Ramipril Alter: detailed information

Package leaflet: Information for the patient

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

ramipril
Please read this leaflet carefully before using 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 other people, 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:

What Ramipril Alter is and what it is used for
What you need to know before taking Ramipril Alter
How to take Ramipril Alter
Possible side effects
How to store Ramipril Alter
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
known as ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).
Ramipril Alter 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 to pump blood around the body more effectively.

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 (with or without diabetes)
to treat heart failure, a condition in which the heart cannot pump enough blood around the body
as a treatment following a heart attack (myocardial infarction) complicated by heart failure.

2. What you should know before taking Ramipril Alter

Do not take Ramipril Alter

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, or swelling of the lips, face, throat, or tongue.
if you have previously had a severe 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 Alter 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 Alter if any of the above conditions apply to you. If you are unsure, consult your doctor before taking Ramipril Alter.

Warnings and precautions

Consult your doctor or pharmacist before taking Ramipril Alter:

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, long-term use of diuretics ["water pills"], or 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 for surgery or dental procedures. You may need to stop taking Ramipril Alter 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 sodium levels, especially if you are elderly
if you are taking any of the following medicines, as the risk of angioedema may be increased:
- racecadotril, a medicine used to treat diarrhoea
- medicines used to prevent rejection of transplanted organs or 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 for high blood pressure:
- angiotensin II receptor antagonists (AIIRAs), also known as "sartans" (e.g. valsartan, telmisartan, irbesartan), particularly 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 Alter".

If you think you may be pregnant (or could become pregnant), inform your doctor. Ramipril Alter is not recommended during the first trimester of pregnancy and may cause serious 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 Alter is not recommended in children and adolescents under 18 years of age, as the safety and efficacy of Ramipril Alter in children has not yet been established.

If any of the above conditions apply to you (or if you are unsure), consult your doctor before taking Ramipril Alter.

Other medicines and Ramipril Alter

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription (including herbal medicines). This is because Ramipril Alter may affect the way some other medicines work. Likewise, some other medicines may affect the way Ramipril Alter works.

Inform your doctor if you are taking any of the following medicines. These may reduce the effectiveness of Ramipril Alter:

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 together with Ramipril Alter 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 treatments (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 for 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)
trimethoprim and co-trimoxazole (for bacterial infections)
vildagliptin (used to treat type 2 diabetes)
medicines more commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus, and other mTOR inhibitors). See section "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 Alter:

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

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 sections "Do not take Ramipril Alter" and "Warnings and precautions").

Ramipril Alter with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

If you think you may be pregnant (or could become pregnant), inform your doctor. You must not take Ramipril Alter 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 Alter, inform your doctor immediately. Before planning a pregnancy, you should switch to an appropriate alternative treatment.

Breastfeeding

You must not take Ramipril Alter if you are breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

While taking Ramipril Alter, you may experience dizziness or drowsiness. This is more likely when you first start treatment or when your dose has just been increased. If this occurs, do not drive or operate tools or machinery.

Ramipril Alter contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Ramipril Alter

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

Take the medicine orally 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 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 or reduce their dosage before starting your treatment with Ramipril Alter.

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 dosage.
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 dosage.
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 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 ranges from 1.25 mg once daily to 2.5 mg twice daily.
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 patients

Your doctor will reduce the initial 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 department. Do not
drive to the hospital; instead, have someone accompany you or call an ambulance.
Bring the medicine’s packaging with you so that medical staff can see what you have taken.

If you forget to take Ramipril Alter

If you miss a dose, take your usual dose at the regular time.
Do not take a double dose to make up for a forgotten 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, your condition may return.
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 Ramipril Alter and contact your doctor immediately if you experience any of the
following serious side effects – these may require urgent medical attention:

Swelling of the face, lips or throat causing difficulty in swallowing or breathing, together with itching and skin rash. This could be a sign of a severe allergic reaction to Ramipril Alter.
Severe skin reactions, including rash, mouth ulcers, worsening of pre-existing skin disorders, redness, blistering and peeling of the skin (such as in 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, 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, 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 extend 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 (inflammation of the liver) 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 of tiredness
Dizziness. This is more likely to occur at the beginning of treatment with Ramipril Alter 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, inflammation of the sinuses (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 muscle 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, stinging or pins and needles (paraesthesia)
Loss or changes in taste
Sleep disturbances
Depression, anxiety, nervousness or restlessness greater 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 compared to usual
Loss or decrease in appetite (anorexia)
Rapid 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
Increase in the number of certain white blood cells (eosinophilia), shown by blood tests
Changes in liver, pancreas or kidney function, shown by blood tests.

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

Feeling of tremor or confusion
Swelling and redness of the tongue
Severe peeling or shedding of the skin, itching, rash characterized by pustules
Nail problems (such as nail loss or detachment from the nail 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 of weakness
Decrease in red blood cells, white blood cells or platelets, or in haemoglobin concentration, shown 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 the available data)

Concentrated urine (dark in colour), 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.

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

Difficulty in concentrating
Swelling of the mouth
Blood tests showing too low a number of blood cells
Blood tests showing low sodium levels in the blood
Fingers of hands and feet changing colour when the patient is cold, and tingling or causing pain when the patient warms up (Raynaud's phenomenon)
Breast enlargement in males
Slowed or impaired reaction ability
Burning sensation
Changes in smell perception
Hair loss.

Reporting of side effects
If you experience any side effect, 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 Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Do not store above 30 °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 no longer used. This will help protect the environment.

6. Package Contents and Other Information

What Ramipril Alter Contains

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milano, Italy

Manufacturer:
Krka d.d. Novo Mesto
Šmarješka Cesta 6
Novo Mesto, Slovenia

This medicinal product has been authorized in the EEA Member States under the following names:
PORTUGAL:
Ramipril Ripzen
FRANCE:
Ramipril Alter Laboratoires Alter
ITALY:
Ramipril Alter
SPAIN:
Ramipril Alter Genéricos EFG.