout*, decreased blood sodium, decreased appetite
• confusion, insomnia, nervousness, decreased libido*
• drowsiness, tingling sensation
• dizziness, ringing in the ears
• myocardial infarction, palpitations
• stroke, hot flush
• asthma, difficulty breathing, voice disorders, sore throat, increased nasal secretion
• pancreatitis, peptic ulcer, intestinal obstruction with severe pain, vomiting, digestive discomfort, constipation, epigastric discomfort, dry mouth, flatulence (gas)*
• alopecia (abnormal hair loss), itching, urticaria, excessive sweating
• joint pain
• kidney function abnormalities, renal failure, presence of protein in urine
• fever, malaise
• increased blood urea, low blood sodium levels

Rare adverse effects (occur in at least 1 in 10,000 and less than 1 in 1,000 treated patients):

• abnormalities in blood cell counts (abnormally low neutrophil count, decreased platelet count, decreased white blood cell count), bone marrow depression (reduced ability of the body to produce blood cells), lymph node inflammation
• autoimmune disorder
• increased blood glucose
• abnormal dreams, sleep disorders
• paresis (partial paralysis of movement)
• changes in skin coloration of hands, feet, nose, or ears (Raynaud's phenomenon)
• respiratory discomfort (including pneumonia and pulmonary edema), pulmonary infiltrates, nasal mucosa inflammation, allergic alveolitis (inflammation of the lung alveoli due to allergy), eosinophilic pneumonia (a condition in which a type of white blood cells called eosinophils accumulate in the lungs)
• inflammation and/or ulceration of the oral mucosa, inflammation of the tongue
• liver failure, hepatic necrosis (can be fatal), liver inflammation, suppression or cessation of bile secretion (including yellowing of the skin or eyes), gallbladder inflammation (particularly in patients with pre-existing gallstones in the biliary tract)
• skin peeling, severe blistering or bleeding of the skin (Stevens-Johnson syndrome), blister formation on the skin, skin peeling, severe redness/skin rash with skin and hair loss, appearance of red spots on the skin, skin redness
• decreased urine output, inflammation of kidney cells
• breast enlargement in men
• increased liver enzymes, increased blood bilirubin, decreased blood hemoglobin, decreased blood cells, increased blood glucose

Very rare adverse effects (occur in fewer than 1 in 10,000 treated patients):

• increased blood calcium
• intestinal inflammation
• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion)

Adverse effects with unknown frequency (cannot be estimated from available data):

• skin and lip cancer (non-melanoma skin cancer)
• confusion, nausea, and irritability due to syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma]

A symptomatic complex has been reported that may include fever, serositis, vasculitis, muscle inflammation/pain, joint inflammation/pain, positive antinuclear antibody test, increased erythrocyte sedimentation rate, eosinophilia, and leukocytosis. Skin rash, photosensitivity, or other skin manifestations may also occur.

*Observed only with hydrochlorothiazide doses of 12.5 mg and 25 mg

¥The frequency of frequent muscle cramps corresponds to hydrochlorothiazide doses of 12.5 mg and 25 mg, whereas the frequency of this event is uncommon in patients receiving 6 mg of hydrochlorothiazide.

Other adverse reactions may also occur rarely, some of which may be serious. Ask your doctor or pharmacist for more information about adverse reactions. Both have access to a more complete list.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acediur

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of ACEDIUR

• The active substances are: 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.
• The other components (excipients) are: lactose, sodium bicarbonate, corn starch, pregelatinized corn starch, magnesium stearate and yellow iron oxide (E-172).

Appearance of the medicine and contents of the pack

ACEDIUR 20 mg/12.5 mg are yellow, round, flat tablets, scored on one side. They are available in blisters in packs of 30 tablets or 500 tablets (hospital pack).

Marketing Authorization Holder

Alfasigma España S.L.

C/ Aribau 195, 4º

08021 Barcelona. Spain

Manufacturer

Pharmaloop, S.L.

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid). SPAIN

Or

Alfasigma, S.p.A.

Via Pontina Km 30,400

00071 – Pomezia (Rome). ITALY

Date of the most recent review of this leaflet: December 2021

Other sources of information

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