HIPERTENE 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

HIPERTENE 10 mg tablets

Imidapril

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

1. What is HIPERTENE and what is it 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, making it easier for your blood to flow. Since blood pressure depends on the diameter of your 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 rest of your body.

2. What you need to know before you take HIPERTENE

Do not take HIPERTENE

• If you are allergicto imidapril, other ACE inhibitors, or any of the other ingredients of this medicine (listed in section 6).
• If you have ever suffered from angioedema(a severe allergic reaction characterized by swelling of the hands, feet, or ankles, face, lips, tongue, and throat, and which can lead to difficulty swallowing or breathing) after taking a medicine similar to imidapril (ACE inhibitor).
• If you or a close relative have experienced angioedema.
• If you have any kidney diseaseor if you need dialysis.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you are pregnant for more than 3 months (it is also best to avoid HIPERTENE at the start of pregnancy – see section Pregnancy).

Do not take HIPERTENE if you are in any of the above situations.

Warnings and precautions

Consult your doctor or pharmacist before starting HIPERTENE

• If you are dehydrated due to treatment with diuretics (water pills), dialysis, a low-salt diet, or because you have had severe and prolonged vomiting or diarrhea. You are more likely to suffer from a significant drop in blood pressure (hypotension) when starting to take the tablets and may feel dizzy or faint.
• If you have been told you have heart problems. Consult your doctor if you think you may have them.
• If you have liver problems.
• If you are diabetic.
• If you are following a treatment with potassium supplements or salt substitutes containing potassium.
• If you are following a treatment with allopurinolto prevent gout, kidney stones, or high levels of uric acid.
• If you are following a treatment with procainamideto correct irregular heartbeats and to slow down a rapid heartbeat.
• If you are taking a medicine containing lithiumused to treat mania or depression.
• If you are allergic to insect bites and are following desensitization treatment.
• If you are following immunosuppressive treatment, for example, after an organ transplant.
• If you have recently undergone a kidney transplant.
• If you are following a treatment called “LDL apheresis”to reduce cholesterol levels in the blood.
• If you suffer from a condition called “cerebrovascular disease”(narrowing of the blood vessels in the brain).
• If you suffer from a disease known as “collagen vascular disease”, such as rheumatoid arthritis.
• If you are going to undergo surgeryor receive anesthesia, inform your doctor or dentist.
• If your blood pressure is not low enough. This type of medicine seems to be less effective in people of black race.
• If you experience sudden swelling of the lips and face, tongue and throat, neck, and possibly hands and feet, difficulty swallowing and breathing, hives, and hoarseness (“angioedema”). This can occur at any time during treatment. People of black race may be at higher risk of suffering from this situation. 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” - e.g., 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 HIPERTENE”.

If you are pregnant (or think you may be pregnant), you must inform your doctor. HIPERTENE is not recommended at the start of pregnancy, and it must not be used from the third month of pregnancy onwards because it may cause serious harm to your baby (see section Pregnancy).

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 dizzy after the first dose. Some people react to the first dose or when the dose is increased, and feel dizzy, weak, faint, or nauseous.
• High temperature, sore throat, or mouth ulcers (these may be symptoms of infection caused by a decrease in white blood cells in the blood).
• Yellowing of the skin and eyes (jaundice) which can 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 you start treatment or in case of dose modification. Your doctor will indicate the necessary frequency of visits.

Using HIPERTENE with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use 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, think you may be pregnant, or plan to become pregnant before using this medicine. Your doctor will usually advise you to stop taking HIPERTENE before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take a different blood pressure-lowering medicine instead. HIPERTENE is not recommended during the first trimester of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as HIPERTENE is not recommended for women during breastfeeding. Your doctor may decide to give you a treatment that is more suitable if you want to breastfeed, especially newborns or premature babies.

Driving and using machines

HIPERTENE may make you feel dizzy or sleepy. Avoid driving a vehicle or using machines until you know how HIPERTENE affects you.

HIPERTENE contains lactose.

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

3. How to take HIPERTENE

Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you. If you are unsure, 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 every day
• The tablet can be divided into equal doses

Dosage (adults)

The usual initial dose is 5 mg per day. After 3 weeks, your blood pressure will need to be measured again to assess the results. Your doctor may increase the daily dose to 10 mg or up to 20 mg.

Your doctor may instruct you to start with 2.5 mg per day

• if you have mild kidney problems or liver problems
• if you have heart problems, chest pain, problems related to the blood vessels in the brain, low salt and/or fluid levels, or
• if there is a risk that your blood pressure may drop suddenly

Patients over 65 years of age

Your doctor will start your treatment with 2.5 mg once a day and increase it to 10 mg, depending on your reaction to the 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 take the remaining tablets and the packaging with you. The most common signs and symptoms of overdose are decreased blood pressure, shock, and stupor (a state of near-total loss of consciousness), decreased heart rate, changes in potassium or other electrolyte levels, and kidney failure. This can cause a feeling of general discomfort, feeling your heartbeat, or swelling of the fingers, legs, and toes (edema).

If you forget to take HIPERTENE

Do not take the missed dose and continue with the scheduled dosing. Do not take a double dose to make up for the missed doses.

If you stop taking HIPERTENE

Do not stop taking HIPERTENE unless your doctor recommends it. If you stop taking this medicine, your blood pressure may rise. If your blood pressure is too high, it can affect the functioning of your heart and kidneys.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 treatmentor when the dose is increased
• difficulty breathing
• rash or itching
• a severe allergic reaction that causes swelling in the face or throat (angioedema)
• blisters on the skin, mouth, eyes, or genitals (toxic epidermal necrolysis, Stevens-Johnson syndrome)
• yellowing of the skin and eyes caused by liver or blood problems (jaundice)

Tell your doctor or pharmacist if you develop any of the following side effects:

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

• fatigue/drowsiness
• cough
• nausea

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

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

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

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

Effects on blood test results

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

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

• blurred vision
• balance disorders; confusion; ringing in the ears
• fatigue; depression; sleep disorders; impotence
• taste disturbances
• heart rhythm disorders (faster, irregular); heart attack; transient ischemic symptoms
• increased risk of bleeding or bruising
• hives; 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 blockage; inflammation of the intestines causing colic
• kidney problems
• fever
• muscle pain; joint pain

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of HIPERTENE

Keep this medication out of sight and reach of children.

Do not store the tablets at a temperature above 30°C. Store in the original carton.

Do not use this medication after the expiration date shown on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of HIPERTENE

• The active ingredient is imidapril (hydrochloride). Each tablet contains 10 mg of imidapril hydrochloride.
• The other ingredients are: Anhydrous calcium hydrogen phosphate, pregelatinized starch, lactose monohydrate, sodium croscarmellose, and glycerol distearate.

Appearance of the product and package contents

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

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

Only some package sizes may be marketed.

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

Caxton Road Bedford MK41 0XZ United Kingdom

This medication is authorized in the member states of the European Economic Area under the following names

Tanatril: Austria, France, Greece, United Kingdom

Cardipril: Portugal

Hipertene: Spain

Date of the last revision of this leaflet: 04/2016

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.