Ramipril Sandoz

Patient Information Leaflet

Ramipril Sandoz 2.5 mg tablets, 5 mg tablets, 10 mg tablets

Generic Medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ramipril Sandoz is and what it is used for

Ramipril Sandoz contains a medicine called ramipril, which belongs to a group of medicines known as
ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).
Ramipril Sandoz works by:

• reducing the body's production of substances that can cause an increase in blood pressure
• relaxing and widening blood vessels
• helping the heart pump blood through the circulation more effectively.

Ramipril Sandoz can be used:

• to treat high blood pressure (hypertension)
• to reduce the risk of heart attack or stroke
• to reduce the risk or delay the worsening of kidney problems (with or without diabetes)
• to treat heart failure, a condition where the heart is unable to pump an adequate volume of blood to the rest of the body
• as a treatment following a heart attack (myocardial infarction) complicated by heart failure.

2. What you should know before taking Ramipril Sandoz

Do not take Ramipril Sandoz

• if you are allergic to ramipril, to other ACE inhibitors, or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• if you have previously had a serious allergic reaction called "angioedema". Signs include itching, skin rash (urticaria), red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing or swallowing.
• if you are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, Ramipril Sandoz may not be suitable for you.
• if you have kidney problems due to insufficient blood supply to the kidneys (renal artery stenosis).
• during the last 6 months of pregnancy (see section "Pregnancy, breastfeeding and fertility" below).
• if your blood pressure is excessively low or unstable. Your doctor must assess this.
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat). Do not take Ramipril Sandoz if any of the conditions listed above apply to you. If you are unsure, consult your doctor before taking Ramipril Sandoz.

Warnings and precautions
Consult your doctor or pharmacist before taking Ramipril Sandoz:

• if you have heart, liver, or kidney problems
• if you have lost large amounts of body salts or fluids (due to illness such as vomiting, diarrhoea, excessive sweating, or due to a low-salt diet, or long-term use of diuretics ["water pills"], or due to dialysis)
• if you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation)
• if you are about to receive an anaesthetic. This may be administered during surgery or dental procedures. You may need to stop taking Ramipril Sandoz the day before; consult your doctor
• if you have high levels of potassium in your blood (shown by blood tests)
• if you are taking medicines or have conditions that may reduce sodium levels in your blood. Your doctor may perform regular blood tests, particularly to monitor blood sodium levels, especially if you are elderly
• if you are taking any of the following medicines, the risk of angioedema may be increased:
• racecadotril, a medicine used to treat diarrhoea.
• medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
• vildagliptin, a medicine used to treat diabetes.
• if you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus
• if you are taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonists (AIIRAs) (also known as sartans – for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take Ramipril Sandoz".
• if you think you may be pregnant (or could become pregnant), inform your doctor. Ramipril Sandoz is not recommended during the first trimester of pregnancy and may cause severe harm to the unborn child after the first three months of pregnancy (see section below "Pregnancy and breastfeeding").

Children and adolescents
The use of Ramipril Sandoz is not recommended in children and adolescents under 18 years of age, as the
safety and efficacy of ramipril in children have not yet been established.
If any of the conditions listed above apply to you (or if you are unsure), consult your doctor
before taking Ramipril Sandoz.
Other medicines and Ramipril Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine. This is because Ramipril Sandoz may affect how some other medicines work.
Likewise, some other medicines may affect how Ramipril Sandoz works.
Inform your doctor if you are taking any of the following medicines. These medicines may reduce the effectiveness
of Ramipril Sandoz:

• medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs [NSAIDs], such as ibuprofen, indomethacin, acetylsalicylic acid)
• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor will need to monitor your blood pressure.

Inform your doctor if you are taking any of the following medicines. Taking these medicines together with
Ramipril Sandoz may increase the likelihood of side effects:

• medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs [NSAIDs], such as ibuprofen, indomethacin, acetylsalicylic acid)
• cancer medicines (chemotherapy)
• diuretics ("water pills"), such as furosemide
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and co-trimoxazole used to treat bacterial infections; ciclosporin, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clotting)
• steroid medicines used to treat inflammation, such as prednisolone
• allopurinol (used to reduce uric acid levels in the blood)
• procainamide (used for heart rhythm disorders)
• temsirolimus (for cancer)
• sirolimus, everolimus (to prevent transplant rejection)
• vildagliptin (used to treat type 2 diabetes)
• racecadotril (used to treat diarrhoea)

Your doctor may consider it necessary to adjust the dose and/or take other precautions:
If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the sections "Do not take Ramipril Sandoz" and "Warnings and precautions").
Inform your doctor if you are taking any of the following medicines. The action of these medicines
may be affected by Ramipril Sandoz:

• medicines for diabetes, such as oral hypoglycaemics and insulin. Ramipril Sandoz may reduce blood sugar levels. Monitor your blood sugar levels carefully when taking Ramipril Sandoz.
• lithium (used for mental health disorders). Ramipril Sandoz may increase lithium levels in the blood. Your doctor must monitor lithium levels in your blood carefully.

If any of the conditions listed above apply to you (or if you are unsure), consult your doctor before
taking Ramipril Sandoz.
Ramipril Sandoz with food, drinks and alcohol

• Drinking alcohol while taking Ramipril Sandoz may cause dizziness or lightheadedness. If you want to know how much alcohol you can drink while taking Ramipril Sandoz, consult your doctor, as blood pressure-lowering medicines and alcohol may have additive effects.
• Ramipril Sandoz can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
If you think you may be pregnant (or could become pregnant), inform your doctor.
You must not take Ramipril Sandoz during the first 12 weeks of pregnancy and must not take it
at all after week 13, as it may harm the unborn child.
If you become pregnant while taking Ramipril Sandoz, inform your doctor immediately. Before planning a pregnancy, you should switch to an appropriate alternative treatment.
Breastfeeding
You must not take Ramipril Sandoz if you are breastfeeding.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
While taking Ramipril Sandoz, you may experience dizziness. This is more likely when you have just started treatment with Ramipril Sandoz or have recently increased your dose. If this occurs, do not drive or operate tools or machinery.

3. How to take Ramipril Sandoz

Always take this medicine exactly as instructed by your doctor. If you have any doubts, you must consult your doctor or pharmacist.
How to take this medicine

• Take the medicine at the same time each day, every day
• Swallow the tablets whole, with liquid.
• Do not crush or chew the tablets.

Dosage of the medicine
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 daily dose is 10 mg.
• If you are already taking diuretics, your doctor may stop them or reduce their dose before starting your treatment with Ramipril Sandoz.

To reduce 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 problems

• Your doctor may start your treatment with a dose of 1.25 mg or 2.5 mg once daily.
• Your doctor will then 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 then adjust the dose.
• The maximum dose is 10 mg daily. It is preferable to divide the dose into two daily administrations.

Treatment after a heart attack

• The usual starting dose is from 1.25 mg once daily to 2.5 mg twice daily.
• Your doctor will then adjust the dose.
• The usual dose is 10 mg daily. It is preferable to divide the dose into two daily administrations.

Elderly patients
Your doctor will reduce the starting dose and adjust the dosage more gradually.
If you take more Ramipril Sandoz than you should
Inform your doctor or go immediately to the nearest hospital emergency department. Do not drive to the hospital; instead, have someone accompany you or call an ambulance. Take the medicine pack with you so that medical staff can see what you have taken.
If you forget to take Ramipril Sandoz

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

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 gets them.
Stop taking this medicine and contact your doctor immediately if you notice any of the following serious side effects – you may need urgent medical care:

• swelling of the face, lips or throat causing difficulty swallowing or breathing, together with itching or rash. This could be a sign of a serious allergic reaction to this medicine.
• severe skin reactions, including rash, mouth ulcers, worsening of pre-existing skin conditions, redness, blistering and peeling of the skin (such as in cases of Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Contact your doctor immediately if you experience:

• rapid heartbeat, irregular or forceful heartbeat (palpitations), chest pain, tightness in the chest or more serious problems such as heart attack or stroke
• shortness of breath or cough. These may be signs of lung problems
• increased tendency to bruise, prolonged bleeding beyond normal, any sign of bleeding (for example, bleeding gums), purple spots on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, fainting, dizziness or pale appearance. These may be signs of blood or bone marrow disorders
• severe stomach pain, which may spread to the back. This could be a sign of pancreatitis (inflammation of the pancreas)
• fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice). These may be signs of liver problems, such as hepatitis (liver inflammation) or liver damage.

Other side effects include the following
If any of the conditions listed below become severe or persist for more than a few days, inform your doctor:
Common (may affect up to 1 in 10 people)

• Headache or feeling tired
• Dizziness. This is more likely to occur at the beginning of Ramipril Sandoz therapy or when the dose is increased
• Fainting, hypotension (unusually low blood pressure), especially when sitting up from lying down or standing up quickly
• Dry, persistent cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath
• Stomach or intestinal pain, diarrhoea, indigestion, nausea or vomiting
• Rash with or without swelling
• Chest pain
• Muscle cramps or pain
• Blood tests showing higher than normal potassium levels.

Uncommon (may affect up to 1 in 100 people)

• Balance problems (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or pins and needles (paraesthesia)
• Loss or changes in taste
• Sleep disturbances
• Depression, anxiety, nervousness or restlessness more than usual
• Stuffy nose, breathing difficulties or worsening of asthma
• Swelling of the intestine, a condition called "intestinal angioedema", presenting with symptoms such as abdominal pain, vomiting and diarrhoea
• Heartburn, constipation or dry mouth
• Increased amount of urine during the day
• Increased sweating
• Loss or decrease in appetite (anorexia)
• Fast or irregular heartbeat
• Swelling of arms and legs. This may be a sign that the body is retaining more fluid than usual
• Hot flushes
• Blurred vision
• Joint pain
• Fever
• Impotence in males, reduced sexual desire in males or females
• Increased count of certain white blood cells (eosinophilia), shown in blood tests
• Changes in liver, pancreas or kidney function, shown in blood tests.

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

• Feeling shaky or confused
• Swelling and redness of the tongue
• Severe peeling or shedding of the skin, itching, rash with pustules
• Nail problems (such as loss of nail or separation from its bed)
• Skin rash or bruising
• Spots on the skin and cold extremities
• Red, itchy, swollen or watery eyes
• Hearing problems and ringing in the ears (tinnitus)
• Feeling weak
• Decreased count of red blood cells or white blood cells or platelets, or decreased haemoglobin concentration, shown in blood tests.

Very rare (may affect up to 1 in 10,000 people)

• Increased sensitivity to sunlight.

Other side effects observed:
Inform your doctor if any of the following conditions become severe or persist beyond a few days.
Not known (frequency cannot be estimated from the available data)

• Difficulty concentrating
• Swelling of the mouth
• Blood tests showing abnormally low blood cell counts
• Blood tests showing lower than normal sodium levels in the blood
• Concentrated urine (dark-coloured), feeling unwell or vomiting, muscle cramps, confusion and seizures which could be due to inadequate secretion of ADH (antidiuretic hormone). If you have these symptoms, contact your doctor as soon as possible.
• Fingers of hands and feet changing colour when the patient is cold, and tingling or painful when warming up (Raynaud's phenomenon)
• Breast enlargement in men
• Slowed or impaired reaction ability
• Burning sensation
• Changes in smell perception
• Hair loss.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ramipril Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and outer carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Ramipril Sandoz Contains
Ramipril Sandoz

• The active substance is Ramipril. Each tablet contains 2.5 mg of ramipril. Each tablet contains 5 mg of ramipril. Each tablet contains 10 mg of ramipril.
• The other components are: microcrystalline cellulose, pregelatinized starch, precipitated silica, glycine hydrochloride, and glycerol dibehenate. Yellow iron oxide (E172) (only in 2.5 mg tablets). Red iron oxide (E172) (only in 5 mg tablets).

Description of the Appearance of Ramipril Sandoz and Contents of the Package
2.5 mg tablets:
Tablets, mottled light yellow in colour, with a score line on one side.
The tablet can be divided into equal parts.
5 mg tablets:
Tablets, mottled pink in colour, with a score line on one side.
The tablet can be divided into equal parts.
10 mg tablets:
Tablets, white to almost white in colour, with a score line on one side.
The tablet can be divided into equal parts.
The tablets are packaged in aluminium/aluminium strips, aluminium/aluminium blisters, or PP containers
with HDPE cap, all placed in a cardboard box.
Pack sizes:
Al/Al strips: 14, 28, 56 and 98 tablets
Al/Al blisters: 14, 28, 56 and 98 tablets
PP container: 20, 28, 30, 50, 100, 250 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (Varese), Italy
Manufacturers responsible for batch release
Salutas Pharma GmbH – Dieselstrasse, 5 – Gerlingen – Germany
Salutas Pharma GmbH – Otto-von-Guericke-Allee, 1 – Barleben – Germany
LEK S.A. – Ul. Podlipie, 16 – 95-010 Stryków – Poland
LEK S.A. – Ul. Domaniewska 50 C – Warsaw – Poland
Sandoz GmbH – Biochemistrasse 10 – 6250 Kundl – Austria

This medicinal product has been authorized in EEA member states under the following names:
United Kingdom Ramipril 1.25 mg Tablets
Ramipril 2.5 mg Tablets
Ramipril 5 mg Tablets
Ramipril 10 mg Tablets
Belgium Ramipril Sandoz 2.5 mg tabletten
Ramipril Sandoz 5 mg tabletten
Ramipril Sandoz 10 mg tabletten
Italy Ramipril Sandoz

This Patient Information Leaflet was last approved on