HIPERTENE 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

HIPERTENE 5 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 HIPERTENE is and what it is 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 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, 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 reactioncharacterized 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 family member have experienced angioedema.
• If you have any kidney diseaseor if you need to undergo 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 to take 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 that 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 heart rate.
• If you are taking a medicine containing lithiumused to treat mania or depression.
• If you are allergic to insect bites and are following a treatment for hypersensitivity.
• If you are following a treatment for your immune system, 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 problem 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 feel a sudden swelling of the lips and face, tongue and throat, neck, and also 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” - for example, 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 (such as 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. The use of HIPERTENE is not recommended at the start of pregnancy, and it must not be used from the third month of pregnancy onwards because it can 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 an 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.

It will be necessary to undergo regular medical check-ups while taking HIPERTENE, including regular blood tests. Close monitoring will be carried out when starting 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. In general, your doctor will advise you to stop taking HIPERTENE before becoming pregnant or as soon as you become pregnant, and will recommend taking another anti-hypertensive medicine instead. It is not recommended to take HIPERTENE at the start of pregnancy and it must not be administered from the third month of pregnancy onwards, as it can cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as it is not recommended to administer HIPERTENE to women during breastfeeding. Your doctor may decide to administer 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 if 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 exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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 always at the same time
• The tablet can be divided into equal doses

Posology (adults)

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

Your doctor may indicate that you 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 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 up 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 the prescribed dose, consult your doctor immediately. Remember to take the remaining tablets and the packaging with you. The most frequent signs and symptoms of overdose are decreased blood pressure, shock, and stupor (a state of almost total loss of consciousness), decreased heart rate, alterations in potassium or other electrolyte levels, and kidney failure. This can produce 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 forgotten dose and continue with the usual dosing schedule. 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 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 other questions about 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, and 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 it more likely to have infections
• reduction (decrease in the number) of red blood cells, which can cause paleness of the skin, 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 described with this type of medicine:

• blurred vision
• balance disorders; confusion; ringing in the ears
• fatigue; depression; sleep disorders; impotence
• taste disturbances
• heart rhythm disturbances (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, even if it is possible side effects not listed in this leaflet. You can also report them 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 through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of HIPERTENE

• The active ingredient 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 package contents

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

The medication is available in aluminum/aluminum blisters, packages with 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 prospectus: 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/.