RAMIPRIL 1.25 mg Tablet

Зміст інструкції

1. Ramipril Alter 1.25 mg tablets, 2.5 mg tablets, 5 mg tablets, 10 mg tablets
   1. What Ramipril Alter is and what it is used for
   2. What you need to know before taking Ramipril Alter
   3. How to take Ramipril Alter
   4. Possible side effects
   5. How to store Ramipril Alter
   6. Package contents and other information

Ramipril Alter 1.25 mg tablets, 2.5 mg tablets, 5 mg tablets, 10 mg tablets

ramipril

Read this leaflet carefully before using this medicine as 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• reducing the production by the body of substances that can cause an increase in blood pressure
• relaxing and widening the blood vessels
• facilitating the pumping action of blood in the circulation by the heart.

Ramipril Alter 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 (whether or not diabetes is present)
• to treat the heart when it fails to pump enough blood to the rest of the body (heart failure)
• as treatment following a heart attack (myocardial infarction) complicated by heart failure.

2. What you need to know before taking Ramipril Alter

Do not take Ramipril Alter

• if you are allergic to ramipril, to other ACE inhibitor drugs or to any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction can include skin rashes, difficulty swallowing or breathing, swelling of lips, face, throat or tongue.
• if you have had a serious allergic reaction called “angioedema”. The signs include itching, skin rash (hives), red patches on the hands, feet and throat, swelling of the throat and

of the tongue, swelling around the eyes and lips, difficulty in breathing and swallowing.

• if you are on dialysis or are undergoing any other type of blood filtration. Depending on the machine used, Ramipril Alter may not be suitable for you.
• if you suffer from 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 will need to make this assessment.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

Do not take Ramipril Alter if any of the above conditions apply to you. If
you are not sure, consult your doctor before taking Ramipril Alter.

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

• if you suffer from heart, liver or kidney problems
• if you have lost a lot of salts or body fluids (due to an illness such as vomiting, diarrhoea, excessive sweating, or due to a low-salt diet, or taking diuretics [water tablets] for a long time, or due to dialysis)
• if you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation)
• if you are going to receive an anaesthetic. This may be given for a surgical or dental procedure. You may need to stop taking Ramipril Alter the day before; ask your doctor for advice
• if you have a high amount of potassium in your blood (shown by blood tests)
• if you are taking medicines or have conditions that can lower the levels of sodium in your blood. Your doctor may have you undergo regular blood tests, especially to check the levels of sodium in your blood, particularly if you are elderly
• if you are taking any of the following medicines, the risk of angioedema may be increased: o racecadotril, a medicine used to treat diarrhoea. o medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus). o vildagliptin, a medicine used to treat diabetes.
• if you have a connective tissue disease, such as scleroderma or systemic lupus erythematosus
• if you are taking one of the following medicines used to treat high blood pressure: o angiotensin II receptor blockers" (AIIRAs) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes. o Aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also what is stated under “Do not take Ramipril Alter”.

If you believe you are pregnant (or might become pregnant) you should inform your doctor. Ramipril
Alter is not recommended during the first trimester of pregnancy and can cause serious harm to the baby
after the first three months of pregnancy (see section below “Pregnancy and breastfeeding”).

Children and adolescents
The use of Ramipril Alter is not recommended in children and adolescents under 18 years of age, as
the safety and efficacy of Ramipril Alter in children have not yet been established.
If any of the above conditions apply to you (or if you are not sure),
consult your doctor before taking Ramipril Alter.

Other medicines and Ramipril Alter
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription (including herbal medicines). This is because Ramipril Alter can affect the mechanism of action of some other
medicines. Similarly, some other medicines can affect the mechanism of action of Ramipril
Alter.
Tell your doctor if you are taking any of the following medicines. These medicines may reduce the
effectiveness of Ramipril Alter:

• medicines used to relieve pain and inflammation (for example Non-Steroidal Anti-Inflammatory Drugs [NSAIDs], such as ibuprofen, indometacin, 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 check your blood pressure.

Tell your doctor if you are taking any of the following medicines. These medicines, if taken in
combination with Ramipril Alter, may increase the likelihood of side effects:

• medicines used to relieve pain and inflammation (for example Non-Steroidal Anti-Inflammatory Drugs [NSAIDs], such as ibuprofen, indometacin, acetylsalicylic acid)
• cancer medicines (chemotherapy)
• diuretics (water tablets), such as furosemide
• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that may increase the amount of potassium in your blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent blood clots)
• 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)
• trimethoprim and cotrimoxazole (for infections caused by bacteria),
• vildagliptin (used to treat type 2 diabetes),
• medicines that are more often used to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors). See the section “Warnings and precautions”.

Tell your doctor if you are taking any of the following medicines. The mechanism of action of these
medicines may be affected by Ramipril Alter:

• diabetes medicines, such as oral hypoglycaemic agents and insulin. Ramipril Alter may lower your blood sugar level. Carefully monitor your blood sugar level when taking Ramipril Alter
• lithium (used for mental health disorders). Ramipril Alter may increase the level of lithium in your blood. Your doctor should carefully monitor the level of lithium in your blood. If any of the above conditions apply to you (or if you are not sure), consult your doctor before taking Ramipril Alter.

Your doctor may need to adjust the dose and/or take other precautions:

• If you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is stated under “Do not take Ramipril Alter” and “Warnings and precautions”)

Ramipril Alter with food, drink and alcohol

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.

Pregnancy
If you believe you are pregnant (or might become pregnant) you should inform your doctor.
You must not take Ramipril Alter during the first 12 weeks of pregnancy and must not take it at all after the 13th week, as it could seriously harm the baby.
If you become pregnant while taking Ramipril Alter, inform your doctor immediately. Before
planning a pregnancy, you should switch to an alternative treatment that is suitable.

Breastfeeding
You must not take Ramipril Alter if you are breastfeeding.
Consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery
While being treated with Ramipril Alter you may experience dizziness or feel sleepy. This is
more likely when you first start taking Ramipril Alter or have just increased the
dose. If this happens, do not drive or use tools or machinery.

Ramipril Alter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially
“sodium-free”.

3. How to take Ramipril Alter

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

How to take this medicine

• Take the medicine by mouth at the same time of 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 a day.
• Your doctor will adjust the dosage 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 the dosage before starting you on Ramipril Alter.

To reduce the risk of heart attack or stroke

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

Treatment to reduce or delay the worsening of kidney problems

• Your doctor may start you on a dose of 1.25 mg or 2.5 mg once a day.
• Your doctor will then adjust the dosage.
• The usual dose is 5 mg or 10 mg once a day.

Treatment of heart failure

• The usual starting dose is 1.25 mg once a day.
• Your doctor will then adjust the dosage.
• The maximum dose is 10 mg per day. 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 a day to 2.5 mg twice a day.
• Your doctor will then adjust the dosage.
• The usual dose is 10 mg per day. It is preferable to divide the dose into two daily administrations. Elderly
• Your doctor will reduce the starting dose and adjust the dosage more gradually.

If you take more Ramipril Alter than you should
Inform your doctor or go immediately to the nearest hospital emergency room. Do not
drive to the hospital, rather have someone accompany you or call an ambulance.
Bring the package of the medicine with you, so that medical personnel can know what you have
taken.

If you forget to take Ramipril Alter

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

If you stop taking Ramipril Alter.
Continue taking the medicine until your doctor tells you to stop. Do not stop taking
Ramipril Alter just because you feel better. If you stop, the disease may return.
If you have any further doubts 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 everyone will experience them.
people experience them.

Stop taking Ramipril Alter and contact your doctor if you notice any of the following serious side effects – you may need urgent medical attention:

• swelling of the face, lips or throat that makes it difficult to swallow or breathe, as well as itching and rash. This could be a sign of a severe allergic reaction to Ramipril Alter.
• severe skin reactions, including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering and peeling of the skin (as in the case of Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Immediately inform your doctor if you experience:

• increased heart rate, irregular or strengthened heartbeat (palpitations), chest pain, feeling of tightness in the chest or more serious problems, including heart attack and 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 compared to usual, sore throat and fever, feeling tired, fainting, dizziness or pale skin. These may be signs of blood or bone marrow disorders
• severe abdominal pain, which may extend to the back. This may 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 (inflammation of the liver) or liver damage.

Other side effects include the following:
If any of the conditions described 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
• Feeling dizzy. This is more likely to happen at the beginning of therapy with Ramipril Alter or with each increase in dosage
• Fainting, hypotension (unusually low blood pressure), especially when sitting up from lying down or standing up quickly
• Dry, irritating cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath
• Stomach or intestinal pain, diarrhea, indigestion, nausea or vomiting
• Rash with or without swelling
• Chest pain
• Cramps or muscle pain
• Blood tests showing a higher than normal level of potassium.

Not common(may affect up to 1 in 100 people)

• Problems with balance (vertigo)
• Itching and unusual skin sensations, such as numbness, tingling, burning, a prickling or crawling sensation (paresthesia)
• Loss or changes in taste
• Sleep disturbances
• Increased depression, anxiety, nervousness or restlessness compared to usual
• Nasal congestion, difficulty breathing or worsening of asthma
• Swelling of the intestine, a condition called “intestinal angioedema”, which presents with symptoms such as abdominal pain, vomiting and diarrhea
• Heartburn, constipation or dry mouth
• Increased amount of urine during the day
• Increased sweating compared to usual
• Loss or decrease of appetite (anorexia)
• Fast or irregular heartbeat
• Swelling of arms and legs. This may be a sign that the body is retaining more water than usual
• Hot flashes
• Blurred vision
• Joint pain
• Fever
• Impotence in men, reduced sexual desire in men or women
• Increased count of certain white blood cells in the blood (eosinophilia), highlighted by blood tests
• Changes in liver, pancreas or kidney function, highlighted by blood tests.

Rare(may affect up to 1 in 1000 people)

• Feeling of tremor or confusion
• Swelling and redness of the tongue
• Severe flaking or peeling of the skin, itching, rash characterized by pustules
• Problems with nails (such as loss of the nail or detachment from its bed)
• Rash or bruising
• Spots on the skin and cold extremities
• Red, itchy, swollen or watery eyes
• Hearing problems and ringing in the ears
• Feeling of weakness
• Decrease in the number of red blood cells, white blood cells or platelets in the blood or concentration of hemoglobin, highlighted by blood tests.

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

• Increased sensitivity to sunlight compared to usual.

Not known(frequency cannot be estimated from available data)

• Concentrated urine (dark in color), feeling unwell or vomiting, muscle cramps, confusion and convulsions, which may be caused by inadequate secretion of ADH (antidiuretic hormone). If you have these symptoms, contact your doctor as soon as possible.

Other side effects reported:
Inform your doctor if any of the conditions described below become severe or persist for longer than
a few days.

• Difficulty concentrating
• Swelling of the mouth
• Blood tests showing a too low number of blood cells
• Blood tests showing a low level of sodium in the blood
• Fingers of hands and feet that change color when the patient is cold and that tingle or cause pain when the patient warms up (Raynaud's phenomenon)
• Breast enlargement in men
• Slowed or impaired reaction time
• Burning sensation
• Changes in the perception of smells
• Hair loss.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at the address: 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 Alter

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 packaging after EXP. The expiry
date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in 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 Alter contains

• The active ingredient is ramipril. Each tablet contains 1.25 mg, 2.5 mg, 5 mg or 10 mg of ramipril.
• The other ingredients are hypromellose 6cP, microcrystalline cellulose, pregelatinized corn starch, sodium stearyl fumarate, yellow iron oxide (E172) - only in 2.5 mg tablets

and red iron oxide (E172) - only in 5 mg tablets.
See section 2 “Ramipril Alter contains sodium”.

Description of the appearance of Ramipril Alter and package contents
1.25 mg tablets: tablets of colour from white to almost white, round, biconvex with bevelled edges
with engraved “1.25” on one side of the tablet. Tablet diameter: 6.5 mm.
2.5 mg tablets: light yellowish-brown coloured, capsule-shaped tablets with bevelled edges,
engraved on both sides. One side of the tablet is engraved, on one half, “2.5” and on the other half “KRK”.
Tablet dimensions: 8 x 5 mm. The tablet can be divided into equal doses.
5 mg tablets: light mottled pink coloured, capsule-shaped tablets with bevelled edges,
engraved on both sides. One side of the tablet is engraved, on one half, “5” and on the other half “ KRK”.
Tablet dimensions: 8 x 5 mm. The tablet can be divided into equal doses.
10 mg tablets: capsule-shaped tablets of colour from white to almost white with bevelled edges,
engraved on both sides. One side of the tablet is engraved, on one half, “10” and on the other half “KRK”.
Tablet dimensions: 8 x 5 mm. The tablet can be divided into equal doses.
Ramipril Alter is available in boxes of 14, 28, 30, 56 or 90 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milano
Manufacturer:
Krka d.d. Novo Mesto
Šmarješka Cesta 6
Novo Mesto
Slovenia

This medicinal product is authorised in the member states of the EEA under the following denominations:
PORTUGAL :
Ramipril Ripzen
FRANCE:
Ramipril Alter Laboratoires Alter
ITALY:
Ramipril Alter
SPAIN:
Ramipril Alter Genéricos EFG.