Ampril 2.5 mg tablets

Package leaflet: Information for the patient

Ampril 2.5 mg tablets
Ampril 5 mg tablets
Ampril 10 mg tablets
Ramiprilum
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Ampril is and what it is used for

Ampril contains the active substance ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors).
Ampril works by:

• reducing the production in the body of substances that can increase blood pressure,
• reducing tension and widening blood vessels,
• helping the heart to pump blood around the body.

Ampril may be used:

• to treat high blood pressure (hypertension),
• to reduce the risk of heart attack or stroke,
• to reduce the risk of or delay worsening of kidney function (in patients with or without diabetes),
• to treat heart failure (when the heart is unable to pump enough blood to meet the body's needs),
• to treat patients after a heart attack complicated by heart failure.

2. Important information before using Ampril

When not to use Ampril:

• If the patient is allergic to ramipril, any other ACE inhibitor, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue.
• If the patient has ever experienced a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red patches on hands, feet, and throat, swelling of throat and tongue, swelling around eyes and lips, difficulty breathing and swallowing.
• If the patient is undergoing dialysis or other blood filtration procedures. Depending on the type of equipment used, Ampril may not be suitable.
• If the patient has been diagnosed with kidney disorders related to reduced blood flow to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see section below "Pregnancy and breastfeeding").
• If blood pressure is very low or unstable. The doctor will assess blood pressure.
• If the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.
• If the patient has taken or is currently using sacubitril with valsartan, a medicine used to treat certain types of chronic heart failure in adults, because this increases the risk of angioedema (rapid swelling of tissues beneath the skin, such as in the throat).

Do not use Ampril if any of the above situations apply. If in doubt about using this medicine, consult a doctor before starting Ampril.

Warnings and precautions

Before taking Ampril, contact a doctor or pharmacist if:

• The patient has heart, liver, or kidney disease;
• The patient has recently lost a significant amount of electrolytes or fluids (due to vomiting, diarrhoea, excessive sweating, a low-salt diet, long-term use of diuretics, or dialysis);
• Desensitisation treatment for bee or wasp venom (allergy desensitisation) is planned;
• Anaesthetic medicines are to be administered. These may be used during surgical or dental procedures. It may be necessary to stop taking Ampril one day before the procedure – consult a doctor.
• The patient has been diagnosed with high potassium levels in the blood (visible in blood test results);
• The patient is taking medicines or has conditions that may lower sodium levels in the blood. The doctor may recommend regular blood tests, particularly to check blood sodium levels, especially in elderly patients.
• The patient is taking any of the following medicines, which increase the risk of angioedema (rapid swelling under the skin, such as in the throat):
  • Racecadotril, a medicine used to treat diarrhoea,
  • Temsirolimus, sirolimus, everolimus, and other medicines belonging to the mTOR inhibitor class (used to prevent organ transplant rejection and in cancer treatment),
  • Vildagliptin, a medicine used to treat diabetes.
• The patient has been diagnosed with collagenosis, such as scleroderma or systemic lupus erythematosus;
• The patient is taking any of the following medicines used to treat high blood pressure:
  • An angiotensin II receptor antagonist (ARB) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if the patient has kidney disorders related to diabetes,
  • Aliskiren. The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading “When not to use Ampril:”.

Inform the doctor if pregnancy is suspected or planned. Use of Ampril is not recommended during the first 3 months of pregnancy, and after the third month of pregnancy, Ampril may seriously harm the unborn child (see section “Pregnancy and breastfeeding”).

Children and adolescents

Ampril is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of this medicine in this patient group have not been established.

If any of the above situations apply (or if there is any uncertainty), consult a doctor before starting Ampril.

Ampril and other medicines

Inform the doctor or pharmacist about all medicines currently or recently taken, or those planned to be taken, including over-the-counter medicines (including herbal remedies). Ampril may affect the action of other medicines, and other medicines may affect the action of Ampril.

Inform the doctor if taking any of the following medicines, as they may weaken the effect of Ampril:

• Painkillers and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs – NSAIDs, such as ibuprofen or indometacin, and acetylsalicylic acid);
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. The doctor will assess blood pressure.

Inform the doctor if taking any of the following medicines. They may increase the risk of adverse effects when used together with Ampril:

• Painkillers and anti-inflammatory medicines (e.g. NSAIDs such as ibuprofen or indometacin, and acetylsalicylic acid);
• Medicines used in cancer treatment (chemotherapy);
• Diuretics (water tablets), such as furosemide;
• Potassium supplements (including salt substitutes), potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride), and other medicines that increase blood potassium levels (e.g. heparin, a medicine used to thin the blood to prevent clots; trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole, used for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection);
• Steroidal anti-inflammatory medicines, such as prednisolone;
• Allopurinol (used to reduce blood uric acid levels);
• Procainamide (used for heart rhythm disorders);
• Vildagliptin (used to treat type 2 diabetes);
• Racecadotril (a medicine used to treat diarrhoea);
• Medicines often used to prevent rejection of transplanted organs (temsirolimus, sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”.

Inform the doctor if taking any of the following medicines. Their effect may be altered when taking Ampril:

• Antidiabetic medicines, such as oral glucose-lowering medicines and insulin. Ampril may reduce blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Ampril.
• Lithium (used for psychiatric disorders). Ampril may increase blood lithium levels. The doctor will closely monitor blood lithium levels.

If any of the above situations apply (or if there is any uncertainty), consult a doctor before starting Ampril.

The treating doctor may need to adjust the dose and/or take additional precautions:

• If the patient is taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also information under “When not to use Ampril:” and “Warnings and precautions”).

Ampril with food and drink

• Drinking alcohol while taking Ampril may cause dizziness and a feeling of “emptiness” in the head. If in doubt about how much alcohol is safe while taking Ampril, consult a doctor, as blood pressure-lowering medicines and alcohol may enhance each other’s effects.
• Ampril may be taken during meals or independently of meals.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

Inform the doctor if pregnancy is suspected or planned. Ampril is not recommended during the first 12 weeks of pregnancy and must not be taken after week 13 of pregnancy, as it may seriously harm the unborn child. If a woman taking Ampril becomes pregnant, she should inform her doctor immediately. The doctor should recommend switching to an alternative, appropriate treatment before conception.

Breastfeeding

Do not use Ampril during breastfeeding.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Drowsiness or dizziness may occur while taking Ampril. The likelihood of such symptoms is higher at the beginning of treatment with Ampril and after increasing the dose. If drowsiness or dizziness occurs, do not drive or operate tools or machinery.

Ampril contains lactose and sodium

If the patient has been informed by a doctor that they have an intolerance to certain sugars, they should consult a doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ampril tablets

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Taking the medicine

• Take the medicine orally, at the same time each day.
• Swallow the tablets whole with a drink of water.
• Do not crush or chew the tablets.

Dosage

Treatment of high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust the dose until your blood pressure is under control.
• The maximum dose is 10 mg once daily.
• If you are taking diuretics (water tablets), your doctor may stop or reduce the dose of your diuretic before starting treatment with Ampril.

Reducing the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once daily.
• Your doctor may decide to increase the dose.
• The usual dose is 10 mg once daily.

Treatment to reduce or delay worsening of kidney function

• The usual starting dose is 1.25 mg or 2.5 mg once daily.
• Your doctor will adjust the dose.
• The usual dose is 5 mg or 10 mg once daily.

Treatment of heart failure

• The usual starting dose is 1.25 mg once daily.
• Your doctor will adjust the dose.
• The maximum dose is 10 mg per day. It is recommended to take the medicine in two divided doses.

Treatment after heart attack

• The usual starting dose ranges from 1.25 mg once daily to 2.5 mg twice daily.
• Your doctor will adjust the dose.
• The usual dose is 10 mg per day. It is recommended to take the medicine in two divided doses.

Elderly patients

• Your doctor will recommend a lower starting dose and adjust the dose more slowly.

Taking more Ampril than prescribed

Seek immediate medical advice from your doctor or go to the nearest hospital emergency department. Do not drive yourself—ask someone to take you to hospital or call an ambulance. Take the medicine pack with you so the doctor knows which medicine has been taken.

If you miss a dose of Ampril

• If you forget to take a dose, take the next dose at your usual time.
• Do not take a double dose to make up for a forgotten dose.

Stopping Ampril

Do not stop taking Ampril unless your doctor tells you to. Do not stop taking Ampril just because you feel better. Stopping treatment may cause your high blood pressure to worsen.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you notice any of the following serious side effects, stop taking Ampril and contact your doctor immediately –
urgent medical help may be required:

• Swelling of the face, lips or throat causing difficulty in swallowing or breathing, together with itching and rash. These may be symptoms of a severe allergic reaction to Ampril.
• Severe skin changes, including rash, mouth ulcers, worsening of pre-existing skin disorders, redness, blistering or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

If any of the following conditions occur, inform your doctor immediately:

• Rapid heartbeat, irregular or forceful heartbeats (palpitations), chest pain, chest tightness or more serious events, including heart attack or stroke.
• Shortness of breath or cough. These may be symptoms of lung disorders.
• Easy bruising, prolonged bleeding, any signs of bleeding (e.g. bleeding gums), purple spots on the skin, or increased frequency of infections, sore throat, fever, fatigue, fainting, dizziness or pale skin. These may be symptoms of blood or bone marrow disorders.
• Severe abdominal pain, possibly radiating to the back. This may be a symptom of pancreatitis.
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, or yellowing of the skin or eyes (jaundice). These may be symptoms of liver disorders, such as hepatitis or liver damage.

Other side effects
Inform your doctor if any of the following symptoms worsen or persist for more than a few days.
Common side effects (may occur in up to 1 in 10 patients):

• Headache or feeling tired.
• Dizziness. The likelihood of occurrence is higher at the beginning of Ampril treatment and after dose increase.
• Fainting, hypotension (abnormally low blood pressure), especially upon rapid change from lying to sitting or standing position.
• Dry, persistent cough, sinusitis or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhoea, indigestion, nausea or vomiting.
• Rash with or without raised skin lesions.
• Chest pain.
• Muscle cramps or pain.
• Increased potassium levels in blood, detected in laboratory tests.

Uncommon side effects (may occur in up to 1 in 100 patients):

• Balance disorders (vestibular dizziness).
• Itching and unusual skin sensations such as numbness, tingling, pricking, burning or crawling sensations on the skin (paresthesia).
• Loss or disturbance of taste.
• Sleep disturbances.
• Depression, anxiety, nervousness or restlessness, especially motor restlessness.
• Nasal congestion, breathing difficulties or worsening of asthma.
• Intestinal swelling known as "intestinal angioedema", with symptoms such as abdominal pain, vomiting and diarrhoea.
• Heartburn, constipation or dryness of the oral mucosa.
• Increased urine output during the day.
• Excessive sweating.
• Loss or decrease of appetite (anorexia).
• Rapid or irregular heartbeat. Swelling of hands and feet. May indicate retention of larger than normal amounts of fluid in the body.
• Hot flushes.
• Blurred vision.
• Joint pain.
• Fever.
• Impotence, decreased libido in men or women.
• Increased number of certain white blood cells (eosinophilia), detected in blood tests.
• Liver, pancreas or kidney function disorders, detected in blood tests.

Rare side effects (may occur in up to 1 in 1,000 patients):

• Feeling of uneasiness or disorientation.
• Redness and swelling of the tongue.
• Severe peeling of the skin, itchy nodular rash.
• Nail disorders (e.g. loosening or separation of the nail from the nail bed).
• Skin rash or bruising.
• Skin spots and cold extremities.
• Redness, itching, swelling or watering of the eyes.
• Hearing disturbances and ringing in the ears.
• Weakness.
• Decreased number of red blood cells, white blood cells or platelets, or decreased haemoglobin concentration, detected in blood tests.

Very rare side effects (may occur in up to 1 in 10,000 patients):

• Increased sensitivity to sunlight.

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

• Concentrated urine (dark-coloured urine), nausea, vomiting, muscle cramps, disorientation and seizures; these symptoms may be caused by inappropriate antidiuretic hormone (ADH) secretion; if these symptoms occur, contact your doctor immediately.

Other reported side effects:
Inform your doctor if any of the following symptoms worsen or persist for more than a few days:

• Difficulty concentrating.
• Swelling of the lips.
• Low blood cell count, detected in blood tests.
• Decreased sodium concentration, detected in blood tests.
• Change in finger colour upon cold exposure, accompanied by tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or impaired reactions.
• Burning sensation.
• Smell disturbances.
• Hair loss.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ampril 5 mg tablets

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25 °C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Ampril contains

• The active substance is ramipril. Each tablet of Ampril 2.5 mg tablets contains 2.5 mg of ramipril. Each tablet of Ampril 5 mg tablets contains 5 mg of ramipril. Each tablet of Ampril 10 mg tablets contains 10 mg of ramipril.
• The other ingredients are: sodium hydrogen carbonate, monohydrate lactose, sodium croscarmellose, pregelatinized corn starch (Starch 1500), sodium stearyl fumarate; Ampril 2.5 mg tablets also contain the colouring blend PB 22960 Yellow: monohydrate lactose, yellow iron oxide (E 172); Ampril 5 mg tablets also contain the colouring blend PB 24877 Pink: monohydrate lactose, red iron oxide (E 172), yellow iron oxide (E 172). See section 2 "Ampril contains lactose and sodium".

What Ampril looks like and contents of the pack
Ampril 2.5 mg tablets: yellow, flat, oblong tablets measuring 10.0 x 5.0 mm
Ampril 5 mg tablets: pink, flat, oblong tablets measuring 8.8 x 4.4 mm
Ampril 10 mg tablets: white to off-white, flat, oblong tablets measuring 11.0 x 5.5 mm
Pack sizes: 30, 60, 90 or 100 tablets in blister packs contained in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia