Hipertene 5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HIPERTENE 5 mg tablets

Imidapril

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 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What HIPERTENE is and what it is used for

HIPERTENE is indicated for the treatment of high blood pressure (hypertension). HIPERTENE belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).

If you have high blood pressure, HIPERTENE will work by dilating your blood vessels, allowing blood to flow more easily. Since blood pressure depends on the diameter of the blood vessels, your blood pressure will decrease with the help of HIPERTENE. It will also be easier for your heart to pump blood through the vessels to the entire body.

2. What you need to know before taking HIPERTENE

Do not take HIPERTENE

• If you are allergic to imidapril, to other ACE inhibitors, or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever had angioedema (a severe allergic reaction characterized by swelling of the hands, feet or ankles, face, lips, tongue and throat , which may lead to difficulty swallowing or breathing ) after taking a medicine similar to imidapril (an ACE inhibitor).
• If you or a close family member has ever experienced angioedema.
• If you have any kidney disease or if you require dialysis.
• If you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant (Hipertene should also be avoided at the beginning of pregnancy – see Pregnancy section).

Do not take HIPERTENE if any of the above situations apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking HIPERTENE

• If you are dehydrated due to treatment with diuretics (medicines to increase urine output), dialysis, a low-salt diet , or because you have had severe and prolonged vomiting or diarrhea . You may be more likely to experience a significant drop in blood pressure (hypotension) when starting treatment with the tablets, which could cause dizziness or fainting.
• If you have been diagnosed with heart problems . Consult your doctor if you think you may have them.
• If you have liver problems.
• If you are diabetic.
• If you are taking potassium supplements or potassium-containing salt substitutes.
• If you are taking allopurinol to prevent gout, kidney stones, or high uric acid levels.
• If you are taking procainamide to correct irregular heartbeats or to slow a rapid heartbeat.
• If you are taking a medicine containing lithium used to treat mania or depression.
• If you are allergic to insect stings and are undergoing desensitization treatment.
• If you are receiving any treatment affecting your immune system , for example after an organ transplant.
• If you have recently undergone a kidney transplant.
• If you are undergoing a treatment called “LDL apheresis” to reduce cholesterol levels in the blood.
• If you suffer from a condition known as “cerebrovascular disease” (narrowing of blood vessels in the brain).
• If you have a disease known as “collagen vascular disease” , such as rheumatoid arthritis.
• If you are scheduled for surgery or will receive anesthesia , inform your doctor or dentist.
• If your blood pressure is not sufficiently lowered. This type of medicine appears to be less effective in people of Black origin.
• If you experience sudden swelling of the lips and face, tongue and throat, neck, and possibly also hands and feet, difficulty swallowing and breathing, hives, or hoarseness (“angioedema”) . This may occur at any time during treatment. People of Black origin may have a higher risk of this reaction. If you develop these symptoms, inform your doctor immediately.
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • An angiotensin II receptor antagonist (ARA) (also known as “sartans” – for example, valsartan, telmisartan, irbesartan), particularly 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 HIPERTENE”.

If you are pregnant (or suspect you might be), inform your doctor. The use of HIPERTENE is not recommended during early pregnancy, and it must not be used after the third month of pregnancy because it may cause severe harm to your baby (see Pregnancy section).

Children and adolescents

The use of HIPERTENE tablets is not recommended in children.

While taking HIPERTENE

If you develop any of the following symptoms, inform your doctor immediately:

• If you feel lightheaded after the first dose. Some people react to the first dose or when the dose is increased, experiencing dizziness, weakness, fainting, or nausea.
• High temperature, sore throat, or mouth ulcers (these may be signs of infection due to a decrease in white blood cells).
• Yellowing of the skin and eyes (jaundice), which may be a sign of liver disease.

Regular medical check-ups will be necessary while you are taking HIPERTENE, including regular blood tests. Close monitoring will be carried out when treatment is started or if the dose is changed. Your doctor will advise you on how often you need to attend check-ups.

Taking HIPERTENE with other medicines

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

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 HIPERTENE” and “Warnings and precautions”).

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant before using this medicine. Your doctor will generally advise you to stop taking HIPERTENE before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive treatment. HIPERTENE is not recommended during early pregnancy and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that point onward.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as HIPERTENE is not recommended for administration to women during lactation. Your doctor may decide to prescribe a treatment more suitable for breastfeeding, especially if the infant is a newborn or premature.

Driving and using machines:

HIPERTENE may cause dizziness or drowsiness. Do not drive or operate machinery until you know how HIPERTENE affects you.

HIPERTENE contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take HIPERTENE

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

Instructions

• Take the tablets approximately 15 minutes before meals
• Swallow the tablets with plenty of water
• Take the tablets at the same time each day
• The tablet may be divided into equal doses

Dosage (adults)

The usual starting dose is 5 mg once daily. After 3 weeks, your blood pressure should be measured again to assess the response. Your doctor may increase the daily dose to 10 mg or up to 20 mg.

Your doctor may advise starting with 2.5 mg once daily

• if you have mild kidney or liver problems
• if you have heart problems, chest pain, cerebrovascular disorders, low levels of salt and/or fluids, or
• if there is a risk that your blood pressure may drop suddenly

Patients over 65 years of age

Your doctor will start treatment with 2.5 mg once daily and may increase it to 10 mg, depending on your response to treatment.

The use of HIPERTENE tablets is not recommended in children.

If you take more HIPERTENE than you should

If you have accidentally taken more tablets than prescribed, consult your doctor immediately. Remember to bring any remaining tablets and the packaging with you. The most common signs and symptoms of overdose include low blood pressure, shock, and stupor (a state of near-complete loss of consciousness), slowed heart rate, disturbances in potassium or other electrolyte levels, and kidney failure. This may result in a general feeling of discomfort, awareness of your heartbeat (palpitations), or swelling of the fingers, legs, and toes (edema).

If you forget to take HIPERTENE

Do not take the missed dose; instead, continue with your next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking HIPERTENE

Do not stop taking HIPERTENE unless your doctor advises you to do so. If you stop taking this medicine, your blood pressure may rise. If your blood pressure becomes too high, it may affect the functioning of your heart and kidneys.

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.

It is very important that you contact your doctor immediately and stop taking HIPERTENE if you develop any of the following symptoms:

• headache, dizziness, lightheadedness, possibly accompanied by vision disturbances. This is particularly important when starting treatment or when the dose is increased
• difficulty breathing
• rash or itching
• a severe allergic reaction causing swelling of the face or throat (angioedema)
• blistering of the skin, mouth, eyes, and genital organs (toxic epidermal necrolysis, Stevens-Johnson syndrome)
• yellowing of the skin and eyes due to liver or blood problems (jaundice)

Tell your doctor or pharmacist if you experience any of the following adverse effects:

Common adverse effects (may affect up to 1 in 10 people)

• fatigue/sleepiness
• cough
• feeling sick (nausea)

Uncommon adverse effects (may affect up to 1 in 100 people)

• awareness of your own heartbeat (palpitations)
• narrowing of blood vessels in the brain (cerebrovascular disease)
• feeling faint
• tingling or numbness in the hands or feet
• swelling and irritation inside the nose
• vomiting
• pain in the upper abdomen
• indigestion (stomach discomfort)
• bronchitis
• viral infection
• upper respiratory tract infection
• chest pain
• limb pain
• swelling of the fingers, legs, and toes (edema)

Rare adverse effects (may affect up to 1 in 1,000 people)

• reduction (decrease in number) of white blood cells, making infections more likely
• reduction (decrease in number) of red blood cells, which may cause paleness of the skin, weakness, and shortness of breath

Effects on blood test results

HIPERTENE may cause changes in blood composition. Your doctor will carry out regular blood tests and explain the results to you.

The following adverse effects have been reported with this type of medicine:

• blurred vision
• balance disorders; confusion; ringing in the ears
• tiredness; depression; sleep disturbances; impotence
• taste disturbances
• changes in heart rhythm (faster, irregular); heart attack; transient ischemic symptoms
• increased risk of bleeding or bruising
• urticaria; skin redness
• hair loss
• shortness of breath; wheezing
• inflammations – for example, of the nasal cavities (sinusitis), tongue (glossitis), liver (hepatitis), pancreas (pancreatitis), or stomach lining (gastritis)
• diarrhea; constipation; dry mouth
• intestinal obstruction; inflammation of the intestines causing colic
• kidney problems
• fever
• muscle pain; joint pain

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 HIPERTENE

Keep this medicine out of the sight and reach of children.

Do not store the tablets above 30°C. Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging and blister pack 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 unused medicines and their packaging at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of HIPERTENE

• The active substance is imidapril (hydrochloride). Each tablet contains 5 mg of imidapril hydrochloride.
• The other components are: anhydrous calcium hydrogen phosphate, pregelatinized starch, lactose monohydrate, sodium croscarmellose, and glycerol distearate.

Appearance of the product and contents of the pack

HIPERTENE tablets are biconvex, whitish, with a flat edge, scored on both sides.

The medicine is available in aluminum/aluminum blisters, in packs containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 100 and 1000 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Laboratorios BIAL, S.A.

C/ Alcalá 265, Edificio 2, Planta 2ª

28027 Madrid

Spain

Manufacturer

BIAL - PORTELA & CIA, S.A.

À Avenida da Siderurgia Nacional (S. Mamede do Coronado) - 4745-457 - Portugal

G.L. PHARMA GMBH

Schlossplatz, 1 (Lannach) - 8502 - Austria

Central Pharma (Contract Packing) Limited

Caxrton Road Bedford MK41 0XZ United Kingdom

This medicinal product is authorized in the European Economic Area member states under the following names:

Tanatril: Austria, France, Greece, United Kingdom

Cardipril: Portugal

Hipertene: Spain

Date of the most recent review of this leaflet: 04/2016

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.