Package Insert: Information for the User

HIPERTENE 10 mg Tablets

Imidapril

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who 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 are not listed in this package insert. See section 4.

1. What is HIPERTENE and for what it is used

2. What you need to know before starting to take HIPERTENE

3. How to take HIPERTENE

4. Possible adverse effects

5. Storage of HIPERTENE

6. Contents of the package and additional informationl

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

If you have high blood pressure, HIPERTENE will act by dilating blood vessels, allowing blood to flow more easily. As blood pressure depends on the diameter of 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 the body.

Do not take HIPERTENE

• If you areallergicto imidapril, other ACE inhibitors, or any of the other components of this medication (listed in section 6).
• If you have ever hadangioedema (a severe allergic reactionthat manifests asswelling of the hands, feet, or ankles, face, lips, tongue, and throat, and which can lead todifficulty swallowing or breathing), after taking a similar medication to imidapril (ACE inhibitor).
• If you or a close family member has experiencedangioedema.
• If you haveany kidney diseaseor if you need to undergodialysis.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.
• If you are pregnant more than 3 months (it is also recommended to avoid Hipertene at the beginning of pregnancy – see Pregnancy section).

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 withdiuretics (medications to urinate), dialysis, a low-sodium diet, or because you have hadsevere and prolonged vomiting or diarrhea. You are more likely to experience a significant drop in blood pressure (hypotension) at the beginning of taking the tablets and may feel dizzy or faint.
• If you have been told that you haveheart problems. Consult your doctor if you think you may have them.
• If you haveliver problems
• If you arediabetic
• If you are following a treatment withpotassium supplements or salt substitutes containing potassium.
• If you are following a treatment withalopurinolto prevent gout, kidney stones, or elevated uric acid levels.
• If you are following a treatment withprocainamideto correct irregular heartbeats and to slow down a rapid heartbeat.
• If you are taking amedication containing lithiumused to treat mania or depression.
• If you are allergic to insect bites and are following someallergy treatment.
• If you are following someimmunosuppressive treatment, for example after a transplant.
• If you have recently undergone akidney transplant.
• If you are following some treatment called“atheresis of LDL”to reduce blood cholesterol levels.
• If you suffer from a condition called“cerebrovascular disease”(narrowing of blood vessels in the brain).
• If you suffer from a disease known as“vascular collagen disease”,such as rheumatoid arthritis.
• If you are to undergosurgeryor receiveanesthesia, inform your doctor or dentist.
• If your blood pressure is not low enough. This type of medication seems to be less effective in people of black race.
• If you experience asudden 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 have a higher risk of experiencing this situation. If you develop these symptoms, inform your doctor immediately.
• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• • A receptor antagonist of angiotensin II (ARA) (also known as “sartanes” – 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 electrolyte levels in the blood (such as potassium) at regular intervals.

See also the information under the heading “Do not take HIPERTENE”.

If you are pregnant (or if you suspect you may be), you must inform your doctor. HIPERTENE is not recommended for use at the beginning of pregnancy, and it should not be used after the third month of pregnancy because it can cause serious 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 dizzy after the first dose. Some people react to the first dose or when the dose is increased, and feel vertigo, weakness, faintness, or nausea.
• Elevated temperature, sore throat, or ulcers in the mouth (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) that may bea sign of liver disease.

You will need to have regular medical check-ups while taking HIPERTENE, which will include regular blood tests. A careful monitoring will be done when starting treatment or in case of dose modification. Your doctor will indicate the frequency of visits.

Use of HIPERTENE with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Your doctor may need to modify 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 medication. Your doctor will usually advise you to stop taking HIPERTENE before becoming pregnant or as soon as you become pregnant, and will recommend taking another antihypertensive medication instead. HIPERTENE is not recommended for use at the beginning of pregnancy, and it should not be used after the third month of pregnancy, as it can cause serious harm to your baby, when administered from that time.

Breastfeeding

Inform your doctor if you are tostart or are in a period of breastfeeding, as HIPERTENE is not recommended for use in breastfeeding women. Your doctor may decide to administer a treatment that is more suitable if you want to breastfeed, especially in newborns or premature babies.

Driving and operating machinery:

HIPERTENE may make you feel dizzy or drowsy. Avoid driving a vehicle or operating machinery until you know if HIPERTENE affects you.

HIPERTENE contains lactose.

If your doctor has informed you that you have intolerance to some sugars, consult your doctor before taking this medication.

Follow exactly the administration instructions for this medication as 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

Dosage (adults)

The usual initial dose is 5 mg per day. After 3 weeks, your blood pressure will need to be measured again to evaluate 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, cerebrovascular problems, low sodium levels, 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 for 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 bring the leftover tablets and the packaging with you. The most common 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 levels or other electrolytes, and renal failure. This may cause a general feeling of discomfort, feeling your heartbeat, or swelling of the hands, legs, and feet (edema).

If you forget to take HIPERTENE

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

If you interrupt treatment with HIPERTENE

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

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

Like all medicines, this medicine may cause side 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, vertigo, possibly accompanied by vision disturbances. This is particularly important when starting treatment or when the dose is increased
• difficulty breathing
• eruption or itching
• severe allergic reaction that causes swelling in the face or throat (angioedema)
• blistering on the skin, mouth, eyes, and genital organs (toxic epidermal necrolysis, Stevens-Johnson syndrome)
• yellowing of the skin and eyes caused by liver or blood problems (jaundice)

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

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

• fatigue/sleepiness
• cough
• nausea (feeling like vomiting)

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

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

Rare side 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 pale skin, weakness, and shortness of breath

Effects on blood test results

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

The following side effects were described with this type of medication:

• blurred vision
• balance disorders; confusion; ringing in the ears
• fatigue; depression; sleep disorders; impotence
• alterations in taste
• alterations in heart rhythm (faster, irregular); heart attack; transient ischemic symptoms
• increased risk of bleeding or hematomas
• 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 cramps
• kidney problems
• fever
• muscle pain; joint pain

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for 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 this medication out of the sight and reach of children.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of HIPERTENE

- The active ingredient is imidapril (hydrochloride). Each tablet contains 10 mg of hydrochloride of imidapril.

- The other components are: Anhydrous calcium hydrogen phosphate, pregelatinized starch, lactose monohydrate, sodium croscarmellose and glyceryl distearate.

Appearance of the product and content of the packaging

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

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

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization

Laboratorios BIAL, S.A.

C/ Alcalá 265, Edificio 2, Planta 2ª

28027 Madrid

Spain

Responsible for manufacturing

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 medicine is authorized in the member states of the European Economic Area with the following names

Tanatril: Austria, France, Greece, United Kingdom

Cardipril: Portugal

Hipertene: Spain

Last review date of this leaflet: 04/2016

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